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Staying Healthy

Reviewer: I Was Pressured To Downplay Vioxx Concern

Man Tells Congressional Panel FDA Overlooked His Conclusion

POSTED: 3:56 pm EST November 18, 2004
UPDATED: 4:11 pm EST November 18, 2004

A government drug safety reviewer told a congressional committee in Washington Thursday that he was pressured to tone down his conclusion that long-term Vioxx use increases risk of heart attack and stroke.



Dr. David Graham said the Food and Drug Administration overlooked his concern four years ago that the arthritis drug -- which was pulled from the market on Sept. 30 -- was dangerous.

"Today in 2004, we are faced with what could be the biggest drug catastrophe in American history," Graham said. "In my opinion, the FDA has let the American people down."

The congressional panel is trying to determine whether safety concerns about the once-popular painkiller were ignored.

The drug's maker, Merck and Co., pulled the drug after a study indicated it doubled the risk of heart attacks and stroke when taken for longer than 18 months.

Graham said research has indicated the drug has caused up to 160,000 heart attacks and strokes.

At least 300 personal injury lawsuits have been filed over Vioxx. Some estimate Merck's potential liability could be as high as $18 billion, Staying Healthy's Stacia Matthews reported.


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