When Janet Woodcock, MD, a top FDA official, appeared before a Senate committee in early February, she tried to put the issue of medical errors in perspective by referring to a patient who dies after chemotherapy. She rhetorically asked whether this would be a medical error, illustrating that just because a patient dies doesnt mean that a physician or a medication is at fault. This is an important distinction, of course, especially given Capitol Hills current focus on the issue of medical errorsa topic that the Institute of Medicine (IOM) tossed onto the political front burner with its incendiary report late last year. The report alleged that between 44,000 and 98,000 people die each year in hospitals from medical errors, and has spurred many congressional committees to hold hearings.
Representative Bill Thomas (R-CA), chairman of the House Ways & Means Health Subcommittee, has suggested that perhaps the commission of medical errors ought to be addressed in the context of the House and Senate managed care bills. These bills passed both houses in 1999 prior to the release of the IOM report without containing any provisions relating to medical errors. One of the steps that the IOM advocated was mandatory reporting to state governments of all medical treatments that lead to serious injury or death. According to this mandatory reporting provision, chemotherapy would most likely be considered as one of these treatments, and the confidentiality of such information, including a physicians identity, would not be protected. However, a General Accounting Office report issued in mid-January questioned the legitimacy of the IOM death estimates. There is little certainty about the frequency of fatal ADEs [adverse drug events], because the data on fatalities stemming from ADEs are even more sparse than the data on overall ADE incidence.