Vioxx ruling: Merck liable; FDA, too

What do drug-makers know about the risks of their products? When did they learn it? Did they tell doctors and patients about it?

Answers to those questions promise to influence outcomes of thousands more lawsuits against Merck & Co. over its painkiller Vioxx, just as they persuaded a Texas jury last week to issue a $253 million verdict against the company in the death of a 59-year-old who suffered heart problems after taking the drug now known to increase the risk of heart attacks.

As jurors pore over Merck's internal e-mails and investors eye the verdicts, more congressional leaders need to pay attention to the warning from Sen. Chuck Grassley, R-Iowa: "The Food and Drug Administration was also negligent in the Vioxx case." The finance committee chairman has proposed legislation to set up an independent drug safety office within the FDA. "Those running the nation's public safety agency," he said after last week's verdict, "dismissed the concerns of their own scientists and kept the public in the dark about emerging problems with Vioxx."

Such a belief about Merck helped seal the verdict, a juror confirmed after learning of a February 1997 e-mail that cited a Merck scientist's "great concern" over the possibility of increased heart risk: "That told me they knew cardiovascular events were possible on this drug, but they failed to tell us about it." Merck had said it learned of the risk only soon before it pulled Vioxx off the market in September.

Distrust of the FDA and pharmaceutical companies is not new. But the FDA's recent efforts to restore credibility would gain more traction if decision-making did not continue to tilt toward those making drugs instead of those taking them. The FDA's belated warnings about the possibility of an increased suicide risk among children taking antidepressants is one example.

Drug companies also must act more responsibly. Medication marketed directly to patients must include prominent -- and comprehensible -- warnings about risks. As one juror in the Texas case said: "Give us in layman's terms what the drug can do to us." Assuring credibility requires disclosure of unfavorable, not just promising, clinical trial results, and a transparency about financial backing and scientists' loyalties.

In attempting to balance the risks and benefits of medication, the FDA must consider that a drug-approval process that is too long and expensive could delay for patients the benefit of lifesaving and life-enhancing aid -- chronic-pain patients will believe that the risk is worth the relief -- and a process that is too lax could lead to unnecessary deaths. The FDA's challenge remains proving that it can balance public safety and private gain.