Doctor claims FDA delayed Vioxx bad news

Nov. 4, 2004 at 11:18 AM   |   Comments

WASHINGTON, Nov. 4 (UPI) -- A doctor with the U.S. Food and Drug Administration claims the agency delayed his findings of danger in the now-recalled drug, Vioxx.

In an e-mail dated Oct. 25, Dr. David Graham, of the FDA's Office of Drug Safety, said one of his bosses, Dr. Anne Trontell, referred to his Vioxx study's conclusions "as nothing more than a scientific rumor."

Graham's study concluded Vioxx, also known as rofecoxib, had a dangerous effect on the heart. The study has since been submitted to the British medical journal Lancet for peer review and possible publication, and the FDA posted a version of the study on its Web site Tuesday after certain parts of it appeared in The Wall Street Journal.

In his notes on an Oct. 29 meeting, Graham wrote he and others in the Office of Drug Safety feel that "the review and clearance process had been turned into a battleground, full of contention and intimidation because our managers ... had created a system where it was taking a great risk to stand firm in our scientific beliefs."

Drug maker Merck withdrew Vioxx in September after finding that it caused an increase in the risk of heart attacks.

Topics: David Graham
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