Tuesday, June 30, 2009

Multiple Sclerosis- Tysabri - miracle drug?

Biogen, the manufacturer of Tysabri, saw its stock fall this week when 3 people taking the medication for Multiple Sclerosis, recently, came down with a potentially deadly brain infection called "progressive multifocal leukoencephalopathy", or PML. This was a disappointment because Biogen had hoped to make its mint off Tysabri since its other drug, Avonex has a lot of competition from similar drugs like Rebif. Biogen apparently is already doing damage control with a video on Fox news promising great results for the medication.

But if we listen closely, even the video tells us some rather unsettling things:

  • How it works: this medication prevents immune cells from crossing into the brain (probably why it can cause that severe brain disorder - how many OTHER brain disorders can it cause which may not have yet, been connected to tysabri?)

  • The patient said it was nice she didn't have to do daily or every other day injections like with the other medications she had tried, but the picture of how Tysabri is administered was quickly flashed with no explanation. It is INFUSED which is done in the oncology ward - an outpatient procedure in the hospital which comes with some issues of its own.

  • Tysabri gives many patients a 70 percent improvement in symptoms said the video - but remember the placebo effect with MS is 85 - 90 percent (i.e. 85-90 percent of MS patients get better even if given sugar pills!) so that means not only is Tysabri NOT effective but since it doesn't even match up to the placebo effect, it must be making some patients worse.

Because several in the Tysabri trials also got PML (2 of whom died which is really bad because Multiple Sclerosis does NOT kill its victims), the medication was shelved by the FDA in 2005 pending more research. However pressure from several including a couple of celebs who wanted to take the drug and probably Biogen, caused the FDA to conditionally approve it the following year with a warning label.

And unfortunately many people with MS who are desperate (and feel they would rather be dead than totally paralyzed) flock to DO SOMETHING, take SOME medication even though with NONE of the MS medications is anything like a "cure" promised. The available drugs are called "disease modifying" which in plain English means it MAY make your symptoms better (but no guarantees), something we are hearing more and more often from the medical profession which no longer promises to "first do no harm".

The truth about the slowly progressive MS (which is the only type the medications are supposed to help) is that if you live healthy, do not smoke or drink, do NOT take any drugs or have any surgery for it and get your head together, reduce stress and other healthy things, MS will likely not progress to the point of causing much disability until you are VERY elderly (if at all).

One study by the MS society found that 10 years after diagnosis, the majority of MS patients were still walking and medical treatment of which the side effects are worse than the disease, has traditionally been that which causes early disability as do bad health habits like smoking, party drugs etc. (Note: this study was long before the so called "disease modifying" drugs many MSers take now)

When Sylvia Lawry was alive, and president of the MS society (which she founded - her brother had MS) the society was not real well funded and did not advocate any medical treatment, repeatedly assuring members that the best treatment for MS was good nutrition, good health habits and "some walking, some sitting, some standing and some lying" (i.e. rest periods during the day).

And as many folks who got sick from medical treatments, people still flocked to each new one. There was for example, the Medrol treatment which initially lightened symptoms but in the long run made patients worse and caused tuberculosis in some,and surgery like stereo-tactic brain surgery which Annette Funnicello had - despite the fact that it was condemned as a too risky not effective treatment for MS tremors at the 1972 symposium for MS at UCLA. There were the less risky quack treatments also, like the guy who sold small trampolines and said if you jumped on them facing east every day, the earth's magnetic field would cure your MS.

But when Lawry died, the MS Society took a different turn, perhaps one which Lawry would NOT have agreed with and formed alliances with several pharmaceutical corporations which yielded them millions of research bucks, and bucks for glitzy monthly magazines but had the down side of causing patients to be "strongly encouraged" to buy the medications from the pharmaceutical companies, most of which had not even been tested on diagnosed patients (they were tested on people who were thought to be coming down with MS) and were not shown very effective. (why they call the drugs "disease modifying").

I once asked one of the researchers why no "double blind studies" had been done on the medications offered for MS and he said "well, because they do show improvement in patients, it would be considered unethical to deny the controls the help." Sounded lame to me. Especially as the "improvement" is judged by the number of white patches in the brain which show on the MRI which are thought to be MS related, but the doctor admitted that these can change by the hour and one patient having a lot of white patches in one MRI could have several of these move or disappear in the next MRI. He also admitted that the white patches seen on the brain could be NON MS related.

All seems a bit of a house of cards to encourage patients to put a chemical into their bodies which is known to challenge the immune system thus making them more susceptible to illness INCLUDING cancer.

As shakey as the research was on the so called "ABC" drugs (Avonex,Betaserone and Copaxon), Tysabri was a different case because even their less than great research found the deadly repercussion of PML. (Other side effects include flu like symptoms, infusion-site reactions, fatigue, headaches, joint pain and Increased Susceptibility to Infections.)

It might be prudent for MS patients to rewind back to the society's advice before their marriage with the pharmaceutical companies - live healthy, de-stress and don't overdo - still the best "treatment" for Multiple Sclerosis.

It seems that only miracle about Tysabri is how MS patients flock to take it!

NOTE: a certain number of people diagnosed with MS may be actually suffering neurological symptoms from other disorders including aspartame allergies and/or B12 shortages. Newly diagnosed patients should quit drinking diet soda and other things with aspartame/nutrasweet in them and also consider taking B12 supplements or even B12 shots.

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