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MS Wonder Drug Questioned Before Approval

When I shared the news with you that Tysabri -- that so-called "wonder drug" for multiple sclerosis (MS) -- had been pulled from the market Monday by Biogen Idec and Elan Corp., I suspected there was more to the story than was being first reported. Particularly when a patient dies unexpectedly of a rare disease like progressive multifocal leukoencephalopathy (PML), a central nervous system disease usually seen in AIDS patients.

There were certainly enough warnings about Tysabri. One Stanford University professor and a MS expert had repeatedly wrote about the potential for serious side effects involving the immune system with this kind of drug. This expert ought know the risks, considering he had spent part of his career developing MS drugs. And his warnings came long before an cautionary editorial published in the New England Journal of Medicine (NEJM) two years ago.

It's unknown whether the FDA listened to any of those concerns, especially when they fast-tracked Tysabri to market under an accelerated program for "breakthrough medicines" that the agency views as offering extraordinary benefits to patients. But that was after a Phase II trial in which a relatively small number of people taking the drug were studied for six months. Not too long after that, NEJM reported, "firm conclusions about safety must await the results of much larger" studies.

Even more telling was a report in USA Today in which three Biogen executives sold hundreds of thousands of company shares in the two weeks before Tysabri was withdrawn from the market to the tune of about $10.5 million.

Stories like these are very upsetting to me, particularly when patients would have been far better served by a therapeutic approach that treats a condition, a crucial part of my vision for the future of health care -- rather than taking a "miracle drug" that allegedly cures it.

Los Angeles Times March 2, 2005

USA Today March 1, 2005

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