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    You are here : Home » About MS » Causes of MS » Chronic Cerebrospinal Venous Insufficiency - CCSVI » CCSVI General News

    CCSVI General News

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    Health Institute rep. critical of Zamboni MS treatment

    CCSVI VenogramA member of an expert group advising the Canadian Institutes of Health Research (CIHR) about the effectiveness of a controversial treatment for multiple sclerosis has likened it to faith healing.

    Dr. Barry Rubin, medical director of the Toronto General Hospital’s cardiac centre, and three American co-authors draw the parallel in an article entitled “The ‘Liberation Procedure’ for Multiple Sclerosis: Sacrificing Science at the Altar of Consumer Demand,” in the current issue of the Journal of the American College of Radiology.

    Rubin sits on the CIHR’s Scientific Expert Working Group, a 23-member international panel created by CIHR in 2010 to monitor and analyse research into the link between MS and chronic cerebrospinal venous insufficiency (CCSVI), a term coined by Italian doctor Paolo Zamboni to describe blockages in the veins of the neck and spine.

    Zamboni’s so-called “liberation treatment” involves opening the blocked veins by inserting a balloon, a procedure known as venous angioplasty. Health Minister Leona Aglukkaq announced last month that a team of researchers has been selected to conduct a clinical trial into CCSVI in about 100 MS patients.

    But the article by Rubin and his three co-authors says funding trials of a procedure “that has minimal basis in rational, empirical knowledge seems questionable.” It cites two cases of Canadian MS patients who underwent venous angioplasty. One died while the other suffered a serious stroke.

    The article places Zamboni’s therapy in the same category as “treatment of breast cancer with laser photodynamics, Laetrile for cancer and other unproven therapeutics found in the retail sphere.” And, it asks, “When is healing ‘faith healing?’”

    Rubin’s views prompted a swift response from Liberal MP Kirsty Duncan, who has pushed for research into the link between CCSVI and MS. In a letter to Alain Beaudet, CIHR’s president, Duncan said Rubin “can no longer be seen to be an independent judge of the scientific literature.

    “Members of the CCSVI community are concerned that a parallel process is being created — one in which the government says it will undertake clinical trial, while a key player appears to work actively to prevent this,” Duncan’s letter says.

    In an interview, Duncan said Rubin’s article, which was not peer reviewed, “clearly shows bias. We want a credible panel. The only way to restore credibility is for him to step down.

    “Canadians have to trust this process,” she said. “How do you trust this? What’s going to be said behind closed doors?”

    But in an email to the Citizen, Beaudet — who chairs the Scientific Expert Working Group — said members “are entitled to freely express their opinions.” The views in the article, he said, “are based on published scientific evidence and solely engage their authors, i.e., neither CIHR nor the working group.”

    Beaudet also noted that Rubin was a member of the working group in 2011 when it recommended that CIHR sponsor trials of Zamboni’s procedure.

    He added that CIHR is “very much committed to ensuring that members of CIHR advisory committees are not in conflict of interest.” To that end, all members of the working group signed declarations of conflict of interest last June, he said.

    But Duncan said the members of the working group only signed conflict of interest declarations after she pushed for it in private correspondence and at public meetings.

    Rubin’s article is the second bit of bad news this month for advocates of Zamboni’s treatment, which has generated much excitement and hope among the estimated 75,000 Canadians with MS.

    On May 10, the U.S. Food and Drug Administration issued an alert to doctors and patients warning that the liberation procedure had caused death, strokes, abdominal bleeding and nerve damage and there was “no reliable evidence” that it was effective.

    More than 12,000 people worldwide — including hundreds of Canadians — have undergone the procedure, but it remains unauthorized and unavailable in Canada.

    The researchers selected to conduct the clinical trial into CCSVI in Canada will study the safety of the Zamboni procedure and gather evidence on its effectiveness. First, though, they need to receive ethics approval from the relevant institutional research ethics boards. The study will begin “if and when ethics approval is granted,” CIHR said last month.

    With about 400 Canadians dying of MS annually, some in the CCSVI community are starting to doubt whether clinical trials will actually proceed in Canada, Duncan said. “The concerns are there.”

    Source: The Ottawa Citizen © Copyright (c) The Ottawa Citizen 2012 (23/05/12)

    Society of Interventional Radiology responds to FDA safety communication on CCSVI

    CCSVI VenogramOn May 10, the Food and Drug Administration issued a medical alert noting that individuals with multiple sclerosis should be aware of the risks of serious injuries and death associated with treatments for chronic cerebrospinal venous insufficiency—and that benefits of those treatments and promotion as an MS treatment “may lead people with the disease to make treatment decisions without being aware of the serious risks involved.”

    As always, the Society of Interventional Radiology strongly urges close communications between doctor and patient. Those persons with MS are encouraged to talk to their interventional radiologists and their other doctors about any concerns or questions. SIR members—interventional radiologists who specialize in minimally invasive targeted treatments and who pioneered venous angioplasty and stenting—endovascular techniques that may be central to novel treatments for MS—may note an increase in calls from concerned individuals who have—or are seeking—treatment for CCSVI.

    About 500,000 people in the United States have MS, and SIR understands the public’s desire to advance treatment for MS, generally thought of as an autoimmune disease in which a person’s body attacks its own cells. Currently, medicines may slow the disease and help control symptoms. The role of CCSVI (a reported abnormality in blood drainage from the brain and spinal cord) in MS and its endovascular treatment (through a catheter placed in a vein to widen) by an interventional radiologist via balloon angioplasty and/or stents to open up veins could be transformative for patients and is being actively investigated.

    The FDA communication is directed toward individuals with MS, health care providers including interventional radiologists, neurosurgeons and vascular surgeons) and clinical investigators. Health care providers were advised to inform patients that (1) there is conflicting evidence about CCSVI as a clinical entity, (2) CCSVI’s relationship to MS is scientifically unproven and (3) consensus on the diagnostic criteria of CCSVI has not been reached.

    The FDA also indicated that it has not cleared or approved any angioplasty device or stents for CCSVI treatment and that the use of those devices in treating CCSVI is considered off label. “While the FDA does not regulate the practice of medicine and health care practitioners may choose to use a legally marketed device, based on their clinical assessment, for purposes other than the cleared or approved use, the FDA believes the safety issues observed to date warrant a communication on the subject,” stated the FDA announcement.

    SIR supports and agrees with the FDA’s recommendations to encourage research on CCSVI and the current knowledge regarding the safety and effectiveness of treatment procedures. SIR also agrees that clinical research of CCSVI should be performed through well-designed clinical trials, which should require approval through the FDA investigational device exemption (IDE) program.

    In 2010, the SIR published the position statement “Interventional Endovascular Management of Chronic Cerebrospinal Venous Insufficiency in Patients With Multiple Sclerosis: A position Statement by the Society of Interventional Radiology, Endorsed by the Canadian Interventional Radiology Association,” which specifically notes:

    SIR recognizes the urgent need for more effective treatments for MS patients and the public’s interest in rapidly making such therapies available to this patient group.

    SIR recognizes that patients with MS constitute a particularly vulnerable population, whose safety must be protected as new therapeutic approaches are evaluated.

    At present, SIR considers the published literature to be inconclusive on whether CCSVI is a clinically important factor in the development and/or progression of MS and on whether balloon angioplasty and/or stent placement are clinically effective in patients with MS.

    SIR strongly supports the urgent performance of high-quality clinical research to determine the safety and efficacy of interventional MS therapies and is actively working to promote and expedite the completion of needed studies.

    SIR recognizes the challenge and the potential opportunity presented by promising early studies of an interventional approach to the treatment of MS. SIR is pleased that public advocacy groups have pushed the medical community forward to meet this challenge and is committed to assuming a national leadership role in launching needed efforts.

    Interventional radiology is a recognized medical specialty requiring dedicated training that encompasses clinical patient evaluation and management, non-invasive venous imaging and the delivery of targeted, image-guided minimally-invasive treatments to patients. Interventional radiologists perform balloon angioplasty and stent placements on a daily basis in thousands of patients with diverse venous conditions, including acute deep vein thrombosis, post-thrombotic syndrome, superior vena cava syndrome and portal hypertension; they also perform procedures to maintain hemodialysis access. Interventional radiologists perform many of the CCSVI procedures in the United States; they are highly qualified to perform such treatments when appropriately indicated.

    SIR will provide additional information for patients as it becomes available.

    Source: Society of Interventional Radiology (11/05/12)

    FDA issues alert on potential dangers of unproven treatment for multiple sclerosis

    CCSVI VenogramThe U.S. Food and Drug Administration is alerting health care professionals and patients1 about injuries and death associated with the use of an experimental procedure sometimes called “liberation therapy” or the “liberation procedure” to treat chronic cerebrospinal venous insufficiency (CCSVI).

    Some researchers believe that CCSVI, which is characterized by a narrowing (stenosis) of veins in the neck and chest, may cause multiple sclerosis (MS) or may contribute to the progression of the disease by impairing blood drainage from the brain and upper spinal cord. However, studies exploring a link between MS and CCSVI are inconclusive, and the criteria used to diagnose CCSVI have not been adequately established.

    “Because there is no reliable evidence from controlled clinical trials that this procedure is effective in treating MS, FDA encourages rigorously-conducted, properly-targeted research to evaluate the relationship between CCSVI and MS,” said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in the FDA’s Center for Devices and Radiological Health. “Patients are encouraged to discuss the potential risks and benefits of this procedure with a neurologist or other physician who is familiar with MS and CCSVI, including the CCSVI procedures and their outcomes.”

    The experimental procedure uses balloon angioplasty devices or stents to widen narrowed veins in the chest and neck. However, the FDA has learned of death, stroke, detachment and migration of the stents, damage to the treated vein, blood clots, cranial nerve damage and abdominal bleeding associated with the experimental procedure. Balloon angioplasty devices and stents have not been approved by the FDA for use in treating CCSVI.

    MS is a progressive, immune-mediated disorder of the brain and spinal cord. In MS, the lining around nerve fibers, and often the nerve fibers themselves, in the brain and spinal cord are injured, resulting in significant and disabling neurological symptoms. The underlying cause of MS is not known.

    Complications following CCSVI treatment can be reported through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

    The FDA also is notifying physicians and clinical investigators who are planning or conducting clinical trials using medical devices to treat CCSVI that they must comply with FDA regulations for investigational devices. Any procedures conducted are considered significant risk clinical studies and require FDA approval, called an investigational device exemption.

    In February 2012, the FDA sent a warning letter to a sponsor/investigator who was conducting a clinical study of CCSVI treatment without the necessary approval. The sponsor/investigator voluntarily closed the study.

    The FDA will continue to monitor reports of adverse events associated with “liberation therapy” or the “liberation procedure” and keep the public informed as new safety information becomes available.

    Source: FDA (09/05/12)

    NICE issues CCSVI treatment guidance

    NICE LogoPercutaneous venoplasty for chronic cerebrospinal venous insufficiency for multiple sclerosis

    Summary
    The National Institute for Health and Clinical Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on Percutaneous venoplasty for chronic cerebrospinal venous insufficiency in Multiple Sclerosis.

    Description
    Improving blood flow to the brain in patients with multiple sclerosis
    It is possible that there is a link between blocked veins in the neck and/or trunk and progression of multiple sclerosis. This procedure aims to open blocked veins by inflating a small balloon in the vein, allowing for better blood flow and a reduction in the symptoms of multiple sclerosis.

    What has NICE said?
    Currently there is not enough good-quality evidence to be certain about how well this procedure works.

    For this reason, NICE has said that this procedure should only be carried out as part of a research study (also called a clinical trial). The research should aim to provide more evidence about the procedure, how well it works in terms of both clinical results and quality of life, and which patients might benefit from it most.

    Other comments from NICE
    NICE recognised the distress and disability caused to people by multiple sclerosis (MS) and the lack of effective treatments for it. It said that evidence that this procedure or any other new treatment could substantially benefit them would be of great value, and this is why NICE has encouraged research into the procedure.

    It is uncertain how many people with MS have CCSVI compared with the general population. It is also uncertain if blocked or narrowed veins cause CCSVI, or what the link is between CCSVI and MS. NICE said that research to resolve these uncertainties would be useful.

    NICE noted that several of the studies that were looked at for this guidance did not report how well the procedure worked.

    NICE recognised that this procedure can be used for other conditions and that its risks and problems are well recognised. But it said that the safety of a procedure can only be judged in context, especially when there may be serious side effects.

    NICE took account of the views and experiences of many patients who had the procedure, many of whom described how they had benefited from the procedure and how it had improved their quality of life. NICE said that these comments and testimonies reinforced the urgent need for well-designed research studies.

    You can read/download the full NICE CCSVI Guidance Document at http://guidance.nice.org.uk/IPG420

    Source: NICE (28/03/12)

    MS patient advocates for better follow-up care

    CCSVI VenogramFaced with the prospect of being bedridden or in a wheelchair, Michelle Walsh went abroad for a controversial treatment she hoped would alleviate her multiple sclerosis symptoms.

    Walsh had the so-called liberation therapy. But when she returned home to Saskatchewan, she says she was "orphaned" in the medical system.

    "Right now patients are either going to the States from Saskatchewan for proper follow-up care or Ontario — and this is ridiculous," Walsh said.

    "That's why I finally said this is enough. If this is going to happen, then I'm going to make it happen, because I refuse to go abroad once again for a simple test that takes less than 20 minutes to make sure everything's still following smoothly."

    Walsh was planning to attend an announcement Saturday by Dr. Ruben Rajakumar, a Saskatoon-based cardiologist and retired University of Saskatchewan professor, introducing a new clinic for screening and follow-up of patients with cerebrospinal venous insufficiency, or CCSVI.

    CCSVI is a hypothesis put forward by Italian vascular surgeon Dr. Paolo Zamboni. His theory is that narrowed neck veins create a backup of blood that can lead to lesions in the brain and inflammation.

    Liberation therapy, which involves opening up blocked neck veins, is not offered in Canada.

    The idea that the condition might be linked to multiple sclerosis, a progressive neurological disease, has divided the medical community. Some patients have travelled around the world to seek out liberation treatment, even though it hasn't been proven to work.

    Specialized training
    Follow-up involves a special ultrasound, called a Doppler, which is needed to see the neck veins more clearly. Only one clinic in Canada currently offers CCSVI screening and follow-up for patients who have had liberation therapy.

    "You need to be trained properly. It's a very specific technique," said Angela Legace, chief vascular stenographer at Barrie Vascular Imaging in Barrie, Ont. She trained in Italy with Zamboni and was invited back to help teach others.

    Legace has probably scanned as many as 5,000 people before treatment and afterwards, people who have travelled from across Canada for diagnosis or follow-up care. They have all said they wished they could get care in their home provinces, she said.

    Legace has been asked to teach staff at the Saskatoon clinic.

    Rajakumar said the clinic in Saskatoon will offer a standardized ultrasound assessment based on Canadian Institutes of Health Research clinical trial protocols. He called it a major step for desperate patients.

    "These patients take their own decision and get this procedure done even though it is not an approved procedure in North America. They get it done and then they get symptoms, and sometimes complications, and they need to be followed by a licensed practitioner," he said.

    "Nobody's providing that follow-up. They go to their family doctors and family doctors are not equipped to assess this. You need somebody with vascular knowledge to assess them."

    Walsh, 38, was diagnosed with MS when she was 18. Her condition had been going downhill and she'd been fitted for a wheelchair.

    She underwent liberation therapy in Bulgaria in July 2010 and said she noticed immediate relief. A few months later, though, some symptoms returned so she went to California the following January for a second procedure.

    Patients like Walsh will have to pay out of pocket if they want follow-up care in Saskatchewan or Ontario.

    The procedure is not covered by the province, unless they are part of a trial group of patient that will be selected to go to New York for treatment.

    U.S. trials
    Saskatchewan announced last month that it will send multiple sclerosis patients to the U.S. to take part in a two-year, double-blind clinical trial of liberation therapy. To date, almost 600 people have submitted applications online or by phone.

    Walsh doesn't qualify, because she's already had the treatment.

    However, she was hoping follow-up care would extend to others like her. It doesn't.

    "Those patients are the only ones that will get follow-up in this province and ... to me that's not enough," said Walsh.

    "Those of us that have already gone abroad and already been tested and treated ... we should be allowed to have proper follow-up in this province and not just a select few, the 86 that will be going to Albany. That's not fair to me. That's not fair to the rest of us who've been the pioneers in bringing that to happen for these patients."

    Source: CBC.ca Copyright © CBC 2012 (13/02/12)

    Patients report controversial Multiple Sclerosis treatment improves their lives

    CCSVI VenogramAlthough using angioplasty to treat multiple sclerosis (MS) is highly controversial, sufferers often insist it helps – in some cases dramatically, such as allowing them to walk without a cane.

    Patients with less severe MS also reported additional quality of life improvements, such as being able to talk more clearly, after having treatment to open blocked blood vessels in the chest and neck, according to research being presented at the 24th annual International Symposium on Endovascular Therapy (ISET).

    A controversial theory holds that MS symptoms may be caused by narrowed veins leading away from the brain, which interrupts blood flow between the brain and heart. This condition, called chronic cerebrospinal venous insufficiency (CCSVI), is treated with minimally invasive angioplasty to open up those narrowed veins. In the research being presented at ISET, more than 65 percent of patients treated for CCSVI report quality of life improvements three months after treatment.

    “The patients reported improvement in common MS symptoms such as brain fog, frozen extremities, dizziness, bladder control and speech, and over time, they continued to improve,” said Marco Magnano, M.D., professor of interventional radiology at the Residency of Vascular Surgery of the University of Catania, Sicily. “Although this could be due to the placebo effect, you have to wonder how that alone could help patients get out of the wheelchair, or forgo a cane or crutches.”

    In the study, 170 patients were evaluated using both disability and quality of life questionnaires. On the disability questionnaire (out of a scale of 0 to 10, with higher numbers indicating more severe disability), patients scored on average of 4.5. Three months after treatment, they improved to an average of 4.0. The patients who initially scored higher on the disability scale were less likely to improve. The other questionnaire asked patients 16 quality of life questions on activities such as recreation and socializing, with answers ranging from 1 (terrible) to 7 (delighted). Out of a total possible score of 112, patients overall improved from 64 before treatment to 70 after one month and 71 after three months.

    Source: International Symposium on Endovascular Therapy (17/01/12)

    MS clinic's practices stir alarm

    CCSVI VenogramTens of thousands of dollars have flowed from multiple sclerosis patients to a Winnipeg-based company that is coming under fire for "pressuring'' patients to fly to India for the headline-grabbing "liberation" procedure.

    CCSVI Clinic, which operates out of an office in Fort Garry, has now come to the attention of Health Minister Theresa Oswald, who said she would forward concerns to the College of Physicians and Surgeons of Manitoba.

    Until early December, CCSVI Clinic, which calls itself a non-profit group of physicians and researchers, had been acting as the Winnipeg referral agency for Mobile Life Screening, a Fargo, N.D., ultrasound clinic.

    As part of that referral service, at least 100 patients were tested for chronic cerebrospinal venous insufficiency (CCSVI) -- blocked veins in the head and neck, controversially linked to MS.

    In mid-October, Winnipeg journalist and former CBC broadcaster Ingeborg Boyens became one of the first patients to get tested at Mobile Life Screening through CCSVI Clinic. She said she knew nothing about CCSVI Clinic other than its Kenaston Boulevard post office box where she sent her payment. Boyens said she was surprised when Randy Spielvogel, Mobile Life Screening's owner, asked her how much she paid. Spielvogel seemed "uncomfortable with how costs seemed to be escalated," she said.

    Boyens said her scans returned only "borderline" results for blocked veins. But in the weeks that followed, she received multiple letters and a phone call from CCSVI Clinic representatives urging her to travel to India for the vein-opening procedure, which she says she was never interested in receiving.

    "Alarm bells just went up when they started getting on my case," Boyens said. "(I thought)... 'So it's medical tourism I've walked into.' I went for a scan; I didn't go to check out if I wanted to go to India."

    A spokesman for CCSVI Clinic said the company is a legitimate non-profit connecting patients with a new study to investigate treatment protocols for CCSVI. MS patients cannot currently be scanned or treated for CCSVI in Canada, and many travel to clinics across the United States and the world to have their veins opened by a simple angioplasty procedure.

    Spielvogel, who ended business ties with CCSVI Clinic in early December, said he worried when he discovered it was charging clients at least $200 more than his base rate. "I wasn't comfortable with that. I thought, 'That's gouging people.' That was one of my big concerns about it."

    That split, and reports of pressure on other patients to travel to India for treatment, pushed MS patients to question seemingly contradictory statements on CCSVI Clinic's website.

    "Who are they? Where are they? You can't pin them down," said Anna Seaman, an MS patient from Selkirk who questioned CCSVI Clinic representatives in email and telephone conversations.

    "For (patients) that are looking for help, they're saying, 'Wow, this is something,' and they could get caught up very easily."

    But caught up in what? The group describes itself as a non-profit organization with offices in Winnipeg, Toronto and Atlanta, Ga., "established by medical researchers and professionals to investigate" the hotly debated link between CCSVI and MS. "Medical tourism is not the intention of our business," its website states.

    But other statements on the website urge clients to discover a "continuum of service (that) sets us apart from all other medical tourism businesses," and a disclaimer states that "CCSVI Clinic is in the business of facilitating travel and hospitality only." The site offers a $15,000 medical travel package to India that includes physician consultations and followups.

    In now-deleted website and Facebook posts, the clinic stated its physicians met with and influenced, Oswald. But neither the Manitoba health minister's office nor the diagnostic imaging departments at Health Sciences Centre have any knowledge of CCSVI Clinic or of two Winnipeg doctors said to be connected to the group.

    "We do pretty active ongoing research with various members of the CCSVI community. This is the first time that (I've heard of this group)," Oswald said, explaining why she was asking the College of Physicians and Surgeons to look into the clinic. "There are likely a number of legislative umbrellas under which questions (about the clinic) would be asked."

    CCSVI Clinic's only publicly identified physicians are doctors at the Noble Hospital in Pune, India, the primary site of what a spokesman said was a proposed research study of patients who are given a longer followup regimen after the vein-opening treatment.

    Doug Broeska, CCSVI Clinic's spokesman, said there are local physicians working with the group. Asked if reports of meetings with Oswald were accurate, he replied: "If they're willing to come out and say who they are, then it will be accurate... Because of the controversial nature of CCSVI, there's physicians that don't want to be mentioned at all in the media."

    Broeska, who identified himself as a medical researcher on a part-time contract with CCSVI Clinic's owners, said CCSVI Clinic cut ties with Spielvogel after the latter charged too much money for scans. CCSVI Clinic now partners with the Kidney and Hypertension Centre in Grand Forks, N.D., for scans that cost $550. He acknowledged there was confusion about CCSVI Clinic's operations.

    "Once the (study proposal) is published... I don't think there will be a lot of confusion after that," he said. "Everything will be under a study. It's not meant (as) tourism anymore, if it ever was... It's a study that happens to be subsidized by the owners of the business to try to keep patients safe."

    Duncan Thornton, co-founder of grassroots group CCSVI Manitoba, said it's important for MS patients to do their homework on treatment options.

    "(Ask) are you getting a 'sell?' There are tens of thousands of people with MS in Canada alone looking for this. Qualified clinics and physicians don't need to work hard to get patients."

    Source: Winnipeg Free Press © 2012 Winnipeg Free Press. All Rights Reserved. (11/01/12)

    Man seeking MS procedure loses human-rights complaint

    CCSVI VenogramA British Columbia man with multiple sclerosis who was denied a controversial medical procedure promoted by Italian physician Paolo Zamboni has had his complaint dismissed by the B.C. Human Rights Tribunal.

    Gregory Turnbull says he was denied access to and funding for treatment and diagnostic procedures normally available to the public because he suffers from MS.

    The tribunal said it found no evidence of discrimination in its ruling last week.

    Turnbull said in his complaint that he was scheduled to receive venous angioplasty by an interventionist radiologist at Victoria General Hospital for treatment of chronic cerebrospinal venous insufficiency (CCSVI) resulting in abnormal narrowing of his left and right jugular veins, a condition ancillary to multiple sclerosis.

    Two other multiple sclerosis patients had previously undergone this procedure, he said.

    Just a couple of days before the scheduled surgery, however, Turnbull said he was informed by the radiologist that he had been prevented by the Vancouver Island Health Authority from performing the procedure on him.

    Turnbull's private health-care centre physician, who had referred him for the procedure, also told him that he had been informed by the B.C. College of Physicians and Surgeons that it would not accredit any private practitioner to perform the procedure.

    Turnbull contended in his complaint that the procedure was readily available to other patients suffering from similar conditions (venous stenosis), and it was denied to him only because he has multiple sclerosis. He also said he was prevented from having a diagnostic procedure in the public health care system to determine if he were suffering from venous stenosis.

    The tribunal found no evidence of discrimination and noted that venous angioplasty is part of the controversial "liberation" procedure promoted by Zamboni as treatment for multiple sclerosis.

    According to Zamboni's theory, CCSVI may be a cause of multiple sclerosis, and venous angioplasty techniques could be used to treat CCSVI resulting in "improved drainage blood flow from the brain."

    Despite the fact that the procedure has been a "source of hope and interest for people in the MS (multiple sclerosis) community," it is yet to be scientifically validated and therefore considered "experimental," said the health authority in its response to the complaint.

    For this reason, the Vancouver Island Health Authority does not permit ultrasound to be used as a diagnostic tool for investigation of CCSVI in MS patients. CCSVI is a term coined by Zamboni and is not an established medical condition, it said.

    To support its claim, the authority also cited the Multiple Sclerosis Society of Canada's position statement on the procedure that "the early results (of Zamboni's study) need to be replicated and validated in much larger well-designed studies."

    Contrary to Turnbull's claim that the venous angioplasty procedure "is available to every single Canadian" suffering from venous abnormality preventing blood from draining properly from an organ, the Ministry of Health Services and the Medical Services Commission said that it is carried out only in "acute" situations because of the risks involved.

    Turnbull also said in his complaint that two venous angioplasties had previously been conducted on MS patients at Victoria General Hospital.

    The Vancouver Island Health Authority said that it only became aware of the two angioplasties through media reports in April 2010 and on investigation found that although the cases had been booked as venoplasties for vascular concerns, the procedures were actually performed for multiple sclerosis. It then issued the order prohibiting any further such procedures as it is not yet scientifically validated and possible risks to patients are not yet fully understood.

    In its judgment the tribunal noted that Turnbull did not provide any medical evidence to show that he needed angioplasty for anything other than multiple sclerosis.

    Turnbull was diagnosed with chronic progressive multiple sclerosis in 1997.

    Source: The Vancouver Sun © Copyright (c) The Vancouver Sun 2011 (15/11/11)

    CCSVI to be spotlighted at the international symposium on endovascular therapy (ISET) 2012

    CCSVI VenogramInnovators in the field of endovascular therapy will explore the often-contentious topic of chronic cerebrospinal venous insufficiency (CCSVI), which is theorized to be a contributing factor in the development of multiple sclerosis (MS), at the 24th annual International Symposium on Endovascular Therapy (ISET).

    Recognized as one of the industry’s foremost meetings in the multidisciplinary field of cardiac and peripheral interventional medicine, ISET is attended by physicians, researchers, scientists and other professionals. ISET 2012 will take place at the Fontainebleau Miami Beach from January 15-19, with continuing medical education (CME) accreditation provided by Complete Conference Management (CCM).

    Internationally acclaimed experts will discuss and debate the latest advances in CCSVI in a dedicated session on the morning of January 19. Vascular surgeon Paolo Zamboni, M.D., of the University of Ferrara, who first developed the theory behind CCSVI, will review new diagnostic methodologies for the disease. Zamboni pioneered the diagnosis and treatment of CCSVI — work that has been heralded by many, yet remains a controversial subject. Michael Dake, M.D., of the Stanford University Medical Center, who was the first surgeon to operate on CCSVI-related stenosis in the United States, will kick off the session by addressing the many unanswered questions in CCSVI today, and will close with an update on ongoing research initiatives.

    Other participants in the CCSVI session include neurologist Jack Burks, M.D., of the Multiple Sclerosis Association of America (MSAA); Lindsay Machan, M.D., of the University of British Columbia; and Gary Siskin, M.D., of the Albany Medical Center. These noted experts will host talks on CCSVI collaboration, imaging evaluation of CCSVI patients, techniques and pitfalls of CCSVI intervention, and the current status of CCSVI in Canada, as well as showcase outcomes of a single center experience.

    CCSVI is just one of the many topics featured during ISET 2012, which will provide a comprehensive overview of new developments in the area of endovascular therapy. The five-day meeting comprises intensive one-day symposia, a variety of general and concurrent sessions, and small-group case reviews. Teams at clinical sites in New York, Miami and Leipzig, Germany, will conduct live case demonstrations during which operators perform the latest procedures while offering step-by-step explanations for the audience. The live cases complement the lectures by virtually transporting attendees into the procedure room.

    ISET brings together practitioners in the fields of interventional radiology, vascular surgery, interventional cardiology, cardiothoracic surgery and others who specialize in treating cardiovascular disease.

    About the International Symposium on Endovascular Therapy (ISET)
    Begun in 1989 and led by acclaimed interventionist Barry Katzen, M.D., ISET is attended annually by physicians, scientists, allied health professionals and industry professionals from around the world. The meeting pioneered the use of live case demonstrations as an educational tool and promotes the multidisciplinary treatment of cardiac and vascular disease by endovascular means. ISET 2012 will take place January 15-19 at the Fontainebleau Miami Beach.

    Source: e-releases Copyright © 1998-2011 eReleases® (MEK Enterprises LLC) (07/11/11)

    Multiple Sclerosis operation changed my life - now I want it on NHS

    CCSVI VenogramAn Inverness woman left virtually housebound after suffering from MS has had a miraculous turnaround in her life after pioneering treatment abroad.

    Since diagnosis over 15 years ago, multiple sclerosis sufferer Audrey Barnett (40) has endured limited walking ability, severe fatigue and dizziness.

    But within hours of treatment, she says a serious eye problem was corrected and her balance also improved. She believes the surgery has made "an amazing difference" to her life, enabling her to resume driving for the first time in two years and horse riding after five years.

    Audrey, who featured in the Highland News after launching a campaign calling for further research into the operation, underwent the percutaneous venoplasty procedure – privately at a cost of £7,500 – last September in Warsaw, Poland.

    The op aims to improve blood flow from the brain by using a small inflatable balloon or stent to widen narrowed veins in the neck which carry oxygen-depleted blood. It is believed there could be a link between narrowed veins and the progression of MS.

    It is the most common disabling neurological condition affecting young adults. Around 100,000 people in the UK have it.

    Audrey has recently spoken to Liberal Democrat MP Danny Alexander about the procedure.

    And another MS sufferer, her friend Anita Duffy (46), of Milton of Leys, has been inspired to follow in her footsteps.

    Audrey said: "I spoke to Danny Alexander who was very interested and amazed at the difference the treatment has made to my life.

    "Anita is about to go to Poland for the same op. Her mum, a very experienced nurse, was so impressed with how well the treatment had worked she asked me about it, researched it and thought it made perfect sense and worth a try."

    Now Audrey is celebrating after the treatment is a step closer to being offered on the NHS.

    In early 2010, Audrey launched a petition calling on the Scottish Parliament to urge the Scottish Government to encourage urgent research into the surgery.

    Clinical trials now look set to take place in the UK and she hopes it will mean other patients will benefit in the future.

    Audrey, of Underwood Place, Balloch, said: "The National Institute for Health and Clinical Excellence (NICE) has announced they want clinical trials to take place in the UK. It means all the hard work by lots of us throughout the country is finally paying off.

    "NICE has opened a four-week public consultation to hear from people who have had the treatment. It’s likely to be as long as five years after the start of trials before the treatment becomes readily available, but that’s much better than we were expecting. I’m delighted."

    Following a public meeting last month, NICE proposed in its draft guidance the procedure should be used to research whether it can impact patients’ quality of life.

    The NICE committee will review consultation comments, hold another public meeting in October and publish its final guidance for the NHS in December.

    Source: Highland News © Scottish Provincial Press 2011 (21/09/11)

    University of Calgary records serious health complications in MS patients

    CCSVI VenogramResearchers at the University of Calgary have documented some serious complications suffered by multiple sclerosis patients who travelled outside of Canada to undergo a controversial treatment for their disease.

    Many MS patients have travelled overseas to find clinics willing to provide chronic cerebrospinal venous insufficiency treatment, which uses balloon angioplasty to open blocked veins in the neck. Italian physician Paolo Zamboni was the first to suggest that blocked neck veins may be linked to MS and use venous angioplasty to unblock them.

    Some patients have reported that the procedure has drastically improved their symptoms, but some studies have called into question its effectiveness.

    The Calgary study followed five patients who had the so-called liberation therapy and were treated in Calgary hospitals in October and November of last year after complications from the procedure.

    The complications included clot formation within stents, stent migration, significant hemorrhage, cranial nerve damage and cerebral vein thrombosis, which is clots in the veins of the brain. Zamboni has always warned against the use of stents.

    The lead author of the paper, Dr. Jodie Burton, admits it's that it is difficult to draw conclusions since there were only five patients involved and it's not known how many Canadians have travelled to locations such as Mexico, India, the United States and Poland to have the procedure done.

    "Every pro has a con. I think the issue is informed consent so you fully understand what the risks are when you undertake something," said Burton, a clinical assistant professor in the department of clinical neurosciences.

    "It's important to make sure when we expose patients to potential risks we're aware of what those are as best we can up front and those are tempered by the potential gains."

    The information was published this week in the Canadian Journal of Neurological Sciences.

    Last month, a Calgary man revealed that his wife died after having the treatment at a California clinic.

    The federal government plans to fund a preliminary clinical trial of liberation therapy, but has warned it could be years before it would be widely available in Canada.

    Alberta is conducting its own web-based study which will consult with MS patients as a precursor to clinical trials.

    Burton said the seriousness of the complications should serve as a "cautionary tale" to anyone considering having the procedure done and for physicians who may be required to provide medical care to future patients.

    "I understand this is a group of people who have not the greatest set of options and are in desperate need. I totally understand that and I can appreciate the interest and the attention to the topic," said Burton.

    "I'm still worried. I think the issue is people are going for procedures that we know are not benign. They're not having the procedures done in this country so it's hard to know exactly what's being done."

    Source: Wiinepeg Free Press © 2011 Winnipeg Free Press (25/08/11)

    NICE consultation on percutaneous venoplasty for CCSVI in MS begins

    CCSVI VenogramNICE announces that the consultation on Percutaneous venoplasty for CCSVI in MS began on 24th August 2011.

    Guidance on commenting on an Interventional Procedures Consultation Document as a patient/carer or member of the public is detailed below.

    This factsheet has been designed to help patients/carers and members of the public when commenting on provisional guidance produced by the National Institute for Health and Clinical Excellence (NICE) on percutaneous venoplasty for chronic cerebrospinal venous insufficiency in multiple sclerosis.

    The sheet:

    • Describes who the Patient and Public Involvement Programme are and the support that they can provide
    • Describes what an interventional procedure is
    • Describes the Interventional Procedures consultation process
    • Suggests issues that patients/carers and members of the public might wish to consider when they comment on provisional guidance issued by NICE

    Who are the Patient and Public Involvement Programme?

    The Patient and Public Involvement Programme (PPIP) are a team within NICE who are here to provide individual patients/carers and members of the public with advice on how they can get involved in the development of Interventional Procedures guidance, including how best to comment on the consultation document. Contact details can be found in the ‘Further Information’ section below.

    What is an interventional procedure?

    An interventional procedure is a procedure used for diagnosing an illness or treating a patient that involves:
    • making a cut or a hole to gain access to the inside of a patient's body - for example, when carrying out an operation or inserting a tube into a blood vessel
    • gaining access to a body cavity (such as the digestive system, lungs, womb or bladder) without cutting into the body - for example, examining or carrying out treatment on the inside of the stomach using an instrument inserted via the mouth
    • using electromagnetic radiation (which includes X-rays, lasers, gamma-rays and ultraviolet light) - for example, using a laser to treat eye problems.

    What is an Interventional Procedures Consultation?

    The Interventional Procedure Advisory Committee (IPAC) has now met to look at and discuss the evidence, and formulate its draft recommendations. Once the committee has made its draft recommendations, NICE issues a consultation document. The main sections of the document are:

    • The draft recommendations
    • A short description of the procedure, along with what it is used to treat and any current treatment options available for this condition
    • A summary of the evidence (assessed by the committee) on how well the procedure works and how safe it is
    • Any other comments the committee wishes to make about the procedure or the evidence presented.

    Practical information

    Dates
    The public consultation period will run for 4 weeks, and will start on the 24th of August 2011, running until the 21st September 2011. During this period anyone is allowed to comment on the draft recommendations that are published on the NICE website.

    How can I comment?
    You can comment in a number of ways, including:
    • Using the online form on the NICE website (you should have receive a link to this from the Interventional Procedures team, if you have registered an interest in this procedure)
    • By email, please submit your comments to [email protected], please make sure you use the name of the procedure in the email title
    • By post, please send your comments to: Interventional Procedures Team, NICE, MidCity Place, 71 High Holborn, London, WC1V 6NA
    • By fax, please fax your comments to the following number: 0845 003 7784, please make sure you mark your fax for the attention of the IP team

    NICE is committed to helping people to comment on their documents. If you have any special requirements that mean that you cannot comment in one of the above ways, please contact Emma Chambers in the PPIP team ( [email protected]) who will try to arrange an alternative method.

    Making your comments

    If you choose to make comments on this consultation NICE would really like to hear the following information from patients/carers and members of the public with experience of this procedure or condition:

    • Your views on the provisional recommendations (these will be in section 1 of the consultation document)
    • Your views on how well the procedure works. This may include any benefits that you may have gained from having this procedure, or any negatives that you may have experienced from having this procedure, that have not been reported in the published literature.
    • Your views on how safe or unsafe the procedure is, including any side effects or complications that you may have experienced that have not been reported in the published literature.
    • New / additional evidence that the Interventional Procedures Committee may have missed when producing its provisional recommendation. This should only include published evidence that is not already included in the evidence overview on how well the procedure works or on the safety of the procedure. The Interventional Procedures programme does not look at any evidence relating to cost or service provision.

    When making your consultation comments you may wish to also consider the following points:

    • The effect the procedure had on the progression of your condition
    • Any results that are really valued by patients/things that have made a big impact on your life, and why
    • The difference (positive or negative) the procedure has made to your
    o Physical wellbeing
    o Lifestyle
    o Mental health
    o Overall quality of life

    There are also some issues, that although are important to patients, unfortunately fall outside of the remit of NICE Interventional Procedures guidance. Comments on these issues are therefore considered less useful by the committee. NICE would encourage you not to comment on the following things:

    • The cost of the treatment, including the cost of private treatment, or comments about the cost savings this would mean to the NHS.
    • Comments about the consent process, this includes comments about your experience of being in hospital and the treatment that you received from the doctors and nurses.

    When making a consultation comment you should bear in mind that your comments may be published on the NICE website. Although personal identifying data will removed from your comments before they are published, you should be mindful that your comments may be made public when discussing any sensitive information concerning your condition.

    Further information

    If you would like any further help or information when submitting your comments, or would like to be sent a link to the consultation document, please contact Emma Chambers in the Patient and Public Involvement Programme on [email protected] or 020 7045 2057.


    Equalities
    NICE is committed to promoting equality and eliminating unlawful discrimination in its activities.

    Source: NICE (25/08/11)

    CCSVI NICE Public Consultation

    CCSVI VenogramNICE are consulting with patients in the UK about CCSVI treatment.

    There is a public consultation running from 24 August until 21 September 2011. Even if you have been treated abroad for Chronic Cerebrospinal Venous Insufficiency (CCSVI) NICE would like to hear from you.

    Anyone is able to comment, and the PPIP team at NICE will be producing a fact sheet outlining the type of comments the committee would like to see from patients, which will help you when making your comments.

    Anyone interested in commenting please contact Emma Chambers at NICE to register your interest and she will send a factsheet about the sort of things they would like to know - [email protected]

    Second reported death after controversial MS treatment

    CCSVI VenogramA Calgary woman has died in the United States following controversial neck vein surgery to treat her multiple sclerosis.

    Maralyn Clarke died April 18, shortly after undergoing treatment at Synergy Health Concepts Inc. in Orange County, Calif.

    She becomes the second victim of the vein procedure, almost a year after Mahir Mostic of St. Catharines, Ont., died in October 2010 following a similar operation in Costa Rica.

    The treatment is based on a procedure developed by Italian Dr. Paolo Zamboni, whose research suggests that multiple sclerosis may be associated with vascular problems.

    Clarke, 56, flew to California on April 13 in search of a cure for an illness she had lived with for years.

    Her husband, Frank Lamb, said his wife experienced severe headaches, nausea and vomiting a few hours after being discharged and was taken to a nearby hospital. She was taken off life support on April 18.

    “I think they discharged her before she could make full recovery,” he said Friday, adding that her blood pressure was still high when she left the facility.

    Clarke’s final diagnosis included irreversible brain injury, according to her medical records.

    Officials at the Synergy Health Concepts refused to comment on the case, saying state laws prevent them from sharing confidential information regarding their patients.

    Because Zamboni’s treatment —— which uses angioplasty or ballooning to open blocked neck veins — is not available in Canada, a number of CCSVI patients have opted for going overseas for treatment.

    Since the procedure was first introduced, it has raised heated controversy among physicians as well as in the general public.

    Some argue there is a risk of provoking a stroke if the vein surgery is not properly carried out.

    Experts say there should be rigorous studies to assess whether the procedure works and is safe.

    But those who have already allegedly been victims to the operation will hardly find any solace.

    “It’s been tough, very tough,” said Lamb, referring to life since his wife’s death. “And every time somebody else calls, it gets tougher.”

    Source: Toronto Star © Copyright Toronto Star 1996-2010

    Canadian government funding for MS 'liberation therapy' trials

    CCSVI VenogramThe Canadian federal government says it will fund clinical trials into the controversial multiple sclerosis treatment known as the "liberation therapy."

    Federal Health Minister Leona Aglukkaq made the announcement Wednesday afternoon during a news conference on Parliament Hill.

    Aglukkaq told reporters the government came to its decision after a scientific working group it convened last summer determined during a meeting on Tuesday that a Phase 1 and Phase 2 clinical trial should proceed.

    "I have asked CIHR, the Canadian Institutes of Health Research, to establish the terms of reference for this clinical trial," Aglukkaq said. "And we are committed to launching an open and transparent call for proposals, and process applications, as quickly as possible."

    The liberation treatment was developed by Italian physician Dr. Paolo Zamboni and is based on his theory that narrowed neck veins are behind MS symptoms.

    The condition, chronic cerebrospinal venous insufficiency, or CCSVI, reduces blood flow and allows iron deposits to build up in the brain, Zamboni says.

    The treatment he developed uses balloon angioplasty to unblock the veins in the hope of alleviating symptoms.

    In an interview with CTV News, Zamboni called the government's announcement "fantastic news," saying Canadian MS patients "waited for this for a long time."

    While Zamboni's research has demonstrated success with the treatment, recent clinical trials have concluded that CCSVI is not a primary cause of MS.

    The controversy surrounding both the condition and the treatment has not deterred Canadian MS patients from rallying across the country over the last several months to call on both Ottawa and provincial governments to fund the treatment, which is not available in Canada. Many Canadians have had the procedure at medical clinics overseas.

    Aglukkaq said the working group was established last August and tasked with reviewing the latest research and making its recommendation to government. The group met in November and again on Tuesday.

    Dr. Alain Beaudet, president of the CIHR, said Wednesday that an analysis of all the research done on CCSVI so far suggested "a trend to an association between the greater prevalence of CCSVI in patients with MS than in healthy controls."

    Beaudet said more results are needed, particularly from seven current studies, to strengthen the committee's conclusion.

    "But, nonetheless, the committee felt that, on the basis of this preliminary evidence and what's published so far, that we should in parallel start already with a Phase 1-2 trial," he said.

    Barrie, Ont. vascular surgeon Dr. Sandy McDonald has treated six patients with the liberation therapy, three of whom experienced a dramatic improvement in symptoms and two who experienced a moderate improvement.

    McDonald said Zamboni's theory represents a "paradigm shift" in how MS is viewed. For decades, neurologists have approached MS as an autoimmune disorder, but the liberation treatment suggests that it is in fact a vascular disease.

    McDonald said he was "ecstatic" when he heard the government's announcement, saying a randomized, controlled, double-armed trial -- during which doctors follow a group receiving the treatment and a group that does not -- will conclusively determine the treatment's effectiveness, as well as risks.

    "We already know from trials done in the United States that the risks are very low, and we already know also from the trials out of the U.S. that it seems to be effective in improving the quality of life in many people," McDonald told CTV News Channel.

    "But we shouldn't expect that it will be the panacea for all patients with MS. It may be a part of MS, and that's why we need the trials to prove it either is or isn't, and hopefully it proves it is and we can actually help patients have a better quality of life."

    During her Wednesday news conference, Aglukkaq hailed MS patients and their families for their struggle with a disease that can lead to symptoms that include difficulty walking, vision problems, fatigue and weakness.

    "It has been a moving experience to meet many of you and to hear from so many MS patients and their families who have shown tremendous courage in the face of such difficult illness," she said.

    Source CTV News © 2011 CTV (30/06/11)

    Nova Scotia won’t fund liberation therapy for MS patients

    CCSVI VenogramNova Scotia’s health minister says there are no plans to follow New Brunswick’s lead and begin funding the costs of the so-called liberation therapy for multiple sclerosis patients.

    New Brunswick announced Wednesday that patients can receive funds to help cover the costs of medical services including liberation treatment outside the province.

    Nova Scotia Health Minister Maureen MacDonald said today that her department will wait for stronger evidence before considering a similar move.

    She says the province wants to see research showing that the CCSVI treatment would be effective and would not pose risk to patients.

    Recent studies have cast doubt on whether the treatment, which involves widening constricted neck veins to improve blood flow from the brain, actually benefits patients with MS.

    Source: The Chronicle Herald © 2011 The Halifax Herald Limited (17/06/11)

    MS: review ordered into surgery for clogged neck veins

    CCSVI VenogramA consultation will take place this summer on a surgical technique that unblocks veins in the neck as a treatment for patients with multiple sclerosis (MS). The National Institute for Health and Clinical Excellence (NICE) has asked a specialist committee to examine whether the procedure, which improves blood flow, is of value to people with MS.

    Chronic cerebrospinal venous insufficiency (CCSVI) has become a popular topic for discussion among MS patients since an Italian scientist first linked the disease with the condition of veins in the neck. Dr Paolo Zamboni put forward the theory that MS can be caused by blockages in veins draining blood from the brain and that, if the blockages are cleared, symptoms of MS may be eased.

    Blocked, damaged veins
    Zamboni's theory rests on a link between MS and iron deposits in blood vessels. He carried out ultrasound tests on blood vessels leading in and out of the brain and found that, in a majority of people with MS, the veins taking blood away from the brain were blocked or damaged. This was not the case in people without MS.

    He further suggested that iron was damaging the blood vessels and allowing the heavy metal, along with other unwelcome cells, to cross the blood-brain barrier: a process he called Chronic Cerebrospinal Venous Insufficiency.

    A number of clinics, notably in Poland and Bulgaria, are offering surgery to clear these blockages in veins — an angioplasty technique, also known as 'liberation procedure'. MS patients in the UK have had to arrange treatment abroad for this surgery, although last year it was offered at a private clinic in Scotland for the first time in the UK.

    Few clinical trials have been carried out and the procedure remains scientifically unproven.

    Evidence review
    NICE has announced a four week consultation on the technique before the Interventional Procedures Advisory Committee (IPAC) is asked to review the evidence. Its findings are expected to be published in Autumn 2011. The committee's conclusions will be reviewed by NICE, which will issue UK-wide guidance.

    Balloon angioplasty
    The review will cover 'balloon angioplasty with or without stenting'.

    Balloon angioplasty involves inserting a catheter with a small balloon tip towards a narrowed stretch of a vein. Once in place, the balloon is inflated to stretch the vein or compress any fatty matter. In a variation of the procedure, a stent (a small metal mesh tube) is inserted to permanently keep the vein expanded after the balloon has been withdrawn.

    IPAC will base its review on evidence from three professional bodies: the Association of British Neurologists, the British Society of Interventional Radiology and the British Society of Neuroradiology.

    'Good news for people with MS'
    "The single most important thing in this announcement is that NICE are seeking specialist advice from neurologists and interventional radiologists together", Helen Yates Chief Executive of the Multiple Sclerosis Resource Centre(MSRC) tells us. Yates continues: "MSRC has long held the belief that these two specialities should be looking at the area of CCSVI together. It is generally good news for people with MS that this procedure is now receiving this kind of attention."

    Source: WebMD © 2011 WebMD, LLC. (05/05/11)

    NICE to review balloon angioplasty with or without stenting surgery for CCSVI

    NHS LogoNICE has been notified about this procedure and will consider it as part of the Institute’s work programme.

    It is possible that there is a link between blocked veins in the neck and progression of multiple sclerosis (CCSVI). This procedure aims to open blocked veins by inflating a small balloon in the vein, allowing for better blood flow.

    The Interventional Procedures Advisory Committee (IPAC) will consider this procedure and NICE will issue an Interventional Procedures Consultation Document about its safety and efficacy for 4 weeks public consultation. IPAC will then review the consultation document in the light of comments received and produce a Final Interventional Procedures Document, which will be considered by NICE before guidance is issued to the NHS in England, Wales, Scotland and Northern Ireland.

    Contact NICE about this [email protected]
    Technical lead (for procedure specific enquiries or comments) Nicola Sloan

    Contact Address:
    Interventional Procedures Programme
    National Institute for Health and Clinical Excellence
    MidCity Place
    71 High Holborn
    London
    WC1V 6NA

    Chronic Cerebrospinal Venous Insufficiency (CCSVI)

    Source: NICE (04/05/11)

    People power: social media can alter research priorities

    CCSVI VenogramWidespread demands in Canada for clinical trials for a controversial treatment for multiple sclerosis show the growing power of the Internet and social media to influence research priorities, according to a paper published April 27 in Nature.

    Paulo Zamboni, an Italian surgeon, suggested in 2008 that MS was not an autoimmune disease but rather a vascular disease caused by blockages in the brain. He proposed unblocking the veins by mechanically widening them — what he calls the “liberation procedure.”

    His hypothesis got little public attention, except in Canada, where more than 500 Facebook pages, groups or events devoted to the theory have been created with tens of thousands of followers. A poll shows more than half of Canadians are familiar with the theory. Stories about it have appeared in the media almost weekly since The Globe and Mail, a national newspaper, wrote about it in November 2009 and it was featured on the CTV public affairs program W5.

    Researchers at Memorial University in St. John’s, Nfld., and St. Michael’s Hospital in Toronto note the reports have sparked a national debate about whether publicly funded trials should be conducted and whether MS patients should have immediate, publicly funded access to the vein-widening treatment known as venoplasty.

    This is despite the fact that virtually none of the country’s MS physicians and researchers, nor the Multiple Sclerosis Society of Canada, have advocated either, and several studies have failed to replicate Zamboni’s original findings.

    “Indeed, the case indicates the unprecedented pressures scientists, politicians and funders worldwide can now face to alter research priorities even in the absence of credible scientific evidence,” the authors wrote.

    The paper’s lead author is Dr. Roger Chafe, director of the Janeway Pediatric Research Unit, which conducts clinical and applied health research within the Discipline of Pediatrics, Faculty of Medicine at Memorial University. His co-authors include Dr. Arthur Slutsky, vice-president of research at St. Michael’s Hospital, and Dr. Andreas Laupacis, executive director of the hospital’s Li Ka Shing Knowledge Institute.

    The authors said that in this new social media environment, researchers and clinicians need to engage more actively with the public to articulate the importance of science in determining the benefits and harm of novel treatments — and to ensure that patients’ concerns and priorities are heard.

    They said unconventional and unproven treatments have long been proposed and tried for many terrible diseases. “Now tools such as Facebook and YouTube make it considerably more likely that patients learn about such therapies, without necessarily learning about their potential limitations.”

    The authors wrote that a clear lesson from the Zamboni example is that the traditional approaches for communicating scientific findings to the public and policy advisers such as reports, briefing notes, news releases and news conferences, are insufficient. “When patient groups are using social media to advocate and mobilize, scientists must employ similarly effective tools to communicate.”

    More effort are needed to improving the scientific literary of the public, politicians and the media, the authors wrote, and to engaging a public that is no longer deferential to experts.

    Source: Human Health & Science (c) 2011 Human Health and Science. (28/04/11)

    One year later, MS patients track their progress

    CCSVI VenogramA year later, five Canadian multiple sclerosis patients have reported their progress to CTV News, and there are positive signs for some from a new MS treatment.

    Last year, Lianne Webb was flattened by fatigue -- the result of a decade of living with multiple sclerosis. But 14 months after receiving a highly debated treatment known as liberation therapy, Webb says she feels more energetic than she has in years.

    Indeed, on a recent afternoon, she was horseback riding; something that would have been unthinkable before receiving the therapy.

    "I feel like I have my life back," she said.

    Webb is one of five Canadian patients given the angioplasty treatment within the country.

    The treatment had been temporarily offered by a medical team in Barrie, Ont., but the program was halted as doctors hoped to launch a formal treatment study.

    Still, many other Canadians have since gone abroad to get the therapy, which aims to open the blocked veins in the neck and chest that are blamed for slowing the flow of blood from the brain.

    The original interviews ran on CTV's W5 in April, 2010. A year later, Favaro and producer Elizabeth St. Philip visited all five of those patients to ask them about their progress.

    Had the treatment helped? How had their lives changed?

    For Webb, the difference was obvious.

    Previously, she was giving herself daily injections of a drug called Copaxone, but she was still having MS attacks. Webb could work, but she would return home at the end of the day exhausted, unable to do housework and too tired to care for her family.

    "I would pass out at 7 at night. Now I am riding many evenings," she says.

    Webb says she has stopped taking the MS medications because she has stopped having relapses associated with the condition. She has since bought a horse and a truck, so she can spend time horseback riding, which is one of her passions.

    She's also been spending some time on the golf course.

    "I feel great," Webb says, adding that while she may still have MS, "I don't have the symptoms."

    Two other patients have reported significant improvements, including Matt Maltese, who only one year ago could not walk up a flight of stairs.

    These days, he's back to working full-time and is coaching sports again.

    "There is no fatigue anymore … I eat more," he says, adding that he wants to return to his job as a physical education teacher.

    That success story is shared by Steve Garvie, a patient who one year ago could barely use his left arm and hand. Now, he can lift his 60-kilogram dog with the arm.

    "I don't have any fatigue ... I don't have any bladder issues," he says.

    Since getting the treatment, he's moved out of government housing and into a new place with his partner. He sleeps better and doesn't take drugs to control his bladder or to alleviate pain.

    When asked about suggestions that the treatment has had a placebo effect, Garvie says that's unlikely.

    "A placebo lasts a month or two. I am well over a year later, am I a placebo?"

    He has also helped set up the CCSVI Foundation which aims to get funding for those seeking the treatment abroad.

    CCSVI is an acronym for the disorder, known as chronic cerebro-spinal venous insufficiency.

    Less success for others

    However, two of the five patients, Sandra Black and Mike Gandhi, have not visibly improved over the past year.

    Black got her treatment on Feb. 26, 2010, and she still uses a walker and occasionally a wheelchair.

    "I was looking for a miracle and I know it didn't happen. But I do feel good. My fatigue is gone. I wish I had my treatment 15 years ago, before my disease got worse."

    Gandhi, meanwhile, has had the procedure twice: first in Canada and then last month in California, after ultrasounds showed that his veins had again narrowed.

    Still, Gandhi says his mind feels clearer.

    Dr. Sandy McDonald, the vascular surgeon who continues to monitor the patients, is pleased with the results so far, given that there have been no serious complications.

    But the doctor says more study is needed.

    "We need to do a well-done study to see if the treatment works and make sure it is not placebo. A treatment would demonstrate that it is safe and effective."

    Earlier this month, the province of Manitoba announced it would spend $5 million to conduct clinical trials, in addition to a similar pledge made by Saskatchewan.

    Source: CTV News © 2011 Bell Media (11/04/11)

    Zamboni says no conflict in applying for MS patents

    Doctor ZamboniThe Italian doctor behind a furiously debated theory of multiple sclerosis treatment applied for several patents to protect his discoveries long before they became widely known, and has worked closely with a company marketing an MS ultrasound machine built according to his specifications.

    Dr. Paolo Zamboni’s patent requests and corporate connections add a new twist to what is often characterized as a clash between entrenched, Big Pharma interests and a scientific renegade with forward-thinking ideas.

    The neurologists who traditionally treat MS patients have been among the harshest critics of the new hypothesis; Zamboni supporters accuse them of being blinkered to non-pharmaceutical alternatives, citing the funding many receive from drug companies whose products are currently the chief MS treatment. The Italian physician himself has said he was personally motivated to explore multiple sclerosis by his own wife’s struggles with the illness.

    Experts on intellectual property and bioethics say it is not unusual or unethical for academic researchers like Dr. Zamboni to apply for patents around their inventions, but note that it normally means the inventor or someone else wants to make money off the discovery, and suggest he should have pro-actively disclosed any commercial interests.

    Many medical journals now require that study authors reveal patent applications around their research, as well as industry ties, a policy encouraged by the World Association of Medical Editors in its ethics guidelines. At least three of Dr. Zamboni’s major MS papers list competing interests as “none.”

    “You would expect that if this was really being done in the public interest, that he would announce it. He would say, ‘Yes, I have these patents, I obtained them on purpose, in order to facilitate access,’ ” said Richard Gold, an intellectual property expert at the McGill University law school.

    “The fact he hasn’t said anything and it was uncovered, it wasn’t him who uncovered it, would indicate it’s likely for profit, and one should question his motives in the same way one should question anyone’s motives who is both publishing research and commercializing a product.’’

    Medical scientists take out patents for a number of reasons, including simply to ensure that their discovery can one day be developed by a company and aid mankind, said Jonathan Kimmelman a bio-ethicist at McGill who specializes in ethics of health research. Accumulating patents can also bolster academic standing, he said. It’s wrong to believe, though, that only drug company ties influence researchers, he added.

    “I think it’s an absolute error of reasoning to suggest there is no financial interest in non-pharmaceutical approaches to treating disease, including multiple sclerosis,” said Prof. Kimmelman.

    Dr. Zamboni, however, said it is “ridiculous” to suggest his patent applications and work with Esaote S.p.A., the ultrasound manufacturer, represent anything like the conflicts of researchers who receive money from drug companies.

    Esaote has merely provided equipment to his lab and funded professional training, and he has no plans to commercialize the inventions described in the patents, he said in an emailed response to questions.

    “Scientific passion is my more relevant conflict of interest,” said the vascular specialist.

    In fact, one prominent Italian neurologist who is highly skeptical of Dr. Zamboni’s ideas dismissed as insignificant any commercial interests the surgeon might have. What is important is completing a slew of studies now under way that should answer whether the theories hold water or not, said Dr. Giancarlo Comi of Milan’s San Raffaèle institute.

    Love for his wife gives Dr. Zamboni a “strong personal motivation,” said Dr. Comi in an interview. “This is really more than any economic motivation.”

    Medicine has never pinned down the cause of multiple sclerosis but the prevailing theory is that it involves an auto-immune response, where the body’s defences essentially turn on itself. Treatment now involves a range of drugs — which earn manufacturers billions of dollars a year — but their effectiveness is limited, and the side effects can be miserable.

    Dr. Zamboni triggered a massive upheaval in the MS world with his theory that the illness is caused by a narrowing of veins in the neck, dubbing the condition chronic cerebrospinal venous insufficiency (CCSVI). That constriction, he said, causes blood draining from the brain to back up, creating iron deposits and setting off the brain inflammation that is key to the disease. He proposed using angioplasty, where a tiny balloon is threaded into the vein and inflated to open up the narrowing — or stenosis — and has published studies suggesting it works.

    Glowing media coverage of Dr. Zamboni’s findings in late 2009 caught the imagination of MS patients, even as their specialists warned that the evidence was preliminary at best. Hundreds of Canadian patients have travelled to foreign countries to undergo the so-called “Liberation” treatment, which is not available here, and many say it has transformed their lives. One Canadian man, though, died after a blood clot formed during repeated treatments in Costa Rica.

    Those initial media reports talked of Liberation as a possible cure, and quoted Dr. Zamboni as saying it “could be a revolution for the research and diagnosis” of MS and that “I am fully convinced that this is very, very important.”

    In the two years before those reports, applications were filed for several patents covering Zamboni inventions at offices in Europe, the U.S., Canada and other countries.

    One details a “system for diagnosing multiple sclerosis,” which includes using a doppler ultrasound machine to detect blood flows and a personal computer to analyze the results. Others are for devices designed to better treat CCSVI, though some experts worry those inventions might increase the risk of internal bleeding and other complications.

    In early 2010, just as excitement about the Zamboni ideas was building, Esaote, based in Genoa, Italy, launched MyLab Vinco, a doppler ultrasound system touted in the company’s online brochure as “the only product designed for the diagnosis of CCSVI.”

    Mariangela Dellepiane, a spokeswoman for Esaote, said the company has worked with Dr. Zamboni and his centre for vascular diseases at the University of Ferrara for years, and developed MyLab Vinco according to his research. The firm pays Dr. Zamboni’s centre to train its customers on use of the system, but provides no other payment linked to its sales, she said in an emailed response to questions.

    Several of the clinics worldwide offering CCSVI diagnosis and Liberation treatment advertise that they have bought MyLab Vinco, stressing its connection to Dr. Zamboni.

    Ironically, the largest stake in Esaote is held by Switzerland’s Bertarelli family, which until a few years ago controlled the pharmaceutical giant Serono. Its top selling drug, with worldwide 2010 sales of $2-billion, is Rebif, one of the MS drugs that Zamboni’s supporters often decry. As well as Esaote, the Bertarellis’ company — Ares Life Sciences — owns two drug firms.

    Source: National Post © 2011 National Post, a division of Postmedia Network Inc. (04/04/11)

    SIR: Vascular MS treatments safe, but efficacy unclear

    CCSVI VenogramAngioplasty for obstructed veins leading away from the brain and spine appears safe for multiple sclerosis patients, although whether it holds any more than a placebo effect for the degenerative disease remains to be proven.

    That was the conclusion of several single-center series reported here at the Society of Interventional Radiology meeting on the controversial treatments for what has been termed chronic cerebrospinal venous insufficiency (CCSVI).

    No Shortage of Questions

    "Currently there are many unknowns and lots of uncertainty," said Michael D. Dake, MD, of Stanford University in Palo Alto, Calif., who called the field "a zone of chaos" in a session dedicated to the debate.

    Venous angioplasty for CCSVI has generated enormous demand among MS patients, but there has been deep skepticism from the neurology community.

    The theory is that blocked venous flow leaves iron deposits in the central nervous system that create the hallmark inflammation of MS -- not the autoimmune process conventionally thought responsible for the disease. The idea was raised by an Italian group that reported CCSVI in nearly every MS patient they studied; they then found MS symptoms improved in many patients who were treated with angioplasty.

    Diagnosis has proven challenging, with many studies failing to replicate this high incidence of CCSVI.

    Another problem is that poor central venous flow, malformed venous valves, and other problems in the jugular and azygos veins found in MS patients don't always translate to elevated pressure or other clear clinical relevance, noted Dake, who spoke at the session.

    "Just because we see anatomic problems, does that really have any physiologic relevance?" he asked attendees, noting that diagnosing serious and significant lesions in veins is totally different from doing so for arteries.

    No Room for Cowboys

    An Ann Arbor, Mich., interventionist in the audience said he had treated one MS patient to spectacular effect despite no clear venous stenosis but "felt like the emperor putting on his new clothes, treating something I wasn't really sure what I was doing."

    "We acknowledge that maybe the genie is out of the bottle with a lot of centers doing this," responded session moderator Ziv J. Haskal, MD, of the University of Maryland Medical Center in Baltimore.

    He and others leading the charge in vascular MS treatments urged others at the meeting who are considering doing the procedure to practice safely in a controlled environment with methodical collection of data "and not have this become a Wild West situation."

    That's what Kenneth Mandato, MD, of Albany Medical Center, Albany, N.Y., and colleagues decided to do.

    The group reported outcomes of 231 CCSVI patients with MS treated with angioplasty under mild sedation at their hospital or medical offices nearby.

    In their experience, 99.2% of patients were discharged within three hours of treatment. One patient had to be hospitalized for sustained arrhythmia (0.4%).

    Major complications occurred in three patients (1.2%), all of whom had post-procedural venous thrombosis within 30 days and one of whom also had stress-induced cardiomyopathy (0.4%). Minor complications included the following:

    Thrombosis or dissection after angioplasty requiring stent placement in 10.5%
    Transient headache for 9.1%
    Transient neck discomfort for 16.9%
    Hives from x-ray contrast in 2.8%
    Transient arrhythmia in 0.9%
    Since then, more MS patients have been treated with fewer complications, driving down the center's complication rates, Mandato noted.

    "This is not a new technology," Mandato emphasized at a press conference where the results were discussed.

    A second study of 24 MS patients treated by angioplasty with stenting in some cases for CCSVI yielded one case of inguinal bleeding, two cases of inguinal hematoma, and one retroperitoneal hematoma.

    The initial clinical effect was "significant" improvement in MS symptoms in 16 of the 24 and "slight" improvement in five, with the other three seeing no benefit, reported João Martins Pisco, MD, of Hospital Pulido Valente and St. Louis Hospital in Lisbon, Portugal.

    By six to eight months later, eight patients had a recurrence of venous obstruction, and one patient each downgraded their improvement to slight or none.

    Haskal reported on another series of 18 consecutive MS patients treated for CCSVI with "uniformly positive" patient-reported improvements in outcomes and quality of life. The group also documented objective motor and balance improvements.

    Complications included one case of contained left internal jugular vein valve rupture, resolved with balloon tamponade and stenting.

    Mandato also anecdotally reported positive changes in symptoms for treated MS patients across the board for those with less severe disease to wheelchair-bound patients.

    No Blanket Solution

    While confirmation of efficacy will take much larger trials, these early safety reports are a reassuring backbone to support them, according to Mandato co-author Gary P. Siskin, MD, also of Albany Medical Center.

    Three deaths have been reported in the worldwide experience with vascular treatments for MS, he noted, but all have been related to blood thinner or anticoagulant use.

    "We acknowledge there are risks with this procedure, and we do believe, based on the data presented here, that overall this is a safe procedure with a very low risk of major complications," he told MedPage Today.

    The Society of Interventional Radiology position is that physicians, in the face of inconclusive evidence, have to make the decision with patients and their families on an individual basis, taking into consideration disease status and response to prior therapies.

    "The problem is these are really desperate patients," Lindsay Machan, MD, of the University of British Columbia Hospital in Vancouver, told MedPage Today.

    With MS patient groups promoting the procedure over the Internet and through social networking, patients are jumping ahead of the scientific process to call asking for treatment, he said.

    "This is an insight into our future as physicians," he predicted.

    Source: Medical News Today © 2011 Everyday Health, Inc. (01/04/11)

    The Facebook treatment for MS

    CCSVI VenogramA patient-led movement, fought via social media, has fuelled the widespread use of a controversial treatment for MS before research has proven it effective, writes Michael Slezak.

    If anyone wants a miracle cure for multiple sclerosis, it's Brian Lee. Diagnosed with MS in 1999 just after the birth of his second son, his disease progressed faster than usual. Within seven years, he was permanently confined to a wheelchair and he has slowly started losing control of his body.

    ''My left arm is stuffed, you might say, and my right is going that way quickly … As a result, I'm having trouble feeding myself,'' he says.

    But like many questions about MS, Lee, 51, has few answers about how his condition will progress.

    ''It's completely unpredictable. I might never get any worse or I could end up bedridden.''

    Like many people living with MS, Lee considered trying the many ''miracle cures'' to be found online. He was too sceptical to try high-pressure oxygen therapy, bee-sting therapy, or many unproven dietary supplements. But he did try removing all his amalgam fillings after claims they caused the disease.

    But one day he heard about an outspoken Italian doctor with a radical surgical treatment for MS. Controversially dubbed ''liberation therapy'', it seemed to have amazing results in early clinical trials, with patients who were previously unable to walk 100 metres suddenly able to walk for kilometres. Stories of miraculous recoveries were posted on YouTube and dominated MS patient forums on the internet.

    This miracle cure appeared to have scientific support and was the kind of thing Lee, a software technician with two years of a medical degree under his belt, could sign up for.

    Dr Paolo Zamboni is a phlebologist - an expert in veins and the circulatory system. When his wife was diagnosed with MS, he discovered what he thinks is the cause of the degenerative brain disease. Perhaps unsurprisingly, given his background, he proposed that MS was essentially a disorder of the veins.

    Almost all neurologists - the specialists who treat MS - think the disease is a result of the patient's immune system attacking the protective coverings of nerves in the brain and spine: myelin sheaths. They have theories about why this happens but nobody knows for sure.

    Zamboni says the degeneration of myelin sheaths is actually the result of a blockage in the vein in the neck that drains blood from the brain.

    Chronic cerebrospinal venous insufficiency, or CCSVI, is said to cause the degeneration by slowing the rate at which blood flows through the brain.

    Ahead of his visit to Australia this week, Zamboni explained the process from his office in Ferrara, Italy.

    He says these blockages result in the brain's natural defence mechanisms being weakened, allowing damage and inflammation in the brain caused by various things, including toxins, bacteria and viruses.

    He proposes MS patients with a blockage have a surgical procedure known as balloon angioplasty. A small deflated balloon is inserted into the groin, guided to the vein in the neck and inflated, stretching the tightened vein and allowing blood to flow more freely. Often this procedure has to be repeated every couple of months as the blockage reappears.

    Initial studies conducted by Zamboni seemed promising but independent teams have had difficulty replicating the early findings.

    Strangely, while there is almost unanimous support for the theory among Zamboni's colleagues of vascular specialists, there is near-unanimous scepticism among neurologists, who mostly think the theory is not just wrong but completely implausible.

    Speaking off the record, several neurologists said the whole idea was ''silly'', with one going as far as to say it was ''completely ridiculous''.

    Those who speak on the record are careful in their criticisms but express universal concern over the ethics of conducting serious surgery on the basis of an unproven theory.

    But the surgery continues. And so it should, says Zamboni, who is pleased that patients around the world, including in Australia, are able to bypass their sceptical neurologists to get the treatment.

    Great strides have been made in MS research over the past few years but a lot remains tragically out of reach.

    New and increasingly effective drugs that protect the brain against the patient's immune response have resulted in a dramatic reduction in symptoms and transformed the lives of many people with MS.

    But there are no drugs that can cure the condition. The newer more effective drugs can be hit and miss with strong side-effects, while others are not completely safe.

    It is widely believed among experts that MS is dramatically more common the further you get from the equator, with people in Tasmania six times more likely to have the disease than people in Queensland. Research has suggested this is explained by links with vitamin D and sunlight but even this latitudinal distribution has recently been questioned (see box).

    MS remains an enigmatic disorder and the lack of knowledge about its cause and the absence of effective therapies for those who are severely affected perhaps partly explains the ferocious enthusiasm many patients have towards Zamboni's theory.

    Almost 2000 people have signed up to the Australian CCSVI Facebook page, with tens of thousands more signed up to similar pages in Canada, the US and elsewhere.

    The global CCSVI movement has the feeling of a political uprising. Patient advocates claim to have the truth: a truth being suppressed by rich doctors who have a financial interest in the current orthodoxy in which there is no cure.

    As a political movement, it is an unusually successful one.

    Adolfo Gianni helps run the Australian CCSVI Facebook page, created in late 2009. ''Effectively, all that was intended was to let other people with MS know about this discovery,'' he says.

    His Facebook group, and others like it, have changed the way MS is treated. A recent article in a phlebology journal points out that while most procedures are required to go through rigorous clinical trials before they are rolled out, treatment for CCSVI in MS is already being done all over the world.

    The paper's authors say this ''is largely attributed to patient demand fuelled by the information conveyed by social networking websites''.

    But enthusiasm can turn ugly.

    Neurologists who have criticised the theory have found themselves the target of vicious internet attacks and several doctors approached by the Herald refused to speak on the record.

    On the Australian Facebook page and other internet forums such as thisisms.com, neurologists are referred to by name and accused of ignoring evidence proving Zamboni's theory. A commonly expressed view is that neurologists are in the pockets of drug companies and are therefore unwilling to consider non-drug treatments. The reasoning is that if CCSVI is the cause of MS, it can be cured and drug companies will stop making money.

    Adolfo says neurologists are keen to maintain the status quo and show an ''indifference'' to their patients' pleadings to consider CCSVI.

    ''Look, the status quo is that it's a $US9 billion a year industry … What I'm saying is that neurologists are willingly overlooking a possibly causative factor which contributes to MS.''

    One of Australia's leading neurologists, who does not want his name mentioned for fear of vilification, says he is deeply upset by the claims.

    ''What we're being accused of is quite nasty from a doctor's perspective; deliberately keeping our patients sick because we want to make money from them.''

    With all the disagreement, it can be difficult for newly diagnosed patients to wade through the debate.

    Brian Lee is very scientifically literate but even he had trouble working out what to believe about CCSVI.

    Initially, Zamboni reported finding that about 90 per cent of people with MS had blockages in their jugular veins, compared with virtually no healthy patients.

    After further trials, this figure was revised and small independent studies have repeatedly been unable to show any difference in the rate of blockages in MS and healthy patients.

    The Herald approached half a dozen of Australia's leading neurologists and they all expressed similar sentiments: the theory is implausible and there is now no credible evidence to support it. Moreover, there is a building body of evidence suggesting the initial findings were mistaken.

    ''If your question is, how plausible is it? I don't think there is any reproducible evidence thus far to support it,'' says Dr Michael Barnett, senior lecturer in neurology at the University of Sydney and head of the MS Clinic at the Brain and Mind Research Institute. He stresses, however, that nobody completely understands MS so the initial findings need to be properly tested in a large controlled trial.

    Until then, the invasiveness of the surgery means he and many other neurologists consider it ''negligent'' for doctors to perform the procedure outside a clinical trial.

    ''The last thing we want to continue is what's happening now, where patients are having ad hoc procedures for something that is unproven and might harm them.''

    Patients who have treatment for CCSVI and experience improvements seem to be powerful arguments in favour of the theory. But as Barnett points out, there are people who seem to get better after receiving all kinds of strange and unproven treatments.

    Early MS is characterised by periods of sickness and of wellness, something that allows for mistaken links to easily be drawn. And placebos are known to be very effective for many conditions, meaning the treatment doesn't have to actually do anything to appear to make a difference.

    ''The problem is, there's up to a 30 per cent improvement with any treatment you give. I have patients who sting themselves 30 times a day with bees and they tell me that makes a great improvement.

    ''I have patients who take low dose naltrexone [a drug for treating heroin dependence] who tell me it makes a great deal of difference. I have patients who spend $50 a week on probiotic yoghurt who tell me it makes a great deal of difference.''

    He is quick to point out that CCSVI may not fall into the same category but we can't decide until further evidence is produced.

    Phlebologists like Zamboni, on the other hand, agree more studies should be done but don't think patients should have to wait for further trials. ''I am fully convinced that CCSVI is a strong contributing factor to a complex multifactorial disease,'' he told the Herald.

    ''It plays a role in increasing the susceptibility to MS and to a bad prognosis, as well.''

    The founder of the Australasian College of Phlebology, Dr Paul Thibault, agrees. He accepts there are problems with the treatment and questions the theory but adds: ''Clinical trials are not necessarily the way to sort these problems out.''

    He says that given the improvements he's seen in patients after the treatment, there's no reason to withhold it from patients who are not enrolled in clinical trials.

    In response to the growing evidence pointing to no association between vein blockages and MS, Zamboni says the researchers are simply not trained properly. He says technicians need time to develop skills to detect CCSVI reliably. When his lab started doing the research, they found CCSVI in only 65 per cent of MS patients but two years later, they were finding it in 90 per cent.

    He believes the negative results of other groups are also a result of bias and that people unwilling to find an association will manage to avoid finding one. But sceptics say this argument runs both ways: his group is clearly invested in finding an association and might therefore be biased in favour of finding one.

    The Australasian College of Phlebology and The Royal Australian and New Zealand College of Radiologists have no official position on the surgery. MS Australia recommends against having it done outside a clinical trial, although CCSVI Australia, supported by MS Australia, will hold an open forum about the procedure on Saturday. It will be live in Melbourne with an interactive broadcast to venues in Canberra and Sydney.

    Zamboni is hopeful the Australian conference and one just completed in Italy will help build consensus around his theory and help more patients obtain the treatment.

    Against the recommendation of his neurologist, Lee parted with about $3000 and underwent surgery for CCSVI last October, joining about 200 other Australians and more than 12,000 people worldwide. The surgery didn't hurt him but it didn't do him any good either.

    ''It left me as stuffed as I was before,'' he says.

    Although he was prepared for the operation not to work, he couldn't help but be disappointed.

    ''You've got to roll with the punches. It's unfortunate but that's what happened to me. I'm getting used to it.

    ''Although the procedure really did me virtually no benefit at all, I don't regret doing it and in the same situation, I would do it again.''

    But Barnett is hopeful about the future of non-invasive treatments for MS patients.

    ''The world of MS therapy is exploding after 20 years of having just four immunomodulatory drugs,'' he says.

    New drugs soon to be available are said to dramatically reduce relapses for patients early in their disease. But Barnett says what is needed are drugs that can promote restorative functions in the brain, allowing damaged nerve coverings to repair, rather than just those that target inflammation in the brain.

    ''At the moment, we don't have those drugs but we have several that are in early-stage trials.

    ''When those drugs come about and we can treat the disease from two angles, that's when we'll really be able to help people.''

    Source: smh.com.au Copyright © 2011 Fairfax Media (31/03/11)

    ISNVD first annual meeting - conclusions

    CCSVI VenogramMany of the issues which are still open on the relationship between CCSVI and MS found an answer at the ISNVD (International Society for Neurovascular Disease) Annual Meeting. The Society, chaired by Prof. Paolo Zamboni, held its meeting in Bologna (Italy) on March 14-15, 2011 under the High Patronage of the President of the Italian Republic.

    The Meeting – attended by registered physicians, researchers and accredited journalists – was preceded by a preliminary meeting of the International Scientific Committee on Sunday March 13. It was organized in the form of a Consensus Conference with the purpose of defining minimum starting points in the approach to the investigated diseases.

    There was a great deal of interest in the research of CCSVI, the vascular condition discovered by Prof. Paolo Zamboni from the University of Ferrara, which seems to interfere with  progression of Multiple Sclerosis.

    The history of CCSVI recognition has indeed gone through a tortuous pathway, more so in Italy than in foreign countries. However, last Spring the Italian Higher Health Council assessed the “18-months’ results of a preliminary experience of correcting the stenosing lesions” as promising and regarded Prof. Zamboni’s observations as “being of undoubted interest and worth being further investigated with all the tools currently available to medical research”.

    Highly distinguished world experts attended the Meeting in Italy, not only to confront themselves with the new scenarios opened up by this discovery, but also to discuss the independent studies successfully carried out by the most famous Universities in the world during the past two years.

    The Meeting will be a milestone for CCSVI research: among the most significant presentations were those documenting the on-going experiences at the University of Stanford and UCSD, to mention just a few.

    In particular, data were presented to show whether CCSVI is associated with MS (recent studies by several independent groups) and how CCSVI treatment with angioplasty may change and/or improve the MS symptoms as pointed out by recent studies performed with this type of treatment with the approval of the Ethics Committees of several Universities of the world.

    The following were among of the main topics of discussion:

    EPIDEMIOLOGY OF CCSVI IN MS

    Many different groups from all over the world clearly showed by the means of gold standard catheter venography that the prevalence of CCSVI in  MS is more than 90% of the cases (USA, Greece, Poland, Jordan, ….).
    To the contrary  the prevalence of CCSVI in healthy people has been calculated in a study by using CT angiography in less than 8% of cases (Wayne state University, Michigan).

    Prof. Bastianello present the data of an international epidemiology observatory that collected more than 700 cases with ECD carried out by trained staff. It is the first large multicenter study on CCSVI while those conducted so far were simply single-center studies.
    The result of this non invasive study clearly confirm the data above because the percentage of MS patients with ccsvi is 86%.

    ROLE OF OXYGENATION AND TISSUE DRAINAGE

    Among the questions that were answered at the Meeting was also a fundamental one which relates to the observation  made by Bruce Trapp from Cleveland (one of the most eminent MS researchers) according to whom nerve cell damage and death are due to an axonal asphyxial phenomenon which has not been yet completely clarified.

    Data from a joint study conducted with perfusional MRI by the University of Buffalo, Prof. Zamboni and Dr Salvi (see relevant press release) - soon to be published in the BMC Medicine journal - were presented in Bologna by Prof. Robert  Zivadinov, showing that this asphyxial cell phenomenon could be related to severe obstruction of the extracranial veins, thus providing a first substantial answer to asphyxial hypothesis in MS.

    ROLE OF IRON

    Major contributions were presented on the role of iron, with particular reference to its build-up around the veins, which is one of the key points of the CCSVI theory.

    One of the pivotal observations is that iron builds up around the cerebral veins, even in the white matter. This is what mostly differentiates MS from many other inflammatory and neurodegenerative diseases.

    The role of iron in nervous system degeneration was the subject of a dedicated session with a presentation by Prof. Iadecola from NY, one of the greatest experts in Alzheimer’s disease.

    ADVANCED DIAGNOSTIC IMAGING

    Over and above the well-established gold standard of catheter phlebography which was presented by Dr Roberto Galeotti, one of the pioneers in the use of this technique, all the new diagnostic tools developed for CCSVI during the past two years were reviewed during the opening session of the Meeting chaired by Profs. Haacke and Salvatore on Monday morning. The groups of Wayne State University, Detroit, and of the Buffalo Neuroimaging Analysis Center of the University of Buffalo presented a large amount of emerging data on advanced diagnostic techniques.

    Concerning the screening methods – in which patients are mostly interested  - new achievements have been proposed. From the diagnostic standpoint, one of the main objections is that diagnosis of CCSVI is being too dependent of Eco-Colour-Doppler and on the reading skills of the physician, therefore not always reproducible.

    To avoid this, Prof. Zamboni and his team at the Center for Vascular Diseases of the Ferrara Hospital have developed a new diagnostic technique, i.e. cervical plethysmography. Data were presented how this non-invasive tool will allow for preliminary screening and diagnosis with high diagnostic reliability without being operator-dependent.

    Cervical plethysmography is currently a prototype which is not yet commercially available but has some advantages: the test lasts only 5 minutes and makes it possible to obtain a final answer in 85% of cases.
    However, this test does not rule out the need for ECD which must be performed if  a subsequent patency procedure is to be carried out. Therefore, this new diagnostic method may become a fast and cheap screening procedure.

    TREATMENTS

    Concerning endovascular treatment, one can state that the highest level of scientific evidence is generated by double-blind randomized trials which require a long time for completion.

    In science it is well-known, however, that scientific evidence can also come from several observational studies which independently and scientifically measure the effects of a certain treatment in a very high number of patients.

    Additional evidence was provided by the results of two American studies which were among the first to be carried out in this field. They are observational studies which measure the effects of angioplasty on a very large number of patients. They can be regarded as a corollary and driving element for other studies such as those which are about to be carried out in Italy.

    The outcome of over 1,000 cases treated in different studies all over the world were presented. The most fascinating piece of research is the one of Dr D. Hubbard from the University of California San Diego.

    Functional MRI is a real-time technique which makes it possible to identify the plastic changes that the brain undergoes during functional brain activities.
    The cognitive skills of a group of 20 subjects with MS were measured by having them perform a series of memory and operational drills under functional MRI control.

    After the necessary examinations, the San Diego team performed angioplasty on all 20 subjects with MS. When re-checked using functional MRI, they showed significant improvement in their cognitive skills which no longer differed from those of the healthy controls used for comparison.

    A second treatment study was presented by Dr M. Mehta from Albany Medical Center, NY, who studied 150 consecutive MS patients where he identified almost 300 jugular and azygos veins with significant stenosis and performed angioplasty.

    In the post-operative phase, he monitored important aspects such as chronic fatigue which is one of the most disabling symptoms of MS and one with no therapeutic response.

    Chronic fatigue improved significantly in all surgical patients. This was further confirmed by more than 25% increase in the quality of life scores as measured by physiatrists who were unaware of the surgical procedure one year after angioplasty.

    Data are also available from the Polish Center of Katowice which alone operated on more than 1,000 patients, while Dr M. Zarebinski  presented the data of 420 patients who underwent venoplasty in Warsaw.
    This study confirmed the safety of the treatment, since in this and all other studies no complications or deaths were recorded. The study also confirmed significant improvement in chronic fatigue and quality of life.

    Finally, Dr A. N. Siddiqui from Buffalo showed some preliminary data on a randomized trial which is currently being carried out on 30 patients at the Departments of Neurosurgery and Neurology of the University of Buffalo.

    ANIMAL MODELS
    As requested by many Scientific Committees throughout the world to legitimate research, the results of the development of animal models of CCSVI were presented by Stanford University, showing a correlation between reduced venous function and impaired motor ability.


    OTHER VASCULAR DISEASES THAT WERE DISCUSSED:

    The Meeting was not limited to CCSVI but also covered important associations with other vascular diseases; for example, Costantino Iadecola spoke about Alzheimer’s disease and vascular dementia; many national and international experts talked about carotid artery treatment for stroke prevention; finally, Dr Fabrizio Salvi spoke about the unusual symptoms observed in his clinical practice in conjunction with cerebral venous diseases.
     
    The vascular mechanisms involved in neurodegeneration were outlined in the keynote lecture of the Meeting which was delivered by a well-known neuroscientist, Prof. Berislav Zlokovic from Rochester NY.

    Source: International Society for Neurovascular Disease (16/03/11)

    Consensus on CCSVI diagnostics from ISNVD meeting in Bologna

    CCSVI VenogramAs a prelude to the ISNVD (International Society for Neurovascular Disease) Annual Meeting, a Consensus Conference was held in Bologna on Sunday March 13th to define the practical guidelines to the screening investigation of CCSVI.
     
    The Consensus Conference focused on the method proposed by Prof Zamboni for the detection of Chronic Cerebrospinal Venous Insufficiency (CCSVI) using Doppler. This diagnostic method was developed by Prof Paolo Zamboni and his Staff at the Center for Vascular Diseases of the Ferrara University.
     
    The conference became necessary to standardize the investigation and reporting techniques all over the world. It will thus be possible to use common diagnostic criteria and standards in the scientific reports.
     
    The Consensus Conference was attended by 40 experts from the International Society for Neurovascular Disease (ISNVD) and 7 representatives of the major national and international societies which are concerned with the diagnosis of the venous system by means of sonographic equipment.
     
    The result was the unanimous approval of a document recognizing 90% of the method already proposed by the Ferrara and Bologna research teams.
     
    Furthermore, a series of improvements were added to increase the reproducibility and the dissemination of the method.
     
    Some parts of the method (the remaining 10%) are for the time being regarded as additional criteria requiring further investigation to obtain the necessary evidence.
     
    The document signed in Bologna will be sent to the main journals in the following disciplines:
     
    vascular diagnostics, radiology, neuroradiology, interventional radiology, vascular surgery, angiology, neurology, vascular diagnostics.
     
    The medical community that participated in the conference was particularly satisfied with these results. This shared view will soon lead to new developments also at the level of the scientific publications which will be enriched by the experience gained in the numerous international centers which participated in the Consensus Conference.
     
    The main societies that deal with the diagnostic investigation of the venous system and attended the Consensus Conference are: the European Venous Forum, the International Union of Phlebology, the International Union of Angiology, the American and Australasian College of Phlebology, the Italian Society of Vascular Pathology, and the Italian Society of Vascular and Endovascular Surgery.
     
    Prof Zamboni’s co-chair was Prof Nicolaides who headed the vascular research team at St. Mary’s Hospital in London and had important roles as President of many vascular societies world-wide.
     
    An important merit of Prof Nicolaides is that in 2000 he chaired the Consensus Conference which defined the way of investigating the venous system using ultrasonographic equipment.

    Source: International Society for Neurovascular Disease (15/03/11)

    'British MS experts have to open their minds’

    CCSVI VenogramLast July, we reported on the battle by MS sufferer Mark Walker to have a controversial new treatment recognised in Britain. Here, he tells how his condition has improved since having it abroad.

    My wife’s reaction when she touched my feet on July 1 2010 was unexpected but very welcome. “They’re the same temperature and nearly the same colour,” Natasha announced excitedly. I should explain that my right foot has felt cold to the touch and been purplish in appearance for many years.

    The day before, I had undergone a controversial treatment at a clinic in Athens and this was tantalising evidence that something had changed in my body as a result.

    I am 51 years old and I have multiple sclerosis (MS). The first symptom – double vision lasting several weeks – developed in November 1991, although I did not receive a definitive diagnosis until April 1997. By 2000, I had accumulating symptoms including numbness, balance and bladder problems and a general feeling that, while it might not be yet apparent to my friends, MS was slowing me down in every way.

    In January 2003, I was hit by physical and mental fatigue so debilitating that I could hardly get out of bed. I was forced to give up my much-loved job as a management consultant with IBM, something that left me depressed. I have never recovered sufficiently to return to work. Despite treatment with conventional drugs and therapies, my MS progressed steadily, with mobility on my right side increasingly impaired, and I have had several serious relapses when symptoms have increased in severity. As a qualified pharmacist, I have used my scientific knowledge to research the disease and its management thoroughly. I am what doctors call an “expert patient”. After 20 years of living with MS, I am willing to try any safe, logical therapy.

    It was in October 2009 that I first heard about Professor Paolo Zamboni, director of the Centre for Vascular Diseases at the University of Ferrara in Italy. In 2005, his wife Elena was diagnosed with MS, and he embarked on a personal mission to discover everything he could about the disease, from medical literature dating back 100 years to the use of state-of-the-art body scanning techniques.

    He concluded that the MS was, in part, a vascular disease caused by restricted, blocked, malformed or twisted veins or vein valves in the neck and trunk. A small clinical study appeared to back his claims. He named the syndrome “chronic cerebrospinal venous insufficiency” (CCSVI) and set about developing treatment to unblock – or “de-stenose” – the veins so that healthy blood flow was restored. He claimed a dramatic improvement in his wife’s condition and that of other MS patients he treated.

    News of Zamboni’s theory and treatment spread within the MS community via chatrooms and websites, leading hundreds of people around the world to seek the treatment, known as venoplasty (similar to angioplasty, in which a balloon is inserted into a blood vessel and inflated to remove a blockage).

    In June last year I was interviewed by The Daily Telegraph about my battle – and failure – to obtain a diagnosis of, and treatment (if required) for, CCSVI in Britain and my decision to seek help abroad. Neurologists at my local hospital, the John Radcliffe in Oxford, claimed that it was not ethical or prudent to even attempt to diagnose CCSVI because of doubts about Zamboni’s work. Quite why it wasn’t “ethical” to use a safe, non-invasive diagnostic procedure (colour Doppler sonography) – which I was willing to pay for – to look at my veins continues to baffle me.

    So I took my quest for venoplasty to a clinic in Athens which had treated many MS patients for CCSVI. You are reading the update on the treatment and my condition that readers were promised in that article.

    I was the 45th MS patient to be seen by Constantinos “Costas” Kartkaletsis, a consultant vascular surgeon. After an initial examination, blood tests and a chest X-ray, he explained that a catheter would be inserted into the femoral vein in my groin and guided into my main trunk and neck veins. I was injected with anti-coagulant and put on a drip. I would have a local anaesthetic only and be fully conscious for the whole procedure.

    I could feel the balloon inflating inside my veins but there was no pain. Restrictions were diagnosed in four major veins (the azygos vein, hemi-azygos, and the left and right internal jugular veins) in the trunk and neck, and all were treated using balloon venoplasty over three hours.

    I had not expected any immediate impact, but Natasha’s surprise at the improved condition of my feet next morning left me elated. I could not explain what had happened but something had changed. Mr Kartkaletsis was interested in Natasha’s observation but he has a policy of treating restricted veins rather than commenting on any change in MS symptoms following treatment.

    Back home, I planned complete relaxation for two months. I decided not to try to record frequent changes but to note trends on a monthly basis, as MS symptoms can vary daily.

    At the end of the first month I felt my concentration had improved. People with MS use the term “cog fog” to describe the deterioration in cognitive functioning. Friends noticed that I no longer needed regular naps and that I focused better on conversations. After three months, I felt I was functioning mentally at least as well as I was a decade ago.

    There were other changes, too: I’d had neuropathic pain (caused by damage to the nervous system) in my right leg for many years. That went and has not returned. After years of not recalling my dreams – an observation reported by many with long-term MS – I have, for the past six months, remembered them again. My need to get up at night to urinate also improved slightly, from three to six times to one to three times a night – something much appreciated by my wife.

    My walking and balance have not changed over the past six months, and I still rely on my Musmate walking aid and trekking poles to get about. But, on the plus side, my osteopath David Harsant, at Oxfordshire’s Multiple Sclerosis Therapy Centre, who made extensive notes before and since the procedure, reports gradual improvement in muscle tone, stiffness and spasm in my neck and back. He says my neck muscles felt ''matted, congested and were indistinguishable.’’ but after the venoplasty ''the matted sensation reduced and the palpability of individual muscles increased”.

    Professor Zamboni has reported that some patients may require repeat treatments if their veins “re-stenose” after venoplasty. Vascular specialists are defining the best way to diagnose restricted veins, the veins to check, the best size, position, pressure and duration of ballooning. I expect to undergo another procedure when the method is finalised.

    CCSVI remains a controversial diagnosis, as does its treatment. However, MS patients are at the forefront of spreading the word and the internet is making that easier. I have watched a doctor from Kuwait present his work on CCSVI to vascular specialists in New York, and heard an interview with a research neurologist who has collated doctors’ reports on CCSVI. Expert patients like me are frustrated by the refusal of the MS establishment in Britain – neurologists and the MS Society – to accept the existence of this condition and consider testing for it. Since I went to Athens, testing for CCSVI and balloon venoplasty has become available to private patients at a clinic in Glasgow. The package costs £7,990 and there is already a waiting list.

    Would I recommend the treatment to other MS patients? I would certainly encourage those with progressive MS to think about balloon venoplasty. There is a small risk of vein injury but, based on doctors’ web reports on 2,000 people treated, I believe there is a chance that it may slow or halt progression of the disease. I was lucky that the cost of private treatment was not prohibitive but sadly this is not the case for many. I have tried explaining to neurologists and vascular doctors why CCSVI syndrome should at least be considered as a possibility in patients with MS but to no avail. Only my caring, supportive GP was prepared to listen. Medical journals refuse to publish patients’ point of view – I know because I’ve tried that, too. One has to ask what the neurology establishment is so frightened of: opening the veins of those with MS or opening their own minds.

    MS and CCSVI syndrome

    Multiple sclerosis (MS) is a degenerative disease of the nervous system affecting 100,000 people, most of them young adults, in the UK. It is believed to be autoimmune in origin, (meaning the immune system mistakenly attacks the body’s own cells) and triggered by genetic or environmental factors, or a combination of both. These cause immune cells to cross the blood/brain barrier (which keeps blood and cerebrospinal fluid separate) and attack the fatty, white myelin sheath that surrounds and insulates nerves in the brain and spinal cord.

    The symptoms of MS vary widely, as does the severity of the disease. In some people, it progresses relentlessly. Other patients suffer the relapsing and remitting form – periods of relative good health interspersed with flare-ups and neurological deterioration. Several treatments are available of varying efficacy, including immuno-modulator drugs (which, as the name suggests, inhibit the immune system) and steroids.

    Research by Professor Paolo Zamboni, director of the Centre for Vascular Diseases at the University of Ferrara in Italy, has led him to call for a radical rethink on MS. He suggests that MS is not only an autoimmune disease, but also a vascular one, caused by restricted, blocked, malformed or twisted veins in the trunk and neck. A small study showed that 90 per cent of his patients with MS had venous obstruction. Prof Zamboni has named the condition chronic cerebrospinal venous insufficiency (CCSVI) syndrome. It is characterised by stenoses (narrowing) of the internal jugular vein (which runs down the side of the neck) and/or the azygous veins (which run up the side of the vertebrae). These veins drain blood from the brain and the spine into the heart.

    Prof Zamboni said that two pilot studies demonstrated the safety and feasibility of day surgery for treating CCSVI by means of balloon angioplasty, also called balloon venoplasty, using minimally invasive techniques to unblock the obstruction. As yet, only initial pilot studies have been published as to the effectiveness of this experimental treatment.

    He also suggests that an excess of iron, which causes inflammation and cell death, was responsible for tipping the immune system out of balance, resulting in MS symptoms.

    British neurologists and the Multiple Sclerosis Society are extremely sceptical of Prof Zamboni’s work, stating that MS patients should wait until ongoing research into his claims is completed before embarking on treatment.

    Source: The Telegraph © Copyright of Telegraph Media Group Limited 2011 (07/03/11)

    Concerns raised about controversial MS treatment

    CCSVI VenogramSerious concerns have been raised about a controversial vein-widening treatment being offered to people with multiple sclerosis.

    An investigation by BBC Inside Out discovered that one doctor carrying out the procedure in Egypt is not licensed to practice medicine in that country.

    The BBC understands that in the UK, an NHS GP has been reported to the doctors' watchdog, the General Medical Council, for organising the treatment through his private company at a cost of nearly £8,000.

    The operation has been dubbed the 'Liberation Procedure' by those who believe it helps relieve the symptoms of MS, an incurable condition.

    Unproven treatment
     
    It involves inserting tiny balloons into the body via an incision in the groin. The balloons are fed up to certain veins in the upper body and neck, then inflated to stretch the vessel wider.

    Some patients also have small metal tubes - or stents - inserted to prop their veins open.

    The treatment is based on a new and unproven theory that MS is caused by vein blockages which impair the flow of blood from the brain.
     
    This is a radical departure from the mainstream view that there is no known cause of the disease.

    It is thought that several thousand people with MS may now have been "liberated" at private clinics in countries like India, Poland and Bulgaria.

    Some have posted before-and-after internet videos showing their apparent improvements.

    But the MS Society says these results could be down to the placebo effect and the fact that multiple sclerosis symptoms can come and go over time.

    Dr Doug Brown, head of biomedical research at the MS Society, says: "One of the complicating factors is the placebo effect where people feel better for going through a treatment process but not necessarily because of the treatment directly.

    "It's an unproven treatment and until this treatment goes through a clinical trial it is impossible to say if its works and if it is safe for people with MS."

    Blocked veins theory queried
     
    The theory that blocked veins cause MS was put forward just over two years ago by an Italian doctor Paolo Zamboni.

    His research seemed to show that only people with MS had multiple abnormalities of certain veins in their upper body which impaired the flow of blood out of the brain.

    He called this supposed condition chronic cerebro-spinal venous insufficiency or CCSVI. He said it never occurred in the healthy people in his study.

    In 2010, a US researcher claimed that he had found CCSVI in just over half of people with MS. This work has not yet been published.

    However seven published studies by independent researchers have failed to back up Zamboni's findings.

    Some of those research teams have suggested that what he interpreted as abnormalities were in fact normal and harmless anatomical variations found in everyone.

    John Zajicek, Professor of Clinical Neuroscience at the Peninsula Medical School in Plymouth, said: "I can understand that people get desperate. But there's virtually one new treatment a year that people with MS get led into and proves to be ineffective.

    "At the moment there's no evidence to my mind that this procedure and this explanation for multiple sclerosis have any value at all."

    Concern about treatment risks
     
    Because the theory remains unproven, the procedure is not available on the NHS.

    There are also concerns about the risks. Two deaths have been connected to Liberation abroad. Both of those patients had stents which are believed to increase the risks of complications.

    BBC Inside Out's Sam Smith outside the Essential Health Clinic Nonetheless, vein widening - without stents - is now being offered in the UK by a Glasgow-based company called the Essential Health Clinic.

    BBC Inside Out presenter Sam Smith went undercover to be scanned by Essential Health - the first stage in the treatment process which in total costs just under £8,000.

    She was diagnosed with CCSVI.

    London-based vascular surgeon Ian Franklin said of Sam's diagnosis: "This reinforces the concern a lot of people have that some of these anomalies might be present in the normal population and raises the question that it might not be specifically linked with MS."

    Essential Health is run by a practising GP Dr Tom Gilhooly. He denies any wrongdoing.

    Dr Gilhooly insists the Liberation procedure is supported by sound scientific evidence.

    He told the BBC: "You are not going to change what we do, you're not going to change our determination to make these patients better. I see these patients, I know these patients, I value these patients, I've looked after them for years. I've seen them after the procedure, the vast majority are improved."

    Asked why he thought he had been reported to the GMC, he said he knew nothing about the complaint.

    British patients seek treatment abroad
     
    Essential Health has a long waiting list and some British patients are seeking treatment abroad.

    Dr Tariq Sinan from Kuwait carries out the procedure on patients from all over the world at a private clinic in Alexandria in Egypt where they do not use stents.

    He says he has seen amazing improvements in the patients he has treated.

    The Inside Out team travelled with MS patient, Karen Lewis, from Devon, to Egypt.

    But shortly before Karen's operation he admitted to the BBC crew that he is not licensed to practice medicine in Egypt.

    Karen agreed to him carrying out the procedure anyway.

    Two months later, she says her walking and the feeling in her hand have improved - and she is convinced the operation was worthwhile.

    She said: "It's like a whole weight has been lifted. Whereas before I used to shed a tear every day, I haven't cried since I had the procedure.

    "If this is placebo, I'll take it every day."

    This programme is broadcast on Inside Out South West on Monday 7 March BBC One at 1930 and nationwide via the BBC iPlayer following transmission.

    Source: BBC News © British Broadcasting Corporation 2011 (07/03/11)

    Experts to assess CCSVI multiple sclerosis treatment

    CCSVI VenogramThe Ontario government has assembled a group of experts to develop guidelines on followup care for multiple sclerosis patients who’ve travelled abroad for a controversial medical procedure not available in Canada.

    Hundreds of MS patients — including some from Windsor and Essex County — have gone to different parts of the world for the so-called “liberation” procedure, which involves opening up blocked veins to improve blood flow.

    Many of them have complained about the lack of followup care and treatment once they return home. They also complain about dealing with physicians who are skeptical of the theory that improper drainage of blood from the brain may be causing MS and could be corrected with angioplasty — a simple vein opening procedure.

    An expert advisory panel, composed of leading MS clinicians, as well as neurology and cardiovascular specialists, will develop best practice guidelines for treating people who’ve had liberation therapy and make recommendations to the government.

    In a news release, Ontario Health Minister Deb Matthews said she is confident the group’s work will ensure those who undergo the procedure out of province will “receive the best possible care when they return.”

    The MS Society of Canada welcomed the move Tuesday, but for one Windsor MS patient, Ontario’s response has been too slow.

    “I’m still on my own. This has been very much my own journey,” said Lisa Maheu-Gauthier, a 45-year-old single mother who travelled to California in January for the liberation procedure.

    “I’m glad that (Ontario) is looking into followup care ... but I’m still very disillusioned with Canada,” she said.

    Maheu-Gauthier now pays out of pocket for physiotherapy and wishes the government would do more for people like her.

    “It’s a real financial hardship,” she said, adding that she was able to go to California only because her sister and brother-in-law paid for the treatment.

    Like a growing number of MS patients around the world, Maheu-Gauthier is a firm believer in the findings of Italian doctor Paolo Zamboni, who suggested that MS is not an autoimmune but a vascular disease caused by an underlying condition which he termed chronic cerebrospinal venous insufficiency, or CCSVI.

    Zamboni used a procedure similar to angioplasty to clear the vein blockages in a number of MS patients, including his wife. He said that of the 65 patients he treated, 73 per cent had no symptoms two years after surgery.

    The results of his study, published in 2009, made waves around the world. But many scientists and physicians remain skeptical and Canada has decided not to fund clinical trials of the CCSVI procedure until more studies are done.

    That has driven scores of Canadians to seek treatment in countries as far away as India, Bulgaria and Costa Rica, with varying results.

    Last October, a St. Catharines man died after undergoing the CCSVI procedure in Costa Rica and developing a blood clot around a stent placed in his neck. Other MS patients whose procedures involved stenting have also complained of blood clotting and other complications.

    Maheu-Gauthier, who uses a motorized chair to get around, opted for a stent-free version of the procedure at a clinic in California specializing in interventional medicine and vascular surgery. She said she could feel improvements immediately.

    “While I was on the operating table, I could feel the blood rushing to my legs, through my body” she said. “It felt like a champagne bottle was popped.”

    She now feels warmth in her hands and feet, which were “blue and cold” before, and says she felt stronger immediately after the procedure.

    Although she still can’t walk, Maheu-Gauthier said she is now able to sit upright in her chair and move her body forward. And she’s determined to walk again.

    “It’s a constant fight and battle. I have to battle for me now.”

    Maheu-Gauthier said she will be filing a claim with OHIP, seeking reimbursement for the cost of her CCSVI treatment and travelling costs.

    “It was an essential treatment and it was not provided to me in Canada,” she said.

    But a ministry spokesman said OHIP will not pay for CCSVI procedures. This fiscal year, OHIP has received 52 claims for out-of-country MS treatments, most of them involving liberation therapy.

    The local MS Society chapter says it knows of at least 10 local patients who have had the procedure or are planning to get it abroad. It has been estimated that there are about 1,000 MS cases in Windsor-Essex.

    Source: The Windsor Star © 2008 - 2011 Postmedia Network Inc. (02/03/11)

    No consensus yet on CCSVI/MS theory

    CCSVI VenogramNeurologists and endovascular interventionalists may be edging closer to agreement on how to evaluate the controversial vascular theory of multiple sclerosis, but important gaps still appear to divide the two groups.

    That was the upshot of a panel discussion held here Monday at the International Symposium on Endovascular Therapy (ISET), featuring the National Multiple Sclerosis Society's (NMSS) chief medical officer -- a neurologist -- along with several representatives of the interventional community and a patient advocate for more aggressive study of the theory.

    Like North and South Korea glaring at each other across the demilitarized zone, relations between neurologists and endovascular interventionalists have become tense over the theory that obstructions in the jugular vein disrupt blood outflow in the brain, leading to the nervous-system inflammation characteristic of MS.

    Although the theory isn't new, the current furor began in late 2008 when Italian researchers claimed they found "chronic cerebrospinal venous insufficiency," or CCSVI, in nearly every MS patient they studied, and that venous angioplasty (with stenting in some patients) reduced or eliminated signs of the disease in many of them.

    Although many neurologists were deeply skeptical, MS patients who heard about the results rushed to their physicians by the thousands to demand the treatment. Many found vascular specialists who would accommodate them -- if not in the U.S., then in Poland, Mexico, Costa Rica, and India.

    Many patients -- including panel member Sharon Richardson, who now leads an advocacy organization for the procedure -- have reported that the treatments helped them. But there have also been widely publicized failures, including a Canadian MS patient who died in Costa Rica in November following jugular vein angioplasty, which apparently ruptured the vessel and caused him to bleed out.

    Neurologists cited the episode as a reason for patients and physicians to be more cautious, while advocates of the theory saw the neurologists themselves as the villains, because they had made it difficult for patients to receive the procedure closer to home.

    Jack Burks, MD, the NMSS medical chief who participated in the ISET panel discussion, acknowledged that the divide was essentially "a turf war" between specialties.

    Speaking with tongue partially in cheek, he said neurologists viewed the interventionalists as "cowboys" who "overstate the positive value" of vascular treatments in an effort to extract money from desperate patients. To neurologists, he added, "commercial interests are overriding scientific inquiry."

    The attitude in the other direction, Burks said, was that neurologists are merely concerned about losing their own lucrative income, and that they are pawns of pharmaceutical companies whose product sales would plummet if the surgical therapy takes hold.

    He suggested that the only way to make genuine progress would be to craft a "united message" that neurologists, endovascular specialists, and MS patients could all endorse. A task force of representatives of the three groups should draft such a statement this year, Burks said.

    From his own perspective as a neurologist, Burks proposed that research to establish benefit and safety of CCSVI-based treatments should not be focused only on determining whether procedures genuinely help patients get better, but should be wider in scope.

    Other goals listed by Burks include:

    •The best test to determine if CCSVI is present
    •Appropriate outcomes to measure
    •Optimal procedures, such as use of balloons and stents
    •Qualifications for CCSVI specialists and centers
    •Establishment of a patient registry to track long-term outcomes
    •Whatever it takes to end medical tourism for CCSVI procedures

    Even before dealing with these points, Burks said, radiologists and interventionalists will need guidance in confirming that patients who come to them for CCSVI testing and correction genuinely have MS.

    "Let me tell you something you're going to be experiencing if you haven't experienced it already," he told attendees. "If this thing is accepted as the major treatment for multiple sclerosis, [patients will say] if this helps in multiple sclerosis, it will surely help in Parkinson's and Alzheimer's and every other disease known to man."

    Burks continued, "The patients will know how to get the procedure -- tell people they have multiple sclerosis, because that is the key to getting tested [for CCSVI]. So we have to have criteria for the diagnosis of MS, so that unsuspecting interventionalists aren't confronted with people who say they have MS but may not."

    He also argued that all treatment should be conducted as part of formal research protocols, vetted by institutional review boards (IRBs).

    James Benenati, MD, president of the Society of Interventional Radiology (an ISET co-sponsor), who also participated in the panel discussion, endorsed most of Burks's suggestions.

    But he appeared to balk at IRB review as a requirement. "We strongly advocate that every patient be followed closely. But if you're not participating in a research trial, you have to at least design your own protocol and monitor your patients very carefully."

    A third panelist took an even dimmer view of IRB review, saying he quit his university job rather than accept what the school's IRB was going to require.

    Salvatore Sclafani, MD, was chairman of radiology at SUNY Downstate Medical Center in Brooklyn, and wanted to perform CCSVI testing in patients there, with treatment for those testing positive.

    He told ISET attendees that the IRB rejected his application, telling him instead to conduct a double-blind, sham-controlled trial.

    Sclafani said such a trial would be premature at this stage, with too many unknowns about techniques, patient selection, and follow-up treatment.

    Rather than give up the research entirely, he left his post at SUNY Downstate and moved to an ambulatory center where, he said, he could evaluate "a thousand patients a year."

    "This awful disease needed me to leave my practice," he said.

    Benenati also pointed out interventionalists have been derided as "cowboys" before for procedures that eventually became standards of care.

    "We were cowboys when we did iliac angioplasties, we were cowboys when we did TIPS [transjugular intrahepatic portosystemic shunt], we were cowboys when we started stroke therapy," he reminded attendees.

    Source: MedPage Today   © 2011 Everyday Health, Inc (18/01/11)

    Studies in 2011 could decide MS theory's validity

    CCSVI VenogramAlmost exactly a year ago, a theory about a potential contributing cause of multiple sclerosis burst into the public consciousness. For many MS sufferers, it seemed an answer to their prayers; for the medical community it was variously viewed as a promising notion worthy of investigation to scientific nonsense or even an outright scam.

    What can be said for certain, however, is that no other medical story has dominated the headlines in 2010 as the contention by an Italian vascular surgeon that narrowed neck veins could be an underlying cause of MS.

    Dr. Paolo Zamboni speculates that reduced blood flow leaves iron deposits in the brain, leading to the neural lesions typical of MS. He suggests that reversing the condition -- dubbed chronic cerebrospinal venous insufficiency, or CCSVI -- by unblocking neck veins could help alleviate patients' symptoms or possibly halt progression of the debilitating disease.

    News of his theory created an avalanche of interest among people with MS and their loved ones, fuelled by discussion on Internet social media sites, YouTube testimonials by MSers "liberated" by Zamboni's suggested technique for opening up the blood vessels, and hundreds of articles in the mainstream media.

    In reaction to pressure from MS patients advocates, a few provinces have announced funding for various studies to help determine if Zamboni's theory has any validity. But the federal government is steadfast in its decision to hold off financing a pan-Canadian clinical trial of the procedure until several other studies underway show whether CCSVI is indeed a hallmark of people with MS compared to those without the disease.

    Meanwhile the MS Society of Canada has come under criticism for its handling of the issue, initially saying it could not back a scientifically unproven theory, then asking Ottawa to provide $10 million to investigate the concept, and finally supporting the federal government's decision to wait.

    "I think from all perspectives -- the patients' perspective, the medical community, the media, the social arena -- the word that describes it for everybody is roller-coaster," Ian Rodger, director of research at St. Joseph's Healthcare in Hamilton, says of the last 12 months.

    "A year ago, the notion when it was first released, gave people a huge amount of hope. And we heard all the positive stories and so it took off like wildfire."

    But as time has passed, reports have increasingly emerged about people who experienced little or no benefit from the procedure, says Rodger, who is leading a study looking at the prevalence of CCSVI in both MS patients and healthy controls. "We don't hear so much about them, but I think we now recognize that it's not a universal panacea."

    That hasn't stopped MS patients from seeking the treatment, which is not approved for CCSVI in Canada. Known as venous angioplasty, it involves inflating a tiny balloon inside the veins to expand them and restore blood flow.

    In the last year, an estimated 3,000 Canadians with the disease have travelled to clinics that have popped up around the world -- from Bulgaria and Poland to Costa Rica and Mexico to India and the United States -- paying thousands of dollars each for the procedure.

    Among them was an Ontario man who died in October after blood clots formed around a stent that doctors in Costa Rica had placed in one of his veins to prop it open. Stents are often used by clinics offering the procedure, despite Zamboni's caution that they shouldn't be used.

    "There's a lot of unfortunate things that have occurred," says Dr. Jock Murray, who recently retired as head of the MS research unit at Dalhousie University in Halifax. "One of the really unfortunate things is that it has polarized all the groups that are normally co-operating."

    "So you have now the patients who see themselves pitted against the doctors and the neurologists. They also feel they are not being supported in the way they want to be by the MS Society, so now they're attacking the MS Society.

    "And they're now pitted against the politicians, because they don't see the politicians as being supportive as they would like to see."

    Murray, a member of a working group advising the MS Society on CCSVI, is among the minority of neurologists who agrees Zamboni's concept should be scientifically assessed, like "any other theory of interest."

    For Linda Molyneux of Toronto, whose 23-year-old son with MS had venous angioplasty in Bulgaria six months ago and is showing improvement, there is no question it should be investigated -- and more than that, she says the procedure should be provided by Canadian hospitals.

    "MS patients would be happy if it was just available to pay for here in Canada, the way they might pay for a nose job or whatever," says Molyneux, one of a number of activists raising money to fund CCSVI research.

    She points out that her son's improvements have been gradual, "not an overnight epiphany."

    "And I think that's what people should look towards if they're going to have this procedure, not that they're going to jump out of their wheelchairs, but that gradually they might start feeling somewhat better and have an improved quality of life."

    Ted Robak, a professor of forestry engineering at the University of New Brunswick, believes that having his neck veins unblocked at a Polish clinic in April has not only improved his MS symptoms, but also will keep him working and mobile.

    Diagnosed in 2004 with secondary progressive MS, one of the more advanced and debilitating forms of the disease, the 57-year-old says he expected he would have to leave his job in the coming year and be forced to use a wheelchair instead of a cane to get around.

    "It's changed a lot," Robak says of his condition, particularly his level of fatigue, which had forced him to take several naps a day in order to do the simplest of tasks.

    "I don't have to steel myself to do little things like go down and check the mail in my apartment. My mobility has improved some ... I don't use the cane anymore except for longer walks ... I'm not talking about retiring or going on disability this year."

    Robak, who spent about $9,500 for the procedure plus another $4,000 for travel-related costs for him and his wife, wasn't prepared to wait the 10 years it might take to rigorously test Zamboni's theory to prove that it works. And he doesn't think others with MS who can't afford to travel outside Canada for the procedure should have to either.

    "We're talking about people who are going downhill. If somebody told me that let's say five years after this I would be exactly the same as I was when I had the treatment (and had not become worse), do you realize how much MS patients would pay for that? How happy they would be?"

    It was that hope of improving the quality of his life and stopping the relentless progression of MS that sent Ben Steinfeld to an Albany, N.Y., clinic for the procedure in November, at a cost of about $5,000.

    But the former Toronto journalist, whose career was cut short by the disease several years ago, has not seen a dramatic change in his symptoms, which include hand tremors and an inability to walk more than about six metres unaided.

    "Are there improvements? Yeah. Do I have better blood flow? Yeah, I know I do," says Steinfeld, who feels he has more energy and a better colour in his skin.

    "But did my tremor go away? No. Can I walk like a I was going for a stroll in the park? No. But I couldn't before. The bottom line is I'm definitely no worse off, it was definitely a non-invasive, non-negative experience."

    Steinfeld, who believes Zamboni's theory has validity but needs refining, recalls that one neurologist he consulted dismissed the notion as here today-gone tomorrow, like so many other purported causes of MS that caused a lot of excitement over the years, then fell by the wayside when they didn't hold up.

    "In a year from now, it'll be totally forgotten," was the way the doctor phrased it, he says.

    Given the level of interest -- and some would say hype -- it's unlikely Zamboni's theory will fade away anytime soon.

    "We're going to proceed with this, trials are going to go on, even though patients object to the time (they will take)," says Murray.

    "I think the level of dialogue is going to calm down somewhat. It's going to become a little more balanced as patients speak more about lack of benefit or complications. And so I think it's not going to go way, but I don't think it's going to increase."

    Rodger agrees, saying the coming year will see more studies being conducted in well-controlled environments that will provide more definitive answers.

    "If we were having this conversation a year from now, I think there'd be evidence that leads us in one direction or another: `Yes, it's a correct hypothesis' or 'You know what, no it doesn't stand up to scrutiny."'

    Source: CTV © 2010 CTVGlobeMedia (28/12/10)

    New Brunswick will fund MS/CCSVI vein-opening treatment

    CCSVI VenoplastyThe New Brunswick government will set up a fund to help people to pay for a controversial multiple sclerosis treatment despite the death of an Ontario man who travelled outside of Canada for the procedure.

    Mahir Mostic, 35, of St. Catharines died on Oct. 19 after complications from the MS treatment that he received in Costa Rica.

    The Progressive Conservative government announced in its throne speech that it will create a $500,000 fund to help MS patients seeking treatments.

    Premier David Alward told a news conference on Tuesday that he still believes setting up a fund is worthwhile despite Mostic's death.

    "Unfortunately, every day in New Brunswick, every day in Canada, we see people who die as a result of medical interventions," Alward said.

    "At the same time, we see the tremendous impact on people who are cured because of medical interventions of all types. It is ultimately about managing the risk and ensuring people are protected."

    Not approved in Canada

    The chronic cerebrospinal venous insufficiency (CCSVI) treatment is not approved in Canada, so several Canadians have travelled outside the country and paid for the surgery themselves.

    Mostic paid $30,000 US to go to Costa Rica for treatment in late June, he was operated on three times to have a mesh stent inserted to prop open a vein in his neck.

    Dr. Paulo Zamboni, an Italian doctor who is a leading proponent of treating MS with angioplasty, bases his therapy on an unproven CCSVI theory that blocked veins in the neck or spine contribute to MS.

    In April, Zamboni warned against using stents — small mesh coils — because of the high risk of the stents moving and lack of knowledge about their long-term effects.

    In Canada and the United States, seven studies are being undertaken to test for vein narrowing in people with MS compared with people without the disease.

    The Progressive Conservatives promised during the fall election campaign that, if elected, they would establish the $500,000 fund for the MS treatment.

    The New Brunswick premier told the news conference Tuesday that he's spoken to an old friend, who lost a relative to MS, since the news of Mostic's death.

    Alward said the message he received from his friend was very clear.

    "He said don't give up the fight on this because the vast impact on human lives and what this intervention could provide says that we need to keep moving forward," Alward said.

    "It is certainly an unfortunate situation that took place. At the same time, we know and I've met other people whose lives have been positively changed because of that action."

    Source: CBC News Copyright © CBC 2010 (24/11/10)

    MS patient dies after CCSVI vein opening surgery complications

    CCSVI VenogramAn Ontario man with multiple sclerosis died of complications after a controversial treatment in Costa Rica to open up his neck veins, CBC News has learned.

    Mahir Mostic, 35, of St. Catharines died on Oct. 19, one day after doctors in the Central American country tried to dissolve a blood-clot complication.

    "We didn’t find exactly what happened with Mahir, but I mean it was very terrible story for us," vascular surgeon Dr. Marcial Fallas of Clinica Biblica in San Jose said Thursday.

    "He was a person that was looking [for] some way to improve his life. He found that for a short period of time his life improved."

    After Mostic paid $30,000 US to go to Costa Rica for treatment in late June, he was operated on three times to have a mesh stent inserted to prop open a vein in his neck.

    "He started feeling better and got his energy back," his girlfriend, Bedrana Jelin, said from Visoko, Bosnia-Herzegovina.

    But his MS symptoms started getting worse and a blood clot formed around the stent in the vein, Fallas said. An ultrasound showed that the vein was 80 per cent blocked.

    Mostic was disappointed and desperate. His friends and loved ones raised another $8,000 US to send him back to Costa Rica after they had trouble getting a specialist to see him in Canada.

    "They didn't want to touch him because he was done outside of Canada," Jelin said.

    Mostic flew back to Costa Rica for treatment, but died in hospital there after doctors tried to dissolve the clot using powerful medication that Fallas thinks triggered internal bleeding.

    Fallas said his clinic normally doesn't use stents because they are considered risky. But he said Mostic was willing to take the risk.

    Unable to walk
    Mostic had been diagnosed with a fast-moving type of multiple sclerosis three years ago. When he first sought the vein-opening procedure, he hadn't walked for 18 months.

    Angioplasty, inflating small balloons to open up arteries, is commonly done for heart patients but is not an approved procedure for unblocking neck veins in MS patients in Canada.

    A blood clot in the vein might be more dangerous to fix than to leave alone, said Dr. Barry Rubin, the head of vascular surgery at Toronto's University Health Network.

    "Since veins have a remarkable ability to grow in other locations if one of the veins is blocked, generally it's extremely safe to just put the patient on blood thinners to try and prevent the clot from extending or breaking off into the lungs, and just waiting," said Rubin, who is also a professor of surgery at the University of Toronto.

    "You don't have to go in and dissolve the clot once it's formed, if it's in a vein."

    Rubin said Mostic isn't the first case of a serious complication in an MS patient who has sought treatment outside Canada. Last week, he treated a woman who had the vein procedure in Mexico.

    "We found extensive clotting in the left arm reaching into the chest veins, and some of the clots had broken off and travelled to her lungs, which is called a pulmonary embolus, which is life threatening, potentially life-threatening complication."

    Dr. Paulo Zamboni of Italy is a leading proponent of treating multiple sclerosis with angioplasty. His therapy is based on an unproven theory, known as chronic cerebrospinal venous insufficiency (CCSVI), that blocked veins in the neck or spine contribute to MS.

    In April, Zamboni warned patients attending the American Academy of Neurology's annual meeting in Toronto against using stents — small mesh coils — because of the high risk of the stents moving and lack of knowledge about their long-term effects.

    In Canada and the U.S., seven research studies are underway to test for vein narrowing in people with MS compared with people without MS.

    "Something has to be done because other people are suffering," Jelin said. "And something has to be done because it's not fair I lost someone very close to me."

    Source: CBC News Copyright © CBC 2010 (19/11/10)

    Glasgow clinic offers controversial MS therapy

    CCSVI VenogramA Glasgow health clinic has been inundated with inquiries after becoming the first in the UK to offer a controversial new treatment for the symptoms of Multiple Sclerosis.

    The Essential Health Clinic, which set up its city practice at The Edinburgh Clinic in Colinton two weeks ago, has more than 1000 people with MS who have been screened or are waiting to be screened for chronic cerebrospinal venous insufficiency, with a further 4000 signing up for more information.

    The condition has been linked to MS but the NHS and the MS Society say there is not enough evidence to determine what effect CCSVI has on MS.

    MS itself is thought to be caused by the auto-immune system destroying myelin, the fatty sheath which surrounds nerves. Essential Health Clinic's medical director Dr Tom Gilhooly, a former government advisor on drug abuse who has worked with those affected by MS for six years, opened the clinic a fortnight ago to coincide with a CCSVI conference in Glasgow.

    Dr Gilhooly admitted that he was initially cautious about the new procedure, which costs around £6000, but changed his mind.

    He said: "There's new 'miracles' all the time in MS so I thought here we go again.

    "I started reading some of the papers and thought there's an actual biological hypothesis here that holds weight and makes sense."

    Dr Gilhooly studied the theory of Italian Dr Paolo Zamboni, of the University of Ferrara in Italy, who was researching treatment for his wife, who has MS.

    Using ultrasound scans he concluded that some symptoms associated with MS are caused by veins leading from the brain becoming narrowed, twisted or blocked.

    He saw that blockages were allowing iron from the blood to leak into the brain tissue, where it caused damage.

    It can be relieved by inserting a tiny balloon device into the blocked vein and then blowing it up to open the blood vessel.

    Dr Gilhooly, whose team has treated 16 people since early November, said: "It's very early days but the experience has been pretty positive.

    "It varies in person to person but there's a clear pattern of some symptoms that do improve and some that don't.

    "I don't think there's a cure but I think there's a tremendous development."

    The Evening News told yesterday how city joiner Kenny Meldrum, 44, had the treatment at a clinic in Belgium three weeks ago.

    The father-of-one, who had an MS attack four years ago, was left with numbness, balance difficulties and fatigue, but says he felt an "incredible" change within hours.

    He said: "I knew they'd come up with something but I didn't think it would be in my lifetime."

    Dr Doug Brown, head of biomedical research at the MS Society, said: "We welcome further research."

    Source: news.scotsman.com ©2010 Johnston Press Digital Publishing (17/11/10)

    Alberta to help MS patients after CCSVI surgery abroad

    CCSVI VenogramAlberta's health minister says patients who need treatment following controversial out-of-country surgery for multiple sclerosis will get help.

    "This is one of the problems you have when you have something that is classified by the medical community as experimental in nature," Gene Zwozdesky told reporters Tuesday following a protest by MS sufferers outside the legislature.

    "But the fact is that if somebody goes out (for the surgery) and has a complication that develops, then we in the province have no choice but to help them best we can to alleviate their difficulties."

    Zwozdesky was referring to treatment for chronic cerebrospinal venous insufficiency, or CCSVI.

    Rather than using drugs to treat MS, the CCSVI "liberation" procedure uses angioplasty to open up twisted or blocked veins in the neck and spine.

    Doctors in Canada are studying the procedure, but say it remains unproven.

    It's not funded under medicare. As a result, many Canadian MS sufferers are now paying thousands of dollars to have the procedure done in countries such as the United States, Poland and Mexico.

    Ginger MacQueen, a Calgary woman who was among the 50 protesters at the legislature, said she went to Poland for CCSVI treatment but said it was clear from her family doctor when she got home that there is a reluctance in Canada to get involved.

    "I asked my GP 'What about after-care? Don't I need to be referred to a vascular specialist now?' He said no. He kind of hemmed and hawed, and I realized I was on my own."

    "He said if there was some type of emergency then he would refer me, but I think what that means is we're kind of SOL."

    MacQueen, 46, and the other protesters say it's important that governments begin funding the treatment immediately given that if nothing else it provides patients with a better quality of life. And if they don't fund the treatment, they can at least take an ownership role in the followup, she said.

    "I didn't have a future before CCSVI treatment. My future was getting worse. I was going into a wheelchair and for me that's not quality of life. I was going to go to Switzerland and euthanize myself," said MacQueen.

    "My husband and I (now) want to move to Hong Kong. I can handle heat now. I don't have heat intolerance anymore. I can go hiking in the sun with my dogs. We have a future."

    The MS Society of Canada says it, too, is concerned about reports that some Canadian patients have had complications and can't get proper followup treatment.

    "We've heard these stories as well but I can’t quantify the number," said society spokesman Stewart Wong in an email.

    "The MS Society believes people with MS who have travelled outside of Canada to receive CCSVI treatment should be allowed post-treatment care and followup from the health-care system," he added.

    Health Canada is now studying the liberation treatment. Health Minister Leona Aglukkaq has said when the results are known they will make a decision on whether to fund clinical trials.

    The issue is moving along on a number of fronts in Canada, which has one of the highest rates of MS sufferers in the world (pegged most recently as high as 240 out of 100,000).

    Zwozdesky said he is pushing to get the studies done and a decision made as quickly as possible, and said he'll do what he can to help "fill the gap of evidence."

    Saskatchewan has already committed to helping fund clinical trials.

    In British Columbia, the provincial College of Physicians and Surgeons is working to try to fasttrack testing to see if liberation treatment is a viable tool.

    In the meantime, the B.C. College will continue to treat patients who need help, said Susan Prins, the college's director of communications.

    Prins stressed doctors are not ethically obligated to re-do an experimental CCSVI procedure, but would treat complications that result, such as a blood clot.

    "The expectation would be that they would take care of that patient in need, absolutely," said Prins.

    In Quebec, the province's College of Physicians warned MS patients last week not to seek the treatment at clinics outside Canada because the procedure remains scientifically unproven and may have unknown risks.

    However, the Quebec body has also assured MS patients that anyone who develops complications from the procedure will be treated at home.

    Liberation therapy is a new frontier in the search for a cure for the debilitating neurological disorder that has confounded scientists for two centuries.

    The CCSVI theory is that the MS brain complications are caused by problems related to poor or obstructed blood flow from the brain to the heart due to constricted or twisted veins in the neck and spine area.

    In CCSVI treatment, doctors cut a small hole in the groin and insert a catheter to open the vein obstruction using a small balloon.

    Source: Yahoo! Canada News Copyright © 2010 Yahoo! Canada Co. (17/11/10)

    MS patients warn of complications after CCSVI treatment

    CCSVI VenogramThree multiple sclerosis patients who went outside of Canada for the "liberation treatment" are warning other patients to make sure they have follow-up care in case they return with complications.

    One of them is longtime MS patient Jan Wexler, who went to a Bulgarian medical clinic in June. Doctors there performed an angioplasty on one of her jugular veins in her neck and the azygos vein in her chest, using a catheter-guided balloon to open up veins in the neck, in an effort to improve drainage from the brain.

    During the treatment, the doctors placed a metal mesh stent inside the jugular vein to try to prop it open.

    For about a week after the treatment, Wexler says she felt great, saying the weight of her symptoms lifted.

    "I could sit up perfectly straight in my hospital bed, I could raise both of my arms way above my head," she remembers.

    But a week later, the improvements disappeared and Wexler was more disabled than before.

    She returned to Bulgaria in July, where doctors found that all the veins were now blocked more than before the first treatment and a blood clot had formed around the stent.

    Now, Jan says her health has deteriorated. She is weaker than ever, she can no longer cook or drive, and she needs help bathing.

    Wexler says she now regrets ever getting the treatment.

    "If I knew that I was going to get worse, I would not have had it done, of course," she says.

    Betty Taylor, a single mother of two from Edmonton, also travelled overseas for the treatment. She too went to Bulgaria in June where she underwent two angioplasties, one to open her azygos vein and another on a jugular vein. After her jugular vein blocked up again within days of the first treatment, doctors went in again and inserted a stent.

    "I noticed an immediate improvement. Overall, I had more energy I felt better and I was just looking forward to feeling, you know, a little better every day." Betty remembers.

    "Right after the treatment I would say I felt 25 per cent better. Within a couple of weeks of the treatment, I definitely felt about 50 per cent better."

    But she thinks either the stents have blocked with blood clots, or the veins have re-narrowed, because the benefits of the treatment are now gone.

    "I feel worse than before the treatment. Yes, right now I do," she says. "I have no idea what's going on. I just know something is not right and it needs to be fixed."

    The Italian surgeon who developed the "liberation treatment," Dr. Paolo Zamboni, used balloon angioplasty to open the veins. He found in his preliminary studies that about 47 per cent of patients saw their veins re-narrow.

    Other vascular doctors and interventional radiologists who have started offering the procedure in various clinics around the world have also seen the re-narrowing. So some have been using stents to try to keep the veins from re-narrowing.

    Dr. Zamboni doesn't endorse this and has discouraged the use of stents. He notes that patients who have stents inserted for other procedures usually require blood thinners and careful monitoring for blood clots afterward.

    There is also the danger that the stents can migrate, pushed down from the neck toward the heart. That has already happened in one patient who was treated In California. That patient required open heart surgery to remove the stent.

    While some MS patients are reporting significant, long-lasting improvements after travelling abroad for the liberation treatment, a small but growing number of serious complications are being reported.

    One severely disabled Canadian MS patient who was treated in a foreign clinic using a stent developed complications and returned to the clinic for follow-up care. He died shortly after. While CTV News attempted to reach the man's family to learn more, our phone calls were not returned.

    Earlier this week, Dr. Yves Robert of the Quebec College of Physicians warned that his members were hearing more of these problems.

    "We are seeing patients with significant thrombosis," he told reporters in Montreal.

    "It is felt that the number of complications are badly monitored internationally and likely under-reported," he said.

    Most foreign clinics offer little or no follow-up after the procedure and few ensure that patients have proper treatment when they return home. Patients who run into problems are left to seek medical care at home, but some are reporting that Canadian doctors won't treat their "liberation" treatment-related complications.

    Taylor says when her MS symptoms worsened, she went to her doctor to ask what to do.

    "I did not get any help. I specifically did ask one doctor that I see if I could get a referral to a local vascular surgeon just to have someone to talk to about the symptoms I was experiencing. I was given the response. ‘No.' I would not get a referral. "Because I have MS, they are not entitled to be treating me in terms of vascular disease," she said.

    Francine Deshaies also developed serious clots after angioplasty treatment in Poland.

    "I thought I was dying. I was really scared because it was really painful and I didn't know what to expect," she says

    She went to a hospital in Montreal where she says she was told "no vascular doctor" would see her. She eventually found a specialist who's treating her with blood thinners and she now says she feels better than ever. But she has a warning for other patients seeking treatment overseas.

    "Follow up is the most important thing. When you come back you've got to see a doctor. If you don't have a doctor or follow-up, you better not go. If you have a problem, you are done," she says.

    Earlier, this week, doctors in Quebec discouraged patients from seeking the treatment overseas until formal studies are completed. But the doctors say that given the possibility of complications of blood clots, patients who choose to go abroad will get follow-up care.

    The message from doctors in other provinces isn't clear.

    Meanwhile, Taylor is booked for another procedure in November where she hopes an American doctor will deal with her complications and give her a lasting improvement.

    Wexler is also hoping to find a way to deal with her situation at a clinic in California. She still believes the treatment will have merit for many of those with MS. But she has her own advice for MS patients eager to get the endovascular treatment and are willing to travel anywhere for it.

    "I would say if you can wait until there is more out there, because you don't want to get worse. That's the thing," she says.

    Source: CTV News © 2010 CTV Global Media (15/11/10)

    Multiple Sclerosis And CCSVI

    CCSVI VenogramThe Collège des médecins du Québec and Its Experts Express Their Opinion on Dr. Zamboni’s Hypothesis.

    During a press conference held this morning, the Collège des médecins du Québec (CMQ) and its experts outlined their thinking with respect to the hypothesis issued by Dr. Paolo Zamboni in 2009 on the possible link between chronic cerebrospinal venous insufficiency (CCSVI) and multiple sclerosis. The Collège des médecins is of the opinion that, outside the framework of research work, current knowledge does not allow for physicians in Québec to practice this treatment, which, for the time being, is not recognized by the scientific medical community.

    “Since my recent election as President and CEO of the Collège des médecins, I have received numerous messages from patients afflicted with multiple sclerosis,” explained Dr. Charles Bernard. “Of course, I lend these patients an attentive ear, and I understand their need to know where science stands with respect to this subject. The Collège is saying to them today that we need to wait for the results of studies that are currently underway before generalizing Professor Zamboni’s treatments. In particular, we are recommending to these individuals that they refrain from consulting any medical tourism clinics offering these treatments prematurely with little regard for their effectiveness and side effects.”

    Over the past few months, a number of studies conducted around the world to validate Dr. Zamboni’s hypothesis have been indicating that venous obstructions are not only present in people suffering from multiple sclerosis, and that they are not necessarily present at the outset of the illness. “According to preliminary data generated by current research,” underlined Dr. Marc Girard, President of the Québec Association of Neurologists, “it would also seem that the venous obstructions appear late into the progression of the illness. As such, these findings show that the obstructions are not the cause of multiple sclerosis, as Professor Zamboni’s hypothesis suggests.” Dr. Girard also emphasized the importance of North American studies currently underway and being subsidized by the Canadian and American Multiple Sclerosis Societies. “Now more than ever, these studies are necessary so as to better understand the prevalence of CCSVI and determine how research should proceed with respect to the approach proposed by Professor Zamboni.”

    Moreover, due to the insufficiency of scientific data on Dr. Zamboni’s hypothesis and on treatment by venous angioplasty, the diagnosis and radiological monitoring of CCSVI and its treatment is difficult. “At this point in time, radiologists are not in a position to identify a standardized examination that allows for diagnosing CCSVI in a patient suffering from multiple sclerosis,” added Dr. Frédéric Desjardins, President of the Québec Association of Radiologists. “Some physicians propose echography, others magnetic resonance, and still others phlebography. There is also no consensus on the norms for interpreting these exams. These factors, among others, constitute the rationale for the need to pursue research efforts so that we can obtain answers to existing questions and, thus, offer patients the best care possible.”

    “I have been suffering from multiple sclerosis for more than 20 years, and this is not the first time that someone seems to be professing a miracle treatment,” concluded CMQ Director, Dr. Guy Dumas. “I understand the hope being raised by Dr. Zamboni’s hypothesis among people like me afflicted with this disease. However, I urge them to exercise prudence. Patients should not be abandoning their current medications in favour of pursuing an unrecognized treatment. We must be sensible and patient. We must wait for the results of the research presently being carried out before taking any other action.”

    The Collège des médecins du Québec is the province’s professional order of physicians. The mission of the Collège is to promote quality medicine in order to protect the public and help improve the health of Québecers.

    Source: Collège des médecins du Québec (10/11/10)

    Calling the Multiple Sclerosis detectives

    CCSVI VenogramScotland’s community of 10,000 multiple sclerosis sufferers will be focused intently on a hotel in Clydebank this weekend, where the potential of a controversial new treatment will be debated by clinical experts.

    Specialists from Poland, Canada, Bulgaria, Jordan and the UK will come together to discuss the theories of Dr Paulo Zamboni, an Italian vascular surgeon, who claims that the symptoms of MS can be treated by clearing the blocked veins which cause toxic build-ups in the brain.

    Already, dozens of Scots with MS have travelled to eastern Europe to be treated for Chronic Cerebro-Spinal Venous Insufficiency (CCSVI), which involves balloon angioplasties or stents being fitted into the jugular and azygos veins in the neck.

    The procedure to tackle CCSVI is the most talked-about MS regimen in recent years, and is already a multi-million-pound industry with treatments costing around £7000. Now, a group of doctors from the fields of vascular, neurological and radiological medicine will meet in Glasgow to discuss Dr Zamboni’s theories.

    But does CCSVI work? Six months ago, Barry McArthur, 29, from Paisley, stood on the steps of his Katowice hotel the morning after his procedure and announced to the world in an exhilarated voice he felt “a million times better”. His dizziness had gone, he could stand upright unaided for the first time in months and his speech was no longer slurred.

    Stephen Law, 47, of Hamilton, was “almost suicidal” before he travelled to Poland, due to the extreme exhaustion he suffered all day and every day and his incredibly poor quality of life. In the weeks after the procedure, however, he felt so well he could clock up 14 kilometres at a time on his stationary exercise bike.

    The same effects were heralded by others who had gone through the CCSVI operation in Poland. Train driver Kevin Quinn, from Glasgow, was “totally energised” after his angioplasties. He could walk greater distances and his eyesight and memory improved. Glasgow-born radio presenter “Tiger” Tim Stevens felt a warmth return to his feet for the first time in years. The spasms in his left leg abated. He felt “wonderful”. Meanwhile, a Californian schoolteacher, Deegie Phelps, 69, threw down her crutches and walked unaided, in a scene straight out of an evangelical church healing

    Six months on, however, the reports are disheartening. Barry McArthur has returned to his wheelchair. Stephen Law has lost his new burst of energy and is tired again and, while his cramps are not so severe, they have returned. Kevin Quinn has also regressed. “I’m still working as a train driver but I’ve lost the energy I had. I believe the balloons I had inserted in my veins have collapsed and I’m back to square one.”

    Tim Stevens has since returned to Poland for a second procedure. The balloon angioplasty he’d had carried out on the left side of his chest had collapsed and he had a stent inserted. Tim’s voice is again slurred, however, and he still can’t walk unaided. “I tried to climb up a single step the other day,” he said. “My brain thought it could but the leg told it otherwise.”

    But why have so many of those treated later regressed? Dr Tomasz Ludyga, of the Euromedic Clinic in Katowice, who carried out the Scots’ procedures, offers an explanation.

    “We can’t explain this entirely but we think when there is a blocked circulation some substances are secreted in the brain to protect it, which results in damage.”

    He added: What we are looking at is a substance called Endoterin 1 and its levels before the procedure and after. After the procedure, the veinous obstructions are cleared and we think these substances disappear. And we can get some initial improvement in the body functions such as headaches going, feet warming, improved retina, balance improving.

    “But if a patient, for example, had a disease for 20 years or more then you can’t expect them to be cured immediately. The damage to the neurons in the brain and the spinal cord means that the restoration could take several years. The feeling of the neurons has just started.”

    Dr Ludyga added that CCSVI was not a cure. Nor could he offer categorical explanations for the initial successes and the subsequent regressions. Tim Stevens puts the procedure in perspective. “I think we have to appreciate we are all guinea pigs at the moment. No-one knows why CCSVI works to a degree for some and not at all for others. Doctors are still putting the pieces together.”

    What pieces seem to fit? MS sufferers and doctors working on CCSVI share the growing belief that MS is not a single illness but a collection of symptoms. But the CCSVI procedures’ initial success at least indicates that venal malfunction is the cause of some MS symptoms.

    Deegie Phelps’s later experience throws additional light on the condition. After her regression, she had another vein checked out for blockage, this time the iliac vein in her hip. She was discovered to have May-Thurner’s Syndrome, whereby a vein was being compressed by the right iliac artery. She had a stent put in place. “It’s been three months, now, and the veins that have been stented have stayed open. I have lots of energy still.”

    If MS is not a single illness but an umbrella label for varying symptoms, Caroline Stevens, a dietician who has researched her husband’s condition extensively over the past five years, believes that the method of diagnosis is hugely important.

    “The problem with CCSVI, as I see it, is that those with MS have to be scanned properly. But it’s complex. Some doctors use a Doppler imaging machine to determine if veins are blocked, but they don’t reveal blocked veins in all patients. Those thinking of undergoing CCSVI should make sure they are scanned properly.

    “What people thinking about undergoing CCSVI should consider is that balloon angioplasties can collapse, which means being re-scanned and a return to Poland to repeat the process, perhaps having a stent fitted. But stents can be problematic. You have to take drugs to prevent the body reacting to them.” Stephen Law, however, says he doesn’t regret undergoing CCSVI. “I don’t have pain any more. I have the fatigue again, though, and I wish there was more follow-up from Poland but at least the research is moving in the right direction.”

    Dr Doug Brown, head of biomedical research for the MS Society, said: “We believe that CCSVI is a very interesting avenue of research but there is currently not enough evidence to draw firm conclusions about whether treatment for CCSVI is safe or effective for people with MS.

    “We are collaborating with other MS societies across the world to speed up research into studying the link between CCSVI and MS.

    “As with any unproven treatment, we do not recommend that people seek this outside of properly regulated clinical trials.”

    CCSVI – The Way Forward, Beardmore Hotel and Conference Centre, Clydebank, October 29 and 30.

    Source: heraldscotland Copyright ©2010 Herald & Times Group (25/10/10)

    'Liberation therapy' doctor urges caution for patients

    Prof. ZamboniThe Italian doctor who created the controversial ‘liberation therapy' for multiple sclerosis -- trumpeted by some as a possible miracle treatment -- is now urging MS patients to wait for more clinical trials.

    Dr. Paolo Zamboni's caution comes after many MS sufferers have already crossed borders and paid thousands of dollars for the procedure, which attempts to open up some of the brain's blood vessels.

    Zamboni has hypothesized that improper blood drainage may be a factor in causing MS, but that position is controversial in the MS community.

    Calling the problem CCSVI (chronic cerebrospinal venous insufficiency), Zamboni's theory states that blocked veins in the neck and chest contribute to the disease. But the commonly held belief is that the affliction is an autoimmune disease. Critics of the treatment believe that MS sufferers have been given false hope.

    However, Zamboni has recently cautioned that those seeking the treatment should hold off, with the exception of patients taking part in clinical trials.

    "Surgery is not recommended at this stage," said Zamboni, who works out of Ferrara, Italy. Additionally, Zamboni said that he did not support such cases of "medical tourism."

    The comments made at an MS conference in Sweden and were published this week in the news service NeuroSens.

    However, many patients have already sought out the treatment, including Canadians who have crossed borders for the therapy. In Poland, India and Bulgaria, some clinics are already offering the treatment.

    In recent weeks, politicians in Saskatchewan, Nova Scotia, Manitoba and Quebec have come out in support of the treatment, calling for clinical trials on a national level.

    "I'm going to be instructing and working with the minister of health to ensure that position is advanced in the health ministers' meeting this fall," said Nova Scotia Premier Darrell Dexter in August.

    Some patients have expressed gratitude for the treatment and said that their symptoms subsided after undergoing the therapy.

    Earlier this week, CTV News spoke with MS patient Julie Goodwin, who was willing to give the therapy a shot later this year in Poland.

    "I just really feel I can't wait indefinitely," she told CTV News. "My symptoms are getting more severe. I have been spending more and more time needing the assistance of this wheelchair."

    Meanwhile, the MS Society of Canada and its U.S. counterpart have pledged $2.4 million for seven studies into the therapy.

    Source: CTV News Copyright CTV GlobeMedia 2010 (17/10/10)

    CCSVI treatment for MS in the UK

    CCSVI VenogramThe first CCSVI operations in the UK for multiple sclerosis patients - known as the liberation procedure - will take place in a private clinic in Edinburgh later this month.

    The angioplasty procedure to treat narrowed veins in the neck is being arranged by the Essential Health Clinic in Glasgow, which has already screened 400 patients for the condition.

    Until now, UK patients have had to travel to clinics abroad for treatment, including in Poland and Bulgaria.

    We talk to Glasgow GP Dr Tom Gilhooly who has arranged the scanning and treatment and seek reaction from other experts in the field about this new treatment.

    CCSVI

    Chronic cerebrospinal venous insufficiency (CCSVI) is a hot topic for people with MS. The theory is that multiple sclerosis can be caused by blockages in veins draining blood from the brain. If the blockages are cleared, MS symptoms may be reduced.

    The idea was put forward by an Italian scientist, Dr Paolo Zamboni, whose wife was diagnosed with MS.

    Zamboni investigated links between MS and iron deposits in blood vessels. He carried out ultrasound tests on blood vessels leading in and out of the brain and found that in a majority of people with MS, including his wife, the veins taking blood away from the brain were blocked or damaged. This was not the case in people without MS.

    He further suggested that iron was damaging the blood vessels and allowing the heavy metal, along with other unwelcome cells, to cross the crucial blood-brain barrier, a process he called Chronic Cerebrospinal Venous Insufficiency.

    Multiple sclerosis is the most common neurological condition among young adults in the UK, affecting approximately 100,000 people.

    CCSVI - lack of evidence

    Few clinical trials have been carried out to assess the CCSVI theory, so the treatment remains scientifically unproven.

    More than 55% of 500 MS patients participating in the initial phase of a study at the State University of New York, Buffalo in the US exhibited narrowing of the extracranial veins, causing restriction of normal outflow of blood from the brain. However, the scientist who carried out the trial admits that neither the theory nor the treatment have been proved in large numbers of people.

    Leading MS experts like David Bates, Professor of Neurology, Newcastle University, remain sceptical about CCSVI. “We know what happens when veins are occluded,” Bates tells us. “We see people who have this condition in the draining veins from the head. We know that apparent narrowings of these vessels are commonly seen and do not cause these changes of multiple sclerosis. Most importantly of all, multiple sclerosis is due to inflammation within the nervous system and the narrowing or slowing of fluid through a vein would not necessarily cause that.”

    CCSVI - YouTube

    While there’s a lack of hard clinical facts to support the procedure, plenty of MS patients who’ve had the procedure have gone online to give before and after accounts.

    47 year old Gabby in the US was told she probably had MS in 2000. Often, MS is not an easy condition to confirm. On YouTube she shows how she walked slowly with a walking stick before the operation. Now she’s showing the world how she can jump again.

    “Fire your neurologist,” she says. “This is a vascular disease.”

    Dr Tom Gilhooly from the Essential Health Clinic admits anecdotes like these are easier to come by than clinical trial results: “Its overtaking the evidence, because the evidence isn’t there. There are only two case studies that have been evaluated by Zamboni and published, but one of them is in the Journal of Vascular Surgery. That’s just about the hardest journal to get a paper in. These things are well considered by those who are refereeing them.”

    Helen Yates, chief executive of the Multiple Sclerosis Resource Centre (MSRC), is also cautious about Internet personal stories. “We live in an age where anyone can get their story out into the public domain easily,” she says.  “This is happening a great deal with YouTube and the procedure for CCSVI.  We see, day after day, new films going on the site showing people who seem to have quite dramatic improvements having had the liberation procedure done.  We welcome the improvements these people are getting but also remind everyone that few people who have little or no improvements bother to make a film about it.”

    One of Gilhooly’s scanning patients has since been to Poland for the CCSVI procedure and has emailed him to say how well she feels after it. “Although it’s an anecdote, it’s from someone you know, someone you’ve seen and it means a lot more than just seeing someone dancing on YouTube,” he says. “When we get first hand reports, that’s when you begin to believe this is a real situation.”

    He further guards against taking too much notice of extreme examples of patient recoveries

    “There’s going to be a spectrum. At one end there’s going to be the people that can jump for the first time. There’ll be others that will say ‘I’ve had this done, and it hasn’t done anything to me at all’.”

    MS patients - well informed

    Gilhooly admits that MS patients he sees have often read the latest CCSVI news before he has. “The vast majority of people who have come for scans have been very well informed,” he says. “In fact, one of the challenges for me and the other doctors who see them after the scans to discuss their results and their MS, is to be as up to date as them. Quite often we’re not, because they’re spending huge amounts on the Internet reading every story, every paper, every single thing they can get their hands on regarding CCSVI.  As a professional, I’m trying to keep up to date, and it’s a rapidly moving landscape.”

    MS patients - well informed continued...

    “There’s been a tremendous fear among the patients that we were going to be stopped by somebody, some authority was going to say ‘you cannot do this’.”

    He says being a pioneer in this field has been stressful for him and his staff, with a lot of interest for one small private GP practice to cope with. Gilhooly tells us: “The key thing is - is this important? Is this a breakthrough in treatment? Is there a new way of treating MS that was previously unthinkable. A year ago, most people would not have conceived that there was an operation for MS.”

    “We have something here which is potentially the biggest breakthrough in my lifetime.”

    Gathering evidence

    As well as scanning patients and arranging the operations, Gilhooly is also collecting data to help build up clinical evidence on CCSVI. “In all honesty, it would be an awful lot easier to just crack on and not do it,” he says. “But people would say you’re just treating people, you’re not monitoring anything. How do you know that they’re getting better?”

    “What’s going to convince the other doctors and other sceptical people out there is the evidence. I think it is important not to say we can only do this as a random placebo [dummy treatment] blinded study.   If you don’t get some experience doing the actual procedures, then you’re never going to be able to do that kind of research properly. Everything starts with experience.”

    “I can understand that we should be cautious and we should proceed carefully and we should collect evidence and we should prove beyond any reasonable doubt that this is a good thing. But to do nothing would be the worst crime that we could commit.”

    Reaction

    An MS Society spokesperson told us by email: “We share people’s enthusiasm for what could potentially be a positive breakthrough in MS treatment. This is something many people with MS feel passionate about and we want to ensure the best outcome and safe treatments for them. Research into the link between CCSVI and MS is currently at a very early stage of development and the Society is monitoring progress of the ongoing collaborative studies. We are currently working collaboratively with an international network of partners on global CCSVI research.

    “People obviously have a choice in whether they want to pay for a treatment but because this treatment is presently unproven, they need to be aware that there is a risk involved. Until properly controlled and regulated clinical trials are carried out, the MS Society can’t give people accurate information about the safety or effectiveness of unproven treatments.”

    Helen Yates from the MSRC agrees that no procedure is risk free. However, she adds: "The screening is non-invasive, pretty straightforward, and the treatment has been performed for other conditions for decades."

    International conference

    Gilhooly is also organising a conference on CCSVI on the 29th and 30th October. Speakers include CCSVI experts from the UK, Canada and Poland.

    “My hope is we’ll get to a consensus,” he says. “What’s the best way to screen, the best way to scan, the best way to treat.”

    Some of it will be very technical, he says, like the size of the balloons used for the angioplasty.

    UK surgery

    Gilhooly is keen to work alongside international centres on CCSVI, but says patients would rather get treatment in the UK: “They’re desperately keen to be treated in the UK and not have to travel abroad. In many cases it’s the aftercare, which is difficult to do if they’re not in the same country.”

    That’s a sentiment echoed by Helen Yates of the MSRC: "If it is not available on the NHS, we would rather see people treated in this country privately with appropriate follow-up."

    Is it something people are eventually going to be able to get done on the NHS? “My feeling is it is going to go that way,” Gilhooly says. “It will be accepted as being a standard treatment. It’s going to be impossible to ignore it.”

    Source: Web MD © 2010 WebMD, LLC (12/10/10)

    Can diet & supplements reduce CCSVI severity?

    Judy Graham undergoing CCSVI scanningI have just got back from Glasgow, Scotland, where I had my veins scanned at the Essential Health Clinic.

    The result was that I have mildly narrowed veins on one side only. Of the 150 patients this clinic has seen so far, only 3 have had stenosis on one side only and I am one of them.

    Dr Tom Gilhooly, who runs this private clinic, told me not to bother with angioplasty as it was unlikely to make much difference to me as the stenosis is so mild. He only recommends treatment for CCSVI in severe cases where the stenosis is higher than 60%.

    Interestingly, he thinks that it is probably BECAUSE I do so much dietary management that the stenosis is so mild in my case. Just as Omega 3, vitamin D, low fat diet and all the other things help to lessen inflammation of the central nervous system, their anti-inflammatory actions are at the same time working on the vascular system and keeping that in good (ish) working order too.

    Dr Gilhooly feels strongly that treatment for CCSVI with angioplasty or – only in severe cases – stents – should not be seen as a treatment on its own but should be done – if at all – IN COMBINATION with dietary and lifestyle interventions.  

    These dietary and lifestyle interventions are clearly laid out in this website, the new book I have just written called ‘Managing Multiple Sclerosis Naturally’ (published by Inner Traditions)and Professor George Jelinek’s book ‘Overcoming MS’.

    Does these mean that there is a definite correlation between doing these dietary things and having stenosis that’s too mild to be concerned about? Dr Gilhooly has a hunch that there is, but this needs to be proved by meticulous research, which we don’t yet have.

    Judy Graham (Editor of New Pathways Magazine) (07/10/10)

    Surgery for multiple sclerosis available at private clinic in UK

    CCSVI VenogramA surgical treatment for multiple sclerosis is to be offered privately in the UK, despite warnings that it has not been proved safe or effective.

    A clinic in Edinburgh will begin operations within weeks that involve a package of screening, consultation, day surgery under local anaesthetic and a six-month follow-up, costing £5,950 in all. As the medical establishment advised caution, the NHS made it clear it would not offer the treatment in its present state, however frustrated patients may be.

    The Essential Health Clinic says the procedure, meant to improve the blood flow from the brain and central nervous system, will be carried out by a surgeon, Donald Reid, and "an internationally recognised" expert from Bulgaria responsible for more than 300 procedures.

    The company's owner, Tom Gilhooly, a Glasgow GP with an interest in MS, admitted the procedure was unproved. "But we are not going to get proof unless we look for it."

    MS experts and surgeons are deluged with requests for screening and treatment, while people with MS in Britain, the US and Canada are spending thousands on packages to countries such as Poland, Bulgaria, Greece, Mexico and India, where the procedure is being performed.

    There are concerns about monitoring the progress of patients after they come home, although UK bodies will not stop people travelling for treatment.

    Gilhooly said: "We have a pretty good safety net [in the NHS] but unfortunately it also stifles innovation. Anything new has to be proven, but we cannot prove [anything] until we have done it."

    If health providers offered only established procedures, "you won't understand what you are trialling. What differentiates this from other so-called breakthrough treatments is that there is a growing body of significant, serious scientists and doctors who are getting involved."

    Patients would face questionnaires before and after the procedure, which typically might take 45 minutes to an hour.

    The clinic has screened about 300 people without offering the procedure. It found between 70% and 80% had vein problems, said Gilhooly.

    MS charities and research bodies have advised people with the condition – there are an estimated 100,000 in the UK, more than 10,000 of them in Scotland – to have treatment only as part of a properly controlled trial. So far, a handful of such trials are under way or planned.

    The procedure, first outlined by an Italian team last year, is similar to the angioplasty treatment for heart problems. It involves inserting a device with a deflated balloon into a blood vessel in the groin and guiding it to affected areas, where the balloon is inflated.

    "The hypothesis is plausible and we don't want to miss an opportunity to help people," said Ian Franklin, a council member of the Vascular Society. But he added: "Internationally, there are only a handful of units that have published results so far and there has to be a properly randomised trial which can be the benchmark for treatment. No one outside the handful of units has reliably confirmed the diagnosis. When you cannot even agree on diagnosis, it is very difficult to agree treatment."

    Franklin, a surgeon at Charing Cross hospital, London, said doctors there recently had to operate on a patient who had had the treatment in eastern Europe. "There are people getting nasty complications. We don't know whether these anatomical anomalies are incidental or contributory to MS."

    Doug Brown, head of biomedical research at the MS Society in Britain, said MS societies were funding projects in the US and Canada to see if there was an association.

    "Within the next year or two we should have a wealth of information and [know] if there is a connection. It is very early days. It is important to get the answers we need before we move on to the clinical trials stage."

    The DoH said "carefully controlled research" was vital. "While the pace of this process may seem frustratingly slow, it is critical to producing the very best results for people living with MS."

    Helen Yates, chief executive of the Multiple Sclerosis Resource Centre, another UK MS charity, was more supportive. "The screening is non-invasive, pretty straightforward, and the treatment has been performed for other conditions for decades," she said, adding that no procedure was risk-free.

    "Would we rather people could get scanned and treated on the NHS, with appropriate follow-up? Of course. If it is not available [on the NHS] we would rather see people treated in this country privately with appropriate follow-up."

    Case Study

    Louise Evans, 41, was desperate to ease her pain after 16 years with multiple sclerosis. For five years she had been in a wheelchair, with blurred vision in her left eye, and continual fatigue.

    The theory and treatment "made sense to me", she said. "If my blood was not running right, I wanted to be put right whether I had got MS or not."

    So when she had the chance to go to a clinic in Warsaw, Poland, just days after it opened in June, she readily paid the £5,200 she needed ffor air fares and treatment. "I was the eighth patient. I was that bad, I thought I have to go now."

    She and her partner Andrew Markley were in the Polish capital for six days, with Evans in hospital for just two nights. The doctors failed to find any blockages when they screened her on the second day, she said, but she opted to undergo the procedure under local anaesthetic the following morning.

    She watched a screen with her good right eye as doctors inserted a device through a blood vessel in her groin looking at both the right and left jugular veins before identifying and treating a problem near her collar-bone on the right-hand side.

    "I was awake through all this. It took about two hours. I could feel the grain on the operating sheet. My right hand has not had feeling like this since I have had MS. Afterwards they bound me up really tightly and wheeled me back to my room.

    "I experienced all these strange sensations round my body I had not felt for years. My eye was straight away better. I could see the details of a fire alarm in my room. I wanted to scream with joy from the rooftops, I was that elated.

    "They checked me over for the next 12 hours. I was discharged by 10am the following day. I felt wonderful". That evening, back at the hotel, "I had steak and red wine."

    After further checks and being told to take blood-thinning injections for a few more days, Evans flew home to Bromsgrove, in Hereford and Worcester. She has not been taking the disease-modifying drugs she used to be on - "I could not face the side effects, the flu-like symptoms" - although she still gets checks on the NHS through a specialist nurse, attends physiotherapy sessions and regularly sees her GP.

    "This changed my life. It is just fantastic. I don't get fatigue, confusion, pain. I am walking with a frame now, although my balance has not returned and my bladder has not got better. I think I will get better. Personally I believe it won't improve the damage already done but I believe there won't be any more. I knew there was a risk but I could have been around another 40 years in agony, snappy and tired".

    Her three children , 21, 16 and 15, "cannot believe the way I have changed", she said. "I would do anything to get this for people in the UK."

    Source: guardian.co.uk © Guardian News and Media Limited 2010 (02/10/10)

    Multiple Sclerosis doctors attacked for their skepticism

    CCSVI VenogramDr. Mark Freedman was unprepared for the onslaught of hate.

    There were the angry letters and phone calls. There were patients who told him he was fired, and others who accused him of conspiring with drug companies to keep them ill in the name of profit. There was the vitriol being poured into online forums, where he was called a pompous windbag with the bedside manner of Adolf Hitler, a pill pusher and, even, the “King of all Turds”.

    He had spent a quarter century searching for a cure for multiple sclerosis, spurred on by being a daily witness to the fear and pain of his patients, but when Freedman urged caution over a proposed new theory of the debilitating disease — something he says he did in the best interest of patients — he was labelled a villain.

    “What did we do — other than point out the obvious careful approach to treatment — to warrant this kind of aggressiveness from their part?” asks Freedman, director of the Multiple Sclerosis Research Unit at the Ottawa Hospital. “What have we done to lose that trust? I think we have worked very hard to gain that trust through our meticulous research, our careful approach, our conservative and inquisitive nature, our demand for high standards.”

    Neurologists across the country are similarly stunned by the backlash from patients furious with their doctors for not wholeheartedly supporting the theory, developed by Italian researcher Dr. Paolo Zamboni, that clogged veins in the neck and chest trigger the disease.

    The doctors say this kind of patient mobilization and hostile response is unprecedented in their field, and they are disappointed their healthy skepticism has been so wrongly interpreted as conspiracy and stubborn arrogance.

    Many of these doctors have, until now, avoided speaking publicly about what it has been like to struggle with a small but vocal group of patients who are intent on ignoring and lambasting their best advice. They have agreed to share their thoughts with the Star so they can explain where they are coming from, and give voice to the quieter majority of patients who agree with their cautious approach.

    “I guess I wonder if some of us are feeling that we are being penalized for being honest about skepticism, to let people know that yes, this is interesting, but gosh, there isn’t a heck of a lot of evidence to support it,” says Dr. Anthony Traboulsee, a neurologist at the UBC Hospital MS Clinic. “Maybe it’s not the cure and people don’t want to hear that messaging.”

    Zamboni postulated that clogged veins — a condition he named chronic cerebrospinal venous insufficiency (CCSVI) — could trigger MS by causing iron to flow up to the brain.

    The former vascular surgeon published results in 2009 that suggested a relatively simple procedure to unclog veins, called venous angioplasty, or the so-called “liberation” procedure, held promise to relieve debilitating symptoms.

    Months after a national television broadcast and subsequent newspaper headlines spread the word of the theory and liberation treatment, patients began travelling to overseas clinics and paying doctors thousands of dollars to open up their veins.

    The CCSVI theory was bolstered by patients who returned home saying they had less pain, more movement and felt better than they had in years. Those who listened to them with great hope have become increasingly frustrated the treatment is unavailable in Canada.

    Through online social networking and protesting with placards calling on the federal health minister to resign, they have been demanding everything from a quicker timeline for clinical trials to immediate access to the procedure for anyone who wants it.

    “They keep throwing this in our faces: ‘well, it hasn’t been proven. We don’t know if it’s safe yet. We don’t know what the long-term effects are,’” says Andrew Katz, 51, a financial adviser in Ottawa who emceed a patient demonstration on Parliament Hill on Monday from his wheelchair. “Well, we know what the long-term effects are. We’re going to wind up in a wheelchair and we’re going to deteriorate and potentially (die). We know that. That’s a given. That’s a fact, so all of this ‘we need to look after you and that’s why we’re not going to help you’, it doesn’t make sense to me.”

    Many were bitterly disappointed when the federal government decided to hold off on funding pan-Canadian therapeutic clinical trials of the liberation treatment after accepting the recommendations of an expert panel convened by the Canadian Institutes of Health Research and the MS Society of Canada that going ahead now would be scientifically and ethically inadvisable.

    Doctors were not the only ones feeling the pressure from the angry crowds.

    “It was a politically tough decision, but at the end of the day, the minister took the advice of the medical community as she has before,” says Tim Vail, director of communications for Health Minister Leona Aglukkaq.

    Freedman was one of the first — and some say the most vocal — Canadian neurologists to voice doubts about Zamboni’s theory, but he says he and his colleagues, although concerned about the safety and efficacy of the treatment, at first believed the plethora of news stories would help the community by bringing MS into the public eye.

    That initial enthusiasm, he says, vanished as MS experts watched the breathless reporting feed the outcry for liberation treatment, overpowering their reasoned caution.

    “(The) media have actually showed some interest and some compassion for a number of patients that claim they were doing better on the therapy. I think that is fair,” says Dr. Alexandre Prat, a neurologist who directs the Neuroimmunology Laboratory at the University of Montreal Hospital Centre. “The problem is that there are a number of scientific truths that have been presented and that do not support the claims of these Italian scientists and (these have) not been very well presented by the media.”

    Prat acknowledged that just as journalists have the responsibility to accurately interpret and convey information — which can be a challenge when it comes to reporting on health and science — so do doctors have a role to effectively communicate their knowledge.

    “Everyone is to blame in this story, I think, except the patient. The patients are actually looking for hope.”

    That hope has not even been officially dashed, although the medical community has its doubts.

    The federal government has said it will support clinical trials if a scientific working group, set up to monitor $2.4 million worth of diagnostic studies into CCSVI sponsored by the MS Society of Canada and its American counterpart, decides they are worth it.

    “I guess we have no choice, do we? I mean, there is so much push and pressure,” Dr. Peter Stys, a professor of clinical neuroscience and an MS researcher at the University of Calgary says of the money being poured into CCSVI research at record speed. Stys does not deal directly with MS patients but he does research the disease. “I think if this issue went through (the) normal, regular, sober, peer-review process, it wouldn’t go nearly as far . . . (as) it has at the moment, because the science is just not there.”

    Freedman, who has refused to speak to the media for months, says he and his colleagues believe a vocal faction of patients have taken over the message.

    “Does the community really want this? Is that what all MS patients want? Because the overwhelming majority of patients I see are too afraid to say anything,” Freedman says. “It is a minority, but they are loud.”

    They are so loud they have been shouting down their fellow patients.

    Richard Oakey, a 45-year-old Toronto man in the coffee import and export business went to India last May. He ended up not being treated because the imaging performed on him showed his veins were not blocked. He has avoided sharing his experience with other patients.

    “People have become vigilantes and (are) bashing doctors and bashing the health care system and bashing the MS Society,” Oakey says. “You know, I’m fully prepared for the hate mail, so to speak.”

    Dr. Katherine Knox at the University of Saskatchewan says, as all her colleagues told the Star, that she takes the time to explain her concerns with the experimental treatment — including the risk of blood clots and that a stent in the jugular vein could travel to the heart as it did for one patient in California — and that some say they plan to wait for more research, while others are willing to take the risk.

    Knox too has come across things written about her online.

    “Many are frustrated,” she wrote in an email. “I wish I could do better for them.”

    Katz, the vocal MS patient who has been organizing others through a website he co-founded that demands testing and treatment for all Canadians, shares the frustration of his fellow patients but disagrees with the personal attacks.

    “I don’t condone that at all,” Katz says of the online slander spewed against Freedman, who happens to be his doctor too. “I mean, that’s ridiculous. The guy is a freaking neurologist, you know. He spent his life studying this stuff and for anybody to demean him in any sort of way is ridiculous as far as I’m concerned . . .

    “It does give you an indication of how high the emotions are around this topic,” he says.

    Katz says he did not tell Freedman when he travelled to India in June for the treatment (like Oakey, his testing showed he did not have blocked veins and so it never happened), and was not planning on telling him about his upcoming trip to New York to try again.

    “You can’t blame a patient for looking out for No. 1,” Katz says. “You can’t, and you can’t hold anything against the neurologists for defending their position, when they have spent 40 years studying this disease.”

    Traboulsee, who took over as president of the Canadian Network of Multiple Sclerosis Clinics from Freedman in June, says he hopes the liberation treatment controversy will not permanently divide the community.

    “I think people should have their opinions on this topic and certainly will have their passions, but it would be a mistake to let this specific issue divide us, to let it polarize people, because the motivation on all sides is the same motivation: we want what is better for people,” Traboulsee says.

    Freedman, who chose to specialize in MS after a friend with the disease asked him to find a cure, talks openly about his general disappointment with what has happened in the last year. He says he is upset about the anger directed at him and worried the field won’t recover from the turmoil and will split. He also says he doesn’t blame patients, that he understands their desperation.

    “There are enough patients who are feeling fairly happy with the care they are getting — yesterday I had somebody give me a hug — I feel good about what I’m doing.”

    Source: Healthzone.ca © Copyright Toronto Star 1996-2010 (27/09/10)

    Health ministers agree to move 'quickly, ethically' on MS treatment

    CCSVI VenogramCanada's provincial health ministers pledged Monday to work together to explore ways to speed up the study of a controversial treatment for multiple sclerosis.

    The agreement came as the ministers gathered in St. John's for two days of meetings on everything from sodium reduction to a national pharmacare program.

    "I think it's safe to say we agonize over many issues that we want to address and certainly MS is one of those issues," Maureen MacDonald, Nova Scotia's health minister, said to reporters.

    "We have agreed as ministers that we want to act as quickly and as ethically as possible for MS patients."

    MacDonald said the goal of the ministers is to move toward clinical trials of so-called liberation therapy "when and if the evidence is available."

    The treatment is based on a theory that narrowed neck veins cause blood-borne iron deposits to build up and damage brain cells, and that unblocking the veins will help MS sufferers.

    The theory was first put forward by Italian doctor Paolo Zamboni.

    MacDonald said the ministers' agreement to create a working group doesn't preclude provinces from initiating their own research projects.

    She said the Multiple Sclerosis Society of Canada is already sponsoring projects in British Columbia, Ontario, Saskatchewan and Alberta.

    Earlier in the day, the government of Newfoundland and Labrador announced plans to fund an observational study of multiple sclerosis patients who have chosen to undergo the procedure.

    The government said the purpose of the provincially based study will be to evaluate the impact of liberation therapy on the symptoms and progression of MS in a patient.

    The government said it will not pay for patients to have the treatment done at this time.

    The province's health minister, Jerome Kennedy, said his department wanted to compliment work being done in other provinces.

    "It's something that will hopefully produce evidence that will show us one way or the other whether the Zamboni procedure works," he said.

    Up to $320,000 will be spent on the study but the provincial government said it will contribute more money if required.

    When asked why other provinces weren't offering to do the same, MacDonald responded: "You don't necessarily have one research project that replicates itself over and over and over again to build the information base that's required."

    The Saskatchewan government has opted to fund clinical trials of the treatment.

    Last month, the Canadian Institutes of Health Research, following a meeting with the Multiple Sclerosis Society of Canada and experts, said it would be premature to support pan-Canadian clinical trials.

    It recommended that the federal government set up a scientific working group to monitor ongoing studies.

    The institute cited a lack of scientific evidence on the safety and efficacy of liberation therapy, as well as a link between blocked veins and MS.

    On Monday, Alberta Health Minister Gene Zwozdesky said he intended to pull together researchers, neurologists, health administrators, MS patients and advocates in his province to see what can be done to accelerate the research.

    "We need to do what we can as ministers to go back to our own jurisdictions and see how we're going to approach this," he said.

    Source: Winnipeg Free Press © 2010 Winnipeg Free Press. (14/09/10)

    Mum revitalised by pioneering MS surgery

    Silvie Wright & familyA multiple sclerosis patient from Sheffield is enjoying a new lease of life after undergoing pioneering treatment abroad.

    Sylvie Wright travelled to Poland for a procedure to clear a blocked vein in her neck.

    She has also had a stent fitted to keep her left jugular vein open - it was originally 80 per cent blocked.

    Although the CCSVI treatment, which is designed to open up blood flow, has not yet been clinically approved, Sylvie said the anecdotal evidence that it could help MS patients was enough to make her determined to try it.

    The 37-year-old from Upperthorpe paid £5,000 to travel and undergo the treatment near Krakow and believes it has been money well spent.

    She said: "The way I saw it was if I had any blocked veins they shouldn't be blocked and they wanted unblocking irrespective of any connection with MS - although that link seemed highly likely to me.

    "I felt I had nothing to lose as my MS is progressing and my life is a constant struggle with severe disability, and particularly against the debilitating fatigue.

    "I think the procedure has already paid itself back because my fatigue reduced by 50 per cent immediately. This has improved my quality of life enormously. Most importantly, I have hope for the future."

    Sylvie, mum to four-year-old Marcus - a 'miracle' child she and husband Steve, 54, thought they would never have because of her health problems - first began taking a tablet called vitamin B3 to increase her blood flow.

    She said the impact on her fatigue was "incredible" and she immediately felt more energetic and able to do more.

    "I just felt so much better," Sylvie said, "I knew there had to be something in it."

    Angioplasty was carried out on her left jugular vein - a main vein in the neck. When it collapsed again, a stent was inserted to keep it open.
    A month on, Sylvie said she feels amazing.

    "We don't know what will happen in the future with this procedure because it's not been trialled, but I couldn't wait for another four years down the line. I could have been dead by then.

    "Since I had the treatment, I've only had one day where I felt really rubbish which is amazing. Before I had it done I felt like an old woman I was so tired all the time."

    Source: The Star ©2010 Johnston Press Digital Publishing (08/09/10)

    Why national MS societies are not acting in the best interests of persons with MS

    Aston EmbryIntroduction

    With the advent of CCSVI as a major factor in multiple sclerosis, it has become painfully apparent that national MS societies do not have the best interests of persons with MS as their highest priority.

    This has taken many people by surprise because most people are under the assumption that the main concern of national MS societies is the well being of persons with MS. This assumption is not, and has never been, true. Perhaps one more benefit of the discovery of CCSVI as an important causal factor of MS, has been to expose the myth the national MS societies have people with MS as their #1 priority.

     The Groups of the MS Societies

    To understand the priorities of national MS societies, it is essential to understand the various groups which compose their structure. These groups are the scientific advisors, the staff members, the board members, and the members of the society who are mainly persons affected by MS. Each of these groups plays a very specific role in how a given national MS society functions.

    The most important and influential group is the scientific advisors who determine the type of information the society provides to the members and to the public at large. They also determine what research will be done and what overall policies will be followed when it comes to lobbying efforts to influence government decisions. The scientific advisors are clinical neurologists who specialize in multiple sclerosis. Many of them also carry out research activities in addition to their clinical work.

    The next important group is the paid staff of the society and, in the case of a large society, they can number in the hundreds. Their salary and benefit packages are on par with workers in similar jobs in both the private and public sectors. Importantly, the staff, for the most part, puts into action the policies and plans of the scientific advisors, that is, the neurologists. There is a very strict adherence to this and no deviation or independent thinking is tolerated. The staff members are like soldiers who do what they are told and are not expected to contribute to the scientific or public policies of the society. They are simply the “go-betweens”, the neurologists and the all those seeking information from the society. Notably, most staff members are not affected by MS.

    By far the greatest responsibility of the staff is to raise money by running various fund raising projects. Most of staff time is spent on this critical activity which is understandable given the majority of the money raised goes to pay staff salaries and benefits. Staff members also arrange some programs for people with MS in terms of education but this activity is rather minor in terms of actual time and effort expended. The staff also fields questions from persons with MS and, as noted previously, the provided information is only that sanctioned by the scientific advisors (neurologists).

    The board of directors of a given national society is most often composed of people who usually have good connections for fund raising from corporations or who have strong political connections. Usually a few persons with MS are included on a board but, in most cases, the majority of board members are not affected by MS. One or more staff members also usually are part of the board.

    Most board members have at best a rudimentary understanding of science in general and the science of MS in specific. They have very little influence on any major policies of the society and, in most cases, simply rubber stamp the scientific and political policies determined by the neurologists and implemented by the staff. Their main responsibility seems to be ensuring that the society is on a firm financial footing and discussing the merits of proposed fund raising campaigns.

    The final group in a national MS society consists of the members themselves and they, for the most part, are persons affected by MS. They are the consumers of the products of the society which consist mainly of information dictated by the neurologists and packaged by the staff. Such information is both hard copy and web-based. Some members act as volunteers and volunteer activities are related to both money raising activities and to helping other people with MS. The members essentially have no say in terms of the main policies of the society although on a local level they can help to get new member services initiated.

    In summary, a national MS society spends most of its time raising money which is used to pay fund-raising costs, the salaries and benefits of the staff members, and substantial administrative expenses. Such expenses require about 80-85% of all money collected. The amount left over is mainly used to fund research projects approved by the scientific advisors (neurologists) and, not surprisingly, projects of former and current advisors usually are well funded. Proposals from “outsiders” don’t fare so well.

    Past Situation

    In the past, everything went along rather smoothly with the society advertising the need to raise money to cure MS, with such a cure being attainable through the research activities funded by the society. Given the severe disabilities sometimes associated with MS, the need for finding a cure for MS is not a hard sell, and the large MS societies raise tens of millions of dollars every year. In the 60 years this routine has been going on, the research funded by the societies has not brought us anywhere even remotely near the prospect of developing an effective treatment for MS. This impressive failure has only led to louder calls for more money for more research.

    The scientific and medical information provided by a national MS society is entirely centred on drug therapies that have been approved for use. The staff members strongly advocate the use of such drug therapies and almost all other proposed therapies are ignored, discouraged and/or denigrated. The main government lobby efforts of the societies usually are to fight for the approved use of the drugs.

    It is imperative to appreciate that most (often all) of the scientific advisors of the societies and the societies themselves have strong financial ties to the pharmaceutical companies which manufacture and market the approved drug therapies for MS. The most blatant of such ties is that of the NMSS of the United States. It partners with drug companies and gives substantial grants to them.

    The existence of such financial ties readily accounts for the policy that only drug therapies are advocated and that the value of such therapies is never, ever remotely questioned. These financial ties also create a serious conflict of interest for the neurologists and MS societies when it comes to any proposed, non-drug therapy and that is one, big reason why non-drug therapies are ignored or downplayed by the societies.

    There can be no doubt that the national MS societies are there mainly for the benefit of the neurologists (scientific advisors) in that they provides them much needed research funding. The societies also provide an excellent vehicle for promoting drug therapies which are financially very important for the neurologists. Of course the societies are also there for the benefit of the staff members who make a good living from keeping everything running smoothly and ensuring the information from the neurologists reaches the desired destinations.

    Before the advent of CCSVI, the drug therapies were the only conventional medical therapies available. By advocating such therapies, the societies could easily claim to be acting in the best interests of persons with MS even though such advocacy was driven mainly by the best interests of the neurologists and the societies themselves. Whether or not the use of the current drugs is really in the best interests of persons with MS is a completely separate issue and will be explored in a separate document.

    CCSVI Rocks the Boat

    The sudden emergence of CCSVI as an important factor in MS, and the great promise of CCSVI treatment for slowing and perhaps even halting MS disease progression for many, have caused a great problem for MS societies around the world. Given all that we now know about CCSVI and its treatment, the national MS societies would best serve the interests of persons with MS by immediately funding a major, comprehensive research program which definitively tests the effectiveness of CCSVI relief in the next few years. Furthermore, it would also be in the best interests of persons with MS if the MS societies lobbied to have CCSVI treatment available as soon as possible given the health problems associated with having impaired venous drainage from the brain and the many hundreds of credible, experiential accounts of very significant positive changes following CCSVI treatment.

    The MS societies have studiously avoided funding any clinical trial studies for CCSVI treatment as was clearly demonstrated by the rejection of proposals from top CCSVI researchers by North American national MS societies. (e.g. University of Buffalo, Stanford University, McMaster University). Notably, those who got their proposals accepted seem to have either very strong ties to the pharmaceutical industry (e.g. Wolinsky at U of Texas) or do not know what they are doing. A fine example of this latter category is Dr Kathleen Knox at the University of Saskatchewan who recently was quoted as saying “The biggest difficulty her team faces, is that they don’t know how to test patients to see if they have the blocked veins”. This is a stunning admission of incompetence and shows the type of researchers favoured by the national MS societies when it comes to CCSVI research.

    Some national MS societies are actively lobbying their respective government NOT to allow CCSVI treatment. A fine example of this is a recent letter the director of the Ontario division of the MS Society of Canada wrote to the Ontario Health Minister emphasizing that the province should not fund any CCSVI testing or treatment. The notice on the website of the Multiple Sclerosis Society of Canada says it all - “the MS Society does not recommend that people with MS be examined or treated for CCSVI outside of an established research protocol”. All in all, any thought that MS societies are acting in the best interests of persons of MS must be abandoned. So who’s best interests are they serving with their actions?

    When it comes to CCSVI, the interests of the neurologists and the societies are best served by having CCSVI marginalized, by not funding any CCSVI treatment research, and by lobbying the government to not allow any treatment of impaired venous drainage in persons with MS despite the obvious health hazard such a condition represents. The reasons for such actions are straightforward.

    If CCSVI treatment by venous angioplasty turns out to be far more effective than the current drug treatments, and there is every reason to expect it will be, then MS drug revenues will plummet precipitously. Such a huge loss of revenue will have a devastating effect on the financial well being of MS neurologists and the national MS societies themselves. Furthermore, persons with MS will be treated primarily by interventional radiologists, thus adding to the financial losses of the neurologists. There is no question that any activity which helps to bring the implementation of CCSVI treatment forward is not in the best interests of the neurologists and the national MS societies that they control and everyone is well aware of this indisputable but somewhat awkward fact.

    Because of the advent of CCSVI, we now have an unprecedented situation of conflicting interests. What is in the best interests of persons with MS is clearly not in the best interests of both the neurologists who provide the scientific guidance for the MS societies and the staff of the societies who put into effect the policies of the neurologists.

    The Current Reality

    Not surprisingly, the best interests of the neurologists and the society staff members will always trump the best interests of the persons with MS. Thus the policies and actions of the national MS societies have been to avoid any funding of proposed CCSVI treatment studies and to lobby government bodies not to provide any CCSVI treatment. They also advise persons with MS not be tested or treated for CCSVI despite the obvious medical need for such treatment (blocked veins are hazardous to one’s health).

    The neurologists and the MS societies also have instituted a policy of casting doubt on the validity of the CCSVI concept and on the safety of CCSVI treatment. This has even gone as far as blatant fear-mongering when it comes to having venous angioplasty to relieve CCSVI. One good example of this recently appeared in a governmental health report written by MS neurologists. The writers claimed that the only venous blockages that exist in persons with MS are clots caused by angioplasty and the only results of venous angioplasty are injuries to the vein. This is of course sheer nonsense but, as they say, truth is the first casualty in any war.

    The current actions of the national MS societies regarding CCSVI are entirely rational once the structure of the societies is understood. The societies are acting in the best interests of the neurologists and staff members as they always have and always will. Unfortunately, when it comes to CCSVI, such actions are not in the best interests of persons with MS. However, it is the false perception that the national MS societies are there primarily to serve the best interests of persons with MS that has created the shock and disappointment with the current actions of the societies in regards to CCSVI.  When it comes to the policies and actions of the national MS societies, persons with MS must fully realize that they are lower in priority than the neurologists and staff members. The CCSVI issue has clearly demonstrated this beyond any reasonable doubt.

    Consequences of the Actions of the National MS societies

    We now have sufficient data to say that, each day a person with MS suffers the consequences of impaired venous drainage, they are doing harm to themselves and such a reality has to be clearly understood. It has been said, “MS Never Sleeps” and one of the main reasons for this is that impaired venous drainage never sleeps and this serious pathology is causing problems every day for persons with MS. Thus it logically follows that every dollar the national MS societies raise is potentially doing harm to persons with MS because that dollar is potentially contributing to actions that are designed to delay the availability of CCSVI treatment for all persons with MS. 

    Given the above, it is clear that the interests of persons with MS would be best served by halting any support of national MS societies and by supporting groups which are actively promoting the need for CCSVI treatment research and government support for the availability of CCSVI treatment as soon as possible.

    Summary

    The advent of CCSVI has revealed the highest priorities of the national MS societies. These are actions and policies that are in the best interests of neurologists and society staff members. The interests of persons with MS are a distant third in this contest of competing interests. Continued support for national MS societies is potentially harmful for persons with MS because of the societies’ deliberate lack of appropriate and much needed actions regarding CCSVI. All persons affected by MS should be supporting organizations which are funding clinical trials to test the effectiveness of CCSVI treatment and which are lobbying governments to make CCSVI treatment widely available in the near future.

    Ashton Embry

    This view expressed in this article is that of the author and not MSRC

    Denied help: MS patient blasts health bosses

    Suzanne HarveyA woman whose life is blighted by MS has slammed the NHS for dismissing a treatment that could help her and potentially save thousands on expensive drugs.

    Suzanne Harvey believes new research holds the key to a condition strongly linked to MS, but funding chiefs say they need more evidence, forcing her to raise thousands of pounds for private treatment.

    Suzanne said: “It’s insane, they’ll put me on expensive drugs that cost £3,000 to £6,000 a month but they won’t look at this.

    “Because of MS I’ve lost the ability to be the person I was. I’m a person who likes to live life and within six months I could be in a scooter.”

    The mother-of-one, from Theale, was diagnosed in July last year and offered drug treatment to slow the progress of the disease, but after talking to other MS sufferers online about potential side effects, she refused. A concerned friend then alerted her to research from Italy into a condition called chronic cerebro-spinal venous insufficiency (CCSVI).

    Nail technician Suzanne, 39, said: “It means the veins that drain blood away from the brain and spinal chord have been compromised, and when that happens you get reflux because it’s carrying iron deposits.

    “It’s dirty blood essentially and that’s what causes nerve damage. Research shows 90% of people with MS had blocked veins in their neck and chest.”

    Suzanne paid for an ultrasound scan at a Glasgow clinic which showed she had a problem with a vein in the right-hand side of her neck, but bosses at NHS Berkshire West are refusing to fund the £6,000 “ballooning” procedure which could be used to try to open up the vein.

    Spokesman Richard McCrann said: “There is wide acknowledgement that there has been insufficient research in this field to establish clearly that there is a major link between CCSVI and MS.

    “While many people welcome any potential breakthrough in treatments for MS, NHS Berkshire West remains cautious about this treatment until its clinical effectiveness has been positively established. The PCT cannot provide routine funding for this procedure at this stage.”

    Source: The Reading Chronicle © Berkshire Media Group 2010 (31/08/10)

    Nova Scotia premier supports clinical trial on controversial MS treatment

    CCSVI VenogramNova Scotia's premier has added his voice to a growing chorus of support for a national clinical trial for a controversial treatment for multiple sclerosis.

    Darrell Dexter's comments in favour of his province's participation in a trial came in response to the Manitoba health minister, who wrote a letter to her provincial, federal and territorial counterparts seeking support for so-called liberation therapy.

    The treatment is based on a theory that narrowed neck veins cause blood-borne iron deposits to build up and damage brain cells, and that unblocking the veins will help people with MS.

    Dexter says his government would agree to a program that is led by the federal Health Department and agreed to by the other provinces.

    "I'm going to be instructing and working with the minister of health to ensure that position is advanced in the health ministers' meeting this fall," he said.

    Nova Scotia's government has to date resisted calls to fund the therapy, but Dexter says he is willing to await the results of a clinical trial before making a final decision.

    He says the province owes it to those with the disease to fully consider the merits of the treatment.

    Quebec's health minister came out in support of trials on Wednesday. And Saskatchewan Premier Brad Wall offered last month to pay for clinical trials of the procedure in his province, encouraging other provinces to consider taking a similar approach during a recent meeting of premiers.

    Clinics in Poland, Bulgaria and India are opening blockages for patients who have travelled from Canada and other countries in the last few months.

    Some patients have posted testimonials on websites, in chat rooms and in YouTube videos, saying the procedure has reduced their symptoms.

    There have also been numerous stories on television networks and newspapers giving the accounts of patients who claimed improvements.

    However, two recent studies have cast doubt on the efficacy of the treatment, and some experts have raised concerns about the potential danger of manipulating veins.

    The MS community is divided on the issue, with many saying more studies are needed before the treatment can be tested on humans.

    Source: Winnipeg Free Press © 2010 Winnipeg Free Press. (20/08/10)

    Quebec ready to collaborate on controversial MS procedure

    CCSVI VenogramQuebec's health minister says he's ready to join other provinces in a national clinical trial of a controversial treatment for multiple sclerosis.

    Yves Bolduc says he's very open to Quebec collaborating on clinical studies, adding he will ask his own experts to provide him with an opinion.

    Manitoba Health Minister Theresa Oswald has written a letter to provincial, federal and territorial health ministers seeking their support.

    She has called for a pan-Canadian randomized clinical trial of the efficacy of the so-called liberation procedure.

    The treatment is based on an unproven theory that blocked veins in the neck or spinal cord are to blame for MS, a chronic disease of the nervous system that can affect vision, hearing, memory balance and mobility.

    Mr. Bolduc says it's a method that shows promise but notes there are no clinical studies to show how efficient it is.

    But he's willing to investigate it.

    “In this case, we will collaborate with all the other provinces,” he said.

    But Mr. Bolduc, who's a doctor, told reporters in Montreal on Tuesday that he's very cautious about all new treatments.

    “It's a new technology. . . and in medicine, we have to be prudent because several treatments have been announced as being very good, but in the end don't provide much help,” he said.

    Clinics in Poland, Bulgaria and India are opening blockages for patients who have flocked from Canada and other countries in the last few months.

    Some patients have posted testimonials on websites, in chat rooms and in YouTube videos, saying the procedure has reduced their symptoms.

    However, two recent studies have cast doubt on the effectiveness of the treatment, and some experts have raised concerns about the potential danger of manipulating veins.

    The MS community is divided on the issue, with many saying more studies are needed before the treatment can be tested on humans.

    Ms. Oswald wants the issue on the agenda for the annual meeting of health ministers, set for next month.

    Mr. Bolduc made his comments after a news conference which was held to announce a modernization of Ste-Justine's children's hospital.

    The work, which would enlarge the Montreal hospital and cost about $1-billion, is scheduled to be completed by the end of 2016.

    Source: The Globe And Mail © Copyright 2010 CTVglobemedia Publishing Inc. (18/08/10)

    Alberta committee to probe new MS procedure next week

    CCSVI VenogramA government committee handpicked to look into a controversial and experimental procedure to treat multiple sclerosis will begin its work next week.

    Alberta Health Minister Gene Zwozdesky said the 13-member committee will be on a fact-finding mission Aug. 27 when the world's top researchers will meet in Ottawa for a summit.

    The group will also try to find ways to improve existing services and treatments for MS sufferers in Alberta, Zwozdesky says.

    "This committee's purpose is to not exclusively look at liberation treatment. It will look at other innovation and technologies," Zwozdesky told the Sun.

    Saskatchewan's government announced plans to pay for clinical trials of the liberation treatment back in July, but Alberta won't go the same route unless there's proof it works.

    Right now, MS patients in Canada must spend thousands of dollars on flights and medical costs to get the experimental procedure.

    Italian researcher Dr. Paolo Zamboni found a majority of his patients who suffer from MS have narrow veins.

    His procedure involves a balloon, which is blown up inside a blocked vein to improve bloodflow to the brain.

    The Multiple Sclerosis Society of Canada says it welcomes the idea of government-paid clinical trials, but more work needs to be done in terms of research.

    Alberta and Saskatchewan have the most MS cases in the country.

    Zwozdesky says he plans to bring up the topic at a provincial and federal health ministers' meeting next month.

    MS can cause a loss of balance, impaired speech, extreme fatigue, double vision and paralysis.

    About 1,000 people are diagnosed with MS in Canada every year, according to figures from the society.

    Source: Edmonton Sun © Edmonton Sun 2010 (17/08/10)

    Manitoba pushing for national trial for MS treatment

    CCSVI VenogramManitoba Health Minister Theresa Oswald on Monday sought support from other Canadian leaders to launch a nationwide clinical trial to test the efficacy of a controversial multiple sclerosis treatment which is currently not available in this country.

    Oswald sent a letter to all federal and territorial health ministers requesting their support for a national randomized clinical trial of the so-called "liberation treatment."

    Oswald's letter said patients with multiple sclerosis have been waiting too long for a treatment breakthrough and that it's "time that we work together to try and find scientifically sound answers as to whether this procedure is effective."

    The minister has requested that top scientists consider a large, co-ordinated clinical trial at their Aug. 26 Canadian Institutes of Health Research meeting.

    The government of Saskatchewan announced several weeks ago that it was willing to fund trials of the unproven treatment.

    It was developed by Italian neurosurgeon Dr. Paolo Zamboni, who argues that the debilitating disease might be caused by a narrowing or blockage of veins in the neck which drain blood from the brain — a medical condition known as CCSVI or chronic cerebrospinal venous insufficiency.

    Source: The Vancouver Sun © 2008 - 2010 Postmedia Network Inc.(17/08/10)

    Social media drives Multiple Sclerosis controversy

    CCSVI VenogramFeeds acrimony over liberation treatment, but also forces researchers to respond.

    A controversial treatment that promises relief from the daily torment of multiple sclerosis has created a deep rift between its proponents and those who say it doesn't work.

    Helping drive the controversy is social media, where it can be difficult for people to determine the truth.

    Neil Pierce, president of the Alberta division of the MS Society of Canada, said he knows other patients who don't want to publicly share their stories of disappointment after the liberation procedure failed them because of the backlash they expect to face from people within the MS community.

    "It's been so divisive," he said. Caught in the middle are doctors and the MS Society.

    Dr. Paolo Zamboni, who developed the treatment in Italy, has theorized the narrowing creates a buildup of blood and iron in the brain, causing vertigo, fatigue, numbing sensations in the limbs and other symptoms related to MS.

    For six weeks after having a controversial procedure for her multiple sclerosis, May Feitsma felt immense relief, energy and hope before the disease again chained her breath, hands, feet and head.

    But despite reverting back to her old self after paying $25,000 to travel to India for what is called the liberation treatment, Feitsma is convinced that once doctors find a way to permanently keep open the jugular vein on the right sideof her neck -- perhaps with a stent -- her MS will retreat.

    "I've seen results that were so good I know that it works," said Feitsma, who had her operation March 30. Soon after, her blue feet turned a flush pink. Her breathing went from laboured and tiring to smooth and refreshing. Then her headaches disappeared for five to six weeks.

    "It has (since) gone back to zero," she said.

    Feitsma went to Calgary for an imaging and diagnostic test, where she learned her jugular had narrowed again.

    "It was very disappointing because I felt so good," Feitsma, 51, said from her farm near Ponoka. But she hasn't stopped believing in Zamboni's research.

    Feitsma said the treatment has brought relief for others.

    "I'm just waiting to see where the Lord will bring us," she said.

    Tom King, pastor of Clearwater Cowboy Church, had the treatment in India. He continues to see improvement. After he had a stent inserted into his left jugular vein in May, his migraines disappeared. The feeling in both hands improved enough to allow him to button his shirt and tuck it in himself.

    No doctors who specialize in MS will speak about what they are advising patients or to further explain the position statement of Alberta Health Services.

    Health services warns patients that the veins can be damaged through angioplasty since their walls are narrower than arteries. It also says the placebo effect may creating the positive results.

    In another corner are patients who believe angioplasties should be made immediately available without years of delay to complete clinical trials. Some have accused physicians of being in the pockets of pharmaceutical companies, which make money from selling drugs to treat the debilitating disease.

    Gregory Chant, an MS patient from Camrose, said he has been called a jerk and berated in website chat rooms for expressing cynicism about the new technique.

    "Nobody wants to hear that," Chant said. "It's frustrating ... I'm not a popular person on this website."

    He believes others, who constantly chit-chat about impending trips to Bulgaria or Poland or India for the procedure, go underground after they get the treatment but aren't cured.

    "They disappear," he said. "The website goes quiet. They don't want to admit they spent $30,000 for an Aspirin."

    Pierce said he also knows such patients and none want to talk publicly.

    Brendan Leier, a professor at the John Dossetor Health Ethics Centre at the University of Alberta, said it's common for popularized medical research to fragment communities, especially in the age of social media spreading the word.

    Take the more mature controversy surrounding autism and the belief of some people that it's triggered by vaccinations, Leier said. The idea has taken hold in some American communities where large chunks of the population are no longer vaccinating their babies, risking the rise of polio or whooping cough.

    "These things are always divisive," Leier said. "Social media enables this, (it) is the kindling that turns this from a small movement into a massive global movement. I don't think it's necessarily a bad thing because it forces a very, very conservative institution to respond and to be critical of themselves and to articulate appropriate responses."

    DOCTORS, DRUG FIRMS

    Leier said the world of medical research is "profoundly conservative," with its standards of clinical trials that take years to hit the market. The pot of research dollars has also shrunk, forcing doctors and researchers to build partnerships with drug companies, which don't usually fund surgical or alternative therapies for diseases such as MS. That doesn't mean the academics are in the pockets of big pharmaceutical companies, Leier said, that's just the reality of research dollars.

    "There's no conspiracy," he said. "There are aspects of that conservatism that are very good," including evidenced-based research. But Leier said both evidence-based and experiential-based science has legitimacy.

    "Physicians can't honestly say this doesn't work because if you hold them to their own standards, they have no evidence to say it doesn't work," Leier said.

    He said people should support Saskatchewan Premier Brad Wall on the liberation treatment. "Premier Wall in Saskatchewan made an excellent decision to fund clinical trials," he said. "I think that was politically ingenious on his part. But it was also a very humane gesture as well."

    Leier said the first clinical trial that needs to be done is to do imaging tests on MS patients to see if they, indeed, have blocked or narrowed veins. Those tests could be done quickly and would be minimally invasive.

    Any results would help offset the often unbalanced portrait on the Internet, Leier said. The problem with relying largely on anecdotal evidence gleaned from a Google search is that people only see the positive stories and not the negative ones.

    "You don't get that balance of testimony," he said. "Negative findings are just as important as positive findings, but negative findings have always been historically under-represented in publications."

    He urged people to wait until the Saskatchewan clinical trial is complete before deciding on travelling for the procedure.

    "You don't want a whole bunch of people running around the world getting angioplasties thinking this might work, but that's just a testament to how desperate people are," he said. "The frustration in communities comes from perceived conservatism, dogmatism and arrogance of the status quo MS community."

    Source: The Edmonton Journal © The Edmonton Journal 2010 (11/08/10)

    Scarborough wife's plea for life-saving procedure

    Angela BaldockA Scarborough couple are fighting for a life- changing treatment for multiple sclerosis to be made available on the NHS.

    The procedure is still being researched and could lead to a breakthrough in the treatment of thousands of people in the UK and across the world.

    Angela Baldock, of Westfield Avenue, off Cross Lane, was one of the first people in the country to have a special type of scan designed to show up blocked veins in those with multiple sclerosis (MS).

    The 49-year-old could now be one of the first people with MS to undergo a procedure to clear the blockages as part of a research project on the NHS.

    The other option is to pay £5,000 to £6,000 for private treatment, either in Glasgow or abroad.

    Mr Baldock, 57, said: "In considering all options for treating Angela we are erred toward waiting for the research project later this summer.

    "Though in truth, if we hear from Scotland or Poland with a date for surgery, we will be very torn at the thought of delaying an opportunity to treat Angela quickly - albeit at a cost we would struggle to afford.

    "The irony of this is that the NHS is not prepared to pick this treatment up when there are real benefits to people with MS in terms of improvements in many symptoms."

    Mr Baldock, who works as an area manager for North Yorkshire County Council adult services, explained that the treatment could have life-changing benefits for Angela such as improved mobility, energy and concentration.

    He added that there are cases of people who have been in a wheelchair and then been able to walk following treatment.

    He has now submitted the matter to the National Institute for Health and Clinical Excellence (NICE), the NHS's advisory body, for consultation.

    NICE has confirmed it is monitoring the procedure under the name of "Balloon angioplasty with or without stenting for chronic cerebrospinal venous insufficiency (CCSVI) in MS".

    The couple are now hoping to hear as soon as next month.

    Source: Scarborough Evening News ©2010 Johnston Press Digital Publishing (09/08/10)

    Canadian premiers to debate CCSVI MS treatment

    Canadian FlagLeaders differ on approach to 'liberation therapy'

    An experimental treatment for multiple sclerosis will be discussed at a meeting of Canada's premiers this week, P.E.I. Premier Robert Ghiz said.

    Ghiz said he was open to considering adding so-called liberation therapy to the list of insured provincial health services.

    Nova Scotia Premier Darrell Dexter rejected calls for changes in the near future.

    Canada's 13 provincial and territorial premiers are scheduled to meet in Winnipeg starting Thursday to discuss Canada's economic recovery, as well as water issues and health care.

    The MS treatment is based research by Italian physician Paolo Zamboni that suggests iron buildup in the brain, due to blocked veins in the neck or spinal cord, might be to blame for the condition.

    Some Canadian MS patients have travelled out of the country to pay for treatments that clear blockages in their veins.

    Clinics in Poland, Bulgaria and India are opening blockages for patients who have flocked from Canada and other countries in the last few months.

    Brad Wall, Saskatchewan's premier, has said his province will pay for clinical trials. He hopes to convince other premiers to do the same at the premiers meeting.

    Online petition
    Ghiz said he has heard requests and concerns on the issue from a number of Islanders, including an eastern P.E.I. man who started an online petition last week calling for coverage.

    "There has been some individual lobbying here in the province of Prince Edward Island, so this is something that I'm going to be talking to Premier Wall about and see where he is," Ghiz said.

    "I think we have to work with the federal government when it comes to these clinical trials and getting them done as soon as possible."

    But Dexter repeated his position that Nova Scotia will not fund trials of the proposed therapy for MS because it is unproven.

    He said that because Saskatchewan has announced it will carry out trials, Nova Scotia doesn't have to repeat the work.

    The provincial government will not financially support Nova Scotians who travel abroad to get the treatment, either.

    "You could imagine what would happen if you were to make a decision to support something that is not an approved procedure and then something would go wrong, and of course people would come to you and ask why you made that decision," he said.

    "So, I think the prudent thing for us to do, of course, is to rely on the best possible medical evidence and to make sure that our decisions are made on the basis of the best evidence."

    Dexter said Nova Scotia will decide what to do about the treatment once the trials in Saskatchewan are complete.

    The causes of multiple sclerosis, a nerve-wrecking condition results in painful spasms and loss of muscle control, are poorly understood. Current theories point to genetics, immune system problems and viral infections.

    Source CBC News Copyright © CBC 2010 (03/08/10)

    Alberta ponders paying for new MS treatment

    CCSVI VenogramThe Alberta government is looking at whether to follow Saskatchewan's lead and pay for studies of a controversial experimental treatment for people with multiple sclerosis.

    Alberta Health Minister Gene Zwozdesky is pulling together a working group of about a dozen people to examine the issue, he said Thursday.

    The group will look into whether the province should pay for clinical studies of the so-called liberation therapy. The treatment is based on research by Italian physician Paolo Zamboni that suggests MS, a baffling nerve-wrecking disorder, stems from iron buildup due to constricted blood flow out of the brain.

    Earlier this week, Saskatchewan announced it will pay for clinical trials of the surgical procedure, which opens up blockages in the cerebrospinal veins.

    Several dozen Canadians have already travelled overseas to Eastern Europe and India for treatment, paying $10,000 to $15,000 each to have balloons inflated inside their neck and chest veins to improve blood flow.

    After talking to patients, Zwozdesky said he's convinced it's worth looking at given some of the experiences people have had after receiving treatment.

    "It's simple stuff, everyday stuff such as the ability to comb your own hair or put on your own clothing or wiggle your toes, to put the cane aside, even if it's just for a few moments, and feel liberated," the minister said.

    "There's some compelling testimonials. The trick now is how do we translate that into the clinical studies that are still necessary."

    'I could walk better'

    Claire Bungay of Stratford, P.E.I., underwent the procedure in Poland earlier this month.

    "I noticed right away I could walk better," Bungay said afterward. "I could lift my right leg over my left leg without having to haul it over with my hand. That was huge."

    York, P.E.I., resident Neva Tremere had her procedure in Bulgaria. She used to average a couple of painful leg spasms a day, each lasting hours, she said. Now she sometimes has spasm-free days, and when they happen they don't hurt as much. It's the best she's felt in five or six years, she said.

    The treatment is not yet available in Canada.

    The Multiple Sclerosis Society of Canada says Zamboni's work — which suggests that MS results from iron buildup in the brain as a result of the vein constrictions, and not from an autoimmune condition — is worthy of interest and optimism. But the society says therapeutic widening of veins needs much broader investigation than Zamboni's trial, which involved 65 people.

    Paul Hébert, an Ottawa physician, medicine professor and editor in chief of the Canadian Medical Association Journal, warned that "the evidence for this procedure is very, very limited to date."

    "The idea of this procedure and this particular hypothesis to the cause of MS is really interesting. It's worthy of further study," Hébert said. "But I have to caution anyone ... that this is highly experimental."

    Zwozdesky said his working group will hold its first meeting in September, and there will be discussions about the experimental therapy at a national conference in the coming months.

    In the meantime, people who go to other countries to get the treatment may not be reimbursed by Alberta medicare, he advised.

    Source: CBC News © CBC 2010 (30/07/10)

    CCSVI – different approaches, different techniques

    CCSVI VenogramA report on the CCSVI Symposium in New York 26/07/10

    Yesterday, a symposium about the vascular theory of MS (aka CCSVI) was held in Brooklyn.  This is a pretty exciting development because it marks one of the first times the medical community–specifically interventional radiologists(IRs)–have come together to discuss CCSVI and its treatment.

    In a nutshell, here’s what was concluded:  we are at the very early stages of our understanding of CCSVI–what it means, how to diagnose it and how to treat it.

    Diagnostic radiologists, who read the MRI or Ultrasound images have remarked that diagnosing CCSVI is not a straightforward affair.  There are incredible subtleties that need to be understood and mastered for a diagnostician to conclude CCSVI is present.

    The IRs who have been treating CCSVI agree about the following:  treating CCSVI is not like anything they have been doing up to now.  It requires new skills, techniques and expertise.   The learning curve is steep.

    Where they disagree (but again, they are all “learning as they go”) is whether to balloon or stent, if they balloon, what size to use, and regardless of whether they balloon or stent, exactly where to do the repair.  Those are a lot of variables, and for patients being treated today, how will their IR’s choices affect their outcome?

    So where does this leave the MS community?  Every individual needs to make the choices that are right for them including whether to get imaged and treated.  Since the medical community who are currently working on CCSVI are still creating more questions than answers for themselves, we know that the right answers are going to take time and rigourous research.  An individual touched by MS might want to consider the pros and cons about acting now, or waiting a little while for more answers.

    Source: Canada Diagnostic Vancouver Bulletins (28/07/10)

    Saskatchewan premier calls for clinical trials of MS treatment

    CCSVI VenogramSaskatchewan is ready to help pay for clinical trials of the so-called liberation treatment for multiple sclerosis sufferers, despite a lack of scientific evidence that it might work, says Premier Brad Wall.

    “There isn't unanimity on the issue, I understand that,” Mr. Wall said Tuesday. “But we also know anecdotally and otherwise, frankly, of reasons for some optimism and some hope about the liberation treatment, so maybe it is time for clinical trials and ... the province of Saskatchewan is willing to play a funding role.”

    The treatment is based on an unproven theory — first put forward by Italian doctor Paolo Zamboni — that blocked veins in the neck or spinal cord are to blame for MS. Clinics in Poland, Bulgaria and India are opening blockages for patients who have flocked from Canada and other countries in the last few months.

    Some patients have posted testimonials on websites, in chat rooms and in YouTube videos, saying the procedure has reduced their symptoms. That has created political pressure to have the treatment provided in Canada.

    Saskatchewan has the highest rate of multiple sclerosis among provinces, with some 3,500 residents affected by it.

    “There isn't anybody who doesn't have a family member or friend who is battling it,” Mr. Wall said.

    Many medical experts are urging caution. Dr. Paul Hiebert, a critical-care physician and editor-in-chief of the Canadian Medical Association Journal, has said that manipulating veins can be dangerous and there is no established link between venous blockages and MS.

    “To date, the published evidence is limited to a case series of 65 patients,” Dr. Hiebert wrote in the latest edition of the journal.

    He and others believe several questions must be answered before clinical trials on humans can begin: Do people with MS really have higher rates of venous blockages, are those blockages a cause of or a result of the disease, and can veins be dilated or opened safely?

    For Mr. Wall, clinical trials are the way to go. His government is inviting proposals from the scientific community and expects to get them shortly.

    “We want to be a leader in at least exploring every possible source of hope for those who are battling MS.”

    Source: The Globe And Mail © Copyright 2010 CTVglobemedia Publishing Inc (27/07/10)

    Doctor calls costly MS therapy ‘robbery’

    CCSVI VenogramClinics charging multiple sclerosis patients thousands of dollars for an unproven treatment are basically stealing, an internationally recognized stroke researcher and Robarts Research Institute scientist said Monday.

    “That is robbery. . . . It is quackery because nobody knows yet if it works,” said Dr. David Spence, director of the Stroke Prevention and Atherosclerosis Research Centre in London, Ontario.

    News reports that Italian doctor Paolo Zamboni last year discovered a treatment for MS that involved unblocking veins have sparked intense interest from people with the disease.

    Proponents say the procedure can reduce, and even eliminate, the damage from MS.

    Clinics offering the controversial angioplasty procedure have sprung up in Mexico, India, Kuwait, Bulgaria and other countries.

    In Canada, the procedure hasn’t been approved and patients have to pay the bills themselves, some as high as $20,000, if they opt for foreign treatment.

    Several MS patients from London, Ontario have said they will have the procedure after seeing media reports and watching YouTube videos showing patients getting out of wheelchairs and walking up stairs.

    “It is a procedure that should only be done experimentally for now because it is based on an unproven theory,” Spence said.

    “For sure we would all love it to be true, it would be great to have a new treatment for multiple sclerosis, but there are a whole bunch of problems.”

    One of the problems with the theory that multiple sclerosis is connected to blocked veins is that narrowed veins in the brain can cause strokes. But the part of the brain affected by strokes is not the same part affected by MS, Spence said.

    In addition, many MS lesions are found in the spinal cord, not in the brain, so the narrowing of veins in the brain is not going to cause those lesions, he said.

    “The theory is implausible because it doesn’t bear any relationship to what we already know about these things,” he said. “Everything we know about MS so far indicates it is an inflammatory condition.”

    Spence likened the current rush of patients to seek the foreign treatment with laetrile, an extract from almonds that was touted as a cancer cure but was later discredited.

    As for the testimonials from patients who reported dramatic improvements after the procedure, Spence said many people, including some doctors, don’t understand the placebo effect.

    “It is very real, very powerful.”

    Spence cited a study of the placebo effect at the University of Western Ontario in which medical students were given dummy pills and told they were being given a heart medication. Tests on the students recorded some had nausea, vomiting and high blood pressure. Some fainted, and some had low blood pressure.

    “They recorded definite physical abnormalities from taking this placebo tablet because they had expectations it would have some affect on their cardiovascular system,” Spence said.

    “You cannot study a new therapy without assigning a certain proportion of participants in a study to a control, a proper double-blinded control where the patient doesn’t know what treatment he or she is receiving and the person evaluating the response doesn’t know what treatment the patient is receiving,” Spence said.

    Such a study should only take about a year, he said.

    Source: IFpress.com © 2010 IFP (27/07/10)

    CCSVI Alliance launches website

    CCSVI Allinace LogoWebsite Provides Information for Multiple Sclerosis Patients,
    Caregivers, and Medical Professionals

    On February 16, 2010, CCSVI Alliance formed as a 501(c)(3) nonprofit and on July 26, 2010 launched their website for multiple sclerosis (MS) patients, caregivers, and medical professionals to learn about a new condition, Chronic Cerebrospinal Venous Insufficiency (CCSVI), that may be significantly related to MS.

    The site will be a resource for patients, caregivers, and medical professionals to explore many aspects of CCSVI. It also will provide patients and caregivers information to advocate for diagnosis and treatment of the condition, and to donate to the cause of advancing CCSVI research.

    The site explains diagnostic and treatment approaches to CCSVI, answers frequently asked questions, addresses myths, and provides a history and timeline of the relationship between CCSVI and MS. There are patients' perspectives -- first-person accounts of what it's like to be diagnosed and treated for CCSVI. The website is comprised of educational information at a basic and advanced level, including links to research papers and a glossary of common terms. There also is information about donating for CCSVI research.

    CCSVI Alliance began with the efforts of individuals who are intimately familiar with multiple sclerosis and CCSVI. Their levels of disability range from mild to severe. These individuals are committed to the exploration of the debilitating disease. MS patients and caregivers are demanding accessibility to the simple endovascular treatment while some in the medical community are advocating for a slow and cautious approach.

    CCSVI Alliance will work to build the bridge between these two disparate opinions.

    "Multiple Sclerosis is a complex disease which affects over 400,000 people in the United States," commented CCSVI Alliance President Sharon Richardson. "A new medical frontier of diagnosis and treatment of MS is opening with the study of CCSVI. CCSVI.org will offer current research-based information about CCSVI for the MS patient and the professional communities. The nonprofit organization will work with multiple disciplines within the scientific community by promoting and funding collaborative educational programs and research studies."

    Chronic Cerebrospinal Venous Insufficiency, a syndrome of the extracranial veins, is a new condition identified in 2008 by Italian vascular surgeon and researcher, Dr. Paolo Zamboni. Initial studies indicate a strong correlation with multiple sclerosis. Research is underway to test the CCSVI hypothesis and develop standardized treatment.

    CCSVI Alliance is a 501(c)(3) nonprofit. CCSVI Alliance is dedicated to educating patients with research-based information, providing tools for patients to advocate for themselves, and supporting medical professionals' exploration of Chronic Cerebrospinal Venous Insufficiency. CCSVI Alliance will keep patients, caregivers and the medical community current with the latest research, emerging practices, and patient perspectives. The Alliance will attend conferences, speak with the medical and patient communities, help bring together patients and doctors, and connect medical professionals with one another.

    Source: CCSVI Alliance (26/07/10)

    Symposium on proposed endovascular treatment of chronic cerebrospinal venous insufficiency

    CCSVI VenogramThe Departments of Radiology and Neurology at SUNY Downstate Medical Center will hold a symposium on CCSVI (chronic cerebrospinal venous insufficiency) on Monday, July 26 from 9:00 am to 4:00 pm, in the Alumni Auditorium, 395 Lenox Road, Brooklyn, New York 11203.

    CCSVI is a syndrome in which blood flow from the brain is compromised. While CCSVI is a disease state that by itself often requires intervention, it has been proposed that the syndrome promotes the development of multiple sclerosis (MS). Speakers from the United States, Bulgaria, Italy, and Kuwait will present a thorough review of CCSVI, including the proposed relationship between CCSVI and MS.

    Salvatore J. A. Sclafani, MD, professor and chair of radiology at SUNY Downstate, has organized the symposium and will provide an overview of CCSVI for interventional radiologists.

    While this free symposium is directed at physicians and other healthcare providers, members of the general public are invited and there will be a presentation on patient activism. Those wishing to attend should respond in advance to [email protected].

    Provided by SUNY Downstate Medical Center (21/07/10)

    'Amazing’ results of radical new surgery for MS patient

    CCSVI VenogramA Knutsford man who suffers from multiple sclerosis travelled more than 900 miles for a pioneering treatment which has divided the medical community.

    Colm McLaughlin flew to a clinic in Krakow, Poland, for a £6,000 procedure not available in the UK but is said to be able to reverse the symptoms of the paralysing disease.

    Now two weeks on, the 47-year-old, who has primary progressive MS, says he has been amazed by the results.

    “I’m over the moon. It’s really given me more than I hoped for,” he said.

    “I noticed my eyesight had improved. Everything came into focus, the colours were a lot deeper. It was amazing.

    “My heat tolerance has improved incredibly. I’ve got scars all over my legs from falling in the shower – I was always in danger of fainting.

    “The odd hot day we have I’m not able to go out.

    “But the last day in Poland my wife went out to the shops and when she came back she said she couldn’t believe how hot it was in the room. I hadn’t even thought about it.”

    Before the operation, Colm told the Guardian that fatigue was a ‘constant battle’, but he now says it is not an issue anymore.

    The procedure, known as chronic cerebrospinal venous insufficiency (CCSVI) treatment, was created by Dr Paolo Zamboni and involves opening a patient’s blocked veins to prevent iron deposits in the brain.

    Colm, of Mereside Road, added: “I saw people who had just been ‘liberated’ and people who were about to have it done who looked nervous.

    “It was relieving seeing people coming back with huge smiles on their faces saying how easy it was.”

    Usually, the operation takes hours but for Colm it was just 25 minutes.

    The father-of-two said: “I had to sign a raft of forms signing my life away basically, and as the day goes on you do get a little nervous, but I didn’t have any second thoughts.

    “Some of my symptoms have been greatly alleviated. I’ve had this condition for 15 years now and it’s not going to go away over night.

    “There’s no guarantees, but I really do believe this will stop the progression of the disease.

    “The best case scenario would mean I can start tap dancing. Some people have remarkable recoveries.”

    Colm, who sent a 10,661-name petition to Parliament, is now fighting to have the treatment recognised in the UK.

    He added: “It has to happen and it will happen. It’s just a matter of time.

    “Multiple sclerosis robs people of a lot of things but one of the first things is the ability to earn money. A lot of people don’t have the money to throw at this.”

    Source: Knutsford Guardian © Copyright 2001-2010 Newsquest Media Group (19/07/10)

    Multiple Sclerosis patient boosted by 'second chance'
    CCSVI VenogramBarb Farrell hesitates about being videotaped. With the exception of a touch of mascara, she's without make-up and that's just not to her liking.

    But she agrees and she begins to answer the question: What's changed?

    "Everything," she says immediately, sitting in a wheelchair for the first time in two months.

    "I was completely paralyzed and I thought that my life was over, but now I have a new start. I have a second chance and that's pretty amazing."

    The video rolls for more than four minutes as the 46-year-old Barrie mother of a 10-year-old boy talks about her new lease on life. There's still a significant drawl to her speech, but it appears effortless, compared to two weeks earlier, when she whispered a few words at a time.

    Barb has multiple sclerosis and wanted a balloon angioplasty procedure that is believed to help many with her condition. She had a collapsed vein, something which appears to be common in those with MS.

    But the vascular treatment of MS, proposed by Italian Dr. Paolo Zamboni, is considered an unproved theory. And although it is used for other ailments, including heart conditions, it's not being made available to patients with MS.

    Barrie vascular surgeon, Dr. Sandy McDonald, thinks that Zamboni is on to something. He's been testing the veins of hundreds of MS patients at his clinic. And six have undergone the angioplasty procedure at Barrie's Royal Victoria Hospital.

    Barb was to be next, but access to the procedure here was halted just two days before she was to receive it.

    It's not available anywhere in Canada and only "through the back door" of the odd facility in the United States, along with a few other countries.

    Barb's condition deteriorated and she had been in a Barrie hospital bed, almost motionless, for a month. She and her husband, Patrick, broached the possibility of accessing hospice care, but ultimately decided they weren't ready.

    Last month, they formally requested to have the procedure done on compassionate grounds at RVH and were denied.

    Three days later, Patrick received a call. A benefactor had come forward to pay, not just for the treatment, but also for the special transport required to get her to the U.S. clinic to have it done.

    Five days later, Barb was on an aircraft equipped with two pilots and two paramedics on her way to the U.S. There, major blockages were discovered in both her jugular veins. She was also discovered to have May-Thurner syndrome, which was also corrected. That's a condition that causes clots.

    Balloon angioplasty worked in one of the veins, but the other didn't hold up. So, two stents were installed to keep it open.

    Barb was back in her Barrie hospital bed that night.

    That weekend she entered into a deep depression.

    "Nothing had happened to me yet," she explained.

    There was some minor movement in her feet and her hand immediately after the procedure, but Barb said she felt the same. She thought that was it for her last chance.

    Then, on July 6, she woke up. And things had changed.

    She dropped her hourly morphine drip. Now she's given Tylenol 3 when she has pain. She follows movement with her entire head, not just her eyes. Her smile comes easily and it broadens when her nurses joke around while putting her back in her bed.

    She's been at Orillia Soldiers' Memorial Hospital's complex care unit for close to 10 days and the goal is to get her onto a lighter unit. Ultimately, she'd like to be back home.

    "She's going to be in a chair every day now," says her husband. "She's so much more vibrant now.

    "She seems genuinely happy. She seems genuinely motivated."

    Because all this is new, it's anyone's guess how far Barb can push the envelope.

    But, she says she has more than a fighting chance.

    "I feel normal again."

    Source: The Barrie Examiner © 2010 , Sun Media (16/07/10)

    Access to treatment for multiple sclerosis must be based on science, not hope
    CCSVI VenogramThe controversial venous angioplasty procedure proposed as a novel treatment for multiple sclerosis by Zamboni and colleagues1 has generated substantial public debate. for an untested procedure first reported mere months ago.

    Patients and their advocates have held well-publicized demonstrations demanding access to the procedure.

    In Ottawa, some MPs are lobbying the federal government for millions of dollars in new funding for multiple sclerosis research and this new treatment.

    Desperation has even led some patients to file a lawsuit against the BC government claiming that denying access is discriminatory.2 But do we want hopeful media reports, special interest groups and political opportunism to decide which treatments we should study, provide and insure?

    The idea that multiple sclerosis is caused by chronic cerebrospinal venous insufficiency and can be treated successfully by percutaneous angioplasty of venous strictures is both novel and unexpected.

    To date, the published evidence is limited to a case series of 65 patients.1 The results reported by Zamboni and colleagues — greater freedom from relapse (50% v. 27%) and fewer lesions seen by magnetic resonance imaging (12% v. 50%) — seem promising but remain untested in controlled randomized trials. In addition, we are lacking a great deal of the relevant basic science, knowledge about the normal anatomy of the venous system, and links between venous anomalies and symptoms of multiple sclerosis.

    Multiple sclerosis is difficult to study because most clinically relevant outcomes are subjective and because the natural history follows a waxing and waning course. These features make it challenging to ascribe benefit to treatment in the absence of a control group. No wonder that skepticism abounds in the medical and scientific communities about this treatment.

    Many patients with multiple sclerosis understand these arguments; nevertheless, they insist that venous angioplasty be offered to them. They can hardly be blamed for this. Understandably, they fear ongoing loss of function and premature death. But good health policy decisions should not based on hope and desperation.

    On the other hand, scientists and skeptics should avoid dismissing novel ideas prematurely. It is precisely the unexpected scientific discovery that often leads to major advances in care. The Nobel Prize-winning discovery that infection with Helicobacter pylori is a leading cause of peptic ulcer disease was met with widespread skepticism that delayed its translation to further research and practice. Unfortunately, for each major discovery, there are hundreds if not thousands of failures, where seemingly promising therapies prove useless and even harmful.

    This controversy over access to novel treatment illustrates how quickly news of promising scientific discoveries can create unrealistic expectations. In contrast to novel medications, all other health interventions have few regulations to help manage expectations with proper evaluation. As a consequence, unproven therapies can be rapidly introduced into practice, overwhelming our ability to evaluate their safety and effectiveness. Regulating the complex process of developing and testing procedures won’t work. Rather, we need to build a new and ongoing capacity to initiate clinical studies in response to promising therapeutic discoveries.

    A major part of this approach involves limiting access to experimental procedures to well-designed clinical studies or research programs. Doing so will ensure access to innovative care for all patients while ensuring that the procedures are introduced safely into practice with appropriate evaluation. Hospital staff and clinicians have a duty to keep unproven therapies from premature use. Similarly, provincial governments should prevent public funds from being diverted to the use of drugs or procedures that lack evidence of safety and effectiveness.

    Patients should insist on evidence. They should also insist on having their views represented when decisions about where to spend research dollars are made. With other diseases, such as breast cancer, patient advocates have successfully provided an important perspective in the decision-making process. It is only with patients that can research priorities can be set, implemented and tested so that we find better treatments.

    The federal government should refrain from allotting funds for specific projects because (a) provinces may be incapable of dealing with the repercussions in clinical care; (b) we may not have organized clinical research networks able to design and execute a study; and (c) the project may not be feasible or the best one to take forward, once examined by experts and peer reviewers, given other promising alternatives.

    Our tax dollars and charitable contributions should target research programs, networks and infrastructures that will leave long-lasting legacies, including a means to safely access innovations. Public funds should also address major questions that will improve care and health while promoting excellence. Failure to do so will leave our academic institutions and research community repeatedly at the mercy of advocacy campaigns and decisions based on political expediency and opportunism.

    Matthew B. Stanbrook MD PhD Deputy Editor, Scientific Paul C. Hébert MD MHSc Editor-in-Chief

    CMAJ

    With the editorial advisory team: Ken Flegel MDCM MSc and Noni MacDonald MD MSc

    Competing interests: See www.cmaj.ca/misc/edboard.shtml CMAJ 2010. DOI:10.1503/cmaj.100835

    REFERENCES

    1. Zamboni P, Galeotti R, Menegatti E, et al. A prospective open-label study of endovascular treatment of chronic cerebrospinal venous insufficiency. J Vasc Surg 2009;50:1348-58.

    2. Feds urged to fund MS trial. CBC News. 2010 June 1. Available: www.cbc.ca/health/story/2010/06/01/ms-ccsvi-trial-funding.html  (accessed 2010 June 14). DOI:10.1503/cmaj.100835

    All editorial matter in CMAJ represents the opinions of the authors and not necessarily those of the Can adian Medical Association.

    Source: CMAJ © 2010 Canadian Medical Association or its licensors 1 Early release, published at www.cmaj.ca on June 28, 2010. Subject to revision. (13/07/10)

    Can a controversial new treatment for multiple sclerosis offer relief?

    CCSVI VenogramA new treatment is giving hope to MS sufferers such as Mark Walker. So why can’t he get it in Britain?

    Mark Walker is what the NHS calls an “expert patient”. He’s someone who knows all there is to know about the disease that has shadowed his existence on and off, for nearly 20 years, forcing him to give up the high-flying job he adored, and curtailing an active life. Walker asks difficult questions of doctors, expects candid answers, and pursues new research doggedly.

    Before our meeting at the pretty bungalow on the outskirts of Oxford where he lives with his wife, Natasha, he provided me with a detailed record of the onset of his multiple sclerosis (MS): from the first signs of a problem (double vision in December 1991) through putative diagnoses (myasthenia gravis and a brain tumour) and accumulating symptoms (numbness, balance and bladder problems) to definitive diagnosis in 2000. Each treatment tried and its result are documented meticulously, as you would expect from someone who qualified originally as a pharmacist.

    Today, at 51, the former IBM management consultant has severely impaired mobility on his right side. He relies on a walking aid known as a Musmate and trekking poles. He knows what, in all probability, lies ahead – a life of increasing debilitation and limitation. It is this glimpse of the future that lies behind his decision – a “rational and considered one” – to go to Athens for tests and, possibly, treatment based on a controversial new theory about the cause of MS.

    Walker is frustrated, however, that he must seek help abroad and, given that he lives close to two world-renowned MS centres at the John Radcliffe and the Nuffield hospitals, angry at the lack of support from MS experts here in exploring new approaches.

    “Yes, I am desperate. Two years ago I was living in a three-storey townhouse in the centre of Oxford. Now, I’m living in a bungalow because I can’t do stairs very well. Ten years ago, I was managing a team of 20 people in Rome. Now, my life is all about managing my disease.

    ''In the 21st century, patients like me, who are well informed about their progressively disabling disease, should be allowed to choose private diagnostic tests and treatment for themselves. And health-care professionals should surely be helping patients’ freedom of choice.”

    MS is a degenerative disease of the nervous system affecting 100,000 people, most of them young adults, in the UK. It is believed to be autoimmune in origin, triggered by genetic or environmental factors (or a combination of them) that cause immune cells to cross the blood/brain barrier (which keeps blood and cerebrospinal fluid separate) to attack the fatty, white myelin sheath that surrounds and insulates nerves in the brain and spinal chord.

    Symptoms vary widely, as does the severity of the disease. In some, it progresses relentlessly. Other patients suffer the relapsing and remitting form – periods of relative good health interspersed with flare-ups and neurological deterioration. There are several therapeutic regimens of varying efficacy, including antibiotics, steroids, and immuno-modulator drugs.

    Now, an Italian surgeon, Professor Paolo Zamboni, director of the Centre for Vascular Diseases at the University of Ferrara, is urging a radical rethink on MS. What began as a labour of love for Zamboni could, he claims, “revolutionise” management of the disease.

    In 2005, Zamboni’s wife Elena was diagnosed with MS and he embarked on a mission to find out everything about it, from poring over medical literature dating back 100 years or more, to using state-of-the-art body-imaging techniques.

    His conclusion was that this wasn’t only an autoimmune disease, but also a vascular one, caused by restricted, blocked, malformed or twisted veins in the trunk and neck. A small study showed that 90 per cent of his patients had venous obstruction. He named the condition chronic chronic cerebrospinal venous insufficiency (CCSVI) and went further, postulating that an excess of iron, which causes inflammation and cell death, was responsible for tipping the immune system out of balance, resulting in MS symptoms.

    For a vascular surgeon, the only response to restricted veins is to unblock – or de-stenose – them so that healthy blood-flow can resume. (The procedure, known as venoplasty, is similar to angioplasty, in which a balloon is inserted into an artery supplying the heart and inflated to remove a blockage.) The effect in this case, it is claimed, was a dramatic alleviation of symptoms in Zamboni’s wife and in subsequent patients he treated.

    News of Zamboni’s approach spread among the MS community, initially by word of mouth, and has accelerated rapidly, via chatrooms and websites, as access to the internet has grown. Vascular surgeons in private clinics in Poland, Bulgaria, Greece, Germany, Belgium, the US and India are now offering diagnostic tests to confirm the presence of stenosed veins, and surgery to unblock them, with waiting lists growing by the day. Anecdotal reports suggest that treatment stops relapses in some patients, and eases symptoms and halts the disease’s progression in others.

    It was in October last year that Walker began his own research, drawing on the limited scientific literature and anecdotal reports on the web. He was sceptical, at first, and questioned Zamboni’s iron hypothesis, but he was open to the possibility that restricted veins may be a factor in MS.

    A diagnosis, then, was his first objective and he assumed that it would not be a problem arranging the test known as colour doppler sonography. He found an interventional radiologist (who worked at the Radcliffe and in private practice) familiar with Zamboni’s work and willing to help. He was also a private patient, happy to pay for the test and surgery if restricted veins were confirmed.

    However, the test was prevented by neurologists at the Radcliffe on the grounds that it was not ethical or prudent because of doubts about Zamboni’s work, which has yet to be formally approved by clinical trials.

    Surgery for CCSVI has had some negative publicity, Walker acknowledges. The MS “establishment” (that is, neurologists) has been riled in particular by Zamboni’s description of his procedure as the “liberation treatment”. In addition, a woman in California died from a stroke after stents (small metal tubes used to keep veins open by a minority of vascular surgeons, but not Zamboni) were inserted in her veins to maintain blood flow following venoplasty. Walker points out there was a familial history of stroke and she was also on the anti-coagulant warfarin, which is a further risk factor. Another patient had open heart surgery to remove a stent that had migrated to the heart.

    “Out of 1,000 or so procedures so far, it is just two cases,” he says. Both are a cause for concern, yes, but not for the hysteria neurologists have generated. Walker believes a “turf war” is under way between neurologists here who believe they “own” MS, and radiologists and vascular surgeons who may have something to contribute to its management. Patients are being caught in the crossfire.

    “Neurologists have been treating MS with powerful drugs for decades. Despite this, many patients suffer continued progression of their disease. Others give up the drugs because of side-effects. Treating any CCSVI symptoms is worth a try for many people.’’

    And Zamboni is not setting himself up in opposition to conventional treatment, Walker adds. “He advises patients to continue with their drug therapy.”

    Having satisfied himself that the risks were minimal, and opted for balloon venoplasty rather than the stent procedure, Walker sought the advice of other MS sufferers in finding a clinic and a surgeon in whom he had confidence. He is lucky, he says, because he can afford the £5,000 fee (plus travel costs). Other British patients cannot and he is angry that they must wait, while their health worsens, for research to be done before neurologists even consider it as an option. The MS Society here has yet to allocate funds to studies, in contrast to MS societies in America and Canada, which last month committed $2.4 million (£1.6 million) to exploring the link between restricted veins and MS. A study at Buffalo University, New York, involving 1,700 patients (and controls), is also in progress.

    “Medicine is practised in silos here,” says Walker. “I want doctors to start talking about this. If I could find something to stop my progression, I’d be happy. If I could get any relief from symptoms, I’d be happy. The cost is irrelevant. I know I’m taking a risk, but it’s my money – £7,000 won’t buy you a lot of adaptation [to accommodate disability] in a house, so why wouldn’t I want to try this?”

    Two weeks ago, Mark Walker saw consultant vascular surgeon Constantinos Kartkaletsis at a hospital in Athens. He diagnosed four “restricted” veins which were then cleared using balloon venoplasty. The Telegraph will update readers on his progress in six months.

    Source: Telegraph.co.uk © Copyright of Telegraph Media Group Limited 2010 (12/07/10)

    MS Society of Qatar urges integrated efforts on care of MS patients

    Qatar FlagThe Multiple Sclerosis Society of Qatar (MSSQ) has called for an integrated approach towards the care of those suffering from the nerve problems.

    MSSQ president Abdulaziz Ibrahim al-Jaber, speaking to the media on the sidelines of a one-day symposium hosted by the society and the Supreme Council of Health (SCH) to discuss various and latest means of treating the disease, said that there is a need to co-ordinate care of MS among different cadres of medical professionals.

    Multiple Sclerosis (MS) is a progressive disease leading to nerve damage (neurodegeneration), which gets worse over time.

    The nerve damage is caused by inflammation, which occurs when the body’s own immune cells attack the nervous system. Repeated episodes of inflammation can occur along any area of the brain and spinal cord.

    Researchers are not sure what triggers the inflammation but the most common theories point to a virus or a genetic defect, or a combination of both.

    People with a family history of MS and those who live in a geographical area with a higher incidence rate for MS tend to have a higher risk of the disease.

    “There is a growing confusion between a new technique for treating MS presenting with chronic cerebrospinal venous insufficiency (CCSVI) and the regular medications as there is no proof that this new procedure for CCSVI can totally cure MS or not. I want the patients to get the differences between the two solutions,” al-Jaber said.

    CCSVI is a syndrome associated with a blockage restricting the blood flow from the central nervous system (CNS), through the cervical and thorac veins.

    It is when the blood supply from the brain and spine has trouble returning to the heart.

    “It is suggested that this blockage is due to stenosis of the jugular and azygos veins. An Italian surgeon, Dr Paolo Zamboni, identified and labelled the CCSVI syndrome and has linked it to MS,” al-Jaber said.

    “We want the doctors carrying out this new technique to come out to the public forum and explain its effectiveness, and work as a team with those doctors who are experts in the old method.

    “We want them all to come together and work as a team in order to find a lasting solution to MS,” he said.

    Al-Jaber said that other treatments for MS are available free of cost in the country.

    He said CCSVI surgeries have been performed on two patients, but only one of the cases was deemed successful.

    The CCSVI procedure is being done in other countries at a cost ranging between $7,000-$10,000.

    “Due to this result, we decided to stop the procedure and wait for results of further research to be approved by our local doctors,” he said.

    Al-Jaber said that officially there are around 200 people suffering from MS in the country, but there are up to 450 unreported cases.
    The QSSM president commended the Minister of Public Health HE Abdullah bin Khalid al-Qahtani for his support towards care for people affected by MS.

    The QSSM now operates under the umbrella of the SCH, he said.
    Al-Jaber revealed that the society is redesigning its website and is planning a new one for children with MS or those exposed to the disease.

    At the symposium, speakers discussed new treatments of MS, highlighting their differences as well as pros and cons.

    The speakers said that although efforts are being made in many areas, including that of stem cell research, there remains no cure for MS.

    Source: Gulf Times © 2009-2010 Gulf-Times.com (02/07/10)

    From M.S. patients, outcry for unproven treatment
    CCSVI VenogramFor her first appointment with Dr. Daniel Simon, Neelima Raval showed up with a rolling file cabinet full of documents. She had downloaded every word written by or about Dr. Paolo Zamboni, a vascular surgeon from Italy with a most unorthodox theory about multiple sclerosis.

    Dr. Zamboni believes that the disease, which damages the nervous system, may be caused by narrowed veins in the neck and chest that block the drainage of blood from the brain. He has reported in medical journals that opening those veins with the kind of balloons used to treat blocked heart arteries, an experimental treatment he calls the “liberation procedure”, can relieve symptoms.

    The idea is a radical departure from the conventional belief that multiple sclerosis is caused by a malfunctioning immune system and inflammation.

    The new theory has taken off on the Internet, inspiring hope among patients, interest from some researchers and scorn from others. Supporters consider it an outside-the-box idea that could transform the treatment of the disease. Critics call it an outlandish notion that will probably waste time and money, and may harm patients.

    These critics warn that multiple sclerosis has unpredictable attacks and remissions that make it devilishly hard to know whether treatments are working — leaving patients vulnerable to purported “cures” that do not work.

    The controversy has exposed the deep frustration of many people with this incurable, disabling disease, who feel that research has let them down. It is a case study in the power of the Internet to inform and unite angry patients—which may be a double-edged sword. Pressure from activists helped persuade the Multiple Sclerosis Society to pay for studies of Dr. Zamboni’s theory, but the Internet buzz has also created an avid market for a therapy that is still unproved.

    “It’s eye-opening the way this group of patients has grabbed hold of the social-networking technology,” said Dr. Simon, an interventional radiologist at JFK Medical Center in Edison, N.J. “They’ve taken this to a level I’ve not seen in other patients. Patients used to read an article or two. Now, they’re actually seeing procedures on YouTube. Is this the future of medicine?”

    Scientifically, the jury is out: Dr. Zamboni’s hypothesis is being studied. It is not known whether narrowed veins are more common in people with multiple sclerosis than in others, and even if they are, whether the narrowings are a cause, or an effect, of the disease. There is no solid proof that opening the veins can help. There have been no studies with control groups — the only way to find out whether a treatment works.

    “In my view the evidence is quite scanty and the biological plausibility is low,” said Dr. Stephen L. Hauser, the chairman of neurology at the University of California, San Francisco. Many neurologists agree. Dr. Hauser said there was much stronger evidence that the disease arose from genetic variations affecting the immune system.

    But Dr. Adnan H. Siddiqui, part of a team at the University at Buffalo that has been studying Dr. Zamboni’s theory, said that it made sense and that the data from Italy was encouraging. Still, he emphasized that more study was needed, and that patients should not be treated until the research was done.

    In Demand

    Despite the lack of proof, many patients are captivated by the idea that multiple sclerosis might turn out to be a vascular disease. They want to believe it can fixed with a relatively simply procedure, and they want to be tested and treated. Now.

    These patients say they cannot afford to wait for research results because they will wind up in wheelchairs before the studies are done. Their only option so far has been a lifelong course of drugs with limited benefits and harsh side effects. To some, balloon treatment seems no riskier than those drugs.

    Dr. Zamboni himself has said that the procedure should not yet be done outside of studies. He said in an interview that he was conducting research only and had turned down thousands of requests from people wanting to go to his clinic at the University of Ferrara.

    But other doctors have set up shop. A clinic in India with a toll-free American phone number has an online advertisement for a “liberation package.” Patients are posting testimonial videos and trading tips on clinics in Bulgaria, Poland and Jordan.

    In the United States, where many hospitals forbid experimental treatments outside of studies, a “back alley” network of doctors willing to perform the procedure has begun to develop, said Dr. Salvatore J. A. Sclafani, chairman of radiology at Downstate Medical Center in Brooklyn. He said he knew of about a dozen. The doctors try to stay under the radar, and patients quietly pass their names to one another.

    “It reminds me of abortion in 1968,” Dr. Sclafani said.

    He said he had treated about 20 patients at Kings County Hospital before the hospital ordered him to stop in early April. He said he had a waiting list of 300 to 400 patients..

    Meanwhile, researchers are trying to answer basic questions. On June 29, the team in Buffalo is to begin the first treatment study to include a control group. The controls will be given a sham procedure, and compared with others who get the real thing. Initially, 30 patients — only those with an early form of the disease — will be enrolled. Thousands of people applied.

    The Multiple Sclerosis Societies in the United States and Canada will spend $2.4 million over the next two years on studies at seven centers. Researchers will study veins in patients with different stages of multiple sclerosis, in healthy people and in those with other neurological diseases. The studies will not test the balloon treatment, but are meant only to find out if the narrowings really exist, if they are related to the disease and if they are a cause or an effect.

    Some patients complain that the society has been too slow to consider the new idea. A splinter group — the Reformed Multiple Sclerosis Society — has formed to increase the availability of the vein treatment.

    Joyce Nelson, the president of the Multiple Sclerosis Society in the United States, said, “I wasn’t aware how thin the veneer was and how close to the surface the frustration was.”

    “ ‘We can’t wait’ has resounded,” Ms. Nelson said. But she added, “There isn’t a way to rush the work that needs to be done.”

    As the procedure has caught on in some places, few serious complications have been reported. But at Stanford University, a woman, 50, treated with stents (wire-mesh tubes used to hold blood vessels open) and blood-thinning drugs, died of a brain hemorrhage after returning home, and another patient needed heart surgery after a stent placed in a neck vein came loose and was swept into the heart. The procedures were stopped.

    Dr. Michael Dake, who treated the patients, declined several requests for an interview, but said by e-mail that he hoped to discuss “a number of exciting developments” about the procedure “in the near future.”

    Dr. Philip Pizzo, the dean of Stanford’s medical school, said the vein theory “deserves to be explored” — but only in studies. A study with a control group is being planned.

    About 400,000 people in the United States have multiple sclerosis; worldwide, there are 2.1 million. (The disease is more common in temperate zones than in the tropics, and affects more women than men and more Caucasians than members of other groups.) It usually begins in young adults, with fatigue, vision problems, numbness, bladder trouble and difficulty with walking, balance and coordination. The disease eats away a fatty substance, myelin, that coats nerves, and gradually scars the nerves. The damage is thought to occur because the immune system, for unknown reasons, mistakenly attacks myelin.

    Most patients, 85 percent, start out with a form called relapsing-remitting. In about half of those the disease becomes progressive, harder to treat and more disabling. Ms. Raval, who is 38 and has had multiple sclerosis for 13 years, implored Dr. Simon to test her for narrowed veins and, if he found any, to open them.

    Dr. Simon regularly uses balloons and stents to open bile ducts and blood vessels. He was impressed with Ms. Raval’s determination, her trove of information and her background. She has a degree in toxicology and works for a drug company. But he was also familiar with Dr. Zamboni’s work—and deeply skeptical of it.

    “My initial take was, it doesn’t make any sense,” Dr. Simon said.

    But Ms. Raval had high hopes. She said she believed that the balloon treatment would be “the next best thing to a cure.” The usual drugs have not worked for her. Her 5-year-old son is eagerly awaiting the day when she can run with him, but she is finding it harder and harder even to walk. Theory Born of Experience

    Dr. Zamboni, 53, (no relation to the inventor of the ice-rink machine) began studying the medical literature on multiple sclerosis in 1995 when his wife learned she had the disease.

    “What I found was like a detective story,” he said.

    He discovered reports of vein abnormalities and of brain lesions forming around veins. But the research had been abandoned. Vein disorders are his specialty; he has been studying them for 25 years. He began using ultrasound and other imaging techniques to examine veins, and found narrowings in the neck and chest veins in people with the disease, but not in healthy ones. He suspected that abnormal blood flow and pressure in the veins— not just narrowing alone — might cause minute amounts of bleeding in the brain, leading to an immune reaction and inflammation that damaged myelin and nerves. Iron deposits could also form, and add to the damage. He wondered if opening the narrowed areas might help.

    In 2006 he began using balloons to treat patients, including his wife, whose symptoms went away and, he says, have not come back. Other patients who, like his wife, had relapsing-remitting disease, also recovered fully, he said; but some did not respond at all. In those with progressive disease, fatigue improved, but not mobility problems, according to a pilot study he published in December in The Journal of Vascular Surgery. And in half the treated patients, the neck veins closed up again. The study did not have a control group, and the patients were also taking drugs to treat multiple sclerosis . More rigorous trials will start in Italy this summer, Dr. Zamboni said.

    Another doctor, Marian Simka, who has been performing the procedure in Pszczyna, Poland, has reported that it has made symptoms worse in some patients..

    Researchers in Buffalo have confirmed (but not yet published) that narrowed veins and abnormal blood flow are more common in people with multiple sclerosis. But, while Dr. Zamboni found them in all patients and no healthy people, the Buffalo team found them in about 60 percent of patients and 15 percent of healthy controls.

    Dr. Simon sensed that Ms. Raval would have no peace unless she could learn whether she had narrowed veins, and he wanted to help her.

    So he offered to perform a test to find out, a venogram. It involves passing a tube into a vein in the groin and up to the neck and chest, and then injecting dye to take X-rays of the veins. He felt sure there would be no blockages.

    “And then she would be able to stop obsessing over this and move on with her life and get some kind of conventional treatment,” he said.

    But he was stunned to find narrowings, right where Dr. Zamboni’s theory predicted: in the jugular vein in the neck, and the azygous, a vein in the right side of the chest.

    Ms. Raval was elated. She felt certain that opening up those veins would solve her problems. Dr. Simon agreed to try.

    Although it was, technically, an experimental procedure, Dr. Simon said he did not have to ask his hospital for permission to perform it. The details were similar to other procedures that interventional radiologists do every day. It is not uncommon for them to take a device approved for one purpose and use it for another, like putting a bile-duct stent into a blood vessel — a practice called “off-label” use, which the Food and Drug Administration allows. Interventional radiology, Dr. Simon said, is an “off-label specialty” that depends on innovation and adaptability.

    On March 24, as Ms. Raval lay on a padded table in a treatment room, Dr. Simon passed balloons to the pinched spots in her right jugular and azygous, and dilated them.

    The procedure took less than an hour. In the recovery room, Ms. Raval said she felt better already.

    Over the next days and weeks, she noticed remarkable improvements. Her fatigue went away. She walked and climbed stairs more easily, and the color in her face brightened. Her husband and co-workers saw the changes, too, she said.

    Was it real, or just one giant, communal placebo effect? Ms. Raval posted exuberant Facebook messages naming her “most amazing doctor.” Other patients began calling Dr. Simon.

    Within a month, Ms. Raval again had trouble walking. She felt sure her veins had closed again. Another venogram showed they had. Dr. Simon reopened them.

    Ms. Raval felt better — and then deteriorated again. On June 18, another venogram, her fourth invasive procedure in three months, suggested that the narrowings had recurred. She struggled over what to do. She could not keep having balloon procedures again and again. Dr. Simon consulted Dr. Dake, his former mentor, who recommended stents.

    Initially, Ms. Raval and Dr. Simon had thought stents too risky. Unlike balloons, which are inserted briefly and removed, stents are permanent. They can migrate to somewhere they do not belong, like the heart, as occurred in Dr. Dake’s patient. Or tissue growth can clog them.

    But Dr. Simon and Ms. Raval could see no other option. On June 23, he implanted a stent in her two jugular veins.

    “I really have a good feeling on this one,” Ms. Raval said a few hours after the procedure. “ I think this is the resolution, long-term. Let’s wait and see.”

    In the meantime, Dr. Simon had conducted venograms on about 20 other patients with multiple sclerosis. He found narrowed veins in all but one. He said he was going to ask the hospital’s ethics panel for permission to perform balloon procedures in those patients. But the hospital would have to figure out how to get paid: insurance might cover venograms, but not an experimental treatment. The total charge for the procedure, including both hospital and doctor fees, would be about $10,000, Dr. Simon said.

    He and his partner, Dr. Noam Eshkar, said they knew many researchers thought patients should not be given unproven treatments outside of clinical trials. They said they did not disagree. But they also sympathized with patients who had progressive diseases and who felt they did not have the time to wait. “In the real world,” Dr. Eshkar said, “things happen at the edge of scientific proof.”

    Source: The New York Times Copyright 2010 The New York Times Company (30/06/10)

    Medical journal urges caution over new MS treatment

    CCSVI VenogramSolid science rather than hopeful media reports and advocacy campaigns should determine whether patients receive access to a new, as-yet unproven therapy for multiple sclerosis, according to an editorial in the Canadian Medical Association Journal.

    Patients and advocacy groups across the country have been lobbying for access to the venous angioplasty procedure, also dubbed “the liberation therapy,” in the wake of a 2009 study that suggested it held promise to relieve the disease’s debilitating symptoms.

    The study, lead by Italian researcher Dr. Paola Zamboni, tested the theory that clogged neck veins, a condition called chronic cerebrospinal venous insufficiency or CCSVI, could trigger multiple sclerosis. The research into unblocking veins made headlines around the world, galvanizing patients to seek the procedure and raising red flags for neurologists.

    On Monday, the country’s top medical journal joined the debate by voicing its concern that allowing hope to trump science will set a dangerous precedent about which treatments Canada decides to study, provide and insure.

    “This is a significant public policy issue,” said CMAJ editor-in-chief and editorial co-author Dr. Paul Hebert in an interview.

    “I’m always concerned when special interest groups and stakeholders get a hold of the public agenda and focus it on very specific diseases and their interests. There is no shortage of diseases to study.”

    Unlike drugs, which undergo rigorous, peer-reviewed study before being used by the public, new medical procedures are not regulated. In the editorial, Hebert and another CMAJ editor argue the safety and effectiveness of unproven procedures cannot be properly evaluated when they rapidly enter medical practice. They say Canada needs to come up with a new process that gets promising procedures quickly into clinical trial. This way, they write, experimental procedures undergo appropriate scrutiny, which ultimately benefits patients.

    “We could, in theory, allow an unproven procedure go unchecked if we start paying for it and we will never know if it hurts people or helps them,” Hebert said in an interview.

    While stating hospitals should not prematurely offer unproven therapies and provinces should not fund them, the editorial also notes the novel MS procedure should not be dismissed prematurely.

    Earlier this month, the Multiple Sclerosis Society of Canada and the National MS Society in the U.S. committed $2.4 million to support seven new research projects – four of which are in Canada – to investigate CCSVI.

    Source: The Toronto Star © Copyright Toronto Star 1996-2010 (29/06/10)

    CCSVI recognised as an independent vascular condition by Italian health authorities

    CCSVI VenogramThe Italian CCSVI Society met with the Ministry of Health, and it was decided that CCSVI can be diagnosed as a stand alone disease, without being correlated to MS.

    It was also decided that Dr. Zamboni can go forward with his blinded clinical trials of CCSVI in MS. Although there was no time-line given for testing and treating CCSVI, the ministry has promised to move quickly.

    Google translation of the press release:

    The cerebrospinal chronic venous insufficiency, "is recognised as a disease"

    The Association CCSVI in multiple sclerosis - Onlus "asks for guidelines for diagnosis and therapy."  Ministry of Health: "The State shall take responsibility to implement what the scientific community in the world has crossed"

    ROME - The cerebrospinal chronic venous insufficiency (CCSVI) is recognized in Italy as a disease in itself that can be quickly drawn up guidelines to be able to diagnose and treat beyond its correlation with multiple sclerosis. This is called the association "CCSVI in multiple sclerosis - Onlus" the Ministry of Health in a just concluded meeting between representatives of the association and Albert Zangrilli, president of the second section to the Board of Health in the same ministry. "While science makes its way to validate the correlation between MS and CCSVI - Tobacco said - as, we ask that, since the CCSVI has already been validated by the scientific world as it has been validated his therapy, the state will face load to implement what the scientific community worldwide has already validated and to draw up guidelines with respect to this disease occur until the science correlation."

    Found in several trials around the world in people with multiple sclerosis, CCSVI is a disease that affects the cervical and thoracic veins that because dell'inspessimento anomalous venous walls, remove inefficient blood from the central nervous system. The correlation between the two diseases in Italy is a study whose results, explain the association, are expected at the end of next year. "Today's meeting went very well" - added Tobacco - "The Ministry has taken note of our request." The timing, however, there are still some news. "On this we had no indications, but the ministry made us know that it will mobilize more quickly."

    Italian News report - http://www.redattoresociale.it/DettaglioNotizie.aspx?idNews=312625

    http://ccsvi-sm.org/?q=node%2F223

    Source: CCSVI in Multiple Sclerosi (26/06/10)

    CCSVI 'Liberation procedure' for multiple sclerosis sparks debate

    Nasha SmithNasha Smith knows that skeptics would say her multiple sclerosis got better after an unorthodox treatment at Lankenau Hospital simply because she believed it would.

    But the 40-year-old Reading resident also knows the "placebo effect" can't explain her transformation. Practically overnight, she went from being homebound - disabled by foot numbness, fatigue, balance problems, and painful bowel spasms that left her incontinent - to being able to complete a three-mile fund-raising walk for MS.

    "I know there's a lot of controversy about this, but I don't know why," Smith said. "The procedure was so simple, yet life-changing."

    The procedure, balloon angioplasty, is routinely used to open clogged heart arteries. But MS patients around the world are seeking what they call "the liberation procedure" to widen veins.

    Groundbreaking research by an Italian vascular surgeon suggests that narrowed veins are common in MS patients, causing blood to drain improperly from the brain.

    For a disease long blamed on out-of-control immune cells that attack the central nervous system, the blocked-vein theory is a radical departure - one that experts say remains speculative. To begin to confirm it, the National MS Society and the MS Society of Canada on Friday awarded $2.4 million to seven groups. They will study the diagnosis and frequency of poor vein drainage but will not treat patients who have the problem.

    "We certainly feel the patients' sense of urgency," said Patricia O'Looney, vice president of the National MS Society. "But there are conflicting reports from scientists. The appropriate action is to bring clarity to the question" of whether veins play a role.

    Patients are not waiting for more clarity. Dissatisfied with the marginal benefits and serious side effects of standard therapies, they are turning to interventional radiologists like Lankenau's Joseph Bonn, who treated Smith.

    At least, until hospital lawyers step in.

    In April, they ordered Bonn to stop performing balloon angioplasty on MS patients pending approval by officials at the Wynnewood hospital.

    Zamboni's discovery

    It's not clear who coined the catchy term liberation procedure, but it stems from the work of Paolo Zamboni, a vascular specialist at Italy's University of Ferrara.

    While trying to help his wife's MS, he discovered that the three main veins that channel blood from the brain back to the heart - the jugulars and the azygos - are often twisted, bent, compressed, or otherwise constricted in MS patients. He gave this abnormality a distinctly uncatchy name, "chronic cerebrospinal venous insufficiency," or CCSVI. His first paper on the condition was published only a year ago.

    Neurologists, the specialists who usually treat MS, as well as others, see holes in his out-of-the-box thinking.

    For one thing, poor vein drainage doesn't bother everyone who has it. Zamboni found it in the majority of MS patients, and few of the healthy people he checked. But then University of Buffalo neurologist Robert Zivadinov did a larger study of 500 patients. CCSVI showed up in 60 percent with MS, 43 percent with other neurological conditions, and 22 percent of healthy controls.

    Another thing: Not all MS patients get better after angioplasty. And the veins often re-narrow within a year. Zamboni found this happened in up to 47 percent of jugulars, although azygos veins usually stayed open.

    Stanford University researchers tried to combat the re-narrowing with stents designed to prop arteries open. One patient needed open-heart surgery when the stent dislodged, and another died of brain bleeding while taking a blood thinner prescribed with the metal devices.

    Still, Zamboni's maverick work offers a neat explanation for the central mystery of MS: why immune cells run amok, attacking nerves in the very body they are supposed to protect.

    Zamboni found that blood backs up in the brain, or "refluxes," as it creates new drainage patterns to circumvent the blocked veins. Iron settles out of refluxing blood and, like toxic pollution, irritates delicate brain tissue. In theory, this signals immune cells to seep out of the blood and try to clean up the mess.

    Normally, vessels in the brain are impermeable, so immune cells can't access that all-important organ. But the constricted veins develop high blood pressure, making them stretch and spring microscopic leaks. In theory.

    Angioplasty techniques are so well-established for treating vessel abnormalities that MS patients feel they are being discriminated against. In their view, they have little to lose and much to gain from trying to get better blood flow.

    CCSVI is diagnosed with ultrasound imaging, followed by special X-ray and MRI imaging. Balloon angioplasty, performed under sedation, involves inserting a tube through a small incision, threading it deep into the vein, and inflating the balloon tip to expand a narrow spot. Serious complications - rupturing the vein or a dangerous blood clot - are rare.

    Bonn, who does procedures on heart, kidney, and cancer patients, knew virtually nothing about MS until two months ago. Then, at a medical convention, he vaguely heard about the blocked-vein theory and made a note to learn more. Just two days later, he saw Janet Grieco, 53, an MS patient who had called out of the blue seeking treatment for CCSVI.

    "He pulled out his BlackBerry and showed me the note he made at the convention," the Chalfont resident recalled.

    Soon, Bonn was getting calls from MS patients near and far as their online community added him to the list of doctors willing to help.

    He treated only three MS patients, including Smith, but the results were good.

    Relief from headaches

    Grieco had suffered from chronic migraines, balance problems, and fatigue that was intensified by insomnia.

    "By the time I got to recovery after the procedure, I didn't have a headache," she said. "When you have a headache for three years and then it's gone, it's remarkable."

    That day, she strolled her neighborhood with her husband and stopped needing her nightly sleeping pill.

    Denise Graff, 43, of Somerset, N.J., experienced a phenomenon that other patients have reported.

    "My toes were like icicles" because of foot numbness, she said. "During the procedure, I could feel them warm up just after he ballooned the first vein."

    Bonn's fourth patient, Paulette O'Leary, 41, of Toronto, was minutes from being wheeled into the angioplasty suite when the hospital lawyers interrupted.

    "I don't know who was more shocked - Dr. Bonn, or me and my husband," O'Leary said.

    Bonn is now designing a clinical trial, the gold standard for studying safety and effectiveness. Patients with CCSVI would be randomly assigned to balloon angioplasty with - or without - the inflation that opens veins. The trial must be approved by the hospital's review board.

    As a scientist, Bonn sees the need for rigorous studies. But he also understands patients' frustration.

    "They suffer for decades on a slow downhill course," he said, "with few options in terms of medications or procedures. So this has been a real roller-coaster ride for them."

    O'Leary stayed on the roller coaster. Last month, she paid $13,000 for liberation at Albany State Medical Center, where a trial was already under way.

    Now, she said, she no longer uses a cane, clings to a wall to climb stairs, or suffers from incontinence.

    Balloon angioplasty is not a cure, not even close, she said. But it offers quality-of-life improvements that are impossible with any of the seven approved MS drugs, as well as a new one, Novartis' fingolimod, that was recommended for approval last week. All the drugs modify the immune system.

    Still, as patients travel to India, Bulgaria, Poland, and other countries for angioplasty, they may underestimate the skill and savvy it requires.

    "I did my first MS patient at the end of last year. It didn't work out too well," said Salvatore Sclafani, chair of radiology at SUNY Downstate Medical Center in Brooklyn. "The anatomy was much more complicated than I expected. I did the balloon, but she developed a [blood clot]. I sent her home on anticoagulants and said, 'I'll try again after I get more experience.' "

    Since then, he's done about 20 patients - a few with "miraculous" results - and become beloved for contributing to an online MS forum.

    Indeed, when he was ordered a few months ago to stop doing the procedure outside of a clinical trial, "there was an outpouring of grief, and of compassion for me," he said. "Then they got angry. So we started to dialogue about the trials and what we want to learn from them. Now they're participating in the development of the research.

    "I was ready to retire," added Sclafani, 63. "But this has touched me. Now my practice will be all MS."

    Source: The Philadelphia Enquirer © Copyright 2010 Philly Online, LLC (16/06/10)

    Touched by Multiple Sclerosis, foes lay politics aside

    CCSVI VenogramConservative MP Larry Miller had just finished speaking Monday night when NDP MP Malcolm Allen rose from his Commons seat, walked over and gave him a great big hug.

    It was a remarkable gesture in a House that is so often filled with acrimony and dissent. But this was a remarkable debate — a so-called take-note debate — on a controversial new procedure to diagnose and treat multiple sclerosis.

    “Those kinds of things don’t happen in the House,” Mr. Miller, the MP for Bruce-Grey-Owen Sound, said Tuesday.

    But Mr. Allen, who lost his father to the disease, was moved by Mr. Miller’s speech, in which he spoke of his youngest sister, Mary Lou, 45, who has suffered from MS for nearly 20 years.

    There is a new hypothesis that MS is not an auto-immune disease but a condition caused byChronic Cerebrospinal Venous Insufficiency,” or (CCSVI), which is the narrowing of veins that prevents the blood from draining from the brain efficiently.

    The diagnosis and treatment for this is not performed in Canada and many MS sufferers have gone abroad to have it done — at great expense and with some positive results.

    Earlier in the debate, Lethbridge Conservative MP Rick Casson was just barely able to hold on to his composure as he stood in his place to speak of 38-year-old daughter, who also has MS.

    “I can put a personal touch on this,” he said. “If I am going to recommend that my daughter takes a treatment of some kind, I want to make damned sure it will not kill her, cripple her or make her worse.”

    She was diagnosed five years ago; she has two children, is a teacher in Edmonton and is contemplating doing a PhD.

    Mr. Casson describes her as “amazing." He wants to ensure that enough caution is used so that MS sufferers are not given false hope by this procedure. He notes, too, that not all MS sufferers would benefit from it.

    There was no vote at the end of this debate.

    Still, it gave MPs the opportunity to look at and debate the reluctance of governments to recognize, through funding, this new procedure.

    Mr. Miller’s sister, meanwhile, is to be tested soon to determine if she can have the treatment. If she can, Mr. Miller, says it is likely she will go try to go to New York to have the procedure done.

    In fact, it was noted that some Canadians are travelling to Poland and other European cities, paying up to $10,000 to have the angioplasty procedure that opens up the neck veins.

    Mr. Miller’s sister was diagnosed with MS about nearly 20 years ago. Reports (first broadcast on CTV’s W5) of the controversial procedure by Dr. Paolo Zamboni gave her “really the first ray of hope or sunshine that she has seen”, he told the Globe in an interview Tuesday.

    She wanted to try the procedure immediately.

    “We want it to be a safe procedure … I’d like to see it here (in Canada),” he said. “If research and science shows that there is something wrong with it, then fine, we will accept that.

    “But everything we have seen in Europe so far it looks very, very promising and I just want to see us piggy back on research that is already done and advance it from here,” he said.

    Last night, he spoke about the provincial and federal governments putting jurisdictional issues aside and working together on this.

    As well, Mr. Miller, who does fundraising for MS, expressed disappointment with the MS Society, who he said, “has not yet taken an even broader approach to include more new treatment options that have shown promise, like CCSVI …”

    Ms. Duncan, whose tenacity sparked the debate, says that at first there were some politics played last night over the role of the federal government in health issues.

    But she said there was a real shift in the debate when “someone on the government side had the courage to say that we have responsibility here.”

    “It was really good,” she said. “What we’re fighting for is that these guys be able to have diagnoses and treatment in Canada. Why are they having to go overseas when everything is available here?”

    Source: The Globe and Mail © 2010 CTVGlobeMedia (16/06/10)

    MS Society board bid foiled for frustrated Multiple Sclerosis patients

    CCSVI VenogramMultiple sclerosis patients and advocates were thwarted in a bid to win two seats on the MS Society of Canada's board on Saturday, positions they sought in order to push for immediate access to an unproven treatment not available in Canada.

    Linda Molyneux, whose 22-year-old son has MS, and Brock Winterton, whose wife has the disease, failed to secure enough votes to unseat two of the five board nominees on a slate proposed by the society's governance committee.

    Though their nominees prevailed in the election, the society's executive and professional staff took a verbal pounding. Member after member denounced them for failing to use the society's clout to demand immediate access to treatment in Canada for a condition called CCSVI ---- short for chronic celebrospinal venous insufficiency.

    "You're not meeting the Number 1 need of your constituents," one angry society member said in a heated discussion that stretched what is normally a 30-minute meeting to nearly five times that.

    "It has become quite clear to me the MS societies have lost touch with their membership," Molyneux said when she appealed for votes.

    Patients feel the single greatest impediment that stands between them and this treatment is the MS Society, she said.

    At issue is the unhappy confluence of a new theory about what causes MS, an untested therapy, a disease advocacy group that feels it must be guided by scientific evidence and a sizable membership that is unwilling to wait for science to prove something they already believe to be true.

    "This house is probably divided and we may not reconcile it today," Yves Savoie, president and CEO of the MS Society of Canada, acknowledged.

    The society gently reiterated that it cannot advocate for treatment for a condition -- CCSVI -- that hasn't yet been proven to be involved with MS, let alone shown to be the cause of, not a side-effect of the condition.

    The theory is the brain child of Italian physician Dr. Paulo Zamboni, who has linked blocked neck veins with MS. He contends a build up of iron in the brain due to insufficient blood drainage triggers the disease. The longstanding belief is that MS is an autoimmune disease.

    Since word of Zamboni's research was publicly aired last November, patients have been demanding access to treatment for the blockages and MS society officials have been struggling to figure out how to cope with the increasingly frustrated demands.

    At Saturday's meeting, society officials noted the Canadian and U.S. societies decision to  grant $2.4 million in research funds Friday, and that the Canadian group had asked the federal government for $10 million to devote to CCSVI research.

    But the patients weren't in the mood to be told to wait several years for research studies to answer those questions, and dismissed the Canadian portion of that funding package -- $700,000 over two years -- as "inappropriate."

    "People with MS don't have the luxury of time," Winterton said.

    "I want my veins opened. Why can't I have my veins opened?" asked MS patient Michele Deverill, 51, of Toronto.

    Deverill said she is outraged that people with other conditions can have the vein-opening procedure -- which involves snaking a balloon into the vein and inflating it -- but because she has MS she cannot have it done in Canada.

    Many patients aren't waiting. Instead they are flocking to clinics in Poland, Bulgaria and India to undergo the procedure.

    In fact, Molyneux just arrived back late this week from Bulgaria, where her son had angioplasty for blocked veins. Winterton and his wife left the meeting early to catch a flight to the same Eastern European country, where she will have the procedure next week.

    While most people attending the meeting demanded the MS Society make CCSVI research and treatment its top priority, a few raised cautionary voices.

    One woman said she was unwilling to be a guinea pig. And a man whose wife suffers from MS worried that too much focus on one theory could prove to be a mistake down the road.

    "If we've put all our eggs in the one basket, we could be years behind on the research to find the cure," said the man, who asked not to be identified because his wife keeps her MS under wraps.

    "I mean, I'm hopeful that this is it. That would be fantastic. But you've got to diversify your portfolio and make sure that you've got all avenues covered so that if this doesn't work, well maybe this does, or this does."

    Source: CTV News © Copyright 2010 CTVglobemedia Publishing Inc (14/06/10)

    MS patients told it'll be years before treatment
    CCSVI VenogramMore than 600 multiple sclerosis patients came to Hamilton hoping to hear about a possible cure to what until now has been a mystery disease with few treatment options.

    Many left Michelangelo's Event and Conference Centre Saturday frustrated that it will be years before they can "be liberated" as the treatment has been called by Dr. Paolo Zamboni, the Italian surgeon who has pioneered it.

    "I'm 70 years old, where do I fit in?" said Barbara Farraway, of Hamilton, who was diagnosed with MS 20 years ago. "It's hard to wait when it's progressing."

    Farraway and her husband took little comfort in reassurances that research is being fast-tracked to test Zamboni's theory MS is a vascular disease involving blocked veins improperly draining blood from the brain and spinal cord.

    While the information session was put on by the MS Society of Canada, there was a lot of anger at the organization and its American counterpart over the decision to give no money to high-profile studies in Hamilton and Buffalo when they handed out $2.4 million in funding Friday to test the theory called chronic cerebrospinal venous insufficiency (CCSVI).

    "One of my questions is why the MS Society didn't back the Hamilton project because it's going to slow the process down," said Jim Palango, of Brantford, about the society's refusal to provide any information about why certain studies weren't recommended for funding by its international review panel. "Will more donations speed up the process and if so, let's get on the bandwagon to help St. Joseph's since the MS Society of Canada is not supporting them."

    The lead researcher in Buffalo says he suspects his study and the one in Hamilton, being done by St. Joseph's, McMaster University and Hamilton Health Sciences, weren't funded because of their ties to Zamboni. Both consulted Zamboni about their studies.

    "I think probably it has to do with it," said Dr. Robert Zivadinov, director of the Buffalo Neuroimaging Analysis Center, and one of the presenters at the information session. "They wanted the people who are not connected with the way Zamboni is doing this."

    Researchers in Buffalo and Hamilton say they will continue with their studies despite being shut out of funding.

    Hamilton's study has about $350,000 to get started, mostly donated from MS patients.

    Today, the House of Commons will have a four-hour debate about whether Ottawa should put money toward testing the theory.

    Zivadinov says he will soon be publishing a paper with Zamboni showing the blockages in the veins return after the treatment far less often than originally believed.

    Zamboni has reported the blockages reoccur about 50 per cent of the time after the veins are opened using angioplasty. Zivadinov says new information shows the blockages return about 30 per cent of the time.

    Despite initial results that support Zamboni's theory, Zivadinov still urged patients to wait until more study can be done before going to other countries and paying to get the treatment.

    He worries about the risk to patients, even though angioplasty is a commonly used procedure for other conditions.

    But patients say the risk is worth it and they don't have time to wait.

    Source: thespec.com © Copyright Metroland 2010 (14/06/10)

    CCSVI scanning & treatment about to start in UK

    CCSVI VenogramFrom the new Essential Health Clinic Newsletter

    It's starting! - CCSVI Scanning & Treatment about to start in UK

    We are pleased to announce that we have now taken delivery of our Premium Echo Doppler Scanner System. This scanner has been specially designed by Professor Zamboni and his team for the diagnosis of CCSVI. We are also proud to b...e the first clinic selected in the UK to have this equipment and we have been told that currently no other establishment in the UK and Ireland is using this sophisticated equipment.

    Professor Zamboni devised five specific protocols for the detection of CCSVI and this equipment is programmed with the algorithms created to aid the analysis of these five protocols. These special measurements available with this equipment have recognised the needs of this type of scanning - and the fact that existing scanners may struggle without the specific measurements required................

    Read More - http://us1.campaign-archive.com/?u=646d7fd51cbebd959c3a5b033&id=a9ce662ff6

    Source: The Essential Health Clinic (11/06/10)

    MS patients to launch rights complaints demanding unproven CCSVI treatment

    CCSVI VenographMultiple sclerosis patients in at least two Canadian provinces are preparing to launch human rights complaints as they demand access to an unproven treatment that has excited the hopes of people living with the degenerative disease and already prompted some to seek the procedure abroad.

    A group of patients in British Columbia and another man with the disease in Newfoundland say denying them treatment for a vein condition that's been called chronic cerebrospinal venous insufficiency, or CCSVI, amounts to discrimination.

    An Italian doctor recently claimed narrowed neck veins cause or contribute to MS and unblocking them could help treat the disease, but the procedure isn't offered in Canada as the medical community waits for large-scale clinical trials and studies to test the theory.

    Jenna Machala, a Vancouver-area realtor who is among the patients preparing a complaint to the B.C. Human Rights Tribunal against the province's Health Ministry, said people living with MS can't afford to wait for governments to give a green light to the treatment.

    "I have friends who have no time to wait for them to make up their minds and do their blind studies," Machala said in an interview.

    "We are begging everybody to have a look at us. It's like we are drowning and no one wants to throw us a life jacket."

    Machala said the complaint will argue MS patients are being discriminated against because, she says, the same type of balloon angioplasty used in the experimental CCSVI treatment is available to patients with other medical conditions.

    She has been meeting with a tribunal lawyer during the past several weeks as she gathers the material for her claim and encourages other patients to sign on. It's not clear how soon the tribunal could hear the case.

    In the meantime, Machala, who underwent tests at a private medical clinic in Vancouver and showed signs of narrowed veins, has already booked a trip to Poland next month to have the procedure done there.

    Mark Lane, an MS patient in Holyrood, N.L., also plans to file a human rights complaint if, as he expects, a vascular surgeon he's set to see next month refuses to schedule the procedure.

    The CCSVI theory gained worldwide attention last year as Dr. Paolo Zamboni of Italy promoted his claim that MS is a vascular condition rather than an autoimmune disease, which is the commonly accepted belief in the medical community.

    MS patients staged rallies across the country this year calling for more funding and research into the theory, and several patients held a news conference in Ottawa last week alongside Liberal MPs urging the federal government to earmark research funding.

    The Multiple Sclerosis Society of Canada has called on Ottawa to set aside $10 million for CCSVI research, and the organization plans to announce its own research grants later this month.

    But the response from the federal and provincial governments has largely been to wait and see.

    "It is not at all appropriate to move forward with a procedure before it's gone through appropriate reviews to ensure that you're providing a procedure that is not going to harm individuals and is actually going to provide a benefit," B.C.'s health minister, Kevin Falcon, told reporters last week when asked about the CCSVI treatment.

    The federal health minister has said researchers interested in testing the theory should apply for existing funding.

    There have been several cases in which patients have complained either to human rights bodies or the courts that denying them treatment was discriminatory, and the results have been mixed.

    One of the most high-profile examples involved a group of B.C. parents who claimed that denying their autistic children a form of intensive therapy violated the Charter of Rights and Freedoms.

    Two B.C. courts agreed and ordered the province to pay for the therapy, but the Supreme Court of Canada overruled those decisions in 2004, concluding the treatment wasn't a "core medical service" that the law requires provincial governments to pay for.

    Also in B.C., a Victoria lawyer has been challenging the province's refusal to pay for a prostate cancer screening test known as PSA, arguing it is discriminatory to pay for mammograms for women but not PSA tests for men.

    The B.C. Human Rights Tribunal ruled against Laurie Armstrong. He challenged the decision in court, initially winning at the provincial Supreme Court but losing in the B.C. Court of Appeal.

    He is waiting to hear whether the Supreme Court of Canada will hear the case.

    Armstrong said the greatest challenge for the MS patients will be to demonstrate they are being treated differently than other patients who are getting similar angioplasty procedures solely because they have multiple sclerosis.

    "They have to make their case that the denial of a service, otherwise available to members of the public, is based on disability," said Armstrong.

    "But then the government will argue that it's got nothing to do with MS, that it's the unproven medical knowledge that is the determining factor.

    "If they can establish a human rights component, then they should go for it. I wish them luck."

    Source: CityTV © 2010 by Rogers Broadcasting Limited (07/06/10)

    Controversial treatment creating bitterness in Canadian MS Society elections

    CCSVI VenogramThe Multiple Sclerosis Society’s national board election next week is expected to become a battleground as members rally to shut out supporters of a controversial treatment.

    An e-mail circulated on Friday urged MS Society supporters to sign up to become members, which will give them voting rights.

    And the e-mail asks them to use those votes to maintain the balance of the current board, effectively closing out candidates who want resources increased for research into chronic cerebrospinal venous insufficiency, a new diagnosis that suggests MS could be caused by iron blockages in the veins.

    Based on this theory, Italian physician Paolo Zamboni has claimed some success with a procedure he developed known as the Liberation Treatment. Publicized in Canada last fall, it has given sufferers a ray of hope, and had them clamouring for the procedure that some people who tried it are saying has eliminated symptoms. It is not available in Canada but is approved some countries, including Bulgaria, Kuwait and Poland. Even proponents say the procedure has not been scientifically proven, and a clinical trial at the University of British Columbia is just gearing up.

    The diagnosis and procedure have become divisive issues in the MS community, and Ontario board vice-chair Valerie Hussey fears they might overshadow other important ongoing research the MS Society is promoting.

    “Anyone with a connection to MS hopes for a ‘liberation’ cure,” she wrote in the widely circulated e-mail. “But is this really it?”

    In an interview, the Toronto woman, who has a loved one with MS said she only hopes to maintain balance on the current board of 10 directors. New members who are staunch advocates of CCSVI might steer decision making in one direction.

    “Because there’s this sense of hope around CCSVI, my concern is that our very balanced approach to research not be diminished, not be altered.”

    But board candidate Brock Winterton, whose wife, Janet Heisey, has battled the disease, says it is necessary to have a strong voice in support of CCSVI and the Liberation treatment on the current board. Many MS sufferers would like to try this treatment, which includes an ultrasound or MRI and then an angioplasty which involves local anesthetic, whether it’s as part of a clinical trial or not, he said.

    He is running for a seat with Linda Molyneux, who he joins on the Blocked Veins MS Research Group which maintains that the MS Society isn’t allocating nearly enough resources to the study of CCSVI.

    “We’re not trying to take anything away from anybody else. We’re not trying to diminish the research dollars that are going into stem cells and many other areas of research,” he said. “We simply want to see the MS society take this seriously and provide the opportunity for MS sufferers to improve their quality of life.”

    In December, the MS Society announced it will include grants to study potential vascular aspects of the disease. The total grants are $100,000 over two years of study, and only part of that will look at CCSVI, said MS Society president and executive director Yves Savoie. The CCVSI competition results will be announced on June 14.

    But the entire $100,000 would only cover about a tenth of the cost of the clinical trials starting up at UBC and 20 per cent of what’s needed to run trials at McMaster University’s St. Joseph Hospital, said Kate Bahen, managing director of Charity Intelligence, an organization that helps Canadians make educated charitable donations.

    “The medical research are not funded and people who want these trials funded should donate directly to UBC faculty of medicine and St. Joseph’s,” she said. “You don’t have to go through the middle guy.”

    Mr. Savoie says he’s excited that there will be such vigorous debate at the upcoming Annual General Meeting in Toronto next Saturday where these votes will be cast (members can also vote by proxy).

    “Our members, many of them who have MS, have mobilized, they’ve pressured governments and we have called for quick action,” he said. “And what we’re seeing is that debate’s taking place everywhere - Question Period, letters to the minister… and now on the floor of our AGM. People who are passionate about this issue and their voices will be heard.”

    In early May, Liberal MP Kirsty Duncan urged health minister Leona Aglukkaq to call a provincial meeting to discuss the controversial treatment and dole out $10 million for more study on the diagnosis.

    About 55,000 to 75,000 Canadians are suffering from the debilitating disease.

    Source: The Globe & Mail © Copyright 2010 CTVglobemedia Publishing Inc (05/06/10)

    MS patients tell MPs about life after CCSVI 'liberation'

    CCSVI VenogramA group of Canadian patients with multiple sclerosis gathered on Parliament Hill Tuesday to testify how a controversial new treatment has changed their lives, as two Liberal MPs reiterated their call for more research.

    The patients included Steve Garvie and Lianne Webb, both of whom were profiled in a recent report from CTV's W5.

    Garvie was diagnosed 10 years ago with secondary progressive MS, which left him using a walker most of the time, suffering profound fatigue.

    But since he's had what's been dubbed the "liberation treatment" to open up a blocked left jugular vein in this neck, his life has transformed.

    He testified to the parliamentary Subcommittee on Neurological Disease Tuesday that he is now able to stand and walk on his own. He told the MPs that he was once suicidal and needed daily care to wash and cook. Now, he has regained his strength and independence.

    Liane Webb, who was diagnosed with relapsing-remitting MS almost 20 years ago, has also been treated for blocked veins, a condition called CCSVI, or chronic cerebrospinal venous insufficiency.

    Webb says she hasn't had an MS attack in the four months since her treatment, and her chronic fatigue has disappeared.

    "I go golfing three times a week and I don't take the cart," she says. "I am able to go on bike rides and walks after work with my family now that I have the energy."

    Dr. Sandy MacDonald, the Barrie Ont. doctor who helped diagnose and treat Garvie and Webb, told the committee that the balloon angioplasty used in the liberation treatment is a safe, relatively easy procedure for what he is finding is a common condition.

    "I've done scans on almost 200, and greater than 90 per cent have venous anomalies," Dr. MacDonald told MPs.

    Also Tuesday, two Liberal MPs reiterated their call for federal investment in research on CCSVI.

    Liberal public health critic Dr. Carolyn Bennett and health critic Dr. Kirsty Duncan called for the Harper government to invest in MS research, diagnosis and treatment, and to immediately convene a meeting of provincial and territorial health ministers to discuss a national approach to funding MS and other diseases of the brain.

    "We support the call by the MS Society of Canada and thousands of MS patients across the country who want the Harper government to provide $10 million for research into MS and its potential cause," Duncan said in a news release.

    Drs. Duncan and Bennett wrote a letter to Health Minister Leona Aglukkaq on May 6 asking for support to research the "liberation treatment." Aglukkaq has yet to respond.

    Dr. Duncan has also called for an emergency debate in the House of Commons on this issue, but so far those calls have been rejected.

    "Liberation treatment centres are popping up daily around the world, and Canada, with one of the highest rates of MS in the world, should be on board," Duncan said. "MS patients and neurologists all agree that well-designed clinical trials must take place as soon as possible."

    MS patients have organized numerous petitions calling on the government to fund liberation procedures, and hundreds of patients gathered for a rally on the Hill last month. Bennett noted that a number of MS patients are going overseas for treatment for CCSVI, at their own expense.

    "What does this mean for a family who simply does not have the financial resources to do so? We believe that, just as heart patients are treated for blocked arteries, MS patients should also have access to this treatment," Bennett said in a statement.

    Source: Sympatico.ca © Bell Canada, 2010 (02/06/10)

    MSIF statement on CCSVI released

    CCSVI VenogramMultiple Sclerosis International Federation (MSIF) Statement


    Chronic Cerebrospinal Venous Insufficiency (CCSVI) - 24 May 2010


    Introduction
    Recent preliminary studies have suggested that a phenomenon called Chronic Cerebrospinal Venous Insufficiency (CCSVI), a reported abnormality in blood drainage from the brain and spinal cord, may contribute to nervous system damage in MS.

    This hypothesis has been put forth by Dr. Paolo Zamboni from the University of Ferrara in Italy. Based on the results of his initial preliminary findings published in June 2009 from a study of approximately 65 patients, Dr. Zamboni and colleagues state that this pilot study warrants a larger and better controlled study to definitively evaluate the possible impact of CCSVI on the disease process in MS.

    MSIF’s Principles for the Promotion of the Quality of Life include that “People with MS must be empowered to take control of the decisions affecting their lives and to self-manage the disease as much as possible. To encourage the highest possible degree of self management, they should be able to access a broad range of information, advice, and education regarding the nature of MS, its treatment, and methods for improving QOL”.

    The risks and benefits of procedures to treat CCSVI have not been established by properly controlled clinical trials. Unless and until strong supportive evidence is produced, and until the risks of treatment are thoroughly assessed, any procedures to mechanically correct the purported problem outside of a clinical trial are not recommended.

    MSIF will continue to facilitate an open exchange of information amongst its members in relation to the research that is being undertaken. Several MS societies are promoting further research in CCSVI as a matter of urgency in order to evaluate the hypothesis of a link with MS, and what could be the short and long term benefits and risks of treatment.

    Question 1 (Q): What is CCSVI?
    Answer (A): Chronic cerebrospinal venous insufficiency is a reported abnormality caused by narrowing of the veins which drain oxygen depleted blood from the brain and spinal cord. It is theorised that the slowed draining of blood can cause reflux back into the brain and spine, leading to a lack of oxygen in the brain and iron deposition in the tissue.

    Q 2: What is the connection between CCSVI and MS?
    A: A recent study by Zamboni et al on 65 people with different types of MS (published in J Neurology Neurosurgery Psychiatry. 2009 Apr; 80 (4): 392-9. Epub. 2008 Dec 5.), compared with 235 people who were healthy or had other neurological disorders, reported abnormal venous flow in 100% of MS cases and in none of the people without MS. Venous drainage of the brain and spinal cord was examined using an ultrasound technique (Doppler). The researchers also noted that patterns of venous obstruction differed between people at different stages and courses of MS although there was no clear relationship between severity of MS and extent of venous obstruction. The treatment status of the people with MS did not appear to influence whether they showed signs of CCSVI. A further study from the same group in Italy (Journal of Vascular Surgery, 2009 Dec 50:1348-58) looked at the effects on MS of improving venous blood flow by a technique called balloon dilation. This open-label study (not blinded or controlled – see Q3 below) evaluated the safety and preliminary outcomes of vascular surgery in 65 people with MS who had previously been diagnosed with CCSVI (35 individuals with relapsing-remitting MS, 20 with secondary-progressive MS, and 10 with primary-progressive MS). Some positive impacts were reported including a reduction in new brain lesions on MRI scans and reduction in the number of relapses experienced by some of the participants in the trial.

    However, results were confounded by a number of factors including; restenosis in 47% of cases (meaning that internal jugular veins went back to having restricted blood flow after the procedure), inconsistency in the timing and type of MRI scans taken and the fact that participants remained on their Disease Modifying Treatments during the study period.

    These are all major factors that need to be considered when data from the study is interpreted. Researchers conducting the study reported that further trials will need to be conducted to measure the benefits and risks of balloon dilation in people with MS.

    Q 3: Why are blinded controlled trials important?
    A: In controlled trials, “blinding” of participants and researchers as well as the use of a comparative control group are considered essential to ensure that the hopes and expectations of the participants and the researchers do not influence the assessment of the trial outcomes or the interpretation of the results. So far, none of the procedures conducted to correct CCSVI have been done in the context of a controlled trial.

    Q 4: What does the latest CCSVI research show?
    A: Preliminary results from a large ongoing Combined Transcranial and Extracranial Venous Doppler Evaluation study at the University at Buffalo Medical Center aimed at investigating if CCSVI is associated with MS, were released on February 10, 2010.

    Doppler scan results were reported on five specific criteria that affect venous blood flow. Patients who met at least two of the criteria were considered to have CCSVI. 289 of the 500 patients enrolled had MS. Of these, at least 56 percent of the MS cohort met the criteria for CCSVI. The same was true for at least 22 percent of the 163 healthy controls and at least 42 percent of people with other neurological conditions. The results were substantially different from those reported by Dr Zamboni and suggest impaired venous flow is not specific for MS.The researchers concluded that further blinded studies are needed to determine the prevalence and significance of CCSVI in MS. A second stage of the study will involve screening a further 500 participants using more advanced screening methods.

    Q 5: What further research is being undertaken into CCSVI?
    A: MS Societies that fund MS research are interested in pursuing all promising avenues of MS research. In December 2009, the MS societies of Canada and USA issued an expedited international request for proposals on CCSVI and MS. Proposals were received from seven countries and final decisions will be announced on 14 June with projects anticipated to start on 1 July 2010. An international review panel of MS and vascular experts has been convened in cooperation with these MS Societies to ensure an expedited, coordinated response.

    Several MS Societies, including those in Canada, Italy, Netherlands, United Kingdom and USA will also consider funding projects on CCSVI through their normal funding process. The Steering Committee of the Italian MS Foundation (FISM) will evaluate proposals on CCSVI that have been submitted through their annual call for projects in March.

    In addition, FISM is promoting an epidemiological study to confirm and extend Dr. Zamboni’s findings by evaluating the prevalence of CCSVI in healthy controls, MS and other neurodegenerative diseases, other inflammatory diseases of the central nervous system and other systemic autoimmune diseases. This study plans to enroll 1690 subjects and will involve15 clinical centres. FISM is also participating in a randomized controlled trial to evaluate the short and long term efficacy and risks of the venous dilation procedure on disease progression and symptoms. Both studies are likely to start in the second half of 2010.

    The MS Society of Canada has also called on its government to make extra research funding available to speed up research on CCSVI.

    Q 6: Does CCSVI cause MS?
    A: At this point there is not enough evidence to draw conclusions on CCSVI and MS. Based on what has been published to date, we can only say that in some people MS may occur in association with impaired venous drainage of the central nervous system. However this phenomenon has also been observed in people who do not have MS.

    There is not enough evidence to determine whether obstruction of veins causes MS, or is caused by MS, or even to determine when this obstruction may occur in the course of disease.

    Q 7: How has CCSVI been treated?
    A: Surgical procedures for CCSVI in MS have used balloon dilation to open up obstructed veins or insertion of stents into veins to help keep them open (endovascular surgery). These procedures have been performed on only a small number of MS patients.

    Q 8: What is known about the risks involved in this treatment? A: No studies testing the safety and effectiveness of treatments for CCSVI have reported detailed safety findings to date. Procedures involving stenting or balloon dilation of the jugular and Azygous veins for the treatment of CCSVI are of unknown safety.

    It is known, however, that endovascular procedures, like any procedures, do carry risks. Balloon angioplasty and stenting both carry a small risk of elastic recoil, rupture of the vein and blood clots. The rates of restenosis (re-narrowing) are also high. Stenting carries additional risks because it requires that the patient takes anticoagulant drugs which could lead to bleeding and also because there is the possibility that the stent could come loose and migrate towards the heart.

    This does not mean that these procedures would not be considered as a potential treatment in the future if further research proves that they are safe and effective at treating MS. At present treatments for CCSVI remain unproven and it is prudent that any such procedures only be performed as part of properly regulated controlled clinical trials, especially in light of adverse events reported to date.

    Reports of CCSVI surgical procedures involving stents resulting in adverse events in persons with MS include one reported death. According to the Annals of Neurology, the person died of a haemorrhage in the brain while taking a blood thinner (anti-coagulant), which is commonly prescribed when stents are inserted into blood vessels. In another individual, a stent dislodged and moved to the heart, requiring emergency open heart surgery to remove the device. MS endovascular surgery was halted at Stanford University after these two adverse events occurred.

    Q 9: Will the treatment of CCSVI be useful for the various forms of MS?
    A: As research on this question is at a very early stage, it is currently unknown whether this type of treatment will be useful in any form of MS. More research is looking at possible links between CCSVI and MS, and/or its effects on MS symptoms and clinical studies on the effects of CCSVI treatment on MS are needed before it will be considered for approval in treating people with MS.

    Dr. Zamboni has suggested that if further evidence supports the link between MS and CCSVI, its treatment may ultimately add to the arsenal of therapies available for MS. He emphasized the need for more research on his hypothesis, and noted that it is still not proven whether CCSVI is a cause of MS or related to MS in some other manner. Dr. Zamboni also noted that people with MS should remain on their immunomodulatory therapies.

    Q 10: Should I have treatment?
    A: The risks and benefits of procedures to treat CCSVI have not been established by properly controlled clinical trials. Unless and until strong supportive evidence is produced, and until the risks of treatment are thoroughly assessed, any procedures to mechanically correct the purported problem outside of a clinical trial are not recommended.

    Source: Multiple Sclerosis International Federation (MSIF) (27/05/10)

    MS Society CCSVI meeting webcast tomorrow (26th May) 1-3pm
    MS-CCSVI-UK Logo

    The MS Society was approached by online CCSVI pressure group MS-CCSVI-UK - http://www.facebook.com/ms.ccsvi.uk who requested a meeting with the MS Society about CCSVI.

    In response to this request, and to news of the CCSVI demonstration being held by MS-CCSVI-UK outside the MSS headquarters the MSS set up a CCSVI Meeting with interactive webcast.

    Watch the webcast at http://bit.ly/dkA588 email [email protected] or tweet at http://twitter.com/mssocietyuk your CCSVI questions to their panel from 1pm..............

    Dr. Ashton Embry responds to the Canwest CCSVI article in Montreal Gazette

    CCSVI VenogramMay 19, 2010

    Dear Ms Levy and Dr Lang,

    I read your recent column on the treatment of CCSVI (Liberation or placebo effect? MS surgery, Montreal Gazette) and was very surprised at how much you left out about the science of CCSVI. You completely missed the implications of the key scientific findings of CCSVI and why these findings strongly indicate that it is important to be treated for CCSVI sooner than later.

    First of all the current science has left no reasonable doubt that CCSVI is associated with MS, that is, it is far more common in persons with MS than the general population. This is based on Dr Zamboni’s research as well as published information from other centres, including a major study at the University of Buffalo. No credible researcher is disputing this clear association. Of course, association alone does not mean cause. Your statement “CCSVI, if that condition actually exists” indicates that neither of you have not read the literature (e.g. the April issue of International Angiology which had 13 contributions on CCSVI). How you think you can write an intelligent column without such background reading boggles my mind.

    Another critical scientific finding which you seemingly know nothing about is that the venous malformations that drive CCSVI are almost exclusively congenital, that is, they were there at birth. Again comprehensive papers have been published on this and it is very widely accepted. This is critical because it shows that CCSVI precedes the MS disease process and is not an effect of it.

    Finally, it is also well accepted that biological mechanisms which are a consequence of CCSVI, such as reflux of venous blood back to the brain, the deposition of iron in the brain, hypoperfusion, and the upregulation of adhesion molecules on the endothelium of the venules, all can be reasonably related to the MS disease process.

    I would also emphasize that no one credible is claiming MS is not an autoimmune disease. The huge MS data base shows it almost assuredly is. However, it also must be emphasized that the biological mechanisms associated with CCSVI all significantly enhance the autoimmune process.

    This brings us to another of your ill-conceived statements. “CCSVI, and MS, breaks down on a number of other fronts, including the fact that patients who have impaired blood flow in their veins as a result of surgeries, for example, don't develop MS. Similarly, vessels tend to narrow as we age and yet MS is not a disease of older individuals. The blocked vein theory of MS is so out of keeping with our understanding of the disease that it might be compared to fixing a burned out car radiator by changing the tires of a car.” I was embarrassed for both you when I read it. MS is an autoimmune disease which is substantially aggravated by the co-occurrence of CCSVI. Not everyone with MS has CCSVI and not everyone with venous problems has MS. This again is well established in the literature. I cringe when I read ridiculous statements which attempt to discredit the CCSVI/MS association. You two are better than the nonsense you wrote.

    I might note that CCSVI helps to explain a major puzzle in MS. As you both well know, the brain is protected from the blood-borne, immune system by what is known as the blood-brain barrier (BBB); greatly strengthened, blood vessel walls which prevent the passage of immune cells into the CNS. It has always been a problem to explain why the autoimmune cells were able to cross the BBB so easily in the MS disease process, given that evolution had ensured this would not happen. Of course the trick is that the biological mechanisms associated with CCSVI degrade the integrity of the BBB and allow the autoaggressive immune cells to cross the BBB much more easily. Thus, with CCSVI as part of MS, we now have an improved, more theoretically reasonable, disease model which fits an evolutionary perspective.

    Given all of the above, there can be little doubt that CCSVI is an important part of the MS disease process because 1) it is associated with MS,2) precedes MS and 3) can reasonably contribute to the actual MS pathogenesis. As an analogy, just imagine if people with persistent back pain were found to have a pin sticking in their backs. If, in most cases, it was found the pins were there before the back pain and the pain was associated with the pin, then it would be reasonable to postulate the pins were part of the problem. Of course, if the pins were shown to be there after the pain, then one would assume the pin is not a big player in the problem and may be an effect of it (a failed treatment?).

    The question now becomes now that once it is established that the pins precede the back pain and can help to explain it, do we wait for 7 years of research before pulling the pins, or do we pull the pins and at the same time do research to determine how they got there, how they cause the pain, what is the safest way to remove them etc. Clearly the latter is the common sense approach. Any advocacy of the first option immediately raises the spectre of a hidden, self-serving agenda.

    Exactly the same logic applies to CCSVI and MS except it is more important that treatment be done as soon as possible. This is because, in the 7-10 years needed for all the research, many people with MS will suffer serious, irreversible damage to the CNS and will experience serious clinical symptoms because of such damage. Because CCSVI is almost assuredly an important part of the MS disease process as the current science has shown, then it is important that it be resolved as soon as possible. There is no doubt that large amounts of research are needed on CCSVI but treatment of those with MS cannot wait until this research is completed.

    In summary, what the media (including you) have missed is that the current science says CCSVI is very likely a key part of the MS disease process and consequently needs to be treated as soon as possible. This is not a treatment which addresses symptoms but one which addresses a main driver. I am not surprised that many people are experiencing major improvements in their MS symptoms once CCSVI is relieved. I expect those with the pin in their backs would also enjoy some relief upon pin removal. Any time you counter a key part of a medical problem, from a bacteria which causes an ulcer, to immune suppression in autoimmunity, relief is to be expected. Claims that all the impressive improvements are simply “placebo effect” are also nonsense. They are just as real as the few cases of adverse effects.

    Persons with MS are simply asking for a serious pathology (impaired venous flow from the brain), which science says is very likely to be a part of their disease process, to be corrected. To an objective observer, and hopefully to the media, this should be seen as a most reasonable request.

    I also hope you can understand why pharmaceutical companies and those who receive substantial financial benefits from such companies (neurological community, MS Society), all of whom have much to lose from the introduction of CCSVI as a standard treatment, are strongly opposed to making CCSVI treatment available. Who can blame them? However, given their blatant and rather large conflict of interest, their opinions on this matter have to be weighed very carefully and seen in the light of the strong subjectivity they carry. Given that you are mouthing the same hollow arguments of those opposed to CCSVI, I have to wonder “who got to you”. A drug company, your favourite neurologist or perhaps a representative from the MS Society?

    I hope this helps you understand why there is so much turmoil concerning CCSVI treatment. From an objective, scientific point of view, CCSVI needs to be treated anytime it is found. From a financial point of view, various factions are strongly opposed to such treatment. I hope some day the media gets at the real stories –1) science supports CCSVI treatment as soon as possible and 2) There is a war going on with the stakes being the physical health of persons with MS versus the financial health of drug companies, neurologists and national MS societies. Which is more important to our society? I know what side you two are on and it is not something you should be proud of. Beating up on persons with MS for financial reasons is as about as ugly as it gets. You are out doing the bankers in terms of a complete disregard for the values of our society.

    I hope I have given you a broader perspective on CCSVI and the importance of treating it sooner rather than later. This issue will not go away until “the right thing to do” is done.

    Sincerely,

    Dr Ashton Embry
    President, Direct-MS

    Liberation or placebo effect? MS surgery, Montreal Gazette  

    Source: Direct-MS (20/05/10)

    MS patient slams NHS operation snub

    Audrey BarnettAn Inverness woman being forced to go private for treatment on a debilitating disease has launched a battle to make the operation available on the NHS.

    And Audrey Barnett (39), who is housebound because she suffers from multiple sclerosis (MS), has claimed it is "scandalous" that a leading research charity has failed to back the surgery - costing up to £6,000 privately.

    She has now launched a fundraising drive to pay for her treatment at a private clinic in Glasgow and is also lobbying the Scottish Parliament for urgent research so it can be offered to all MS patients.

    This is despite the MS Society saying there is not enough evidence to prove its success.

    She said: "This operation gives me hope I can get my life back - but I want it available to all MS patients on the NHS."

    Mrs Barnett, of Underwood Place, Balloch, was diagnosed with MS, the most common disabling neurological condition affecting young adults, after she temporarily lost the feeling in one leg and the strength in the other 15 years ago.

    At first, she had "long good spells" in remission, but her most recent relapse severely affected her quality of life.

    Mrs Barnett, a former civil servant who retired on health grounds, said: "My main ongoing problem is fatigue and my walking is limited. Last year, I had three relapses which is frightening as the illness often becomes progressive.

    "My last relapse in August started as very severe dizziness, which slowly improved to being slightly dizzy/very light headed but it has not improved any further.

    "I can no longer go out of the house on my own, as I don't feel safe to, and am not able to drive which leaves me feeling very isolated. Nobody can do anything for me apart from treat the anxiety it causes."

    But a ray of hope came when she learned of pioneering MS surgery by an Italian doctor.

    Involving angioplasty to open a blocked vein, Mrs Barnett found it has been carried out overseas with "dramatic" results.

    She said: "This is not a procedure that is new to vascular surgeons as it is already being performed for many reasons - it's just new as a possible treatment for MS.

    "As it is not a proven treatment for MS, the UK is not prepared to carry out this simple operation on the NHS until it is proven. This could take years. It is being done in many other countries with amazing results.

    "I'm now campaigning to get the Scottish Parliament to push the NHS to do research into this with a view to starting treatment for all MS sufferers as soon as possible."

    As well as writing to local politicians, she has submitted a petition proposal to the parliament which will go online before being considered by the Public Petitions Committee.

    A stumbling block, however, are some MS charities which have not yet come out in support of the treatment.

    She said that after news broke about the treatment last year, the MS Society quickly stated it was not convinced by the evidence. And, she added, when a petition with more than 10,000 signatures calling for the procedure to be made available was handed into Downing Street, the Government's response was similar to the MS Society's statement.

    Mrs Barnett said: "For some reason the MS Society, which is a private charity and not in the public health domain, seem to be calling the shots with the Government and do not appear to be working in our best interests - it's nothing short of scandalous."

    Source: Highland News copyright 2010 Scottish Provincial Press Ltd.(14/05/10)

    MS patient blossoms, however, doctor rebuked

    CCSVI VenographA woman is crediting an experimental procedure performed at Victoria General Hospital for clearing up her multiple sclerosis symptoms, even if the treatment earned her doctor a professional rebuke.

    Kornelija Valentic, a 38-year-old mother of three from Surrey nearly disabled by MS, said all she hoped to get from a procedure last month to open the veins in her neck was an end to her constant headache.

    But, within 48 hours of the procedure, she was walking better, her vision improved, she recovered feeling in her hands and feet and regained control of her bladder -- and her headache was gone.

    "I wanted the headaches gone," said Valentic in a telephone interview. "My little bonus is being able to make it to the bathroom, being able to see, hand tremors that are gone -- and I can drink my coffee without spilling anything.

    "I wasn't expecting it. But you know what? I'll take it," said Valentic.

    But last week it was learned the Victoria radiologist who performed the procedure, along with one other, had been chastised by medical officials at Vancouver Island Health Authority for performing what's considered an experimental procedure outside of an approved trial.

    The treatment, known as "liberation procedure," has unleashed enormous pressure from MS patients and their supporters on doctors and health administrators ever since it was first reported in 2008 by Italian vascular surgeon Paolo Zamboni.

    Zamboni has theorized many of the symptoms associated with multiple sclerosis -- pain, crippling fatigue, blindness and progressive paralysis -- is the result of an iron buildup in the brain.

    Zamboni's liberation procedure uses angioplasty to clear blocked veins and increase circulation to the brain. A small balloon is inflated in the veins that carry blood away from the brain.

    The first reports turned medical scientific opinion about multiple sclerosis on its head. Traditionally, it is considered a disease where the body's immune system attacked the fatty, insulating coating on the nerves, called myelin, destroying the nerve's ability to transmit signals to and from the brain.

    Clinical trial of Zamboni's liberation procedures are now being fast-tracked across the world, including the University of B.C. and McMaster University in Hamilton, Ont.

    But patients who have been slowly losing their lives to MS are less than patient. They have been paying thousands of dollars to fly to Italy, Poland and, most recently, India, to obtain the procedure.

    Just last week, MS patients and their families demonstrated across Canada, at the House of Commons in Ottawa and the B.C. legislature for governments to start funding the procedure.

    Source: The Province © Copyright (c) The Province (13/05/10)

    The Essential Health Clinic Announces CCSVI Treatment Packages

    Essential Health Clinic Logo

    EHC have announced further information on the CCSVI Treatment Packages that will be available through The Essential Health Clinic in Scotland from July onwards.

    Full details are on their website at - The Essential Health Clinic Treatment Packages.

    Source: The Essential Health Clinic (13/05/10)

    MS patients rally for experimental treatment

    CCSVI ProtestCanadians with multiple sclerosis rallied across the country Wednesday to demand access to a controversial procedure not available in Canada or covered by provincial health insurance policies.

    The procedure, developed by Italian researcher Dr. Paolo Zamboni, involves angioplasty to help ease the flow in neck veins of blood from the brain to the heart. Zamboni believes narrowed or blocked veins force blood to move backwards or reflux back into the brain and spine, causing damage.

    He's termed the condition chronic cerebrospinal venous insufficiency, or CCSVI.

    Rallies were planned for Halifax, Ottawa, Toronto, Regina, Edmonton, Vancouver, Victoria and elsewhere.

    "With this kind of an illness, there isn't time for them to take three years to find out something," said Jennifer Noriega of Edmonton, a 38-year-old mother of two who has been living with MS for 11 years.

    Noriega, who can no longer walk, tried many different medications, including chemotherapy drugs, and now plans to travel to Bulgaria for the treatment.

    "The risk might be that it works and then three months later it doesn't work," Noriega said. "But at least I'll have those three months."

    More than 20 Canadians travelled to a clinic in Poland between February and April for the treatment.

    Many MS specialists say Zamboni's procedure is experimental at best and could be dangerous.

    Studies are underway to show how common CCSVI is in MS patients, those with other neurological conditions and healthy people, as well as to explore its potential role as a major risk factor in MS.

    But despite the specialists' hesitation, some Canadian patients are travelling overseas, paying for tests and surgery out of their own pocket. Others are lobbying for the Canadian health-care system to cover the diagnostic tests to look for blocked veins in people with MS.

    "I've been fixed," Steve Garvie, 53, told the crowd gathered at Queen's Park in Toronto. Garvie was one of five people who had the procedure at Royal Victoria Hospital in Barrie before the surgeon voluntarily stopped.

    "What they're doing is criminal," Garvie added in an interview. "Every person that wants the operation should have it." About 150 people gather at Queen's Park in Toronto to demand that multiple sclerosis patients get access to a controversial new surgical treatment. (Mike Crawley/CBC)

    "With any new treatment, whether it's drugs or technology, we need to ensure that it is thoroughly researched before it is approved for use," said Andy Weiler, a spokesperson for Alberta Health. "It needs to be an evidence-based decision that it is a safe and effective treatment."

    Likewise, Nova Scotia's Minister of Health, Maureen MacDonald, met with protest organizers in Halifax for about 30 minutes on Wednesday but was not swayed by their arguments.

    "We still don't know what the risks or the evidence are of the treatment," MacDonald said. "At this stage, it would be premature to have kind of a mass testing process for a treatment that is still unproven."

    MacDonald said no other province is funding this kind of testing or treatment for MS.

    Last month in Toronto, Zamboni and his collaborator, Dr. Robert Zivadinov, associate professor of neurology at State University of New York at Buffalo, cautioned people with multiple sclerosis to not rush to seek out the surgical procedure to unblock veins unless it was through official clinical studies

    Source: CBC News Copyright CBC/Radio-Canada (06/05/10)

    Canadian MS Society lobbies government for $10 million for funding into CCSVI and MS research

    CCSVI VenographThe Multiple Sclerosis Society of Canada is calling on the government to provide $10 million for research into chronic cerebrospinal venous insufficiency (CCSVI) and MS.

    The request for funding comes as Canadians with MS continue to seek diagnostics and treatment for CCSVI elsewhere, paying out-of-pocket for tests and experimental therapies that could be provided in Canada.

    "The safety and health of people living with MS is our primary concern," says Yves Savoie, president and CEO of the MS Society. "The Government of Canada can play a leadership role in addressing the needs of Canadians living with MS by funding research, including clinical trials in CCSVI and MS. Doing so will both advance research and provide safeguards to those seeking treatment."

    The Government of Canada has acted quickly in the past to respond to health crises with innovative research, such as its 2009 investment of $6 million to support research to find alternative medical isotopes.

    "The MS community has spoken. They want access to diagnostics and treatment for CCSVI in Canada," says Linda Lumsden, chair of the national board of directors for the MS Society. "The MS Society has already committed to funding CCSVI research and now we are calling on the Government of Canada to do its part."

    Tomorrow, Lumsden will formally ask Minister of Health Leona Aglukkaq for the funding. The MS Society proposes that the $10 million be appropriated to the budget of the Canadian Institutes of Health Research and earmarked for CCSVI research.

    MS Society representatives are in Ottawa for the next two days meeting with various Members of Parliament to advocate on key MS issues.

    "It is obvious that the relationship between CCSVI and MS requires further investigation," says Savoie. "This funding request will give researchers the tools to examine both the prevalence of this condition and the potential benefits of treating people with it."

    In late 2009 the MS Society of Canada announced a special research competition for CCSVI related studies. The results of this competition will be announced on June 14th, 2010.

    "I fully support the MS Society's efforts to lobby the government for research into CCSVI and MS," says Joan Ozirny, a volunteer board member with the MS Society's Alberta Division who lives with MS. "Increased research funding is the only way we'll get closer to unraveling this complicated disease."

    As part of its overall lobbying effort, the MS Society, in collaboration with other Canadian health charities, is calling on the federal government to increase overall funding to the CIHR annually to a level equivalent to 1% of total health spending in Canada. This amounts to $1.8 billion based on $183.1 billion in health care funding as of 2009.

    Source: PR Inside.com (c) 2010 Market Wire. (06/05/10)

    American MS Society fast-tracks research on chronic cerebrospinal venous insufficiency (CCSVI)

    CCSVI VenographThe National Multiple Sclerosis Society in the United States is assuming a leadership role in disseminating information and mobilizing research on the role of chronic cerebrospinal venous insufficiency in the etiology and treatment of multiple sclerosis. The move comes in response to mounting pressure from patients and the scientific community questioning the hypothesis.

    The society and the American Academy of Neurology jointly organized a 90-minute Web forum during the annual meeting of the AAN that was open to thousands of off-site patients, family members, researchers, and members of the press. The forum featured two of the investigators whose research on chronic cerebrospinal venous insufficiency (CCVI) has sparked so much interest. In addition, the society has implemented an expedited research program to see whether scientific results can be replicated and further avenues explored.

    “I know the MS Society shares the public’s sense of urgency in advancing any lead that may help us understand the cause, provide the cure, or change the course of MS,” said Dr. Aaron E. Miller, the society’s chief medical officer. Dr. Miller, who is also professor of neurology and director of the MS Center at the Mount Sinai School of Medicine, New York, participated in the forum.

    “The MS Society suggested holding a cosponsored educational Web forum on the CCSVI and MS because of the extent of misinformation and general confusion we were observing both on the Internet and in the media. We also felt the timing to be apropos because of the number of experts who would be [at the AAN meeting],” Arney Rosenblat, the society’s vice president of public affairs, said in an interview.

    More than 5,000 people were preregistered for the forum, and more than 1,000 questions were submitted.

    The speakers included Dr. Paolo Zamboni, director of the Vascular Diseases Center at the University of Ferrara, Italy, whose team was instrumental in hypothesizing a link between cerebrovascular insufficiency and MS.

    In June last year, he and his colleagues described evidence of slowed and obstructed drainage in cerebrospinal veins in 100% of patients with MS, a condition that they called CCSVI (J. Neurol. Neurosurg. Psychiatry 2009;80:392-9). They also suggested that blood flow is detoured around obstructions and that reversed blood flow might initiate the inflammation and immune-mediated brain damage characteristic of MS. The investigators had used advanced ultrasound techniques to evaluate blood outflow in 65 people with MS and in 235 controls who were either healthy or had other neurologic disorders.

    Later last year, in December, the group reported on the safety and preliminary outcomes of surgical intervention using percutaneous transluminal angioplasty in 35 patients with relapsing-remitting, secondary progressive and primary progressive MS (J. Vasc. Surg. 2009;50:1348-58). Some positive effects were described – significant reduction of relapses and active lesions, improved function and quality of life, and less fatigue – although a high rate of restenosis was reported. The group issued a call for larger, controlled trials.

    Dr. Robert Zivadinov, director of the Buffalo (N.Y.) Neuroimaging Analysis Center, was another featured speaker. He and his group are exploring the prevalence of venous obstruction in 1,700 children and adults with MS, healthy controls, autoimmune-vascular disorders, and other neurologic diseases using a combination of transcranial and extracranial venous Doppler methods.

    They released their preliminary results earlier this year, and Dr. Zivadinov unveiled the results of phase I of the Combined Transcranial and Extracranial Venous Doppler Evaluation Study during the forum. In these first 500 patients, 62.5% of MS patients met CCSVI diagnostic criteria, compared with 25.5% of healthy controls and 45.8% of those with other neurologic diseases. Although there was an increased likelihood that MS patients would meet the criteria for CCSVI (odds ratio, 4.85; P less than .001), compared with healthy controls, CCSVI seemed to be present in a proportion of healthy controls as well – in contradiction to Dr. Zamboni’s hypothesis.

    By late 2009, patients and their families began asking for more information about CCSVI as a possible cause of MS, and endovascular stent treatment as a possible cure. At Stanford (Calif.) University, vascular specialist Dr. Michael D. Dake embarked on a program to insert stents into the internal jugular veins of MS patients based on Dr. Zamboni’s reports – a program that was terminated in December because the procedure was deemed experimental. Complications included the death of one of Dr. Dake’s patients who had been on coumadin and a dislodged stent that required surgical removal in another patient.

    With research reports published in reputable medical publications and calls from patients for more information, the MS Society decided to take an active role in evaluating “this interesting hypothesis that needed to be further explored: whether there is an association between CCSVI and MS,” said Patricia A. O’Looney, Ph.D., the vice president of biomedical research for the society. She cited previous research programs in gender differences in MS, genetics, and myelin repair mechanisms, as examples of the society’s role in encouraging research in “underexplored” areas.

    On Dec. 16, 2009, the society invited researchers worldwide to submit applications for funding and proposals for further research on CCSVI in MS. The deadline for submissions was Feb. 9, and decisions are expected mid-June.

    In an interview, Dr. O’Looney declined to specify how much money has been allocated by the society. She said that she expects more than one project to be funded and that the hope is that definitive information about the CCSVI-MS association would be available within 2 years.

    “We felt that answering this question was critical before patients underwent interventional treatment, which carries its own risks,” Dr. O’Looney said.

    Source: MedConnect Copyright (c) 2009 Elsevier Global Medical News.(05/05/10)

    Essential Health Clinic CCSVI Waiting List


    CCSVI Treatment Packages Waiting List

    We are now pleased to give further information on the CCSVI Treatment Packages Waiting List which opens on Wednesday 5th May.

    We fully appreciate the problems some of our patients have experienced in trying to book CCSVI Scanning appointments and we have taken on board all the comments you have sent to us. We are a committed team and have dedicated considerable time and resources towards putting systems in place that will enable us to cope with the number of enquiries we have received (and continue to receive). We are putting the final details together for a range of Treatment Packages (including Scanning, Venogram, Liberation Treatment) and will be announcing these within the next 10 days. These will be designed to cope with the requirements of our patients; many of whom are traveling considerable distances to see us.

    "We believe that patient experience should be seamless from consultation and diagnosis through to treatment and surgery. Our priority is to give every patient the highest standard of care."

    If you are interested in having the CCSVI Treatment, we strongly recommend that you take a place on our waiting list as soon as possible (opening Wednesday 5th May). Deposits paid are fully refundable (see terms below). This not only gives you the peace of mind in knowing you have secured a place, but helps us with our forward planning for the next 12 months.
     
    Waiting List
    Anyone can apply to go on our waiting list. A deposit of £100 is required and this is fully refundable at any time prior to booking one of our treatment packages. This service opens on 5th May at 11.00 GMT (12.00 BST).

    Places will be reserved on our waiting list in the strict order in which we receive your deposit. Each month we will email those on our waiting list to advise them on the anticipated length of time before it is expected that they will receive an appointment.

    Once the next block of appointments is available they will be offered to those who have been on our waiting list the longest. These people will then be able to book their appointment online using a special code to deduct their deposit from the Treatment Package of their choice.

    Our Basic Treatment Package at £450 includes;

    CCSVI Screening Scan (up to 60 minutes) followed by a Consultation with one of our Doctors (up to 60 minutes). This will take place at our Glasgow clinic in Rutherglen on weekdays only.
     Extra option of Blood Testing package (Vitamin D, Omega-3, Nitrotyrosine) at an additional £125
    (both fees are fully refundable up to 30 days before CCSVI Screening Scan).
    Note: Our Treatment packages will only be offered to people on our waiting list and in strict rotation.

    Please note we can only accept waiting list applications via the website. We are unable to take orders/payment for the waiting list or Treatment Packages over the phone.

    Note: Waiting list places are not transferable

    Prior to the opening of the Waiting List
    If you choose to go on our waiting list, you will be asked to log into your online account with us. It is strongly recommended that you set this up prior to Wednesday as this will save you some time when obtaining your place on our Waiting list. To Register for your FREE account please click here. Once you have entered your basic details you will be taken into your account 'dashboard'. Under the heading 'Address Book', please click on the 'Edit Address' link and enter your address details. This is then recorded as your 'primary address'. Please also enter your telephone details. Once you click on the 'save address details' (bottom right of the screen) and your account will then be setup ready for booking on our Waiting List on Wednesday. All you will need to do is log into your account (by clicking on the Login button on the top right of our website).
    The Scottish Clinic we have partnered with for the Venogram and Liberation treatment is the ultimate, state of the art, 5-star healthcare facility based in Scotland. This clinic offers unparalleled access to leading consultants in serene, comfortable surroundings.

    London facilities are still being looked into but are not likely to be available until the start of 2011.

    Dr Tom Signature


    Click Here for Waiting List Page

    Legal fears thwart doctor's bid for ‘liberation' from MS pain

    CCSVI VenogramPaulette O’Leary already had an IV in her arm when the lawyers arrived.

    The 41-year-old Toronto doctor and mother of two had flown to Pennsylvania over the weekend to undergo a controversial “liberation” treatment she hoped would alleviate the symptoms of multiple sclerosis that have plagued her for 22 years.

    On Sunday night, she and her husband went out for dinner on the instructions of the doctor who would perform the surgery – he was so confident it would work, he had instructed her to celebrate.

    But on Monday, the same doctor, a vascular radiologist named Joseph Bonn, sat at her bedside at Lankenau Hospital outside Philadelphia and informed her that he had just been ordered by lawyers to cancel her procedure, as well as those of countless other MS patients who had booked his surgery time solid through to October.

    “I was in shock, because I was so pumped up,” Dr. O’Leary said Wednesday before flying back to Toronto. “It’s going to be awful when I arrive back at the airport because my daughter’s expecting me to run to her, and she’s going to see me still walking with a cane.”

    Dr. O’Leary, a researcher with the University Health Network in Toronto, had paid $18,000 (U.S.) to be just the fifth MS patient, and first Canadian, to be treated by Dr. Bonn.

    Since an Italian vascular surgeon named Paolo Zamboni released a study suggesting MS was connected to Chronic Cerebrospinal Venous Insufficiency (CCSVI), patients in Canada and around the world have been desperately seeking out doctors who will perform procedures to unblock their veins.

    But in the U.S., hospitals are beginning to ban the procedures for MS patients until more research is done, as fears of legal liabilities surface. Dr. O’Leary and others in the MS community worry that this reluctance will force the treatment underground, with people lying about why they need an angioplasty or paying large amounts to receive the treatment overseas.

    “People are willing to mortgage their houses for this,” Dr. O’Leary said.

    A statement released by Lankenau on Wednesday said that while CCSVI “may offer a breakthrough” in the treatment of MS, the hospital is suspending the unblocking treatments until they are approved by its Institutional Review Board.

    In December, Stanford University in California also ordered vascular specialist Michael Dake to stop performing a procedure to open the veins of MS patients. Although many of his patients reported improvements in their symptoms, one woman died of a brain hemorrhage on the way home from the treatment, and another patient required surgery after the stent installed to open his jugular vein broke free and floated into his heart.

    Since then, other U.S. doctors who had been quietly performing the procedure – their names spread swiftly by online MS support groups – have been ordered to stop by their legal departments.

    In New Jersey, Steven Sclafani was told to cancel all appointments for MS patients, even though he was performing a balloon angioplasty that is commonly used to treat other congenital vein abnormalities, and was not using stents.

    “I believe that our IRB understands the importance of this treatment and will not unduly delay their review,” Dr. Sclafani wrote on a message board for MS patients.

    Denise Graff, a 43-year-old from New Brunswick, N.J., was on Dr. Sclafani’s waiting list when his procedures were shut down, and quickly found Dr. Bonn. Last Tuesday, she became his third MS patient to have her veins surgically unblocked. Diagnosed with MS in 1999, she said she felt an immediate change.

    “I felt energetic,” she said. “The fatigue I had is beyond any tired you’ve ever known. It’s somebody sucking the life out of you. It was gone and I have not felt it since.”

    But not everyone is convinced. Some critics say such anecdotal reports are the result of a placebo effect.

    Ian Rodger, vice-president of research at McMaster University, St. Joseph's Healthcare, said Dr. Zamboni has simply raised a hypothesis that must now be proved by the research community, something that will take time.

    But he understands some MS patients might not be willing to wait. “If I were in their situation, I might well feel the same way,” Dr. Rodger said.

    The relative safeness of the procedure is what led Dr. O’Leary to seek out Dr. Bonn, whom she learned of through a Toronto colleague. “They’re saying it’s not tested, but it’s an angioplasty,” she said.

    Dr. O’Leary has learned to live with her disease, but said she needs to try the new procedure, even if it doesn’t work. It would not be the first time she’s made a difficult and controversial decision regarding the illness.

    She gave birth to her two daughters, now four years old and eight months, since her diagnosis. In the last trimester of her second pregnancy, she became temporarily paralyzed from the waist down. To manage her symptoms, she is also taking Tysabri, a drug that has been linked to the development of brain disease.

    She is considering a trip to Bulgaria, where an angioplasty appointment will cost her just $8,000, but has been promised by Dr. Bonn that she’ll be his first patient once the procedure is approved.

    As a doctor, she understands the introduction of novel medical treatments requires precaution and due diligence, but she thinks hospitals could move faster to approve what is already established as a relatively safe procedure.

    “I do believe in this liberation procedure, I don’t know how it could get much safer,” she said. “But they’ll have crossed all their t’s and dotted all their i’s. And I have to agree with that.”

    Source: The Globe And Mail © Copyright 2010 CTVglobemedia Publishing Inc.(29/04/10)

    Networking power of the web shifting power balance between doctors and patients

    The InternetRebecca Cooney may have a debilitating, degenerative disease, but that doesn't mean she's ready to automatically defer to the authority of the medical community.

    "I've never been a person who thinks somebody else can make decisions for me. Even my doctors - they're the experts, I take what they say, but I have my own mind and my own information," says Cooney, 42, who has been living with multiple sclerosis for the past 18 years.

    "I'm not one that believes the Pope is the only one who can speak to God. I can speak to God myself."

    There have always been patients with Cooney's independent bent. But these days there seems to be hordes of them, due in large measure to the extraordinary reach of the Internet.

    A technology that makes a pioneering or profiteering clinic somewhere overseas a mere Google search away, the Internet is changing the nature of patient advocacy. It's amping up the activism.

    And those more activist patients, who share information and strategies through email, discussion boards and Facebook, are actually in some cases altering the research agenda in fields such as cancer, alternative medicine and now multiple sclerosis.

    Some want access to experimental drugs or therapies before science has proven that they are safe or useful. In other cases, they are agitating for a say in which theories, techniques or treatments get research funding.

    Patients like Cooney are thrilled about what she describes as the huge power shift she has seen in the years since she was first diagnosed.

    "The Internet - email - has really allowed me and most of the MS patients to really work in conjunction with the doctors, which we've never been able to do," she says.

    "It used to be almost what your neurologist said or what your doctor said was God. You couldn't really debate it. You couldn't say anything. Because you didn't know."

    "Now, I'm empowered. I can find out information."

    Other players are not so enthusiastic, saying the change is fostering tension within disease advocacy organizations and between doctors and their patients.

    Such is the case with multiple sclerosis, where the patient community is aflame with hope about a new and as-yet unproven claim by Dr. Paolo Zamboni that clogged neck veins may be triggering the disease or contributing to the destruction it wreaks. The condition has been dubbed chronic cerebrospinal venous insufficiency or CCSVI.

    Individually, a number of MS patients have already flown to clinics in places like Poland to undergo a vein opening operation that has been given the hope-inspiring name "the liberation procedure."

    Collectively many MS patients are pushing the MS Society of Canada and the National Multiple Sclerosis Society in the U.S. to fast-track funding for CCSVI research.

    The societies have jointly issued a special call for research proposals and will review them next month. The first funding awards are due to be announced in June. Donors - the societies get the bulk of their funding from the patient community - are even being allowed to earmark donations specifically to CCSVI work.

    Dr. Aaron Miller is a neurologist and head of the MS clinic at New York's Mount Sinai Medical Center. As the chief medical officer of the National Multiple Sclerosis Society, he tries to keep an open mind towards new claims about MS, noting that there are times when ideas from out of left field propel scientific advances.

    He points to the example of stomach ulcers, which were long thought to be the product of stress. Then Barry Marshall and Robin Warren, two Australian researchers, proved they are caused by a bacterium, Helicobacter pylori and are treatable with antibiotics.

    Marshall and Warren won the 2005 Nobel Prize for Medicine. Still, those kinds of paradigm shifting successes aren't everyday occurrences. Miller suspects CCSVI isn't going to join that list but he fears that answer won't be arrived at quickly or cheaply.

    "We know that research dollars are extremely scarce, especially these days. And when you have to divert large sums of money to investigate something that's probably going to be barking up the wrong tree, it certainly is distressing," Miller says.

    He points out that the MS community has seen other provocative claims in the past, prior to the Internet's emergence as a communications tool for the masses. In the early 1990s, for instance, the TV newsmagazine "60 Minutes" aired a piece advancing the notion dental amalgam might be the cause of MS. Patients flocked to dentists to have old-fashioned fillings removed.

    "But the pace at which this happens now and the numbers of people to whom these stories and the information reaches is astronomical compared to what it once was," says Miller, who notes that Internet counselling has become a part of his routine interactions with patients.

    "It's a real challenge in how to interact with patients on issues like this," he admits.

    The scenario is unfolding in other subspecialties of medicine too.

    Dr. Maurie Markman, vice-president for clinical research at the University of Texas M.D. Anderson Cancer Center, says the advocacy community has long been vocal in cancer care and research.

    Some bristle when they are told putative treatments need to be tested in staged clinical trials, he says.

    "Online, the New England Journal of Medicine has no more authority than Mr. Smith's or Mrs. Smith's website telling you that 'Here's the cure for cancer,"' Markman says.

    He explains the kind of pushback those insisting on proper trials sometimes encounter: "Five thousand people who are online say it's correct. So who are you ... Dr. Scientist, to tell me I'm wrong?"

    What's the answer? "It's not confrontation," Markman continues. "It's discussion and an awful lot more effort to explain."

    Still, a confrontational dynamic can emerge.

    The hesitancy of MS specialists towards CCSVI has frustrated and angered some patients. Some doctors who are viewed as impeding access to the treatment have received abusive hate mail. People on both sides of the divide say the situation has given rise to an us-versus-them mentality.

    "I do think the Internet has created an us-and-them thing," admits Cooney, who has co-founded a group called MS Liberation that is lobbying for the procedure to be available in Canada.

    "I don't like it. I wish it would stop. But ... I don't think it will until both people (parties) acknowledge that the playing field has changed."

    "I think the patients are not giving the neurologists and the doctors the time to really learn about this and to investigate it properly. But I also think the neurologists don't acknowledge that it's a different ball game."

    "They're used to holding back information from the patients. And what's happening is they can't do that anymore."

    [email protected] AOL News © 2010 AOL Canada Inc All Rights Reserved. (27/04/10)

    Latest from the Essential Health Clinic on CCSVI Testing and Treatment

    Essential Health Clinic Logo

    CCSVI Appointments Update

    We anticipate being able to release information to you next week with full details of the treatment plans we will have available in Scotland.

    We are aware that you are keen for news on our CCSVI treatment plans and are now very pleased to tell you we expect everything to be in place for us to offer the liberation treatment in Scotland and from as early as August. Our final complete package(s) will be released to you as an E-brochure next week.

    A number of you are the first people to register with us for a Screening appointment in July/August and we realise that you are eager to know what happens if it is felt that you need to move onto the venogram and Liberation process. This will be in our E-brochure and will include full costings and information on our follow-up support. The final costings are almost complete and we just ask you to bear with us so we can announce everything in its entirety.

    As many of you will know, we are the organisers of The 2nd European LDN conference which is being held in Glasgow this coming weekend. The inclusion in the conference for the first time of CCSVI has generated a lot of additional interest. More information can be found at www.bigonLDN2010.com. The closure of European airspace has created many challenges and caused a lot of extra work for us, but we can assure you that we have team members still working on the CCSVI package(s) and the conference will not delay us in releasing the additional information as soon as we have it.

    Dr Tom Signature


    Waiting List?

    We anticipate being able to offer an online waiting list system for CCSVI Scanning, very soon. This will be announced through this Newsletter system. This will be for new patients and it will be followed, soon after, by the release of further Scanning appointments available in September. Please DO NOT phone the clinic for any other information on CCSVI as we have no other information that we can give at the moment.

    Venous abnormalities and multiple sclerosis: another breakthrough claim?

    CCSVI VenogramRecent reports of a possible link between venous abnormalities and multiple sclerosis have been associated with high levels of media hype. Many experts caution against premature promotion of the hypothesis and call for objectivity and scepticism in follow-up studies. Jane Qiu reports.

    Poor judgment in medicine can lead to interventions with fatal consequences. Lives should not be lost before these interventions are halted, but they often are. In August, 2009, a patient with multiple sclerosis (MS) had two stents inserted into her right jugular vein; she died shortly afterwards of a brain haemorrhage while on the anticoagulant warfarin as a result of the procedure. 3 months later, another patient with MS had to have open-heart surgery to remove a jugular-vein stent that had come loose and moved into the right ventricle.

    In December, 2009, Michael Dake, chief of interventional radiology at Stanford Medical Centre (CA, USA), who inserted stents in both patients as a way to treat MS, told his colleagues and patients that no further endovascular procedures would be done for the assessment or management of extracranial venous obstruction in any patients, with or without a diagnosis of MS, until clinical protocols were approved. The decision was made after “deep soul-searching”, said Dake in an email to his colleagues.

    Dake is among the investigators who believe that venous stricture is a cause of MS and that endovascular procedures, such as balloon angioplasty or stent placement to widen the vein, could alleviate some of the symptoms. But the hypothesis is yet to be proven, let alone the safety and efficacy of the intervention. Many experts, such as Alasdair Coles, a neurologist at the University of Cambridge, UK, are openly critical that Dake subjected his patients to a grave risk without any evidence that the procedure would help to treat MS.
    For a long time, neurologists have noted that some patients with MS have venous abnormalities in the brain. But it took many experts by surprise when Paulo Zamboni, a vascular surgeon at the University of Ferrara, Italy, and his colleagues reported that almost every one of the 65 patients with MS who they had examined with doppler ultrasound and venograms showed venous stricture in the jugular or azygous veins.

    They also noted that different forms of MS were associated with different patterns of venous abnormality and, on the basis of ultrasound results, named the condition chronic cerebrospinal venous insufficiency (CCSVI). Such abnormalities were absent in the 235 control individuals, including healthy controls and patients with other neurological diseases.

    The researchers suggested that venous stricture could lead to hypoxia and a breakdown of the blood—brain barrier, causing red-blood cell and fluid leakage into brain and spine tissues; as a result, iron and plasma from the blood that accumulate in the CNS over time might break the immune tolerance and set off a cascade of immune responses.

    The team then reported an open-label prospective study of 65 patients with MS—35 relapsing-remitting, ten primary progressive, and 20 secondary progressive—who had undergone angioplasty to widen the veins. The researchers found that the procedure had “a minor and negligible complication rate” and, despite the fact that the study was neither blinded nor controlled, concluded that the treatment “significantly improved MS clinical outcome measures, especially in the [relapsing-remitting] group”.

    Some neurologists think that the CCSVI hypothesis has weight. “The autoimmune hypothesis doesn't explain everything about MS, especially the neurodegeneration aspect of the disease, which has been increasingly noted in the past few years”, says Bianca Weinstock-Guttman, a neurologist at the University at Buffalo (NY, USA). For years, Weinstock-Guttman and other research groups have noted iron deposits around injury sites in the brain; the amount of iron deposits as measured by MRI seems to be associated with MS disease progression.

    Others, however, are unconvinced. “The sensitivity and specificity of Zamboni's ultrasound tests are so high that they are hardly believable”, says Richard Rudick, director of the Mellen Centre for MS at the Cleveland Clinic Foundation (OH, USA). Similarly, Coles finds it “extremely surprising that Zamboni could distinguish different types of MS based on different patterns of venous abnormality”.

    Experts are adamant that the observation needs to be confirmed by independent research groups and the underlying physiology and CCSVI better defined using modalities other than ultrasound. However, a recent study (as yet unpublished) by Robert Zivadinov, also at Buffalo, seems to have led to more confusion than assurance.
    The team examined the venous system of 500 people, including 161 healthy controls, 280 patients with MS, mostly the relapsing-remitting form, as well as patients with other neurological disorders, and found that 56% of patients with MS and 22% of healthy controls showed narrowing of the extracranial veins. Furthermore, the more serious the disease was, the more venous abnormalities there were.
    Many note that the prevalence of venous abnormalities in Zivadinov's study is much lower than that reported by Zamboni, and wonder what the real association is. Zivadinov says that his study might have been “better blinded”, which might have removed some levels of subjectivity during ultrasound scanning. “All patients walked in [to the ultrasound test room] with a walking stick, so the technician wouldn't know which subjects had MS or other neurological disease”, says Zivadinov.

    Zamboni's team also used a more sensitive ultrasound machine, which might explain the much higher prevalence of CCSVI among patients with MS in their study, says Zivadinov. This, however, does not explain why Zamboni's more sensitive machine did not pick up any venous abnormalities in the control individuals, whereas the Buffalo team found that 22% of healthy control individuals had CCSVI.

    “What all these are telling us is that we really don't know where we are at the moment in terms CCSVI and MS”, says Rudick. Even if there is an association, many suspect that venous abnormalities are likely to be part of the overall pathology of MS, rather than a cause of it. “The brain of patients with MS is a diseased organ: you get all sorts of abnormalities there and it would be almost impossible to imagine that the venous physiology would be normal”, says Rudick. “There are well known syndromes of venous occlusion where you don't get the kind of self-perpetuating autoimmune responses you see in MS.”

    Many experts think that Zamboni's open-label study falls short of the standards and quality that are acceptable in clinical research. “The study is not blinded and is uncontrolled”, says Coles. Indeed, the study didn't include patients with MS with CCSVI who didn't undergo angioplasty, and those who had the surgery were also on other treatments for MS. Therefore, their findings “are totally uninterpretable in terms of efficacy”, he says.

    There is also widespread criticism of the media hype associated with the CCSVI hypothesis, which has been partly promoted by some of the investigators and has caused a whirlwind of exaggerated claims and expectations. For example, there is a CCSVI page on Facebook; a newsletter dedicated to the syndrome is sent to thousands of patients with MS by Zivadinov's team; and, according to a press release about a meeting in Bologna, Italy, in which Zamboni presented his studies, “endovascular therapy showed a decrease in the number of disease relapses, a marked reduction in the number of active brain and spinal lesions, and also a clear-cut improvement in the patients' quality of life”.

    The premature promotion of the CCSVI hypothesis has led to a situation in which many patients with MS seek venous testing and, if the result turns out to be abnormal, endovascular interventions. “Patients are desperate for help, and the media and some of the investigators have played into that desperation in pushing forward this hypothesis”, says Rudick.

    MS societies on both sides of the Atlantic are cautious of the CCSVI hypothesis. While acknowledging that it is “an interesting avenue of research”, Doug Brown, biomedical research manager at the MS Society in the UK, stresses that “the evidence isn't there at the moment to back up some of the bold claims that CCSVI is a cause of MS or that the treatment of CCSVI will cure MS”. He adds: “We would absolutely recommend against seeking so-called treatment of CCSVI because there is no evidence that this would benefit people with MS.”

    Patricia O'Looney, vice president of biomedical research at the National MS Society in the USA agrees: “It's important that this possible association [between CCSVI and MS] is fully evaluated by others.” The society has made a special call for research proposals around the world to look into this issue. Rudick, who chairs the advisory committee of its research programme, says that the priority at the moment is to establish an association, rather than to fund a clinical trial.

    Meanwhile, venous testing and surgical procedures for CCSVI “should be undertaken only as part of formal clinical trials that include all of the standard safeguards”, says O'Looney. Critics are adamant that clinical trials have to be undertaken with considerable objectivity and scepticism. “For clinical research to be valid, there needs to be equipoise on the part of the investigators who have no personal interest in what the outcome is”, says Rudick. “There should be real uncertainty in terms of research findings.”

    “We have to guard against therapeutic misconception”, says Judy Illes, an ethicist at the University of British Columbia (BC, Canada). “Patients mustn't get into a trial thinking that they would benefit from it. That's the fundamental nature of clinical research and informed consent, especially when it comes to early trials.”

    As for the CCSVI hypothesis, experts like Rudick would rather take it with a pinch of salt. “Over the years, we have seen all sorts of claimed breakthroughs that have come and gone in the field of MS”, he says. “We are yet to see whether this is one of them.”

    Source: The Lancet © 2010 Elsevier Limited. (21/04/10)

    CCSVI Debate on Alberta Primetime - Dr Simka's Response

    CCSVI VenographyLast week, Alberta Prime Time had a debate between Alberta Neurologist Brad Stewart and False Creek Surgical Center's Clinic Director, Mark Godley.

    Dr. Marian Simka, who has treated around 250 patients for CCSVI in his clinic in Poland, has responded to this debate as follows:

    Dr. Stewart emphasized that published results from Italy (Zamboni's initial study) show that many patients do not improve after the surgery. These are real facts. But in going into the details of this article we will find that early stage patients (relapsing-remitting), in general, improve. Progressive patients stabilize (that is not bad, but not as good as an improvement). The issue of chronic fatigue was not discussed, yet - it is perhaps not necessary to point how important this problem is for the patients. Anyway, knowing that the earlier that venous obstacles are removed, the better the result, an approach of "just wait for more evidence, unless there is no option for you" makes no sense. On the contrary, the treatments should be performed immediately after the first symptoms appear.

    And now I am going to Dr. Godley's statement. In short, "Forget MS, is is vascular problem. MS should be managed by neurologists, while narrowing of blood vessels belong to vascular surgeons". You know, being a surgeon, I would never discuss a doseage of neurologic drugs, for example. So, why are the neurologists discussing which type of surgery should or should not be performed? Have they ever held a lancet?

    The whole discussion about stent migration is ridiculous. All are saying: "Don't perform stenting because of the risk of migration". Nobody is discusing: "How to perform the procedure to avoid this complication". In Poland, we have spent hours discussing this issue. And it is only a technical problem that CAN be solved and HAS been solved. It is the problem of proper preop diagnostics, proper intraop tactics and proper choice of the stent. The stent should be tailored to the vein. And such a stent CANNOT migrate. And if you cannot tailor the stent, or stenting is just not necessary - you simply perform ballooning. But Zamboni's statistics show that in 50% of the patients ballooning is not enough. Consequently, either you will require repetitive balloon angioplasty (most likely not very successful), or you will have progression of MS.  Or - you should use stent. (In Latin: Aut, aut, tertium non datur)

    What about safety. In our department we have already performed ~250 procedures, in over 100 patients we have applied stents. Serious complications: ZERO. Yet, in some patients, anticipating potential risks, only balloon angioplasty was done.

    Another problem. Many doctors say: "We should establish the actual link between MS and CCSVI, and having these data we can perform treatments". Is such an approach correct? No !

    Imagine, after some 3-5 years we have those data. They will be, most likely (I am nearly sure, since I already have the results), somewhere in between Zamboni's and Zivadinov's findings: ~90% MS patients and ~10-20% healthy people will have CCSVI. Another association, like EB virus, Actually, no argument for surgery.

    And now forget MS. You have compromised blood flow in the most important organ of human's body (tens of articles on that, only an explanation was missing). This disturbed blood flow is manifested by many symptoms, not even mentioned in the criteria for MS, like: fatigue, "brainfog", headaches, etc. It has been already demonstrated in Zamboni's study that these symptoms dramatically improve after restoring the proper blood flow (anyway, it seems logical, but if anyone were asking for data - here they are).

    Unblocking obstructed veins is rather a simple procedure and a safe procedure (much safer than leaving those "diabolic" strictures). The real problem actually is: how to perform preop diagnosis (Zamboni's protocol is very far from ideal). What about other test (we are very proud of our MRV protocol (some images are at: http://www.ccsvimri.blogspot.com). Which endovascular equipment should be used (a very technical problem, but can be solved). What about postop medication (we know that oral anticoagulants are not a good option, but what about other drugs?). Those are real topic for clinical trials.

    In Poland we say: Dogs are barking, but they will not stop the caravan."

    Source: For Greet (19/04/10)

    MS doctor says patients don't have time to wait

    Dr ZamboniThe Italian doctor behind the theory that multiple sclerosis is a vascular disease says patients with no other option should get the treatment now instead of waiting for proof it works.

    "They do not have time," said vascular surgeon Dr. Paolo Zamboni in an interview yesterday with The Spectator.

    "I can totally understand the desperation of people without treatment that day by day are worsening."

    He's urging governments to provide and fund, on compassionate grounds, the treatment called the liberation procedure. It involves inserting balloon catheters to open up malformed or blocked veins in the neck, which Zamboni believes plays a significant role in MS.

    He says too many patients -- particularly from Canada -- are travelling abroad to get the procedure. He's had 56,000 MS patients worldwide, including thousands from Canada, contact him about getting tested or treated.

    "I recommend to treat these patients in their home country," he said.

    "Canada... is in the perfect position to offer to their patients this treatment."

    Zamboni says it's "safe and cheaper" for patients who are rapidly declining, have tried all drugs treatments available and have no other options.

    In contrast, he recommends MS patients who are not getting worse and have other treatments available should wait for more evidence before getting the procedure.

    But the Ontario government considers the treatment to be "experimental" and won't fund it for anyone without more evidence that it works, says Ministry of Health spokesperson Andrew Morrison.

    There are also no doctors in Canada providing the liberation procedure to MS patients.

    Doctors and researchers overwhelmingly recommend patients wait for more evidence that malformed veins play a role in MS and that the treatment works.

    Hamilton researchers are embarking on a study to test Zamboni's theory called Chronic Cerebrospinal Venous Insufficiency (CCSVI) that so far has been primarily funded by MS patients themselves.

    The study, which will use MRI scans and ultrasound to compare the veins in the head of 100 MS patients with varying degrees of illness to 100 similar healthy people, needs at least $400,000 to get off the ground.

    Zamboni says patients and their families shouldn't have to pay for the research themselves considering the promise his theory holds to revolutionize the treatment of MS, which until now was thought to be an autoimmune condition.

    He believes research dollars should be freed up to test his theory.

    So far only the Multiple Sclerosis Society of Canada -- after being pressured by patients -- has offered funding in Ontario and it's limited to $200,000 over two years.

    "We need really to investigate CCSVI," Zamboni said. "It is irresponsible to not fund completely this kind of research."

    Source: TheSpec.com © Copyright Metroland 2010 (16/04/10)

    Doctors who believe MS linked to damaged veins urge more testing

    Dr ZamboniThe researchers behind a controversial theory that multiple sclerosis may be cured with simple surgery are now urging patients demanding immediate access to the treatment to wait until it is properly tested.

    Doctors who are already offering to perform the procedure are acting irresponsibly and may risk harming patients, the researchers said during a forum at a major neurology conference n Toronto this week.

    It is a cautious message coming from Paolo Zamboni and Robert Zivadinov, two researchers who helped propel the notion that MS is linked to blocked blood vessels leading from the brain, rather than the conventional thinking that it is an autoimmune condition. But it illustrates how little scientific research examining the theory has been done – and how many important questions remain unanswered.

    “I think that the steps should be respected of scientific research,” said Dr. Zivadinov, associate professor of neurology at the University of Buffalo who is conducting research on the new theory, which was developed by Dr. Zamboni. “We need to first find whether something is safe, then whether it might be effective.”

    But some members of the medical community say unjustified risks have already been run as MS patients around the world invest their money and fly to foreign destinations in hopes the unproven treatment will eliminate their often-debilitating symptoms.

    “We’ve seen over and over again in the history of medicine claims for other surgical procedures, other kinds of interventions that come out with great hype and then, if they’re ever studied adequately, turn out not to be valid,” said Aaron Miller, who was part of Wednesday’s panel. He is professor of neurology and director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at New York’s Mount Sinai School of Medicine.

    At the heart of the debate is a theory developed by Dr. Zamboni, director of the Vascular Diseases Center at the University of Ferrara in Italy. He believes multiple sclerosis is a vascular condition caused by blocked or malformed veins responsible for draining blood from the brain, and that it can be treated with surgery to reopen the veins. After news of his research was published, patients flooded doctors offices with phone calls and some have travelled to such countries as Poland to get the controversial treatment.

    Research conducted by Dr. Zamboni and published last year showed that nearly three-quarters of a group of 65 patients had no MS symptoms two years after they had surgery to repair the brain drainage problem.

    However, critics say the study had serious limitations, such as the fact that results may have been biased because patients and doctors knew what the treatment was designed to do.

    Another major issue is the fact that Dr. Zivadinov, who is also the director of the Buffalo Neuroimaging Analysis Center, wasn’t able to identify a vein problem in nearly half of the 500 MS patients involved in a study he is conducting. Furthermore, 22 per cent of the healthy control group involved in the study had the vein blockage problem.

    Some members of the medical community say those kinds of facts cast doubt on Dr. Zamboni’s research. They also say it’s impossible at this stage to judge whether the vein drainage problem triggers MS, contributes to its progress, or is simply a secondary issue common to some people with the disorder.

    “I think that a lot of people aren’t getting the full picture,” said Katherine Knox, director of the MS clinic at Saskatoon City Hospital. “We have to be very careful that we don’t conclude that association equals causation.… We cannot make those conclusions at this time.”

    Dr. Knox is planning a study to determine whether the vein problem is present in people with symptoms of MS, as well as those at high risk of developing the disorder.

    But Dr. Zamboni says his research clearly shows there is a link between vein blockage or malformation and multiple sclerosis. Now, it’s up to researchers to determine the extent of the link, how it might be related to the progression or onset of MS, and whether it’s associated with other neurodegenerative diseases.

    Source: The Globe & Mail © Copyright 2010 CTVglobemedia Publishing Inc. (15/04/10)

    A live Web forum on CCSVI and what it could mean to people living with MS

    AAN LogoOn 14th April the American Academy of Neurology, in partnership with the US National Multiple Sclerosis Society hosted a live web forum with regards to CCSVI and Multiple Sclerosis.

    Those taking part included: 

    Dr. Paolo Zamboni, Director, Vascular Diseases Center, University of Ferrara, Italy
    Dr. Robert Zivadinov, Associate Professor of Neurology, University of Buffalo, State University of NY
    Dr. Andrew Common, Radiologist in Chief, St. Michaels Hospital, University of Toronto, Ontario, CA
    Dr. Aaron Miller, Professor of Neurology & Director of the MS Center at Mount Sinai, NY, member of the AAN Board of Directors, Chief Medical Officer of the National MS Society

    You can watch the whole meeting here. (15/04/10)

    AAN: Caution urged in stenting veins in MS patients

    CCSVI VenographInvasive procedures designed to correct venous blood flow in multiple sclerosis patients should not be performed until clinical trials can prove that the treatment is safe and effective, physicians here suggested.

    John Corboy, MD, professor of neurology at the University of Colorado School of Medicine, Denver, reviewed studies performed by Paolo Zamboni, MD, professor of vascular surgery at the University of Ferrara in Italy. Zamboni has been the leading investigator into the possibility that chronic venous insufficiency could be a causative problem in multiple sclerosis.

    "The logic for this is based on the fact that multiple sclerosis plaques are perivenular and that multiple sclerosis and chronic venous insufficiency share several features," Corboy said at the annual meeting of the American Academy of Neurology. Among those features are the expression of adhesion molecules, hyperactivation of matrix metalloproteinases, macrophage and T-cell infiltration, and iron deposition in the location of the lesion.

    In the first paper in 2007 (Curr Neurovas Res 2007; 4(4): 252-58) Zamboni and colleagues found significantly increased bidirectional flow and/or reflux in deep middle cerebral veins and the transverse sinus in 89 multiple sclerosis patients compared with 60 controls, Corboy noted.

    In an expanded study published in 2009 (J Neurol Neurosurg Psych 2009; 80(4): 392-99), the researchers looked at extracranial flow in the jugular and vertebral veins among 65 multiple sclerosis patients and 235 controls. They noted abnormalities in the blood flow in the multiple sclerosis patients and performed balloon angioplasties in those 65 patients, Corboy said.

    That study found what the researchers termed a "dramatic" association between multiple sclerosis and venous abnormalities, with an odds ratio of 43 (95% CI 29 to 65, P=0.0001).

    "After the procedure there was a small drop -- and I would emphasize small drop -- in the pressure gradient of about 2 to 3 cm of water," Corboy said. "They did report statistically significant reductions in relapse rate, an increase in the number of patients who were free from relapse after 18 months, a reduction in magnetic resonance imaging gadolinium enhancing lesions, and improvements in quality of life. In this uncontrolled fashion it was perceived that these were improvements for the patients." In an uncontrolled study these are likely to reflect regression to the mean -- a phenomenon frequently observed in the placebo arms of MS clinical trials.

    He also noted that a study from the University at Buffalo, according to the institution's press release, described similar numbers when comparing 280 multiple sclerosis patients and 161 controls.

    However, Corboy suggested several limitations of the studies, including difficulty in replication of the work and the unblinded nature of the trial. "When I showed this information to our pathologists they said, 'Wow. A couple of centimeters of water . . . that's nothing. Who would ever notice that?' There is no pathological or MRI correlation. We need controlled trials to see true effects of stenting."

    Corboy said doctors who began treating chronic venous insufficiency at Stanford University, in Stanford, Calif., have halted their work following two devastating adverse events. In one case, a patient was stented, put on warfarin to prevent stent-related thrombosis, and then developed a fatal intracranial hemorrhage. In a second case, the stent mobilized and became lodged in the right atrium of the heart, requiring cardiac procedures to remove it.

    Corboy acknowledged that the reports from Italian investigators have already gotten interest from multiple sclerosis patients but said that while early studies indicate there may be improvement in blood flow, the risks of the procedure may be too great to proceed without completing major, controlled clinical trials.

    "Many of you are quite aware of this work and have been getting many phone calls from angiographers and other people about this procedure," Corboy said in his lecture updating developments in multiple sclerosis -- part of an all-day clinical review of neurologic developments. "I would not recommend it until we had a much better idea whether this approach has any merit whatsoever."

    Lily Jung, MD, medical director of the Neurology Clinic and chief of neurology at Swedish Medical Center, Seattle, concurred with Corboy: "It is absolutely too early to recommend this procedure. There are a lot of methodological issues with the studies, and until those have been standardized in a randomized, double-blinded study and found to be effective, it is unreasonable to suggest that this procedure is ready for prime time."

    She told MedPage Today, "There are reputable centers that are now beginning to look at the first step, which [is] identifying whether, in fact, multiple sclerosis patients have the finding suggested by Dr. Zamboni to be present. It is then another big leap to decide whether the procedure can be safely performed in humans. [And that is] before even going to full-blown clinical trials."

    Corboy disclosed financial relationships with Orasi, Novartis, Lilly, Peptimmune and Genentech. Jung reported no financial disclosures.

    Primary source: American Academy of Neurology
    Source reference: "2FC.002 Neurology Update I, April 11, 2010" AAN 2010; pp. 100-102.

    Source: MedPage Today © 2004-2010 MedPage Today, LLC. (13/04/10)

    CCSVI: Why Multiple Sclerosis patients aren't waiting for proof

    CCSVI VenogramA fascinating medical drama is unfolding on the Internet among patients and scientists – who are struggling to study a new theory and experimental treatment for multiple sclerosis.

    W5 caused a huge stir among MS patients last November, when it broadcast a report about the new theory, which suggested that blocked veins in the neck and chest could be contributing to the disease.

    Since then, patients have scrambled to learn more about the theory, promoted by Italy's Dr. Paolo Zamboni.

    Zamboni believes that malformed veins cause blood from their brain to drain improperly, sending it back to their brain, and potentially setting off the immune response that marks MS.

    In a preliminary study published last November, Zamboni found that opening these veins with a balloon improved MS symptoms and reduced new attacks. He dubbed the procedure the Liberation Treatment.

    With many of Zamboni's patients reporting relief from some of their MS symptoms (for as long as the veins remain opened), MS patients from all over the world have been rushing to find someone willing to offer them the experimental treatment.

    One of them was Steve Garvie.

    He was diagnosed 10 years ago with secondary progressive MS. The disease left him using a walker most of the time, suffering profound fatigue and living in supportive housing.

    Garvie had few options since there are no drug treatments for secondary progressive MS. "The clock is ticking. People die. People with MS commit suicide at an alarming rate. There is no hope. So why don't we give them hope?" he wondered.

    But his neurologist told him to wait for more studies. So, Steve went to see vascular surgeon Dr. Sandy McDonald, who runs an imaging clinic in Barrie, Ont.

    McDonald decided to test Steve's blood flow with ultrasound, using money from his own pocket.

    When the ultrasound scan showed signs of blood flowing backward into Garvie's brain, McDonald sent Steve for a venogram, in which dye was injected into his veins to look for problems.

    Just as the Chronic Cerebrospinal Venous Insufficiency (CCSVI) theory suggested, Garvie had abnormal blood drainage from his brain, because of a narrowed left jugular vein.

    Dr. McDonald and his colleagues decided to unblock the vein with a small balloon, a procedure called a venoplasty.

    "I had to tell Steve very specifically: I don't treat MS. I have no idea what effect the balloon angioplasty would have on MS, but I knew from studies that had been done that the abnormal flow characteristics warranted further investigation," Mc Donald says.

    Steve says as soon as the vein was opened, he immediately felt warmth in the left side of his face and he could wiggle his toes.

    "One of the nurses came over and said ‘Are you alright?' I said, ‘Yes, shake my hand.' She shook my left hand which was useless before," remembers Garvie.

    "It was quite remarkable," remembers McDonald.


    ‘The link has not been made'

    "The question as a physician, though, was: is it a placebo effect or is it real?," McDonald wonders. "I mean, when a patient really wants to get better, sometimes when you do something, they seem to feel better and it comes down, over time, to assessing whether or not his improvements are real or lasting."

    All over the world, MS patients are seeking out physicians who will test and treat them. They are then posting the results online.

    But many doctors who treat MS, such as Dr. Mark Freedman, the director of the MS research unit at the Ottawa Hospital, say the rush to test and treat vein problems bypasses the normal route of science.

    Freedman says theories have to be proven before patients are treated.

    "The link has not been made. The association has been made. But no one has convincingly shown this has anything to do with the disease," Freedman says. "Why would you fix something that may not have anything to do with the disease?"

    Garvie was one of five Canadian patients treated by Dr. McDonald's team. Another was Lianne Webb, who was diagnosed with MS almost 20 years ago. She has relapsing-remitting MS, had been taking the drug Copaxone, but still suffered MS symptoms and the occasional attack.

    "At one point, I didn't have any movement in my right side," she remembers.

    Ultrasound testing found she also fit the theory, with a venogram showing a narrowed left jugular vein. McDonald opened the vein a month ago. She says she feels better than she has the last five years or six years. "It's not a miracle, but if it stops progression, I'm all for it."

    Matt Maltese, 26, has suffered relapsing-remitting MS for a decade. His whole right side would often go numb. He couldn't go up and down stairs, and his family had installed an elevator into the house.

    When doctors performed the venogram in February, they discovered blockages in one of his jugular veins and the azygos vein in his chest. Both were opened with a balloon. The next day, Maltese was able to up and down the stairs with relative ease.

    Dr. Christopher Guest, an interventional radiologist who performed some of the procedures on Dr. McDonald's five patients, says venoplasty is a technique that has been used for years in veins in other parts of the body. He doesn't think performing it in the neck is much different.

    "If this were a risky procedure and there was poor data to support it, this would be a little more questionable. But these patients are severely debilitated, and the procedure is exceedingly safe," he says.

    Many neurologists, such as Dr. Freedman, have been confronted by anxious, sometimes angry, patients, who demand testing and treatment. His message to MS patients is: slow down.

    "It's an idea. All ideas on the table are important but we don't have the answers, and until we have all the answers you need to have a wide scope of understanding and belief."

    Balloons vs Stents

    Dr. Freedman and some colleagues wrote an article that appeared in the Annals of Neurology that urged doctors and patients not to test or treat vein problems until the theory has been proven in clinical trials.

    They also highlighted the dangers of a modified form of the Liberation Treatment, in which some clinics used metal stents to prop open the veins, which are prone to re-narrowing.

    One patient, treated in California last year, required surgery after the stent fell into his heart. Another patient died from bleeding linked to medications prescribed following treatment.

    The five Canadian patients were not treated with stents, only with balloon angioplasty, as per the Italian protocol, which has showed no serious reactions from the procedure.

    "I don't think it's a dangerous procedure," says Dr. Guest. "If you look at the complications that have been reported, they are related to stents, rather than the actual angioplasty. And we would certainly never place a stent until there was data to support doing that."

    Impatient patients question, 'why the wait?' 

    While patients agree that more study is needed, many aren't willing to wait several years for answers. Webb says the damage that could be done while waiting two or three years for clinical trials may not be reversible. "So why would you wait," he wonders.

    Matt Maltese's father Vito says some patients and their families are willing to assume some risks. "Let us know what our risks are, let us know what our choices are, let us make the choice," he says.

    Another patient, Sandra Black, remains disabled by her MS, despite the treatment in Barrie two weeks earlier. She also has secondary progressive MS, and uses a walker and a wheelchair. While she can't walk, she says the circulation to her feet has improved. They're no longer blue, and she feels more energetic.

    "I am happy to stay awake all day, get up earlier and warm feet when I go to bed," she says.

    Steve Garvie has had some of the most noticeable improvements. He can now walk where once he used a walker. He also was able to vacation with his partner Donna in the Dominican Republic, where for the first time, they danced.

    But Garvie wouldn't call it a cure.

    "No, I don't think so. There are some things I may never get back. But I am about 75 per cent better than I was before. That would be a fair statement."

    These cases are anecdotal reports. They don't add up to much the scientific world, where only carefully controlled large studies will prove if this theory has merit.

    That's why Dr. McDonald and his colleagues are no longer treating patients and instead are planning a formal study.

    "We have to look at the rationale of doing venoplasty in MS patients aggressively. We need to study a lot of patients, done with neurologists, in a multi-specialty focus," says McDonald.

    At the same time, McDonald is continuing to monitor patients with ultrasound to see if their vein narrowings recur, something reported in 47 per cent of patients treated in the initial Italian treatment study.

    Canadian teams take training in Italy

    The drive to learn more drew scientists to the San Giorgio Hospital in Ferrara, Italy, where Zamboni and his team are teaching researchers how to test for vein abnormalities using ultrasound. There are now some 100 other doctors and ultrasound technicians lined up for future classes in Italy -- and there are plans to open up training programs in North America.

    "Interest is really exploding and we are moving really faster because I have continuous contact with colleagues all over the world," says Zamboni.

    Canadian vascular surgeon Dr. Sandy McDonald and his technician, Angela, joined the s first international training program in Ferrara.

    Also there, were teams from the University of Saskatchewan and the University of British Columbia, including radiologist Lindsay Machan. He says the CCSVI theory is intriguing because is means that balloon venoplasty might lessen symptoms of a disease that is now treated only with expensive medications that carry heavy side effects.

    "If you think of the societal cost of MS young people, think of what we can accomplish for a relatively simple procedure. So we don't want this to languish and go on for a long period. We really want to get to the bottom of this," Machan says.

    Scientists are now seeking research dollars, through donations, or through scientific grants and from MS societies.

    Yves Savoie, the president of the Canadian MS Society, says 80 per cent of the phone calls the society now receives are about CCSVI. A one-time funding call was announced November. Grants for studies on CCSVI will be announced in June. The researchers selected will receive a maximum grant of $200,000 for a two-year study. But there have no details on how many centres have applied for funding.

    "I am quite convinced as a result of the excitement, the mobilization, the media attention, the process of discovery is going to be much accelerated," he says.

    But neurologist Dr. Freedman, who has spent much of his career testing other promising MS treatments, including stem cell therapy, worries the MS Society could be diverting funds away from other promising leads.

    "It's being forced, I think, to head down that road because patients are the main drivers of funds supporting the Society's work. And basically, they are looking at this and saying ‘Stop everything else. Redirect your funding to this project because it's worth it. And I don't think that's the truth over many other projects that may have more scientific rationale to move forward."

    Still, Freedman says his Ottawa team has submitted a bid to study the theory.

    Yet studies could take years. Patients such as Christopher Alchenbrack have already learned he has problems with his neck veins, and is in a hurry to get them opened.

    So the Wolfville, N.S. father of two, is funding his "study of one," spending more than $10,000 from his retirement fund to get the experimental treatment at a private clinic in Poland.

    "The reason I am so insistent on this procedure is that I have secondary progressive MS and nothing, none of the medicines I have used over the years, have worked to stop my MS. I've still progressed nonetheless."

    Countless MS patients are travelling to new clinics opening up in eastern Europe and India that are charging thousands of dollars for testing and treatment with metal stents, rather than balloons, and claiming Dr. Zamboni trained them, when he did not.

    "I understand that they are desperate and they can be attracted by this. I do not recommend this, because I do not know the quality. And probably this can be dangerous for the patients," says Zamboni.

    He insists the best way of protecting patients is by convincing established medical communities with hard scientific data from more studies that test and treat patients.

    "My position is to stand and respond with scientists and to tell the patients to give patience, because we are really running very, very fast."

    Source: CTV © Copyright 2010 CTVglobemedia Publishing Inc. (11/04/10)

    MS vein theory has roots in rejected research

    Dr. Franz SchellingInterest in a controversial new theory that blocked veins in the neck and chest could be triggering multiple sclerosis has received huge interest since CTV's W5 first broke the story last November.

    Italy's Dr. Paolo Zamboni brought the concept to the forefront of the medical world, yet it has roots in decades of research. In fact, researchers have been investigating the link between MS and blood flow in the neck for close to a century.

    Austria's Dr. Franz Schelling was among those who studied the link. For 30 years, the now-retired doctor has been on a frustrating mission to get someone to study his findings. He theorized that poor blood flow from their brains of MS patients might be caused by damaged veins, which then triggers or contributes to the symptoms that mark MS.

    Dr. Schelling worked as a family doctor trained in radiology and neurology and spent much of his career treating patients with MS. He became convinced it was not just a disease of the immune system.

    He collected research that pointed to damage in the brains in those with MS. He also analyzed X-rays of MS patients and found odd anomalies in the neck and skulls of patients compared to healthy people.

    But Schelling's requests for more study were repeatedly rejected by MS specialists who insisted what has long been promoted: the disease is caused by immune problems, not the veins.

    "It really cracked me down, because I had patients that… patients died of MS," he told CTV News from his home in Dornbirn, Austria.

    Schelling says he went to Vienna, New York, London and points in between, asking doctors and researchers to investigate the vein-MS link. But no one was interested.

    Now, the long-proposed theory is being explored at high speed. Scientists from Europe, Canada and elsewhere are in Italy to learn about Dr. Zamboni's breakthrough research, as well as learn from his team how to test for the vein problems that Zamboni has dubbed CCSVI, or chronic cerebrospinal venous insufficiency.

    Those scientists include radiologist Lindsay Machan from the University of British Columbia.

    "We don't want this to languish for a long period. We want to get to the bottom of this," Machan says.

    Zamboni tells CTV News that in the last six months, there has been "an explosion of interest and we are going really fast." At least half a dozen studies on CCSVI are planned or underway around the world.

    Doctors say many of these studies are coming following a push from MS patients, who don't want doctors to wait any longer testing the CCSVI theory. They also want doctors to begin providing Zamboni's Liberation Treatment, a venoplasty procedure in which a balloon is inserted into the neck veins to open them.

    But MS specialists say it's important to do the studies to test the CCSVI theory methodically before proceeding with possible treatments.

    "It may be a few years, but very quickly we'll get to research that helps us make sure that treatments are offered with the appropriate safeguards," says Yves Savoie, the president and chief executive of the Multiple Sclerosis Society of Canada.

    But scientists in Italy hope to have further data from studies to conform or refute the theories available in less than a year, as patients around the world wait eagerly for an answer.

    Source: CTV © Copyright 2010 CTVglobemedia Publishing Inc. (10/04/10)

    Kuwait to offer CCSVI treatment to all its MS patients

    Kuwait FlagFollow-up article to that of 08/04/10

    Kuwait has become the first country in the world to offer a controversial treatment to all its patients with multiple sclerosis who have blocked veins in their necks.

    CTV News has confirmed that Kuwait's minister of health has given interventional radiologists in the country the go-ahead to use the state-financed medical system to begin treating patients who have blocked veins and abnormal blood flow in their necks.

    According to a theory proposed by University of Ferrara's Dr. Paolo Zamboni in Italy, and first broadcast on CTV's W5 last November, many patients with MS have blocked or narrowed veins in their necks and chests. He calls the condition CCSVI, or chronic cerebrospinal venous insufficiency.

    He theorizes that the blockage prevents blood from draining properly, sending it back to their brain, a problem that could contribute to the immune response that marks MS.

    The theory has generated a lot of interest in Kuwait, which has high rates of MS, particularly among women.

    In a telephone interview with CTV, Dr. Tariq Sinan, an interventional radiologist and an associate professor at the Department of Radiology in the Faculty of Medicine at Kuwait University says the health ministry will allow radiologists to begin treating MS patients who have CCSVI, starting next week, as part of an ongoing study.

    The Kuwait News Agency KUNA also reported the development, quoting the chairman of the standing committee for co-ordination of medical research at the ministry, Dr. Youssof Al-Nesf, as saying: "The presentation meets the legal, moral and scientific criterions specified by concerned organizations, including the World Health Organization."

    The decision is based on research by a team headed by Sinan who studied 12 MS patients in March. All of them had CCSVI and were offered what Zamboni has dubbed the Liberation Treatment. The treatment is a vein version of angioplasty, in which a small balloon is inserted into a blocked vein to force it open.

    (No stents were used in the procedures, a practice some doctors around the world have tried and one that Dr. Zamboni does not endorse.)

    Sinan says all of the patients saw improvements in their MS symptoms, with some noticing "dramatic" results.

    "On one day, on March 3, we did three patients. Two had dramatic improvements on the table and started crying because they couldn't believe what they were feeling," Sinan reported.

    He says patients with more severe MS reported fewer improvements, but did notice feeling less stiffness and more energy. Those with less severe disease, reported up to 90 per cent improvements in their fatigue and numbness in their hands and leg.

    "In one case, the patient couldn't see from one eye and started to be able to see," Sinan reported.

    Sinan said he's confident the results he saw were not the result of the "placebo effect," a phenomenon in which patients fool themselves into feeling better by an otherwise ineffective treatment.

    "If this is a placebo effect and I have MS, I would want this placebo effect," Sinan said.

    "It is amazing the kind of improvements the patients say they have. It cannot all be attributed to placebo. Not being able to see and then being able to see, better bladder control, end of foot drop -- that cannot be placebo."

    Last week, Dr. Sinan says a group of neurologists petitioned the country's ministry of health to stop the treatments. Their concerns – shared by other MS specialists around the world -- is that the link between blocked veins and MS has not been proven, and that the treatment could be dangerous. They have called for more studies.

    But after review, and submissions from physicians and patients, the decision was to allow the treatments, which will be covered by the state-financed medical system.

    The procedure will not be performed to treat MS per se but to treat only "improper blood flow" in the veins.

    "So we say this is a vascular problem in the neck. Patients, when you dilate the veins, they feel better. We don't have to talk about MS or the link to MS," said Sinan.

    Patients will be warned that the procedure is experimental, and the potential risks of venoplasty will be detailed in consent forms. Patients who agree to treatment will be part of an ongoing study that will be done in cooperation with a Kuwait neurologist.

    The team will use ultrasounds and magnetic resonance venograms to scan the neck veins, as well as MRIs to track changes in the brain, including the appearance of MS-related lesions.

    Doctors hope to treat 10 Kuwaiti patients a week, beginning next week.

    Source: CTV © Copyright 2010 CTVglobemedia Publishing Inc. (10/04/10)

    Direct-MS CCSVI Information Evening April 30, 2010

    Direct-MS CCSVI Information Evening

    A webcast will be made available on the Direct-MS website in the presentations section after the event for those who cannot attend.

    Kuwait government decides to treat all its 600 MS patients with CCSVI angioplasty at the rate of 10 a day
    Kuwait FlagThe Ministry of Health will resume surgeries for CCSVI in Multiple Sclerosis (MS) in a few days following approval of a relevant protocol for treating this disease.

    Health Minister Dr. Hilal Al-Sayer said in a statement to KUNA on Monday the operations would be conducted after a written approval by the patients and informing them on possible side-effects of the operation.

    He indicated that this surgery is still classified in the testing stage, has not been accredited by the relevant international health authorities and warrants further researches to ensure that the patients undergoing such surgeries would not suffer from serious side-effects.

    Dr. Paolo Zamboni, an Italian vascular surgeon, devised an experimental treatment similar to angioplasty, which involves removing the blockage in the veins that carry blood to and from the brain. Zamboni gained international attention after he published a study in 2009 that suggested the treatment was highly successful in reducing MS symptoms.

    However, some experts have expressed concern that the surgery may cause clots in the brain.

    Source: Kuwait News Agency (08/04/10)

    New Multiple Sclerosis test comes to the UK

    CCSVI VenographGlasgow clinic offering testing for CCSVI – narrowing of veins in the skull which recent studies have linked to MS

    Chronic cerebrospinal venous insufficiency (CCSVI) is a hot topic for people with MS at the moment. The new theory is that multiple sclerosis can be caused by blockages in veins draining blood from the brain: Clear the blockages - and MS symptoms may be reduced.

    The idea was put forward by an Italian scientist, Dr Paolo Zamboni.

    Up until now anyone from the UK wanting to be tested or treated for the condition has had to travel to clinics in Italy or Poland.

    Now a Glasgow clinic has started to take bookings for diagnostic tests this summer and plans to offer treatment to patients who are found to have CCSVI.

    About MS
    Multiple sclerosis is the most common neurological condition among young adults in the UK, affecting approximately 100,000 people.

    CCSVI: The theory
    Zamboni investigated links between MS and iron deposits in blood vessels.

    He used ultrasound on the blood vessels leading in and out of the brain and found that in a majority of people with MS, including his wife, the veins taking blood away from the brain were blocked or damaged. This was not the case in people without MS.

    He further suggested that iron was damaging the blood vessels and allowing the heavy metal, along with other unwelcome cells, to cross the crucial blood-brain barrier, a process he termed Chronic Cerebrospinal Venous Insufficiency.

    Putting CCSVI to the test
    MS is a condition which has attracted more than its fair share of miracle cures and scams. However supporters of the blocked vein theory remain optimistic after the first randomised clinical study in the US.

    More than 55% of 500 MS patients participating in the initial phase of a study at the University of Buffalo exhibited narrowing of the extracranial veins, causing restriction of normal outflow of blood from the brain.

    The study findings will be presented to the American Academy of Neurology meeting later this month.

    Testing comes to the UK
    The Essential Health Clinic in Glasgow has a large private practice for MS. Dr Tom Gilhooly sees patients from all over the UK and abroad for treatments like low dose naltrexone (LDN).

    At first he thought the CCSVI concept was “whacky” but his patients kept asking about it. He read the scientific papers about it and tells us “I thought there is a biological plausibility here. You could see why venous drainage could impact on the immune system and therefore on the central nervous system and MS.”

    The new approach, he says, is “potentially revolutionary”.

    Gilhooly then set about planning for a screening service with a vascular stenographer and is setting up training for his staff at Zamboni’s clinic and at a centre in Poland.

    Demand is such that he’s also expanding to set up a London clinic to offer the service.

    “Interest has been intense. We’ve almost been blown away by it. The organisation has struggled to cope with the number of phone calls”.

    More than 2,000 people have registered an interest in the screening at his clinic.

    The treatment
    The blockages in the veins are either dealt with by the insertion of a tiny tube, called a stent, or by balloon dilation. In both, the narrowed veins in the head are expanded in a procedure beginning in a leg vein.

    Gilhooly hopes his clinic can help with research into the condition and treatment by carrying out a randomised clinical trial.

    Charity support
    The Multiple Sclerosis Resource Centre (MSRC) is following the CCSVI treatments and studies in detail. Chief executive Helen Yates tells us by email: "MSRC is fully supportive of Essential Health Clinic's efforts to enable scanning for CCSVI in MS patients in the UK.

    “Currently anyone who believes that they have this problem has to go to Europe even just to get scanned, never mind treated. Enabling the scanning to take place here in the UK will represent a big step forward for people affected by Multiple Sclerosis who believe this venous insufficiency problem lies at the root of their MS."

    “The idea that venous insufficiency might be either responsible for or partly responsible for MS is a very new one and opens up all sorts of possibilities. Whilst the procedure is relatively well tolerated by most people, it is not without risks.

    “Of course more research needs to be done in this interesting and novel approach to MS, but in the meantime many people with MS feel that the least they can do is get scanned to see if this issue applies to them.

    “No one is claiming the ‘liberation procedure’ is a cure,” she says, “What is apparent however, is that the procedure does seem to produce some positive effects for the majority of people who undergo it and for some the effects are quite profound.”

    Source: Web MD © 2010 WebMD, LLC (08/04/10)

    Cardiac surgeon calls foot-dragging on CCSVI 'unethical'

    Gianfranco CampalaniAs a multiple sclerosis patient, Gianfranco Campalani has been treated for Chronic Cerebrospinal Venous Insufficiency (CCSVI) twice and knows firsthand how this procedure has improved the quality of his life. As a doctor, he feels the reluctance that CCSVI is getting from the medical community is “unethical”.

    “I believe that when a new treatment has practically only minor possible complications (as reported by Zamboni with venogram and angioplasty) and a good potential for benefits, as opposed to the pharmachological treatment rich in harmful side-effects, the need for rigorous scientific double-blind trials is nonsense. We need a few more intelligent and courageous vascular surgeons and radiologists to start treating vascular anomalies (strictures of the jugular veins) on their own merit, not mentioning MS. But the medical establishment is notorious for being conservative and generally lazy.”

    Sixty-four year old Campalani is a cardiac surgeon. He was recently featured on BBC Northern Ireland’s Superdocs, a TV programme that chronicles the men and women who are saving and changing lives on a daily basis. His life, however, has been changed by Superdocs of his own.

     Sometimes where you come from makes big difference to your life, and it’s been like that for Campalani. Born in Ferrara, Italy, his 35-year medical career took him first to London and eventually to Belfast fourteen years ago. Diagnosed with chronic progressive MS in 1986, he’s one of an estimated 100,000 people in the UK with the disease.

     Three years ago, on a visit back to his hometown, his brother arranged a dinner party with a good friend of his, Prof. Paolo Zamboni, because, as he’d told his brother, Zamboni had some rather different ideas about Multiple Sclerosis. The year before, Zamboni had published a paper called “The Big Idea” on the iron-dependent inflammation in venous disease and proposed parallels in multiple sclerosis. Campalani, of course, was interested in Zamboni’s ideas on venous disease and their discussion was friendly and collegial.

    “Dinner was on a Friday in July 2006 in my brother's house. We were three couples. My brother did the cooking: an oriental dish. Paolo knew I had MS from my brother Andrea and Paolo asked me a few questions, like how long, how bad and so on. I had the plane back to Belfast the following day in the afternoon and Paolo wanted to check my neck with a Doppler. Saturday morning I was in his lab and had the study: Paolo told me that I had obstruction in the venous drainage from the brain. He then organized for me to come back for a liberation procedure a month later.”

    Campalani’s blockages were corrected by angioplasty, a ballooning technique that was used to expand his veins.

    “Five hours after the balloon dilatation, I could walk without my walking stick and my bladder improved,” he explains, “And another thing. I stopped using the little blue pill.”

    Last year, however, Campalani started having a recurrence of MS symptoms. He began to have spasms in his legs and back, and he was worried that it might affect his surgical abilities as he regularly spends eight hours or more in an operating theatre saving the lives of his patients.

     “I had to convince a vascular surgeon to convince a radiologist to examine my jugulars,” Campalani says. “Luckily I had the images from my previous intervention. They saw the same narrowing that they treated in Ferrara.”

     The vascular surgeon - who coincidently studied under him, performed the second balloon dilatation and Campalani again was back to his pre-MS condition, spasm free.

     Despite having MS and being a part of the medical community, he refused to take any drugs to lessen his MS symptoms at any time since he first learned of his MS – with the exception of Viagra.

     “I always refused to take any medication whatsoever because I don’t believe you should take drugs to treat something the doctors don’t know the origin of,” Campalani explains. “But for the last 4-5 years I’ve taken fish oils, Vitamin C, Vitamin B complex because these are antioxidents.”

    Source: For Greet (01/04/10)

    Moment of truth for Tiger after his CCSVI MS treatment

    Caroline & Tiger Tim Stevens Tim Stevens travelled to Poland in the hope of finding a cure for his MS, the hugely debilitating illness which has robbed him of the use of his legs.

    In this final part of his account of the trip, BRIAN BEACOM reveals how Tim got on after leaving the clinic in Katowice ...

    As miracles go, it’s not exactly up there with the biblical classics. But for Tiger Tim’s wife, Caroline, the sight of her husband tucking into his Hawaiian pizza using a fork in his left hand was nonetheless astounding.

    "My God," he’s holding it," shouts, Caroline of the fork adventure. "This is the first time in 10 years Tim has been able to use his left hand to eat, even though he is left handed.

    "I can’t believe it."

    Nor could Tim. The afternoon pizza experiment was carried out in hope rather than expectation. But then today had already been about a series of great surprises.

    It began at 10am outside the 27-storey Hotel Qubus in Katowice.

    Already 18 degrees and a beautiful day, those assembled to greet the patients as they returned from the Euromedic Clinic wanted desperately to believe that the bright sunshine overhead was a sign, a metaphor for the first day of Tiger’s new life.

    After spending a precautionary night in the clinic after his ‘Liberation Treatment’ to clear his blocked veins, Tim had called to say he was on his way back to the hotel. But how would he feel? Doctors at the clinic don’t promise immediate results; they say that improvement can take up to six months, as the body begins to repair itself after the damage done to it by iron deposits in the brain.

    However, they do say there have been some remarkable early results. Perhaps none more so than the 60-something US woman from Los Angeles, who two days earlier was restricted to using crutches.

    "Look at me today," she exclaimed, with a smile as bright as the sunshine.

    "We’re going shopping in Krakow and I want to walk, but my daughter says I should take my crutches – just in case."

    She demonstrated her walk, which for a woman, who’s been dependent on crutches for years, is amazing.

    But will Tim, and the others who had the same procedure on the same day, have such a positive a result?

    First back from the clinic was Mark, the 29-year-old from North London, who uses a motorised wheelchair.

    "I feel good," he said, his face beaming. "Normally, my hands and feet are cold, but feel them." He extended his hands and they felt ‘normal’.

    "It’s amazing. But what’s also incredible is I can sit here in the sun. People with MS can’t take the sun."

    He added grinning, "Maybe I’ll be able to get a sun tan for the first time in 10 years."

    Next to return was 28-year-old Barry, from Shawlands. Mark’s delight seemed like downright misery by comparison. "Just look at me!" he said at the top of his voice.

    Now, all Barry was doing was standing up. But as he pointed out, it’s been a few years since he’s been able to do that without support.

    "I can stand, and I don’t feel dizzy! Watch me walk."

    And he does. A few, faltering steps that gained confidence, which transformed into confident semi-strides.

    It’s hard not to be moved by the sight of someone being so exhilarated by an action we all take so much for granted. Barry’s pregnant Katy was reduced to tears at the sight of her husband’s transformation.

    "My speech is better," said Barry, whose voice was slurred.

    "And I had this fuzziness in my head. But it’s gone. I feel, well, incredible."

    But then there’s a moment of despair. Cecille, 38, from Colorado, emerged, clinging onto the back of her friend, Aidi. CC, as she’s known, has no improvement.

    "I don’t feel a bit different," she said, her voice fighting back the horrid disappointment that she can’t celebrate with her new chums.

    And what of the Tiger? Finally, he arrived, pushed up the ramp by wife Caroline. He relaxed for a few moments in the sunshine before taking stock.

    "I feel good," he said "My feet are warm, and I’m enjoying the sun in my face."

    He thought for a minute. "Yes, I feel better. But I’m tired." He added, grinning: "I had to share a room with these two blokes last night (Mark and Barry) and they both snored like elephants."

    Caroline was hopeful about his progress. "Of course, you dream of a miracle, but the reality is it may not happen."

    She added, her voice dropping in tone. "Really, we would be happy if Tim’s condition didn’t worsen. Already his breathing is very laboured. That’s what we’re really worried about."

    One of the doctors who carried out Tim’s procedure, Dr Ludyga was cautiously optimistic. He said: "In general, we see the best results in people who haven’t had MS for very long. Tim has had MS for many years (36). But we would still hope to see some improvement."

    After a nap, Tim craved a pizza. And that’s when the hand movement occurred. Then he realised he could move his left leg. The spasms which locked it rigid abated. Later than night Caroline reported another huge improvement.

    "Tim can move the toes on his left foot, which he hasn’t done for years," she says, in an excited voice.

    Now, the implications of this are immense. If, and it is a big if, Tim can move his toes and recover feeling in his foot, it won’t drag. And this is the primary reason he’s been confined to a wheelchair – combined with fading energy of course.

    But then the following day comes another bombshell. Tim has a nap every afternoon. He doesn’t want one.

    "I’m not tired," he says, chuckling like a naughty schoolboy who stays up late on a weeknight. "I don’t need to go to bed. That is absolutely amazing."

    There’s more good news. CC texts to say she’s feeling warmth in her hands and feet. Mark feels better, stronger and Barry has walked outside his house in Shawlands for the first time ever.

    Is it all too good to be true? The medical world point out this procedure is still an unproven experiment.

    "What you’ve seen is merely an observation," said one consultant. "Until it’s been tested and compared it doesn’t prove anything. And the people involved could have had the same improvement had they been pumped full of steroids. Or, there could be a placebo effect."

    They weren’t treated with steroids however. And would the placebo effect be so pronounced? It’s now a week since the operation and all are continuing to improve by degrees.

    "I feel great," says Tim. "Gradually things are getting better. My head is clear, friends say my speech is so much better. Is there hope for the future? You bet."

    Source: Evening Times © 2010 Herald & Times Group (01/04/10)

    It’s my chance to live

    DJ Tiger TimDJ Tiger Tim has suffered from MS for 36 years and is now wheelchair dependant.

    But last week he travelled to Poland to undergo a controversial new treatment which he hopes will give him some quality of life. BRIAN BEACOM travelled with the Radio Clyde legend.

    It’s Tuesday, it’s 11pm at night and we’re on the 26th floor of a swish hotel in Katowice, Poland, an industrial town about 60 miles from the city of Krakow.

    The Tiger is lying on his bed, bleary-eyed and exhausted, yet at the same time excited – and desperate for the new day to begin.

    His mixed emotions are entirely understandable. Since Sunday, 58-year-old Tim has either been travelling or undergoing the scans that he hopes will help alleviate the symptoms of his multiple sclerosis.

    Just a few months ago, his wife Caroline heard of a new treatment – still experimental – which, it is claimed, has achieved some remarkable results in treating MS patients.

    The procedure is based around the belief that MS is at least partly caused by Chronic Cerebrospinal Venous Insufficiency. (CCSVI).

    Put simply, it means that narrowed veins in the neck prevent blood from the brain and spine getting back to the heart.

    And blood that stays in the brain too long can result in iron deposits, which can damage the central nervous system.

    Dr Tomasz Ludyga of the Euromedic Clinic in Katowice, who will carry out Tim’s procedure, says: “It’s basically a plumbing problem.

    “What we are looking for is blocked veins to show up on the MRV scans or the ultrasounds.

    “If they appear, we believe we can carry out the procedure and make an improvement to the patients’ lives.”

    Meantime, Tim’s mind is racing with possibilities; what sort of improvement can he expect?

    His MRV scan, said the Polish medical team, revealed a blockage in Tim’s left jugular vein. However, the doctors are in fact looking for extensive vein narrowing (stenosis) because the greater the blockages the more they can repair – and allow the body to begin healing.

    Initially, Tim feels encouraged. But he still has concerns.

    He says: “In the morning I’m to have a Doppler ultrasound – MRVs don’t always reveal a full picture.”

    There are other concerns, calculated risks. The treatment, ‘the liberation procedure,’ isn’t hugely invasive and is similar to angioplasty, where a wire is passed up through the groin and into the veins, which are then unblocked either by inserting a small balloon or a metal stent.

    Euromedic’s Polish MS clinic has been open for six months and during that time has treated 200 patients. Of that 200, they say 80% have had ‘some improvement’ to their condition.

    But how do you quantify the phrase ‘some improvement’? And could Tim be one of the 20% who see no improvement?

    Tim says: “I have to go through with this. I have to be positive.”

    The procedure costs around £7000, but expenses, travel and hotel bills can take this up to £9000. Tim’s journey to Poland however was funded by a special benefit show at Glasgow’s Pavilion Theatre.

    Caroline says: “This isn’t about money, it’s about a future for Tim. It’s about praying that he will be able to breathe better, that he’ll be able to concentrate better and continue to work.

    “It’s about Tim’s quality of life. But there’s much more to it. Tim is an explorer for every one of the 10,500 MS sufferers in Scotland.

    “His experience will indicate to others if there is a glimmer of light for them in what would otherwise be darkness.”

    Tim nods in agreement.

    “I’ve tried every possible cure imaginable,” adds the DJ legend, who only realised he had MS when his legs suddenly collapsed under him one day while he was running along Prestwick beach.

    The realisation came as quite a shock to the fun-loving broadcaster.

    “I’ve tried natural therapies, conventional drugs, spiritual healing, new diets, exercise, goats’ serum, everything, but I’m still in a wheelchair,” says Tim.

    “And my breathing is becoming difficult – and my eyesight is failing.

    “I hope this treatment can make a difference.”

    Tim adds, his voice full of emotion: “Even if the progress of the disease can be halted, then I’d be happy with that.”

    Eight hours later Tim is waiting in the hotel lobby to taken by taxi to the clinic. Around him are people in wheelchairs, some on crutches, all set to be treated, including 28-year-old Barry from Shawlands, 29-year-old Mark from North London and 38-year-old Cecille from Colorado.

    “It’s like a mini Lourdes,” says Tim, smiling. “But hopefully with better odds of success.”

    Tim and the others are given early hope in the form of a 60-something lady from California.

    “I had the treatment yesterday,” she says, her face beaming with delight.

    “Before I couldn’t walk without crutches, my leg dragged behind me. But look at me now. Watch.”

    And as we look on, she puts down her crutches and walks. Not an easy, flowing walk, but a walk nonetheless. And she smiles like an Olympic gold medallist.

    Tim, Barry, Mark and Cecille’s eyes almost pop out of their sockets. But will the treatment give them such an immediate result? Or any result at all?

    Only tomorrow will tell.

    Source: Evening Times © 2010 Herald & Times Group (30/03/10)

    The Essential Health Clinic Releases First CCSVI Scanning Appointment Dates
    EHC LogoThe Essential Health Clinic Releases First CCSVI Scanning Appointment Dates - http://www.essentialhealthclinic.com/website/  Source: The Essential Health Clinic (28/03/10)

    MS-CCSVI-UK delivers CCSVI campaign to Downing Street
      Alison, Gary and Omar at Downing Street with ColmHope was in the air on the fine spring day of Monday 22nd March when Colm Mclaughlin and a group of team members from MS-CCSVI-UK passed security clearances then walked, or wobbled up to the iconic steps leading to the door of 10 Downing Street.

    They were there in person to deliver a copy of the petition calling for clinical research into CCSVI procedures to take place in the United Kingdom. The petition, which was initiated by Colm prior to his joining the group, had later been embraced as an early element of the MS-CCSVI-UK campaign and promoted with enthusiasm on the team’s Facebook page, followed up with publicity on the website http://www.ms-ccsvi-uk.org/ which was established some time later.

    After surpassing the initial target of10,000 supporters by reaching 10,651 signatories at its closure date, the team was keen to maximise the exposure of this tremendous petition result. Permission was therefore requested from Downing Street for the group to deliver a copy of the document in person to Number 10.

    After the event Colm commented: “Just got home after a day with some really good people. Thanks for making it a day to remember. Now on with the fight, there’s a war to win!

    When I first stumbled across CCSVI whilst surfing the web last year it made so much sense to me and I just wanted the world to know there was hope. For 4 years since my diagnosis with Multiple Sclerosis I had had none. I started the Petition in a bit of a rush – we have no time to waste, we need action, which is why I let it run for just 2 months. I knew I had to get 500 people to sign to get it in front of a Minister. I am a member of a fan site called "Red Issue" and that is where I started getting the first people to sign. Now the petition is ended with over 10,000 signatures I feel proud, justified in starting it, and committed to carry on the fight. The emails, and facebook messages I've had from people who can't afford to go to Poland and pay thousands of pounds is reason enough to carry on. The message of support I've had from around the world is humbling and inspiring.”

    Michele Findlay added: “It was indeed a day to remember; it was the first time most of us had met each other, although of course we knew each other well from working together. Special people with an important job to do... onwards and upwards.”

    Source: MS-CCSVI-UK (25/03/10)

    Testing new MS theory as patients demand care now

    CCSVI VenographUnder intense pressure from patients, some U.S. doctors are cautiously testing a provocative theory that abnormal blood drainage from the brain may play a role in multiple sclerosis -- and that a surgical vein fix might help.

    If it pans out, the approach suggested by a researcher in Italy could mark a vast change for MS, a disabling neurological disease long blamed on an immune system gone awry. But many patients frustrated by today's limited therapies say they don't have time to await the carefully controlled studies needed to prove if it really works and are searching out vein-opening treatment now -- undeterred by one report of a dangerous complication.

    ''This made sense and I was hell-bent on doing it,'' says Nicole Kane Gurland of Bethesda, Md., the first to receive the experimental treatment at Washington's Georgetown University Hospital, which is set to closely track how a small number of patients fare before and after using a balloon to widen blocked veins.

    In Buffalo, N.Y., more than 1,000 people applied for 30 slots in a soon-to-start study of that same angioplasty procedure. When the University at Buffalo team started a larger study a few months ago just to compare if bad veins are more common in MS patients than in healthy people -- not to treat them -- more than 13,000 patients applied.

    The demand worries Georgetown neurologist Dr. Carlo Tornatore, who teamed with vascular surgeon Dr. Richard Neville in hopes of getting some evidence to guide his own patients' care.

    ''A lot of people are starting to go to fly-by-night places,'' says Tornatore. Doing this research takes time, he said. ''It's a marathon, not a 100-yard sprint. We have to be very careful.''

    Multiple sclerosis occurs when the protective insulation, called myelin, that coats nerve fibers gradually is destroyed and scar tissue builds up, short-circuiting messages from the brain and spinal cord to the rest of the body -- impairing walking and causing fatigue and vision, speech, memory and other problems. It affects about 2.5 million people worldwide, including 350,000 Americans.

    A condition with an unwieldy name has become the hottest topic of debate in MS: Chronic Cerebrospinal Venous Insufficiency, or CCSVI. An Italian vascular specialist, Dr. Paolo Zamboni, was hunting ways to help his wife's MS when he discovered that veins carrying oxygen-depleted blood down the neck or spinal cord were narrowed, blocked or twisted in a group of patients. Zamboni reported that made blood back up in a way that might be linked to MS' damage, by causing tiny leaks of immune cells into the brain that start a cascade of inflammatory problems.

    Then came the step that spread excitedly through MS patient Internet forums: In a pilot study, Zamboni's team used balloon angioplasty -- similar to a longtime method for unclogging heart arteries -- to widen affected veins in 65 patients. He reported varying degrees of improvement, mostly in patients with the relapsing-remitting form of MS who experienced fewer flare-ups of symptoms over the next 18 months and some improvements in quality of life.

    But nearly half had their veins relapse, and Zamboni urged a larger, more scientifically controlled study be done.

    Next, Buffalo researchers scanned the veins of 500 people. About 55 percent of MS patients had signs of CCSVI, compared with 22 percent of healthy people, says lead researcher Dr. Robert Zivadinov, who will present his data next month at a major neurology meeting.

    Meanwhile, a Stanford University surgeon tried implanting scaffolding-like stents -- also developed for heart disease -- into some MS patients' narrowed veins. Dr. Michael Dake halted the work in December after 35 people were treated, saying in an e-mail to colleagues that he decided ''after deep soul-searching'' not to continue outside of a clinical trial. Stanford won't discuss details, but the journal Annals of Neurology reported that one patient's stent dislodged and flowed to the heart, requiring emergency open-heart surgery to remove it. (An earlier death was reported by family members to be from a stroke unrelated to the MS treatment.)

    The US MS Society soon will announce funding for additional studies.

    Like many neurologists, Georgetown's Tornatore watched the developments with a mixture of skepticism and curiosity. After all, decades ago some doctors first suggested circulation might play a role. The scars tend to cluster near veins, and blood-thinning treatment was tried before immune-targeting drugs were proven to help many MS patients.

    He ticks off the possibilities: This could be a blind alley, like so many to befall MS over the years. Or it could work a little. Or it might be revolutionary.

    ''I have no idea. I'm not predisposed to any of them,'' Tornatore says.

    But he and Neville decided angioplasty was the least risky option for a limited test. In 30 patients who've undergone a $400 ultrasound exam so far, about half have evidence of the vein abnormality.

    Gurland was the first treated earlier this month, her jugular veins blocked so tightly that Neville had a hard time even pushing the tiny angioplasty wire inside. But right after the treatment, Gurland's feet that for years had been cold and purplish became warmer and normally colored.

    What about MS' hallmark fatigue and weakness, and her scarred nerve cells? While Gurland thinks her balance in the morning, often her worst time, is improving a bit, it's too soon to know; those tests are yet to come.

    But last week, her close friend Heather Tuck, 61, came in for a vein check, too -- calling it the first MS test she ever hoped to pass.

    Source: The New York Times (C) The New York Times Company (23/03/10)

    New data on CCSVI and vitamin D underscore the need for taking action

    CCSVI VenographBy Ashton Embry Direct-MS

    CCSVI
    Any suggestion that CCSVI testing and treatment should not be available until
    definitive trials have been done (5 -10 years), is irresponsible, reckless and
    completely out of touch with the needs of persons with MS. Time is Brain and
    everyone wants to preserve as much brain as possible.

    Key findings from two recent studies show that CCSVI is a major problem in
    MS and each person with MS should be tested and, if need be, treated for
    CCSVI as soon as possible.

    Having CCSVI makes MS worse - it is a significant driver of the MS disease
    process and any person with MS and CCSVI has a much higher chance of
    major disease progression.

    Of course the major problem facing persons with MS right now is that those in
    power, the neurologists and the big MS charities, are dead set against such
    testing and treatment. There is no easy solution to this problem and it is
    basically a test of wills.

    I suspect the only hope persons with MS have is to get the media to see the
    obvious logic of why CCSVI testing and treatment is necessary and to expose
    the self serving and harmful agenda of the neurologists and MS charities. It
    took a big media production (CTV documentary) to force the neurologists and
    charities to finally acknowledge the existence of CCSVI. And it will take
    similar media exposure to embarrass them sufficiently so that they will have
    to do what is best for people with MS.

    Definite Link Between CCSVI and MS

    Two recent American trials have shown a definite link between CCSVI and
    MS. One is ongoing at the University and Buffalo where researchers are
    testing 1600 people for the presence of CCSVI in three phases. The 1600
    includes 950 with MS, 100 who experienced an initial demyelinating event,
    300 with other CNS diseases, and 350 healthy controls.

    The results of Phase 1, which involved 500 patients (280 MS, 161 healthy
    controls, 59 others), included:

    - 56% of persons with MS had CCSVI
    - 22% of healthy controls had CCSVI
    - 38% of those with an initial demyelinating event had CCSVI
    - 80% of those with more advanced MS had CCSVI

    The second study at Georgetown University looked at the nature and origin of
    the venous malformations responsible for CCSVI. The vascular researchers
    found that the venous malformations are of congenital origin and are not the
    product of post-birth, environmental insults or the MS disease process itself.
    This in utero formation of the venous malformations means CCSVI occurs
    BEFORE the MS disease process begins, an important constraint for
    understanding the cause/effect relationship between MS and CCSVI.................

    More - http://tinyurl.com/yfzhs4o (22/03/10)

    CCSVI Press Conference at False Creek Healthcare Centre

    CCSVI Press conference at False Creek Healthcare Centre. Featuring Dr. Mark Godley and Dr. Marian Simka

    Scottish doctor hails breakthrough CCSVI treatment for MS
    Glasgow GP Dr Tom Gilhooly is at the forefront of an exciting new treatment for sufferers of MS. He comments ‘Scotland has the greatest incidence of Multiple Sclerosis in the world – and has more to gain than any other country from new developments such as CCSVI.’

    CCSVI (Chronic Cerebrospinal Venous Insufficiency) is now an internationally recognised condition which has been found more commonly in MS patients. Gilhooly explains ‘We need more research to establish if treating CCSVI will improve outcomes in MS, but the theory does make sense. Leakage of iron from leaky veins could increase immune activity and contribute to breakdown of the blood brain barrier. Also MS lesions tend to occur round veins which makes sense if CCSVI is present. It’s early days, but this could be one of the greatest medical breakthroughs of the early 21st century.’

    Gilhooly has one of the largest MS private practices in the UK, based at the Essential Health Clinic in Glasgow. There are plans to open a similar centre in London and they are actively seeking to offer scanning services for CCSVI in both London and Glasgow at some point later in 2010.

    Gilhooly continues ‘The beneficial impact of vitamin D, antioxidants and omega-3 also fit the CCSVI hypothesis, and could be used to alleviate the symptoms and treat MS. The Doppler ultra sound scan required to show the CCSVI abnormalities has been specially adapted and we hope to have an ultrasound technician fully trained later this summer.’

    The cost of the scans in the UK is still to be finalised. Gilhooly and his team are also liaising with intervention radiologists to develop treatment centres around the UK.

    People wanting to find out more should visit http://www.essentialhealthclinic.com/ for more details, and to
    sign up for a free newsletter.

    Gilhooly is also due to chair the 2nd European LDN Conference which will also explore groundbreaking treatments for MS and other debilitating inflammatory conditions. The conference will take place in Glasgow on 24th April. The conference is sponsored by BIG ON Glasgow, and more details can be found at http://www.bigonldn2010.com/.

    Source: Cisionwire © Cision 2010 (18/03/10)

    Gloucestershire Multiple Sclerosis sufferer calls for pioneering treatment

    CCSVI VenographMultiple sclerosis sufferer Stefan Cambridge is calling for a pioneering treatment to be available in the UK.

    As a child, the now 34-year-old spent years caring for his father who had MS before seeing him die. Just five years later he received the devastating news he too had the disease.

    Stefan, who uses a wheelchair and walking sticks, recently travelled to Poland for surgery which he says has halted the progression of the debilitating condition which affects all kinds of nerve function.

    He is now calling for the pioneering surgery to be made available on the NHS.

    The dad-of-one, who has a progressive form of the condition, said: "I lost my dad to MS at a young age and I know what this illness can do.
     
    "For someone like me not to progress is like a miracle. For people who have the procedure done early on before the damage starts then it's more of a cure."

    Stefan, whose father died from MS at the age of 42, paid £4,000 to have an angioplasty performed on his jugular vein to widen it.

    The surgery, which is not available on the NHS in the UK, follows initial studies abroad which suggest MS is linked to a narrowing in the veins which drain the spine and brain.

    It is not known if this condition, known as chronic cerebrospinal venous insufficiency (CCSVI), is a cause of MS but researchers are reported to have said it is at least an important association.

    Some patients who have had similar procedures have even reported an improvement in symptoms.

    Stefan, from Bishop's Cleeve, returned from Poland in January and believes the surgery he had has stopped his MS getting worse. The former Bournside School pupil found out about the studies on internet MS forums.

    Stefan and his sister Gillian cared for their father until his death in 2003. There is no cure for MS but it has not been shown to be hereditary in medical studies, so Stefan was shocked and devastated when he was diagnosed.

    "I just couldn't believe it when I got diagnosed. I have done everything I possibly can to try to get better," he said.

    Opinion is divided in the medical world about the treatment Stefan received.

    Researchers at Stanford University in America are reported to have halted treatments after one patient died from a brain haemorrhage following a procedure and another required emergency open heart surgery after a jugular vein stent dislodged.

    The MS Society says it is open to receiving grant applications to fund research into CCSVI within the UK.

    Dr Doug Brown, biomedical research manager at the society, said: "The MS Society has followed reports on CCSVI closely but we need to see more evidence before we can make any firm conclusions on whether CCSVI can cause MS or whether treating it would have any effect on MS. We would not advise people to seek unproven treatments outside of a properly controlled clinical trial."

    A Department of Health spokesperson said: "The NHS is constantly expanding the range and types of treatments available and we are always interested to know about new and innovative treatments that will not only provide benefits for the patients but for the NHS as well.

    "Surgery is not without risk and all new treatments must be examined for their effectiveness, safety and cost. We look forward to further research in this area."

    A group is trying to get this treatment set up in the UK. Visit http://www.ms-ccsvi-uk.org/ for details.

    Source: thisisgloucestershire.co.uk Copywrite Gloucestershire Media Ltd. (15/03/10)

    Dr Dake's CCSVI Presentation To The SIR 25th Annual Scientific Meeting

    Part 1

    Part 2

    BNAC CCSVI Update 12/03/10

    BNAC Logo

    BNAC CCSVI UPDATE - http://www.bnac.net/?page_id=561

    MS Society of Canada - CCSVI Web Streaming Event

    MSS of Canada Logo

    MS Society Of Canada - CCSVI Web Streaming Event - http://www.mssociety.ca/en/research/ccsviWebcast.htm

    Date:Wednesday, April 7, 2010

    Time:1:00pm - 3:00pm E (6pm - 8pm GMT) 

    Donors have the power to get MS research underway

    Charity Intelligence LogoSubmitted to the Globe and Mail – by Charity Intelligence Canada

    Donors have the power to get MS research underway.

    The Globe and Mail reported Buffalo’s preliminary but promising results on MS research adding further evidence to the existence of blocked veins in people with MS. The discovery of Dr. Zamboni continues to gain merit. Two years ago his published report based on his findings sparked a new avenue of research into MS, which only continues to gain momentum.

    Dr. Zamboni’s findings, known as Chronic Cerebrospinal Venous Insufficiency (CCSVI), show that MS may be triggered by a ‘plumbing problem’ rather than the auto-immune theory pursued for the last 60 years. When veins in the neck are blocked or constricted, blood is pushed back up into the brain, perhaps causing the inflammation and brain lesions seen in people with MS.

    This contrarian idea is naturally raising eyebrows. Could this devastating disease that affects and estimated 1.5 million people worldwide be related to such a common sense idea? And if so, the treatment of angioplasty could offer the first possibility of remission for some symptoms of MS.

    The medical establishment is legendary in its resistance to new ideas. The trials of Dr.s Marshall and Warren from Australia have become well known. Dr. Marshall, an unknown pathologist, and Dr. Warren, then a medical intern, made the medical breakthrough that stomach ulcers were not caused by stress or spicy food, but rather by bacteria. After four years of unsuccessfully battling the establishment, Dr. Marshall drank a toxic potion, giving himself stomach ulcers and then took his cure to prove antibiotics were effective. Ten years after the discovery, antibiotics became the recognized treatment ending suffering for millions of people. Subsequently, researchers re-examined bacteria’s role in medicine, finding new roles played in heart disease and cancer.

    Skeptics tell Canadians with MS to wait and be patient for more work to be done. Yet MS is a progressive disease leading to permanent brain damage and disability. It is the most common neurological disability affecting young adults. Most people with MS are diagnosed between age 20 and 40. Within 10 years of diagnosis, 70% can no longer work. Disability payments and health care costs for MS add up to $1.1 billion each year in Canada. Time is a luxury people with MS don’t have.

    Is it any wonder thousands are requesting ultrasounds of their necks, volunteering to be guinea pigs to be a part of the advancement of knowledge that so directly impacts them?

    This is a most exciting time for MS research. This could be one of those rare leaps forward in science. After decades of minor incremental steps in treatment, this is a glimmer of hope for some with MS.

    CCSVI is a legitimate scientific theory that merits funding for further investigation and evidence. Yes, this is just the beginning. Yes, more work needs to be done. Yet nothing is happening in Canada for want of $1.5 million in funding.

    Two preliminary and rigorous studies into CCSVI will cost $1.5 million. UBC in collaboration with the University of Saskatchewan is seeking $1 million, with less than$10,000 received to date. The St. Joseph Healthcare and McMaster initiative in Hamilton requires $500,000. With this funding it could be up and running within two weeks with results by year end. The MS Society of Canada may award each of these initiatives $100,000 in June 2010.

    The power to get CCSVI research underway is in the hands of Canadian donors. Canadians care about MS. Last year Canadians gave $62 million to charities working in the MS sector. Donors can bypass the skeptics by donating directly to Canada’s research institutes waiting to get started.

    Donations should be made to St. Joseph’s Healthcare in Hamilton and UBC Faculty of Medicine, specifically restricting donations for CCSVI research. This direct route is fastest and most cost-efficient.

    Has there ever been a time when $1.5 million in donations can achieve such high impact – a legacy perhaps similar to underwriting Banting and Best, advancing medical knowledge, and potentially bringing us closer to ending MS?.

    Respectfully submitted

    Kate Bahen, CFA
    Managing Director
    Charity Intelligence Canada

    Source:  Charity Intelligence Canada (10/03/10)

    MSRC comments on Stanford University reportedly halting CCSVI treatments after two serious adverse events

    CCSVI Blood Flow DiagramResearchers at Stanford University have halted treatments for chronic cerebrospinal venous insufficiency (CCSVI) according February's edition of the journal Annals of Neurology.

    The decision came after two people experienced serious side effects following stenting of the jugular veins, a procedure thought to correct CCSVI. One patient died from a brain haemorrhage following the procedure in August and another required emergency open heart surgery in November after a jugular vein stent dislodged into the right ventricle of the heart.

    Dr Jeffrey Dunn, associate director of Stanford's MS centre, called on other neurologists to speak out about the potential "dangers" of the unproven procedure: "If I can do anything to protect MS patients from the potentially devastating effects of false hopes or the risks of invasive and unproven treatment, I am happy to do so".

    Helen Yates, Chief Executive of the Multiple Sclerosis Resource Centre (MSRC) said: “Whilst the case of the man who had to have open heart surgery to deal with a slipped stent is accurate, the case of the woman who had a haemorrhage is less so.  The lady in question had a pre-existing condition that  meant she was much more susceptible to haemorrhage, in fact it has been ascertained since her death that it was nothing to do with the procedure at all and was, in fact, an adverse drug reaction to one of the blood thinning drugs exacerbating  a genetic familial problem.  The first case is, of course, a reminder that no procedure is without risk and with stenting, there is always a slight risk of the stent coming loose.

    It is important that these two cases are viewed accurately and in perspective”

    The theory that CCSVI may play a role in causing MS was developed by Italian Cardiovascular Surgeon Dr Paolo Zamboni and has resulted in much debate and controversy. It has also sparked interest in many of the 2.5 million people with MS world-wide as a potential cause of MS.

    Dr John Richert, executive vice president for research and clinical programs at the National Multiple Sclerosis Society in the USA said, "When dealing with a disease like MS, where we don't know the cause or have many therapeutic options, it's important to think outside the box. Dr Zamboni is doing this, but his techniques need to be confirmed.

    He went on to add, "All of the evidence today is preliminary. There is not even enough evidence to say that obstruction of veins might be a factor in MS, or to determine when this obstruction may occur in the course of disease."

    MS Societies around the world have emphasised that new research studies will be pivotal in determining the link between CCSVI and MS before surgical procedures should be made available to treat CCSVI.

    Researchers in Buffalo NY are investigating the prevalence of CCSVI in people with MS. Dr Robert Zivadinov, Director of the Buffalo Neuroimmaging Analysis Centre and principle investigator of the Buffalo says: "If we can prove our hypothesis, that cerebrospinal venous insufficiency is the underlying cause of MS, it's going to change the face of how we understand MS", but he added that media coverage of CCSVI so far has been premature and "unrealistic".

    Source: MSRC &Medical News Today © 2010 MediLexicon International Ltd  & MSRC (08/03/10)

    Stars are all coming out for Tiger

    Tim StevensGlasgow’s top stars are to appear on stage at a special benefit night for one of the city’s best-loved entertainers.

    Pop stars such as Marti Pellow, Midge Ure and Hue and Cry will appear on the bill at the Pavilion theatre in Tribute To Tiger Tim.

    All proceeds will go to a special benefit fund to send veteran DJ Tim Stevens, who is battling multiple sclerosis, to Poland for radical new treatment.

    Also on the bill will be Tony Roper and Gerard Kelly, who will appear as Francie and Josie, and Tam Cowan.

    The glittering event, on Saturday, May 15, promises to be one of the best variety shows in the theatre’s history.

    Pavilion boss Iain Gordon said: “There are few people as popular in Glasgow as Tim Stevens.

    “When I heard that Tim was having to raise £9,000 to pay for his treatment I figured it shouldn’t be down to him to pay this sort of money out of his own pocket, so I offered up the theatre for a special show.

    “It really makes so much sense. Tim once starred here in panto, and as a radio presenter and charity worker he’s given so much to the city.

    “It’s fantastic that our top performers are prepared to recognise that. And I’m sure the public will want to enjoy the night and show their appreciation for all that Tim has done for them.”

    Tim and his wife Caroline will attend the event, being organised by Wet Wet Wet drummer Tommy Cunningham.

    Ex-Radio Clyde DJ Paul Coia will host the event and several other top Clyde DJs will make an appearance.

    Tommy said: “Tim Stevens is a man of the people. He’s been a great broadcaster and communicator but, more importantly, he’s a great bloke.

    “When I left the band, Tim was one of the first people to call and offer support.”

    The evening will also feature filmed messages of support for Tim and show his career highlights.

    The finale will feature all the performers on stage for a rendition of the Beatles classic, With A Little Help From My Friends.

    Tiger Tim’s MS was first diagnosed in the late 1980s and his condition has steadily deteriorated and he now uses a wheelchair.

    However, in recent months new hope for MS sufferers has emerged with a surgical procedure called ‘the liberation procedure’.

    Tim’s wife Caroline said: “I heard about this CCSVI treatment from family in Canada and since then we’ve been tracking down more information from Italy, America and Poland before deciding to go ahead. From what we’ve discovered, the results achieved in Poland seem to be incredible.”

    The surgery is based on the theory that MS is caused by narrowed veins.

    However, there are no guarantees that it will cure Tim. But Tim, 58, who has tried almost every possible ‘cure’ for MS over the years, is optimistic.

    He said: “I hope to have some degree of success. But what I want most is to be able to offer some degree of hope to the other 80,000 MS sufferers in Scotland.”

    Tickets for Tribute To Tiger Tim, priced £25, will go on sale at the Pavilion on Monday.

    Source: Evening Times © 2010 Herald & Times Group (05/03/10)

    Multiple Sclerosis sufferer shows improvement after CCSVI treatment in Poland

    CCSVI Blood Flow DiagramA mother from Seaford said her MS sufferer daughter has shown initial improvements after travelling to Poland for tests.

    Michele Findlay made the trip with her 30-year-old daughter Ella and Ella's boyfriend last month.

    Since returning to the UK the Kedale Road resident said Ella, who was diagnosed with multiple sclerosis 10 years ago, has seen some positive changes.

    Mrs Findlay said her daughter did not feel much in the way of improvement in the first four to five days but added, "Her feet are warmer and that is one of the problems she had for a long time with the inability to keep her feet warm. When we got home she seemed to be more energetic and she says she is walking better and walking longer distances than she had been in the last nine, 10 months.
    "People are noticing that she is more alert and more energetic."

    Mrs Findlay travelled abroad to find out if her daughter had Chronic Cerebrospinal Venous Insufficiency (CCSVI). This follows a preliminary study by a leading surgeon called Dr Paolo Zamboni from Italy who used ultrasound and magnetic resonance venography to examine the blood vessels leading in and out of the brain of hundreds of patients. He found that the majority of all his patients with multiple sclerosis he treated had defective circulation in their neck - a defect he has called CCSVI. Mrs Findlay said tests on Ella showed that she did have CCSVI.

    She added, "I'm pleased that we had the most experienced doctor in this to look at her because if it hadn't been for his experience at treating patients we may well have come home without any treatment at all because it wasn't very obvious at first sight where the problem was.

    "They found it in the right jugular vein between the jaw and ear."

    After tests confirmed CCSVI the Farnham resident then had what is called liberation treatment which in her case involved being injected with an opaque dye and then a deflated balloon is guided up to the point of constriction and once there is inflated to widen the vein.
    The procedure is designed to help free the blood flow.

    Mrs Findlay said, "There is a worry that the vein will collapse and that could happen tomorrow, in six months or a year but if it remains opens for as long as a year then they would do another treatment using the balloon. Hopefully things will improve some more, if the only thing that happens is she doesn't get worse that's good as well."

    Mrs Findlay has, with another UK resident Gary Barclay, helped to set up a website about CCSVI.

    For more information visit: http://www.ms-ccsvi-uk.org/

    Source: Eastbourne Herald ©2010 Johnston Press Digital Publishing (03/03/10)

    UBC researchers planning to study Multiple Sclerosis vein theory

    Venous system of head and neckA medical centre in British Columbia says it wants to become the first in the country to test the controversial theory that multiple sclerosis patients have blocked veins, preventing proper blood flow from the brain.

    "There's a large demand for us to look into this," Dr. Anthony Traboulsee told CTV News. "Patients are very excited. We are very interested ourselves, and we want to meet the demand of our patients."

    A group of researchers at the University of British Columbia MS Clinic, part of the Vancouver Coastal Health Authority, are planning to study the theory, using a variety of imaging techniques. If it gets approval and funding, it appears to be the most comprehensive examination of this novel theory in the world.

    They will be studying the findings of Italian researcher Dr. Paolo Zamboni, who believes that blocked veins in the neck and chest of MS patients lead to blood drainage problems and triggers the immune responses that mark the disease.

    Zamboni contends that angioplasty surgery on these blocked veins, a procedure he calls the Liberation Treatment, can then open them. A preliminary study of the treatment in 65 patients showed it improved the quality of life for many patients, and as long as the veins remained open, symptoms of MS were reduced and new attacks were halted.

    The BC team envisions a study that begins with MS patients being scanned for abnormalities, likely using the ultrasound test pioneered in Italy. They would also be given MRI scans, to see how the different tests detect possible problems. The prevalence of vein problems would also be assessed in MS patients and in normal healthy control patients. Data would also be blinded to minimize the risk for bias in the research.

    Once these non-invasive scans have been done, test patients would proceed to the angiography suite. There they would undergo a venogram. That's where a probe is inserted, from the groin, into the vein system that travels through the chest and into the neck. Doctors inject a dye and watch the blood-flow. This is also, according the University of Ferrara team, the definitive way of seeing blockages in the jugular veins in the neck and the azygos vein in the chest.

    And if there are blocked or narrowed veins, the UBC researchers want to open them up to see what happens.

    "Not only do we want to see if we can detect these abnormalities, we also want to see, if we change them, does it improve peoples' lives?" said Traboulsee.

    The B.C. researchers, who include radiologists, vascular specialists, and physicists working on new imaging technologies, say they had heard about the theory before CTV's W5 aired a story describing the theory, and were investigating the possibility of a study.

    But interest in the theory in Canada has exploded since the episode aired.

    A professor of neurosurgery at the University of Buffalo, Dr. Robert Zivadinov, who worked on an early study with Zamboni, says his office was contacted by 8,000 MS patients in the three weeks after the W5 episode aired.

    The Vancouver researchers want to determine the prevalence of the vein abnormality, which Zamboni has dubbed CCSVI -- or chronic cerebrospinal venous insufficiency. They also want to know how easily it can be detected with ultrasound and MRI testing.

    Joining the study will be Alex Rauscher, a physicist. He hopes to look at MRI scans of patients to search for evidence of iron deposits in the brain, since some research has suggested that iron in the brain may contribute to the inflammation and the immune system attacks that mark MS.

    "It is our duty to find the answers," said Rauscher.

    The Vancouver Coastal Health researchers say they have applied for funding from the MS Society of Canada to fund research to determine the most practical and reliable test for CCSVI. But because of the size and scope of the study -- and their desire to begin quickly -- they are also accepting funding from other agencies and private donations.

    Donations should be directed to: VGH and UBC Hospital Foundation  - UBC Faculty of Medicine (funds can be specified for CCSVI research)

    The researchers note that their study is not accepting patients yet and likely won't for a few months until they acquire funding, obtain ethical approval, and develop an MRI and ultrasound testing protocol.

    Patients are asked to refrain from contacting the clinics until they are ready to proceed with the study.

    Meanwhile in Italy, one of the companies that manufactures the ultrasound machines used in the testing for CCSVI, is beginning to hold training sessions for doctors and technicians who want to learn the novel technique for scanning the neck and head.

    One training program is being held this week at the University of Ferrara with technicians who developed the tests, and with Zamboni. A second session is planned for March.

    Contact information for the course is available through: [email protected]

    Source: CTV News © 2010 CTVGlobeMedia (03/03/10)

    Chronic cerebrospinal venous insufficiency (CCSVI) and multiple sclerosis - counter arguments

    CCSVI Blood Flow DiagramChronic cerebrospinal venous insufficiency and multiple sclerosis

    Omar Khan, MD 1 *, Massimo Filippi, MD 2, Mark S. Freedman, MD, FRCPC 3, Frederik Barkhof, MD, PhD 4, Paula Dore-Duffy, PhD 1, Hans Lassman, MD 5, Bruce Trapp, PhD 6, Amit Bar-Or, MD, FRCPC 7, Imad Zak, MD 8, Marilyn J. Siegel, MD, FACR 9, Robert Lisak, MD, FRCP 1

    1Multiple Sclerosis Center, Department of Neurology, Wayne State University School of Medicine, Detroit
    2Neuroimaging Research Unit, Scientific Institute and University Hospital San Raffaele, Milan
    3Multiple Sclerosis Research Unit, The Ottawa Hospital General Campus, University of Ottawa, Ottawa
    4Department of Radiology and Amsterdam MS Center; VU University Medical Center, Amsterdam
    5Centre for Brain Research, Medical University of Vienna, Vienna
    6Department of Neurosciences; Lerner Research Institute, Cleveland Clinic, Cleveland
    7Montreal Neurological Institute, McGill University, Montreal
    8Department of Radiology; Wayne State University School of Medicine, Detroit
    9Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis
     
    *Correspondence to Omar Khan, Multiple Sclerosis Center & Image Analysis Laboratory, Department of Neurology, Wayne State University School of Medicine 4201 St Antoine, 8A-UHC, Detroit, Michigan 48323

    Ph: (313) 745-4280; Fax: (313) 966-9271

    Abstract
    A chronic state of impaired venous drainage from the central nervous system, termed as chronic cerebrospinal venous insufficiency (CCSVI), is claimed to be a pathologic phenomenon exclusively seen in multiple sclerosis (MS).

    This has invigorated the causal debate of MS and generated immense interest in the patient and scientific communities.

    A potential shift in the treatment paradigm of MS involving endovascular balloon angioplasty or venous stent placement has been proposed as well as conducted in small patient series.

    In some cases, it may have resulted in serious injury.

    In this Point of View, we discuss the recent investigations that led to the description of CCSVI as well as the conceptual and technical shortcomings that challenge the potential relationship of this phenomenon to MS.

    The need for conducting carefully designed and rigorously controlled studies to investigate CCVSI has been recognized by the scientific bodies engaged in MS research.

    Several scientific endeavors examining the presence of CCSVI in MS are being undertaken.

    At present, invasive and potentially dangerous endovascular procedures as a therapy for patients with MS should be discouraged until such studies have been completed, analyzed, and debated in the scientific arena. 

    Annals Of Neurology © 1999-2010 John Wiley & Sons, Inc.


    An Open Letter to the Authors of Chronic Cerebrospinal
    Venous Insufficiency and Multiple Sclerosis (Khan et al,
    2010, Annals of Neurology)

    Ashton Embry, Direct-MS

    Background: A week ago a “Point of View” article on Chronic Cerebrospinal
    Venous Insufficiency and Multiple Sclerosis was made available online at the
    website of Annals of Neurology.

    It was written by 11 authors, with both
    neurologists and radiologists being represented. Notably 7 of 11 authors
    (including the first four, senior authors) disclosed significant financial interests
    with pharmaceutical companies which produce drugs for MS (see Appendix).

    In their opinion piece, the authors discussed Dr Zamboni’s published work on
    CCSVI and concluded it should be considered “preliminary”. To my knowledge
    no one has ever considered it to be otherwise. Most of the article consisted of
    points and arguments that suggest it is not reasonable to consider CCSVI to be
    the main cause of the MS disease process. Such a discussion has some value
    although I must point out few are claiming CCSVI is the main driver of MS. Dr
    Zamboni has been very clear on this and simply says CCSVI may be a significant
    contributor to MS onset and progression. Thus, in their Point of View, the authors
    essentially put up a straw man and then spend most of the article taking it apart.
    Overall, most of their arguments against CCSVI as the main cause of MS are
    readily dismissed once MS is seen as an autoimmune disease often exacerbated
    by the presence of CCSVI.

    The only truly offensive part of the article was the authors’ attempt to rationalize
    their self-serving desire that no one with MS should be tested for CCSVI. They
    emphasized the very rare occurrence of a serious adverse event associated with
    endovascular treatment and totally neglected to discuss the risks of not being
    tested and treated for CCSVI. Such a one-sided rationalization which is nullified
    by a blatant conflict of interest of most of the authors cannot be taken seriously.

    Below is an open letter to the authors.

    Dear Dr Khan and fellow authors,

    I recently read your opinion piece on CCSVI which was made available online in
    Annals of Neurology (Khan et al, 2010) last week. I see it as part of “MS Wars:
    Part II – The Medical Empire Strikes Back”. Overall, I enjoyed reading your article
    because I always find it useful to read the arguments of those who hold a
    different opinion than me on an important subject. I was also pleased that you
    restrained yourselves and did not follow Mark Freedman’s infamous lead and call
    Dr Zamboni’s work “a hoax”. The only part of the article I found distasteful was
    your advice for persons with MS to not get tested for CCSVI for at least 5-10
    years (while further research is being done). I discuss this point in detail later.

    For a more up to date and more objective opinion piece on MS and CCSVI, I
    direct you to my recent article “CCSVI and Multiple Sclerosis: Integrating New
    Data to Help Guide Actions” which can be downloaded at http://tinyurl.com/yf36ege.

    This article interprets the relationship between the
    CCSVI and MS in light of the recently available results from CCSVI-related
    studies at the universities of Buffalo and Georgetown. Given you must have
    known this critical information would be available in early 2010, I am surprised
    you rushed into print before such crucial data were available. This made your
    “Point of View” hopelessly outdated on the day it became available. I can only
    surmise you did not want any solid data from the Buffalo and Georgetown studies
    to cause problems for your critique.

    In my article I also address the question of whether persons with MS should get
    tested and treated for CCSVI as soon as possible or should wait 5-10 years until
    major clinical trials are completed and analyzed. A reasonable answer to this
    question depends on the major new data from the universities of Buffalo and
    Georgetown. Your analysis of this same question without the benefit of these
    crucial data is sadly premature and poorly supported. As I will discuss later, my
    advice on this key question is the opposite of yours and, unlike yours, mine is
    supported by the new data and is not hopelessly compromised by unacceptable
    and major conflicts of interest.

    To me, given the robust results of the University of Buffalo Phase 1 study and the
    findings of hundreds of endovascular procedures which have already been done
    to relieve CCSVI (almost all have found major blockages in the veins draining the
    brain), there can be little doubt that CCSVI is associated with MS. And, as I
    argue in my article, because the vascular malformations which constitute CCSVI
    are mainly congenital (Georgetown data), there can be little doubt that CCSVI is
    an important factor in the MS disease process in many cases (definitely not all
    cases). Of course, without this new data, you could not offer any worthwhile
    opinions on whether or not CCSVI is part of MS.

    Furthermore, any claim that the established, robust association of CCSVI and
    MS is purely coincidental cannot be taken seriously although I am sure such an
    implausible thought will be offered by some. In my article, I interpret MS as an
    autoimmune disease which, in many cases, is exacerbated by the co-occurrence
    of CCSVI (in 25% of the healthy population and perhaps up to 60% of persons
    with MS according to the University of Buffalo work). I find the “either it’s
    autoimmune or it’s CCSVI” polarity which dominates your article to be overly
    simplistic. An integration of the two phenomena is the most reasonable model
    because both have very strong evidence supporting their involvement in MS. Of
    course, the new data were required for such an integrated model to become
    obvious.

    Another key question which you could not evaluate without the new data is
    whether or not CCSVI contributes to MS progression. The University of Buffalo
    results nicely show that the higher the disability, the higher the chance that
    CCSVI is involved. The congenital origin of the vascular malformations dictates
    that such results mean that CCSVI is an adjuvant to the MS disease process. If
    one has MS and CCSVI they have a much higher chance of progressing to a
    higher disability level than a person with MS but no CCSVI. Given the potential
    adverse effects of CCSVI on the CNS vascular system, such an empiricallysupported
    association is certainly rational and plausible.

    The argument that this relationship is due to MS causing CCSVI, an argument
    you mentioned in your article, is ruled out by the data although once again I am
    sure such an illogical interpretation will continue to be put forth. Many of you
    have experience with EAE, the animal model for MS as an autoimmune disease.
    I suggest you try to see the relationship of CCSVI and MS as being similar to the
    addition of tetanus toxin (opens BBB) to the myelin/adjuvant mix which drives
    autoimmunity in EAE.

    Given the above, if one has MS, they would be wise to get tested for CCSVI and,
    if necessary, treated for it. This is based on the logical reasoning (precautionary
    principle) that the chance of harm associated with doing nothing (i.e. progressing
    more rapidly and farther if CCSVI is present) is substantially greater than the
    chance of harm associated with having endovascular surgery to relieve CCSVI
    (extremely rare, serious side effects). As Mark “It’s a Hoax” Freedman correctly
    and perhaps prophetically said, “Time is Brain” (Freedman, 2009). With this, and
    the apparent role of CCSVI as an accelerant of the MS disease process, in mind,
    persons with MS do not have the luxury to follow your self-serving, time table and
    wait 5-10 years for what you see as required research to be completed.

    Of course, most people with MS realize the obvious and are desperately seeking
    such testing and treatment. Who wouldn’t if they had MS and were progressing
    (the current drugs really don’t do much for most in the long run). Notably, most
    neurologists are unable to understand or empathize with such a logical decision
    to want to get CCSVI treated if present. The advice in your opinion piece of not to
    get treated for CCSVI for at least 5 -10 years from now is both irresponsible and
    dangerous. And this brings us to the topic of the serious lack of objectivity of
    such advice.

    One big problem with you saying not to get treated for CCSVI is that almost all of
    you are closely aligned with the pharmaceutical industry and thus have a major
    conflict of interest when you offer such advice. Should we heed the advice of
    scientists closely allied with the petroleum industry when it comes how to
    address the potential problems of global warming? Of course not! We do not
    heed it because they have a blatant conflict of interest so we just don’t know if
    they are pulling a fast one or not. One thing we know for sure, it is highly unlikely
    their advice will be objective.

    Like it or not, the long list of drug company associations for most of the authors
    (see appendix below) disqualifies your “Point of View” as being a credible source
    when it comes to advice on what to do about a non-drug treatment like CCSVI. I
    would stress, you can’t have it both ways. You can’t take money from drug
    companies and then turn around and offer advice on a treatment which
    potentially would harm the drug companies. Naturally your advice is going to be
    “Don’t use the non-drug treatment. Use only the drugs”. How can it be otherwise
    and that is why advice from those with obvious conflicts of interest is self-serving
    and worthless. It is too bad that most neurologists aren’t like George Ebers of
    Oxford University and rise above the temptation to take the easy money from the
    drug companies and thus escape a barefaced conflict of interest.

    In summary, your Point of View is completely out of date and your advice
    regarding CCSVI testing and treatment is totally compromised and of no value. It
    is also potentially very harmful for persons with MS. Five to ten years is a very
    long time to have to wait for testing and treatment of CCSVI and such a long time
    represents a huge amount of lost brain (Time is Brain). I can only suggest you try
    hard to take a patient-centred, evidence-based approach and do everything you
    can to make testing and treatment of CCSVI available as soon as possible.

    Sincerely,

    Dr Ashton Embry
    President, Direct-MS

    Appendix- Financial Disclosures of the Authors

    Dr Khan has received research support from the National MS Society (NMSS),
    the National Institutes of Health (NIH), Teva Neuroscience, Genzyme Corporation, Biogen Idec,
    Novartis Pharmaceuticals, and Acorda Therapeutics; consultancy and speaking honoraria from
    Teva Neuroscience, Biogen Idec, Novartis Pharmaceuticals, and Bayer Healthcare.

    Dr. Filippi has received research support from Bayer-Schering Pharma, Biogen-
    Dompé AG, Genmab A/S, Merck Serono, Teva Pharmaceutical Industries Ltd.,
    Fondazione Italiana Sclerosi Multipla (FISM), and Fondazione Mariani; consultancy and speaking
    honoraria from Bayer Schering Pharma, Biogen-Dompé AG, Genmab A/S, Merck Serono, Teva
    Pharmaceutical Industries Ltd.

    Dr. Freedman has received research support from the Canadian MS Society, EMD Merck-
    Serono, Genzyme, and Bayer Schering Pharma; consultancy and speaking honoraria from Teva
    Neuroscience, Bayer Healthcare, and EMD Merck-Serono.

    Dr Barkhof has received research support from the Dutch MS Research Foundation and Merck-
    Serono; consultancy and speaking honoraria from EMD Merck-Serono, Bayer-Schering Pharma,
    Biogen-Idec, UBC, Sanofi-Aventis, Novo-Nordisk.

    Dr Dore-Duffy has received research support from the NMSS and the NIH.

    Dr Trapp has received research support from the NIH, NMSS, Canadian MS Society, Ohio Third
    Frontier, Vertex, and EMD Merck-Serono; consultancy and speaking honoraria from Teva
    Neuroscience, Biogen Idec and Pfizer.

    Dr. Bar-Or has received research support from the MS Society of Canada (MSSC) and the MSSC
    Research Foundation, The Canadian Institutes of Health Research, the FRSQ, Bayhill
    Therapeutics, Biogen Idec, Bio MS, Genentech, and Teva Neuroscience; consultancy and
    speaking honoraria from Biogen Idec, Eli Lilly, Genentech, MerckSerono, Novartis, Roche and
    Teva Neuroscience.

    Dr Lisak has received research support from the NMSS, NIH, Teva Neuroscience, and Questcor;
    consultancyand speaking honoraria from Teva Neuroscience and Bayer Healthcare.

    Drs Siegel, Lassmann, and Zak have nothing to disclose.

    Miracle MS 'cure' made me feel 'born again'

    CCSVI Blood FlowMultiple sclerosis is a devastating disease which, until recently, had no possible cure.

    Martin Jones suffered with MS for 13 years. But following a groundbreaking operation on his veins, Martin is now enjoying using parts of his body he thought he had lost forever. Reporter HOLLY THOMPSON talks to him about his remarkable recovery.

    This time last year, Martin Jones could hardly leave the sofa.

    His body would spasm involuntarily, he couldn't walk, he couldn't sleep because his arms and legs twitched at random, and he would regularly choke on his food.

    "I was very close to being put in a nursing home and then probably dying," said Mr Jones.

    "I had lost my life. As far as I was concerned it was over. I couldn't do anything – just lie there on the sofa endlessly trying to sleep. I was basically paralysed."

     
    Now he can happily open the door to visitors, drive his car, and get up the stairs in one go.

    He is almost completely cured of a disease which doctors claim is incurable. And all it took was two operations on his veins under local anaesthetic.

    Mr Jones, 43, said: "I feel born again.

    "Life was pretty much over for me but now I'm trying to find time to fit in everything I want to do."

    The retired IT analyst was diagnosed with MS 13 years ago.

    He said: "I suddenly started to lose my balance and began accidentally treading on people's feet in the tube.

    "I went to the doctors for a scan, and it took them two years to diagnose MS.

    "They told me it was progressive and therefore incurable. It was a crushing blow but I tried not to let it get me down."

    Over the next few years Mr Jones's body began to deteriorate. He was forced to retire and spent his time lying on the sofa desperately scouring the internet for a cure. And last year, he struck gold.

    Mr Jones, of Sycamore Drive, Woodhatch, said: "I read about this syndrome called chronic cerebrospinal venous insufficiency(CCSVI) and how it can be cured with a simple operation. I was on the phone immediately to book myself in.

    "I had to travel to Poland to get it done but it was worth it. The moment it was over the first thing I realised was that I could feel my feet. I hadn't felt them for years. It was amazing."

    Mr Jones had his first operation in November last year, and the second in January. He now wants to use his newly-restored health to help others suffering from MS.

    He said: "The experience has made me evangelical. I want everyone to know about CCSVI and what it means.

    "Scientists in this country are dismissing the treatment and calling it a placebo, but I'm proof that it works and that there is hope for MS sufferers all over the world."

    Mr Jones and other MS sufferers are lobbying the Government to take this treatment seriously and perform it in the UK. To sign their petition, go to http://petitions.number10.gov.uk/CCSVINOW/

    Source: thisissurrey.co.uk (c) East Surrey & Sussex News and Media Ltd (23/02/10)

    Alberta Health Services statement on venous imaging and angioplasty in Multiple Sclerosis (MS)

    Alberta Health Services LogoAlberta Health Services Position

    1.At this time, it is only a hypothesis that CCSVI contributes to, or causes, Multiple Sclerosis, and that venous angioplasty is clinically beneficial.

    2.Further, independent and controlled studies are required to prove, discount, or better understand Dr. Zamboni’s study results.

    3.The nature and frequency of the risks on venous angioplasty are not yet fully understood. Without a clear indication that venous angioplasty carries a clinical benefit that outweighs the risks, it cannot yet be supported as standard practice.

    4.At present, there is no proven indication for venous imaging or venous angioplasty in patients with Multiple Sclerosis. Therefore, unless part of an approved research protocol, these procedures will not be provided by AHS to persons with MS.

    5.If, and when, there is independent scientific validation of Dr. Zamboni’s results, Alberta Health Services will seek approval from Alberta Health and Wellness, under the province’s health technology assessment process (described at http://www.health.alberta.ca/initiatives/AHTDP.html), to introduce the new procedure into practice in Alberta.

    Full Statement - http://www.albertahealthservices.ca/1409.asp

    CCSVI and Multiple Sclerosis: Integrating New Data to Help Guide Actions

    Direct-MS LogoAuthor: Ashton Embry, Direct-MS (www.direct-ms.org)

    Summary
    The recent scientific results on CCSVI and MS from both the University of Buffalo and Georgetown University have essentially left very little doubt that CCSVI is a causal factor in MS in the majority of, but not all, cases. Furthermore, persons with MS with more disability are much more likely to also be affected by CCSVI and thus there is little question that CCSVI accelerates the MS disease progression. Given the above, every person with MS should be tested for CCSVI.

    If CCSVI is detected, it should be treated as soon as possible. Persons with MS do not have the luxury to wait five to ten years for research to prove what is reasonably well established at present. Nutritional strategies which counter CCSVI, BBB breakdown and autoimmune reactions are essential both before and after CCSVI treatment.

    Full article : CCSVI and Multiple Sclerosis: Integrating New Data to Help Guide Actions 

    Multiple sclerosis sufferers lobby for research into radical new treatment

    Prof. ZamboniA group of local multiple sclerosis sufferers are urging residents to lobby their MP to support a radical new treatment for the chronic illness.

    The 20-strong group, which meets at the Multiple Sclerosis Forum at the Sanctuary of Healing, Langho, want more research into the theory MS is a vascular disease that can be treated by a simple surgical procedure.

    They are asking people to send a letter, which the group has compiled, to their local MP asking for pressure to be placed on the Minister of Health to sanction vascular scans and follow-up treatments for all MS patients.

    The theory that MS is a vascular disease that can be treated with angioplasty, which clears blockages in veins, is the work of Italian Dr Paolo Zamoni. His early findings suggest MS may, in fact, be a condition called CCSVI, which stands for chronic cerebro-spinal venous insufficiency.

    Dr Zamboni believes CCSVI causes veins in the neck and upper chest to twist, narrow or become blocked; in some cases, these veins never form at all. The result is poor blood drainage from the brain. He found that more than 90% of patients with MS have these malformed veins, and improper blood flow from the brain.

    This theory is a radical departure from current thinking and many in the medical community remain sceptical of Dr Zamboni's work.

    However, local MS sufferers who are members of the Forum think no time should be wasted and more research should be conducted.

    Forum spokeswoman Julie Hitchen explained: "The MS Society UK is very sceptical and dragging their feet, with no plans for research into CCSVI, although there are now 10 planned projects worldwide.

    "We are asking everyone affected by MS, their families, friends, MPs, the media and the Great British public for their support in lobbying the Minister of Health to sanction vascular scans and the follow-up treatment for all MS patients in the UK."

    The letter can be downloaded from the MSRC website at http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=2964

    A petition calling for Prime Minister Gordon Brown to make the CCSVI procedure available in the UK can also be signed at http://petitions.number10.gov.uk/CCSVINOW/

    Source: The Clitheroe Advertiser & Times ©2010 Johnston Press Digital Publishing (17/02/10)

    Will drug companies censor possible MS cure?

    MS CCSVI QuestionsBy Sheila Casey 

    A former vascular surgeon from the University of Ferrara in northern Italy has apparently cured his wife and 65 other people of multiple sclerosis (MS) by using balloon angioplasty to open the narrowed veins in their necks.

    All of the MS patients who have had Paolo Zamboni’s procedure have remained attack-free, as long as their neck veins remained open. But if their veins close up again, their MS symptoms return.

    Zamboni began hunting feverishly for the cause of MS after his wife was diagnosed with the disease at age 37 and began to deteriorate. MS patients often lose the ability to walk, to talk, to feed themselves, and even to swallow.

    Scientists have known for more than 100 years that MS patients had excess iron in their brains, but assumed it was a byproduct of the disease. Zamboni noticed that the excess iron was usually in the core of the brain near a vein. In addition, the lesions that form in the brains of MS patients are grouped near veins.

    Using ultrasound, Zamboni examined the neck veins of MS patients and compared them to the veins of healthy people or those with other neurological diseases. He found that nearly 100% of the MS patients had significant narrowing in the veins that should be carrying blood from the brain back to the heart, while none of the other subjects had this narrowing.

    In addition, there was a relationship between the amount of narrowing and the severity of disease, with patients with only one blocked vein suffering milder disease and those with two or more blocked veins suffering more severely. He also found narrowing in the central vein that goes down to the heart through the chest, and patients with narrowing there often had the most serious form of MS, known as primary progressive. They deteriorate very rapidly, with no remissions.

    Zamboni reasoned that the blood that was being forced back into the brain, (because it could not drain as it was supposed to) was leaving behind excess iron, as well as forcing immune cells through the blood-brain barrier and initiating an auto-immune response. Zamboni termed the condition CCSVI, or Chronic Cerebro Spinal Venous Insufficiency.

    When he showed his findings to some neurologists, they were excited. But, Zamboni says, when he suggested a method to treat the condition, their enthusiasm waned markedly.

    Zamboni hypothesized that opening up blocked veins with balloon angioplasty – the same procedure used to open blocked blood vessels in cardiac patients – and allowing the blood to drain normally, would stop the build-up of iron in the brain and stop the progression of the disease. He teamed up with vascular surgeon R. Galeotti, and they operated on 65 MS patients with a procedure now dubbed the “Liberation Treatment.”

    Surgeons thread a thin wire through the vein and into the patient’s neck, where they expand a small balloon at the stricture to open the closed vein. Within seconds, they see the blood begin flowing normally again.

    All of the 65 patients have shown significant improvement, some immediately. Jeff Beale, an Emmy Award winning music composer, was the first American to have the procedure. He relates that, as the doctors were opening his veins, he felt “the lights come on.”

    He is now able to perform duets with his son, help his son with his homework, and has the energy to get through the day – whereas before he was continually sidelined by soul-crushing fatigue.Other patients have exclaimed, within 20 minutes of having the procedure, “I can feel my hands!” Within ten days, one woman regained use of her legs. Their health often continues to improve over the following months, with some patients returning to full health and no sign of disease at all. Others do not recover their former capacities, but suffer no new attacks.

    Zamboni said: “if you maintain open veins, you will not have more attacks, and you will not have active lesions.”

    Zamboni’s wife Elena was one of the first to have her veins “liberated,” and now, two years later, she has had no more attacks and is considered neurologically normal.

    “This, for me, is the best prize,” says Zamboni.

    The results of Zamboni and Galeotti’s study were published in The Journal of Vascular Surgery on November 24, 2009, and the response from MS patients has been overwhelming.

    Zamboni has been deluged with calls and emails from patients desperate to have the procedure before their condition degrades further.

    But the response from the MS Societies in both the US and Canada has been dismissive, with the Canadian society urging patients to “not abandon the treatment they are on,” and the US society issuing the following statement: “At the present time, there is insufficient evidence to suggest that this phenomenon is the cause of MS.”

    They have discouraged patients from seeking treatment, or even getting tested to see if their veins are blocked.

    When I called the press contact at the National MS Society to ask about CCSVI, I was told that she was busy working with ABC on a story about exciting new oral therapies for MS, and that I could find all I needed about CCSVI on their website.

    On the society’s webpage titled “Intriguing Leads on the Horizon,” no mention is made of CCSVI.

    There has been scant coverage of Zamboni’s discovery in the mainstream media.

    A search for “Paolo Zamboni,” on the websites for The New York Times, Washington Post, LA Times, CNN and MSNBC brings up, again and again, “no results found,” or “no relevant documents.”

    A Swiss blog called The Daily Bell opines about this news blackout with: “It is too often the same weary story. Establishment scientific institutions and their planetary satellites - non-profits, etc. - huddle together to keep out anything that remotely challenges business as usual. Have you read about this potential MS cure in manifold versions in the mainstream press? You would think that journalists would leap at the opportunity to cover this astonishing research. Maybe there is nothing to this, but mainstream media silence, as usual, seems deafening.”

    Exempt from this criticism are a few outlets: The Globe and Mail & W5 TV in Canada, and The Huffington Post’s Erika Milvy, who wrote: “The pharmaceutical industry stands to lose a lot if Zamboni’s one-time treatment pans out. The most common drug therapies for MS cost about $30,000 a year. And there are well over 100 medications for various MS symptoms…On one MS forum is a link to another pharma-gate headline: “Big Pharma’s Crime Spree”, in which the reporter for Bloomberg Markets Magazine assesses that “finding cures is not even remotely a consideration by pharmaceutical executives.”

    Newly radicalized MS patients are outraged at the media blackout and are banding together to publicize Zamboni’s treatment and help each other find doctors who will test their veins.

    A search for CCSVI on Facebook brings up 21 recently formed groups with names like “M.S. (Millions Strong to raise awareness of C.C.S.V.I.)” An MS patient named Andrea has created a YouTube channel called MS Vlog Support Group. In a plaintive speech to the camera, she asks. “Where is the news coverage of this? I don’t understand why it’s not all over the place. It boggles the mind.”

    As has been seen with numerous other diseases, those who make their living from people being sick are far more interested in treating symptoms than in effecting a cure that would have the patient walk out the door and never come back.

    Evidently these groups – the nonprofit MS societies, neurologists who specialize in treating MS and, most importantly, the pharmaceutical companies, who sold $8.2 billion in MS drugs in 2007 – have the power to suppress the news about this astonishing development.

    The possible threat to their livelihoods apparently trumps the value of returning health and hope to the two and a half million people worldwide who suffer from MS.

    Sheila Casey is a DC based journalist. Her work has appeared in The Denver Post, Reuters, Chicago Sun-Times, Dissident Voice and Common Dreams.

    Source: Zimbio © 2010 - Zimbio, Inc.

    Possible MS 'cure' comes to Britain

    CCSVI Blood FlowBritish doctors are set to offer patients a ground-breaking treatment for the devastating nerve disease ­multiple sclerosis.

    An Italian doctor has successfully treated MS patients with pioneering surgery to widen narrowed veins. Now specialists in this country are poised to use the same procedure.

    A private clinic said last night that it would offer the treatment within a matter of weeks in Glasgow and London.

    Dr Tom Gilhooly, of the Essentials Clinic, said: “The consultants we have been speaking to use this type of procedure elsewhere in the body and so are happy to treat MS patients with narrowed veins.”

    Until now doctors have believed MS is caused by a faulty immune system. But some experts are now convinced that damage to the nervous system may instead be caused by poor blood flow in narrowed veins in the chest, neck and head. This allows toxins to break through what is known as the blood-brain barrier to attack nerves in the brain.

    The solution, say surgeons, is to widen the veins with keyhole surgery using a balloon or thin metal tubes known as stents. Both techniques are already used to treat narrowed heart arteries.

    The discovery was made by Italian vascular surgeon Professor Paulo Zamboni, who cured his paralysed wife of MS five years ago using vein-widening surgery. Dr Zamboni says scans show the vast majority of patients with MS suffer from narrowed veins.

    New research backing his findings was released yesterday by doctors at the University of New York. They found the same vein narrowing when they scanned MS patients.

    Singer Amy Winehouse’s mother Janice, 52, who suffers MS, said: “This is very promising. I would like to find out if I could be a candidate for treatment.” Alex Gibbs, 38, is convinced the pioneering surgery has stopped her MS in its tracks.

    Mrs Gibbs, of Chelsea, travelled to Stanford University Hosp­ital in California for the operation. “The effect was immediate,” she said.

    “I was able to walk straight away and found I was able to sleep through the night because my leg spasms had gone. I haven’t felt as well as I do now since before I was diagnosed.”

    Journalist Ian Cook, of Birmingham, flew to Katowice in Poland for the same surgery three weeks ago, paying £3,500 for treatment. “I would say I’ve seen a 20 per cent improvement,” he said.

    Heart surgeon Gianfranco Campalini, from Belfast, has also been to Poland for treatment. He said: “I saw almost straight away an improvement in my condition.”

    Helen Yates, of the Multiple Sclerosis Resource Centre, said: “We are delighted that UK patients will not have to travel abroad if facilities are set up in this country. This could be a major breakthrough. If proved correct it turns the whole theory of what causes MS on its head.”

    But the Multiple Sclerosis Society said the jury was still out and more research was needed before the theory could be widely accepted.

    Source: Express.co.uk ©2006 Northern and Shell Media Publications (14/02/10)

    The science and politics of CCSVI and Multiple Sclerosis

    Dr Lorne Brandesby Dr. Lorne Brandes

    The headline over the Feb. 10, 2010 news release from the University of Buffalo, “First blinded study of venous insufficiency prevalence in MS shows promising results” seemed straightforward and encouraging. The statement went on to explain that, in the initial phase of the 500-patient trial, ultrasound (Doppler) examinations unequivocally showed narrowed neck or chest veins in 62% of patients with MS compared to 26% of normal volunteers. Complete data on these subjects will be presented at the American Academy of Neurology meeting in April.

    Describing himself as “cautiously optimistic and excited”, the study’s principle investigator, Dr. Robert Zivadinov, went on to say “[the data] show that narrowing of the extracranial veins, at the very least, is an important association in multiple sclerosis.”

    To most observers, Zivadinov’s preliminary results lend a significant degree of credence to Dr. Paolo Zamboni’s as-yet unproven hypothesis that multiple sclerosis is primarily a vascular, rather than an auto-immune disease. Zamboni has coined the term CCSVI (chronic cerebrospinal venous insufficiency) to describe the toxic backup and leakage of iron-containing blood into the brain resulting from obstructive vein abnormalities in the neck or chest, that he believes is at the root of MS lesions or “plaques”.

    Yet, the “spin” on the significance of Zivadinov’s findings depends on which news source reported them. For example, The Globe and Mail story header read, “Second MS study finds high rate of blocked veins”, while that in the National Post stated, “Research casts doubt on new MS theory”.

    Like other major news media, including the BBC , London’s Daily Telegraph, and the Canadian Press , The Globe and Mail report, written by Caroline Alphonso, limited itself to a factual report on the Buffalo results, and included comments on the inherent weaknesses in the studies to date.

    On the other hand, the National Post story, by Tom Blackwell seemed to display a distinctly negative tone. Yet, that should not come as a total surprise as it was consistent with a previous piece Blackwell wrote in the NP, entitled, “Is new MS research the real thing, or a media-driven frenzy?” It was accompanied by an article, “A cure in sight? Not so fast”, with the sub-heading “Media coverage reeks of typical hope-mongering”, authored by Financial Post editor, Terence Corcoran.

    What is going on here?

    All journalists have their expert “sources”. For example, over the years, I have advised CTV’s Avis Favaro, among others. Similarly, readers of Tom Blackwell may conclude that one of his expert sources is Dr. Mark Freedman, head of U. of Ottawa’s MS program. Dr. Freedman’s mainstream orthodoxy in the immunological treatment of MS, and his negative opinion of Dr. Zamboni and CCSVI is well documented. "I think there are going to be millions of dollars spent now to follow a hoax.... If I thought for one instant there was substance to this, I'd be all over it,” Freedman told Blackwell in January, before the interim results came out of Buffalo.

    And what did Dr. Freedman think of Zivadinov’s new findings? Commenting in Blackwell’s latest NP story on the Buffalo data showing that abnormal veins were between 2 and 3 times more common in MS patients as compared to the nine-to-one ratio reported by Dr. Zamboni, he stated, "The whole notion of cause and effect is out the window."

    Now, this is a free country where Mark Freedman, Tom Blackwell and Terence Corcoran, are entitled to their opinions. But, should not everyone, especially physicians and scientists, maintain an open mind to new and provocative information? As I noted in a previous posting, history provides us with some very sad examples attendant on the reflexive rejection of new ideas without any thought or inquiry as to their validity. Should we not learn from the past? And if we do not, how will progress be made, especially in science and the treatment of disease?

    Before giving you my personal thoughts on where we currently stand with CCSVI, it is important to remember that I am an oncologist, not a neurologist, and certainly not an MS expert like Dr. Freedman. However, especially when judging the merit of new theories, sometimes outsiders to a specialty can see the “big picture” with more clarity (and perhaps less bias) than those who are “up close and personal”. And as one who, for over 35 years, has been heavily involved in laboratory and clinical research, I believe I know a thing or two about science and (sadly) the politics of science.

    First, I continue to believe that the CCSVI theory of MS proposed by Dr. Zamboni is scientifically plausible and deserving of serious and intensive investigation. Those health professionals, and others who, for whatever reason, remain in denial should get over it and commit to finding the answer rather than obstructing progress.

    Second, I believe that the preliminary findings of Dr. Zivadinov and his colleagues in Buffalo are significant and support a link between MS and CCSVI. However, their early data are not as robust as Dr. Zamboni’s and their study raises many new questions. For example, what is the true incidence of vein abnormalities in MS patients and normal controls?  Does MS only occur or progress in people with more severe types of venous obstruction?

    While we do not yet know, it is important to understand that Dr. Zamboni used both ultrasound and the direct injection of dye into veins (called venography) to obtain his results. The first phase of the Buffalo study employed only ultrasound. Of the two tests, venography is more sensitive and definitive in demonstrating anatomical abnormalities and blockage in veins, akin to angiograms being the “gold standard” in diagnosing coronary artery disease in the heart. In acknowledging this important difference, Dr. Zivadinov has stated that more “advanced diagnostic tools” (including, I suspect, venography) will be used to test the next 500 subjects in his study.

    Finally, taking into account Dr. Zamboni’s preliminary results, there is no “level 1” evidence that unblocking veins is an effective treatment for any type of MS. As Paolo Zamboni himself has stated, the answer to that most important question will require further independent assessment and will take time, probably 3 to 5 years at a minimum, to answer. Until then, I strongly advise that patients wishing to have their veins tested, and an unblocking procedure performed, should do so only in approved clinical trials that are properly designed to insure their safety and provide an accurate assessment of efficacy.

    In this respect, Canadian MS patients are especially fortunate that centres at McMaster and UBC already have teams of neurologists, radiologists and vascular surgeons who are committed to carrying out these complex studies. While they have our thanks and best wishes for success, they also desperately need our donations. Please be generous and help if you can.
    Source: CTV News © 2010 CTVGlobeMedia (13/02/10)

    'I had controversial Multiple Sclerosis treatment twice'

    Gianfranco Campalani A team in New York has reported the first results of a trial to test the theory that restricted blood flow in the brain may underlie some of the symptoms of multiple sclerosis.

    Gianfranco Campalani knows a thing or two about the vascular system.

    He's one of Northern Ireland's leading heart surgeons.

    He was diagnosed with multiple sclerosis (MS) in 1986 - it left him with a series of problems in his lower body.

    He finds it hard to walk more than fifty yards, or he did until he met an Italian compatriot and fellow vascular surgeon Professor Paolo Zamboni.

    New theory

    Professor Zamboni has pioneered a new theory of the cause of MS and has suggested a potential new treatment.

    MS has always been thought of as an autoimmune disease.

    For reasons that are not clear, the bodies' immune system attacks nerve cells in the brain which send messages to the rest of the body.

    Professor Zamboni starting investigating MS when his wife was diagnosed with the condition.

    He discovered she had constricted jugular veins in her neck.

    His theory is that the narrow veins decrease the flow of blood from the head.

    Pressure builds up in the smaller vessels in the head leading to deposits of toxic iron from the blood which cause damage in the brain.

    He then tested a further 65 patients with MS and found they all had twisted or constricted jugular veins.

    Gianfranco was one of those patients.

    Chance meeting

    They met three years ago in Italy when Gianfranco was visiting his brother - they all come from the same town - and the conversation soon turned to MS.

    Prof Zamboni invited Gianfranco to be tested.

    What happened at the clinic was electric.

    "I nearly kissed him!" Gianfranco said. "It's funny, somebody tells you you've got something wrong and you are so happy.

    "Finally you realise MS is not a disease of unknown origin. It's due to these anomalies in the veins which are present from birth."

    A year later Gianfranco returned to Italy for treatment.

    It was done under local anaesthetic. Gianfranco watched it happening.

    Dramatic effect

    An angioplasty - a small balloon was positioned in the vein and slowly inflated.

    When the balloon is removed, the vein - which was constricted - was a normal width and the blood flows more freely.

    The effect was dramatic.

    "Five hours after the procedure I got up and I walked the corridor without my stick.

    "My partner cried.

    "She never saw me walking like that.

    "I was walking before the procedure but with a lot of difficulty.

    "I was not able to lift my leg easily.

    "But five hours after the procedure I can walk without my stick, I can lift my leg, my back is stronger I'm taller.

    "In the subsequent days and weeks I see that other functions which were not working 100%, they work."

    Last year, Gianfranco felt his condition worsen.

    He asked colleagues in Belfast to check his jugular veins.

    They had both constricted again.

    He had a repeat angioplasty in Belfast in October and claims to have improved.

    Questions

    Yesterday researchers at the University of Buffalo revealed early findings from 500 patients.

    They found that 55% of patients with MS had narrow veins in the neck - twice as much as healthy people.

    Zamboni's theory and the new research from America raises many questions.

    Is this a new explanation for the cause of MS?

    Is angioplasty of the jugular veins a potential new treatment ?

    Many experts are sceptical.

    They say at this stage there is no proof of a causal link between blood flow and MS.

    There is uncertainty about the level of pressure needed in the blood vessels in the brain for red cells containing iron to cross the blood brain barrier.

    The MS society says there have been no clinical trials of the procedure and much more work is needed.

    "We need more investigation - more scientific research into cause and effect," Gianfranco acknowledges.

    But for him, Prof Zamboni has opened up a new way of looking at MS and one that has improved his life.

    Source: BBC News © British Broadcasting Corporation 2010

    Brain blood vessels clue to MS - BBC News 11/02/10

    Research from the University of Buffalo in New York has shown patients with multiple sclerosis are more than twice as likely to have abnormal blood flow from the brain as healthy people.

    Scientists say they are cautiously optimistic that the research shows a link between narrowing veins in the head and neck and MS. Up until now MS was believed to be an auto immune disease.

    The MS society says the theory is intriguing but there's no proof that abnormal blood flow from the brain causes MS.

    http://news.bbc.co.uk/1/hi/health/8509830.stm 

    Sky News Story On CCSVI 10/02/10

    First blinded study of venous insufficiency prevalence in MS shows promising results

    CCSVI Blood FlowMore than 55 percent of multiple sclerosis patients participating in the initial phase of the first randomized clinical study to determine if persons with MS exhibit narrowing of the extracranial veins, causing restriction of normal outflow of blood from the brain, were found to have the abnormality.

    The results were reported today by neurology researchers at the University at Buffalo.

    When the 10.2 percent of subjects in which results were border line were excluded, the percentage of affected MS patients rose to 62.5 percent, preliminary results show, compared to 25.9 percent of healthy controls.

    These preliminary results are based on the first 500 participants in the Combined Transcranial and Extracranial Venous Doppler Evaluation (CTEVD) study, which began at UB in April 2009. Investigators are planning to examine 500 additional subjects, who will be assessed in the second phase of the study with more advanced diagnostic tools. Complete data on the first 500 will be presented at the American Academy of Neurology meeting in April.

    Robert Zivadinov, MD, PhD, UB associate professor of neurology and principal investigator on the study, says he is "cautiously optimistic and excited" about the preliminary data. Zivadinov directs the Buffalo Neuroimaging Analysis Center (BNAC), located in Kaleida Health's Buffalo General Hospital, where the study is being conducted.

    "The data encourage us to continue on the same course," he says. "They show that narrowing of the extracranial veins, at the very least, is an important association in multiple sclerosis. We will know more when the MRI and other data collected in the CTEVD study are available." The analyses are being conducted by an independent statistician.

    The investigation is the first step in determining if a condition called chronic cerebrospinal venous insufficiency (CCSVI) is a major risk factor for MS. CCSVI is a complex vascular condition discovered and described by Paolo Zamboni, MD, from Italy's University of Ferrara. Zamboni's original investigation in a group of 65 patients and 235 controls showed CCSVI to be associated strongly with MS, increasing the risk of having MS by 43 fold.

    Zamboni and Zivadinov hypothesize that this narrowing restricts the normal outflow of blood from the brain, resulting in alterations in the blood flow patterns within the brain that eventually cause injury to brain tissue and degeneration of neurons.

    The first 500 patients, both adults and children, were grouped based on their diagnosis: MS, clinically isolated syndrome (CIS) and "other neurologic diseases" (OND), in addition to healthy controls.

    All participants in the first phase underwent ultrasound (Doppler) scans of the head and neck in different body postures to view the direction of venous blood flow. MS subjects also underwent MRI scans of the brain to measure iron deposits in lesions and surrounding areas of the brain, using a method called susceptibility-weighted imaging. Iron findings on these images will be related to subjects' disability and neuropsychological symptoms.

    Of the total participants, 97.2 percent were adults, with the 280 MS patients comprising the largest disease cohort examined in the study to date. The majority of MS subjects were diagnosed with the relapsing-remitting form of MS. There were 161 healthy controls. Doppler scan results were reported on five specific criteria that affect venous blood flow. Patients who met at least two of the criteria were considered to have CCSVI. More detailed analysis of specific Doppler criteria and their association to disease status is underway.

    When the 10.2 percent borderline subjects were included in the "normal" category (no venous insufficiency), the CCSVI prevalence was 56.4 percent in MS subjects and 22.4 percent in healthy controls.

    In this large MS cohort, the presence of CCSVI did suggest an association with disease progression, a finding that was not shown in Zamboni's smaller cohort, Zivadinov notes.

    The finding that 22.4 percent of healthy controls also met two CCSVI criteria requires continuing investigation, he says.

    Bianca Weinstock-Guttman, MD, UB associate professor of neurology in the UB School of Medicine and Biomedical Sciences and a co-principal investigator on the study, notes that the results of the CTEVD research will pose new and provocative questions about the CCSVI theory.

    Murali Ramanathan, PhD, associate professor in the Department of Pharmaceutical Sciences, UB School of Pharmacy and Pharmaceutical Sciences, and Ralph Benedict, PhD, UB professor of neurology and psychiatry, also are major contributors to the study.

    The University at Buffalo is a premier research-intensive public university, a flagship institution in the State University of New York system and its largest and most comprehensive campus. UB's more than 28,000 students pursue their academic interests through more than 300 undergraduate, graduate and professional degree programs. Founded in 1846, the University at Buffalo is a member of the Association of American Universities.

    Source: The University at Buffalo © 2010 University at Buffalo (10/02/10)

    Leaders from the US National MS Society meet with Dr. Zamboni at NYU-hosted scientific presentation

    Prof. Zamboni and members of NMSSNational Multiple Sclerosis Society leaders met with Paulo Zamboni, MD, today in advance of his invited lecture at New York University’s MS Center of Excellence. Dr. Zamboni, of the University of Ferrara in Italy, is a vascular surgeon who has put forth the hypothesis of a connection between CCSVI, or blocked blood flow in the brain, and MS.

    In meetings and during today’s lecture, Dr. Zamboni suggested that if further evidence supports the link between MS and CCSVI, that its treatment may ultimately add to the arsenal of therapies available for MS. He also emphasized the need for more research on his hypothesis, and noted that it is still not proven whether CCSVI is a cause of MS or possibly a product of MS. Dr. Zamboni also noted that people with MS should remain on their immunomodulatory therapies as has his wife after her endovascular surgery.

    The National MS Society is aggressively pursuing this potential MS lead by undertaking the funding of new research on CCSVI in MS. Today (February 9) is the deadline for investigators to submit their research applications on this topic to both the National MS Society and the MS Society of Canada. An international panel of experts will conduct an expedited review of the applications, and funding decisions will be announced in June 2010.

    Source: National US Multiple Sclerosis Society (10/02/10)

    First UK Clinic soon to offer CCSVI testing starts registration

    Essential Health Clinic Logo

    Glasgow Health Solutions are actively seeking to offer scanning for CCSVI in the UK in 2010 in both London and Glasgow.

    The Doppler ultrasound scan required to show the CCSVI abnormalities has been specially adapted and requires specialist training from Prof Zamboni and his team. It is vital to work with the recognised specialists in this field and they hope to have ultrasound technician trained by Dr Zamboni later this year.

    The cost of the scans in the UK is still to be finalized but should be around 250 to 300 pounds. They are also liasing with intervention radiologists to develop treatment centres in the UK.

    If you wish to register your interest and be kept informed of these developments you can register your interest in the web site - http://www.essentialhealthclinic.com/website/index.php/clinic/ccsvi/ccsvi-newsletter.html

    Helen Yates, MSRC Chief Executive said: "MSRC is fully supportive of Essential Health Clinic's efforts to enable scanning for CCSVI in MS patients in the UK. Currently anyone who believes that they have this problem has to go to Europe even just to get scanned, never mind treated. Enabling the scanning to take place here in the UK will represent a big step forward for people affected by Multiple Sclerosis who believe this venous insufficiency problem lies at the root of their MS" 

    New theory suggests Multiple Sclerosis treatable

    CCSVI Blood FlowA controversial theory touting multiple sclerosis as a vascular disease is a "step in the right direction" but not a panacea, says a McMaster University professor.

    Dr. Mark Haacke, director of the imaging division in the school of biomedical engineering at Mac, says it would not be a good idea for people to call the theory by Dr. Paolo Zamboni a cure for the disease.

    "I think the key here is that these people who've had the disease, it may take a long time for the problems in the brain to clear up," said Haacke, who is also a professor at Wayne State University.

    "They may still require the conventional treatments that they're getting now."

    Zamboni has proposed that multiple sclerosis (MS) is a vascular disease that can be treated, rather than an auto-immune disorder with few treatment options.

    His theory is called chronic cerebrospinal venous insufficiency.

    He was in Hamilton yesterday for a scientific workshop at St. Joseph's Healthcare's Charlton Avenue site.

    About 200 people, a mix of professionals, doctors, scientists, and people who suffer from MS attended.

    The workshop was a closed event.

    "I think it went very well," said Kevin Smith, CEO of St. Joseph's Healthcare.

    "Obviously this was an opportunity for the scientific community to come together and chat with Professor Zamboni about his observations and others who've been involved in replicating his observations."

    In addition to Zamboni, those in attendance say information from others doing similar work around the globe was presented.

    Dr. Ian Rodger, vice-president of research at St. Joe's, said the workshop heard "undeniably" that there are patients who have had the medical procedure that is done based on his theory (it unclogs veins to the brain and improves blood flow) who quickly had relief from some MS symptoms such as fatigue and buzzing in their ears.

    "What we don't know is how long does it last? ... No one's been following it long enough. But I think at the end of it all, (it's) highly encouraging that the data is steadily coming out."

    Rodger also said Zamboni has not presented something "mind-shattering" as talk about problems with blood vessels in the brain leading to MS was around 100 years ago.

    Smith said the MS Society of Canada has now put out a call for proposals to research the subject further.

    St. Joe's and McMaster will be involved in bidding for the chance to conduct the study, he said.

    St. Joe's has currently done some imaging work around the theory and was swamped with 22,000 request from MS patients wanting to take part.

    Source: Thespec.com © Copyright Metroland 2010 (08/02/10)

    CCSVI & MS discussed on BBC local Essex Radio morning of 4th February
    Ben Parker from MS-CCSVI-UK and Helen Yates, MSRC Chief Executive, will be interviewed on BBC Radio Essex tomorrow morning at 7.05 and 8.05 respectively on CCSVI and MS.

    You can listen live via http://news.bbc.co.uk/local/essex/hi/ or listen anytime via BBC iPlayer - http://www.bbc.co.uk/iplayer/console/bbc_radio_essex/

    Pioneering surgery for MS clears British woman of disease symptoms

    Alex Gibbs © MDV 2010Doctors believe they have cured a British woman of ­multiple sclerosis after a pioneering operation.

    For years sufferers have been told there is no cure for MS, but the apparent success of the surgery has given new hope to those who are battling the disease, which attacks the nervous system.

    And Alex Gibbs is so certain she has now beaten the disease that she has even become pregnant – something she would never have dared do before.

    Alex, 38, travelled to the United States last June after reading on the internet about the breakthrough procedure, which involves widening the veins.

    She contacted surgeons in the UK and asked them to perform the surgery but none would agree.

    Alex, from Chelsea, West London, said: “I’ve only had MS since 2004. But I got it really badly right from the start.

    “I couldn’t walk more than 300ft without having to stop. I had stiff limbs and muscle spasms through the night in my sleep.

    “My future didn’t look very good having such ­severe MS at the outset. Normally it worsens slowly. Within a couple of years I would probably have been in a wheelchair.”

    Many ­experts believe MS is caused by a faulty immune system, but a number of ­doctors now believe damage caused to the nervous system in MS is actually from poor blood flow in the chest, neck and head.

    One is Italian surgeon Paulo Zamboni, whose solution is to widen the veins using a ­balloon or thin metal tubes. Alex had followed the work of Prof Zamboni, who cured his wife of MS five years ago and has now cured 100 more patients.

    As no UK doctors who specialise in MS are prepared to carry out Zamboni’s procedure until further studies are carried out, Alex went to ­California, where a ­surgeon at Stanford ­University was willing to perform the ­procedure.

    After the £5,000 op which widened her jugular veins, Alex’s symptoms improved immediately.

    Alex – whose mum died of MS at 68 – just months before she was diagnosed, reported back to her MS ­consultant at the National Hospital in London.

    She said: “He’s not ­convinced by Zamboni’s research, but he has accepted that my symptoms have ­improved. And the lesions on my brain caused by the MS have not worsened.”

    Source: sundaymirror.co.uk © Mirror Group Newspapers 2010 (17/01/10)

    CCSVI in MS Workshop on February 7, 2010

    CCSVI  in MS Workshop

    From Dr. Haacke's website-

    "We are delighted to announce that we will be holding the first of what we hope will be an annual "Workshop on CCSVI and Multiple Sclerosis". This meeting will be held Sunday afternoon, February 7th, 2010 in Hamilton at St. Joseph's Hospital in conjunction with McMaster University. More details will appear as this event develops. Dr. Zamboni and several of his colleagues are planning to come and Dr. Zivadinov and Dr. Dake have both been invited as well. Stay tuned for more details."

    If you are a doctor interested in learning more about CCSVI, have them contact Dr. Haacke at McMaster University or through his website-
    http://www.ms-mri.com/news.php

    Source: CCSVI in Multiple Sclerosis Facebook Page

    Could multiple sclerosis by caused by blocked veins?

    Joan and Jeff Beal
    Five years ago, opera singer Joan Beal had one of those life-changing shocks when her husband Jeff was told he had multiple sclerosis. She and Jeff, an Emmy-award-winning musical director, had been married for more than 20 years and the news came as a huge blow.

    The diagnosis was bad enough, but just as distressing was that the treatment - anti-inflammatory drugs and chemotherapy - was aimed only at reducing symptoms. What Joan wanted to know about was the underlying cause.

    'Jeff was really sick by the time he agreed to see the doctor,' she says. 'He was numb on his left side and his feet were burning. When they ran tests on him, he also had signs of liver damage and little blood spots all over his shins and ankles.

    'When I asked the neurologist why he was so sick, she said Jeff needed to stop drinking. That was flippant and made me angry because Jeff didn't touch alcohol.'

    The encounter sent Joan off on a search for a better approach, and in May Jeff became one of the first in the world to have a new and controversial operation based on a radical theory about the cause
    of MS. Seven months later, the improvement has been dramatic. 'Jeff had immediate and profound relief of very severe fatigue,' says Joan.

    'Before the op he had trouble getting out of bed and needed naps during the day. Since then, he has had no MS attacks (when symptoms get much worse). He still has leg pain, spasms and headaches, but these are less than before.'

    So, has Joan Beal discovered an effective treatment for MS? MS affects around 100,000 people in the UK. The conventional view is that it's an auto-immune disease, like rheumatoid arthritis.

    For some reason, the body turns against itself and starts destroying the myelin, the insulating fatty layer around nerve cells in the brain and spinal cord.

    This affects how messages are transmitted in the brain, causing the classic symptoms of MS, including vertigo, numbness, temporary vision loss and crushing fatigue. It can also cause paralysis and incontinence.

    Jeff's operation was inspired by a new theory about why the myelin gets destroyed - it's thought MS is a disease of the blood vessels, specifically the veins. The doctor at the forefront of this approach is Dr Paolo Zamboni, a professor at the University of Ferrara in Italy. He began investigating MS when his wife Elena, 51, developed the disease ten years ago.

    He examined MS patients with ultrasound and found that in nearly all, the veins leading from the brain had signs of narrowing, twisting and blockage; something he didn't find in healthy patients.

    He saw that blockages were allowing iron from the blood to leak into the brain tissue, where it causes damage.

    Dr Zamboni called the condition chronic cerebrospinal venous insufficiency (CCSVI). He calculated that by clearing the blockage in the main neck vein, he could help reverse MS symptoms.

    To do this, he used a technique known as angioplasty - inserting a tiny balloon into the blocked vein and then blowing it up to open up the blood vessel. It is a standard procedure for expanding the arteries of heart patients.

    By the time Joan found out about Dr Zamboni, he'd operated on 65 MS patients - including his wife, who is symptom free three years after surgery.

    Of those, 50 per cent were 'relapse-free' for at least 18 months compared with only 27 per cent in a control group who didn't have the operation.

    Inspired by his findings, Joan contacted one of the top cardiology experts in the U.S. who has pioneered the use of stents - another standard procedure opening blocked arteries - and sent him reports of Professor Zamboni's work. He agreed to scan the veins in Jeff's neck.

    'When we saw Jeff's mangled veins on the MRI scan,' says Joan, 'our doctor was amazed. He said he'd never seen this in the jugular veins before. The left one was closed 95 per cent, the right 80 per cent.'

    Just why the veins get blocked isn't clear. Dr Zamboni believes it could be a structural problem that is present from birth.

    Jeff had stents put into his neck veins at Stanford University hospital in California. After describing the success of Jeff's operation on an internet MS bulletin board (thisisms.com), Joan was inundated with requests for more information.

    And the cardiologist was swamped with requests for the operation. So much so that he has asked for his name to be withheld. But in the past seven months he has operated on 70 MS patients and many of them have posted reports on the website.

    One wrote: 'Less spasticity in left leg; facial pain is gone; right side back pain is gone; normal sweating; high altitude headaches gone; walking gait is smoother. No progression since intervention.'

    But the accounts don't gloss over the potential side-effects of the operation; these include nerve damage that stents can cause and bleeding in the stomach as a result of drugs used in the operation. So is this a breakthrough in the treatment of MS?

    Dr Robert Zivadinov, leading a study for more evidence at Buffalo University in New York, says: 'If we can prove the hypothesis that CCSVI is the underlying cause of MS, then it is going to change the face of how we understand the disease.'

    But the theory has attracted criticism.

    Dr Alasdair Coles, an academic neurologist at Cambridge University, says: 'We know MS is an auto-immune disease because if you block the immune response with drugs, people get better.'

    Dr Susan Kohlhaas, of the UK MS Society, adds: 'Our experts don't accept that blockages to draining veins from the brain are specific to people with MS or that this explains the cause of MS.'

    There have been many false dawns in MS research. The cause of the damage has been linked with lack of vitamin D, lack of the hormone prolactin, mercury fillings and now CCSVI is added to the list.

    Joan and many others pray that it's not another example of offering false hope.

    Source: Daily Mail © Associated Newspapers Ltd (12/01/10)

    Dr. Zamboni to address the Myelin Interest Group at NYU

    On February 9, 2010, Dr. Paolo Zamboni will present his current research on CCSVI in MS to the Myelin Interest Group, as part of a forum discussion between clinicians and scientists with an interest in myelin disorders. Source- Fondazione Hilarescere
    http://fondazionehilarescere.org/eng/attivita.html
    Where: NYU Hospital for Joint Diseases
    MS Comprehensive Care Center
    301 East 17th Steet
    New York, NY
    http://www.med.nyu.edu/hjd/ms/

    Source: CCSVI in Multiple Sclerosis's Facebook Page (10/01/10)

    The contrasting emotional responses to the revolutionary discoveries in MS made by Dr Zamboni

    CCSVIHope and Elation - Frustration and Anger – Fear and Loathing: The Contrasting Emotional Responses to the Revolutionary Discoveries in MS Made by Dr Zamboni

    Dr. Ashton Embry


    The beautifully crafted, CTV documentary on the astounding findings of Dr Zamboni and his team for multiple sclerosis has hit the MS community like a tidal wave and has evoked a variety of emotional responses. Most people with MS see CCSVI as a huge breakthrough for understanding and treating MS and had an initial feeling of unbridled elation that finally there was some real hope for an effective treatment on the horizon. I expect most people with MS thought “I have to get my veins checked out!”, even before the credits rolled on the Zamboni documentary.

    Such a reaction is completely understandable. Dr Zamboni’s research leaves very little doubt that most people with MS have impaired venous flow from the brain and that such a problem is caused by narrowings and outright blockages in the main veins which drain the brain. To anyone with a semblance of objectivity, this is a “no drainer”. I might note that small studies in Poland and at both Stanford and the University of Buffalo in the USA have already confirmed these findings. The University of Buffalo is now doing a very large study to add further confirmation. I would be willing to bet the farm that this study will validate Dr Zamboni’s findings and, most importantly, it will silence the vocal skeptics, many of whom are neurologists with a blatant conflict of interest regarding the emergence of a potentially effective, non-drug treatment.

    I have noticed from discussions with numerous persons with MS over the past few weeks that the initial feelings of excitement and hope have been replaced in many cases by anger and frustration. This has come about because everyone is finding it impossible to get an MRV to determine if they indeed have venous blockages. In Calgary, one person I was speaking with called every private imaging clinic and got no where. The receptionist at each clinic simply read a prepared response they had gotten from Alberta Health that there is not enough evidence to warrant such a scan. I quote from a November 26th email from the manager of one clinic “Until we get further instruction … we don't feel that ethically
    we can institute these scans for patients”.
    Always nice to know the Alberta government is out there making sure persons with MS do not find out if they have a serious venous problem or not.

    I have spoken to a few dozen persons with MS and each one expressed their burning desire to find out if CCSVI affects them and if so, how badly. And each one was very angry and frustrated that there was no way they could get such an important test done. The fact that the government substantially contributed to the problem only made them angrier.

    When it comes to fear and loathing, I expect these feelings are being harboured by other constituencies of the MS community, namely the MS clinicians, researchers, drug companies and charities. Why would such pillars of medicine fear and hate CCSVI? Regarding the clinicians, I have no doubt that they quickly realized that, if relief of CCSVI is an effective treatment, especially for the newly diagnosed, then they would essentially be cut out of the action when it comes to treating MS patients. Once a person was diagnosed with MS they would be immediately be referred to a vascular specialist who would then oversee the person’s treatments. It would be “diagnose and adios” for the neurologists, a somewhat ironic development given that is how the neurologists used to treat MS patients before the advent of MS drugs in the mid-90s .

    As far as the MS researchers go, I can definitely empathize with them. I have been involved in research for over 40 years and I know, if someone suddenly demonstrated that I had spent the last 40 years barking up the wrong tree, I would have a variety of intense, negative feelings. One thing that has never been mentioned is how the Zamboni results demonstrate that the EAE animal model, which is widely used in MS research and upon which 10s of millions of dollars are spent every year, is clearly not suitable and is almost worthless. The mice do not develop CCSVI and thus the EAE model is no better than an animal model in which the mice developed CCSVI but no CNS lesions. A viable animal model for MS needs to exhibit both phenomena – end of story. Such a realization will cause great gnashing of teeth in the wide world of MS research.

    It is also not a stretch to predict that fear and loathing in the MS research community will turn to anger and I hope Dr Zamboni is prepared for some blistering attacks on both his work and his character. Hell hath no fury like a researcher proven wrong or disenfranchised. Finally, I won’t belabour the fears and anger of both the clinicians and the researchers regarding the potential loss of all that drug company largesse and research money which has been a bonanza over the past 15 years.

    That brings us to the drug companies that supply the drugs that currently are used to treat MS or are in development. I have no doubt these companies must be having hand- wringing meetings these days to discuss the threat of a potentially effective, non-drug treatment for MS. The boardrooms must reek of fear and loathing when the obvious implications of the Zamboni discoveries are discussed. The bottom line is that there are tens and possibly hundreds of billions of dollars at stake in the foreseeable future and the drug companies are not going to let that kind of serious cash simply disappear without a fight. It is impossible to predict how the companies will deal with this real threat to their bottom lines and stock prices but you know it is not going to be pretty.

    Finally I suspect there is a lot of fear and loathing going on at the national MS societies in the countries with high rates of MS (e.g. Canada). For the MS Society of Canada this has been a public relations disaster which potentially will translate into a loss of revenue. The most obvious, embarrassing aspect of this fiasco is the fact that MSSOC wasn’t even aware of the Zamboni research until mid October when they put up on their website a few, pathetic paragraphs on CCSVI that were cribbed from NMSS. They had absolutely no plans to fund any research on CCSVI until the CTV documentary put a gun to their head and they then hastily cobbled together a press release (in which Dr Zamboni’s name was mis-spelt) and issued a call for CCSVI research proposals.

    The big question is why, with their blue-ribbon scientific advisory board, did MSSOC have no clue about CCSVI when papers on the subject began appearing in 2006 and major contributions were publicly available in late 2008 and early 2009. Were all their scientific advisors asleep at the switch? Assuming these renowned researchers read the scientific literature, do they have they the ability to recognize a watershed contribution when it crosses their desk? The fact CCSVI went unnoticed by MSSOC for more than a year is cause for serious concern about the competency of the organization in terms of providing reliable and timely scientific information to their members. What other important information is currently out there going unnoticed by MSSOC and its scientific advisors?

    To sum up, Dr Zamboni’s amazing and groundbreaking discoveries have induced a wide variety of emotions in the different factions of the MS community. Such emotions are going to make it even harder for his findings to be properly tested and, if proven to be correct, to be incorporated into clinical practice. Regardless, it is important to realize that such strong emotions exist and to be cognizant of the different and somewhat antagonistic views and goals of the two groups that comprise the MS family – those that live with MS and those that live off MS. 

    Source: Direct-MS © Direct-MS 2009 (21/12/09)

    Possible MS breakthrough neglected by American media

    Erike Milvyby Erika Milvy

    Folks who suffer from Multiple Sclerosis are not really a rowdy bunch. Activism and outrage are hard to muster for the chronically fatigued. But since Thanksgiving, people with MS and their loved ones have gone all ACT-UP 2.0.

    That is, the past few weeks have seen a surge in online activity within the MS community - as bloggers, vloggers and forum posters are calling one another to action in response to the lack of response to what many perceive to the scientific breakthrough they've been waiting for.

    If you haven't heard about the report in December's Journal of Vascular Sciences by Italian vascular surgeon Dr. Paolo Zamboni, then you probably live in America.

    I don't suffer from premature ejaculation but I do know, (thanks to the New York Times), that there's a new drug for it available in nine countries, but that it hasn't yet been approved for sale in the United States.

    But when I went looking for news about Dr. Zamboni's research, I could not find it the mainstream press. I did find it all over the Canadian Press and European Press.

    Let me start by saying I am not a doctor nor do I play one on TV.

    On November 21, CTV W5 (Canada's top television network), aired an in-depth story about "a stunning new discovery of a revolutionary new treatment for a debilitating disease." They interviewed Dr. Paolo Zamboni, from the University of Ferrara in northern Italy. His research suggests that MS is not, as widely believed, primarily an autoimmune condition, but a vascular disease (CCSVI, short for chronic cerebrospinal venous insufficiency.) Dr. Zamboni found that, in over 90 percent of people with Multiple Sclerosis, the veins draining blood from the brain were constricted and this led to a buildup of iron in the brain that, he theorized, causes the neurological symptoms of MS.

    MS would therefore be caused by a drainage problem, a plumbing clog that Zamboni posits can be rectified with a simple but experimental surgical technique similar to an angioplasty. Zamboni (and up until last week, a doctor at Stanford) have since done the procedure on over 100 patients and Zamboni reports vast improvement in patients' symptoms nearly immediately. Zamboni's wife, Elena Zamboni was one of his first success stories - her MS being his driving force.

    Since then, a battle between patients and practitioners has hit the net. Fervor has collided against skepticism and medical cynicism - and media disregard has stirred up resentment and even conspiracy theories.

    Patients' blood (whether it is or is not circulating adequately in the veins) has been boiling.

    It began after the Canadian television aired their interview with Dr. Zamboni. The broadcast went swine viral. Avis Favaro, the reporter who broke the story, said that she has been "shocked at the tremendous response to this story. It is beyond that for any other medical story we have worked on." The segment has been linked to countless times worldwide and translated into other languages."

    The web was ablaze. People with MS finally heard the word "breaththrough" and heard the long long-awaited announcement of what was a potentially paradigm shifting game changer. These were not just mice getting better.

    "My legs don't work, but I'm jumping up and down," said one hopeful MS patient on YouTube.  So when the videos and links arrived in the inboxes of MS patients in the U.S. they looked to the reputable news media for more information.

    But still the mainstream press wasn't reporting the story. On ThisIsMS.com, an MS info-exchange, postings about CCSVI topped 16,000, (other treatment news numbers in the tens or hundreds.) In online forums, discussions turned to "where is the coverage on this?" "No one will listen" is the title of one long thread. A Facebook group called "MS Uprising" was born, a YouTube channel was born.

    The MS society of Canada crafted a statement of cautious optimism. They adapted a "wait and see stance, urging patients to "temper their euphoria."

    Web activists were not satisfied and began to draft petitions and suggest diverting donations to directly support hospitals like University of Buffalo where Zamboni's approach is being further studied.

    Of the MS society's statement, Dr. Lorne Brandes, an oncologist who blogs for CTV News' Health Blog, wrote, "If their official response to Dr. Zamboni's research was any cooler, icicles would form on their spokespersons' lips. Why am I not surprised? These organizations are big money operations, run by risk-adverse professionals and fundraisers who are absolutely petrified of making a mistake and prematurely backing a losing horse. Their interests are also heavily intertwined with those of Big Pharma."

    This sentiment is echoed again and again. Online articles scream out with Woodward and Bernstein-wannabee headlines like "Simple Surgical Cure for Multiple Sclerosis Opposed by Big Pharma" and "Multiple Sclerosis cure found, MS societies in panic" - (but the article's content is just a reprint of The Globe and Mail's less provocatively titled "Researcher's labour of love leads to MS breakthrough."

    But when bloggers and vloggers and posters invoke "Big Pharma," they start sounding like they think they're Ralph Fiennes in "The Constant Gardener" - blowing the whistle on the industry's evils.

    Still, when newly radicalized sick people notice that the media isn't reporting on this big story and notice that neurologists and advocacy organizations are minimizing or denigrating the importance of Zamboni's findings, their conspiracy theories start to sound sort of plausible.

    That is, just because they're paranoid doesn't mean that Big Pharma isn't out to get them. The pharmaceutical industry stands to lose a lot if Zamboni's one-time treatment pans out. The most common drug therapies for MS cost about $30,000 a year. And there are well over 100 medications for various MS symptoms.

    On one MS forum is a link to another pharma-gate headline: "Big Pharma's Crime Spree", in which the reporter for Bloomberg Markets Magazine assesses that "finding cures is not even remotely a consideration by pharmaceutical executives."

    While this idea is not a new one, when you pair it with the recent directives from the MS Society (well-funded by the drug industry) patient distrust doesn't seem unwarranted.

    The Canadian MS Society urged patients "not to abandon the treatment they are on." The US went further, discouraging patients from getting tested at all. Prescribing ignorance is bad advice. At best it's condescending.

    Much of the medical establishment's approach seems to be likewise paternalistic. Some patients have concluded that naysaying neurologists are territorial - MS is their disease. And if Zamboni is right, MS researchers have been barking up the wrong tree for decades.

    Bloggers gripe that the US scientific establishment is mired in red tape and is overly-concerned about malpractice. So some have already undergone experimental surgery. With degenerative disease breathing down their necks, some patients are ready to pursue even a glimpse of a cure, damning the torpedoes. Which alarms many of their doctors. Who rain on their parade. Which causes more suspicion and activism.

    Dr. Elizabeth Crabtree, a neurologist at UCSF's MS Center, has plans to begin an ongoing podcast to better inform MS patients of new developments. So they don't have to learn it on the streets, as it were. "No wonder there's so much distrust," she said. "The treatment options are inadequate." She expressed frustration that medical facilities compete instead of collaborate. Patients, doctors and support groups should be working in alliance, she said.

    Whether egos and money do get in the way of out-of-the-box thinking, one cautionary tale does loom. A patient at Stanford died following CCSVI surgery recently and another patient underwent open heart surgery after a stent migrated to his heart. The Stanford program was swiftly halted.

    Dr. Michael Dake's "under the radar" stent implants (Zamboni uses a "balloon" procedure ) were conducted before a clinical trial. But instead of being deemed unethical, Dr. Dake was called a hero and a "pioneer" in online groups.

    "This I would do," said Dayle Baich of the Zamboni procedure. Baich, who now uses a walker because of her MS, told The Ottawa Citizen, "it's a very simple surgery, compared to two years of chemotherapy. In three years, I have gone from being normal to now. So where am I going to be in two or three more years? I don't have the time. Neither do most of the people here."

    As a direct result of patient activism, the MS Society has announced plans to fund CCSVI research and clinical trials will commence at several medical centers in 2010. CBS and other esteemed news outlets have caught wind of the whirlwind. Their coverage is due out soon.

    Such is the story of keyboard activism - among the "handicapable" (a term the TV show "Glee" recently coined.)

    In case Ralph Fiennes is looking for his next project.

    Source: The Huffington Post © 2009 HuffingtonPost.com, Inc (18/12/09)

    Multiple Sclerosis Society UK 'Experts' question CCSVI vein disorder-MS theory

    CCSVIBritish medical 'experts' from the MS Society are questioning a new theory put forward by Italian vascular surgeon Dr. Paolo Zamboni that multiple sclerosis (MS) was caused by blocked veins in the neck or chest.

    Dr. Zamboni’s theory centres around the repeated references in research text books to deposits of iron in the blood vessels and a link to MS.

    Excess deposits of the heavy metal have been proven to lead to inflammation and cell death in the laboratory. These are both characteristics of MS.

    Using ultrasound to examine the vessels leading in and out of the brain, he said he had tested his theory in people and found that in a majority, including his spouse who he also experimented upon, the veins draining blood from the brain were malformed or blocked. In people without MS, they were not.

    He further suggested that iron was damaging the blood vessels and allowing the heavy metal, along with other unwelcome cells, to cross the crucial brain-blood barrier, a process termed Chronic Cerebrospinal Venous Insufficiency (CCSVI).

    He said he had devised an experimental procedure that involved removing the blockage in the veins that carry blood to and from the brain.

    So far, he has performed the angioplasty-like surgery, known as "la liberation" in Italian, on 120 MS patients, including his wife, whose multiple sclerosis provoked his interest in tackling the disease.

    His findings were published in the Journal of Vascular Surgery and scientists at the University of Buffalo in New York announced they would test his theory by recruiting for a large study.

    However, British "experts" sound skeptical. Research Communications Officer at the MS Society, Dr Susan Kohlhaas, said: "Several medical advisers to the MS Society have read through the papers published by Dr Zamboni, and have heard him lecture on the subject.

    "They are not convinced by the evidence that blockages to draining veins  from the brain are specific to people with MS, or that this explains the cause of MS at any stage of the condition."

    Dr Zamboni's most recently published work examined CCSVI in 65 people and suggested that 50 per cent of people with relapsing-remitting MS were relapse-free for 18 months.

    Among the control group of MS patients who did not undergo the procedure, Zamboni found that only 27 per cent went 18 months without a relapse. There was no published benefit for people with progressive forms of the condition.

    Participants with relapsing remitting MS, however, were allowed to continue receiving their usual form of treatment, so it is inconclusive whether any reduction in relapse rate was due to the CCSVI procedure.

    Importantly, the result of the procedure was measured using different MRI scanning machines and at different times, meaning the data is inconsistent and not a useful measure.

    Professor Alastair Compston, Head of the Department of Clinical Neurosciences at the University of Cambridge, is one of the six medical advisors of the MS Society, UK.

    He said: "The treatment for CCSVI is not available for patients with multiple sclerosis in the United Kingdom because there is no convincing evidence to suggest that it is safe or beneficial to people with MS.

    "People with MS are unlikely to benefit from treatments that dilate blood vessels."

    Dr Susan Kohlhaas stressed, “The MS Society supports evidence-based information concerning MS and welcomes new avenues of research into the causes and possible treatments.

    “More research is needed to pin down any relationship between CCSVI and MS and in that respect we welcome the trial currently recruiting in New York.”

    Source-Medindia GPL  © All Rights Reserved 1997 - 2009 (17/12/09)

    Iron, Multiple Sclerosis and the Semmelweis Reflex

    CCSVIHave you heard of the Semmelweis reflex? It is defined in Wikipedia as "the automatic dismissal or rejection of scientific information without thought, inspection or experiment."

    Although it is not certain who first coined the term, it takes its origin from the story of Professor Ignaz Semmelweis. In 1847, the Hungarian physician discovered that puerperal sepsis (childbed fever), an often fatal infection occurring in women after giving birth, could be prevented if only the attending doctors would wash their hands.

    As Louis Pasteur was still years away from developing his germ theory of disease, Semmelweis' admonition was at once rejected and widely ridiculed by his peers. In desperation, he publicly denounced obstetricians as irresponsible murderers. Fearing that he had become insane, his wife, among others, had him forcibly confined to an asylum where he was soon beaten to death by guards.

    Not a good end for the man who discovered the antiseptic technique that ultimately saved tens of millions of lives!

    With that as background, was the initial response of most neurologists and the Canadian and American Multiple Sclerosis Societies to Professor Paolo Zamboni not a classical example of the Semmelweis reflex?

    His paradigm-shifting hypothesis that MS is primarily a vascular, rather than an autoimmune, disease immediately hit a brick wall of uninformed and often violent criticism.

    In dismissing his theory, one Canadian MS specialist wanted Dr. Zamboni, who is already treating humans, to go back and do studies in mice, while a blogger venomously denounced his findings as a myth... all without a second of pause or reflection, let alone a single shred of experimental proof to back up such statements.

    Happily, in response to the demands of thousands of patients afflicted with MS, who are generally unimpressed with the results of standard immunosuppressive therapies, the MS Societies on both sides of the border did a rapid 180 degree turn from their initial negative stance and are now prepared to jointly fund research proposals testing the Zamboni hypothesis. Good on them.

    Central to Dr. Zamboni's theory is the destructive role played by iron from the venous blood that backs up and leaks into the brain as a result of impeded flow at sites of blockage further down in the neck or chest.

    There is not a physician or scientist who could disagree with Dr. Zamboni that heavy metal deposition in the brain is toxic, whether it be iron, copper or lead. That said, are there any other data that might specifically support a role for iron in the causation of MS?

    As it turns out, there are!

    Similar to other neurodegenerative diseases, including Parkinson's and certain forms of dementia, researchers at the University of Calgary and Imperial College, London, have linked the inflammation and nerve destruction in MS to an important, but poorly-understood protein called alpha-synuclein.

    Although usually present in a harmless soluble (amorphous) form in cells, a series of alpha-synuclein molecules can join together to form an aggregate that is toxic to the brain. Moreover, larger-sized aggregates, called "oligomers", do the most damage to nerves.

    Now, in two recently-published studies, German scientists have demonstrated that, even at low concentrations, oxidized (ferric) iron dramatically increases the aggregation of alpha-synuclein molecules into their most neurotoxic oligomer form.

    Voila! We appear to have a newly-discovered mechanism that could explain how leaked iron in brain tissue might promote the development of MS plaques, thereby providing a new level of support for the central theme of Dr. Zamboni's vascular hypothesis.

    Somehow, I believe that Ignaz Semmelweis may be smiling...not to mention Paolo Zamboni.

    Dr. Lorne Brandes

    Source: CTV News © 2009 CTVGlobeMedia (14/12/09)

    Dr. Zamboni responds to Dr. Mark Freedman's comments of 25th November - 'I invite scientists to develop MS models'

    Dr Paolo ZamboniDr Paolo Zamboni, MD has responded to the comments made by Dr. Mark Freedman, director of the MS research unit at The Ottawa Hospital (Canadian Multiple Sclerosis specialist questions validity of CCSVI theory but his motives are questioned by audience)

    I want to respond to the Citizen article on chronic cerebrospinal venous insufficiency (CCSVI) syndrome, a vascular disease we found 40 times more frequent in multiple sclerosis (MS) sufferers.

    I never discouraged MS patients from following treatments prescribed by their specialists. I never had "a hard time in answering any of the questions from the MS experts." Rather, I think that scientific exchanges between experts in venous circulation and experts in MS are still insufficient.

    Beno Schlessinger, in 1939, while injecting the cerebral venous system with increased pressure, noted the extravasations produced around the lateral ventricles "closely stimulate the distribution and even shapes of plaques in multiple sclerosis." So we have a model of venous MS from 60 years ago.

    Dr. Mark Freedman is right when he suggests we develop an animal model of CCSVI. Despite all the models of tissue injury from venous insufficiency described in the medical literature, such a scientific step will be certainly necessary.

    On the other hand, the autoimmune concept in MS is built on feet of clay -- the animal model EAE (experimental autoimmune encephalomyelitis) where the antigen is brain tissue from another animal. In contrast, the recent description of CCSVI in MS demonstrates how inadequate EAE is. EAE assumes that brain circulatory function is normal and thus does not reflect what really happens in humans.

    In turn, I invite scientists to develop a new model of MS, which takes into account the presence of extracranial venous blockages. I disagree that the development of a new animal model has to precede further studies on patients. This would be a parallel track.

    It is irresponsible to delay further studies on the value of the endovascular treatment of CCSVI in MS, the so-called liberation procedure. Patients need to have clear answers and it is mandatory to face the problem. Either to organize educational programs for Doppler screening of CCSVI in MS, or to find support for a randomized controlled trial on liberation procedure are more than urgent and reasonable projects.

    Paolo Zamboni, MD,

    Director Vascular Diseases Center,

    University of Ferrara,

    Ferrara, Italy

    Source: The Ottawa Citizen © The Ottawa Citizen (07/12/09)

    UK MS Society medical advisors 'unconvinced' by Zamboni's CCSVI theory

    CCSVIMedical advisors to the UK MS Society have raised doubts about a theory put forward by Italian doctor Paulo Zamboni, who this week proposed that a vein disorder is the cause of multiple sclerosis (MS).

    In a statement, the experts have found fault with the theory that MS is caused by blockages in veins that drain the brain and suggest that people with MS are unlikely to benefit by any treatments developed to treat what Dr Zamboni called chronic cerebrospinal venous insufficiency (CCSVI).

    This week, results have been published of Dr Paulo Zamboni's work investigating whether CCSVI plays a role in multiple sclerosis (MS). The authors admit, however, that the recent paper published in the Journal of Vascular Surgery, A prospective open-label study of endovascular treatment of chronic cerebrospinal venous insufficiency,  has significant drawbacks.

    Last week, early news of Dr Zamboni's novel theory sparked international interest and has led to scientists at the University of Buffalo in New York to test his theory by recruiting for a large study.

    Research Communications Officer at the MS Society, Dr Susan Kohlhaas, said: "Several medical advisers to the MS Society have read through the papers published by Dr Zamboni, and have heard him lecture on the subject.

    "They are not convinced by the evidence that blockages to draining veins from the brain are specific to people with MS, or that this explains the cause of MS at any stage of the condition."

    Dr Zamboni's most recently published work examined CCSVI in 65 people and suggested that 50 per cent of people with relapsing remitting MS were relapse-free for 18 months.

    Among the control group of MS patients who did not undergo the procedure, Zamboni found that only 27 per cent went 18 months without a relapse. There was no published benefit for people with progressive forms of the condition.

    Participants with relapsing remitting MS, however, were allowed to continue receiving their usual form of treatment, so it is inconclusive whether any reduction in relapse rate was due to the CCSVI procedure.

    Importantly, the result of the procedure was measured using different MRI scanning machines and at different times, meaning the data is inconsistent and not a useful measure.

    Professor Alastair Compston, Head of the Department of Clinical Neurosciences at the University of Cambridge and winner of the 2007 Charcot Award for a lifetime achievement in MS research, is one of the MS Society's six medical advisors.

    He said: "The treatment for CCSVI is not available for patients with multiple sclerosis in the United Kingdom because there is no convincing evidence to suggest that it is safe or beneficial to people with MS.

    "People with MS are unlikely to benefit from treatments that dilate blood vessels."

    Source: MS Society (UK) © 2009 Multiple Sclerosis Society (05/12/09)

    Dr. Alex Rae-Grant of the CMSC comments on CCSVI
    Dr Alex Rae GrantThe Consortium of Multiple Sclerosis Centers asked Dr. Alex Rae-Grant, CMSC website's Project Leader for Neurology, to share his expertise and views about CCSVI and the "The Liberation Treatment". Here is his reply:

    Multiple sclerosis, even in 2009, remains mysterious and has escaped our full understanding. Why do certain people get it? Why does it affect the brain and spinal cord in the way it does? What causes it? The recent interesting work by Zamboni et al raises an idea from far out in left field; could MS be caused, or at least accompanied by narrowing or blockage of the veins that drain the brain and spinal cord? Ok, so none of the 50 years of research in MS so far have suggested this. And people who are known to have blockage of the veins draining the brain (Cortical vein thrombosis) don't get MS. Pathological studies of MS patients have never suggested this. But on the other hand, it's probably good for us to have an open mind, especially when there are new ideas that can be tested, and possibly ones that have a therapeutic option.

    Before we all run out suggest that people with MS get stents in their veins, there may be a few steps along the way.

    1. It will be important for other centers to independently confirm or refute the ultrasound and or venographic findings of Zamboni et al. This work is beginning at the present time. Adequate care in selecting age and sex matched controls and making sure the tests are not biased will be key.

    2. It will be important to understand, if this finding is true, what proportion of the MS population may have such problems. Many in the MS field have felt there are more than one disease within our population; even if 20% of our patients have a venous insufficiency problem, this would be revolutionary.

    3. Any therapeutic claims need to have an unbiased methodology to prove benefit. We know that the placebo effect is strong in MS particularly when we are talking about symptoms and not measurable aspects of the disease such as MRI. A randomized trial of therapy in people shown to have such 'stenoses' would be both ethical and necessary before potentially hundreds of thousands of people are subjected to invasive procedures with measurable risk.

    The work of Zamboni et al deserves a long, hard, look; it would be wrong to either clamber on board the bus, or to dismiss this out of hand.

    About Dr. Alex Rae-Grant
    Alex Rae-Grant, MD, recently transitioned from his long-term position at Lehigh Valley Hospital to the Cleveland Clinic. At Lehigh Valley Hospital, he was President of the Medical Staff, Chair of the Ethics Committee, Chief of the Division of Neurology, and founded the Multiple Sclerosis Center of the Lehigh Valley. His role at Cleveland Clinic's Mellen Center is to oversee education about multiple sclerosis in the northeastern Ohio region, assist with clinical trials and be involved with resident and student education at the clinic. He works with regional physicians and Mellen Center staff to distribute approaches to treatment for various aspects of MS.
    He was recently awarded the Teacher of the Year award by the neurology residents at the Cleveland Clinic. He is co-director of the neurology clerkship at the Cleveland Clinic and is a Clinical associate professor of medicine at the Cleveland Clinic Lerner College of Medicine. He has previously co-authored two textbooks in neurology, Neurology for the House Officer and 5 Minute Consult in Neurology. (04/12/09)

    Canadian Multiple Sclerosis specialist questions validity of CCSVI theory but his motives are questioned by audience

    CCSVIResearch head at The Ottawa Hospital questions validity of clogged veins theory during education session.

    The “liberation procedure,” a controversial new surgical procedure that appears to cure multiple sclerosis, is based on circumstantial evidence and MS sufferers should not rush into getting it.

    That was the message delivered by Dr. Mark Freedman, director of the MS research unit at The Ottawa Hospital, during an education session hosted by the MS Society of Ottawa on Tuesday night. For many in the audience, his words dashed much of their newfound hope.

    One of a series of education events regularly presented by the society, this meeting attracted throngs of MS patients and their loved ones, all curious about the new theory proposed by Italian researcher Dr. Paolo Zamboni. A vascular surgeon by training, Zamboni believes MS is not an autoimmune condition, as widely believed, but rather a vascular disease that can be cured with surgery.

    Zamboni’s theory is that MS is caused by clogged veins, a condition he calls “chronic cerebrospinal venous insufficiency” (CCSVI). Zamboni first performed the angioplasty-type surgery on his wife, who suffered from MS, and her symptoms disappeared. He then tested it on a group of 65 patients with remarkable results: 73 per cent had no symptoms two years after the surgery.

    However, Freedman, like many neurologists, is skeptical. During his presentation, Freedman said he confronted Zamboni at a recent meeting in Lisbon.

    “He was there presenting some of his data and had a hard time answering any of the questions from the MS guys,” Freedman said. Among their concerns was Zamboni’s claim that the clogged veins are present at birth, yet no studies had been done on children. Zamboni had not done animal studies, either.

    “I said, ‘Why don’t you tie off a few of the blood vessels in animals and see if they develop MS?’ His answer was, ‘I’m not a mouse researcher’,” Freedman said.

    “If his observation stands up to other people being able to reproduce it,” Freedman said, “I think we’re going to have something of interest to chase, but we need to have the supporting evidence before we start reaming out blood vessels and pretending that this is going to cure the disease.”

    Still, the fact that most of Freedman’s presentation was devoted to explaining the new drugs that are being developed to treat MS did not satisfy many members of the audience on Tuesday night.

    “The problem I have is that you take Dr. Zamboni’s work very lightly, and, quite frankly, you haven’t done any better,” Mike Sastre said during the question-and-answer session. His wife, Linda Hume-Sastre, has lived with MS for almost seven years.

    “All I want to say is give the man a chance, give the people here a chance who haven’t been helped very much by what you’re promoting,” Sastre said. “If they get better using something very simple, you lose a lot of research money, and so does the MS Society.”

    Zamboni’s research has given hope to MS patients such as Dayle Baich, who uses a walker to get around.

    “This I would do,” Baich said. “It’s a very simple surgery, compared to two years of chemotherapy. In three years, I have gone from being normal to now. So where am I going to be in two or three more years? I don’t have the time. Neither do most of the people here.”

    The MS Society of Canada has issued an invitation for research operating grant proposals on CCSVI related to multiple sclerosis from qualified investigators based in Canadian institutions. The competition opens Dec. 9. The deadline for applications is Jan. 22.

    Source: The Ottawa Citizen © The Ottawa Citizen (26/11/09)

    MS Society of Canada announces request for research operating grants related to CCSVI and MS

    MS Society Canada LogoThe Multiple Sclerosis Society of Canada announced it will request research operating grants related to chronic cerebrospinal venous insufficiency (CCSVI) and MS.

    A recent study released by Dr. Paulo Zamboni, University of Ferrara, Italy, describes CCSVI as a disruption of blood flow in which the venous system is not able to efficiently remove blood from the central nervous system resulting in increased pressure in the veins of the brain and spinal cord which in turn results in damage to these areas.

    “These early results are encouraging and show that this warrants more study,” said Yves Savoie, MS Society President and CEO.  “This is truly a new avenue to explore in MS research, and we want to be a part of furthering this investigation.”

    The MS Society of Canada will issue an invitation for research operating grant proposals on CCSVI related to multiple sclerosis from qualified investigators based in Canadian institutions. Proposals will be evaluated for their scientific merit and relevance to the field of MS.

    The competition will open on December 9, 2009, and the deadline for applications will be January 22, 2010.

    “There has been tremendous interest and excitement about this study from people with MS, supporters, volunteers and staff across the country. While we acknowledge that the concept of CCSVI as a cause of MS needs to be replicated and validated in larger well-designed studies, the Society looks forward to contributing to this body of work,” said Savoie.

    While excited about the potential of the CCSVI study, the findings are preliminary. Thus the MS Society advises that while further research is underway people follow their physician's recommendations and continue their current course of therapies.

    Source: Multiple Sclerosis Society of Canada (24/11/09)

    Researcher's labour of love leads to breakthrough in treating Multiple Sclerosis

    Dr Paolo Zamboni“ I am confident that this could be a revolution for the research and diagnosis of multiple sclerosis ”
    — Dr. Paolo Zamboni

    Elena Ravalli was a seemingly healthy 37-year-old when she began to experience strange attacks of vertigo, numbness, temporary vision loss and crushing fatigue. They were classic signs of multiple sclerosis, a potentially debilitating neurological disease.

    It was 1995 and her husband, Paolo Zamboni, a professor of medicine at the University of Ferrara in Italy, set out to help. He was determined to solve the mystery of MS – an illness that strikes people in the prime of their lives but whose causes are unknown and whose effective treatments are few.

    What he learned in his medical detective work, scouring dusty old books and using ultra-modern imaging techniques, could well turn what we know about MS on its head: Dr. Zamboni's research suggests that MS is not, as widely believed, an autoimmune condition, but a vascular disease.

    More radical still, the experimental surgery he performed on his wife offers hope that MS, which afflicts 2.5 million people worldwide, can be cured and even largely prevented.

    “I am confident that this could be a revolution for the research and diagnosis of multiple sclerosis,” Dr. Zamboni said in an interview.

    Not everyone is so bullish: Skeptics warn the evidence is too scant and speculative to start rewriting medical textbooks. Even those intrigued by the theory caution that MS sufferers should not rush off to get the surgery – nicknamed the “liberation procedure” – until more research is done.

    U.S. and Canadian researchers are trying to test Dr. Zamboni's premise.

    For the Italian professor, however, the quest was both personal and professional and the results were stunning.

    Fighting for his wife's health, Dr. Zamboni looked for answers in the medical literature. He found repeated references, dating back a century, to excess iron as a possible cause of MS. The heavy metal can cause inflammation and cell death, hallmarks of the disease. The vascular surgeon was intrigued – coincidentally, he had been researching how iron buildup damages blood vessels in the legs, and wondered if there could be a similar problem in the blood vessels of the brain.

    Using ultrasound to examine the vessels leading in and out of the brain, Dr. Zamboni made a startling find: In more than 90 per cent of people with multiple sclerosis, including his spouse, the veins draining blood from the brain were malformed or blocked. In people without MS, they were not.

    He hypothesized that iron was damaging the blood vessels and allowing the heavy metal, along with other unwelcome cells, to cross the crucial brain-blood barrier. (The barrier keeps blood and cerebrospinal fluid separate. In MS, immune cells cross the blood-brain barrier, where they destroy myelin, a crucial sheathing on nerves.)

    More striking still was that, when Dr. Zamboni performed a simple operation to unclog veins and get blood flowing normally again, many of the symptoms of MS disappeared. The procedure is similar to angioplasty, in which a catheter is threaded into the groin and up into the arteries, where a balloon is inflated to clear the blockages. His wife, who had the surgery three years ago, has not had an attack since.

    The researcher's theory is simple: that the underlying cause of MS is a condition he has dubbed “chronic cerebrospinal venous insufficiency.” If you tackle CCSVI by repairing the drainage problems from the brain, you can successfully treat, or better still prevent, the disease.

    “If this is proven correct, it will be a very, very big discovery because we'll completely change the way we think about MS, and how we'll treat it,” said Bianca Weinstock-Guttman, an associate professor of neurology at the State University of New York at Buffalo.

    The initial studies done in Italy were small but the outcomes were dramatic. In a group of 65 patients with relapsing-remitting MS (the most common form) who underwent surgery, the number of active lesions in the brain fell sharply, to 12 per cent from 50 per cent; in the two years after surgery, 73 per cent of patients had no symptoms.

    Augusto Zeppi, a 40-year-old resident of the northern Italian city of Ferrara, was one of those patients. Diagnosed with MS nine years ago, he suffered severe attacks every four months that lasted weeks at a time – leaving him unable to use his arms and legs and with debilitating fatigue. “Everything I was dreaming for my future adult life, it was game over,” he said.

    Scans showed that his two jugular veins were blocked, 60 and 80 per cent respectively. In 2007, he was one of the first to undergo the experimental surgery to unblock the veins. He had a second operation a year later, when one of his jugular veins was blocked anew.

    After the procedures, Mr. Zeppi said he was reborn. “I don't remember what it's like to have MS,” he said. “It gave me a second life.”

    Buffalo researchers are now recruiting 1,700 adults and children from the United States and Canada. They plan to test MS sufferers and non-sufferers alike and, using ultrasound and magnetic resonance imaging, do detailed analyses of blood flow in and out of the brain and examine iron deposits.

    Another researcher, Mark Haacke, an adjunct professor at McMaster University in Hamilton, is urging patients to send him MRI scans of their heads and necks so he can probe the Zamboni theory further. Dr. Haacke is a world-renowned expert in imaging who has developed a method of measuring iron buildup in the brain.

    “Patients need to speak up and say they want something like this investigated … to see if there's credence to the theory,” he said.

    MS societies in Canada and the United States, however, have reacted far more cautiously to Dr. Zamboni's conclusion. “Many questions remain about how and when this phenomenon might play a role in nervous system damage seen in MS, and at the present time there is insufficient evidence to suggest that this phenomenon is the cause of MS,” said the Multiple Sclerosis Society of Canada.

    The U.S. society goes further, discouraging patients from getting tested or seeking surgical treatment. Rather, it continues to promote drug treatments used to alleviate symptoms, which include corticosteroids, chemotherapy agents and pain medication.

    Many people with multiple sclerosis, though, are impatient for results. Chatter about CCSVI is frequent in online MS support groups, and patients are scrambling to be part of the research, particularly when they hear the testimonials.

    Kevin Lipp, a 49-year-old resident of Buffalo, was diagnosed with MS a decade ago and has suffered increasingly severe attacks, especially in the heat. (Heat sensitivity is a common symptom of MS.) His symptoms were so bad that he was unable to work and closed his ice-cream shop.

    Mr. Lipp was tested and doctors discovered blockages in both his jugular and azygos veins. In January of this year, he travelled to Italy for surgery, which cleared five blockages, and he began to feel better almost immediately.

    “I felt good. I felt totally normal. I felt like I did years ago,” he said. He has not had an attack since.

    As part of the research project, Mr. Lipp's siblings have also been tested. His two sisters, both of whom have MS, have significant blockages and iron deposits, while his brother, who does not have MS, has neither iron buildup nor blocked arteries.

    While it has long been known that there is a genetic component to multiple sclerosis, the new theory is that it is CCSVI that is hereditary – that people are born with malformed valves and strictures in the large veins of the neck and brain. These problems lead to poor blood drainage and even reversal of blood flow direction that can cause inflammation, iron buildup and the brain lesions characteristic of multiple sclerosis.

    It is well-established that the symptoms of MS are caused by a breakdown of myelin, a fatty substance that coats nerve cells and plays a crucial role in transmitting messages to the central nervous system. When those messages are blurred, nerves malfunction, causing all manner of woes, including blurred eyesight, loss of sensation in the limbs and even paralysis.

    However, it is unclear what triggers the breakdown of myelin. There are various theories, including exposure to a virus in childhood, vitamin D deficiency, hormones – and now, buildup of iron in the brain because of poor blood flow.

    While he is convinced of the significance of his discovery, Dr. Zamboni recognizes that medicine is slow to accept new theories and even slower to act on them. Regardless, he can take satisfaction in knowing that the woman who inspired the quest, and perhaps a dramatic breakthrough, has benefited tremendously.

    Dr. Zamboni's wife, Elena, has undergone a battery of scans and neurological tests and her multiple sclerosis is, for all intents and purposes, gone.

    “This is probably the best prize of the research,” he said.

    Source: The Globe & Mail © Copyright 2009 CTVglobemedia Publishing Inc (22/11/09)

    © Multiple Sclerosis Resource Centre

    Related Items
    CCSVI General Information
    CCSVI Glossary
    CCSVI Organisations and Groups
    CCSVI Standard Letter To MPs
    CCSVI Treatment - Patient Comments
    Quotes on CCSVI
    The venous connection to MS- a timeline


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