Patients Beg FDA For Access To MS Drug


Multiple sclerosis patients are begging the U.S. Food and Drug Administration to allow the drug Tysabri back onto the market. The biotech companies Elan and Biogen pulled the drug when 3 patients in a 7000 patient drug trial came down with progressive multifocal leukoencephalopathy, or PML.

One 36 year old patient, Heather Smith, told an FDA panel, "I know Tysabri worked for me when all other MS drugs failed. Each patient has the right to make their own choice." Earlier drug trials indicated that Tysabri is perhaps twice as effective in delaying the progression of MS than are older drugs. However, it is estimated that 1 in 1000 MS patients would die of PML induced by the drug. This compares favorably with an American's lifefime odds of 1 in 228 of dying in a car accident.

The drug companies propose to register and closely monitor all patients who take Tysabri. Such a system essentially becomes a post-market drug trial which should become the model for future drug approvals.

Disclosure: I have owned 100 shares of Elan and 100 shares of Biogen for many years. The benefit to me of an FDA approval pales in comparison to benefit that suffering MS patients would get.