MS Study Blatantly Driven by Financial Concerns, Not Patient Welfare

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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.

Ugh.

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• FDA warns of brain risks with frequent Tysabri use (seattletimes.nwsource.com)