Two weeks ago, I headlined my blog with this question: Is the FDA violating its own mandate to approve safe drugs? Four days later, the national Institute of Medicine (IOM) released a 233-page report concluding that FDA’s current approach to drug oversight “is not sufficiently systematic and does not ensure consistent assessment of benefits and risks associated with a drug over its lifecycle.” In other words, the FDA may indeed be violating its own mandate.
The IOM report was mentioned almost in passing near the end of a Nature article today on the debate over an earlier journal study that found significant noncompliance with a 2007 federal law that requires researchers to post clinical trial results on a publicly available website. The Nature article focused on the fact that the FDA and the NIH disagreed with the findings of several researchers who reported in the British Medical Journal that only 22% of trial sponsors posted their results within one year of completion, as the law requires. The FDA, in response to letters from Congress investigating this lapse, argued, among other things, that the BMJ researchers included some trials that were completed before the 2007 law came into effect, and did not exclude some — such as uncontrolled trials — that are exempt from the reporting requirements. According to Nature magazine, the researchers stand by their results and note that the FDA itself is having trouble determining which trials should be included under the 2007 mandate.
Regardless of who is right in this particular dogfight, the fact remains that the Institute of Medicine, possibly the most respected advisory body in medicine, has determined that the FDA is not doing an adequate job when it comes to drug safety oversight. The report also concluded that substitute or “surrogate endpoints are often relied on in the drug-approval process” (instead of the originally designated primary outcome measures), and that “their use has been related to a number of high-profile drug-safety problems.” They are obviously referring to such high-profile cases as Paxil (which I chronicled in Side Effects and subsequent blogs), Vioxx, Avandia and so on.
The IOM report makes a number of recommendations, including:
- that the FDA should “adopt a consistent decision-making framework for regulatory actions across the lifecycle of all drugs…”
- that the agency should require, for each new drug and for already
approved drugs for which there are questions of safety, “a
publicly available and understandable document that would capture information about a drug before it is approved and throughout its time on the market.”
- that the FDA should develop more tougher and more consistent guidelines about what kind of controlled trials they consider scientifically valid in determining both efficacy and safety.
- that the FDA should work with other federal agencies in evaluating and resolving concerns about the ethics and quality of the increasing number of clinical trials performed outside of the United States.
Last week, the British Parliament came out with a report concluding that Rupert Murdoch is unfit to run News Corp., and its findings made headlines on this side of the Atlantic. How come when the Institute of Medicine comes out with a 233-page report concluding that the FDA is not doing its job, the only mention I can find of it is near the bottom of a short news article in one scientific journal? Why doesn’t this report merit front-page news too?
This blog was originally published at www.alison-bass.com.
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Weak Field Trials Scuttle DSM-5 Diagnoses
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