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    You are here : Home » Get Involved » MSRC Interactive » Tysabri® User Diaries » Lauren's Tysabri Diary

    Lauren's Tysabri Diary

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    Lauren

    Lauren was one of the first people to be given Tysabri in the US, and has been keeping an online blog of her experiences with the drug since 2006. Lauren has kindly agreed to provide her older blog entries plus maintain an ongoing up to date diary for the MSRC Tysabri Dairy section to help those thinking of starting to use Tysabri as their MS treatment of choice.


    Monday, August 21, 2006

    Hi all, My name is Lauren. (keep in mind that I am in the US, so any qualifications for Tysabri might be different in your country).

    I have been living with MS for 30+ years (luckyme!). I have been on Avonex and Copaxone, oral and IVSM (which no longer work for me) and Novatrone is not an option for various reasons.

    I had one dose of Tysabri in early 2005, and had miraculous results just two weeks after my infusion (my slurred speech, right drop foot, limp, and a host of other symptoms were gone! And my balance was just starting to improve).

    After it was removed voluntarily by the manufacturers, I suffered a severe relapse in June 2005 that has left me wheelchair bound and homebound. I was RRMS for 29 years (I was amazed and grateful I remained RR for so long, my neuro was shocked and baffled) up until last year when my neuro upgraded me to SPMS with relapses. I am currently waiting to go back on Tysabri, as it is the only MS therapy that stopped my attacks, improved my symptoms dramatically within 2 weeks of the infusion, and provided me with a better quality of life. It was re-launched on 6/5/06, and the TOUCH program went into effect on 7/18 (scheduled training of neuros and infusion centers) with enrollment forms being accepted and processed by Biogen on 7/19.

    I will support anyone's choice of MS therapy, no matter what that choice is. I would, however, like to set the record straight due to any misconceptions and/or mis-information regarding Tysabri. I also testified at the FDA AC hearing via videotape on 3/7/06 in an effort with other MS patients to bring Tysabri back to MS sufferers that want and need it, like I do. If you would like to view my videotaped testimony (try not to die laughing, ok?  LOL), it can be found on my blog profile entitled Living With MS (My Tysabri Diary) which is located at:  http://lauren-livingwithms-aolcomlglbgl2003.blogspot.com/ .

    In a nutshell, for me,Tysabri's 68% superior efficacy, improvements in current disabilities, safety when used as a monotherapy (by itself as a sole therapy), improvements in Quality of Life (which no other MS drug can claim) and protection from further relapses: the benefits of Tysabri far outweigh the very small risks of developing PML (.01% or 1:1000-probably less than that, actually). It is more of a risk for me NOT to have Tysabri, as Tysabri protected me from further attacks/relapses.

    For more information on Tysabri, see http://www.biogen.com/site/home.html , http://www.elan.com/, and/or http://www.tysabri.com/touch.html.

    As to Tysabri being used as a First Line AND/OR Second Line therapy, NOTE: Dr. Richard Katz of the FDA specifically indicated in his Conference Call that the language in the FDA formal statement re: Tysabri's use was to be decided by the treating doctor and the patient (as it should be) and the FDA's formal statement[1]was intentionally left open for indications of use as First AND/OR Second line therapy. In order to bolster this argument, I highlight in bold the text from the FDA approved label for Tysabri which states in part,"TYSABRI® is indicated as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations."

    [1] http://www.fda.gov/bbs/topics/NEWS/2006/NEW01380.html

    Tysabri= to shelter (abri in French). Is that the perfect name for a MS drug that "shelters" patients from further relapses & disabilities, or what? :)

    If you have a neurologist that has taken a "Wait and See" attitude, ask yourself, "What is he/she waiting for? For you to get worse???"

    For any MS patient or treating neurologist reading my comments, I ask you this question: If "Time is Brain", why are neurologists willing to allow their patients to suffer relapses, increased likelihood of further lesion load, possible permanent disability and possibly develop "black holes" therefrom, BEFORE they will prescribe Tysabri to protect their patient by 68% or 2/3rds efficacy over the 1/3 possible efficacy of the ABCR's?

    Please feel free to leave me a comment on my blog:  http://lauren-livingwithms-aolcomlglbgl2003.blogspot.com/.  I do try to check my blog site daily ( today is the first day of my blog, as I literally created my first entry here late late late last night (did I mention late?).  You can also reach me through my AOL address [email protected].  (the Legal Beagle...laughing). You can also visit my homepage which is located at: http://hometown.aol.com/lglbgl2003/myhomepage/profile.html

    Right now though, I am going through the "Tysabri Saga" of endless delays and run-arounds, in addition to having difficulties typing. I will try to update it daily, but if you do not see new posts from me (from time to time), you'll know why.

    Being diagnosed with MS is not the end of the world (at the time I was dx'd in 1976, it came pretty dayum close though!!!). Whatever any of you decide to do re: your choice of therapy, I wish you only the very best that life has to offer. May you always be blessed, 

    Lauren.

    45th Tysabri infusion report

    Hi everyone, I completed my 45th Tysabri infusion on Tuesday 3/16, all went well as usual. I saw my neurologist the day before on the 15th, and he was very pleased that my progression has slowed down considerably. He renewed my Tysabri prescription for another six months, woo hoo! He said that my blood tests looked fine, and he won't order more blood tests until next year unless things change--that was good too. He was also testing my cognitive function/memory, and I aced every question he asked me, including the three questions asked earlier that I was supposed to remember 

    My infusion center has another new Tysabri patient; I'm not sure how many they have now--but it seems to me that each month ago there, there is another new Tysabri patient.

    I received an e-mail from a friend of mine who had an acquaintance that was recently diagnosed with MS. He asked me to talk with him and provide him with a bunch of different links I had for newcomers to the disease. I haven't heard back from him yet, so he is probably still researching the resources that I provided to him. I would, however, like to share an e-mail that I received from another MS patient just recently diagnosed in 2009 & whose doctor wants to switch her over to Tysabri, and she was pretty nervous..., also my reply to her is included below.

    Have a great weekend everyone!

    ((((hugs))))

    Love, Lauren :)

    *****

    Hey Lauren!

    I found your group on Facebook. I would love it if you would share the information that you have on Tysabri with me. I was diagnosed in September 09. I tried Rebif and it was a horrible experience! My neuro then put me on Copaxone. I've been on it for only about 8 weeks. I had my first MRI "check up" last week since it has been 6 months since I was diagnosed. I have 3 new lesions. The neuro said that was a lot for the first six months (I can't find any research about what the "normal" number of lesions is during a certain time period. Do you happen to have any idea?). My neuro suggested that I go on Tysabri. I am super nervous so I am trying to learn as much as I can about the drug.

    Thank you so much for your advice and knowledge,

    XXX

    Hi XXX, it is so nice to meet you!

    Since you were recently diagnosed in late 2009, obviously Rebif was not working for you (interferons have very harsh side effects-I know, I was previously on Avonex, and then I moved to Copaxone)...., to have 3 new lesions in only six months, that's quite a few for a newly diagnosed MS patient. I don't have any specific link I can give you for that kind of information, but since I've had MS for more than 35 years, trust me, that's a lot of lesions for only six months, which leads me to believe you have an aggressive form of MS (I'm not a doctor, but I'll take a guess that you are Progressive Relapsing or PRMS perhaps?).

    See: http://www.nationalmssociety.org/about-multiple-sclerosis/relapsing-ms/index.aspx, which states: "Progressive-Relapsing MS --(PRMS)--the least common disease course--is characterized by steadily worsening disease from the beginning, but with occasional relapses along the way. People with this form of MS may or may not experiencesome recovery following these attacks, but the disease course continues to progress without remissions. PRMS is considered to be both a progressive and a relapsing form of the disease because experience steady disease progression and relapses." PRMS is also known as "an aggressive form of MS".

    You also stated, "My neuro suggested that I go on Tysabri. I am super nervous so I am trying to learn as much as I can about the drug."..., you have a smart neurologist since the ABCRs (Avonex, Betaseron, Copaxone, & Rebif) have only 29% to 34% effectiveness [respectively] at slowing the progression of MS down & preventing further relapses, you obviously need a more effective Disease Modifying Drug (DMD).

    Tysabri is 68% more effective at slowing the disease process down and preventing further relapses. I've been on Tysabri for more than three years, and I haven't had a relapse since October 2006!

    And I don't understand why you are super nervous about Tysabri--if you are concerned about PML (Progressive Multifocal Leukoencephalopathy), that is not caused by Tysabri, a compromised immune system (a very low immune system) can cause the person that carries the dormant JC virus to ultimately develop into PML.

    Most MS patients have a very strong and active immune system because that is why we keep having relapses. If you were previously on medications that can last in the body for a long time such as Azathioprine/Imuran, Remicade, Novantrone, CellCept, Raptiva, etc. or treatments that drastically reduce the function of your immune system such as IVIG treatments, regular monthly pulse steroids, etc., all of those can potentially lower your immune system to where it becomes compromised, and from what you've told me, you haven't had any of those medications or treatments, so you really don't have anything to fear.

    Now if you want a few links to read up on accurate Tysabri data and information, check the following out:

    My personal blog (which is also my Tysabri diary), and has tons of links regarding Tysabri: Living With MS (Lauren's Tysabri Diary)

    Information from the expert authors of the New England Journal of Medicine regarding PML: NEJM - Conclusions re: PML

    Tysabri Brochure

    TYSABRI.com (Natalizumab)

    TYSABRI® Has Sustained Effect on Relapse Rate for up to Three Years

    ***ABCR Comparison & TYSABRI® Shows Reduction in Steroid Use/Hospitalizations

    TYSABRI® Demonstrate Significant Improvements in QoL

    TYSABRI® Reduces Vision Loss in MS

    TYSABRI® Demonstrates Improvement in Cognitive Function

    TYSABRI® Demonstrates Sustained Improvement in Function

    TYSABRI® Demonstrate Significant Reduction in Steroid Use and Hospitalizations

    My personal favorite: TYSABRI® Promotes Remyelination & Suggests Improvements In Symptoms TYSABRI® Provides Greater Treatment Satisfaction As Reported By MS Patients

    Have I given you enough information to research for now? (Heehee)

    You can write me at any time, and I will be more than happy to try and help you as much as I can. I need to go do my physical therapy now, so take care dearheart!

    Lauren :)

    42nd Tysabri infusion

    I had my 42nd Tysabri infusion yesterday, and was advised that our little infusion center now has 11 Tysabri patients ranging in age from 20 to 56. My infusion went just fine, no problems at all. I did however receive THE BEST Christmas gift of all -- news from my infusion nurse that one of their newest Tysabri patients (female-early 30s-diagnosed with MS approx. 8 years ago), after just her second infusion of Tysabri, she no longer uses a cane and walks perfectly normal again --in addition, one of the other newer Tysabri patients (female-mid-40s-diagnosed with MS approx. one year ago), was prescribed Tysabri as a first-line medication and after her very first infusion of Tysabri, she was noticing her balance had significantly improved! Can you imagine how many more improvements she will start seeing with continued Tysabri infusions? I can, reminds me of the improvements I had gained after just two weeks of my first infusion back in 2005-before Tysabri had been temporarily removed from the market for approximately 18 months..., good for her - Woo hoo!

    In addition to the news above, I was also advised that 6 out of the 11 Tysabri patients in our little infusion center are receiving Tysabri as a first-line medication, which leads me to believe that most Kaiser neurologists are not waiting for their MS patients to get worse while using one of the ABCRs prior to starting Tysabri, it's about time - double woo hoo!!!  :)

    While I too wish I was noticing improvements (unfortunately I'm not anymore), I am happy that my MS is now stable and has remained stable for more than three years--what PML scare? ;)

    And even though I am still a little tired today after my infusion yesterday, I wanted to wish all of my friends (even prospective friends & of course any enemies I might have made in the past), awonderful, prosperous and blessed Merry Christmas, Happy New Year-and Happy Holidays to those of you who do not celebrate Christmas --

    All my very best to each and everyone of you, always..., Lauren

    41st Tysabri infusion report

    A belated Happy Thanksgiving everyone! I had my 41st Tysabri infusion yesterday (11/26), and boy was I thankful everything went superduper smoothly. I am also very thankful that I am on the best and most effective MS therapy available to us MS patients, and I am also very thankful for all of the friends I have made that have posted on my blog, and elsewhere.

    I would also like to take this opportunity to thank everyone for the very kind & sincere birthday wishes I received from everyone. Turning 55 so far is turning out to be a good year!

    The two infusion nurses that gave me so much trouble last month at Kaiser are no longer there (whew), and I also learned that two more patients are now receiving Tysabri at my small infusion center. The two new infusion nurses will shortly be Touch Certified so as not to overburdened the two remaining infusion nurses.

    I got a very good night's rest last night, and I woke up with a very clear mind (I've noticed that over these last few infusions, my cognitive issues seem to have been pretty much resolved--yaaay) --but I am still just a little tired today. My caregiver Ray & I cooked yesterday after my infusion (a broccoli casserole, a sweet potato pie, turkey dressing, dinner rolls, cranberry sauce, turkey gravy,a Turkey breast stuffed with softened butter, cilantro, garlic, & lemon zest, and a homemade cherry cheesecake). Oh I'm getting hungry just thinking about all the food we made, yummy yummy yummy.

    I hope that each of you, your family, loved ones and friends had a very wonderful, safe, and joyous Thanksgiving Day!

    Gobble gobble ( heehee )

    Lauren

    39th Tysabri infusion report
    Hello everyone!

    I had my 39th Tysabri infusion on Wednesday 9/30, but more important was the week before when I was invited by the Vice President -  CorporateRelations of Élan Pharmaceuticals to speak at their Élan  Employee Day on 9/25. My infusion went well with no problems, but let me get to my week prior to my infusion.

    The photos list on my blog ( http://lauren-livingwithms-aolcomlglbgl2003.blogspot.com/ ) are of a few of my friends that got together for dinner up in San Francisco Thursday night 9/24-the night before I spoke at Élan Pharmaceuticals.  The photo descriptions are: Ray,doodah, Me, Dexter, and Roy; Me and my friend Roy; my friend doodah snatching a little smoocherooooni; the band that performed at Élan's Employees Day; Mr. Kelly Martin (the CEO Of Élan Pharmaceuticals) & me; Mary Stutts (she's the Vice President of  Corporate Relations) & me; Dr. Ted Yednock (he's the brilliant scientist that discovered Tysabri & he is my hero!) & me; my friend Pam that I met up there in San Francisco who also has MS and just completed her 39th infusion, me, and an Élan employee that was all over the dance floor!

    I had such an awesome time at dinner Thursday night with doodah, dexterstinks, Roymulus, and my caregiver/assistant Ray. I am not sure if the food or the company at our table was more sinfully wonderful!!! All three of my friends mentioned above were so generous, compassionate, and caring, it was all I could do to not burst out in tears (happy tears) at getting to see doodah again but especially to meet Roymulus for the first time (none of you could ever know how absolutely wonderful this man is), and to meet dexterstinks for the first time as well..., everyone was so funny & gracious, I'm surprised I didn't choke on my food laughing or have my mudslide fly out of my nostrils! I just hope they all had a good time and if they only had a minute decimal of the good time I had, I know they enjoyed themselves.

    The trip up to San Francisco was rather tiring on me, but all of the arrangements made by Élan getting up there and the accommodations they provided me with were great. It's the trip back home Friday night that was a disaster (no shuttle was available to pick Ray and I up once we landed), even though I had the confirmation itinerary which was previously sent to me by Élan. After a two hour wait upon landing, Ray finally made arrangements with the shuttle, and we both made it home after a total five hour delay, through no fault of Élan or the airline, it was the shuttle service ( grrrrrr ).  And to top it all off, the shuttle driver was waiting for a tip ....I was so p.o.'d off at them, the only tip I gave them was not to swim in shark infested waters!

    A brief synopsis of what transpired on Friday at Élan is below, and Friday, 9/25, was not only the Élan Employee Day, it was their 40th birthday celebration for the company, and it was a huge, and I mean HUGE production they put on for not only their employees, but their guests as well! A live band (which was phenomenal), professional dancers in the band (which were also phenomenal), a film of Élan's history which was shown on two large screens, and food-food-food-and more food!

    Some of the speakers were Kelly Martin, Shane Cooke, Carlos Paya, Mary Stutts, one of the representatives from J&J, so many people, I can't remember them all. Above are photos of Kelly Martin and I, Mary Stutts and I, my HERO TED YEDNOCK and me (he came over to talk to me after my speech and spent at least 45 minutes talking to me-and me talking to him-both of us trying to speak over a live band that was playing) so he told me that we could speak later...(he could not believe that was my very first speech, we talked briefly about PML, how that all came about, the continued research of what happened with the patients that developed PML, the immune system, my personal experience with MS, etc. etc.) and oh so many top executives & researchers & employees that came out to meet me personally and thank me for being there...,

    but it was me thanking them for inviting me, and everything that they are doing for patients. They are some of the most gracious, dignified but humble, caring individuals that I've ever met in my entire life..., they completely blew me away! I could not remember everybody that came up to me, because I was so exhausted by the end of the day and I'm sure some of them thought I didn't want to speak with them, but that wasn't the case at all..., I just ran out of steam. So I hope that they understand if they are reading this message.

    Mary Stutts told me that she will be providing me with a copy of the video they were makingof the entire event, including all patient stories. I'm not sure when their professional videographer will make this available to them, but she definitely and most graciously told me that they would be happy to provide me with a copy of same. She also mentioned to me that they might possibly use portions of my patient speech on their "Patient Voices" website..., woo hoo!

    So here is the brief synopsis of my speech (I was allotted five minutes): I introduced myself, thanked several people including Mary Stutts for inviting me to speak there, her assistant Julie (who was utterly amazing- Mary, she is worth her weight in gold), Mary's other assistant Myesha, Mr. Kelly Martin, Ted Yednock, and everyone who works at Élan; I told them how old I am, how long I've had MS, that I was the first person (post marketing) in both 2005 & 2006 through Kaiser Permanente in Southern California to receive Tysabri, the kinds of  improvements I made/had in2005 just two weeks after my very first infusion:

    (my limp was gone, my right drop foot was gone, my slurred speech was gone, my optic neuritis was gone, I put away my walker & was only using my cane for balance, and on the day my second infusion was to take place,Tysabri was removed from the market and how devastated I was. I then mentioned to them that it was in June 2005 that I got hit hard with a severe relapse which left me in a wheelchair and they could see how disabling a severe relapse can be. I then mentioned so many thanks go out to David Kaplan for actually bringing together so many Élan investors to help mobilize and assist many of us patients getting to the FDA Tysabri hearings in March 2006, MSpatientsforchoice, and how everyone just came together to bring about this endeavor, including the videographer that was arranged to videotape my testimony and then the delivery process to get it out to be viewed by the FDA ACcommittee.

    I then mentioned that I basically am all over the Internet, specifically the MS boards, providing accurate Tysabri information, answering e-mails from scared MS patients about PML, advising them not to be scared, not to believe all the lies that are posted by idiots on the different MS boards, to speak to their doctors - I tell them about my experiences with Tysabri, and not to be afraid if their immune systems are okay.

    I closed by telling them that Tysabri has given me hope once again and I am no longer afraid of waking up wondering what MS has taken away during the night (you never know when you might lose your eyesight, you might losethe use of your hands, legs, right side or your left side, maybe one of these symptoms, maybe all of these symptoms at once). With Tysabri, my MS is now stable, I have not had a relapse in over three years, and no new lesions showing on my recent MRIs. I may never be able to walk again, but that is never going to stop me from having hope for a better quality of life which Tysabri has already given me.

    Aftermy speech, Kelly Martin came up to me and just started talking to me, asking me if I've ever given a lot of patient speeches before, and I told him no, that was my first one and I was so nervous I almost threw up (seriously-LOL). He looked shocked and said that was your very first speech? And I said yes. I wanted to talk to him more, but they whisked me away to help cut their 40th birthday cake, and when I was finally done, I was told that Mr. Martin had to catch a plane. Darn it!

    It does not matter to me whether or not you like him or don't like him,all I can tell you is that he is a truly gracious & caring individual when it comes to how he feels about patients, and how his and the company's focus is on the patients. I cannot you how many Élan employees came up to me after my speech to not only meet me but how much they thanked me for everything I'm doing..., but again, it was me thanking them for everything that they're doing! Some of us exchanged e-mail addresses, some of us patients also exchanged e-mail addresses, etc.

    Okay, I'm exhausted now, so I'll have to call it a day.

    All my very best to each and everyone of you, Lauren

    PS: Oops, I forgot to mention that BAP was also discussed in a favorable light, and many researchers at Élan came up and told me that they are very excited about this medication and the implications that it will have on the Alzheimer's patient population..., a couple of of them also told me that they were working on a Parkinson's medication. Just remember that I am unable to go into great detail about our conversations because the live band was playing at the same time we were trying to talk and listen to each other, and that was very frustrating for all of us, but especially me because I can no longer talk very loud. I really, really, really wanted to visit more with Mr. Yednock, but it was almost impossible for either of us to understand what each of us were saying to each other (Argh!)

    ((((hugs))))

    Love, Lauren :)

    38th Tysabri infusion report
    I had my 38th Tysabri infusion on Wednesday, 9/2. All went well as usual, no problems... yaaay!

    I thought I would post a recent press release about Tysabri as follows:

    http://newsroom.elan.com/phoenix.zhtml?c=88326&p=irol-newsArticle&ID=1330919&highlight=

    Data Supporting Unique Efficacy of TYSABRI Presented at the 25th
    Congress of the European Committee for Treatment and Research
    in Multiple Sclerosis


    Which states in part:

    "[Data] showing the potential of TYSABRI® (natalizumab) to redefine successful multiple sclerosis (MS) therapy. These data were from observational studies and retrospective analyses of the Phase III AFFIRM clinical trial, demonstrating that TYSABRI:

    Significantly improves measures of physical and cognitive disability using the Multiple Sclerosis Functional Composite (MSFC) in patients from use some of the symptoms seen in MS patients, as measured by advanced MRI technology; and Shows improvement in quality of life as reported by patients. "MS patients should expect more from an MS therapy and studies such as these demonstrate the potential for TYSABRI to satisfy their expectations," said Michael Panzara, M.D., M.P.H., vice president and chief medical officer of neurology, Biogen Idec.

    “These data presented at ECTRIMS show that, for many MS patients,TYSABRI may lead to improvement in a broad range of physical and cognitive symptoms.” “The strong efficacy profile demonstrated in clinical trials is enhanced further from these and other important TYSABRI data presented at ECTRIMS," said Carlos Paya, M.D., Ph.D., president, Elan Corporation.

    “TYSABRI is the first approved MS therapy with reported data suggesting some signs of the progression of MS can be stopped, whether measured by clinical, radiological or patient-reported measures.”

    The data goes on to state the following, and details of the analyses is contained in their press release:

    TYSABRI significantly improves physical and cognitive function

    TYSABRI stabilizes and restores damage to the myelin sheath

    TYSABRI patients report improvement in physical and psychological well-being

    "TYSABRI is approved in more than 40 countries. In the U.S., it is approved for relapsing forms of MS and in the European Union for relapsing-remitting MS. According to data from the Phase III AFFIRM trial published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68 percent relative reduction (p<0.001) in the annualized relapse rate, when compared with placebo, and reduced the relative risk of disability progression by 42-54 percent (p<0.001). TYSABRI is redefining success in the treatment of MS. In post-hoc analyses of the Phase III AFFIRM trial and as published in The Lancet Neurology,37 percent of TYSABRI-treated patients remained free of their MS activity, compared to seven percent of placebo-treated patients.

    In addition, data has been presented showing that treatment with TYSABRI significantly increased the probability of sustained improvement in disability in patients with a baseline expanded disability status scale (EDSS) score = 2.0 by 69 percent relative to placebo."

    Pretty impressive proven data, don't you think? (Smiling) OhI forgot to tell you all that Élan Pharmaceuticals invited me to comeup to San Francisco and speak at their "Employee Day"..., pretty exciting for me! (They'll probably all be bored to death - heehee).I'll report more when I get back home (I'll probably include this in my 39th Tysabri infusion report which will be on 9/30). Enjoy your weekend everyone!

    ((((hugs))))

    Love, Lauren :)

    37th Tysabri Infusion Report
    Hi everyone, I had my 37th Tysabri infusion Wednesday, 8/5, and all went well -just one stick and my infusion nurse got a line in - and after just five minutes of having a saline solution started, my Tysabri arrived in the infusion center and I got started right away, yaaay!

    The young lady that I spoke of in my last infusion report continues to do well, and none of us currently on Tysabri therapy where I receive my infusions are afraid of developing PML, so I've been told....,  I wanted to share an article written about Tysabri, my reply, and two e-mails that I received from different MS patients currently on Tysabri therapy, one of the US, and one in Puerto Rico -

    I'm so glad that Élan finally took some action against Biogen - I guess we will see what happens next..., enjoy your upcoming weekend everyone!

    Lauren

    I have permission by both of these authors to share their e-mails..., the first is from an attorney that wrote to me regarding PML, with my replies; and the other is an e-mail that I received from the young lady in Puerto Rico that is singing the praises of Tysabri to everyone that will listen to her!

    First the article and my reply:

    http://www.medicalnewstoday.com/articles/159129.php


    11th Tysabri Patient Develops PML

    Main Category: Multiple Sclerosis
    Also Included In:  Neurology / Neuroscience
    Article Date: 29  Jul 2009 - 3:00 PDT

    An 11th patient taking Biogen Idec's multiple sclerosis (MS) drug Tysabri has developed a potentially deadly brain infection.

    In the latest confirmed case of progressive multifocal leukoencephalopathy, or PML, the patient took Tysabri for 29 doses,continuing the trend of the last six reported cases of the infection,where each patient had therapy for two years or longer.

    The latest patient was located in the USA, the third American to have developed the infection. Of the 11 reported cases, one patient has died.

    The PML incidence rate remains below the long-projected risk rate of one in 1,000 patients for those patients receiving the therapy for 12 months or 18 months.

    The drug was temporarily withdrawn in 2005 after it was linked with PML, but was then brought back in 2006 with stricter safety warnings.

    Tysabri continues to receive strong support from patients and doctors, however, because of the drug's perceived effectiveness. That support has remained steady because patients are made well-aware of the PML risk before they start taking Tysabri for MS.

    This is the last case of PML that the company plans to announce on its website. In future any new cases will be reported by word of mouth to medical professional and patient groups.

    Source
    Multiple Sclerosis Society

    My published opinion:

    http://www.medicalnewstoday.com/youropinions.php?opinionid=40864

    11th Tysabri Patient Develops PML

    posted by Lauren on 29 July  2009 at 2:06 pm 

    This is probably one of the most unbiased, accurate, and well-balanced articles I've read to date as it relates to Tysabri and the possible link to PML. In addition, eight out of the last 10 patients (that we know of-excluding the latest patient) were all on very strong immunesuppressants prior to Tysabri therapy (these included azathioprine, methotrexate, Novantrone/mitoxantrone, & IVIG therapy). It is unclear from the 6th & the 11th patients' past medical histories of prior treatments as they have not been made available to all of us.

    Nevertheless, this is one of the most informative articles I have read recently with regard to Tysabri and the possible link to PML.

    Lauren (MS patient for 34+ years and current Tysabri patient that recently completed her 36th infusion)


    Subj: Interested in Your Thinking
    Date: 7/30/2009 6:22:06 AM Pacific Daylight Time
    From:
    To: [email protected]
       Sent from the Internet (Details)

    Lauren:

    Greetings. It was a pleasure to digest your blog and its entries.Excellent work. I have a few questions. But, before I go there...here is a little on who I am. As you can see from my signature block below, I am an attorney. Just what you need...another damn lawyer. At any length, I was diagnosed with Relapsing Remitting Multiple Sclerosis in April of 2008 and started Tysabri around June of 2008. I have completed infusion #15.

       What may make my case of interest is that I have had no prior MS medications whatsoever. Also, my specific diagnosis is "mild" RRMS. Further, I am a real wimp when it comes to needles. I do not believe that I could self-inject, which made my decision easier to go with Tysabri. In fact, I had no hesitation to go that route since I am married and support not only my wife, but also my two children, and to a lesser degree, my former wife and my mother. Thus, being able to remain productive and actively employed are key goals of mine. (I am of Greek national origin and the teaching to me as child and in that culture was to sacrifice for family at the sacrifice to yourself. I am made form that cloth.)

    My symptoms prior to my diagnosis included a "palsy" type numbness on the left side of my face that lasted 6 weeks, then numbness in my left hand, then an inability to feel the bottoms of my feet requiring me to look at my feet when walking to get feedback to make sure I was placing my feet properly. My first neurologist (who is the head of the Neurology Department at University Hospitals in Cleveland) was very conservative and did not do perform the ologloconal (sp?) banding test on the CSF despite my suggestion that he do so. It was not until I experienced significant imbalance (making me do the "wall walking") and complete double vision that he went forward with the CSF test. He managed to screw up the test because he did not draw the serum (i.e.,the blood) from me within the required time in order for my blood to be tested for ologloconal banding. Absent that serum, a true clinical diagnosis could not be made. So, my diagnosis was "probable" RRMS. The neurologist sent home some literature to me on Avenox and Copaxone and asked that I read it and then call him in a week. In the meantime, I found a "real" neurologist, who is the head of the Mellen Center for MS, which is part of the Cleveland Clinic hospital system and, in my opinion, one of the best facilities for MS in the world. They are doing all sorts of MS studies, including stem cell therapy as part of research. My new neurologist told me about Tysabri, where the prior one did not. (No I will not sue. Too much of that in my life.) 

    That is my story in a nutshell. Now, to my question. I am a big Tysabri believer. So far, it has been just over a year for me on Tysabri with no relapse. That is great. I have no symptoms form the infusion other than some very minor tingling in various places on my skin during the infusion. However, I am having a problem buying in to your theory, if I understand it correctly, that Tysabri does not cause PML. Rather, you opine that a compromised immune system causes PML, principally through the use of prior MS medications. If that proves to be true, then Happy Days are here because I have never had any form of MS medication other than Tysabri.
     
    However, my understanding is that Tysabri itself is a compromise to the immune system by keeping those sneaky white blood cells from entering my brain. And, if Tysabri does compromise the immune system, then Tysabri can cause PML. I have read many articles connecting Tysabri to PML for this reason. Can you bring some illumination on where we have a disconnect?

    By the way, I hope you do not mind my saying so, especially since I am a happily married man...you are beautiful. And, I cannot understand how a 54 year old paralegl can retire. I am 49 years old and may never be able to retire. How did you do it?    Thank you very much. I truly  enjoy your blog. Cheers!!

    XXX

    My reply:

    In a message  dated 7/30/2009 6:22:06 AM Pacific Daylight Time, XXX writes:

    However,my understanding is that Tysabri itself is a compromise to the immune system by keeping those sneaky white blood cells from entering my brain. And, if Tysabri does compromise the immune system, then Tysabri can cause PML. I have read many articles connecting Tysabri to PML for this reason. Can you bring some illumination on where we have a disconnect?


    Hi XXX, it is so nice to meet you! And it was such a pleasure to read youre-mail and your English composition skills are outstanding! Oh boy, do I miss reading such well-versed sentences, and your analogies therein. (Not only am I a Certified Paralegal, but I am also a Business English major-heehee). I honestly do miss reading my attorneys' trial briefs, and even composing some of them for him. But sadly, I had to retire early because I was starting to confuse & interchange "plaintiffs"& "defendants", and I would never place my boss in a situation where he could be sued for legal malpractice (he is a partner in a lawfirm, and he is one of the best trial attorneys in California). His specialty is ...defense and .... Although I have worked for "certified specialists" representing both the applicant and defendant, I became well versed in the litigation field. I would have absolutely died of embarrassment if I ever screwed up a trial brief for him. He is a very kind and understanding family man, and he was such a pleasure to work for (can you tell I miss the legal field?).

    Now on to your question: yes Tysabri does prevent a majority of the inflammation cells from crossing the Blood Brain Barrier and entering the CNS where they cause our damage (lesions/symptoms, etc.), but Tysabri in and of itself does not cause PML, a  severely diminished immune system can cause PML.  This is why PML was  mostly seen in patients with AIDS.  I reference the following from the New  England Journal of Medicine:

    "...the emergence of two cases of progressive multifocal leukoencephalopathy (PML), a rare but deadly viral infection of the central nervous system (CNS)   is associated with  immunosuppression. Owing to the effect of natalizumab on central nervous system leukocyte recruitment, the emergence of PMLhas been attributed to diminished immunosurveillance. The lack of additional opportunistic or CNS  infections among natalizumab-treated patients, however, suggests that alternate  mechanisms may contribute to the infectious risk.."...,

    In addition, it is the  activation and proliferation of the JC virus entering the cell tissues of the  host which causes PML, notTysabri. The JC virus is carried by 80% of the population, irrespectiveof whether they have MS or not. It usually remains dormant in the kidneys until it is activated by a compromised immune system that can no longer fight it and keep it dormant.

    Lastly, in my opinion (and I am not a doctor), the immune system is very fragile and any attempt to modulate it (with the various previous use of the ABCRs, etc.), or suppress it with the various  strong immunosuppressant medications such as Imuran/azathioprine, Remicade, methotrexate, Novantrone, etc., whose effects can last for years in the body, can cause serious damage when adding Tysabri to the mix, and therefore I believe can lead to eventual disaster for certain patients  (i.e. the activation of the JC  virus leading to the development of PML).  You also have to remember that not  all MS patients & their immune systems are alike, and some of them will be at a greater risk of developing PML (like the EU patients where Novantrone/mitoxantrone is commonly used & where the PML cases are higher in number), while a majority of us won't have any problems with our immune systems whatsoever (I also think that most MS patients have a very strong immune system, which is why we keep having relapses!).This is why I firmly believe that Tysabri should be used as a first line of defense against MS before  any damage can become permanent. Kudos to you and your neurologist for choosing the most effective MS medication we have to date as a first-line therapy to fight your MS.

    A portion of  the above is only my opinion and  thinking when it comes to my conclusions regarding Tysabri.

    I'm so happy that Tysabri is working for you, and that your prior damage/symptoms have been reversed. Obviously, the following holds true as it relates to remyelination of previous nerve damage that you suffered due to MS:  TYSABRI®   Promotes Remyelination & Suggests Improvements In Symptoms .

    Now XXX, I need to ask you a question..., your e-mail was so well written I would like to share the pertinent portions of same with others & with those that might also be sharing your views..., may I have your permission to do so? I will of course remove any personal information,including your e-mail address.

    I won't do anything until I receive your response to my reply. Again, it was so nice to meet you,and I hope we can continue our dialogue regarding Tysabri.

    All  my very best to you and your family...,

    Lauren


    "Yes.I have been thinking about it. You know...I am a biased observer because I am hoping (OK—praying) that your theory is right. Like a lawyer, I must answer your question with another question. I can buy into your argument, but can you explain to me why PML is not a risk for those persons taking Avenox or Capaxone? I believe that these are immuno-modulatory medications and it is an absolute no-no to take them with Tysabri. But to the question...why is there no PML risk for those two medications. I believe they suppress the immune system. Many people have been taking them for years. So, if you can sway me on this, I would be more apt to buy into your theory. Remember, I am praying that you are right. I would hate to be the living (or not living) example of you being wrong.  ... Cheers!! XXX''


    If I lived in Cleveland, Ohio and was not as disabled as I am - I would probably want to work for you.

    I believe that Dr. Richard Rudick practices out there in the Cleveland clinic ..., did you know that he testified at the "Tysabri Hearings" before the FDA AC in March 2006? He was among only a small handful of MS specialists there were proponents of reinstating Tysabri to the market? I felt honored that I testified as well (although be it via videotape)..., he is such a great doctor!

    Okay, I should let you go since you're probably at work right now (or maybe you're just goofing off on the job - did I just say that out loud? Oops,heehee)..,have a wonderful weekend XXX!

    Lauren

    PS: thank you for the compliment on my picture in your prior e-mail, I forgot to thank you previously (that was either my aging brain or my MS brain, take your pick)


    "A few things. Ok. I'm trackin' with you. First, I like calling them theCRABs. That sounds so much more creepy. Or, it can be seen as humorous.Hey I heard you got the CRABs dude. Dr. Richard A. Rudick is my Neurologist. One of my Partners is married to Dr. Rudick's nurse-practitioner. That is how I was able to see Rudick. He is doing a lot of research, too. What a small world. I am at work, but I am smiling,which is pretty nice given that nature of the practice.

    Second,try to keep it positive. Delight in the fact that we are alive! Maybe we are a little beat up, but damn alive nontheless.

    Third,consistent with what I just noted, I would not count the dead. Yes.That is valuable information when considering medication options, but,once I made my mefication decision, I would then choose to suppress that information from my conciousness and defend my psyche against harm. I am told that us guys do that better than women. Of course, I am also told that women multitask better than men.

    I am not preeching and I admit to being a hypocrit. I currently represent a funeral home in defending against an allegation that the funeral parlor did not bury the deceased with the casket of her choice. Let me tell you. Exhibit A, which is a picture of the deceased is overshadowed by Exhibit B, which is a picture of the deceased's husband in his coffin.Charming. I digress. XXX

    One more thing. What doyou mean, specifically, that they had a problem with their immune system. What peoblem and is it shown that these meds can cause such problems? Cheers."

    Here was my latest reply to him:

    What I mean is that I believe they could have already had a problem with their immune systems ( i.e., they were at the beginning stages of developing PML before Tysabri was even introduced into their systems, perhaps they already had compromised immune systems, perhaps the immune modulatorsaltered their immune systems to the point where they became immune compromised, etc.).

    Unfortunately, I cannot be more specific as I do not have all of the prior medical histories of the patients, nor am I a medical professional. I just don't believe that Tysabri was the cause of PML..., my main argument being why didn't PML show up earlier in the Tysabri trials (both the Affirm & Sentinel trials)? Probably because the trial patients were better screened, perhaps.

    Lauren  :)

    Here is the e-mail from the young lady in Puerto Rico:


    Hey! Greetings from Puerto Rico. My name is Maria Elena, I'm 20 years old and I've been a MS patient since I was 15 years old. It's been pretty hard for me to deal with this condition, academic obligations, my social activites, my fights for medical coverage and life itself. I even lost my short term memory for a while (You should have seen my boyfriend's face when I told him not to kiss me because I didn't even knew who he was), but with treatments and all the protocol, I recovered it. I have 14 spots on my MRI pictures (12 on the brain, 2 on my spinal cord). Lots of people tell me that I'm too young, and yet, they admire me for keep on living (I tell you, it's not so sexy to wear Poise or Depend or not being able to wear other shoes other than my trustful sneakers, but I don't care, I gotta keep on living in spite of what others may think of me).

    Currently, I'm using Tysabri and I feel as if I was the girl I used to be 5 years before. I feel way more confident and more happy. I have no idea why people, doctors and media are criticizing so much this wonderful medicine. When I first started filling out the papers for my first Tysabri, people asked me stuff,like: "Oh, my God! Do you have any idea of what you're doing?" and "But you're so young! Do you want to die?" But I stood up to them with attitude and clearly stated that this is my only chance to experiment an improvement in medicine, and if I should die trying to get better, I will die HAPPY, for I'm close to a healthy body, the one I used to have.

    I'm getting ready for my 6th Tysabri infusion. The nurse will use a needle and I'll be there for an hour. I'll listen to other people's stories, critics and non-believable stuff. But when I get out of there, and I wake up to see a new day, I'll look at my face in the mirror and I'll know I'm in the right path, I'll know I'm fine and most of all, I'LL KNOW I STILL HAVE A LONG WAY TO GO. And I will not die because of my beautiful, perfect therapy. I'll die old by any other thing, but not by my medicine because my medicine is just perfect!

    I try to pass on the message that Tysabri has helped me and other people so much, it's incredible. I would like to vanish those awful rumors about such a perfect medicine. This Friday, I'll have my 6th infusion and I really can't wait. I get excited about it, because I actually feel it's working. I used to have relapses around this season before,but this is the first summer I have felt so...alive! I'll tell everyone I can about your blog and how we all should comfort each other, because the weight of our situations is really heavy but there'll be people who can help us make this burden a little more bearable.

    Thanks for everything and cheers to you, for you're doing a great job with your body and physical therapy (I don't know which exercises are you practicing, but this lets me know you're not giving up, so GO GET 'EM,TIGER!! )

    Blessings from Puerto Rico to California
    XXX

    36th Tysabri infusion report

    Hi everyone - I had my 36th Tysabri infusion on Wednesday, 7/8.

    All went well, no problems. I did find out that the young lady that just started Tysabri recently at my infusion center is doing really, really well according to my infusion nurse. Apparently, this particular patient is responding favorably and in a very drastic way to her Tysabri infusions. In particular, prior to her first infusion she was on the verge of progressing to the use of a wheelchair, but now after her third infusion, she no longer even uses a cane!

    After sending various e-mails to Élan requesting information which had been omitted from the "Tysabri for Crohn's" page on Élan's website under the PML patients' past treatment histories (specifically, post marketing patients #1 and #6), I was finally contacted just this Tuesday by the person responsible at Élan for posting the information.

    I had a lengthy telephone conversation with the Sr. Manager of Medical Communications with the Élan Medical Information group.

    Now for the frustrating part & an explanation for my mixed feelings ..., She stated that because I am not a medical professional, she could not disclose that information to me, nor did they even have further information about patients #1 & #6. She then proceeded to tell me all about the FDA restrictions regarding disclosure and that I should speak with my neurologist if I want further information.

    We went round and round and round and she had in her head that there was nothing wrong with the information posted there, and I emphatically insisted that there was notably incomplete information regarding past treatments for patients #1 & #6..., were they previously on monthly pulse steroids, IVIG, any kind of immunosuppressive therapies for other conditions, etc.? She finally acquiesced and said she would take a look at it, but if the patients' doctors do not advise Biogen/Élan of such therapies/conditions, their hands are basically tied because they cannot force the doctors to provide such information. I asked her if she would even discuss this with Biogen and send a follow-up questionnaire to these two doctors, and she never said anything. (first she states in her e-mail that she has additional information, and then she says she doesn't).

    The information I am referring to is located on the www.elan.com website, and to access this information you must be a medical professional, and because the information is copyrighted, I cannot post the information here.

    I told her that a doctor friend of mine sent me the information from their Tysabri/Crohn's website, and she said that was fine, but was significantly rattled when I was making the connections between these PML patients and prior immuno modulating therapies & immunosuppressive therapies as it related to the link to PML - and not the link to Tysabri.

    So all in all, I'm not sure she will do anything if it becomes too much work for her. I am thoroughly exasperated and disgusted at this blasé attitude, especially from Élan. They really don't seem interested in promoting Tysabri (even though this is Biogen's contractual obligation here in the US) , nor do they seem interested in protecting Tysabri's good name..., oh well - I tried (sigh) Lauren .

    In closing to my post here, we exchanged the following e-mails..., Here is her original e-mail to me:

    Hi Lauren,

    My name is Michelle XXX within the Elan Medical Information group, and I was forwarded your TYSABRI questions that you had initially sent to XXX here at élan. Thanks so much for bringing the inquiries about the TYSABRI PML cases to our attention. From my understanding, we do have data that we can share in response to the questions you posed [the bold is mine]. Typically however, our guidelines are to make sure that patients receive this type of medical information through their doctors, to allow for a better discussion with them, especially as they may tie into discussions about their own personal medical care.

    So, what I would like to do is get in touch with your doctor as soon as possible and share some of the medical data that we do have in response to the questions you provided, so that he/she can discuss them with you.

    For any other patients who have similar PML case questions, we would instruct patients to contact their doctors with questions. If their physicians do not have the answers, we are happy to provide them with the data that is available.

    I would have loved to call you directly, but I don’t seem to have your phone number! If you would like to talk directly, please feel free to contact me directly. At minimum, if you would forward your physician’s contact information to you, I will let him know the questions you have brought up to us, and provide him information that he can then discuss with you.

    Thank you,

    Michelle


    Hi Michelle,


    Thank you for your e-mail. In answer to your questions below, please be advised that my doctor is not interested in becoming involved due to his busy schedule and for various other reasons even though I previously spoke to him about my two questions. Yet here again, the information that I seek is being withheld from me. I would have expected this from Biogen so that they can protect their Avonex franchise, but never from Élan.

    In a message dated 7/6/2009 4:05:54 PM Pacific Daylight Time, [email protected]Élan.com writes:
    >
    > I would have loved to call you directly, but I don’t seem to have your phone number! If you would like to talk directly, please feel free to contact me directly. At minimum, if you would forward your physician’s contact information to you, I will let him know the questions you have brought up to us, and provide him information that he can then discuss with you.
    ...,I am available today (right now as a matter of fact) for you to contact me.

    For the life of me, I cannot understand what is so difficult about providing this information to me..., I am not asking for any names so there will not be a violation of those two patients' right to privacy..., you either have the information or you don't.

    On the various MS forums that I visit daily, false information is being provided by God knows who to these patients that are having a difficult time deciding on Tysabri therapy. I cannot provide accurate information about Tysabri if I don't have any cooperation whatsoever from either Biogen or Élan.

    Please call me to discuss the above which will not only help these MS patients which are confused about Tysabri, but whose doctors wish to keep them in the dark when you and I both know very well that they will probably benefit from Tysabri therapy and not have to needlessly suffer debilitating relapses, which could probably leave them disabled. Is Élan really that heartless & uncaring?

    Sincerely,

    Lauren Roberts


    I then asked her to send me an e-mail confirming our phone conversation, and this is what I received:


    Subj: Getting back to you regarding your request for TYSABRI PML information
    Date: 7/8/2009 10:43:57 AM Pacific Daylight Time
    From:
    To: [email protected]
    Sent from the Internet (Details)


    Dear Lauren,

    It was good talking to you on the phone yesterday. Thanks again for providing your comments and feedback to us about the PML case information you mentioned you were shown by a health care professional.

    As mentioned in our phone conversation, we have a policy against directly sharing clinical data that goes beyond what is publically available or what is within the prescribing information for TYSABRI, with patients. If in the future, you would like to obtain TYSABRI clinical information beyond what can be shared with patients, this would need to be done through your prescriber, who we could provide information to if requested by the prescriber. I know you are not happy with that, however I believe we were able to come to an agreement as to why our policies exist.

    With much respect,

    Michelle XXX

    As mentioned in our phone conversation, we have a policy against directly sharing clinical data that goes beyond what is publically available or what is within the prescribing information for TYSABRI, with patients. If in the future, you would like to obtain TYSABRI clinical information beyond what can be shared with patients, this would need to be done through your prescriber, who we could provide information to if requested by the prescriber. I know you are not happy with that, however I believe we were able to come to an agreement as to why our policies exist.


    Dear Michelle,


    Thank you for calling me Tuesday, 7/7.

    As I mentioned to you, there is much false and misleading information posted on the different MS forums about Tysabri. Furthermore, not to sound conceited, but I happen to know more about PML and clinical Tysabri information than my own doctor because I have been studying Tysabri/Antegren since 2000, and it is absolutely ridiculous that any information I request should go through him first, taking up his valuable time.

    And we reached no agreement whatsoever other than you saying you would take a look at your website (Tysabri for Crohn's) so that you could see why I have been emphatically insisting that there is notably incomplete information regarding past treatments for patients #1 & #6..., were they previously on monthly pulse steroids, IVIG, any kind of immunosuppressive and/or immunomodulating therapies for MS or other conditions, etc.??? I am not asking for names of these individuals nor is this invading their privacy due certain restrictions under HIPAA.

    I completely understand if these patients' doctors choose not advise Biogen/Élan of such prior therapies/conditions and that you cannot force the doctors to provide such information. You can't even issue a Subpoena Duces Tecum to obtain this information unless discovery is needed for litigation purposes. I offered the suggestion that you discuss this with Biogen and send a follow-up questionnaire to these two doctors, but you really didn't seem all that interested.

    When I was making the rational connection between these 10 post marketing PML patients and prior immunomodulating/immunosuppressive therapies as it related to the link of PML (not the link to Tysabri), you disagreed and stated there was a link of PML to Tysabri. I disagreed with you again, indicating that the expert authors of the New England Journal of Medicine published data that PML is caused by a diminished immune system [not by Tysabri].

    NEJM - Conclusions re: PML

    This is why disclosure of any prior treatments such as IVIG, Novantrone, methotrexate, Imuran/azathioprine, etc., even for other conditions such as rheumatoid arthritis, are so very important, and therefore a supplemental questionnaire should be sent to the doctors of patients #1 & #6.

    Do any of the Novantrone, methotrexate, Imuran/azathioprine, CellCept, Remicade, Rituxan, etc. websites plaster PML information all over their webpages and product labels?!?!?? No, they don't!!! When is a label change for Tysabri going to take place so that it is in line with the other medications which have been linked to PML??? When is Élan going to step up to the plate and call Biogen into action?!?

    And you think I am unhappy??? You're darn right I am unhappy!!! Obviously, Élan appears to be quite complacent and uncaring that MS patients around the world are allowed to suffer needless relapses and possible permanent disability instead of fighting for Tysabri to be used as soon as possible with all of its outstanding data released to date..., why? For what? It probably has to do with the almighty dollar, sad, really, really sad.

    I am thoroughly exasperated and frustrated that Biogen (but especially that Élan) is apparently doing nothing not fighting to get the correct information out to "information hungry" patients. Telling patients to seek information from their doctors that are highly uneducated when it comes to Tysabri is like telling a thirsty horse to go and drink water from an empty trough. In my eyes, and in the eyes of many MS patients, this is apparently because no one really seems interested in promoting accurate facts about Tysabri to patients that are seeking this information (even though this is Biogen's contractual obligation here in the US), nor does anyone seem interested in protecting Tysabri's good name.

    For example, one MS patient wrote to me indicating that their neurologist told them that Tysabri can cause brain cancer..., excuse me??? Hellooooo??? And you think that these uninformed MS patients should talk to their doctors who are also uninformed??? These patients unequivocally have the right to access accurate Tysabri information.

    Regards from a very unhappy & sad MS patient because many of her fellow MS'ers remain uneducated about the wonderful breakthroughs of early Tysabri therapy and how they could benefit tremendously if; their damage from prior relapses is not permanent; and if only one person cared enough to fight the good fight rather than allowing them to be kept in the dark, confused, uninformed, and hurting needlessly by perpetuating inaccurate misinformation and untruths about Tysabri.

    Lauren Roberts (MS patient for 34 plus years, and current Tysabri patient that just completed her 36th Tysabri infusion)

    35th Tysabri infusion report
    Hi everyone, happy 4th of July tomorrow!

    I wanted to post some additional information that was sent to me regarding the recent PML cases that have been linked to Tysabri..., as to prior treatments involving immunomodulators and/or very strong immunosuppressants, please note the following with regard to the Tysabri/PML chart that will be updated at a later time (my friend is currently on vacation for the next 10 days so it will have to be updated later)..., but specifically, the patients listed in the chart:

    #7.    Prior use of Rebif, Avonex, and Copaxone.

    #8.    Prior use  of interferon beta 1-a (Avonex), and mitoxantrone  (Novantrone).

    #9.    Prior use of Avonex, Rebif, and  Novantrone.

    #10.  Prior use of interferon-beta, glatiramer acetate,  and IVIG.

    I am still waiting to receive information regarding prior use of medications for patient #6. It is most strange that no "prior treatments" information is given (and I'm not sure I'll ever receive this information). Once again, please note the prior use of very strong immunosuppressants and treatments such as Novantrone & IVIG are designed to suppress the immune system, and the different ABCRs were previously used to modulate the immune system.

    Again, 8 out of the 10 new cases of PML occurred outside the US.

    The above information can be found on the Élan website under Tysabri for Crohn's disease. Here is the Tysabri/PML chart which still needs to be updated:
    http://pietynorwit.com/Tytable.htm

    Have a wonderful and safe holiday tomorrow everyone!

    ((((hugs))))
    Love, Lauren :)

    33rd and 34th Infusion Updates

    33rd Tysabri infusion report:

    Hi everyone, I completed my 33rd Tysabri infusion last Wednesday.Everything went fine; I even found out that my neurologist started another patient on Tysabri, woo hoo!

    With respect to the latest PML case reported, I am not concerned at all, in fact the following remarks are from a treating neurologist that prescribes Tysabri & is anacquaintance of mine:

    "Tysabri-The Benefits

    1. Reported reduction in relapse rates 100% better than any exisitng therapy. Comparable MRI results

    2. Reported reduction in disability progression up to 50% betterthan any existing therapy. Since this is a LAGGING indicator, expect the reduction in disability progression to get even better(COMPOUNDING) assuming yearly reduction in relapse rates holds.

    3. First drug to show quality of life improvements

    4. First drug to show IMPROVEMENT in visual function

    5. First drug to show reduction in fatigue

    6. First drug to show significant subset of patients demonstrating IMPROVEMENT in EDSS scores.

    7. First drug to demonstrate significant HAULT in ALL evidence of disease activity for a significant subset of patient population.

    8. First drug to demonstrate significant improvement in patients with highly active MS

    9. First drug to show significant improvement in Cognitive function (to be presented at an upcoming MS conference

    10. First drug to show in-vivo evidence of re-myelination

    The Risks -

    1. Increase risk of liver enzyme elevations in very rare patients-jaundice

    2. Increase risk of opportunisitc infections-small increase risk of herpetic reactivation

    3. PML-6confirmed cases since re-introduction out of over 55,000 patient exposures, 40,000 active patients, and probably upwards of 40,000patient years of drug. Well within label. One death-I have been told that this one patient death was from IRIS and that patient and/or family refused hospitalization and treatment (to be hopefully confirmed at AAN). PML serious potential side effect, with often moderate to severe neurological sequella.Importantly, NOT a death sentence, and can be detected early through clinical vigilence. MAY be treatable through PLEX and methoquine."

    As to the most current MS patient that developed PML, this is from a German blog & also a German friend of mine stated:

    "The docs out there were amongst the first to leave the DDR via Hungary-before the wall fell. With docs/nurses gone west & techers too-the DDR was about to lose so many qualified people , which the state depended on,that this fact was one of the major reasons they finally had to open the border. Many of the docs who escaped the DDR have moved back since.What I have seen from patients' posts was that TY had been prescribed for patients who would normally not qualify as RRMS. Many of them claiming you just had to go to certain ms-centers-in Leipzig or Dresden.I know that for maybe 10 years now, docs in general have to prescribe generica if they are exactly the same compounds as the original med-Many patients write that they will take Ty "nevertheless"  because" what else is there left for us to go on ?" It only takes a few of these uninformed specialists who think they are informed, but never take the time to read the newest abstracts.  I would say that there are also Neuros in western Germany who treat their patients with mainly Aza and Mitox, due to low costs."


    Ich hoffe Pit, deiner Frau geht es besser.Ich wünsche dir viel Kraft und ihr alles alles Gute.
    Tini says that she had been to her neurologist today and he told her that the 6th case was from Dresden


    This is from a MS forum  & my reply to same:

    These are my opinions and accurate published facts, so here goes...,

    XX stated: "See, this is an perfect example of how distorted the truth can get, and why I speak up as I do....It was predicted as far back as the early 90's that Tysabri could these kind of deadly infections, by the doctor/researcher that originally worked on this drug, Dr Lawrence Steinman.  In fact, that is why he opted out of continuing on with researching this drug: http://www.yourlawyer.com/articles/read/11457 "

    My reply:
    That article was written by a lawyer, not a doctor. Professor Steinman participated in an early animal study that led to the development of Tysabri. Dr. Steinman is a co-founder and director of Bayhill Therapeutics, a company developing competing drugs for MS.

    XXX: "HOWEVER, it was Harry's, Cherie's, BBS', etc. that fought to ensure YOU got the protection that you are under TOUCH program"... NONE OF YOU had  anything to do with ensuring our protection under the Touch program, the FDA's Advisory Committee personnel were responsible forensuring our protection under the Touch program.

    XXX states: "There isn't one iota of doubt that Tysabri causes PML, and that Tysabri is the ONLY constant in the onset of PML with these patients.  Yes, some of the original trial patients used other immune suppressing drugs while on Tysabri, but since then, Tysabri has been used only as a monotherapy and (at least) six more people have come down with PML.  MOST OF US will have taken DMD's or other drugs prior to going on Tysabri (well, except the one guy who got PML fromTysabri, who was drug naïve...).  PML is not a disease that we are inclined to get, and has only become a concern since Tysabri came onto the scene."


    This is the kind of false/misleading information that is being perpetuated.  The expert authors of the New England Journal of Medicine state that PML is caused by a diminished immune system (not by Tysabri).
     
    http://tinyurl.com/2mhn8

    It wasn't only the trial patients that were previously on very strong immunosuppressants; in each of these recent PML cases, they were previously on either Azathioprine, Methotrexate,or Novantrone  & 1 of them was treatment naïve;  however many MS specialists believe that because this patient had an aggressive form of MS,  he was more than likely treated with regular doses of steroids, thus inducing the compromised immune system.

    In the latest patient that developed PML, their prior medical history is still unknown at this time (although we now know she was on Novantrone). 

    See this is how distorted misinformation can be construed as being the "truth", when in fact it is nothing more than misguided and false information, no matter how " well-intentioned" it is. Again, most of what I posted above are undisputed accurate facts that disproved the misinformation posted about Tysabri. 

    Lauren



    34th Tysabri infusion report:

                    
    Hi everyone, I completed my 34th Tysabri infusion on Wednesday, 5/13.

    After doing some research on the side effects of the interferons vs.Tysabri, here are a couple of interesting observations I've made over the last two weeks:

    1. There are some MS patients who are still afraid of Tysabri (see the message below that I received from a MS patient);

    2. A startling report from the Institute For Safe Medication Practices dated May 7, 2009 and you will specifically note pages 9 (see the chart below for the interferons: Avonex, Betaseron, & Rebif were the leading medications which caused serious, disabling, or fatal adverse events) as well as pages 11, 12, & 13 which specifically states the following:

    "The interferon beta case reports for all three drugs,however, did suggest a possible additional risk of cancer—an adverse effect for which warnings do not currently exist. The latest quarter of data included 131 possible cases of cancer, including reports of cancers of breast, lung, prostate, ovary, thyroid, esophagus, colon,rectum, kidneys, brain, liver, kidneys, bladder and skin. Since the drugs were first approved we noted 1,338 reported cases of possible malignancies."

    Here is the chart that I was referring to on page 9:

    Table 1. Serious, disabling and fatal events in 2008 Q3
    Drug Name Cases Rank
    INTERFERON BETA 1380- 1
    DIGOXIN 1023- 2
    BACLOFEN 872- 3
    VARENICLINE 659- 4
    ESTROGENS 586- 5
    ROSIGLITAZONE 494- 6
    ETANERCEPT 412- 7
    INSULIN 399- 8
    EXENATIDE 399- 9
    INFLIXIMAB 369- 10 (a.k.a. Remicade)
    FENTANYL 369- 11
    QUETIAPINE 339- 12
    ADALIMUMAB 336- 13 (a.k.a. Humira)
    DIANEAL 335- 14
    NATALIZUMAB 319- 15 (Natalizumab/Tysabri rated last on this list)

    Here is the full report:

    http://www.ismp.org/quarterwatch/2008Q3.pdf

    Here is the comment/message that I receive from a MS patient that is going to start Tysabri next week & she was scared to death (I get these all the time, and after I explain the accurate facts of Tysabri to  them, their responses are usually the same as this one below):

    "Thank you for your post on Tysibri. I am going for my first infusion next week & I am scared to death. I have been so worried about the scary side effects. PML in paticular. I have done a lot of research, your post & the comments after have helped me a great deal. Thank you again!!!!!!"

    Here was my reply to her:

    Hi there! (Sorry, I don't know your first name)...,I think it's wonderful that you're about to start Tysabri (I just had my 34th infusion a couple of weeks ago)..., in my opinion (I'm not a doctor) you really don't need to be scared of PML unless your immune system is severely suppressed. The expert authors of the New England Journal of Medicine indicate that PML is caused by a diminished immune system, not byTysabri. And if your neurologist pretreats you with a Benadryl drip for 30 minutes just prior to your Tysabri infusion, or if you take a Claritin-D tablet (like I do) approximately 1 hour before yourinfusion, this can drastically reduce the possibility of having any side effects. It's always best to speak to your neurologist.

    Relax, you're going to be on the most effective MS medication we have to fight our MS, woo hoo! ....."

    Here was her final reply to me:

    "Thank you Lauren! My name is XXX by the way!....You have eased my fears a lot! Have a great Weekend!!!!!! ~XXX".

    As to this latest case of PML that just surfaced, I do not know this patient's past medical history with regard to medications that she was on. I wrote to Biogen requesting this information, but I do not know whether or not they will release this information to me.  Once I find out, I will post the information on my blog.

    My guess is she was probably already immune suppressed and this could be due to being on prior medications such as Azathioprine/Imuran,Methotrexate, Novantrone, or regular pulse steroid use, etc.

    In light of the unbiased current serious, disabling, and fatal/adverse events report of the interferons indicated above, I still don't understand why MS patients are so afraid of Tysabri when it is the most effective MS medication we have to fight our MS. Maybe someday they will, I just hope it's not too late for them.

    Time Is Brain, you know?

    ((((hugs to all))))

    Love, Lauren :)

    32nd Tysabri infusion report
    Hi everyone,

    I just returned home from my 32nd Tysabri infusion, all went well this time as my regular infusion nurse was there, and she got me on the first stick, yay!

    It was pretty quiet in there today, and really nothing new to report..., although a friend of mine that just changed over to Kaiser and also receives Tysabri, wanted to know if we can have our infusions together, so we're trying arrange that for next month.

    During the last couple weeks, I had the pleasure of working with a friend of mine that prepared a Tysabri/PML chart posted here: http://www.pietynorwit.com/Tytable.htm, which I hope helps to explain that the MS patients who developed PML were severely immune suppressed due to prior medications they had been on. We will try to keep it updated as time goes on, if necessary.

    Ray is on his way to pick up mudslides & pizza for dinner..., I'm pretty tired right now and I just wanted to check in to let everyone know my infusion today went much better than last month.

    I have a ton of e-mails to read & reply to before Ray returns, so I bid you all a wonderful evening. Take care everyone,

    A very tired Lauren :)

    October 16, 2006

    (First infusion since restarting Tysabri)
    I'm Infused and I'm Enthused! Wooohoooo!!!

    Thank you everyone for your well wishes..., I had a few snafoos with my first infusion, but I was assured things will run more smoothly with my second infusion, plus they were being triple cautious with me as I, again, was the first MS patient to receive Tysabri in the Kaiser So. Calif. system, just like in 2005! Whoa..(smiling).

    TOUCH protocol, including pre-infusion checklist and taking of vitals took approx. 30 mins. No Benadryl, just on standby if I needed it, a Saline drip for 30 minutes prior to my Tysabri ( I guess to ensure I was well hydrated), then infused with Tysabri for an hour. Then they observed me for an hour afterwards and took my vials again (total 2 1/2 hrs.) I dozed off twice during the 2 1/2 hr. appt...haha!

    I had NO side effects whatsoever (other than being happy and relieved)...I didn't forget to bring doughnuts for the infusion nurses,but I forgot to ask for the Lot # of my vial and the expiration date!(DUH me!) It had been placed in a Sharp's container by the pharmacist and taken away before I got home, but I was told that the pharmacist made a note on my chart that they are to send my empty vial up with each infusion bag (after being mixed by the pharmacist), or at least that information on my chart each time as I'm entitled to it!

    <---HAPPY CAMPER! I'M JUST SOOOO GLAD THERE IS JUSTICE AND THE REWARD FOR FIGHTING THE GOOD FIGHT! WOOOOOOHOOOOOOO!
     

    November 01, 2006

    Yesterday was a milestone for me that I've crossed with my recovery. Since my horrible relapse in June of 05, I have been confined to a wheelchair, and after my two very bad falls in September of 06 (which landed me in the hospital-in need of a caregiver if I was to return home), as I could no longer lift myself out of my w/c (and I'm thin!) to make a transfer (chair transfer) on my own, as I could no longer stand for more than a few seconds without my caregiver's assistance.

    Well, after my Tysabri infusion on 10/16/06, my balance has started improving, my short term memory has started improving, I can now move my feet about an inch from side to side (I even lifted my right foot one time about an inch), and I can wiggle my toes bilaterally a little bit too. These 'physical' improvements may not seem like much to others, but for a person that had no ability to move her lower extremities at all for approximately one year, and has to be lifted and placed out of her w/c, these small improvements are huge.

    I've been doing physical therapy exercises too (3 x's a day = morning, noon,and night), which stretch the tendons in the back of my legs so that they don't atrophy (I hate doing those as they hurt like hell, but I do them anyway because I know they are helping me)...I also do strengthening exercises for my arms and thighs 3 x's a day.

    So guess what I did yesterday, on my own with no assistance from my caregiver (other than to stand near me to catch me if I fell)? I stood up for the first time since September '06,while holding onto a grab-bar, and put myself on the toilet (I know,gross-but when you haven't been able to do that anymore on your own, this was a GREAT accomplishment for me). Now came the scarey part, having to stand again on my own while holding the grab-bar, and praying my knees don't buckle again leading to a fall, and getting back in my w/c on my own with no assistance. Challenge city, but Okay Lauren (I said to myself while praying silently, "Please God, don't let me fall"), on 3.....1.....2......3 (gulp!), I grabbed the grab-bar with my left hand (while pulling up), and at the same time-placed my right hand on my w/c seat (while pushing up), and I stood up! (long enough to turn and pivot back into my w/c)...on my own!!!

    My caregiver was applauding me as if I just hit a grand slam-bases loaded-home run! LOL

    Of course, my legs were in total spasm, and he had to bend them for me (they turn into tree trunks, literally when they spasm), in order to get them onto the foot pedal of my chair, but hey, I stood up without my caregiver's help, and I did that 3 times yesterday!!! Wooooohoooooo!

    And, I was able to do the same thing (while holding onto my caregiver's arm with my left hand, and pushing up on my w/c's arm with my right hand), to stand up long enough to get into a sitting position on my bed, and I did that too! Yeeeeeeehaaaaaaaaaw!!!

    I cannot express the estatic feelings I felt in being able to re-gain some of what I lost to MS, with Tysabri's help.

    Naturally, I over-did yesterday due to my enthusiasm (my bad), and this morning I needed assistance getting out of bed, into my w/c, and into the bathroom...but after my p.t. excercies, I am ready to take on the task of standing on my own again...come on second infusion of Tysabri in November! OH YEAH......... :)

    November 9, 2006

    I totally freaked my caregiver out this am (lol), when he got up, and found me 1) out of bed (which I accomplished with alot of difficulty on my part -- I won't try THAT again until after my 2nd infusion) and 2) merrily sitting on the toilet with a fresh cup of coffee that I made for myself (while he was snoring away in his room at the other end of the house)!  The first words out of his mouth were, "What the...How did you do that???" (I think I detected a slight "shrill" in his voice, and his unspoken chastisement of, "but what if you had fallen?"..ok ok).
                   
    Not much more improvement for me, other than what I've reported previously, but my small improvements have been sustained . . . for those, I am so very grateful . . .

    November 17, 2006

    I had my second Tysabri infusion yesterday, 11/16, again ZERO side effects, yay! :)

    I took it easy last night as the drive for my caregiver into the city for my infusion (which normally takes 90 mins one way, took an unbelieveable and grueling 2 1/2 hrs to reach the infusion clinic (one of the connecting freeways [the 210] was shut down, all 4 lanes this am), 2 1/2 hrs for the infusion as they were late starting me as I was late in arriving, as were most patients arriving out of the city, and 1 1/2 hrs to get back home.

    No side effects again, just a slight headache (which I believe had to do with being stuck in traffic all day which was barely moving at 2 mph)...., I sent our website my Tysabri Lot # and Exp. date and I'm keeping the cute little Tysabri vial that once held it's liquid gold, now flowing in my veins :)

    On a side note, more problems plague Kaiser (see the article: IT disaster at Kaiser), as well as a local news story that aired [while I was receiving my Tysabri infusion!]wherein after So. Calif. Kaiser Drs treated a homeless woman for 3 days (I believe), and then Kaiser in Bellflower transported her via ambulance to the middle of 'Skid Row', just dropped her off and left her there. I don't remember any other details of this news story today, other than a press conf. held by LA City Attorney Rocky Delgadillo BLASTING Kaiser for their unspeakable actions (he was major pi**ed off-I think he even filed criminal misdeamor charges against Kaiser today?),with Kaiser issuing a pathetic apology/statement indicating they won't do that anymore unless there is someone from an agency to rendevous with and pick up the continuing care when they drop a homelesspatient/person off again...geeee ya think? Sheesh! CA health care at it's finest...NOT!

    Okay, so today I promise I won't over-do (fingers crossed behind my back-heehee), and just do my p.t. exercises (maybe I'll just increase the repetitions from 7 to 10 tomorrow), yeeehaaaw!

    November 19, 2006

    I took my first step last night in over a year!!! Woooohoooooo! ...,

    It was only one step with my right foot (with me hanging onto my caregiver, and my caregiver holding me around my waist-in the event I fell)..and lifting my foot to take that step was like lifting a 25 lb weight with only one finger (it took all the strength and concentration I had, and it wasn't very graceful), but I did it! :)

    It's a good thing he had me by the waist as I collapsed afterwards (my stupid left foot was just plain frozen and would not move at all), but I started crying happy tears of joy. My hopes to walk again withTysabri's help just went off the scale! Now I'm pushing my caregiver for more p.t. exercises..but I'm taking it slow, so no worries. I couldn't take that one step again yet to day, but maybe I can try again later tonight...

    I wish for each of you and your families a wonderful and Happy Thanksgiving holiday...I have sooo much to be thankful for this year-including, but not limited to, feeling so very blessed that I will be rewarded by the continuing hopes I have with Tysabri.

    November 20, 2006
    I could not take another step late last night, but I took a tiny one today with a lot of effort again on my part.  However, I am notdiscouraged in the least, because I could stand today unassisted by my caregiver for up to 1 and 1/2 minutes while holding onto a grab-bar (he had a stopwatch -- lol), without my legs spasming and without my knees buckling under me during the time I was standing.  Nice trade off if you ask me, considering I could only do this for a few seconds the day before my 2nd Tysabri infusion (11/16)!  Come on December!         

    December 20, 2006

    I just got home from my 3rd infusion of Tysabri...After waiting over 1/2 the day at Kaiser, they finally started my Tysabri at 1:30 p.m. No problems just had to see my neuro afterwards...which by the time she could fit me in after the infusion center screwed up not only my schedule, my caregiver's schedule, and my neuro's schedule, it was after 5 pm so, of course, coming home we hit all the rush hour traffic again...(sigh).

    All in all, I'm glad today is almost over. I'm drained of emotion (other than getting into a mild verbal altercation over my Jan. infusion being set 31 days away). Ummm, I don't think so! I'm sure you all know who won that battle - heehee.

    Oh, and I found out 2 other Kaiser patients in another Kaiser facility are being infused with Tysabri also...wooooohoooo!

    December 27, 2006
    I had been so stressed out recently due to non-holiday stressors, I felt practically no improvements after my 3rd infusion Wednesday, and Iwas having what felt like a relapse last night...but Saturday morning, 12/23 - I received a very special Christmas gift:  my entirebody felt stronger than it ever been over the last year and a half, I could wiggle all of my toes on both feet, I could literally uncross my feet without the assistance of my hands, I could slide both feet from side to side, and best of all, I could touch my knees together repeatedly approximately 10 times!
                   
    I usually lose some of these improvements within a couple of weeks of my infusion, but then again, I usually get them back too after my next infusion.  Therefore, I can only surmize my relapsing form of MS is fairly aggressive, and it will require several infusions of Tysabri in order for Tysabri to gain control over the cascading effects of the damaging T-cells before I see longer and more sustained improvements.   But for now, I'll   take those improvements for as long as they last - wooohooo!

    January 24, 2007
    4th infusion of Tysabri on 1/19/07. I have not experienced any "significant" improvements yet this time around on Tysabri and I believe its due to the accumulating disabilities I've suffered for 18 + months not having Tysabri's superior efficacy to protect me from all the relapses I was having (approx. once a month).  I'm much more disabled now than most who currently receive Tysabri, and therefore I also believe I will need many more infusions before I see "dramatic" improvements.
                     
    The thing is...from my perspective, I am thrilled for others that  show improvements so fast, and thrilled when a patient makes the switch toTysabri or starts their therapy with Tysabri because I know they will be happy they did, just as I was in early 2005.

    Right here, right now, I have experienced some minor improvements (which are HUGE for me)....but I'm sooooo not disappointed or disheartened that I'm not receiving the miraculous results I once had.  I am thrilled that Tysabri (for me) is doing exactly what it has been designed to do:  "...to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations."  I haven't had a relapse, no increased disability, nor any disease progression since 10/06 - Wooooooohooooooo! 
    In my book, Tysabri Equals Hope, always.

    February 20, 2007

    Woohoo hoooooo! Talk about empowering!               When I woke up today, after my 5th infusion yesterday, I felt like taking on THE WORLD!

    Of course, I can't, but I felt like I wanted to - God I LOVE these first few days after my infusions - what a Rush!!!
                       
    I feel like I've regained my old self - my spirit for living- once again, that my disabilities keep weighted down.  Heck - I even beat my caregiver Ray in starting my physical therapy exercises!  He was yelling, "Slow Down Woman!" And I yelled right back at him, "Keep Up Slow Poke - Whatcha Waiting For - Christmas?!?!?" - LOL
                       
    I can move my feet again, (not much - but a little bit) and can reposition my legs once again (a little bit) without using my hands! Ican even hold my coffee mug (it's BIG and HEAVY) and take a sip from it without holding on to anything and not falling over! Woooooohooooooo!
                       
    It's amazing what we all take for granted in our lives...the simple things - I 'm loving being able to do the simple things again - and I want more - I'm gonna walk again dammit!
                       
    THANK YOU TYSABRI!!!!!!!!

    March 25, 2007

    I had my 6th dose of Tysabri last Wednesday - 3/21/07
                   
    It usually takes a couple of days after the infusion for me to feel it's full effects, and just 3 days later, I feel stronger already.  My legs feel stronger and I have increased my p.t. repetitions by one for my legs (i.e., I am up to 10 stretching reps of the long leg tendon that runs down the back of the leg, behind the knee-per leg, 3x's a day, plus 10 leg presses from a sitting position in my w/c 3x's a day) and I feel the constant urge to wiggle my toes, which I can still do on both feet.  Absolutely zero side effects. 

    With each infusion of Tysabri I receive, I have renewed hope of walking once again.
                     
    And even if I never walk again, I know Tysabri is working because it is performing (for me) exactly the way it was designed to do...from the Tysabri Label: "TYSABRI® is indicated as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations."
                     
    I still haven't had a relapse or any disease progression (that I can tell of anyway) since re-starting Tysabri in Oct. 06 - that's 6 months now - pretty amazing considering I was having a relapse with accumulating disabilities approximately once a month prior to my Tysabri therapy -  Woooohooooo!!!             

    April 23, 2007

    April 23, 2007    (Warning, long post-Ha!)           
                   
    I had my 7th Tysabri infusion on 4/18/07, and right now, right at this moment, I feel terrific! Wooohooo!

    Am I still w/c bound since re-starting Tysabri 7 months ago? Yes (I have been since 6/5/05. Is it permanent? I honestly don't know, but my attitude remains positive and hopeful that with the help of Tysabri and my physical therapy exercises that I still do 3 x's a day, I will walk again someday - albeit kinda funny looking - lol )...,  My exhuberance is a bit tempered though as I am receiving a small handful of emails from Tysabri MS patients that are not achieving/feeling the same results of symptom improvement(s) as others have, and are becoming disheartened...so this post is for them, and for "newbies" to both MS and Tysabri:

    For the disheartened....please try to remember three things - 1) The current level of your MS and disability did not happen overnight, therefore you must learn patience in your Tysabri treatments (attitude is everything when fighting your MS); 2) Tysabri is not a cure for MS or for your symptoms (especially if those disabilities are permanent); and most importantly - 3) If your disease has not progressed and you have no new symptoms since starting Tysabri, it's apparently working for you! Tysabri's label states: "TYSABRI® is indicated as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations."

    Which is why I firmly believe (in my humble opinion) that Tysabri intervention is needed EARLY - at the first onset of MS (so that the damage does not become permanent).

    Are both my hands still numb? Yes (And they have been since my dx back in 1976 (so the damage is probably permanent, but I still have hope that I'll gain back some of the coordination and dexterity that I still had in them prior to 6/5/05 );

    Is my balance still bad? Yes (But it's highly improved for approx. 3 weeks after my infusion, but I still have hope that I'll completely gain back my balance one day);

    Are both my feet still numb? Yes (But I can still curl my toes on both feet and move them a bit for approx. 3 weeks after my infusion, but again, I still have hope of walking one day);

    Is my optic neuritis better in my right eye?  Yeah..., for approx. 2 weeks after my infusion, I don't use my glasses to watch TV, but alas, I need them again going into the 3rd week after my infusion. I think part of this is due to 2 other factors: all the steroid damage I've had over the years, and age (gulp).

    Is my memory better? You betcha, and it remains so for approx. 3 weeks after my infusion. (wait, what were we just talking about? - )

    Is my slurred speech better? Yeth, and sustained. (Errr, was that a lisp I just heard? )

    Are my bladder issues better? Yes, vast improvement, and sustained.

    Is my energy level better? Yes, definitely, for approx. 3 weeks after my infusion.

    Is my Quality of Life better?  Abso-friggin-lutely!    Without Tysabri, I was rapidly approaching SPMS without relapses and becoming bedridden...helpless and hopeless, and ineligible for Tysabri.

    With Tysabri, for me, HOPE SPRINGS ETERNAL that my body still has a fighting chance to regain/heal itself temp. or even partially regain what has been lost to MS providing the damage isn't permanent, and at the very least, maintain my disability level and not get worse. When I start to feel my small improvements fading away about 3 weeks after my infusion, I can tell myself: "Lauren, hold on, only one more week, soon you will get back to where you were 3 weeks ago, and there might even be a surprise waiting for you (a new improvement!)"

    Tysabri = Hope? For me, oooh yeeah!          

    Now, for those unfamiliar to Tysabri and/or MS, first let me say that the following is not medical advice regarding either Tysabri or MS. These are only my experiences and layperson's opinions after having MS for 31 years, and from having 7 infusions of Tysabri since 10/16/06.

    Tysabri works differently than the older generation MS medications (the ABCRs), as Tysabri is specifically designed as a Selective Adhesion Molecule (S.A.M.) that attaches itself to the T-cells (inflammation cells) that attempt to cross the Blood Brain Barrier (BBB) and enter the Central Nervous System (CNS) which is comprised of our brain, optic nerves, and spine.

    This is when the T-cells see our myelin (the protective coating for our nerves) as foreign, and starts to attack it, leaving scarring (sclerosis) that shows up most of the time on a MRI as white/grey spots, which eventually leads to axonal loss (i.e., damage resulting in disability). It is also explained as a misfiring of nerve signals to the receiving nerves (which can result in such symptoms as numbness, tingling, weakness, temp. or permanent optic neuritis, fatigue, bladder problems, balance problems, and even paralysis sometimes, etc.)

    Generally speaking, if lesions/spots are showing on MRI and lit up like lightbulbs, that usually means the disease process/lesion/relapse is active.

    Further, even if a person still feels great while not on a Disease Modifying Drug (DMD), they can still have "silent lesions" forming with no resulting disabilities at that time...unfortunately, due to the nature of MS being a chronic and progressive disease, the resulting disabilities usually show up later, and by then, the resulting damage might be permanent. This is why most neurologists want the patient to start on one of the various DMDs, as soon as possible.

    Tysabri's mechanism of action against MS: When Tysabri attaches itself to the damaging T-cells, it prevents a majority of them from crossing the BBB and entering the CNS. And even if a few do get across the BBB and enter the CNS, Tysabri is able to migrate (move) them away from our myelin, providing us with double coverage from those pesky, damaging T-cells.

    This accounts for part of the fantastic studies recently reported re: Natalizumab (Tysabri) and it affect on Optic Neuritis

    Tysabri basically stops/slows the cascading effects of the continuous onslaught of damaging T-cells from attacking our myelin, which in turn, gives our body an opportunity to try and heal itself (providing the damage is not permanent).

    Regarding various mis-information circulating all over the web about Tysabri, please note: Pursuant to the approved FDA labeling, Tysabri is for patients with relapsing forms of MS that generally have not responded to, or cannot tolerate, other MS treatments. What this means is that Tysabri is a first line (like the ABCRs) AND/OR a second line defense/treatment for MS.

    The phrase "cannot tolerate" can be interpreted by the treating physican to include their "needle-phobic" patients...or patients with "aggressive forms of relapsing MS"... , therefore, the patient does NOT necessarily have to fail one med first in order to have Tysabri. Pursuant to Dr. Katz and Dr. Temple of the FDA, they explained to the public in a Conference Call shortly after their Advisory Committee hearings in March, 2006 that the FDA's decision/language above was purposely left open and left up to the treating physican (as it should be, in my humble opinion).

    With regard to Tysabri and the use of steroids to treat a relapse: According to the TOUCH protocol, the patient CAN have SHORT courses of steroids (IVSM or Prednisone), to treat a relapse/flare-up while on Tysabri (see the NMSS website for verification and further clarification). Again, these decisions should be left up to the patient's treating physican, as the FDA intended.

    Lastly, regarding PML: The experts and authors of the world renowned New England Journal of Medicine attributes PML to diminished immunosurveillance (or a very low immune system), and not to Tysabri.

    Additionally, think about this for just a minute: there were 3 trial patients that developed PML: 2 of which were given Tysabri in combination with Avonex (which is another immunomodulator), and 1 Crohn's patient that had a previous severely compromised immune system due to being on Azathioprine for 6 years. Of these 3 patients - 2 died, and neither of them had MS.

    This means that out of approx. 3,000 trial patients that had a confirmed dx of MS and Crohn's disease, that did not have a compromised immune system, and received Tysabri as a monotherapy (by itself), and the approx. 5,000 general population patients that also met the above criteria (me included) from 11/04 to 2/05, that's 8,000 patients total, plus the additional approx. 8,000 patients that have received Tysabri since it's relaunch in 2006 (with the same above criteria) - that's a grand total of 16,000 patients - get this: not one of us developed PML and died - which is a risk factor of ZERO in 16,000 or 0:16,000.

    Each patient should discuss Tysabri with their treating physican, and weigh the minimal 0.1% risk of PML vs. it's enormous benefits of superior efficacy of 67%.

    The above is not meant to scare anyone (because we are all different and there's no "one size fits all" explanation for a complicated disease like MS, nor a complex medication like Tysabri)- it's only meant to pass on my experiences with Tysabri and MS, and to try and help educate others in their disease...again, the above is not to be construed as medical advice by any means...it's only my (layperson's) attempt to briefly and very simply explain Tysabri's mechanism of action against MS.

    Remember dearhearts, Knowledge Is Power - MS symptoms are like snowflakes...all uniquely different for each of us - and yet - all similarly the same.

    What we choose to do with the information we learn about our disease and its available therapies can make the difference between a lifetime of pain, suffering, disabilities, fear and confusion - or a lifetime filled with hope, possibilities, and a better Quality of Life.

    It's our choice.

    July 15, 2007

    8th infusion - May 16th,  9th infusion - June 13th,  10th infusion - July 11th

    All three of my last infusions went smoothly and without a hitch.  ZERO side effects.  Tons of energy the day after my infusions. 

    I had a very mild exacerbation on May 22 due to some emotional distress that I was feeling due to the death of a loved one, but it completely cleared upwithin a matter of days and left no residual disability (which was a first for me!).

    I definitely believe that Tysabri kept that exacerbation at a minimum, allowing a full recovery from it.
                       
    My 10th Tysabri infusion has left me feeling rejuvenated in mind and body, and having more hope than ever before.  For me, Tysabri has stabilized my MS and to date, my MS has not progressed, which is just fine by me!
                       
    My infusion center is infusing more MS patients weekly with Tysabri-and more  MS patients are reporting to me in personal e-mails and on the various MS boards, that they too are switching to Tysabri!  Am I looking forward to Tysabri infusion #11? Oh yeah  (smiling)            

    September 06, 2007

    Infusion #11 and #12 I had my 11th infusion on August 8.  I can still wiggle my toes a little bit this morning and move my feet slightly, my balance is improving, as well as my strength, speech, cognition, and coordination. Even though these improvements for me don't last the full 28 days until my next infusion, when I do feel them again, the feeling is just awesome,woooohooooo!
             
    Considering August is the month for the heat of the Summer to kick in, and a majority of MS patients don't do well in the heat (the heat can cause relapses and exacerbations of MS symptoms), I am doing really well at this time of year and my active MS has been abated/controlled outstandingly with the help of Tysabri.

    I am still thrilled with the use of Tysabri because it is preventing further relapses and slowing my disease process down. I can and will never lose hope for making more improvements (even in the face ofreality) with Tysabri because for me, Tysabri = Hope!

    Infusion number 12, September 5.  I was pretty tired the day of myinfusion, so when I got home I took a very long nap.  The temperatures yesterday reached 104° and we hit rush hour traffic going to and from theinfusion center, so I was pretty wiped out when we got home.

    This being the next day however, I can feel my strength returning again and oh my goodness, it's such a wonderful feeling (better than any steroid treatment I ever had!). My balance issues, my slurred speech issues, and my optic neuritis issues are slowly but surely improving with each infusion that I receive.

    I am going to enjoy the next three weeks to the best of my ability, and continue to fight my MS with the most effective therapy that we have to date.  Tysabri continues to instill hope in me, and hope for others as well, as we battle this disease on the front lines with Tysabri!

    September 17, 2007

    (One year evaluation with my neurologist)

    I just returned from my one year follow up appointment with my neurologist, and I am pleased to report that she was "delighted" with my progress (those were her words).

    What she was most happy about is that she did not feel I was progressing in my disease, and that what I thought was a mild relapse in early May of this year...was really not a relapse at all but a pseudo-exacerbation when I was so upset over Mina's death, soooooooo, no relapses in a year and no disease progression = WOOOHOOO! She also did not feel that a follow-up MRI was necessary, as she only saw good things when it came to my examination (strength, coordination, balance, etc.), and these were her findings, not my subjective opinions as relayed to her. She also said that if I wanted another MRI, she would order one, but she was trying to save me from the ordeal.

    I guess because I live with this disease, and I struggle with its daily challenges, I initially did not think that she would be delighted. I am of course happy that I am able to continue with my Tysabri infusions, I just thought that she was going to be more disappointed that I hadn't made more significant improvements in my symptoms (actually I had been more disappointed than anyone, because I had only felt these minor improvements for about three weeks after my infusions - however I am never ever giving up hope and trying to maintain a positive attitude)...but after this appointment, I'm flying!

    She does want me to continue with my physical therapy exercises, and I wowed her with what I had accomplished to date (especially my improved strength). She does however want me to work on my "hip flexors" (I think that's what she called them) which enables the foot/leg to be lifted upright (aka vertically from a sitting position), and which enables one to take a step/walk. She wants my caregiver and I to be trained by the physical therapists in the exercises that will best help me in this area? We need to follow up with Kaiser in this regard.

    She also said that of the Tysabri patients that she is aware of within her practice (that being in So. Calif. Kaiser), she believes that I am doing better than most of those patients. When I asked her how many patients she was talking about, she said roughly 10 to 15, but she has not asked the different neurologists throughout Kaiser, as she mainly stays focused on me as her most challenging patient - LOL.

    Now I am off to do more grueling physical therapy exercises... no pain, no gain - right?

    October 5th, 2007

    #13th infusion

    My infusions now have been moved closer to my home as Kaiser has finally Touch Certified the infusion center nearest me.   My 13th infusion at the new site it was 8 minutes 43 seconds one way!  Woooohoooooo!  That's a far cry from 90 minutes one way to my old infusion site. 

    This is a smaller Kaiser infusion center and they are much more accommodating to their patients. They are currently infusing Tysabri in three patients, with another one being added next week.

    One stick, she was in, hardly felt anything at all, and after my required 30 min. Saline drip, I started receiving my liquid gold-Tysabri...aaaahhhhh. Heehee.

    My physical therapy is starting to pay off as I am now able to stand for a few seconds unassisted before my knees buckle underneath me (I never forget that I have been wheelchair-bound for more than two years now), so baby steps are fine with me.  I always feel renewed strength right after my infusion which lasts for approximately 3 weeks.

    I'm pretty tired right now (which usually happens to me right after my infusion), so as soon as Ray (my caregiver) comes back with pizza and mudslides (Yaaay again!), I'll probably turn in early...boring Friday night, eh?
    I can hardly wait for my next infusion in November!

    November 2nd, 2007

    #14th infusion

    I really like my new infusion center.  Everyone is so nice there.

    Nothing new really to report about the infusion as they are becoming very routine. Ray (my caregiver) went out to get pizza and mudslides, yum! I think that we need to start making this a tradition after each of my infusions

    I spoke to my infusion nurse about one of the other Tysabri patient being seen there, and asked how she was doing.  She said, "not too well."  I asked, "did she have side effects or an adverse infusion reaction?"   My nurse said, "No Lauren, she is not doing well with her MS."  It turns out she's in her young 20s, has been in a wheelchair for a couple of years, and has Progressive Relapsing MS with only three infusions so far, and losing hope.

    I asked the nurse to tell her the next time she saw her for her Tysabri infusion, "sometimes it could take 4 to 6 Tysabri infusions for the medication to really get a handle on her MS, and if she hasn't had any relapses in those three months, Tysabri is keeping a majority of those nasty inflammation cells from wreaking havoc with her MS. As it is now,Tysabri is also (apparantly) keeping her rapid progression to a slow progression. And because she's still young, she has a good chance that her damage is not permanent and might eventually see improvements in her condition. And I stress this most of all, please, please tell her, never ever give up hope. She is on the best medication available to us to fight our MS!"

    My infusion nurse lit up like a light bulb and said, "oh I didn't know all of that, I'll be sure and tell the young lady everything you told me!"

    In my opinion, we should never lose hope, especially when we have Tysabri to fight our MS.

    December 2nd, 2007

    I had my 15th Tysabri infusion yesterday, Friday the 30th, and after  a long nap when I got home, I was feeling wonderful.

    I am happy to report that I still have no side effects or infusion site reactions.  Even with the cold, rainy, dreary day out here, I was happy to have been headed off for my 15th infusion only a few miles away, rather than fight the rush-hour traffic in the rain going 53 miles one way like I used to have to do.  Wooohooo!

    The funny thing was, most of the infusion patients (not Tysabri patients of course-ha ha) were canceling and reschedule their appointments due to the rain.

    My infusion nurse is so wonderful, she got me on the first stick.  Even one of my favorite infusion nurses was there (she had just returned from her vacation) and had pictures galore to share with me which helped pass the time, and before I knew it, it was time for me to leave!

    An update on the young girl that was receiving Tysabri and was so disheartened after receiving only one or two (I believe) infusions (she is only 22 years of age and has Progressive Relapsing MS).  My nurse spoke to her mother after I had been there last month and conveyed my message to her.  I am even more happy to report that I was advised that this young girl has perked up quite a bit, and has hope once again... she is even starting to see some minor improvements in her balance and slurred speech.  My nurse also stressed to her mother that as I explained to her last time, if Tysabri is able to slow down the disease process and prevent further relapses, then it is doing the job for her daughter.   What a wonderful early Christmas present it must be not only for the young patient, but for her family as well.

    I had pizza with mudslides for dinner, and today I am enjoying strength that is returning to my body.  With Tysabri, I never lose hope that I will one day begin to see better days ahead for me.

    Have a wonderful weekend everyone, take care now.

    Lauren  :)

    December 26th, 2007

    I just returned home from my 16th Tysabri infusion...Nothing new to report about my infusion, as I stated before, they are becoming pretty routine now (I like that!). 

    No mudslides and pizza tonight as we are having leftovers from Christmas dinner last night (I taught Ray, my caregiver, how to make my pineapple baked ham with maraschino cherries, my sweet potato pie topped with golden marshmallows, and my broccoli/cheddar cheese casserole). These three recipes are special and I only make them once a year (errrr, Ray made them this year as I can no longer cook).  But they are Sooooo good and so rich!  I think he is going to teach his wife how to make them now - heehee.

    I was a little worried about leaving Noël home alone for the first time since she arrived here (Noël is my 10 week old Christmas  kitten that I received as a gift two weeks ago from my friends Chuck and John)... I was contemplating coming home and finding our little Christmas tree tipped over, with all the ornaments broken that Chuck's wife Sheri had so painstakingly selected.  But we only arrived home to find Noël sleeping on my bed with her little mouse toy...soooooo cute!  When she saw me,  she immediately jumped into my lap, mouse in mouth-LOL. 

    Lauren

    January 23rd, 2008

    I had my 17th Tysabri infusion today, and it went smooth as silk.  No problems, no allergic reactions, basically boring (I'm  enjoying being bored regarding my infusions-gives me a chance to get all caught up on my court shows like Judge Mathis, Judge Joe Brown, Judge Christina, Judge Millian, etc., heehee).  The other lady that I met last month had to reschedule her Tysabri infusion because she was sick.  No one else was having Tysabri today, just me.  The other two patients that were there were having chemotherapy.

    The infusion center was pretty quiet today because it was pouring rain outside.  Same thing happened last month, just a lot of rescheduling (although last month it was pretty busy and jammed packed because it was the day after Christmas).

    I did learn that two additional Tysabri patients will be going to my infusion center (these are in addition to the other two patients that were added last month), so Tysabri use is picking up.  I guess Biogen can add another four more Tysabri patients to the over 21,000 patients currently on Tysabri therapy!

    I'm going to go check my e-mails, and then I am headed off for pizza and mudslides for dinner ( Yum! ), and then I'm hitting the hay early because I'm pretty tired right now.  I'm sure looking forward to tomorrow!

    Have a great evening everyone, all my best-

    Lauren  :)

    February 20th, 2008
    I had 18th Tysabri infusion today (why is it that each of my Tysabri infusions lately have been when it's pouring rain outside?  Oh yeah, it's winter- heehee)..  I learned that my small infusion center currently has 10 Tysabri patients that they are infusing, and to the best of the nurses' recollections, none of them have had a relapse since starting Tysabri.

    My infusion, as usual (thank goodness) was uneventful and my wonderful infusion nurse got me on the first try (Lordy, I love it when I don't have it to endure multiple sticks).

    But mainly, what I wanted to pass on was that I had the opportunity to speak with a young MS patient and her mother that had stopped by the infusion center to say hi to everyone as they were on their way for the young girl to have her six-month neuro appointment.

    When the young girl and her mother found out that I was there having my 18th Tysabri infusion, they asked the infusion nurses if I could possibly speak with them for a while (this is the young girl that I previously told all of you about that had two (I think) previousTysabri infusions and was feeling kind of depressed as she had not seen any improvements in her condition-that was when I asked my infusion nurse to pass on a message of hope to her when she saw her next). 

    The young girl (I believe she said that she was only 19) was very shy, but her mother wasn't.  Her mother told me that even though her daughter had been diagnosed with MS at age 16, had tried all of the ABCRs, with the exception of Rebif,  just continued to get worse and ultimately, wound up in a wheelchair two years ago.  Her mother also said that her daughter had various symptoms of MS throughout the years, but none of them had made the connection that it was MS, until she got the final diagnosis (this is very common among MS patients as they look back prior to their diagnosis and can see the various symptoms that they were trying to attribute to other circumstances).

    Are you ready for this?  Her mother told me that her daughter is now able to take six steps with a walker, and is determined to get her driver's license!  Also, her tremors have all but disappeared, and the strength is returning to her hands where she can almost write her name again.  Just her balance has not made any improvement, yet.  They are both ecstatic about Tysabri, and feel so blessed that they are able to have this medication available to treat her MS.  The young girl told me that she has had no side effects whatsoever from Tysabri, other than a slight headache that lasts the day of her infusion.  They told me the name of her neurologist, and I knew who she was (her doctor happens to be my neurologist's partner).

    And the best part was the mother told me that two of her daughter's lesions on her brain have all but disappeared!  Her daughter's face lit up like a light bulb, she was so happy!  I mentioned to them both that because she is still young, her body has a fantastic opportunity to heal itself (with the help of Tysabri keeping most of the inflammatory cells from attacking her central nervous system), and with her positive attitude and future Tysabri infusions, anything can happen!  But I reminded them that Tysabri is not a cure for MS...it was designed to try and prevent further relapses and their accumulating disabilities, and to slow the disease process down.  What the daughter is experiencing is icing on the cake (improvements).  And for some patients (like me), Tysabri is able to keep their MS stable (I have not had a relapse in over a year since restarting Tysabri in October 2006). 

    I also told them about my experiences with Tysabri after my very first infusion ever in early 2005.

    We talked about other things regarding Tysabri/MS/PML/the ABCRs, etc.,and just before they left, her mother asked me how long someone can take Tysabri.... I said, "Well, I am on my 18th infusion, and so far sogood, so I don't see any reason why your daughter would ever have to stop Tysabri infusions unless she developed neutralizing antibodies to Tysabri, unless she became highly allergic to it, suffered severe side effects from it, or until a superior MS medication came along and/or a cure for MS was found, but I am not a doctor and you should double-check with Dr. X.".

    They both threw their hands up in the air and yelled "Yes!  Thank you God!", and then they hugged each other (you would not believe the smile on my face when that happened).

    Well, it's time for pizza and mudslides.  I hope everyone has a wonderful evening....All my best,

    Lauren  :)

    March 20th, 2008
    Hi everyone...I just finished my 19th Tysabri infusion and everything went fine.  Even had my blood drawn afterwards to check my liver function enzymes which I have done every six months pursuant to my neurologist's instructions.  I even have a six-month follow-up appointment with my neurologist tomorrow.

    One of the infusion nurses at my infusion site mentioned to me that her sister is being tested for MS, and so far, it's looking like she's going to receive a confirmed diagnosis of MS very soon.  She asked me many questions about Tysabri, and I gave her whatever information I had, as well as my opinions about Tysabri, and suggested that her sister discuss Tysabri with her neurologist...Time is Brain.

    When I got home, I checked my e-mails, and here is one from a very sweet lady who is inquisitive about Tysabri:

    "Hi Lauren, my name is Becky and I was dio. in1995 at the time we were wanting to have a baby so no meds plus we didn't have any health insurance. In 2000 I had an exerbation that took my right side and with therapy for 2 weeks (which I hated) I was able to regain my life with only a limp. 2003 I had another on and I haven't came back yet I had therapy but I lost it I walk holding onto everything but outside my house I'm in a wheelchair I was on Avonex for 1 year but the side effects I could not handle so have been on Copaxone since august of 2007 the first week I felt my feet they weren't numb to I really got excited thinking it was gonna help me get my life back BUT all I can tell now is that I haven't had any more relapes and I feel like I'm gaining weight.

    I have a friend that's going to start Tysabri, was just wanting another opinion. She thinks I should try it. I'm also taking low dose Naltrexone it makes me not so tired but not a lot else.

    Please I need some input. I have 2 young children, my boy is 8 and he pushes me in wheelchair i hate that.

    Sorry about my typing, wanting to make a friend who understands.

    Becky"

    (Here was my reply to her)

    "Hi Becky!

    Thank you so much for your e-mail, sorry for the late reply, but I just got back from my 19th Tysabri infusion and I'm a little tired.

    I absolutely hated Avonex, I just could not handle the side effects.  I failed Copaxone is that it never stopped any of my relapses.  I then went on Tysabri in early 2005, and boy oh boy, what a miracle drug that turned out to be!  I had put away my walker and my cane, my slurred speech was gone, my optic neuritis was gone, my limp was gone, and my right drop foot was also gone.  My balance was just starting to come back, but it was not back fully with just that one infusion (all of those improvements I had in early 2005 happened within two weeks of my first infusion!).

    Tysabri was then removed from the market when I was due for my second infusion in February 2005, and in mid-June, 2005 I suffered a massive relapse which landed me in a wheelchair.  Until Tysabri r
    eturned to the market in July 2006, I was having a relapse almost every month (and that lasted over year).   I even tried LDN too for about six months, waiting for Tysabri's return its market... it did help initially for about two months, but that stopped working for me.

    When I restarted Tysabri in October 2006, I have not had relapse nor any disease progression since that time, and that has been 17 1/2 months!  I still hold on to the hope that one day I will walk again, but even if I don't, my quality of life is still 100% better than it was without Tysabri.

    You asked for my opinion, so here it is:  you and your friend should start Tysabri therapy as soon as possible so that your respective disabilities do not become permanent.  Enjoy the benefits of Tysabri while you can, don't wait... Time Is Brain... who's brain?  Your brain!

    In my book, Tysabri = Hope... Hope for a better future, not just for me, but hope for anyone on Tysabri.

    You have young children, they need you, and you need them.  Here is a link that you need to read about Tysabri (it is a Tysabri Brochure) that will help explain the medication to you:  http://yedi.com/elan/Tysabri_Booklet_08_2007.pdf

    I will be here if you need me Becky, so please don't ever hesitate to contact me in the future and I will help you as best I can, even if it is only to listen to a friend... no worries Becky, think positive and remain hopeful.

    All my best,

    Lauren :)"

    It is dinnertime here, and I'm getting ready to have my regular treats: pizza and mudslides, then I'm off to bed after I do my physical therapy exercises. Life is good...,

    I hope everyone is well, and stays well.

    All my best, Lauren  :)

    April 16th, 2008

    I had my 20th Tysabri infusion on Wednesday, April 16th.  Everything went just fine, and I turned in early after I had my monthly infusion treats of pizza and mudslides for dinner. 

    I also spoke to my neurologist just before my infusion and she told me that I hadn't had any new lesions since restarting Tysabri on October 16, 2006 (over a year ago, 18 months to be exact).  My liver function tests which she indicated she would continue to order as she had been every six months, all came back normal, woo hoo!

    I am going to enjoy the next few weeks to the best of my ability... good luck to everyone on Tysabri.

    All my best,
    Lauren 

    May 20th, 2008
    My Tysabri Diary... Hi everyone,

    I just returned home a little while ago from my 21st Tysabri infusion... everything went well, no problems at all.

    My infusion nurse told me that she went to a four-day seminar that was held by The Infusion Nurses Society, where Biogen presented more information to them about Tysabri, and the Biogen representatives spoke highly of Tysabri's efficacy and the great results that many MS patients are experiencing, etc....the only thing that bothered me was that she said the Biogen representatives presented Tysabri as a "second line therapy" and that it works great when other treatments have failed... grrrrrr.  (these statements by Biogen are incorrect as Tysabri can and has been used as a first-line therapy, especially when the MS patient  has a very aggressive form of MS and their neurologist does not want to wait and try the older generation drugs first).

    My infusion nurse also mentioned that they were going online with part of the Touch procedures, but she could not remember everything that the representatives presented regarding this aspect presented.

    When I got home, I called MSActiveSource (1-800-456-2255) and spoke to a Touch Case Manager and he told me the following:

    The aspects of going online for part of the Touch program were mainly to cut down on the paperwork required regarding the infusion center nurses' checklist (they used to have to fax the checklist over to Biogen) , for better communications between the infusion center and Biogen, to go over any PML questions/concerns (i.e. keep an open line of communication with the infusion center), to track the Lot Numbers of the vials (which will help Biogen/Élan better calculate how many patients are currently on Tysabri therapy), check the authorization dates for infusing Tysabri, etc. He further told me that there were not many infusion centers currently involved in going online, as they [the infusion centers] have been unaware of same until recently (that seemed rather odd to me, and I questioned him about that, but he told me that he didn't have any further information on the subject).

    My infusion nurse did mention to me that a special code will be given to the infusion centers, the prescribing neurologists, and the patient so that they could access said information (which I think she said will be the date patient was last infused, their infusion schedule, etc.).

    Sorry that I don't have any more specific information, but my infusion nurse couldn't remember everything from the four-day seminar, and the Tysabri Case Manager only gave me the generalizations above. So all in all, it was a good day.

    Ray (my caregiver) and just arrived with pizza and mudslides, so I'm off for a quick dinner, my PT exercises, and hitting the hay early because I am a little fatigued (which is normal right after my infusions)...., my friend Chuck (who surprised me with my new Christmas kitten, Noël, last December) is coming by tomorrow for a visit, and it will be wonderful to see him again.

    Have a great evening everyone, all my best to you...,

    ((((hugs))))

    Love, Lauren :)

    July 11th, 2008
    My Tysabri Diary...

    A very happy belated Fourth of July wish for all of you, I hope your holiday was safe and filled with good food (heehee). I made my famous barbecued chicken wings recipe, no-mayonnaise potato salad (the potatoes are parboiled and then grilled for a smoky flavor, mixed with grilled onions, bacon, blue cheese dressing and balsamic vinegar), and then I made my delicious carrot & raisin salad...., oh my goodness, everyone stuffed their faces...soooooooo yummy!

    As I watched the spectacular fireworks display out here, I couldn't help but remember my MS friends who were never able to see the fireworks on Friday the 4th because they had lost their vision (or a majority of their vision) due to their MS. Because of this, I wanted to post the following link on my blog which is a short 3 1/2 minute video that explains How Tysabri Works. I thought it was fitting considering that not only does Tysabri prevent worsening of vision loss in patients with relapsing MS, Tysabri is also associated with significant reductions in the likelihood of sustained vision loss.

    How Tysabri Works:

    http://tinyurl.com/How-Tysabri-Works

    So, on to better subjects...here is my 23rd Tysabri infusion report: I had my 23rd Tysabri infusion on Wednesday, 7/9... all went well, no problems, no surprises, and no terrible multiple "sticks"... one stick and my regular infusion nurse had a line in. I asked my infusion nurse how the other Tysabri patients in our small infusion center were doing, and she said they are all doing very well. So I really have nothing new to report.

    In the interim, someone asked me a question regarding a friend of theirs that was recently diagnosed with MS, and their neurologist placed him on Avonex, which his friend really didn't want to go on, so he asked me this question: "Can my friend go directly onto Tysabri as a first line therapy? Or does he have to fail on a CRAB first? I just don't know what the TOUCH protocol is"..., my answer is yes, he can go directly onto Tysabri as a first-line therapy IF his neurologist recommends it (which obviously, his neurologist doesn't); there is also the issue of whether or not the patient's insurance would question Tysabri as first-line therapy, and the neurologist really has to convince the insurance company that 1) the patient cannot tolerate the other therapies [the patient is needle phobic], or 2) the patient has a highly aggressive form of MS and the neurologist does not want to wait and try the other ABCRs first.

    The FDA clarified their response to Tysabri's use as a first-line and/or second-line therapy for MS...see:

    http://tinyurl.com/FDA-Memorandum

    Clarification article by the FDA regarding Tysabri's use as a first-line AND/OR second-line therapy for MS patients

    First-line Tysabri therapy in some MS patients

    MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE

    FOOD AND DRUG ADMINISTRATION
    CENTER FOR DRUG EVALUATION AND RESEARCH

    SUBJECT: Errata to FDA Background document for the Tysabri (natalizumab) Advisory Committee on July 31, 2007 In the reviews, Tab 1 (FDA Clinical Review) and Tab 2 (Office of Surveillance and Epidemiology Review), it was stated that the MS population to receive Tysabri should be those “unable to tolerate or with an inadequate response to other available MS therapies” and it was stated that the indication was revised to “relegate it [Tysabri] to a second-line therapy for relapsing-remitting MS.” The indication in the current label states “…Tysabri is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternative multiple sclerosis therapies.”

    FDA would like to clarify to the reader that the MS indication for Tysabri was carefully written by FDA and the Sponsor to indicate that its use is generally recommended for patients who have had an inadequate response to, or are unable totolerate [i.e., needle phobic patients] alternative multiple sclerosis therapies (e.g., as second-line therapy).

    However, the indication statement does not explicitly preclude the possibility of first-line therapy in some MS patients as part of the approved use. FDA recognizes that the health care provider needs to consider its use based on the unique circumstances of each patient.

    So as you can see, it really depends on the neurologists' recommendation. If the newly diagnosed MS patient feels that a second opinion is in order (I mean really, Avonex is a once a week shot into the muscle and is only 32% effective at preventing further relapses/slowing the disease process down with horrible flulike side effects, whereas Tysabri is 67% effective with only minimal to no side effects for most of the MS patients, has proven data showing an 83% reduction in the accumulation of new or enlarging lesions over two years, as well as 92% fewer lesions during Tysabri therapy after both one and two years)..., he should contact MSActiveSource at 1-800-456-2255 and request three names and numbers of Touch certified neurologists near him so that he can make an appointment with one of them...he only needs to provide his ZIP code to them.

    I hope that this information was of some help to that new MS patient. I also told him that if he decides to go with Avonex first, I suggested that he take a liquid Advil approximately 20 minutes before the shot, and ice the injection site (place an ice cube wrapped in a washcloth) for approximately 5 minutes before the injection as this will help with the pain of the needle going into the muscle...and I also suggested that he do his shot just before he goes to bed (hopefully he can sleep through the majority of its flulike side effects) and has the next couple of days to recuperate from its side effects. And I also reminded him that I was not a doctor, the above is only my opinion, with the exception of the proven Tysabri data that I mentioned (proven data is not my opinion, it is fact).

    I was pretty tired Wednesday after my infusion so I ate a small dinner of pizza & pasta, accompanied by a mudslide or two, and then turned in.

    I have a ton of new e-mails and messages that I need to answer, and I hope to respond to some of your comments left recently on my blog... until then, have a wonderful weekend everyone.

    ((((hugs))))

    Love, Lauren

    August 9th, 2008
    My Tysabri Diary...

    I just returned home a little while ago from my 24th Tysabri infusion...nothing new to report other than there was a terrible accident coming home from the infusion center, and having to sit quite awhile in traffic pretty much wiped me out. So I'm going to go to bed early tonight after Ray (my caregiver) returns with the pizza (I'm already sipping my mudslide, yaaay!) <---- laughing.

    I asked my infusion nurse if there had been any changes in the number of Tysabri patients they were infusing, if any had dropped out, or if they had added anymore... she said that everything was "status quo", and that all of the patients were doing very well on Tysabri and had absolutely no complaints about the medication (remember, this is a very small infusion center)... she did tell me that she noticed my MS has been stable since I've been going there to receive my Tysabri infusions, so this is a good sign :)

    I haven't really checked many of my e-mails because I am really superduper tired, but happy and pleased that I still experience zero side effects from this medication.  I can only hope and pray that other patients are loving Tysabri as much as I am.

    I am also please to hear that most MS patients & neurologists are not swayed at all by the 2 recent PML reports in the two European Union patients..., it is my understanding that Biogen/Élan (the manufacturer/distributor of Tysabri) is holding approximately 20 different Neurologist Conference Calls through the end of Friday this week to update them regarding the situation, and answer any questions that they might have. I am also pleased that most of these neurologists (I hear) have not changed their minds at all about Tysabri, and they are still very excited about Tysabri's prospects for their MS patients in need, while they are becoming very aware of the need to continue in their vigilance of observing their patients and monitoring them closely... I don't ever remember my neurologist closely monitoring me when I was on Avonex & then Copaxone... I like being monitored closely, it makes me feel not only safe, but closer to my neurologist :)

    Have a great evening everyone,  

    ((((hugs))))
    Love, Lauren :)

    My Tysabri Diary 4th September, 2008
    My Tysabri Diary...,

    Hi everyone,   I just returned home a little while ago from my 25th Tysabri infusion... once again, no problems, no side effects, no adverse reactions, and no problems with the infusion... my nurse was able to"stick me" with just one jab, yay!

    When I asked how the other Tysabri patients were doing, I was told "just fine", no problems there either and no one was concerned about the two new cases of PML in Europe.

    So other than that, I have nothing new to report (which is a good thing).

    I did want to share an e-mail that I sent to the editor in chief of the AAN (American Academy of Neurology) recent publication regarding the new guideline that their authors published yesterday (I've received no reply from them as yet, and I really don't expect one either)...., they kind of pi$$ed me off (oops).

    I'm off to have an early dinner of pizza and mudslides, and then turn in early... have a wonderful evening everyone,

    ((((hugs))))
    Love, Lauren :)

    Subj: AAN's Publication for Use of Natalizumab dated 9/2/08                     
    Date:9/2/2008 3:22:43 PM Pacific Daylight Time                     
    From:LGLBGL2003                     
    To: [email protected]                     
                                                           

    Gentlepersons,

    I just reviewed your publication of the New Guideline Published on the Use of Natalizumab for MS:

    http://www.aan.com/news/index.cfm?event=read&article_id=6024&page=72.45.45

    From a review of the publication above, strong  exception is taken to the following language used:

    "it is recommended that natalizumab be reserved for use in selected patients with relapsing-remitting disease who have failed other therapies either through continued disease activity or medication intolerance, or who have a particularly aggressive initial disease course.".

    This recommendation is in direct conflict with the FDA approved Tysabri label and which furthermore is in direct conflict with the FDA memorandum which previously issued, stating in part: "FDA would like to clarify to the reader that the MS indication for Tysabri was carefully written by FDA and the Sponsor to indicate that its use is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternative multiple sclerosis therapies (e.g., assecond-line therapy). However,the indication statement does not explicitly preclude the possibility of  first-line therapy in some MS patients as part of the approved use.FDA recognizes that the health care provider needs to consider its usebased on the unique circumstances of each patient.

    http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4313b1-02-FDA-Errata.pdf ".

    In addition, Tysabri is to be used for "relapsing forms" of MS, which include Relapsing-Remitting, Progressive Relapsing, and Secondary Progressive with relapses. The authors of the article indicate that it is for relapsing-remitting disease, which is completely incorrect.  The Tysabri label states: "TYSABRI® is indicated as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations.".

    While I understand that the AAN is a medical specialty group and as such, does not preclude recommending a narrower scope of Tysabri's use, what in fact the AAN authors of this article are doing is condemning a wide variety of MS patients to suffer additional relapses and disease progression needlessly by relegating treatment first with one of theABCRs, not to mention a very large patient population of noncompliance to the ABCRs treatment regimes due to their side effects and injection site reactions.  Furthermore, said language will make it extremely difficult for insurance companies to provide approval for the use of Tysabri in these patients and as a first-line therapy when first-line therapy use is clearly approved by the FDA. The authors of said article should take into consideration that the health care provider needs to consider its use based on the unique circumstances of each patient.

    Your authors begin by commenting: "Strong evidence suggests that natalizumab reduces disease activity and severity in people with relapsing MS by both clinical and MRI measures."..., would it not behoove MS patients to begin treatment as soon as possible with Tysabri in order to achieve these results?

    Lastly, your authors state that: "strong evidence suggests an increased risk of developing PML in patients receiving combination therapy with interferon (IFN) and natalizumab"...,considering Tysabri can only be prescribed as a monotherapy for non-immunocompromised MS patients pursuant to the FDA approved label and accompanying RiskMAP, there is no increased risk of developing PML.

    As a Tysabri patient for more than two years and a MS patient for more than 32 years, I really must object to the language used by your authors in this publication, and respectfully request a clarified and corrected publication issue which will help truthfully guide physicians when treating their MS patients rather than mislead them into allowing their MS patients to continue suffering possible permanent damage needlessly due to the AAN's authors current language.

    I look forward to your prompt reply.

    Respectfully submitted,

    Lauren Roberts

    6th October, 2008

    I had my 26th Tysabri infusion Wednesday the 1st and all went well, I was just extremely tired when I got home, and just skipped dinner that night and went to bed, and just having a light dinner Thursday night. I had my traditional pizza dinner Friday night.

    The weeks prior to this infusion were more hectic for me than usual...., I changed neurologists (I really didn't want to because I had my neurologist for more than seven years), but she had a baby and was cutting back her hours, plus she was 53 miles away from me [and that's just one way], so the Kaiser neurologist near me agreed to take me on as his patient once he evaluated me...he is Touch Certified and after my appointment with him, he authorized another six months of Tysabri for me.

    One miracle for me was my vision has dramatically improved to the point where I no longer have to wear my glasses when watching TV... my optic neuritis from my MS is almost completely gone. He was very happy to hear this and a big grin flashed across his face. Even though I will miss my former neurologist, I like this new doctor very much. He is very kind, caring, and really listens to the patient...he actually encourages patient dialogue with him, which I found incredible.

    Then I had to go through the hassle of notifying my Tysabri Case Manager, the infusion center, making sure that the appropriate "doctor's orders" were in place, etc...., sheesh!

    To make matters worse, the infusion center did not have his Tysabri orders in my file the morning of my infusion, so after I made several important and insistent phone calls, I was able to reschedule my infusion for that afternoon...,

    At the end of the day, I was totally wiped out, but my infusion nurse was excited to tell me that they are getting two more Tysabri patients next month, Woooohoooo!

    All my best to everyone, take care now...,

    ((((hugs))))

    Love, Lauren :)

    My 27th Tysabri infusion report.......

    First of all, I have/had been helping a fellow MS patient that had to go off of Tysabri therapy because he could no longer afford the exorbitant costs of his monthly infusions....,  his name is Vic (I have his permission to use his first name). 

    I had initially contacted the Patient Services Supervisor over at Biogen and after about a week, they had temporarily resolved this MS patient's situation, however subsequent to that time, I received a phone call from this person the following week and I was told that there was nothing further that they could do  & unfortunately, everything was going to revert to the same way it was before their intervention the following month.  Therefore, this patient as well as 12 other patients in his neuro team's practice, had to definitely drop out of the Touch program because their monthly financial output for their therapies was making it impossible for them to continue on Tysabri.

    When I had nowhere else to turn to try and get assistance for this patient, I contacted Élan (the company that discovered Tysabri, Biogen's partner with regards to Tysabri).  Below are a few of  our various paraphrased e-mail exchanges between my contact over at Élan, myself, and the patient - after just two days of Élan being made aware of this situation (I advised them on a Friday - so obviously, they worked on this problem over the weekend!), Vic is now going to start back on Tysabri therapy November 4th and all of the other MS patients that were in his neuro team's group are also able to resume their Tysabri infusions. Woo hoo!

    In addition, I had my 27th Tysabri infusion on the 29th..., all went fine, although I'm still feeling a little tired.  When my infusion nurse told me what happened with the paperwork we filled out over a month ago regarding the changeover to my new neurologist, ummmmm, let's just say that not only was I not surprised at Biogen/MSActiveSource's inaction,  grrrrrr, but I definitely let the person that has been helping me over at Élan know what happened, and I have been assured that the information I provided will be sent to the appropriate person(s) at Biogen....,

    I will report again after my 28th infusion.

    Lauren

    28th Tysabri Infusion Report & A Happy Thanksgiving Message
    I got home late yesterday afternoon from my 28th Tysabri infusion,everything went fine and nothing new to report other than feeling a little tired..., so I went to bed early last night.

    I wanted to wish everyone a very happy Thanksgiving, and below are some thoughts that I want to dedicate to my wonderful friends who touch my life with the treasure of their being... May your soul decisions always be made with your heart, and not your head. (the words below were shared with me by a friend, and I wanted to share them with you as well).

    Happy Thanksgiving Everyone!  

    Lauren :)

    1.  Don't go for looks, they can deceive.  Don't go for wealth, even that fades away.  Go for someone who makes you smile.

    2. There are moments in life when you can miss someone so much that you want to pick them up from your dreams and hug them. I hope you dream of that someone.

    3. Dream what you want to dream, go where you want to go, be what you want to be, because you have only one life and one chance to do all the things you want in life.

    4.  May you have: Enough happiness to make you sweet
    Enough trials to make you strong
    Enough sorrow to keep you human
    Enough hope to make you happy
    And enough money to keep you comfortable

    5. When one door of happiness closes, another opens. But we often look so long at the closed door, that we don't see the one which has been opened for us

    6. The best kind of friend is the one you can sit on a porch with, swing with, never saying a word and then walk away feeling like that was the best conversation you've ever had

    7. It's true that we don't know what we have until we lose it, but it's also true that we don't know what we've been missing until it arrives

    8.  Always put yourself in others' shoes.  If you feel that it hurts you, it probably does hurt the other person too

    9. Every careless word may kindle a strife
    A cruel word may wreck a life
    A timely word may level stress
    A lovely word may heal and bless

    10. The beginning of love is to let those we love be perfectly themselves and not twist them with our image otherwise we love only the reflection of ourselves we find in them

    11. The happiest people don't necessarily have the best of everything, they just make the most of everything that comes along the way

    12. Maybe God wants us to meet a few wrong people before meeting the right one so that when we finally meet the right person, we should know how to be grateful for that gift

    13. It takes a minute to have a crush on someone, an hour to like someone, and a day to love someone, but it takes a lifetime to forget someone special

    14. Happiness lies for those who cry, those who hurt, those who have searched and those who have tried. For only they can appreciate the importance of people who have touched their lives

    15.  Love is when you take away the feeling, the passion, the romance and find out you still care for that person

    16. A sad thing about life is that when you meet someone who means a lot to you and then only to find out in the end that it was never meant to be and you just have to let go

    17.  Love starts with a smile, develops with a kiss, and ends with a tear

    18. Love comes to those who still hope even though they've been disappointed, to those who still believe even though they've been betrayed, to those who still need to love, even though they've been hurt before

    19. It hurts to love someone, and not be loved in return but what is most painful is to love someone and never find the courage to let the person know how you feel

    20. The brightest future will always be based on a forgotten past. You can't go on well in life until you let go of your past failures and heartaches

    21. Never say goodbye when you still want to try;
    Never give up when you still feel you can take it;
    Never say you don't love that person anymore when you can't let go

    22. Giving someone all your love is never an assurance that they'll love you back. Don't expect love in return, just wait for it to grow in their hearts, but if it doesn't, be content it grew in yours

    23. There are things you love to hear but you might never hear it from the person whom you would like to hear it from, but don't be deaf to hear it from the person who says it with all their heart

    24. When you were born, you were crying and everyone around you was smiling. Live your life to the fullest so that when you die, you're smiling and everyone around you is crying

    Author Unknown

    Here is a really nice Thanksgiving card from Jacquie Lawson (this was shared with me by my friend Cyndee..., Yum!):

    http://www.jacquielawson.com/preview.asp?cont=1&hdn=0&pv=3111922

    29th Tysabri Infusion Report & A Happy New Year
    I had my 29th Tysabri infusion on December 24th, all went well, and it was pretty quiet being that it was Christmas Eve at my infusion center..., one thing of interest happened there that day..., a gentleman was having Remicade for his RA (he usually has a pretreatment with Benadryl, but declined it yesterday), and he developed an allergic reaction almost immediately.

    The infusion nurse stopped his IV, and then administered Benadryl..., I mentioned to him that Claritin-D tablets work really well (Claritin-D is what I take to pretreat my Tysabri infusions), and that he may want to discuss using same with his doctor, rather than pretreating with having Benadryl. He said he definitely would.

    Also, I've been really busy answering all the questions on the different MS boards and e-mails about the latest PML case/death..., I will answer them here as well; there is some additional information which was posted by Biogen on the SEC filings website, which they are required to do:

    Here is the link: http://tinyurl.com/54x5rm  (US Securities & Exchange Commission)

    Basically, it states the following:

    "• Background:

    - Patient has a history of MS and prior disease modifying therapies, including beta-interferons and glatiramer acetate.

    - Patient had also received prior therapy with methotrexate for a rheumatological condition.

    - Patient received 14 infusions of TYSABRI monotherapy.

    - Clinical vigilance led to early identification of signs and symptoms of possible PML and to clinical evaluation which included MRI scanning and CSF testing.

    - Patient is under the care of patient's treating physician."

    Unfortunately, methotrexate has been positively associated with PML because of its extremely strong immunosuppressive actions. See page 1 of the following NEJM article, which states the following:

    "Progressive multifocal leukoencephalopathy (pml) is a rare, oligodendroglial infection caused by the polyomavirus JC virus. It usually occurs in people infected with the human immunodeficiency virus (HIV), but it has also been reported in immunocompromised patients receiving prolonged treatment with methotrexate, cyclophosphamide, and azathioprine."

    Here is the link for the New England Journal of Medicine article:
    http://tinyurl.com/4qeddp  (NEJM)

    I hope this information helps. So anyway, I wish you all the very best the holiday season, and a very happy, healthy, and promising New Year!

    ((((hugs))))

    Love, Lauren :)

    5th March 2009
    Hi everyone,

    I had my 31st Tysabri infusion last Wednesday. My regular infusion nurse was not there that day, nor was her backup, so a lesser experienced states infusion nurse had to stick me three times to get a good line in (owie!)

    Below are some Tysabri charts/graphs that an acquaintance of mine compiled from Tysabri patient reports being posted on various MS forums that I belong to.  A different friend of mine sent them to me and I am posting them on myblog as well.

    Also, below is my reply to a post from a patient that is, how should I say this politely, not very Tysabri friendly and never has been... she is always posting negative and erroneous misconceptions about Tysabri on various MS boards.

    Anyway, hopefully each of you will have a good week.

    ((((hugs))))

    Love, Lauren :)

    Slide 1

    Slide 2

    Slide 3

    Slide 4

    (Percentage of patients responding to various "Tysabri Polls”)

    This reply is in response to the post by XXX Re: the IRIS condition and other various misconceptions/assumptions...,

    The patient who died was a United States patient who had received 14 monthly infusions of Tysabri as a stand-alone treatment. Previously she had received other therapies, including methotrexate for her RA condition... methotrexate has been specifically linked to causing PML.

    Unfortunately,methotrexate has been positively associated with PML because of its extremely strong immunosuppressive actions. See page 1 of the following NEJM article, which states the following:

    "Progressive multifocal leukoencephalopathy (pml) is a rare, oligodendroglial infection caused by the polyomavirus JC virus. It [PML] usually occurs in people infected with the human immunodeficiency virus (HIV), but it has also been reported in immunocompromised patients receiving prolonged treatment with methotrexate, cyclophosphamide [a.k.a. Cytoxan], and azathioprine [a.k.a. Imuran].."  Here is the link for the New England Journal of Medicine article:

    http://content.nejm.org/cgi/reprint/353/4/375.pdf   (NEJM)

    After developing the brain infection, the patient was treated with a procedure known as plasmapheresis, in which blood is removed, cleared of the drug, and replaced. While the U.S. patient died, two patients who developed PML in Europe, and whose cases were announced in July, appear to be recovering following treatment, even though one had not been expected to survive.  Earlier this month, Biogen announced that a fourth patient had developed PML. This patient, in Europe, is still alive.The European patient that had not been expected to survive had developed a condition known as immune reconstitution inflammatory syndrome, or IRIS. This occurs when the immune system, in eliminating an infection, produces an excessive inflammatory response that can worsen symptoms.

    From an e-mail reply that I received from the Senior Director of Research Information of the NMSS which posted information/their opinions regarding IRIS, she stated "What is not known is whether IRIS would have occurred whether PLEX was performed or not.  Further experience will probably answer that and many other questions as time goes by....Biogen Idec is to be applauded for supporting research into PML and possible ways to quickly clear the system of their drug when it's deemed necessary."

    "Geoff Meacham, an analyst at J.P. Morgan, said it seems likely the U.S. patient, having gone through plasmapheresis, died of IRIS... ", Mr. Meacham is a financial analyst, not a doctor/researcher.

    Drugs that have been known to cause PML include Imuran/Azathioprine, regular steroid use, Rituxin, Remicade, CellCept, methotrexate, Raptiva, etc, and to unfairly single out Tysabri causing PML/IRIS is ludicrous.

    All of these patients that developed PML were previously treated with one of the following: Remicade, Imuran/Azathioprine, methotrexate, regular steroid use, and possibly CellCept in the latest PML case. So as youcan see, all of these patients received strong immune suppressing medications which can last in the body for years (even though previously discontinued by the patient) prior to starting Tysabritherapy.

    As of end of December 2008 there were approximately 37,600 patients currently on therapy. A total of 52,900 have been treated with Tysabri at some point in time (clinical trials, first launch, second launch), so the 1:1000 risk of developing PML is still well within the guidelines as listed on the label.

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