The FDA Is Doing Its Job. Part 2

In 1999, two similar agents for diabetes treatment were approved and marketed — SmithKline Beecham’s Avandia, and Lilly’s Actos. Thus far, the liver toxicity that led to 63 deaths among those on Rezulin has not been seen with these drugs.

Last week, as a result of standard post-marketing surveillance, and given the availability of the newer, safer agents, the FDA sensibly requested Warner-Lambert to withdraw Rezulin. But this remedial action came too late to suit Dr. Sidney Wolfe, of the Naderite group Public Citizen. He immediately criticized the FDA for having approved the drug in the first place. He argued that since FDA’s fast-track procedure was initiated, dangerous drugs have been unleashed on the American public, injuring patients. He went on to note that if the agency had acted earlier, as had authorities in Britain, some patients would still be alive.

But many diabetics would be sicker, or dead, without Rezulin, given that its two alternatives were not available in 1997 and 1998. That’s the real lesson — Rezulin’s unique benefits justified its risks. The risk-benefit ratio is as paramount when the FDA evaluates a medicine, as it is when a physician prescribes one. The enviable health and longevity of the American people is in large measure attributable to the professionalism and responsibility of the FDA in evaluating our pharmaceuticals. Of the more than 500 drugs approved since 1980, only 15 (or slightly more than 2 percent) have been withdrawn.

The FDA rightly stands by its approval process on Rezulin. The agency asserts what should be self-evident, even to those aiming at sensation rather than truth: all side effects of a drug cannot possibly be detected in the small-scale clinical trials that precede mass marketing. Rezulin was tested on 2,500 patients before release, and severe liver damage was not detected. Officials of the FDA’s Clinical Drug Evaluation Center pointed out that Rezulin would not have been withdrawn even now if not for the recent availability of the newer, safer insulin-sensitizer drugs. Even the most thorough regulatory process will fail if the appropriate safeguards are ignored when a drug is mass marketed. This is the responsibility of the treating physician.

To pontificate now that the drug should never have been approved amounts to Monday-morning quarterbacking, or “viewing through the retrospectroscope” in medical parlance. Ninety serious reactions out of 1.9 million patients is evidence of a job well done, not of dereliction. All drugs have risks, especially new drugs, and we often need the data from post-marketing surveillance to detect them. There are many drugs on the market more dangerous than Rezulin — it’s all about benefit vs. risk.

The withdrawal or restriction of a drug does not mean that its approval was inappropriate or the process shoddy. To shy away from releasing breakthrough drugs because of fear of unpredictable side effects would cripple the system that has benefited us immeasurably. The withdrawal of Rezulin during post-marketing surveillance shows that the system works.

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December 9th, 2011 - Posted in Health Care | | Comments Off

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