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Drug DealingWho should decide when a medication is safe?

By Darshak SanghaviPosted Wednesday, March 11, 2009, at 1:25 PM ET

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The simple fact is that package inserts aren't terribly useful because they're too damn complicated, much like the laundry list of side effects at the end of television commercials for drugs. How can anybody make sense of labels that list dozens of horrible outcomes, even for the most commonly used drugs? In ruling against Wyeth—and concluding the FDA-approved labels may be insufficient—the Supreme Court has invited manufacturers to lard medications with even more useless warnings to head off lawsuits. It's hard to see how this will prevent future harms to innocent patients, since adding yet another warning to the dozens already listed for Phenergan probably wouldn't have saved Diana Levine's arm.

Remarkably, some of the nation's most respected physicians, such as a collection of editors of the New England Journal of Medicine (one of whom wrote a book assailing the ridiculously unscientific breast-implant litigation that bankrupted the Dow Corning Co.), supported Levine: They think personal injury attorneys can do a better job than the FDA in protecting Americans from complicated and sometimes dangerous medications on the market. In an editorial in last summer's New England Journal of Medicine arguing against Wyeth's position, several editors pointed out that Avandia, Vioxx, and Redux were all approved by the FDA and were later found to have important safety risks. They suggest that ruling in favor of Wyeth would "erase" a harmed patient's "right to seek legal redress," even though the truth is that outright lying wouldn't be protected. And they also overlook their own contribution to our nation's drug problems.

Consider the example of Vioxx, Merck's pain medication that caused heart attacks. Merck likely was truthful in submitting its clinical trial data to the FDA during approval, including those suggesting an increased risk of heart attack. As nicely documented by physician John Abramson in Overdosed America, these data were easily accessible to the public and also emphasized by warning letters issued to Merck by the FDA. It wasn't exactly a secret. In 2001, the Journal of the American Medical Association published a clear warning about the excess risks. Yet the New England Journal of Medicine published a review article at the same time minimizing the extent of the problem, uncritical health insurers added the drug to their formularies and paid for them, and many doctors happily wrote prescriptions without reviewing any data. If the drug companies should pay for resulting harm, shouldn't the New England Journal of Medicine also be sued? How about health insurers? Or the pharmacists who fill the prescriptions?

Now, there's no question Merck deserves punishment if the company blatantly lied about risks. But here's the thing: The data are really, really complicated. Major medical journals published vastly different takes on it. And in the end, further studies on Vioxx within a brief period of time confirmed the preliminary risks, and the drug was withdrawn from the market—arguably a regulatory success story.

Ultimately, there is no such thing as a "safe" medication. Drugs each have a balance of risks and benefits best evaluated by highly qualified sources. And the truth is that sometimes drugs have unforeseen side effects. Complex nuances of medical practice rarely survive courtroom battles—which, unfortunately, is where many drug debates may continue to occur.

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Darshak Sanghavi is Slate's health care columnist. He is chief of pediatric cardiology and assistant professor of pediatrics at the University of Massachusetts Medical School as well as the author of A Map of the Child: A Pediatrician's Tour of the Body.

Photograph of Diana Levine by Toby Talbot/AP Photo.

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