Share this article

print logo

PHARMACEUTICAL WARNINGS
WHISTLE-BLOWING BY A DRUG SAFETY REVIEWER RAISES CONCERNS OVER MEDICINES AND PROCESS

The recent warning by a reviewer from the Food and Drug Administration's office of safety research that federal regulators are "virtually incapable of protecting America" from unsafe drugs should hardly be a surprise, given the Bush administration's penchant for pleasing the pharmaceutical companies.

Still, Dr. David Graham deserves credit for pointing out just how vulnerable Americans are.

Graham named five drugs now on the market whose safety needs "to be seriously looked at." He criticized the FDA for being "feckless and far too likely to surrender to demands of drug makers." In his view, this may be the single greatest drug safety catastrophe in the history of the country or the history of the world.

His words should send chills up the spines of every American who takes one of these drugs: the anti-cholesterol drug Crestor, the pain pill Bextra, the obesity pill Meridia, the asthma drug Serevent and the acne drug Accutane.

The makers of these drugs have said these medications are safe, and the director of the FDA's Center for Drug Evaluation and Research called Graham's new numbers "junk science." But in the wake of health questions concerning Vioxx and questions over the safety of antidepressants long prescribed for children and adolescents, Americans rightly can question those blanket assertions.

Many patients still are dealing with their own concerns about using Vioxx, a pain pill recently withdrawn by Merck following a company-sponsored study that found the risk of heart attack or stroke doubled after 18 months of using the drug. The news also understandably agitated critics of the FDA, who said that studies from as early as 1999 and 2000 revealed that the drug showed signs of posing a risk to the heart. The argument that the FDA should have acted earlier is a valid one, as is a call by medical researchers and editors of the Journal of the American Medical Association recommending the nation consider establishing an independent drug safety board.

There are those who disagree with Graham, such as Sam Kazman, general counsel at Competitive Enterprise Institute, a libertarian group based in Washington. Over-caution can be just as deadly, said Kazman: "One image that portrays that is if someone is drowning and I'm about to throw him a life rope and some federal official steps in and wants to see the paperwork on the rope and then he wants to put it through a strength meter. By the time we're all done and I can throw him the rope that person may well have long gone under."

But Americans expect protection from federal drug regulators. Graham, a 20-year FDA employee who now contends he is being pressured to transfer to another job, took a professional risk by criticizing his own agency. That adds weight to his argument -- and should add more than a little concern to public consideration of pharmaceutical safety. A fuller investigation is warranted, for both the drugs and the process.