From an op-ed piece by Dr Marcia Angell in the Boston Globe:
As part of the emphasis on speed, the FDA often approves brand-name drugs on the basis of less evidence than in the past. In these cases, approval may be contingent on companies conducting further safety studies after the drugs are on the market.
But the companies usually don't honor that commitment.
Of the roughly 1,200 such studies outstanding -- some for years -- over 70 percent haven't been started.
The FDA is strangely silent about this inexcusable dereliction.
When questioned, it weakly protests that it doesn't have the authority to compel the research. In fact, it has enormous leverage, since it can withdraw drugs from the market.
The FDA also refuses to release unfavorable research results in its possession without the sponsoring company's permission. Here again, it contends not to have the authority to do so, but providing evidence of side-effects or negative results would seem to be an integral part of its job.
It's no wonder that serious safety concerns about drugs such as Vioxx, Paxil, and Zyprexa have emerged very late in the day -- years after they were in widespread use.
Boston Globe
Hat tip: http://www.furiousseasons.com/
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