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Commentary

Ominous Prospects for an Aging Population
Tech Central Station, 1-3-06

As a response to many of the concerns over clinical trial disclosures that have been vented in the press recently, Miller offers his opinion that the angst has been largely unwarranted:

Many issues that surround the development of new drugs are far more complex than they seem. Although it is true, for example, that several major medical journals recently introduced a requirement for companies to register clinical trials in a publicly available database before they are launched in order for the results subsequently to be considered for publication, that initiative has been widely misunderstood, and its usefulness exaggerated. The rationale is that “negative” results from clinical trials could no longer be obscured and simply not reported. In other words, companies should not be able to “cherry pick” studies, making public only those that give favorable results and suppressing the rest.
This unilateral action by journal editors was arguably little more than a power trip. Nothing in our society is more stringently regulated and monitored than drug development. During each phase of clinical testing, the FDA reviews and must grant permission for every clinical trial and has access to all of the proprietary information about the drug (as well as related drugs). When the manufacturer has accumulated evidence that the drug is safe and effective -- as part of the application for marketing approval, the results of every trial and everything else that is known about the drug – all, must be reported to the FDA. That means in the United States and abroad. And, of course, trials must be performed with appropriate treatment of statistics. Moreover, the FDA serves as a repository for data on similar drugs made by other manufacturers. All of this prevents statistical “cherry-picking” or “data mining” that could mislead regulators.

While admitting that it may be possible for companies to exert “some selection bias when researchers submit a paper to a medical journal”, peer reviewers can always ask for more data if they feel it is necessary. Perhaps the real problem is, as the recent fabrication of stem cell cloning data by Korean researchers proved, peer review at medical journals is based largely on an honor system. Pharmaceutical companies face much higher standards at the FDA—and in the media—than academic researchers often do among their peers.



Project FDA.
  
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