Editorial
Vioxx case: a failure to protect the public

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The decision by Group Health Cooperative in Seattle not to give the drug Vioxx to its patients five years ago supports a whistleblower's assertion last week that federal regulators failed consumers.

Dr. David Graham, a Food and Drug Administration drug-safety official testifying at a Senate committee hearing, said the agency ignored evidence that patients who took the painkiller had a higher risk of heart attack. He suggested the FDA, which downplayed the results of a study he did, was too cozy with drug companies it is supposed to monitor. In scathing testimony, he warned more questionable drugs were likely on the market. In September, Merck withdrew Vioxx from the market five years after it was introduced and four years after the company acknowledges it was aware of a study that suggested it might pose a higher risk to patients. The company chose not to do a comprehensive study on the specific risk but rather monitor ongoing studies of Vioxx for other purposes. It was one of those studies that prompted Merck to pull the drug.

But when the drug was new, Group Health officials reviewed existing studies and concluded there was not enough evidence it was safe or effective. Vioxx is more expensive than some traditional painkillers but is less likely to cause ulcers.

Even though Vioxx was approved by the FDA, it was not an option for Group Health's half-million members — a decision that possibly spared some of its members heart attacks.

Graham has estimated that Vioxx use probably has caused 27,000 heart attacks but says the number may be as high as 139,000.

His assertions that the FDA is not scrutinizing new drugs as it should is especially disturbing. The agency has come under fire in recent months for not cracking down more on the use of some anti-depressants in adolescents after evidence suggests they cause some to become suicidal.

In the case of Vioxx, the FDA drug-approval process and subsequent monitoring clearly failed consumers.

But an even larger problem here might be the FDA and whether it is being vigilant enough — before and after drugs are approved — in protecting the public.