An alarming and highly influential 1999 report which concluded that as many as 98,000 Americans die every year from preventable medical errors is itself being criticized as erroneous by some experts.
The debate, which has been simmering for months, attains prominence Wednesday with the publication of dueling opinion articles in the prestigious Journal of the American Medical Association. The articles highlight the difficulty of accurately tallying medical errors and underscore the extreme sensitivity of the topic in today's litigious medico-legal environment.
In one of the articles, three critics assert that the medical error figures used in last year's Institute of Medicine (IOM) report were greatly exaggerated and that the subsequent flurry of efforts to increase oversight of medical professionals was ''premature.''
''The available data do not support IOM's claim of large numbers of deaths caused by adverse events, preventable or otherwise,'' write Clement J. McDonald and two colleagues from the Indiana University School of Medicine in Indianapolis.
In the opposing article, a Harvard University public health specialist who helped write the IOM report, and who conducted some of the original research upon which it is based, defends the error figures as, if anything, conservative.
The researcher, Lucian L. Leape, reiterates the report's conclusion that health care professionals, lawyers, regulators and patients must rise above the long tradition of blame and denial and uncover together the systematic flaws in the U.S. health care system that lead to repeated errors.
''Rather than attempting to assuage guilt or outrage about errors by punishing, discounting, or self-flagellation, physicians need to look to preventing recurrence of errors,'' Leape writes.
The headline-grabbing 1999 report, ''To Err is Human: Building a Safer Health System,'' was released last November by the IOM, a branch of the independent, congressionally chartered National Academy of Sciences. It concluded that errors cause between 44,000 and 98,000 deaths in U.S. hospitals every year -- more than the number caused by breast cancer, highway accidents or AIDS.
The response from many quarters was quick. Hospitals and insurers launched task forces to examine the problem while federal agencies quickly funded new research. In February President Clinton said he would create a new federal office to study and promote patient safety. He also called for new legislation that would allow hospitals and doctors to investigate their errors and publicize their findings without fearing that the information would later be used in malpractice suits against them.
But the legislative approach collapsed last month. Republicans and Democrats, failing to agree on how uniformly and openly hospitals should investigate errors, introduced competing bills that many on Capitol Hill predict will remain stymied indefinitely by congressional deadlock.
Now the growing debate over the validity of the IOM report, some experts said, could affect other nascent efforts to understand and prevent medical errors.
The dispute began when word got out that one of the studies that the IOM had relied upon had been criticized previously in a medical journal article for counting deaths due to drug abuse as ''medication errors.''
Then, in April, a Harvard researcher, who with Leape and others had conducted the two most important studies upon which the IOM report had relied, wondered aloud in the New England Journal of Medicine whether the IOM report might itself be erroneous and harmful.
The author, Troyen A. Brennan, who holds degrees in both medicine and law, noted that those two key studies looked not at medical errors per se but at ''adverse events,'' or bad outcomes -- many of which may not have resulted from errors or even have been preventable. For example, some patients with liver damage must be returned to surgery because of persistent bleeding. That is an adverse event of surgery, but not necessarily the result of an error.
''A careful reader must have some reservations about the IOM report,'' Brennan wrote in the April 13 New England Journal.
In the newest contribution to this debate, McDonald and his Indiana colleagues go further, claiming that the original studies upon which the IOM report relied assumed wrongly that all patients who experienced errors or ''adverse events'' and then died might have lived if not for those adverse events.
''The implication is that if it were not for the adverse event they would have lived,'' McDonald said in an interview. ''But there's a reason these people were in the hospital. My fear is we'll start spending money on error accountants instead of on more nurses or other ways to help patients.''
But Leape, in his published rebuttal, says the original research took into account patients' underlying risk of death. He also notes that the studies looked only at hospital patients. With more than half of all surgeries now occurring on an outpatient basis, he writes, those studies, if anything, underestimate the total number of medical errors.
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