Saturday, March 27, 2010

MS Study Blatantly Driven by Financial Concerns, Not Patient Welfare

337/365: The Big MoneyImage by DavidDMuir via Flickr

This is the kind of thing that really gets me pig biting mad. The beneficent overseers of Biogen, makers of Tysabri, announced the commencement of a study (click here for details) that will test the effectiveness of its blockbuster drug vs. two rival medicines.

The study, which will involve 1800 people in 27 countries (wonder how much that will cost?) will pit Tysabri against Rebif and Copaxone, two drugs that have already been shown to be less effective than Tysabri in reducing relapse rates and the appearance of enhancing lesions on MRI studies.

According to the press release, "A significant number of MS patients continue to experience clinical relapses and disease progression despite treatment with disease-modifying therapies such as Copaxone and Rebif. The SURPASS study, a large, well-controlled comparative trial of MS treatments, will evaluate switching to TYSABRI versus staying on or switching between Copaxone and Rebif and determine whether early use of TYSABRI in the treatment algorithm ultimately leads to better outcomes".

In plain English, the study will prove that Tysabri is more effective than Copaxone and Rebif, which is something that we already know (previous studies have shown Tysabri to be about twice as effective as the other two drugs), in the expectation that these results will lead neurologists to prescribe copious amounts of Tysabri to their patients earlier in their disease course. Of course, I'm sure the study results will skirt around the fact that neither Rebif nor Copaxone have potentially deadly side effects, while Tysabri has been linked to the deadly brain infection PML, the danger of which appears to increase with the length of time that Tysabri therapy is continued.

Rebif and Copaxone are immunomodulators, which leave the patient’s immune system intact, and try to redirect it from attacking the patient's own nervous system. There side effect profiles are relatively benign; Rebif leaves some of its users experiencing flulike symptoms, and Copaxone can sometimes induce a short but frightening allergic reaction after it is injected. Tysabri, on the other hand, is a targeted immunosuppressant, profoundly affecting the workings of the human immune system. Granted, the incidence of PML is small, but comparing Tysabri to Rebif and Copaxone is like comparing a howitzer to a handgun.

Please don't get me wrong, Tysabri has been an extremely effective drug that has benefited many, many patients, some of whom will testify that Tysabri dramatically changed their lives for the better. I am not "anti-Tysabri", and in fact, in the fall of 2006 I was on Tysabri, but received no benefit from the drug. My point here is that conducting this massively expensive study will do nothing to advance our understanding of Multiple Sclerosis, nor bring a cure anywhere closer to fruition. This is merely a marketing ploy, an attempt by Biogen to take a bite out of the market shares of Rebif and Copaxone. Might these research funds not be better spent in, say, actually trying to find the cause of Multiple Sclerosis, or to at least develop more effective drugs with less potentially deadly side effects? Apparently not, as it will be more cost-effective for Biogen to simply prove that which has already been proven for PR purposes, rather than do some actual, groundbreaking scientific research.

The obsession with suppressing the immune system of MS patients must stop. I've said this before, I'll say it again, and I'll keep saying it until the jolly men in the crisp white coats throw a net over my head and drag me away to a rubber room, but an aberrant immune system is a symptom of the disease, not the cause of Multiple Sclerosis. Treating MS by suppressing the immune system is almost like treating a broken leg with painkillers. Yes, the symptoms subside, but the underlying cause of those symptoms is left entirely unaddressed. The current assortment of MS pharmaceuticals have definitely improved the lives of countless MS patients, and I am certainly not anti-MS drug. Lord knows, I've been on most of them. Unlike painkillers treating a broken leg, the MS drugs do significantly alter a patient's prognosis for the better, but they do nothing to combat the as yet undiscovered cause of Multiple Sclerosis. I find it incredibly frustrating that billions of dollars are being spent developing drugs to treat MS without actually attacking the disease at its core.

It's high time for neurologists and MS researchers to end of their love affair with the autoimmune theory. There is mounting evidence that the immune response that is now thought to be the cause of MS is actually a secondary phenomenon, and that there is an unknown mechanism killing nerve cells well before the immune system gets involved. A recent study (click here for the abstract) by an Australian MS pathologist and his colleagues examined autopsy brain tissue of 15 deceased MS patients, and found that nerve cell death precedes the involvement of the immune system, which appears to be activated by the damage that some unknown entity is doing to brain and spinal cord tissue (click here for an analysis of this study, provided by The Accelerated Cure Project).

We don't know what nasty process is killing off the oligodendrocytes of MS patients, but studies like the one above show that it most likely is not the patient's own immune system. The cause could be CCSVI (click here for more info), it could be infectious, it could be genetic, or it could be a combination of factors coming together to form a deadly storm of brain cell toxicity. We'll never know, though, as long as research monies are spent to benefit pharmaceutical companies rather than the patients who are beholden to their products.

I think a few of my brain cells just exploded while I was writing this post. Maybe the real cause of MS is the asinine research that is purportedly being done to help patients, but is really designed to line the coffers of the companies conducting that research with cold, hard cash.


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  1. So let me get this straight. Biogen wants to prove the superiority of Tysabri over interferon beta-1a (Rebif made by Serono) but undoubtedly wishes to continue to sell and promote the consumption of interferon beta-1a (Avonex made by Biogen)?


  2. Wow, thanks for all the info. I'm trying to decide what drug to try next and Tsyabri was in the running but I'm more tempted to just let my body be. Great research.

  3. I have to totally agree with you, Marc. Although, you put it into words better than I ever could.
    Money is the huge powerful evil. I feel like we as MS patients have huge dollars signs on us and I find that extremely sad. This "new" study has already been proven and seems rather repetitive. The money going towards this study should definitely be going towards discovering the cause of MS so a cure can be found.

  4. Weeble-you'll notice that Biogen is testing Tysabri against Rebif and Copaxone, made by rival companies, rather than its own Avonex, which, as you so astutely point out, is pretty much the same drug as Rebif. I'm sure Biogen will have some convoluted reason why Avonex, despite its comparative lack of efficacy compared to Tysabri, should remain a frontline drug. Certainly you remember that during the initial Tysabri studies, Biogen attempted to show that the combination of Tysabri and Avonex was better than Tysabri alone, only to prove that the two were a potentially fatal combination. Oops.

    briana-please, don't let me scare you off of Tysabri. I'm not anti-MS drug, as the available drugs have immensely improved the quality of life of those patients that respond to them. The CRAB drugs and Tysabri have revolutionized the treatment of MS, by at least providing a treatment, as before the interferon drugs were introduced in the mid-90s, MS had no proven treatment options. Tysabri has improved the lives of thousands of MS patients, and the risk of PML is slight. My point is more that studies like this, done for marketing purposes, distract from the real problem at hand, actually finding a cure...

    Desinie-we have unfortunately developed a medical industrial complex in this country that thrives on treating patients with outrageously expensive drugs. I really can't blame the pharmaceutical companies for doing what they're supposed to do, which is to make a lot of money. Like any other company, their bottom line is the price of their stock, not the benevolence of their products. Unfortunately, good economics often makes for bad medicine.

  5. Too many years spent chasing the ghost of autoimmune is a convenient catch-all for so many disorders including MS. It is time to move on to finding the cause. Researchers are falling over themselves studying the same issues with no positive revelations. With MS on the increase, LOOK SOMEWHERE ELSE.
    Right on, as usual, Marc.

  6. The phrase "beating a dead horse" keeps crossing my mind. Tysabri, Rebif, etc. etc., nothing helps this red-headed PPMS orphan child of MS. Look at me!!! look at me, I want to scream. No wonder people go Anti Big Pharma. All I get is Anti pee meds and puppy-uppers (Amantadine). When I'm dead and gone, the generations to come will look back and laugh at the ignorance of this one with MS.

  7. The problem lies in the fact that the pharmaceutical industry has by and large bought the acquiescence of the medical community, and patients are paying the cost. Here are just two articles and The editor of the New England Journal of medicine writes regularly about medical corruption.

    The problem is grossly compounded by the fact that the senate has been bought, lock stock and barrel, by big pharma and the insurance industry. I agree with what all you say, Marc, but how the problem can be resolved when 'campaign contributions' [bribes] outweigh patient care is anyone's guess.

  8. AMEN! Thank you for sharing. Just discovering your journal.

    Caregivingly Yours, Patrick

  9. I was formally diagnosed with PPMS in 1976, but the doctor said "Don't be too worried we're right on the verge of a cure." Well it's 34 years later and not only no cure, but still no understanding of cause. Other than a course of IV ACTH in the very beginning I've never done any of the parade of the next great drugs for MS. All too risky in my opinion .... corticosteroids, powerful drugs used in cancer therapy and now the Immunosuppressant drugs. Since I've also been battling cancer, the last thing I want to do is suppress my immune system!! During these same 34 years I've watched Capitalism progressively run amuck with concern for money pushing all other values down the priority list. So hey, I'm open to a cure or some significantly beneficial treatment, but I don't dwell on it daily. My commitment is to live the best I can with a daily effort to recognize, and be grateful for all the quality I still have ... and it's plenty! But isn't this everyones task regardless of circumstance?

    very best, Barry

  10. Marc, I so, so so-o-o agree with you. I've been harping for so long that we'll probably never learn the cause of MS, nor will we see a "cure" for it. As long as "Big Pharma" rules the roost, their money will squelch any studies for either. [For example furthering the study of CCSVI.] I'm so glad you've discussed this issue.

  11. My previous Neuro is being paid by Biogen to give talks on "living well with MS". (what a joke!) They are in high gear promoting their drugs.
    CCSVI is making them nervous. I'm going to attend this "talk" and question him about CCSVI!

  12. Read your post this morning, left the house laughing and returned the same way, "pig biting mad" for sure. Maybe if Nike would jump in there, they could solve this thing. At least they've got the financial incentive to cure it since they'd sell more tennis shoes to MSers who can still run and walk. Wouldn't I love to see the medical industry eat that!

    AMF Adventures

  13. Preach on, Brother Mark. Just out today, from the WSJ reporter who spent three weeks interviewing us, promised me he'd "break the CCSVI story", only to do another hatchet job on Dr. his blog today.

    Coincidence? A study at Stanford regarding beta coming out less than a week after the "other" Stanford story. hmmm.

    It won't be easy, but we need to keep asking...what starts MS?
    your bud-

  14. Great post, Marc. I think a few of my brain cells exploded reading it :) Hope there will be more research into root causes instead of symptom treatments (that often don't work). CCSVI seems like a promising piece of the puzzle, and maybe things will move in the right direction for the ultimate 'fix'. I'm hoping... prairiegirl

  15. Big Pharma and insurance companies exert a great deal of influence in the research of MS in the United States but what is going on in other countries that have universal health care, i.e. England, France, Italy (CCSVI is all I know there) and Israel?


  16. I like the idea of Nike getting involved. I think we would all pledge to buy their shoes, as would our caregivers, families and friends. :)

  17. Great post, I know big pharm controls a lot more than MS societies or my MS clinic will ever acknowledge or admit to. Having said that, you're right that these drugs have had a huge impact on the course of disease in many people. I've been on most of them including Tysabri which i am just about to start again after a 2 year break. I am also being treated by Dr. Sal in early June so I'm now thinking I might reconsider the Tysabri decision. My insurance co. will pay for the drug but won't offer any financial help for the liberation procedure...go figure!

  18. It was not just your post that made me think twice, it was also the article in the Seattle Times about the lasting damage done that does not stop when you quit the drug. I read the WSJ article as well. I was excited to see CCSVI in the paper, but disappointed they only featured the two worst-case scenarios. Where can I find more information on the Australian doctor and his work, or any research that happens in response to it? How/where do you get your information? It is hard to cull the internet every day to find things, and sometimes I don't know where to look. I always check here first so thanks for all the work. I see how you got your award.

  19. Hilda-I think more and more neurologists are coming around to the realization that autoimmunity is bunk, but so much money is being derived by treating MS as an illness of the immune system that there is an almost unstoppable momentum about it...

    kicker-I hear you. PPMS has been ignored by researchers simply because it is so difficult to figure out if a therapy is working or not. Much easier to count relapses and enhancing lesions, so that's where the money goes...

    WW-I agree with you, the problem seems intractable. What we have is the corrupting influence of mega dollars that is strangling both our political and medical establishments. What to do? Your guess is as good as mine...

    Patrick-thanks for your note, I hope you get some value from my blog...

    Barry-as a regular reader here, I know that you are aware that I share your commitment to staying in the moment, and doing the best you can with the hand you're dealt. Still, it is maddening to see so much time and effort wasted on amassing wealth, when it could be put to use for the betterment of mankind.

    muff-I plan on discussing this issue more, as our medical practices have been warped by blockbuster drugs and hyper expensive diagnostics and therapies. The sad part of it is, the drug companies are doing exactly what they're supposed to do, make lots of money. What's gotten lost is the fact that sometimes what's good for the investor is not good for the patient.

    Anonymous-I'd love to be a fly on the wall for that one. Please report back with the response you get. Good luck...

    AMF-well, as Nike would say, just do it. Glad I could make you laugh, hope I made you a little angry also. It would be great for some benevolent source of funding that didn't have any "skin in the game" would take the bull by the horns and start curing some diseases. Bill Gates? The(gasp)government? At this point, I couldn't care who did it, as long as some attentions were being redirected...

    J.-well, the Wall Street Journal is now owned by Rupert Murdoch, so blatant corporate meddling is only to be expected. There are no independent news organizations left in America, a huge, and potentially fatal, problem...

    Prairiegirl-I have high hopes that CCSVI it will at least prove to be a major part of the puzzle. At the very least, it's getting some researchers to tear their attentions away from autoimmunity, which can only be a good thing...

    Aarcyn-the fact is that medical research is so expensive that it is primarily funded by private corporations these days. Many of the world's governments are broke, in all forms of the word.

    Anonymous-the least people would have footwear for the MS walks if Nike were involved...

    Lee-sorry that your insurance company won't pay for your "liberation". Different insurers are reacting differently to the procedure, some are paid for without question, others absolutely refuse. We're very early in the game, here, and much has yet to be decided...

    Briana-if you look under the "popular posts" list on the left side of this site, you'll find two blog entries called "MS on the Internet" and "More MS on the Internet". You'll find lots of sources for MS news and info in those entries...

  20. and just to put in my two cents

    i hand an allergic reaction to Tysabri. not the usual hives, but a full blown anaphylactic shock, and if i had not been in the hospitle, i would have most likely died.

    just saying my expereance, that came from being off it for 4 years.

    (i had one treatment of it b4 it was pulled from the market


  21. I found another article on Dr Prineas' work. It was dated 2004! And why have we not heard about before? I can't wait to ask my neurologist his thoughts. He is pretty even keeled and will discuss any new bit of information I bring up.

    Here's the link:

  22. Marc, you're spot on when it comes to researchers treating the symptoms, not the cause of the disease--but the reality is that this is the modus operandi for all diseases, really. What diseases have we actually "cured"? None, really, but instead patients with chronic disease manage to stretch out their life with cocktails of uber-expensive drugs that only target the symptoms of their ailments. This type of shoddy research is the rule, not the exception. Researchers focus on finding "Therapeutic targets", not *cures*.

    and yeah, the autoimmune/immune suppressant business blows my mind too. Yet even the biggest names in MS research who are supposed to be on our side, don't bark anywhere but up the wrong tree. Sigh....

    -ms mama

  23. Marc, thank you for saying this:

    "The obsession with suppressing the immune system of MS patients must stop. I've said this before, I'll say it again, and I'll keep saying it until the jolly men in the crisp white coats throw a net over my head and drag me away to a rubber room, but an aberrant immune system is a symptom of the disease, not the cause of Multiple Sclerosis. Treating MS by suppressing the immune system is almost like treating a broken leg with painkillers. Yes, the symptoms subside, but the underlying cause of those symptoms is left entirely unaddressed."

    I could not agree more. I do everything I can to boost my immune system, now that I've tried it "their" way and it didn't work. Why in heaven's name would I want to weaken my defenses against disease? My immune system was designed by God to heal me. I want to do everything I can to nurture it and cheer it on. I personally think the immune system is being wrongly accused. I think it goes in to mop up somebody else's damage (perhaps CCSVI) and the scars etc. are left behind. But what do I know, I'm just a cheerful person who refuses to feel sorry for herself. I go to the doctor to find out how he's doing, not the other way 'round. Cheers and blessings to you from another wheelchair warrior!


  24. Marc,Interesting post, esp the link to the Australian study. Makes me hesitant to follow the neuro's suggestions, esp since he's a provider of us guinea pigs for clinical trials for meds like the oral drugs coming down the line (which I think he's going to suggest I join...gulp).I've been on Copaxone for over a year, and the symptoms have gotten worse. I don't want to end up in a chair (even though you make it look so exciting) is difficult enough getting up and down the crappy stairs in this house without hoisting up a chair (just kidding).I hate this stupid disease...wish these researchers would get their acts together and figure this thing out.Thanks for all you do for the MS community!Debbie D

  25. Marc, the argument has passed it's sell by date. We are not fighting the theory, they understand it, we are fighting for media attention as you are well aware.

    Here is my understanding from an athletic background...

    It is my sister who has MS (UK scan in August), my knowledge is somewhat limited so I hoped I could approach this with a blank canvas.

    I tried to keep to the facts as I saw it. I would appreciate if you have the time to have a quick look over it, possibly correct some of the flaws & maybe even kick-start another one of your explosive articles.

    Keep up the great work.


    (PS. Please don't post this as a comment - I am just lost at the moment after the poor No.10 Petition response - recharging my batteries as I predict this is going to be a long dirty battle)

  26. lets take those same 1800 and do a Messenchymal stem cell trial?! Safer, more effective, and could help millions more people with or withous MS...I share your frustration...The tysabri camp continues to grow. I am happy for those that it helps believe me. I just would rather infuse some of my own Stem cells.
    The Greek

  27. Marc,
    You are so special and I want to thank you for all the wonderful information you give us! It is all so clear after reading your blogs. Keep it coming! Your an inspiration!
    The Greek's better half :)

  28. Marc,
    Thanks for such a wonderful blog. This post really caught my eye. I was diagnosed with RRMS a year ago. I tried Rebif for 4 months, and got back-to-back flairs and then each shot gave me hives. I started Tysabri in February, and I know it's supposed to take a few months to see results, but I still havent recovered from my last flair last November. I'm a fingerstyle guitarist and I had to quit performing, because I can't play for more than 20 minutes without my arms either falling numb, or my fingers just don't "fire" as fast as my brain tells them to.

    The whole autoimmune angle fascinates me. Thanks for the Australian study link!

    I'm going for a 2nd opinion at UCSF's MS center. I really don't want to be on Tysabri, but I feel like I'm progressing. I'm not sure what to do next. I'm open, but I'm also really pissed off with the whole situation - mine, yours, the $$$ angle, and everybody else who suffers from this MiSunderstood MonSter.

  29. Our government's suppression the truth about the beneficial use of cannabis for suppression of MS symptoms is a disgrace and medical scandal. Big Pharma throws a lot of money behind whatever "study" it can fund or "expert" it can pay off. "In view of this control and the conflicts of interest that permeate the enterprise, it is not surprising that industry-sponsored trials published in medical journals consistently favor sponsors’ drugs—largely because negative results are not published, positive results are repeatedly published in slightly different forms, and a positive spin is put on even negative results" ( The best medication for MS is not any pharmaceutical drug at all, but a simple, formerly common, herb which is now pejoratively called marijuana. Total U.S. sales of multiple sclerosis drugs exceeded $5.9 billion last year, so is it any wonder Big Pharma invests so heavily to deprecate cannabis. Try the herb. You may find that, like me, you are much better off.