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The FDA and MS
Wall Street Journal, 4-7-06

The Journal takes issue with FDA reluctance to allow the multiple sclerosis drug Tysabri back on the market despite demands from patients and a wealth of evidence that the drug provides powerful benefits to its users.

Tysabri...for many MS patients…appears to halt progression of the degenerative neurological disorder. But a year ago—just months after it was approved—corporate partners Biogen and Elan "voluntarily" withdrew their drug because of FDA pressure and litigation fear after two patients developed a rare brain infection. That infection might have been linked to Tysabri, since the drug works by suppressing parts of the immune system. But these patients also had other immuno-suppressive therapies, and in any case the MS patients were almost all willing to run the risk.

Just a few weeks ago prospects were looking better for [one MS patient, Audrey Greenfield]. She and scores of other MS patients had made their voices heard at an FDA advisory panel, which voted unanimously to return Tysabri to the market. The agency was due to rule on the issue by late last month.

But shortly before the deadline, the FDA announced it would take a 90-day extension until the end of June because of concerns over Tysabri's "risk management" plan—a preposterous excuse given that Tysabri is delivered by injection and only under the supervision of doctors. With its delay, the FDA is denying very-well-informed doctors and patients the freedom to "manage" the risks of untreated MS. "I haven't had any treatment in over a year," says Ms. Greenfield, who got one injection of Tysabri before it was withdrawn. …

Several recent studies reported in the New England Journal of Medicine conclude that, among other benefits, Tysabri appears to cut the number of new or expanding brain lesions in MS patients by 83%, and for many induces near-complete remission. Yet the FDA was unable to get its act together and meet its March deadline. It's still likely that Tysabri will return to the market, but the agency's apparent nonchalance in the face of progressive neurological damage is a sad spectacle.

The FDA is probably concerned that the drug would be prescribed to MS patients with only a minor disability that may (or may not) progress to the more dangerous, progressive courses of the disease. Still, many MS patients will develop the progressive disease, and for those patients and their doctors, delays in Tysabri's return seem to do more harm than good.

Project FDA.
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