ADVERSE DRUG REACTIONS: A Leading Cause Of Death, Study Says

      Well over 100,000 Americans die each year in hospitals because of adverse drugs reactions (ADRs), and more than two million become seriously ill because of prescription drugs, according to a study published in today's Journal of the American Medical Association. The University of Toronto study found an "extremely high" incidence of ADRs in the data compiled from 39 American hospitals over 30 years (1966-1996). In fact, the researchers say even their most conservative estimates make ADR the sixth leading cause of death in the U.S. -- ranking behind heart disease, cancer, stroke, pulmonary disease and accidents -- but causing more deaths than pneumonia and diabetes. The overall incidence of "serious ADRs" was 6.7% in the data studied, and that of "fatal ADRs" was 0.32%. For 1994, the researchers estimate that 2,216,000 hospital patients had serious ADRs and 106,000 died from the ADRs (Lazarou et al, 4/15 issue). Click here to view an abstract of the study.

Bigger Than Anyone Ever Thought
      "This is the most careful study that's ever been done, and I think the size of the problem is much larger than anybody had thought," said Dr. Bruce Pomeranz of the University of Toronto, one of the co-authors. "These are not mistakes, that's the remarkable thing," he added ("World News Tonight," ABC, 4/14). The results are surprising because the "deaths ... are not due to mistakes by doctors in prescribing drugs or by patients in using them. Rather, drug reactions occur because virtually all medications can have bad side effects in some people, even when taken in proper doses," the New York Times reports (Grady, 4/15). "These are properly prescribed, properly administered drugs," said Pomeranz. However, he said, "We're not advocating taking fewer drugs, or that drugs are bad. Our purpose is to increase awareness" (Kong, Boston Globe, 4/15).

FDA To Blame?
      "[S]ince drugs are only tested on a few thousand people before approval, it is impossible to determine all of their potential side effects, or their severity," ABC's George Strait reported. "After a drug is approved, the FDA depends on doctors and patients to call them if there are problems. But it only has 50 full-time investigators to look into millions of injuries and deaths -- 50 investigators," he continued ("World News Tonight," ABC, 4/14). The Wall Street Journal reports that Pomeranz blamed the problem "in part" on the FDA because it "fails to track it closely and relies on hospitals, doctors and drug companies to report such cases voluntarily." According to Pomeranz, "This fosters a 'lull' or false sense of complacency that the problem is not as endemic or widespread as it really is." But FDA Acting Commissioner Michael Friedman said, "I wouldn't point fingers in blame here. I see this as a shared responsibility" with the pharmaceutical industry, physicians, nurses and hospital administrators.

Health Care Industry To Blame?
      American Hospital Association's Rick Wade agreed that the medical community "can do a better job." But he said the "old way of doing it" -- with medical charts -- "doesn't work. We need better systems" (4/15). Public Citizen's Dr. Sidney Wolfe said, "The drug industry needs to be the main culprit here because they have promoted the use of prescription drugs to the tune of about 12 billion dollars a year of advertising promotion every year" ("FOX Report," 4/14). But the Pharmaceutical Research and Manufacturers Association released a statement yesterday "urging consumers not to take the findings 'out of context,'" the Washington Post reports. "Drugs are powerful substances and affect different people differently. They cannot be made completely safe for all patients in all circumstances," said PhRMA President Alan Holmer in an interview.

Better Reporting
      Pomeranz called for better reporting of ADRs by hospitals and said "additional research" is needed to determine "which drugs are most problematic and which patients are most at risk," the Post reports. The FDA "in recent years has implemented new systems for preventing, identifying and keeping track" of ADRs, said Friedman. According to the Post, a nationwide electronic system allows doctors to report ADRs, and pharmacies can use a system that automatically prints out side-effects. "The important message is not to be afraid of your medication but to be respectful of the possibility of side effects," said Friedman (Weiss, 4/15).

Questionable Results
      But some researchers "urged caution in interpreting the findings," the Globe reports. "It's a matter of context. How seriously ill are the patients, how many drugs were they taking?" said Dr. Hershel Jick of the Boston University School of Medicine (4/15). In a related editorial in today's JAMA, Dr. David Bates of Brigham and Women's Hospital criticizes the way the study was conducted. "I think their estimates are probably high," he said. First, Bates says "an inherent limitation of meta-analysis is that combining the results of small, heterogenous studies does not necessarily bring one closer to truth, particularly if the processes used to identify and to validate the presence of the events were heterogenous." He also contends that "the hospitals studied are probably not representative of hospitals at large." However, Bates does concede that the results are "important." "It's a serious issue, and one that hasn't received attention it deserves," he contends. He goes on to call for better reporting methods, such as computer surveillance, but notes that many hospitals cannot "readily implement such a system" but should be able to in the near future (4/15 issue).

Warning Label
      The Los Angeles Times notes that the "analysis did not specify which drugs were most risky or what diseases patients had when the adverse reactions occurred." But other studies, according to the Los Angeles Times, "have found that the drug types causing the most serious medical problems in hospitalized patients are painkillers ... antibiotics and antiviral drugs." The elderly are also the most likely to suffer ADRs "because they are more likely to have multiple, underlying health problems and also tend to have a weakened liver and kidneys, the organs that break down and eliminate medications" (Monmaney, 4/15).