Senate Finance Committee Hearing on Vioxx®

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Dr. David Graham told the Senate Finance Committee on November 18, 2004, "I would argue the FDA as currently configured is incapable of protecting America against another Vioxx®. We are virtually defenseless." This was said during the Committee hearing into Merck and the Food and Drug Administration's handling of the recall of the COX-2 inhibiting painkiller Vioxx®.

The FDA has failed the public in its oversight and is "incapable of protecting America," he also said. According to Reuters, he felt pressured by his supervisors to water down finding showing that Vioxx® users had a 50 percent greater change of heart attack or sudden cardiac death that those taking a competitor's drug.

According to Committee Chairman Senator Charles Grassley, "Now we have scientists in this particular case who are being harassed within the agency because of sticking to their own science." According to CNN, Grassley said the FDA had a "far too cozy" relationship with drug makers. Dr. Graham felt pressured to change the recommendation in his study and instead to inform Merck of his findings. Graham said, "I thought if I didn't [get the information out], that the data would never see the light of day."

According to Dr. Graham the VIGOR study, that Merck uses to defend the drug, was poorly designed. It tested Vioxx® on younger, healthier subjects instead of the elderly patients that were more likely to be receiving the drug. "These studies do not protect Americans... they protect the drug," he said.

In addition, Dr. Graham is calling for further scrutiny on 5 additional drugs approved by the FDA. Those drugs are:

Crestor® marketed by AstraZeneca
Bextra® marketed by Pfizer
Accutane® marketed by Roche
Serevent® marketed by GlaxoSmithKline
Meridia® marketed by Abbott Labs

If you believe that you or a relative were injured by taking Vioxx® please use the form below to contact our law firm.

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