A new prescription for dysfunctional FDA

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Everybody is having a swell time bashing the Food and Drug Administration for its failure to identify heart risks to patients taking Merck’s blockbuster pain reliever Vioxx. It turns out Merck knew about the problem since 1998 but didn’t take Vioxx off the market until this fall after 20 million people had taken it.

Vioxx, which we now know increases heart attack risk fivefold after 18 months use, is not the first drug to produce side effects worse than the condition for which it’s prescribed. Vioxx is just a standout for its popularity with arthritis sufferers because it is advertised as being easier on the stomach than aspirin and other anti-inflammatory drugs. But there are safety problems with other “super aspirins,” the family of Cox-2 inhibitors that includes Vioxx alternatives Celebrex and Bextra.

Merck ignored early evidence from its VIGOR study (published in 2000) and, almost a year later, a letter from the FDA warning that cardiac toxicity risks weren’t included in advertising for the drug. Since 40 percent of these heart attack victims died, one would assume the FDA could have done more than issue a warning about TV ads.

This gets to the heart of problems at the FDA. It’s not just Big Pharma’s hefty lobbying force. Merck, like all other drug makers, pays the FDA a “user fee” (a significant chunk of FDA’s budget) to process results of its own safety and efficacy studies, not to do independent research. Drug companies are free to bury studies that show disturbing reactions and give the FDA only those trials (sometimes only one in 12) that are blemish free. Drug companies also aren’t required to publish the others, which are often uncovered only during a class-action lawsuit.

Years ago, there was a general hue and cry from advocates for victims of untreatable, fatal diseases urging the FDA to speed up the glacial pace of new drug approvals. So Congress got into the act and passed legislation to accelerate the process. Problem is, FDA applied the new rules to medications that just treated symptoms of less serious conditions (heartburn, allergies, arthritis pain) as well as to life-threatening diseases. Inside the agency, researchers who warned of adverse reactions to new drugs were told to stifle their opinions or were removed from approval panels. Some, we hear, were removed from the FDA.

The result of this accelerated approval process is limited research before consumers are exposed to new drugs and limited oversight after drugs come on the market. In effect, new drug users, lured by full-page ads in slick magazines and celebrity promotions on TV, become guinea pigs in nonrandomized tests with no published results.

The other part of FDA’s organization problem is that approval of new drugs and safety monitoring of existing drugs are relegated to separate offices within the agency, which has limited resources and authority to require doctors and hospitals to report adverse effects of drugs on patients.

At a Senate Finance Committee hearing Nov. 18, a veteran FDA drug reviewer cited five other popular drugs that should be reappraised. The Journal of the American Medical Association has called for an independent board to monitor drugs and medical devices after they are in common use. Editors of the widely respected journal called for major restructuring at FDA. Without it, they said, the country will be far short of an effective, vigilant, trustworthy system to protect the public. Of course, they’re right. But can Congress appoint such an independent panel?

Right now, we have serious scientists addressing these issues-Center for Science in the Public Interest and Public Citizen Health Research Group-but though they have limited access, they regularly publish health warnings years ahead of the FDA. Public Citizen’s monthly newsletter Worst Pills, Best Pills News three and a half years ago labeled Vioxx and Celebrex “Do Not Use” drugs. In other high-profile cases, Baycol, Propulsid, Rezulin and diet aid Redux, the newsletter beat FDA by a year or more.

How do they do that? They use the courts to demand release of public information and they’re not beholden to Big Pharma or government. We still don’t know how the administration’s proposed tort reform will thwart these litigation efforts.

The FDA says it can solve its own problems, thank you. Its critics are asking Congress to legislate reform. If lawmakers tackle this one, they will probably need suggestions from unvested interests.

A humble suggestion from someone who steadfastly shuns all prescription and most OTC drugs: Require doctors to report all adverse drug reactions directly to the FDA, and secondarily to the manufacturer. Doctors already have too much to do, but they’re the ones most likely to know if their patient took the drug exactly as prescribed and what other medications they used. The FDA also could require drug companies to submit the results of all studies, not just the favorable ones, for new drug approval. And the agency should give up all attempts to muzzle researchers with dissenting views.

Once again, science should not be the handmaiden of public policy, nor legislation beholden to vested interests.