Monday, March 06, 2006

Is Drug Data Delayed, Drug Data Denied?

An annual report by the US Food and Drug Administration (FDA) admits that about two-thirds of the post-marketing drug studies it had mandated have never been finished. According to the Times, one such study was mandated in 1955.

US Representative Maurice D. Hinchey (Democrat- New York), "said while the agency insisted that it demanded that drug makers prove their medication safe, those demands 'continue to be blatantly ignored by the pharmaceutical industry.'"

In reply, Dr John Jenkins, director of the FDA Office of New Drugs, "emphasized that only 5 percent of promised drug trials were officially considered 'delayed.' In many cases, trials have been pending for more than a decdade but are not considered delayed because the agency never insisted on a specific timeline for them."

Fellow blogger Roy Poses has a good comment on this story:

I agree that potentially beneficial drugs should be put on the market as soon as possible with the least red-tape. Randomized controlled trials that have adequate statistical power to determine if a drug has benefits when compared to a placebo may not have enough power to determine all its important adverse effects. Thus it may make sense, when a drug offers important benefits beyond any treatment currently available, to allow it on the market without complete safety information, and then to require post-marketing studies, with more statistical power (but perhaps also with more methodologic biases) to assess its adverse effects. But patients and physicians need to know about the all important possible hazards of potentially beneficial medicines to make optimal decisions about whether to use them. So it is crucial that these post-marketing studies get done as quickly as possible.

I don't understand why the FDA has been mandating these studies, but not mandating any deadlines for their completion. Patients and physicians are ill-served by delays (whether officialy defined or not) in accomplishing these studies.

If pharmaceutical companies really want to increase their trustworthiness to patients and physicians, they ought to consider completing all pending post-marketing studies expeditiously. And in my humble opinion, the FDA needs to hold pharmaceutical companies accountable for their failure to complete such studies in reasonable amounts of time.

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