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The recall of Merck's arthritis drug Vioxx, because studies showed it doubled the risk of heart attacks and strokes has opened a pandora's box that questions who knew what, when they knew it, and how many other drugs are on the market that might become the next Vioxx.
A US Senate Finance Committee hearing into the Vioxx recall has shed some light on the events that eventually led to the recall of Vioxx.
The US Food and Drug Administration was aware of the dangers associated with taking Vioxx and heart disease but failed to take action on the information. Merck, the manufacturer of Vioxx suspected problems for at least four years, but once again, no action was taken until September, 2004.
During the hearings, more drug safety issues were brought to the table when a FDA safety reviewer warned senators that at least five other common drugs currently on the market could become the next Vioxx.
Dr. David Graham said AstraZeneca's Crestor, a cholesterol levels lowering drug; Meridia, a weight-loss drug by Abbott Laboratories; Accutane, an acne-fighting drug by Roche Holdings; Bextra, an arthritis pain-relieving drug by Pfizer; and GlaxoSmithKline's Serevent, an asthma drug could become the next Vioxx.
Death's Due To Vioxx
Dr. Graham also told the Senate Finance Committee that Vioxx may have caused 55,000 deaths alone, more than the 28,000 projected by the FDA. Graham also indicated Vioxx may have caused as many as 160,000 heart attacks, strokes and deaths, combined.
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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