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Elizabeth Cooney is a health reporter for the Worcester Telegram & Gazette.
Boston Globe Health and Science staff:
Karen Weintraub, Deputy Health and Science Editor, and Gideon Gil, Health and Science Editor.
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Wednesday, August 15, 2007
Encouraging signs on drug reviews, critic says
The voices of independent scientists are more important than ever, according to a critic of drug-company influence on government regulation, and there are signs they are being heard more than before.
Writing in tomorrow's New England Journal of Medicine, Dr. Jerry Avorn of Brigham and Women's Hospital and Harvard Medical School warns that Congress's re-authorization of user-fee funding from pharmaceutical companies to support the Food and Drug Administration means unbiased outside experts are critical to proper drug evaluation. As an example, he compares the approval of Vioxx in 1999 to this year's rejection of Arcoxia. Renewed assertiveness by FDA's external advisers made the difference in reviews of the painkillers linked to cardiac risk, he writes.
"Though the quiet voice of science may often be no match for powerful vested interests or ideology, some encouraging signs may be in the air," he writes. "The same reauthorization bill, disappointing in so many respects, may tighten somewhat the conflict-of-interest rules for outside advisers."