Loosening Drug Firms' Grip on Medical Data

Commentator John Abramson was a family doctor for 20 years. As he observed his patients asking for new drugs they saw on TV commercials, he started investigating the existing research on some of those drugs.

Abramson found discrepancies between the articles about Vioxx and Celebrex in two of our nation's most respected medical journals — the New England Journal of Medicine and the Journal of the American Medical Association. But he had trouble convincing his patients to switch medications.

A Journal Responds

NPR offered the Journal of the American Medical Association and the New England Journal of Medicine the opportunity to write a response to this commentary. JAMA declined; a response from Jeff Drazen, editor of NEJM, is below:

Our original report indeed showed an increased incidence of heart attacks, and that the authors had financial ties to Merck, just as we reported to readers in 2000.

Rather than focus on these early warnings of cardiac risks, the manufacturer chose to launch research into the drug's effectiveness for other conditions. And the FDA did not compel the company to determine whether cardiovascular events in early studies were just a fluke or important warning signals of cardiac toxicity.

If clinical trials designed to show the true heart risks had gone forward with urgency in 1999, perhaps a substantial number of heart events and deaths could have been prevented.



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