Commentary: The Big Hole In The Drug Safety Net

It's almost a grim routine by now: After the Food & Drug Administration gives the go-ahead for a new drug, the product is yanked from the market when some unforeseen problem arises. In the latest instance, American Home Products Corp. announced on June 22 that it was pulling its painkiller Duract from the market after four patients using the drug died and eight needed liver transplants. The move came just two weeks after the hypertension drug Posicor was yanked because in some patients it caused other drugs they were taking to build up to dangerous levels. And it was just last fall that the diet drugs Pondimin and Redux were withdrawn after data showed the two might cause heart-valve damage.

"TIGHTER SHIP." All four cases highlight a serious weakness in the current U.S. regulatory system. The FDA has accelerated its review process, and record numbers of new drugs are coming to market. But the system fails to provide comprehensive data on what happens after pharmacies start dispensing them--to determine whether and to what extent people are injured as a result of taking them. Regulators need a system to identify problems earlier and let health-care providers come up with strategies for stopping them. "We need to run a tighter ship in tracking drugs when they hit the market," says Thomas J. Moore, a George Washington University Medical Center senior fellow.

Is the FDA'S faster drug-approval process to blame? Not really. While the agency requires extensive clinical trials before approval, such tests can't detect many problems that arise in widespread use. Trials are conducted under tightly controlled conditions. Participating physicians carefully monitor dosages and track what else patients are taking.

The real world is never that neat. Many patients taking a new drug will have other serious conditions or be taking other medications. And because doctors can prescribe drugs for conditions other than those for which the drugs are approved, drugs often are used in ways trials can't anticipate. Duract was only approved for 10-day use, but most of the patients who had problems were taking it for longer periods. In addition, even large trials may be too small to pick up rare side effects. "We always learn more about a product after it is approved than before," says Dr. Michael A. Friedman, acting FDA commissioner.

What can be done? The easiest step is to beef up the system for tracking bad drug reactions. Today, physicians and pharmacists voluntarily report adverse drug incidents to the FDA, while drugmakers are required to report any incidents they hear of. But many go unreported by healthcare providers. A controversial study in the Journal of the American Medical Assn. in April estimated that up to 100,000 deaths in the U.S. in 1994 were related to adverse drug reactions. The FDA'S system showed just over 3,500 such deaths that year.

There are a number of ways to improve the system. Dr. David W. Bates, associate professor of medicine at Harvard Medical School, says the program for tracking hospital-acquired infections could serve as a model. Infectious-disease experts use ongoing surveillance at selected hospitals to estimate the incidence of infections that develop in U.S. hospitals. Bates says a similar program to monitor prescription drugs "could identify strategies for reducing the likelihood of what are now seen to be unpredictable reactions."

The FDA could also be more aggressive about hunting for drug problems. George Washington's Moore says that by monitoring data about certain illnesses such as aplastic anemia, a bone-marrow disorder frequently caused by drugs, problems could be spotted quickly. The FDA'S Friedman says the agency is looking at such programs and is trying to improve the FDA'S statistical expertise to spot trends earlier.

Such a system will not come cheap. Fees levied on the industry can only be used to fund the drug approval process, so the FDA remains on a tight budget to fund other activities. The agency spends about $9 million a year to track approved drugs. Drugmakers say they aren't aware of the FDA needing more money for oversight, but they would do well to push for it in this case. New drugs will be a harder sell if the public questions the strength of the regulatory safety net.

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