Summary

Original source:
http://www.heartcenteronline.com/myheartdr/home/research-detail.cfm?reutersid=4751

Details

• The US Food and Drug Administration denied charges it tried to suppress a safety official's findings that painkiller Vioxx, which was pulled from the market last week, raised heart attack risks.
• Dr. David Graham's study on the Merck & Co Inc. arthritis drug was sent through the "standard review process" before being made public in August, the FDA said in a statement released late Thursday.
• Graham told Senate Finance Committee Chairman Charles Grassley on Thursday that FDA officials pressured him to keep quiet or water down his conclusions about Vioxx, according to Grassley.
• Conversations between Graham and his supervisor were part of the "open discussion and frank exchange about scientific and medical issues" that are part of the process for reviewing staff research presentations, the FDA said.
• "After that discussion, it was Dr. Graham's decision to revise the abstract," or a summary of his findings, the FDA said.
• Graham, associate director for science in the FDA's Office of Drug Safety, concluded that patients taking Vioxx were more likely to suffer heart attacks than others who took rival medicine Celebrex, made by Pfizer Inc.
• Graham's findings were presented at a medical conference in France on Aug. 25.
• Grassley, an Iowa Republican, is investigating how the FDA handles safety concerns about medicines.

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