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The Risk-sharing Scheme, the mechanism that makes disease modifying drugs for MS available on the NHS, was debated in Parliament on 2 February.

James Gray MP, Chair of the All Party Parliamentary Group on MS, was very critical of the scheme and of the methodology and conclusions of the recently published two year analysis of the Scheme so far. In the light of the development of oral drugs for MS, he concluded by calling for the abolition of the Scheme.

In reply, Health Minister Mike O'Brien drew attention to the reasons for setting up the Scheme and how it makes the disease modifying drugs available on the NHS. When asked about the new, oral drugs for MS, the minister reminded Mr Gray that these have yet to receive a licence and be assessed by NICE. But if they are recommended by NICE, the MS risk-sharing scheme will not detract from their appropriate use.

Pam Macfarlane, Chief Executive of the MS Trust, said "This statement by Mr Gray must be very disappointing for the dedicated clinicians and the 4,900 people with MS who are currently being monitored and it must also be worrying for approximately 14,000 people currently receiving disease modifying drugs under the Scheme.

"Until the oral drugs are licensed and widely adopted, we must ensure that people with MS can continue to have access to the therapies they need and do not end up re-living the problems of the 1990s with postcode prescribing and a lack of MS specialists and clinics."

Source: MS Trust (09/02/10)

Further Information

Disease Modifying Drugs Risk Sharing Scheme

One of the first clinics in North America devoted to testing for a vascular condition that some experts believe is linked to multiple sclerosis is set to open later this month in Buffalo, just as scientists are to release more findings on the controversial theory.

The Buffalo Neuroimaging Analysis Center (BNAC) has announced that it will begin to offer testing for the newly discovered condition, called chronic cerebrospinal venous insufficiency (CCSVI), in mid-February due to overwhelming demand from MS patients.

Italian scientist Dr. Paolo Zamboni believes that 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.

Zamboni has found that more than 90 per cent of patients with MS have these malformed veins, and improper blood flow from the brain.

Due to the overwhelming response to Zamboni's research and to its own study on the condition, the BNAC said it will begin offering diagnostic venous testing to patients beginning in mid-February 2010.

Testing will include:

• An MRI of the brain to measure the level of iron deposits
• An MRI of the neck to study the jugular, vertebral and other collateral veins
• A Doppler exam of the head and neck to determine blood flow
• A follow-up visit with a doctor to discuss the findings
  

News of the findings comes days before scientists from the BNAC release data from their study that includes 500 MS patients who were tested for CCSVI.

"What I can tell you today is that the preliminary results are exciting scientifically and will generate a great deal of discussion among our colleagues, the worldwide press, and individuals like you who are following very closely any developments about CCSVI," Dr. Robert Zivadinov said in the BNAC newsletter.

Zivadinov said the second phase of the study will include another 500 patients and will "pose new and provocative questions about the CCSVI theory."

Scientist welcomes scepticism

Zamboni told CTV's Canada AM Monday that he welcomes skepticism about his findings.

"This is normal when there is a new finding in science," Zamboni said. "I think that this is positive because it stimulates debate."

Zamboni was in Hamilton, Ont., Sunday for a scientific workshop looking into the relationship between MS and CCSVI. Scientists from the United States, Europe and the Middle East reported that they had found CCSVI in more than 95 per cent of MS patients.

"The meeting yesterday was quite successful because we met a lot of colleagues from all over the world that are actually working on our theory," said Zamboni, who is a professor of medicine at the University of Ferrara in Italy.

According to Zamboni, a surgical procedure to restore proper blood flow, which he dubbed the "Liberation treatment," can reduce MS symptoms.

In a study of 65 patients who underwent the procedure, released in the Journal of Vascular Surgery, Zamboni says that 50 per cent of patients with the most common form of MS were relapse-free for at least 18 months.

In a control group of MS patients who did not undergo the procedure, only 27 per cent went 18 months without an MS attack.

Additionally, only 12 per cent of patients in the surgery group had brain lesions -- a sign of active disease -- compared to 50 per cent in the control group.

Research will take time

Dr. Mark Haacke, director of the imaging division in the school of biomedical engineering at McMaster University, organized the weekend conference and said "no one is claiming it's a cure."

"It's a cardiovascular problem first, it may be related to MS, it may cause MS -- but we don't know all those answers yet," he told CTV.ca. "That's going to take time to do very careful research to evaluate those MS patients that do get the operation.

"Do they get better? Do they stay the same? Do their lesions go away? Or do they at least not get worse. (It) may take years and years to really determine the effectiveness of this surgery."

MS societies around the world have responded with funding for research into CCSVI. The Italian Multiple Sclerosis Foundation has allocated up to $4.5 million for research and the MS Society of Canada has called for applications for grants for those studying Zamboni's findings.

Charity Intelligence Canada, a group that provides donors with research and information, called for additional research and funding into Zamboni's findings on Monday.

The group said Canadians donated $62 million to MS-related charities in 2009, and said "supporting CCSVI research presents an opportunity for donors to have high impact in their giving."

"Donors wanting to support CCSVI research in Canada should donate directly to St. Joseph's Healthcare and McMaster University in Hamilton, Ontario and University of British Columbia, designating their donations to CCSVI research," the group said in a statement.

However, experts have warned that the findings are far from being validated and those with MS should continue with their current treatment.

"Although the early data are of great interest, it is important to acknowledge that the concept of CCSVI as a cause of MS and the use of stents or balloons to widen veins as treatments, are ideas that are far from being accepted by most researchers in the field," the MS Society of Canada says on its website.

Experts have expressed concern that the initial excitement over the new procedure was leading some to drop their current treatment.

"To people with MS we say: don't abandon the course of treatment that you have started," Yves Savoie, the president and CEO of the MS Society of Canada told CTV News in November.

"Those treatments have been proven in large trials to be effective in reducing the burden of disability that comes with MS."

Haacke says that since most MS patients have MR scans performed, clinicians should consider performing additional scans for CCSVI.

"It's important for clinicians to begin to realize that they should be taking some time clinically – not on the research side – to scan their patients and find out if this is a problem," he said.

Canada has one of the highest rates of MS in the world, affecting between 44,000 to 78,000 in the country.

Source: CTV News © 2010 CTVGlobeMedia (09/02/10)

A 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)

Fewer African Americans than Caucasians develop multiple sclerosis (MS), statistics show, but their disease progresses more rapidly, and they don't respond as well to therapies, a new study by neurology researchers at the University at Buffalo has found.

Magnetic resonance images (MRI) of a cohort of 567 consecutive MS patients showed that blacks with MS had more damage to brain tissue and had less normal white and grey matter compared to whites with the disease.

Results of the study appear in the Feb. 16 issue of the journal Neurology.

Bianca Weinstock-Guttman, MD, UB associate professor of neurology in the UB School of Medicine and Biomedical Sciences, is first author on the study. Weinstock-Guttman directs the Baird Multiple Sclerosis Center in Kaleida Health's Buffalo General Hospital.

"Black patients showed more brain tissue damage and accumulated brain lesions faster than whites, along with rapid clinical deterioration," confirms Weinstock-Guttman. "The results provide further support that black patients experience a more severe disease, calling for individualised therapeutic interventions for this group of MS patients."

"White matter" refers to the parts of the brain that contain nerve fibers sheathed in a white fatty insulating protein called myelin. The white matter is responsible for communication between the various grey matter regions, where nerve cells are concentrated and where cognitive processing occurs.

"Initially, multiple sclerosis was considered primary a white-matter disease," says Weinstock-Guttman, "but today we know that the grey matter may be more affected than white matter."

In general, black MS patients tend to have more severe and more frequent attacks, followed by an incomplete recovery even after the first episode. Studies on signs and symptoms of MS among populations have shown that blacks experience gait problems sooner after their diagnosis, show faster cognitive decline than whites with MS, and become dependent on a wheelchair sooner, she notes.

The study's MRI scans were conducted at the Buffalo Neuroimaging Analysis Center (BNAC), part of the Jacobs Neurological Institute/UB Department of Neurology. Robert Zivadinov, MD, PhD, a UB associate professor of neurology, is director of the center.

Seventy-nine black patients and 488 white patients were entered in the study. Participants were older than 18 and had been scanned within 90 days of their most recent clinical visit. Black participants were significantly younger, and their disease was more severe than white patients, despite having MS for a shorter amount of time.

"Results of the MRI scans showed that the aggressive disease process in blacks appears to be associated with increased macroscopic and microscopic tissue damage, as measured by specific MRI parameters," says Weinstock-Guttman.

"Based on our MRI findings, a plausible hypothesis that would explain the more aggressive disease in blacks compared to whites with MS may be that blacks have a reduced capacity for remyelination, the brain's ability to repair the protective myelin sheath. However, to confirm this hypothesis, we will need to conduct more longitudinal studies."

Murali Ramanathan, PhD, associate professor in the departments of Pharmaceutical Sciences and Neurology in the UB School of Pharmacy and Pharmaceutical Sciences and School of Medicine and Biomedical Sciences, respectively, also contributed significantly to the study.

Additional contributors were David Hojnacki, MD, Michael G. Dwyer, Sara M. Hussein, MD, Niels P. Bergsland and Frederick E. Munschauer, MD, former chair of the UB Neurology department, now vice president of U.S. medical affairs for Biogen Idec in Boston, Mass.

The study was supported by grants from the National Multiple Sclerosis Society and the UB Pediatric MS Center of Excellence.

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: University of Buffalo © 2010 University at Buffalo.(08/02/10)

Finding a treatment for multiple sclerosis holds as much promise for Hamilton as it does for patients.

St. Joseph's Hospital is one of just two places in Canada testing Italian vascular surgeon Dr. Paolo Zamboni's controversial theory that MS is a vascular disease -- a radical departure from long-held beliefs that it's an autoimmune condition. The University of British Columbia is the other place.

It has brought Hamilton to the attention of the world with about 22,000 MS patients from Asia to Africa to South America to all over the United States and Canada vying to be one of the 100 chosen for the study. It will also recruit 100 healthy people to take part.

"This is a watershed moment," said Dr. Ian Rodger, vice-president of research at St. Joseph's Healthcare. "Opportunities like this don't come along very often."

Hamilton has the chance because of McMaster's affiliation with Detroit imaging expert Dr. Mark Haacke, who met Zamboni in September when the Italian doctor held a conference about his theory.

Zamboni believes the veins draining blood from the brain are blocked and leaking in MS patients. This allows iron to leak into brain tissue and he thinks the buildup causes many symptoms of MS. Zamboni found those veins blocked or malformed in more than 90 per cent of MS patients he studied -- including his wife.

Haacke has long researched the role iron plays in MS and is eager to test Zamboni's theory. His main lab is in Detroit but he's also an adjunct professor at McMaster. With eight other Hamilton doctors, he plans to use St. Joseph's MRI, which is twice as strong as traditional machines, to look at the veins in the brains of MS patients and healthy people to see whether there is a difference.

Haacke says there has been a lot of resistance to Zamboni's theory -- Chronic Cerebrospinal Venous Insufficiency (CCSVI) -- from medical professionals, particularly neurologists.

"It was just so flabbergasting to them," he said.

But the idea can't be ignored.

"We're going to have 10 years of fascinating research."

St. Joseph's, McMaster and Hamilton Health Sciences want to play a big role in that. They don't have funding yet, but are together putting in a proposal to the MS Society of Canada Tuesday for $100,000 a year for two years.

Rodger is leading the research and hoping other funders will come forward so that they can do a much bigger study that would produce results in 12 to 15 months instead of two years or longer. Philanthropists and/or their advisors are expected to be at the workshop Zamboni and Haacke are presenting in Hamilton tomorrow.

The stakes are high for MS patients, as there are few treatment options. Zamboni performs an experimental surgery similar to angioplasty to unclog the veins and improve blood flow. He says it has worked for his wife and others.

Hamilton MS patient Vasilios "Bill" Smyrnios wants to know if that surgery could help him. The 50-year-old who was diagnosed 10 years ago can't walk anymore and has to live in supportive housing.

"This disease is relentless," he said. "It keeps getting worse. It has amazed me. I never expected to get like this."

He has newfound hope since researching Zamboni's theory.

"It was the first thing I've read in a long time that made sense."

While St. Joseph's is studying the theory and hosting the conference, it is a long way from endorsing it.

"There's a great deal of skepticism about the observational study (that Zamboni did)," said Kevin Smith, CEO of St. Joseph's Healthcare. "A lot of the scientific community has already rejected the view. But it resonates profoundly with patients and families so it's our responsibility to determine if this is more than unusual observation."

Source: Thespec.com © Copyright Metroland 2010 (07/02/10)

Biogen Idec Inc. is planning the first clinical trial that could lead to use of controversial multiple sclerosis treatment Tysabri, sold with Elan Corp, at earlier stages of the disease.

The long-term trial, dubbed Surpass, will measure the effectiveness of Tysabri in patients with active MS that have switched from either Teva Pharmaceutical Industries Ltd.'s Copaxone or Rebif, sold by Pfizer Inc. and Germany's Merck KGaA.

Tysabri is considered a highly effective therapy for MS, and its growth is important to the future of both Elan and Biogen. But its sales have been slower than originally hoped amid concerns about the risk of a rare brain infection that led to its 18-month market withdrawal beginning in 2005. The study comes after Tysabri brought in more than $1 billion in 2009, and it is part of Biogen's push to accelerate Tysabri's growth.

It also comes amid increased competition in MS treatments. Novartis AG and Germany's Merck KGaA could launch oral treatments for the disease this year, a notable advance compared to the injections and infusions required with current drugs.

The goal of the Surpass trial is to get physicians to use Tysabri when patients aren't responding to their current therapy, rather than switching them to more mainstream therapies.

Beside Copaxone and Rebif, other common options include Biogen's Avonex and Bayer AG's Betaseron, while Tysabri is generally reserved for patients with very aggressive disease or have no other options.

"We are trying to establish that there is no use in switching around [prior to using Tysabri]," Biogen spokeswoman Naomi Aoki. The company is signing up sites for the trial and has yet to enroll the first of an estimated 1,800 patients.

The study will follow participants for about two years and isn't likely to yield data until 2013 or 2014. If successful, the result should allow Biogen to update Tysabri's label and allow it to market the earlier use to physicians.

Source: ADVFN III Copyright 1999-2010 ADVFN PLC (07/02/10)

In the latest blow to the controversial multiple sclerosis drug Tysabri, the U.S. Food and Drug Administration announced that it was slapping a new warning on the drug's label.

In an advisory sent to health-care professionals and patients, the FDA warned that the risk of developing progressive multifocal leukoencephalopathy (PML), a rare but deadly brain infection, increases as more infusions are received.

"This is updated information, taking new cases into account," explained Dr. William Sheremata, professor emeritus of neurology at the University of Miami Miller School of Medicine, who gave the drug to the first humans.

European patients account for most of the new cases and many of them might have been taking multiple drugs, raising their risk for PML, he added.

"This is not new information. We've had this information for a couple of months now [but] the labeling in the past did not make a distinction between the time frames that people were on the drugs," said Dr. John Richert, executive vice president for research and clinical programs at the National Multiple Sclerosis Society. "The risk-benefit ratio continues to be about the same as we anticipated since the time the drug was brought back on the market."

Another expert agreed that the clinical picture hasn't been altered by the new label warning.

"I think as long as the medication is being prescribed for the appropriate patient with MS, then the new information we have today is not going to alter medication management," said Dr. Jeffrey Tramonte, director of neurology at the Scott & White University Medical Campus in Round Rock, Texas. "Right now, Tysabri is the most efficacious drug that's ever been approved for the treatment of relapsing-remitting MS, which represents 85 percent of all patients out there who have MS," he said.

"However, it also carries the single most dangerous risk factor, and that's PML," added Tramonte, who only gives Tysabri if his patients have failed or have severe side effects from conventional immunomodulating drugs.

Natalizumab (Tysabri) first received FDA approval in November 2004, only to be pulled from the market three months later after several patients in clinical trials developed PML.

In June 2006, the FDA allowed the drug back on the market, but with strict conditions. According to those revised guidelines, Tysabri can only be administered by approved doctors, at infusion sites and at pharmacies that register and comply with a patient-safety program called CD Touch, designed by drugmaker Biogen Idec and approved by the FDA.

The FDA said the new action was based on reports of 31 confirmed cases of PML as of Jan. 21, 2010.

Information on the risk will also be included in the patient Medication Guide.

However, the FDA did not suggest discontinuing the drug, stating that it "believes that the clinical benefits of Tysabri continue to outweigh the potential risks."

The drug was approved to treat Crohn's disease in early 2008. It is also linked with liver damage. Patients do take the drug long-term, Richert said.

Source: HealthDay © 2010 HealthDay. (06/02/10)

Fueled by windfall profits from swine flu vaccine sales, GlaxoSmithKline reported a big spike in revenue for the fourth quarter. But the extra money hasn't stopped the pharma giant from sharpening its budget-cutting axe once again. Glaxo executives this morning outlined an additional 500 million pounds ($791.6 million) of budget cuts as it scales back on R&D.

Specifically, Glaxo says it will stop R&D efforts in certain neurological areas, with work grinding to a halt in depression and pain, according to Bloomberg. The company will focus on Alzheimer's, Parkinson's and multiple sclerosis and create an R&D unit that will concentrate on new therapies for rare diseases. Glaxo makes it quite clear that this new unit would be an active collaborator.

"We are allocating capital to areas where we can get the best return on investment," the company says in the statement. CEO Andrew Witty told reporters that the budget cuts included a further reduction in the company's workforce that would amount to the "hundreds rather than thousands" in the U.K.

"In addition to our existing discovery effort, alternative opportunities need to be explored to make treatments available for rare diseases," says Marc Dunoyer, GSK's president of Asia Pacific and chairman of Japan, who will head the new rare diseases unit. "This complementary approach will combine our existing global expertise with specialist partners. Over time, this new unit has the potential to deliver multiple therapies responding to high medical needs of underserved populations of patients."

Source: Fierce Biotech © 2009 FierceMarkets, Inc. (05/02/10)

Compugen Ltd.  announced today the discovery and
experimental validation of CGEN-15001 for the treatment of autoimmune
disorders. CGEN-15001 is the extracellular region of a previously
unknown membrane protein in the B7/CD28 family. The existence and
potential utility of the newly discovered parent protein from which
CGEN-15001 is derived was predicted in silico utilizing
Compugen’s LEADS Platform and other proprietary algorithms.

Autoimmune diseases develop when defects in the immune system lead the
body to attack its own cells, tissues, and organs and include more than
80 chronic, and often disabling, illnesses. Among the most common
autoimmune diseases are rheumatoid arthritis, systemic lupus
erythematosus, multiple sclerosis, inflammatory bowel disease, and type
1 diabetes. Collectively, autoimmune diseases are among the most
prevalent diseases, affecting an estimated 25 million people in the U.S.

CGEN-15001 is a novel soluble recombinant fusion protein corresponding
to the extracellular region of the Compugen discovered parent protein.
The discovery of the parent protein, which is a membrane protein, was
accomplished through the incorporation in Compugen’s LEADS Platform of
additional algorithms specifically designed to predict novel members of
the B7/CD28 family of co-stimulatory proteins. This approach relied on
Compugen’s proprietary understandings and modeling of genomic structure,
gene expression, protein structural domains, and cellular localization.
Compugen has filed for patent coverage on both the parent protein, which
potentially has other medical uses such as a target for antibody
therapeutics, and CGEN-15001.

The in vivo validation of CGEN-15001 utilized a mouse model of
multiple sclerosis, relapsing-remitting experimental autoimmune
encephalomyelitis (R-EAE). In this model, administration of CGEN-15001
resulted in potent amelioration of the disease state. These results
indicate that CGEN-15001 could have therapeutic utility for the
treatment of multiple sclerosis and other autoimmune diseases, such as
rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel
disease, and type 1 diabetes. Earlier in vitro studies validated
the predicted functional activity of CGEN-15001 as a new member of the
B7/CD28 family proteins.

Professor Stephen Miller from Northwestern University, a leading
scientist in this field who supervised the studies, stated, “Our studies
have indicated robust disease suppressing activity for CGEN-15001 in the
SJL R-EAE model, a recognized mouse model for multiple sclerosis. These
studies have also demonstrated that CGEN-15001 has the unique ability
to inhibit proliferation, differentiation, and cytokine production of
pro-inflammatory Th1 and Th17 responses while at the same time sparing
or actually promoting regulatory Th2-derived cytokines. As far as I am
aware, this potentially very beneficial pattern of inhibiting Th1/Th17
while promoting Th2 responses is unique among the reagents targeting the
B7 family of co-stimulatory molecules that have been published to date.”

Compugen’s VP R&D, Dr. Zurit Levine stated, “We are extremely pleased by
this further demonstration of the unique discovery capability that has
been created at Compugen. In view of its recognized potential in the
largely unmet and critical field of immune regulation, the B7/CD28
co-stimulation protein family has been an area of extensive research for
a number of years. In our opinion, in addition to providing Compugen
with a very attractive product candidate, the predictive discovery and
experimental validation of a previously unknown member of this
extensively researched protein family represents a major milestone in
the transition from experimentally based therapeutic discovery to in
silico prediction and selection.”

Source: Compugen Ltd. (03/02/10)

Summary
Several studies suggest an increasing prevalence of multiple sclerosis (MS) in Canada. Canadian MS neurologist and researcher Dr. Marrie and colleagues aimed to validate a case definition for MS using administrative health insurance data, and to describe the incidence and prevalence of MS in Manitoba, Canada. Neurology. 2010 Jan 13. [Epub ahead of print]

Details
Provincial administrative claims data were reviewed to identify persons with demyelinating disease using International Classification of Diseases 9/10 codes and prescription claims. Questionnaires were mailed to 2,000 randomly selected persons with an encounter for demyelinating disease, requesting permission for medical records review. Diagnoses abstracted from medical records were used as the gold standard to evaluate candidate case definitions using administrative data.

From 1984 to 1997, cases of MS using claims data were defined as persons with seven or more  medical contacts for MS. From 1998 onward, cases were defined as persons with three or more medical contacts. As compared to medical records, this definition had a positive predictive value of 80.5% and negative predictive value of 75.5%. From 1998 to 2006, the average age- and sex-adjusted annual incidence of MS per 100,000 population was 11.4 (95% confidence interval [CI] 10.7-12.0). The age-adjusted prevalence of MS per 100,000 population increased from 32.6 (95% CI 29.4-35.8) in 1984 to 226.7 (95% CI 218.1-235.3) in 2006, with the peak prevalence shifting to older age groups.

Authors conclude that the prevalence of multiple sclerosis (MS) in Manitoba is among the highest in the world. The rising prevalence with minimally changing incidence suggests improving survival. This study supports the use of administrative data to develop case definitions and further define the epidemiology of MS.

Source: MS Society of Canada National Research and Programs (03/02/10)

Pregnancy is associated with reduced activity of multiple sclerosis (MS). However, the biological mechanisms underlying this pregnancy-related decrease in disease activity are poorly understood.

We conducted a genome-wide transcription analysis in peripheral blood mononuclear cells (PBMCs) from 12 women (7 MS patients and 5 healthy controls) followed during their pregnancy. Samples were obtained before, during (i.e. at the third, sixth, and ninth month of gestation) and after pregnancy. A validation of the expression profiles has been conducted by using the same samples and an independent group of 25 MS patients and 11 healthy controls. Finally, considering the total group of 32 MS patients, we compared expression profiles of patients relapsing during pregnancy (n = 6) with those of relapse-free patients (n = 26).

Results showed an altered expression of 347 transcripts in non-pregnant MS patients with respect to non-pregnant healthy controls. Complementary changes in expression, occurring during pregnancy, reverted the previous imbalance particularly for seven inflammation-related transcripts, i.e. SOCS2, TNFAIP3, NR4A2, CXCR4, POLR2J, FAM49B, and STAG3L1. Longitudinal analysis showed that the overall deregulation of gene expression reverted to “normal” already within the third month of gestation, while in the post-partum gene expressions rebounded to pre-pregnancy levels. Six (18.7%) of the 32 MS patients had a relapse during pregnancy, mostly in the first trimester. The latter showed delayed expression profiles when compared to relapse-free patients: in these patients expression imbalance was reverted later in the pregnancy, i.e. at sixth month.

Specific changes in expression during pregnancy were associated with a decrease in disease activity assessed by occurrence of relapses during pregnancy. Findings might help in understanding the pathogenesis of MS and may provide basis for the development of novel therapeutic strategies.

Francesca Gilli¹*, Raija L. P. Lindberg², Paola Valentino¹, Fabiana Marnetto¹, Simona Malucchi¹, Arianna Sala¹, Marco Capobianco¹, Alessia di Sapio¹, Francesca Sperli¹, Ludwig Kappos², Raffaele A. Calogero³, Antonio Bertolotto¹

¹ Regional Centre for Multiple Sclerosis (CReSM) and Clinical Neurobiology, Azienda Ospedaliera Universitaria San Luigi Gonzaga, Orbassano, Italy, ² Departments of Biomedicine and Neurology, University Hospital Basel, Basel, Switzerland, ³ Genomics and Bioinformatics Unit, Department of Clinical and Biological Sciences, Azienda Ospedaliera Universitaria San Luigi Gonzaga, Orbassano, Italy

Full Paper - http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0008962

Source: PLoS ONE © 2010 Gilli et al. (02/02/10)

A 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: Claudio.Buffagni@esaote.com

Source: CTV News © 2010 CTV Globe Media (30/01/10)

Investigators at the University of Sydney have published a study suggesting that the earliest activity seen in the brain in MS is the destruction of cells that make myelin (oligodendrocytes), occurring before the onset of immune activity usually blamed for triggering the disease.

This provocative study, co-funded by many sources including the National MS Society, opens up new possibilities for finding the cause of the disease and developing new treatments. The study is authored by Drs. John W. Prineas, Andrew P.D. Henderson and colleagues, and is published in the December issue of Annals of Neurology (2009;66:739–753).

Background: Multiple sclerosis has long been thought to be triggered by immune attacks in the brain and spinal cord, causing a spectrum of neurological symptoms. Extensive research has been underway to better understand what triggers the immune attacks and which immune cells are involved, and to better understand the damage to the central nervous system that occurs during the course of MS. In addition to studies of immune activity underlying what has been considered an autoimmune process, another important approach has centered on pathology studies involving microscopic explorations of MS lesions (damaged areas, also called plaques) in the brains of people with MS.

The lead author of the current study, John W. Prineas, MB, BS, FRCP, was the 2001 winner of the John Dystel Prize for MS Research, an award given jointly by the National MS Society and the American Academy of Neurology. He was recognized for being the investigator who first described how myelin, the substance that insulates nerve fibers, is broken down in MS, and he was the first to demonstrate that myelin repair occurs during the course of MS through the body’s natural repair processes.

Current Study: For this study, the team used brain specimens from 11 people who had died early in the course of their MS, and the team also used comparison specimens from people with other disorders including stroke. Some of the tests focused on subsets of specimens from seven people who had lesions showing active myelin destruction. To get a sense of immune cell activity in the brain and at what stage it was occurring, the team examined newly active and resolved lesions, as well as nearby blood vessels, surrounding areas showing some disease activity and surrounding areas that appeared normal, and areas that were farther away from the lesions of interest.

Results: In tissues surrounding newly forming lesions, the investigators found evidence of the loss of oligodendrocytes with an absence of immune T or B cells that would normally be held responsible for launching the immune attack against oligodendrocytes and the myelin they produce. These and other immune cells, including scavenger cells (macrophages and microglia), were more numerous in lesions and surrounding tissues at apparently later stages of destruction and sometimes in lesions that were in the process of repair. In specimens from two very early cases of clinical onset of disease, they found few immune cells within the lesions and no evidence of activation of scavenger cells.

These and other unexpected findings from this study led the investigators to propose that the early immune activity seen in active lesions is that of macrophages and microglia, whose job it is to clean up and remove damaged myelin. They propose that lesion formation is caused by something other than destructive immune activity led by inflammatory cells against a component of myelin or oligodendrocytes.

Comment: This study is a significant addition to a small but growing body of evidence that highlights the question of what triggers MS and whether there is something other than, or in addition to, the immune attacks that lead to tissue damage in the brain and spinal cord of people with MS. Further research, which is ongoing by investigators around the world, should shed further light on this question and may offer novel treatment approaches.

Note: The availability of donor brain specimens was crucial to this and other studies focusing on disease pathology

Source: US National Multiple Sclerosis Society (30/01/10)