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The FDA and MS
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 agojust 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.
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.
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