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A DUTY TO WARN
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August 27, 2001

HEALTH CARE

THE anti-cholesterol drug Baycol is gone, voluntarily withdrawn from the market this month after being linked to 31 deaths. But the problems exposed by this latest recall will linger until doctors and federal regulators take meaningful action.

In an eerie repeat of failures that prompted the withdrawal of the diabetes drug Rezulin last year, federal officials sent several warning letters to doctors over the last 18 months advising them about potential problems with Baycol and suggesting strategies to prevent them. But the alarm apparently went unheeded, as it did when four separate warning letters were issued on Rezulin. Side effects are inevitable with any effective drug. But without stepped-up requirements for reporting medication problems, and an improved system for ensuring doctors receive and heed warnings, future tragedies are inevitable.

An estimated 12 million Americans take one of the class of cholesterol-lowering drugs called statins, of which Baycol is a member. Statins are an important new weapon in the fight against heart disease, the nation's leading killer. They block formation of cholesterol. But it has long been recognized that they can cause serious side effects. In a small percentage of users, statins cause the breakdown of muscle tissue. When that happens, waste floods the bloodstream. That can shut down the kidneys, causing death.

No one knows how many people died after taking statin medications. Drug makers are required to report so-called adverse reactions to federal regula tors, but doctors and hospitals are not. Drug companies don't see patients. Changing the rules to require doctors or hospitals to report suspicious illness or deaths would give regulators more accurate and timely information.

But even that is only useful to a point, because federal regulators don't prescribe drugs. Doctors, often overwhelmed with information about new studies and breakthrough treatments, are sometimes slow to heed warnings about potential problems. They often rely on drug company sales r epresentatives for information.

The solution is to create a federal drugs database, where information could be easily obtained and readily updated. Doctors could consult it for updated information about drug warnings and potential interactions.

Deaths linked to Baycol, Rezulin and several other recalled drugs have exposed shortcomings in the system for regulating medications. The U.S. Food and Drug Administration has an obligation to act now, before the next tragedy inevitably occurs.