Merck and the FDA get grilled by Senate over Vioxx and 5 other dangerous drugs.
According to CNN, on November 18, 2004, "Merck and federal regulators came under fire Thursday for their handling of Vioxx but the drugmaker's CEO staunchly defended the company's withdrawal of the drug after increased risks of heart attacks and strokes were found."
During the hearing Sen. Charles Grassley(R) announced that the FDA had ignored warnings from within about the dangers of Vioxx. Vioxx sales had been $2.5 billion per year.
According to Grassley's statements, the FDA was "cozy" with drugmakers and this may have been the reason they ignored the warning signs. The FDA gets revenue from drug manufacturers. This may have had sway on their decisions regarding allowing the dangerous Vioxx to stay on the market.
Grassley suggested that a new agency may be needed, just to focus on drug saftey, rather than approval and safety combined in one agency.
Grassley said, "My investigators have come up with information that both before Vioxx went on the market and even after Vioxx went on the market there were various red flags coming up within the organization of Merck that raised these legitimate questions about the safety of the drug."
Merck claimed that Merck pulled Vioxx as soon as the company had proof of the health risks. But studies going back over the last 5 years show that this is not the case. Merck's CEO said, "Withdrawing Vioxx was consistent with an ethic that has driven Merck actions and decisions for more than 100 years. Merck puts patients first" and claimed that estimates of harm caused by the drug were merely "speculation."
But according to The New York Times, nearly one year ago Merck had evidence of the dangers from preliminary study results. Merck has confirmed to the Times that this study existed.
"The FDA has let the American people down," said Dr. David Graham, an FDA drug safety reviewer. Dr. Graham's study is the one that essentially forced the recall of Vioxx. Graham said, "I thought if I didn't, that data would never see the light of day."
The FDA's first study of Vioxx found a nearly seven-fold heart attack risk in low dose use of the painkiller, according to Graham.
A second trial, the Vigor study, initiated by Merck after the drug was on the market, found a five-fold increase with high dosages, Graham said, adding the findings didn't prompt the FDA to put new information in the warning section on Vioxx packaging or ban high-dose use.
But Graham contended that tests of the drug were poorly designed -- noting, for example, that Vioxx was tested on younger, healthier subjects instead of on elderly people who were more likely to receive the drug.
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