CLINICAL TRIALS: Patient Protection System ‘Flawed’
Clinical trial participants could be exposed to "unsafe and unethical practices" because the national system charged with protecting them is riddled with problems, a new federal investigation reveals (Pear, New York Times, 5/30). The draft report by Department of Health and Human Services Inspector General June Gibbs Brown pointed to "crushing workloads, inadequate training and potential conflicts of interest" among the institutional review boards that protect patients who are involved in clinical trials of experimental drugs and medical devices, the Wall Street Journal reports (McGinley, 6/1). Brown said the boards "review too much, too quickly, with too little expertise" -- a serious warning signal to consumers and the drug companies and federal agencies that conduct the studies, the Times reports (5/30). The findings come as President Clinton and lawmakers on Capitol Hill are pledging increased spending on biomedical research. Some legislators have floated proposals that would double the budget of the National Institutes of Health over the next five years, a change that could mean a fivefold increase in clinical trial participants, according to the Journal.
A System In Jeopardy
The Journal reports that some 3,000 to 5,000 review boards across the nation are charged with protecting clinical trial participants -- part of a government mandate "that research be approved and monitored by the review boards, which are mostly locally based panels of experts and laymen." Most boards are hospital-affiliated, but some are associated with managed care companies or other for-profit organizations. But the government investigation reports that the current system "is in jeopardy" and calls for an overhaul including better education of researchers and reviewers about patient protections and the inclusion of "an adequate number of consumer representatives to promote independence and objectivity." Brown also urged the Food and Drug Administration to regularly inform the review boards of any actions taken against researchers who are conducting a clinical trial (6/1).
The government report noted several problems with clinical trial review boards, including: a lack of expertise among panel members about techniques like genetic testing, gene therapy and animal tissue transplants; scarce information about patient protection when studies are conducted simultaneously at several hospitals and a deluge of research proposals that makes "perfunctory review" the norm. Review boards frequently are inundated by "reports on drugs' harmful side effects," but their workloads might be so heavy that they "spend just 'one or two minutes of review per study,'" the investigators report (Times, 5/30). Brown also raised concerns about potential conflicts of interest: "Clinical research provides revenue and prestige to the institutions to which (the review boards) belong. The institutions expect (the review boards) to support these interests at the same time that they protect human subjects" (Journal, 6/1). Dr. Bert Spilker, senior vice president of the Pharmaceutical Research and Manufacturers of America, said the review boards are "harried by an enormous workload," but said he was "surprised and offended" by the report's claim that conflicts of interest are rampant, the Times reports (5/30). To ease the burden on local panels, Spilker "urged the establishment of a national review board to handle multihospital trials" (Journal, 6/1).
Fewer Patients To Protect
As the federal government reports that patients in clinical trials may not be getting adequate protections, researchers are struggling to find patients willing to participate in their studies. The Baltimore Sun reports that even as current studies make strides in the fight against cancer, "many trials go begging for volunteers." Researchers who recently reported success in treating breast cancer with the drug tamoxifen cited "the slow pace of recruitment" as one factor that caused the trial to "take five years rather than two to complete." Ultimately, researchers settled for a smaller sample than they had originally hoped to use. Among the problems in finding patients to participate, researchers cite difficulty in convincing doctors to recommend an experimental drug, overcoming patients' concerns about the drugs' risks and recruiting patients when some of them are likely to get a placebo instead of the experimental therapy. Problems also occur when patients are saddled with medical costs associated with the trials that their insurance companies refuse to pay. Although drug companies and research grants "typically cover experimental therapies," the cost of related hospital stays or other costs stemming from complications often fall on the patient (Bor/Sugg, 5/31).
See the current issue of U.S. News & World Report for the story of a California family's struggle with its insurance company to obtain coverage for experimental breast cancer treatments (6/8 issue).