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April 15, 1998

Controversial Study Finds Drug-Reaction Toll Is High

By a WALL STREET JOURNAL Staff Reporter



A controversial new study argues that more than 100,000 Americans die in hospitals each year from adverse drug reactions.

Millions more suffer serious injuries, such as heart irregularities and internal bleeding, as a result of allergic reactions or other complications from drugs that are often prescribed by doctors, the study asserts. The mortality and casualty statistics are even higher when researchers include cases in which patients got the wrong medication or improper doses.


If the researchers are right, adverse reactions to drugs is the fourth leading cause of death in the U.S., after heart disease, cancer and stroke. Even using their lower estimate of 76,000 deaths, drug-reaction mishaps would still be the sixth leading cause of death.

An author of the study, which was published this week in the Journal of the American Medical Association, said the problem is widespread in hospitals large and small but has gone largely undetected, in part because the Food and Drug Administration fails to track it closely and relies on hospitals, doctors and drug companies to report such cases voluntarily. The FDA's numbers for hospital deaths due to adverse drug reactions are "absurdly low" argues Bruce Pomeranz, a professor at the University of Toronto and co-author of the report.

False Sense of Complacency

Dr. Pomeranz added that this fosters a "lull" or false sense of complacency that the problem is not as endemic or widespread as it really is.

The FDA concedes that it doesn't closely track the problem of adverse drug reactions but says it lacks the resources to thoroughly review the 250,000 cases it hears about each year. Doing so would not be the best use of the agency's expertise, argues acting FDA Commissioner Michael Friedman.

"I wouldn't point fingers in blame here," said Dr. Friedman. "I see this as a shared responsibility," he added, citing the pharmaceutical industry, as well as physicians, nurses and hospital administrators. Dr. Friedman said he thinks that if more awareness were paid to the problem, the incidences might decrease.

The report immediately came under attack from some experts, who questioned its methods and conclusions. It was based on a "meta-analysis" of data compiled from 39 studies spanning more than 30 years, rather than on original research that is projectible to a nationwide picture. By examining the data, the scientists concluded that 0.32% of deaths occur due to toxic reactions to drugs. Out of 35 million patients admitted to U.S. hospitals each year, the scientists extrapolated that more than 100,000 die of adverse drug reactions. Nearly 7% of hospital patients, or 2.2 million, develop serious injuries, the scientists said.

Focus of Study

The new study encompassed both prescription medications and over-the-counter drugs. The researchers excluded drug abuse, suicide and mistakes, concentrating instead on what happens even if a patient were to take the appropriate dose of a prescribed or recommended medication.

The complications, which can result in longer hospital stays and costly interventions, help drive up medical costs by $1.5 billion to $4 billion, the study contends. Drugs are highly effective, but "it is a two-edged sword; for every drug, you have to know the odds" of side effects and whether they outweigh the benefits, said Dr. Pomeranz.

"I think their estimates are probably high," countered David Bates, an associate professor of medicine at Harvard Medical School. But even he cites a mortality estimate that might startle many people: He figures that of the approximately 180,000 patients who die in U.S. hospitals each year, about 50,000 deaths are caused by adverse reactions to properly prescribed medication.

Dr. Bates, who attacks the study in an editorial in JAMA, nonetheless concurs that the problem has been overlooked. "It is a serious issue, and one that hasn't received the attention it deserves," he said. And while the authors of the new study avoid laying blame on doctors, drug makers or hospitals, Dr. Bates argues that hospitals should get the lion's share of the blame.

Call for Vigilance

"Hospitals should be more vigilant, because it is only at the hospital level that you can build an effective tracking system," Dr. Bates said. He noted that only a small number of hospitals now use computer systems that are highly effective at monitoring patients and their reactions and track changes in lab-test findings. At Brigham and Women's hospital in Boston, where Dr. Bates practices, a system monitoring reactions was installed approximately a year and a half ago, with beneficial results. The outcomes will be reported in a future study.

Some hospital officials agree with that critical assessment. "We absolutely can do a better job. The old way of doing it --trying to do it in the medical charts -- doesn't work," said Rick Wade, a senior vice president at the American Hospital Association, which represents 4,800 hospitals. "We need better systems."

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