OBSERVATIONS – Brief Article

Larry Thompson

There is an old saying in the newspaper business that doctors bury their mistakes while reporters put them on the front page. These days, doctors’ mistakes are too often finding their way onto the front page. Medical errors–from giving the wrong patient the wrong dose of the wrong drug at the wrong time to bypassing the wrong coronary artery–have become too common.

The more sophisticated and complicated medical technology becomes, the more likely it is that something unexpected will go wrong. Patients need to be protected from that something going wrong. That’s where the Food and Drug Administration fits in. As a governmental agency, FDA is all about managing risks. When evaluating the risks and the benefits of marketed products–from a new drug or biologic to a medical device, from the safety of foods to the hazards of cosmetics–the agency works to minimize the dangers to the consumer. And once a product goes into widespread use, FDA continues to watch for trouble, putting out warnings when problems arise and even removing products when the risks exceed the benefits.

But it’s not a perfect world and FDA will never be able to eliminate all the risks–especially working alone. In its May 1999 report, the FDA Task Force on Risk Management concluded that “FDA plays only a part in the complex system of risk management. Numerous other groups [including doctors, nurses, pharmacists and other care-givers, patients, and medical product manufacturers] participate in decision-making related to the use of medical products.”

Too often, according to a recent report by the Institute of Medicine, there is little that the individual patient can do to avoid mistakes. Both IOM and FDA recommend a systems approach to solving the overarching problem of medical errors. In this issue’s cover story, staff writer Tamar Nordenberg explores the IOM report, the challenges raised by medical errors, and the actions taken by FDA to prevent them.

But sometimes nothing can be done to stop a mistake. An error by scientists conducting clinical research burst onto the nation’s front pages last year when the hot field of human gene therapy suffered its first casualty, the death of an Arizona teenager named Jesse Gelsinger. The death came only months before gene therapy researchers appear to have achieved their first concrete victories over illnesses and the field itself is celebrating its 10th anniversary. Gelsinger’s death has prompted considerable introspection and the ratcheting up of federal oversight.

But government regulators can never be everywhere; the research community, too, must respond to the Gelsinger case, according to this issue’s Last Word commentator, Savio Woo, M.D. He describes the concrete steps taken by the American Society for Gene Therapy to shore up the clinical research apparatus and restore patient confidence that the system will protect them from unnecessary risks.

All this is not to say that consumers have no control or voice in this process of developing and marketing medical products. Staff writer Carol Lewis details the essential role that patient and consumer representatives play in FDA’s advisory committee system. Their points of view remind the medical community that real people reap the benefits–and bear the risks–of their decision-making.

All these institutional responses to medical errors are essential, but consumers need to remember that the body in question belongs to them, and they need to be their own advocates. On a trip out West recently, an acquaintance in a leg brace told me the story of how he twisted his knee on the job. At the medical center, a health professional put him on a treadmill and turned up the speed to see what he could do. The resounding pop and shooting pain of a separating medial collateral ligament showed he couldn’t do much. Surgery was pending negotiations with the managed care organization.

My acquaintance isn’t stupid; he was trusting. He’s the kind of guy who figured they know more than he does and did whatever they said. Most of the time, health professionals do know a great deal and use their knowledge to help; no one intentionally does harm. But if someone is proposing something you don’t understand, ask questions until you do. If it sounds stupid, don’t agree until you know it isn’t. And if your knee hurts, stay off the treadmill.

COPYRIGHT 2000 U.S. Government Printing Office

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