An important, timely, and on-target editorial from today’s edition of the Washington Times. Attention must be paid.
Today, an advisory committee to the Food and Drug Administration will review information and hear from patients about whether to permit a medicine for multiple sclerosis called Tysabri back onto the market after a year’s absence. The FDA approved Tysabri in November 2004 after only year of clinical trials.
The agency did so because the drug worked extremely well in stopping what are known as “relapses,” a diplomatic term for describing the loss of memory, the inability to walk and permanent disability that occurs when the protective insulation of the nerves necessary for healthy brain function, and then the nerves themselves, are slowly destroyed. And compared to other MS drugs, Tysabri appeared to have few side effects.
Last February, Tysabri was voluntarily withdrawn from the market after someone taking it in combination with Avonex, another MS drug, died from progressive mulitfocal leukoecephalopathy (PML), a rare neurological disease. Another patient suspected of having PML at that time was later confirmed. An exhaustive study of all patients who took the drug found no new cases of PML. Overall, there is a 0.1 percent risk of contracting PML if you use Tysabri. That’s half the risk of dying from aspirin. Meanwhile, MS causes about 53,000 relapses yearly and 5 percent of relapses cripple or kill their victims.
Too often, in the wake of Vioxx withdrawal, pundits have ignored the health risks of not making a medicine available. Those risks cannot be ignored in this case. All the information about Tysabri’s benefits and risk are available. A plan is in place to reduce risk further and determine the best treatment strategy for every patient. MS patients have taken a page from HIV/AIDS activists and are descending on the hearing en masse. Their message: Our lives, our choice. Let’s hope the FDA and its advisory committee listen with open hearts and minds.