Just when you thought it was safe to say “FDA”, and things seemed to be calming down ever so slightly with the uproar over COX-2 inhibitors and scrutiny over the FDA approval processes, the issue of suspect drugs plaguing the pharmaceutical industry has now spread to the biotech sector, with one of its best performing companies and a partner pulling their highly touted multiple sclerosis drug from the market.
Biogen, Inc., the makers of Tysabri, a new drug used to treat multiple sclerosis, announced Monday they are voluntarily suspending sales of the drug after one patient died and another developed a serious disease of the central nervous system.
Biogen Idec hammered out the details of the marketing suspension over the weekend in talks with FDA officials. The decision by Biogen Idec and the FDA to immediately suspend distribution and administration of Tysabri is a cautious approach that may have been influenced by the recent disclosure of newly discovered risks associated with the COX-2 inhibitors. Recall that in September, Merck pulled Vioxx off the market citing a new study linking the medication to increased risk of heart attack and stroke.
The Food and Drug Administration approved Tysabri in November, 2004, in an accelerated process after a late-stage study showed that it reduced MS relapses by 66 percent compared with a placebo.
This most recent withdrawal likely reflects the recent intense scrutiny of the drug industry and FDA from Congress over the agency’s response to negative trial results, such as those that exposed risks posed by popular painkillers and antidepressants. But it also reflects the challenges faced by the industry and regulators, who must balance safety concerns and possible risks when new drugs show tremendous health benefits. Once again, it comes down to risk assessment and being able to have access to the data one needs in order to accurately balance the risks and benefits of these treatments.
Tysabri helps MS patients in a different way than most of the existing treatments on the market. Tysabri works by blocking the immune system’s disease-fighting T cells from migrating to the brain and attacking healthy nerve tissue. Many patients who had seen their symptoms worsen under existing drugs had eagerly anticipated the drug. Though it doesn’t cure the disease, Tysabri works in a different way than existing treatments, and was able to reduce symptoms in some patients resistant to current treatments.
Is Tysabri only the tip of the iceberg in the realm of biotech sector drugs? Time will tell.
