Commentary: Drug Safety Needs a Serious Overhaul

By Amy Barrett

Consumers taking some popular prescription drugs may find their heads spinning these days. On Aug. 8, Bayer withdrew its cholesterol-lowering drug Baycol after a series of deaths from a rare muscle-related side effect. Then on Aug. 21, a study from a Cleveland Clinic analysis of existing clinical trial data prompted concerns that two popular arthritis pills known as Cox-2 inhibitors may raise the risk of heart problems. Yet the Food & Drug Administration says other cholesterol drugs on the market are safe, and Merck & Co. (MRK ) and Pharmacia Corp. (PHA ), makers of the Cox-2 drugs, say the data on their pills show no cardiovascular risk. Small wonder patients who suffer from heart disease and arthritis want to know what's going on.

The debate about these drugs highlights a major problem with the regulatory process: The system for tracking the safety of prescription drugs after they hit the market is inadequate. The FDA spots those problems mainly through voluntary reporting by physicians when patients have bad reactions. But by the FDA's own estimates, no more than 10% of these reactions ever get reported. "We know how many suitcases were lost last year by the airlines," says Dr. Raymond L. Woosley, vice-president for health sciences at the University of Arizona. "But we don't know how many people have been harmed by prescription drugs."

While that flawed system has long been in place, concerns about those weaknesses are mounting. In part, that's because the FDA sped up new-drug approvals in the 1990s, a slew of new products have hit the market in recent years. Drugmakers have also ramped up their marketing. Merck and Pharmacia spent $239 million last year on consumer ads for the Cox-2 drugs Vioxx and Celebrex. Launched less than three years ago, global sales should reach $6 billion this year. Such giant rollouts mean more patients can be hurt when a problem surfaces. Fixing this system will require effort on the part of many players in the medical system. Here are some remedies:

-- EDUCATE DOCTORS. Dr. Peter K. Honig, director of the office of postmarketing drug-risk assessment at the FDA, argues that medical schools are not putting enough emphasis on training doctors to report bad reactions. Medical schools and professional groups must mount a major push for doctors to make this a priority.

-- ENSURE THAT WARNINGS ARE HEEDED. In the case of Baycol, the label warned as early as December, 1999, that the product should not be taken with another heart medicine called gemfibrozil. But physicians continued prescribing the two in combination. Of the 31 deaths related to Baycol that are on file with the FDA, 12 involved patients taking both drugs. The FDA needs a system that rapidly pulls data from managed-care operators to show whether doctors in those networks are heeding new warnings.

-- HUNT FOR PROBLEMS. How can the FDA do that? The agency recently linked up with a network of transplant centers, for example, to get information on the causes of liver failures among their patients. Liver damage can be caused by a bad drug reaction. While the FDA has a few such partnerships in pilot studies, the agency needs to establish many more of them, which Congress should quickly fund. "The clustering [of bad reactions] would become evident very early rather than a year or two later, after a lot of people had a problem," says Dr. Eric J. Topol, chairman of the Cardiovascular Medicine Dept. at the Cleveland Clinic and co-author of the controversial Cox-2 drugs report.

-- CREATE A WATCHDOG. Much as the National Transportation Safety Board investigates plane crashes, an independent body should be set up to investigate drug recalls. It would assess whether early warning signs were missed in a drug's approval or whether other drugs could have similar problems. "We keep making the same mistakes," says the University of Arizona's Woosley. With prescription drug sales soaring, the price of such mistakes will only mount.

Philadelphia Bureau Chief Barrett covers the pharmaceuticals industry.

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