Tysabri, the MS Drug Haunted by Deadly Side Effect, Doesn’t Look So Deadly Anymore

Xconomy Boston — 

Few doctors knew much about a rare brain infection called PML back in 2005, when two patients on a hot new multiple sclerosis drug from Biogen Idec and Elan died from the side effect. The infection, at the time, was generally considered a death sentence. But now with three years of data from more than 60,000 patients worldwide who have taken natalizumab (Tysabri) under strict monitoring by physicians, a new picture is emerging that shows PML is still very much a serious threat, but that it isn’t nearly as deadly as first feared.

While each and every confirmed case of PML, known formally as progressive multifocal leukoencephalopathy, scares investors in Cambridge, MA-based Biogen (NASDAQ: BIIB) and Ireland-based Elan (NYSE: ELN), I sought to assemble a big picture view of exactly how deadly PML really is when I interviewed Al Sandrock last week. He’s the senior vice president of neurology R&D at Biogen, and an assistant clinical professor of neurology at Harvard Medical School.

Before diving too far into the numbers about the risk of Tysabri, a little background is required. This drug, an antibody treatment designed to block certain white blood cells that cause MS when they attack nerves, has a history of also making patients vulnerable to infection. Biogen and Elan yanked it off the market in February 2005 after two cases of the brain disease were confirmed among patients taking the drug; a month later, a third case was confirmed. But legions of patients still demanded the drug, considered to be the most effective medicine on the market at reducing the disabling nerve damage from multiple sclerosis flare-ups. The FDA allowed the drug to return to the market in July 2006 after determining its benefits outweighed the risks, but it also forced doctors into a strict monitoring program to keep an eye out for the early signs of PML.

This matters not just for doctors and patients, but for Biogen’s and Elan’s financial futures. The drug, Biogen’s fastest-growing product, generated $560 million in sales in the first nine months of this year. (The importance of this drug is one reason why investors get so ticked at Biogen when it isn’t exactly forthcoming about every newly diagnosed case, but that’s a bone to pick another day.)

When the drug came back on the market, its FDA-approved prescribing information contained a prominent warning that about 1 out of every 1,000 patients on the drug were likely to get PML. But that was really just a forecast, and the actual risk-benefit balance for this drug is really a moving target that shifts over time when a new case is confirmed. So I sought to build a simple chart when I spoke to Sandrock that provides a snapshot of PML cases in February 2005, when the drug was pulled off the market because of the PML risk, versus those confirmed as of yesterday. Here’s what I gathered:

Number of patients
who have taken Tysabri           

Number of
PML cases               

February 2005              
Nov. 18, 200963,000275

The February 2005 figures came from clinical trial data and formed the foundation for the FDA-required warning of the 1-in-1,000 chance of getting PML. The more recent figures include all the experience of patients who have gotten the drug since it was returned to the market in July 2006. The thing that jumped out at me was the fact that only five of the 27 confirmed patients with PML have died—meaning that the current survival rate stands at over 80 percent.

That curious fact has been buried under a rash of scary headlines … Next Page »

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67 responses to “Tysabri, the MS Drug Haunted by Deadly Side Effect, Doesn’t Look So Deadly Anymore”

  1. D. Munafo says:

    Finally an article that explains the positive as well as negatives on Tysabri. Great to read such an informative and fact filled description.

  2. Remy says:

    Wow. That read like an infomercial praising the wonders of Tysabri and simply positing the company line. Noting the declined death rate is positive news but as a patient taking Tysabri I want to know more details about the lives of those people who survived.. If I live but I’m on a ventilator, or confined to my bed, or can’t remember how to speak–do I even want to be alive? The patients really seem to come last. Biogen has a blockbuster drug that generates significant revenue so they have an incentive to keep the investors happy with a rosy outlook. I plan to stop Tysabri right before the 24 month mark. I no longer trust Biogen to be transparent and give me the info I need to truly make an informed decion about being on this drug.

  3. Remy—You raise a good point about the lack of full transparency about what’s going on with PML cases. I agree it’s important that the public get more information about what has really happened to those 27 patients diagnosed with PML. How many of them are severely disabled, and how many have recovered? How badly has the disability from PML damaged the patients’ quality of life? How much more disability do they suffer from PML,compared to the symptoms of their MS that would return if they quit taking Tysabri? These are all questions I expect to hear more about in the medical literature for months and years to come as the body of evidence evolves. Biogen and Elan certainly need to figure out a better way to satisfy all the demand for information about this drug. But as I said, that’s a story for another day.

  4. Ken says:

    Biogen/Elan need to be more transparent and quit playing statistical games…the % of PML cases where patient has been continously on Tysabri >2 yrs is approaching 0.1% but a disproportionate number of cases are from Germany — which raises issues if the patients were monitored closely or switched to Tysabri before the Avonex/Betaseron/Rebif protocol was followed
    No one recovers from PML – just experiences different levels of neurological damage

  5. Pit says:

    Nice article, but why don’t you ask for:
    – Why does biogen inform only his shareholders about new pml cases and not users of ty?
    – Why do they stop this since july?
    – Why does biogen not say that pml risk for people taking ty over 24 month is higher than 1:1000?
    – Why do they speak at Q3 earnings at 20th of october about 17 pml cases while the right number is 23?
    – Why do they take for statistic all ty users who ever take ty, also those who stop ty therapy or this one who take ty only 1-3 month?

    I could continue with this list for many questions. Fact is that biogen gives the apparent they won’t like to inform the users of ty about new pml cases. You also can’t read somewhere about detailled pml risk for ty users over 24 month.
    If you take 13.400 patients taking ty over 24 month and divided by 18 pml cases you will get result of 1:744 for pml risk.


  6. Pit says:

    @ Ken:
    I agree with you but about disproportionate number of cases are from Germany:
    Of first 24 cases, 8 from Germany and also 8 from the United States, each 2 from Sweden, France and Switzerland, 1 from Spain and 1 from the Czech Republic.
    Newest 3 cases up to 27 I don’t know yet.


  7. Lisa says:

    As a patient on this drug, what galls me is Dr. Sandrock’s contention that DOCTORS are ‘watching for telltale signs’ and will withhold the drug if any are NOTICED. That’s not the way the TOUCH monitoring program works. What really happens is that each time I go for an infusion, my NURSE reads a written list of questions to me, including one asking ME whether I’ve noticed any ‘changes in thinking.’ She knows me and is a caring person, and I trust her. But Dr. Sandrock’s assertion paints a picture of patients being interviewed by their neurologists at each infusion, and that is not what happens. It would cost even more than it already does if that were happening.

  8. Iralia says:

    PML is seen is many types of patients, but for some reason Tysabri gets the biggest headlines. PML in a Tysabri patient isn’t much different from PML in an AIDs, Transplant, Chemo, or Psoriasis patient. Tysabri is a heavy duty drug and it’s efficacy is not match by any of the other MS injectables. Ultimately, the patient is their best advocate.

  9. Trish says:

    I’ve done 27 Tysabri infusions and was told to stop by my neurology clinic a few weeks ago. They quote the new PML odds (for people >24 infusions as 1:600. My neurologists are not comfortable with those odds.

    This article’s headline is that “Tysabri is not so deadly”. No, not exactly. The risk of PML is less than we thought for the first 12 months. After that, it’s higher – much higher – than we thought. I suppose you could calculate further odds based on the people who were on Tysabri, got PML and died. But that doesn’t give you a full picture of PML. Only the picture of those particular cases of PML. Sorry, I think it’s a reach. The real headline is that anyone on Tysabri for more than 24 months should re-evaluate.

    Regarding PML, it seems strange to me to argue that PML isn’t really so bad because not as many people in this very small subset died.

    I know that the real message is “Investors – Don’t Panic. There’s no reason to sell your Biogen shares.” But maybe it’s the neurologists you should be trying to convince. If they keep taking people like me off of it, then maybe shareholders aren’t Biogen’s biggest problem.

  10. Tisha says:

    All Biogen is worried about is that their stock doesn’t tank. I don’t believe they give a damn about the patients. It’s the almighty dollar on wall street that’s the main concern! They r not forthcoming giving all the information on the cases of PML. The Touch program is a joke as said by Lisa the nurses are very caring but I hardly feel that I am being closely monitored by a doctor especially since you don’t have to see them, according to the touch program, for every three months once established on the drug. I am on Tysabri & will be coming up on my 21st infusion. I am seriously thinking of not continuing this medication. I do not feel any difference since taking this drug. I did stop taking it for about 2 months this year because I became concerned about the pml & could not find any info on what happened to the people of the cases reported. I did have problem & needed steroids & was convinced to go back on ty, but then again i had another problem while on the ty and was treated with steroids. I am sorry to say that I don’t trust the doctors or Biogen and if patients stop taking it the doctor’s lose and Biogen loses. It is disturbing to me as a patient with such a dibilitating disease that has changed the course of my life & the life of my spouse that Biogen is so not forthcoming about the truths of what’s going on with this drug. It’s a shame there is so much distrust of the very people who could possibly be holding our lives in their hands.

  11. Penny says:

    I took myself of Tysabri this summer after 17 months.

    I’m so encouraged by comments I see here admitting skepticism about for-profit drug manufacturers being genuinely “concerned” for the patients who take their drugs.

    Biogen is bitterly disappointed in their inability to get their anticipated windfall profits out of Tysabri, and I believe they will do and say just about anything to forestall defectors and prop up the price of their stock.

    If this article was supposed to make me (or anyone) feel better about Tysabri, they missed the mark completely by not providing one shred of corrobative evidence that a life post PML is one worth living. The ommission actually speaks volumes about how potentially misleading the headline is.

    My own decision to get off the drug came about when articles about Tysabri having the ability to “reverse” MS damage suddenly started showing up, immediately following reports of how poorly their stock was performing due to the increase in PML cases. It seemed to me to be a blatantly transparent ruse to trick patients into staying on the drug, as the reports provided no insight into how such a miraculous thing could possible occur.

    I’m glad the public’s finally waking up to the strings the puppet masters at these big pharmaceutical companies have not one moral qualm about pulling if it means more profits for them and their stockholders, regardless of how it might endanger the people paying for – and sometimes dying for – the hope these drugs represent. Shameful.

  12. Mary says:

    My Tysabri experience is vastly different than Tisha’s. I feel that I am getting more than cursory medical attention. I am about to get my 25th infusion. I get a full battery of blood tests each month as well as visiting a hemotologist before every infusion. I see my neuologist every three months as well. They do yearly MRI’s as well as yearly lumbar punctures. Before Tysabri, I never went more than 10-12 months between relaspses, and over the last 12 years, have been on all of the ABC drugs with little results. I am now over 28 months without an exacerbation. I feel normal. I am aware of the risks of PML but I could just as easily get into a car accident on my way to the store.

  13. Sherri says:

    I was on Tysabri 20 months before my neurologist pulled me off for a holiday. I was getting recurrent respiratory infections that my body couldn’t fight off right about the time I was due for another infusion. I was really scared to go off Ty because of reports that the disease would accelerate rapidly once being taken off the drug (usually after three months). I’ve been off Ty going on seven months now, and I feel great. I even went in for an MRI earlier this month and it showed no new lesion activity. I didn’t go back on any disease-modifying drugs like the CRABs, either. I started low dose naltrexone (LDN), and I’m feeling so much better!

    I agree with Lisa and Tisha. The TOUCH program is a joke. Just from reading everyone’s posts, it sounds like each neurologist does what he/she feels best in regards to diagnostic tests; there is no standard protocol, per se, that each one must follow. I had MRIs and labs (CBC & Chem 12) done every six months. I’ve never had my CD4 counts analyzed, nor have I EVER had a lumbar puncture.

    I am disgusted at Biogen for no longer disclosing their weekly PML cases like they did the first half of the year. I remember reading somewhere that the drug representatives would be informing the neurologists of any new cases after the company quit reporting them in July. Guess who informed my neurologist? ME! I have a Google alert set for Tysabri. How pathetic is that?

    Also for anyone interested, I ran across this site out of Germany. It documents the PML cases around the world. I go there each day to see if anything is new. Usually he has information on the website a full day before it hits the Internet as news. Here’s the site: http://chefarztfrau.de/?page_id=716

    It’s all about the money…

  14. Lisa says:

    Well, I am more disillusioned than ever, after reading all the posts. I’ve never been really convinced that Tysabri was doing anything for me: sometimes, I seem to be doing better, other times, I don’t notice any difference. But I too read about it possibly ‘reversing damage.’ Before I started Tysabri, my neuro suggested the other option would be to try Copaxone, as I’ve never taken it. It’s so disheartening. I’ve gone to ‘MS specialists,’ in an effort to get a second opinion and figure out what to do, but nobody will do that. My neuro didn’t want me to get anymore Novantrone (although I had not reached my limit yet), which is the main reason I went on Tysabri. As Tisha says, what the hell are patients supposed to do when their lives are so detrimentally affected?

  15. Nat says:

    Yes, the TOUCH protocol is a complete joke as some have said. I had a nurse that didn’t ask the questions before each infusion such as “have there been any changes in your symptoms?”. The nurse is responsible for faxing the answers to the questions to Biogen by the end of the day. Does anyone at Biogen even look at these forms? The neurologists are not there with you every month looking you over. If you are in a big MS clinic there is greater possibility of oversight or slipping throught the cracks. I finally wrote a letter to Biogen to complain about the lack of adherence to the protocol. But what if I had not? And then someone came down with PML because they were never asked about their MS status before the infusion.
    Regarding Biogen they are so slippery with the little bits of information the give out now. Little drips of info are always coupled with statements that PML is not as bad as you think it is and scare tactics that the disease will come roaring back immediately if you go off. That last goodie articulated by Naomi, the Biogen PR spokesperson, is false. My neuro told me that disease activity would return (if it’s going to) in 3 months–not right away.

    Biogen values dollars and the investors more than the patients. I’m going off Tysabri and looking forward to the pills that will come out mid next year. I never used to believe in the stories about the big bad pharmaceutical companies but now I do since I see it first hand based on my research and being an informed consumer of the drug I take (with what little info there is) Patients only get info about Tysabri now through “leaks” or in business reporting.

  16. Richard says:

    How ironic that this article would appear on the day we buried my sister, an MS patient taking Tysabri who died from complictions of PML. She was diagnosed as patient #14. It’s been almost 8 weeks since her PML diagnosis and we’ve never heard a peep from the drug manufacturer. Not even to offer condolences. This drug had absolutely no benefit to helping my sister’s MS and ultimately led to her death. It wasn’t the illness that killed her it was the cure.
    Believing that neurologists and their support staff are proactive on detecting PML is completely laughable. The hospital treated my poor sister for a bladder infection instead of dealing with the larger issue of her brian infection and loss of speech despite our concerns. Doing my own research I made the PML call weeks before the “official” diagnosis. That was valuable time lost for my sister’s survival. If PML infection occurs right after an office visit then it’s possible a month can go by before it’s detected. That’s way to long.
    You also failed to mention immune reconstitution inflammatory syndrome in PML recovery. A person in weakend physical health will have a very difficult time surviving this.
    I appreciate your continued coverage on this controversial drug and look forward to future developments on finding a cure for patients suffering from MS.


  17. Richard, I’m very sorry to hear about your sister. Whenever you start asking about statistics in medicine, it can be easy to forget that each case, and each death, represents a real person and family.

    Based on some of the comments above, it sounds like people want to hear more about Biogen’s disclosure practices on PML. I doubt we’ll hear much from them during Thanksgiving week, but that’s a follow-up you can expect in the not too distant future.

  18. Penny says:


    I’m so saddened by your loss. Your account sounds exactly like the kind of horror story I suspected was occurring in these cases. The TOUCH system is wholly inadequate for such an insidious invader. My cynical interpretation of TOUCH has always been that it’s nothing but a useless token, a CYA mechanism erected as the impenetrable protective legal shield of a voracious, profit-driven monster. Hearing from one of its real victims is sobering beyond explanation. Thanks for sharing.


    I start Copaxone in January. I wish you well, whatever course you pursue.

  19. Peter says:

    Sounds like the Teva sales force is here in full. Do these people understand how serious their next relapse might be and that Tysabri is twice as effective than Copaxone and the other CRABS. FWIW, I hear that a test will be available early in the new year to chack for JC virus. You can’t get PML without JC, and 50% of us don’t have the JC virus.


  20. Peter says:

    I would like to add that Biogen also sells Avonex for MS as well as Tysabri. Avonex generates almost twice the amount of revenue per patient for Biogen because they have to split Tysabri revenue with another company. Biogen are certainly not pushing Tysabri in my opinion!

    If anything, Biogen could be accused of underselling the attributes of Tysabri. They certainly have a vested interest to do so because it’s clear they would be in much better financial shape if patients decided to use Avonex instead of Tysabri.

    Tysabri is about twice as effective as other MS therapy. There is now mounting evidence that this may mean the difference between certain worsening versus potential recovery through natural healing. Tysabri tips the balance in favour of the natural healing process. It’s also relatively painless to administer and is once a month versus regular injections.

    In my view, any MS patient not on Tysabri for at least 24 months is crazy. I would then look to continue if JC negative. Otherwise look to drug holiday, PML vaccine or effective PML treatment as options.

    MS pills in the pipeline have a long way to go for many reasons.

  21. Remy says:

    Wow Peter. Contrary to what you think we are not part of the Teva salesforce. We are legitimate patients struggling with how to weigh the risks and benefits in the face of lack of transparency from Biogen. But your statement, on the other hand, sounds like it came right out of the Biogen sales handbook!

  22. Penny says:

    Thanks Remy! (Couldn’t have said it better.)


    But, I’m moved to add how audacious – and silly – you sound supposing you’re privy to events in any one MS patient’s future.

    Neither Avonex, Betaseron nor Tysabri did a thing to alter the course of my slow, chronic progressive “type” of MS.

    By all means, continue on in a bubble if your livelihood depends on it, but refraining from insulting the intelligence of those who actually have MS, and have taken these drugs only to live with the consequences of their worthlessness for our particular type of MS every day, would be deeply appreciated.

    • back2sanity says:

      I hope your still around Penny….all these drugs are not worthless, just some of us are in the 5-10% range of where the drugs don’t work because of our type of MS.

  23. Marty says:

    The Tysabri risk/benefit ratio evaluation is an evolving one. While I do not have MS, I work with and around those who do on a daily basis. The disease is personal, as are the reactions to various drugs.
    The personal nature of MS can not, however, mask the over all, very favorable results of Tysabri compared to other drugs or no drugs. One way to look at it is to measure what the risks are of NOT taking Tysabri. Without Tysabri, exacerbation rates are way higher, EDSS declines are much greater and no other drug has been able, to date, to generate the genuine, dramatic reversals of sysmptoms seen regularly with Tysabri’s use.
    For the record, I work with the largest MS practice in the world and, not surprisingly, the largest user of Tysabri in the world. Our day-to-day and real life experience is that Tysabri stops clinical declines in virtually all patients and has led to a clinical IMPROVEMENT in almost 2/3rds of the patients on it for at least 3 months.
    What prompted me to write this now? Perhaps it is a reaction to the fears expressed here in earlier comments. Perhaps it is because I just got off the phone an hour ago with a 31 year old female who 1 year ago had lost her job, was in a wheel chair, could not drive or use her hands effectively and had significant problems speaking. Today, after swithcing from [a well known MS drug] last November, she can drive normally, speak well and walk with little impairment. More significantly to her, she is back at work full time at her old job!
    This is not to diminish the PML risk or effects as they remain real, harsh and difficult to measure. However, the risk of Tysabri is frequently shouted while the benefits are, relatively speaking, spoken in whispers.
    When you look at it every day, the greater risk for many may well be NOT using Tysabri.

  24. Dave says:

    I feel with the patients that feel Biogen is not being upfront about PML disclosures but they are doing far more in alerting doctors of SAEs than any other company. Tysabri is a biologic medicine and biological therapies will product different levels of effects based on genetic background and/or concurrent therapies. Tysabri is a very safe drug as it relates to SAEs, even PML. The current risk of PML is .1%, which means that 99.9% of people are not getting PML. Considering the progressive nature of MS, that majority of the patients currently on Tysabri did not respond to other therapies and are stable/improved on Tysabri says wonders about this drug.

    There is so much negative press about Tysabri and what would you expect in a modern day drug war. Tysabri is more effective than any other MS drug out there! It carries risks associted with PML but the other drugs carry risk associated with MS progression and othe SAEs. It is a shame that this drug has gotten such a black eye. I can not think of another instance where a doctor would push an inferior drug to a patient prior to treating with the most effective medication. If my doctor told me that he had a better drug but he was only only going to use it if the drug he was prescribing for me didn’t work and I would suffer something to a MS relaspe, I would be upset at his decision.

    I understand that PML has taken the lives of 5 people and I pray for their families. However, there are many families benefiting from Tysabri treament due to the better quality of life for the patients. So, lets pressure Biogen to provide full disclosure on PML but focus on the 99.9% of people that the drug is actually helping.

  25. Peter says:

    Firstly, I would like to compliment Marty for his well-balanced and truthful comments. I direct every reader to his comments.

    Secondly, I would like to apologise to others if my own comments seemed to represent something different, but I did want to attempt to address obvious falsehoods and I guess I was angry at the time of writing.

    It’s false to claim that Biogen is benefiting from pushing Tysabri when they have a clear vested interest not to do so. Their other MS product (Avonex) is the most widely prescribed MS therapy. They own 100% of Avonex and just 50% of Tysabri. Clearly it’s in their interest, if anything, to hide the benefits of Tysabri. I’m not suggesting they’re doing that, but many others do indeed suspect that to be the case.

    Biogen will loose substantial revenue for every patient that switches from Avonex to Tysabri. They receive the full revenue from Avonex but only receive 50% of the revenue from Tysabri. Elan Pharmaceuticals invented Tysabri and still own the other half of that product.

    With respect to cost effectiveness and monies saved by healthcare, Tysabri is about twice as cheap from a cost effective point of view than all other MS therapy. This is despite the fact that Tysabri is now very slightly more expensive in real terms.

    With Tysabri, massive monies are saved in healthcare costs associated with dealing with MS symptoms. It’s the only MS therapy approved in some nations where cost effectiveness is a major consideration, e.g. the UK. That should say something to you in terms of what is the better therapy for MS!

    MS patients should also consider their own costs and the dangers associated with every MS relapse. MS is a v/serious business and should be managed aggressively. You do not want to allow yourself to progress.

    People need to make their own choices, but let’s have an honest debate. Copaxone, Rebif, Avonex and Betaseron are 30% effective against MS. Tysabri is 70% effective, and higher. It is easier to use and has less other side effects. It’s effectiveness seems to make the difference between definite worsening overtime until you could become progressive, or with Tysabri, the likelihood that you will gain ground against the disease and may even recover from MS systems altogether.

    OK, PML is scary. I would be very scared if exposed to Tysabri for greater than two years and was JCV positive. I would seriously be considering a drug holiday. Yet you cannot get PML without the JC virus, or a certain strain of this virus. There is a test coming in weeks that will be able to identify the 50% of people who cannot get PML. There is also talk of a vaccine and a treatment coming for PML. Tysabri seems very safe for at least the first two years.

    Contrary to what has been said here earlier, I believe that Tysabri has had very bad press overall and that MS patients are loosing out big time because of that. That’s all I’m trying to say.

  26. Kristin says:

    I took myself off Tysabri after my 30th infusion because of the sudden rise in PML cases and Biogen’s simultaneous shut-down of information sources for patients. My experience of Touch pretty much matches Lisa and Tisha’s. I would love to have Mary’s medical resources, but I think that’s far from the norm. My next concern is whether to go back on Tysabri. I’m concerned that there’s not enough longitudinal information about post-drug-holiday Tysabri use for long-term users, and of course, I doubt that Biogen will be of much use on that front.

  27. Larry says:

    I have had 40 infusions of Tysabri and think it is the best thing since wheat bread! I hope that they quickly come up with a blood test to determine who may have the JC virus in them. I have gone on a holiday one month on Tysabri one month off; until Biogen gets more information on the long term use. I am actually thinking about a holiday and simply taking Copaxone during the holiday!

  28. Sherri says:


    Have you looked into low dose naltrexone (LDN) while you’re on a holiday? Like I stated earlier, I was on Ty for 20 doses. I stopped six months ago and started LDN. Two months after starting it, I regained feeling throughout my body. I had an MRI done earlier this month and there was no disease progression. I’m not saying it’s a cure, but it may help keep the progression at bay. I have no plans on going back on Tysabri or any of the other CRABs. My neurologist at this time, agrees.

  29. Tisha says:

    I still don’t trust Biogen-Elan because the bottom line is they do not release any facts concerning the patients who contracted the PML and what is their quality of life. Why did they say they would not inform the ADA of new cases unless the ratio went higher than 1:1000. Who else is watching these numbers if the cases are not being released. It is also true in my case that my doctor and nurses did not know of a case that occured until I informed them. What are we to believe? This is our lives in their hands!

  30. Penny says:


    I can’t tell you how earnestly I’d hoped I’d have a wonderful story to tell about how Tysabri had significantly reversed of some of my disability – I’d have been happy simply to report no progression – but, alas, I’m not among the lucky for whom the drug produced even minor miracles.

    As we all know, the MS diagnosis covers a wide range of symptoms and comes in many “flavors.” It is often said that no course of MS is identical to another. Because no one drug is effective against all types, and some, like me, never find one that shows efficacy, I agree with those who believe MS is an umbrella for several disorders each with a different epidemiology. (And the “recovery” you described, Marty, could have been a spontaneous remission, and have nothing to do with the Tysabri.)

    Therefore, the assumption that everyone with “MS” not on Tysabri is a) missing a miracle, 2) is risking further deterioration by missing one or 100 infusions of Tysabri, is ludicrous in general, unnecessarily insensitive in its general assumptions, and downright dangerous considering the drug’s flaw (i.e., a deadly brain infection). (And to whoever threw out the low “odds,” suggesting a risk of DYING is inconsequential – please.)

    What’s also not in question is the greed and subterfuge (read “lies”) that corrupts the pharmaceutical industry in America, and Biogen is right at the vanguard of that zeitgeist. Their ABM’s seem to be anxious to get out, citing the extreme pressure to meet impossible goals.

    If each of you speaking fervently in favor of this drug is NOT a shill for Biogen, you’re all doing a remarkably good imitation of one. You’ll have to forgive us skeptics, but as an investor (in general stocks) I keep up pretty well with what’s going on with Biogen and ELAN, and the comment suggesting Biogen is under no “pressure” to sell Tysabri because Avonex is their cash cow is disingenuous at best.

    Biogen’s first dream of riches was their plan to have Tysabri prescribed with Avonex, but that dream evaporated after the first PML scare and it came back in 2005 with new restrictions that it be administered as a stand-alone.. Rebif is already causing serious erosion to Avonex’s revenues, and Avonex’s patent is set to expire in 2011. Long-held plans to tweak it in order to get the patent extended is probably Biogen’s next revenue disappointment, since the government wants to pass a new law against “evergreening,” which is the name for the way drug companies add something to alter a drug slightly and extend the patent, i.e., a way to keep the revenue flowing and cheat consumers from being able to obtain affordable generics. And now Tysabri’s under review – again – for PML, and even if it survives this review, it’s likely to come back with restrictions on usage length – more revenue loss – and the dug is already falling way short of revenue expectations and not likely to achieve anywhere near its projected revenues as long as the PML threat remains substantial. (What I’m not up to date on is the Icahn situation and who’s for sale and who’s suing who this week.)

    (And, If any of you ARE being “pressured” or paid to monitor these conversations and purposefully mislead – shame on you.)

    I advise anyone considering taking Tysabri (or any drug) to simply stay informed and be vigilant. Never take anyone’s “on-line” suggestion that there’s “nothing to be alarmed about”; there could be, not the least of which are drug companies that really don’t have the health and welfare of the trusting, often desperate patients who take their drugs on their list of priorities.

  31. Penny says:


    If you’d care to share with us the origins of your your interest in MS and Tysabri, I’m sure we’d all benefit from what seems to be your rather detailed knowledge.


  32. Chris says:

    Wow everybody. I would like to share my own R/R MS experience. I got sick in 2000, couldn’t get a formal diagnosis for 1 year (thanks HMO!) and then took Avonex for 1 year. Took myself off of it because my quality of life was so much lower on the medication. I’ve had zero relapses — but the docs are freaky every time I get a new lesion. I keep asking them to prove that the number of lesions directly correlates with my health status… but for me at least, it doesn’t. So after watching a friend die from taking contraindicated MS & seizure meds, and after watching 2 other people (including my mother) take MS drugs for so long they think the side effects are MS symptoms, I am med free — and relapse free so far. I wish us all luck, and health.

  33. Janel says:

    This is the first time I have visited this website and I am struck by the amount of information that seems to be available regarding events of PML and new stats regarding Tysabri and PML. I have not found any of this information prior to today and feel I must have been living in a vacuum.

    I have been on Tysabri for about 2 1/2 years. I did not know that perhaps the risk of PML increases with the length of time I stay on this drug. When I was first diagnosed in 2003 I was put on Avonex and stayed on it for 3 years. I was then changed to Copaxone and only managed it for 1 month because of the injection site reactions. Tysabri became available (for the 2nd time) and I was advised of the PML risk. At the time I made the decision to try Tysabri, I weighed the risk and decided quality of life was most important to me. I did not want the slow debilitation that would be in my future with MS and my greatest fear was the effects the disease would ultimately have on my family. So I took the risk and I will take it again today even with the new limited knowledge that I gain.

    I understand that money is an underlying factor for drug companies – doesn’t it have to be? Can they produce drugs and drug research for free? I don’t see a way around this. I will say, however, the the cost is certainly high and I could not afford it without insurance. My “Explanation of Benefits” that I receive from my insurance company shows that a single infusion of Tysabri costs in excess of $10,000. I do not know how much of that cost is for the drug itself and how much goes to the nurse and the infusion site. When I was taking Avonex, the cost was around $2500 for the drug. There will come a time when my insurance will no longer cover me and I’ll need to rely on Medicare and a supplemental insurance, if I can find one to cover me. If not, I will not be able to afford any treatment. That’s what is really scary! I think we need to look at all these things in their proper perspective.

    When I read that someone says they don’t feel any different taking Tysabri, I must ask “are you still having all the symptoms you were having before? And, if you are, have your symptoms continued to progress”. I was never promised that I would get better by taking Tysabri. I was only encouraged that I would experience fewer exerbations – not that it would go away completely. And that appears to be true – at least for me. Further, on the up-side, I’m not suffering from the flu-like side effects I did with the other drugs. My life style is currently good. I am mobil, can play golf (not well), but I’m independent. The only ongoing MS condition that I can see continual progression in is my short -term memory loss, and that can also be caused by other factors, can’t it?

    I’m not able to do the in-depth research that many of you have achieved, so I will have to rely on a balance of information that you researchers provide, my doctor’s advise, and my individual needs to make decisions by.

    Chris, I can understand your quality of life issues, but please re-evaluate you decision to be med free. I strongly recommend that you see a new neurologist that specializes in MS (all neurologists are not equal in MS knowledge/practices). Your relapse-free may just be your current remission. Be aware that your condition with each relapse will worsen and you may lose mobility that you cannot regain. Doing nothing can be dangerous. Find a treatment that you can live with.


  34. Matt Gatewood says:

    Hi… my name is Matt. I was diagnosed with MS 2 years ago. There are two people in my family on my wife’s side, that have MS. One is in the hospital right now because of Tysabri! They have tried everything to save him. He is on chemo treatment as of yesterday. I think the number of people who contract PML is higher than they say. Just like the number of people with MS is higher than they say. There is a reason for that. Google: The Orphan Drug ACT, introduced to Congress 1993. I do not take any of their drugs. They say MS is such a mystery. Well…disease is not a mystery. All disease originates from four things: 1.You have too many toxins in your body 2.You have nutritional deficiencies. 3. You are exposed and effected by electromagnetic chaos. 4.You have trapped mental and emotional Stress. I know I had 3 of the 4 listed. These are the only four reasons why your immune system could be weak or why genetically weak areas in the body can break down, thus allowing illness and disease to develop. I ordered my Avonex from Biogen Idec when I was diagnosed. Then I read the fine print. There was no way I was injecting Chinese Hamster ovarian cells mixed with imbulim into my body. There is a way to cure yourself! Don’t let them tell you there is no cure. You see, If people can heel themselves they are out of work. You have to stop eating what your eating. Only eat Organic. Get 15 colonics in 30 days. Don’t drink alcohol. No Sugar. No dairy. Pray everyday. Stay positive. I have read over twenty books on natural cures and alternative therapy, because conventional methods are poisonous. Your liver is burdened with toxic medication, never giving the body a chance to heal. Your body wants to remain in homeostasis. Get a PH test Kit. Get your Vitamin D levels checked. Fix those 2 things, and virtually no disease organisms can live. Read “Spontaneous Healing”, “The Makers Diet”, Natural Cures They Don’t Want you to Know About” Overall health starts in the gut. We have to restore health in our digestive systems. There are countless books on how to do this. I can go on all night. I want to help people understand that they have the power to heal themselves. My first serious symptom of MS was Vertigo. I could not walk 3 feet without vomiting. I became so dehydrated I ended up in the hospital. I did a round of steroids for five days. Then I went on a raw vegetable diet for 20 days. Instantly helped. I read Anne Boroch’s “Curing Ms”. Gave me the hope and inspiration I needed to get me where I am today. NO symptoms. Feeling great! Oh! “But your brain can still shrink, your lesions can still grow, It can come out of nowhere” BS! Not if you Stop what you are doing and change the way you are living. You may think your healthy, but there are poisons in every food off the shelf. Change your thoughts. Fill your heart with love. I am so sad! and pissed! that I have a family member in a dire situation. He had just begun to listen to me. I am trying to reach all of you. email me if you want [email protected]il.com

  35. Gael says:

    I just had my 13th Tysabri infusion today and can attest that all the hoopla about the Touch “strict monitoring system” is totally laughable. I wasn’t even asked anything and I rarely am. The poor nurses don’t really know anything at all about Tysabri or PML.

    Before I started on Tysabri, I filled out a living will stating that if I got PML, I want to be let go. Some things are worse than death. So yeah, I find it kind of misleading to make it sound like some kind of victory when death rates go down.

    And I know for a fact (not going to be more explicit here) that Biogen has been very deliberately trying to keep new cases of PML hush-hush. I think the ONLY reports or press releases they do on it are for the stock market, not for patients or their doctors. THAT makes me nervous!

  36. Lori says:

    I was diagnosed 8 years ago. I failed copaxone, avonex and after just 9 infusions I have now failed on tysabri. I must say that I have had wonderful experience with TOUCH. The nurses went through the booklet & questionairre every time I was in. In addition Biogen called me every other month to “check in”. Especially after it was determined that I tested positive for JC virus. I agree with the above statement that while Tysabri may carry a risk, I could just as easily get step of a curb and be hit by a car. In fact, it is more likely that developing PML. I loved Tysabri….after 3 infusions I started to feel better. Alas in less than a year of treatment I developed severe acute Optic Neuritis and have been getting IV steroids. An MRI showed that I had black holes and further axonal damage leading my MS doc to determine taht I was going SPMS from RRMS. No CRAB drug has been proven effective for SPMS. So, I will soldier on and live everyday as it may be my last as an independent, or seeing person. Take care everyone. I wish you all the best on whatever course of action you decide to take.

  37. Rita says:

    Our hospital allowed Biogen reps to use the conference room for a seminar on Tysabri. Two, very well dressed, well spoken, reps (professional sales people)spent about an hour extoling the benefits of Tysabri. Then question and answer time came. Of course, one of the questions most of us had on our minds was about PML. They slickly sidestepped it, and answered that they had two patients that had developed PML and they did not die. Any follow-up questions were just as slickly sidestepped. This worried us, the lack of straight forwardness felt like deceit.

  38. Linda says:

    My husband stopped taking Tysabri a few months ago. Since then he has became more depressed, irrational, angry all the time, he cannot process his thoughts, suicidal,he stutters, generallly, he is not the same person at all. I just dont think this is a coincidence.

    • Guest says:

      extreme personality changes are something which happens with both MS and PML, definitely want to get him to his specialist ASAP and you going with him. Though also many medications do have a bit of a fallout after stopping them too.

  39. gail says:

    I am a 46 year old wife and mom. I have relapsing and remitting MS, diagnosed 8 years ago. I have been on copaxone for most of the time. My nero and I thought leaving copaxone for Tysabri was my next and best step to take for my treatment. I stopped and cleared myself of all the copaxone, had my first course of Tysabri and did fine. Last week I had my second…it did not go so well. About half way in I had a horrific allergic reaction. Hives from head to toe, itching like you would not believe, couldn’t breath, crushing chest pain and extreemly red in the face and hands. I did fine because the nurses were there with me the whole time letting me know my vitals were good and talking me through it. It took about 40 minutes for everything to stop. I am seeking stories from others that may have had this happen to them…what did you do next? I see my nero in a few weeks to talk about what the next step will be. Any others like me out there? I’d love to hear any stories, it will help me figuer out what to do next…thanks, Gail

  40. Word Warrior says:

    I notice that that many assessments of Tysabri avoid the fact that people who develop PML and survive ALWAYS have some amount of brain damage from it, frequently cripplingly so.

    I’ve been on Tysabri four years (worth the risk to me due to cognitive decline) and if i get PML, I PREFER death to such a state, and suspect I’m not alone in this.

  41. deniseb2 says:

    When I had RRMS I was taking Rebif, then several exacerbations later my neuro put me on Copaxone, but I quickly became secondary progressive, so there were no drugs to help me other than symptom management. I went on disability in Spring 2009. I went to California for CCSVI treatment in May 2012 and it was like someone flicked a switch from ‘sick’ to ‘healthy’ I returned to work and at my last 2 appointments with my neuro he has said my SPMS is now “Stable”, and we all know that is supposed to be impossible! No Tysabri and brain infections for me, thank you very much!

    • Douglaschase says:

      Sounds like my story except Aveonex stopped working. Haven’t started Tysabri yet and still on a medical leave from work. Hopefully story ends the same.

  42. Lynne Heal says:

    Prolonged use of any MS drug is deadly

    • back2sanity says:

      Says who?

        • back2sanity says:

          Lynne, that is a great article, and this information is prevalent, but it still doesn’t prove that prolonged use of any MS drug is deadly. I think that statement is your opinion. MS is deadly, and debilitating. There are a lot of people out there that would take death over being completely succumbed to this disease. There are definitely side effects that can affect each individual, but you can scare yourself to death by reading all that information. The truth is that most of these drugs don’t have that terrible effect on most users. I have researched and talked to Dr.’s that treat MS, and the science behind the diet just ins’t there. I absolutely believe it helps without a doubt. I have had stomach issues for years that I could get no diagnosis on until my MS diagnosis this year. I changed my diet to basically what the article suggested about18 months ago, and I went gluten free, and my stomach issues got much better. I do still take in a little sugar (it’s hard to give up). I currently take Copaxone, which I’ve done well on. I went to a specialist and she suggested Tysabri because I have lesions on my spinal cord. It is scary thinking about getting a viral brain infection and being paralyzed, but the reality is that Tysabri has a 80% success rate in managing and even reversing some of the MS symptoms. I’m in a good place right now, so I’m probably not going to take this medicine, but if the disease progresses, I will. Just like everyone reacts differently to MS, so they react differently to the drugs. Some of these have transformed lives, and to say that prolonged use of MS drugs are deadly is just not the full truth. When I started Copaxone I spoke with a guy that has been on the medicine for 17 years with no issues at all. It gave me hope.

          • Lynne Heal says:

            I know lots who have died in my hometown drugged up on MS drugs http://www.family-announcements.co.uk/localworld/view/1490466/julie-wingfield and I have lost many friends to MS who all die din their 30s and 40s. I have had MS for 43 years NO MS drugs ever to slow MS down and lived longer says a lot to me

          • back2sanity says:

            I wouldn’t really call an obituary proof. I’m glad you have lived so long with MS and no treatment. Have you ever though that MS is different for everyone, and that maybe your just one of the lucky few?? My aunt has it and has been living with it for 3 years since she was diagnosed. She is starting treatment because the symptoms are getting to be too much. For many, they would rather live a while with quality of life rather than a long time with suffering.

          • Lynne Heal says:

            Read she was on a lot of medication please

          • Lynne Heal says:

            I worked many years even 70 hours a week with secondary progressive MS and kept myself active

          • Lynne Heal says:

            How dare you talk to me like that. I nearly died in 2010 with MS complications and have had to live with words of you can die any day since 2009 . I am NOT lucky at all and lost best friends with MS take notice of this video on drugs and wake up .https://www.youtube.com/watch?v=AazObF_pHSU

          • back2sanity says:

            I wasn’t trying to be disrespectful. I’m just trying to understand. I’m currently taking copaxone and a specialist recommended tysabri because I have lesions on my spinal cord. I was told these lesions are the ones that cause disability more quickly. I’m just trying to understand the science behind what your saying. An obituary and one article aren’t enough proof to me. I’ve read tons of articles like the one you recommended. I’ve also read a lot of articles that have positive results from taking these medications.

          • Lynne Heal says:

            You are a TROLL

          • back2sanity says:

            Thank you for your positive insight from a grown man that was recently diagnosed with multiple sclerosis. I hope your infinite wisdom can help others in the future with this debilitating disease. Your a true inspiration.

          • Lynne Heal says:

            Yet I am abused lots online classed as disabled hatered which is an offence many are doing online because I .speak truths hopefully when someone checks all the IP addresses of those that have done all this to me things will change and that’s whats needed

          • Lynne Heal says:


      • Lynne Heal says:

        Here is someone who died drugged up with MS from where I live I know what am talking about http://www.family-announcements.co.uk/localworld/view/1490466/julie-wingfield

    • MicheleAnn Slater says:

      And how do you figure that?

  43. phil joshua says:

    I discovered I was HIV+ in 2004. I was devastated and ashamed. But today I have learnt so much about HIV in my life. Since I started working in 2005 and had a medical aid from r Odia with the help of his herbal herbs, I checked my CD4 count every 6 months. To my GP’s surprise, it stayed between 532 and 528 all these years. I am not doing anything different and I don’t know what I’m doing right to stay with dat count on CD4 this long. I don’t disclose my status at a go but I insist on protection. Though the partner who accepted my + status dumped me for unknown reason, I still stay positive with life. I don’t see death sentence with HIV, but I see life to be lived to the fullest. People die everyday in different ways, I will die but I know and positive that it will not be by HIV as I look after myself and the people around me. I want to go open with my status especially my family, but I’m scared. I’m still gathering strength, one day I will. Come what may, I will still have my life to live and enjoy.
    My mother wont accept his lobola, the rest of the family just wont speak to me, even about my future plans. It’s been tough but i have this firm belief that things will be ok. The worst part is that I come from an “educated” family and I thought that they would understand, Im embarrassed by how they’ve become, it’s a shame. I know they feel they are protecting me, but they’ve also lost my trust somehow.While they see disgust in me, I see someone who’s protected me throughout my pain, i want you out there to know that it never a shame to be infected with HIV positive but the shame is when you know and didnt do a thing about it.
    Dr Odia is really a great make and bless with roots and herbs, I want to advice everyone with HIV to contact him Via ( [email protected] ) for the cure.

    I really hope your efforts to curb the spread of this virus will penetrate through these young minds,so that they make better and wise choices for themselves.

    For those who are already infected, they could learn a thing or two from you!

    Contact him: ( [email protected] )….