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Archives | (March 2003)
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FEDERAL FRANKENSTEINS: PART ONE
ARE CLINICAL TRIALS BREEDING FEDERAL FRANKENSTEINS? (cont.)
------------------------------------------------------------------ Page 2 of 9 To illustrate the point, in just the first four months of 2002, the newly restructured OHRP, with its limited staff, issued no less than 60 warning letters to major medical centers and universities conducting medical research. The deficiencies identified encompassed a wide range of issues, but among the most common was the failure to assure the informed consent of the subjects – making sure they knew what they were getting into. Nor were these just mere paperwork snafus. They were often substantial omissions – for example the failure to tell subjects in one experiment that the drug they were being given could increase their risk of endometrail cancer! In another case, the agency found an institution allowing individuals with Alzheimer’s disease to sign informed consent documents for an experiment that carried significant risk without considering whether or not they were truly competent to do so. Moreover, the institutions cited were among the most prestigious in the nation, including the Harvard School of Public Health, Yale University and the University of Pittsburgh. The routine failure to assure that research subjects give properly informed consent is an ethical disgrace that strikes at the most fundamental responsibility in medicine: first, do no harm. Indeed, in case after case, researchers have routinely lied to human subjects about potentially life-threatening risks, concealed information of prior fatalities and withheld critical information about serious adverse effects from oversight authorities. But that’s not all. In a growing number of cases, researchers are arbitrarily altering their experimental protocols – the only safeguard a patient has against being harmed – without first obtaining clearance from the Institutional Review Boards that are supposed to oversee their work. Sometimes the results are fatal. Indeed, it was just such a violation that led to the death of Jesse Gelsinger, the 18-year-old young man who died as a result of a gene therapy experiment at the University of Pennsylvania. On the day he received what turned out to be a lethal dose of the adenovirus, tests revealed that the level of certain enzymes in his bloodstream exceeded the limits set forth in the study protocol. The researchers ignored the test results and hours later he died. But, the Gelsinger case was not an isolated example. Prior to Jesse’s death, it was believed that few people had experienced adverse effects from gene therapy research. Only 40 incidents had been reported among some 4,000 research subjects. Following the report of his death, however, a very different picture emerged. A flood of reports poured into the federal government raising the total number of adverse events from 40 to 691. Among these were at least seven fatalities. In other words, less than 6% of the adverse reactions had been reported. It is not just gene therapy where the problem exists. Some of the worst abuses have taken place in the field of cancer research – and at some of the nation’s most prestigious institutions. Among the most egregious examples took place at Seattle’s renowned Fred Hutchinson Cancer Research Center. In two separate experiments at Hutchinson researchers pursued worthless cancer therapies, ignoring clear evidence that they did not work, that the experiments ultimately caused the deaths of at least two dozen patients. Worse, in both cases, there were safer alternatives available that might have allowed the patients to survive. In both cases, federal funds helped to underwrite the deadly research. |
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