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- - - - - - - - - - - - Aug. 18, 2000 | Like many academic scientists, John W. Norton supplemented his salary by giving talks sponsored by drug companies. A few nights a month the University of Mississippi psychiatrist would drive to some town in the boondocks and, over rubber chicken dinners, lecture the local general practitioners about antidepressant medications. Norton made an earnest effort not to promote any particular company's drugs, and when the $500 checks arrived in the mail a few weeks after each talk, he'd cash them without the slightest qualm about his scientific objectivity. But the sweet arrangement ended in February, when Norton published a brief article discussing the sexual dysfunction triggered by the very drugs whose makers were paying his honoraria. After the article appeared, Norton's career as a pharmaceutical educator came to a sudden end.
"My invitations to speak suddenly dropped from four to six each month to essentially none," Norton says. "As the father of five children, I began to feel uneasy." He found himself seeking out drug company representatives to tell them he was "still on the team," and even looking for reasons to prescribe their drugs. "I had deluded myself into thinking I was educating physicians and not being swayed by the sponsors," he says. "I was naive about what was at stake" -- i.e. the millions of dollars in profits that come from antidepressant drugs. Norton's wake-up call is an echo of the alarms sounding throughout the biomedical community, where researchers are starting to realize the extent to which their livelihood is reliant on commercial interests. Changes in the structure of medicine in recent years have meant that funding for research increasingly comes from the drug industry. Researchers and the universities they work for are often stakeholders in the products they are supposed to be testing with objective distance. Just because research is funded by drug companies doesn't mean it's inaccurate. But investigators are starting to detect patterns of research bias with subtle and obvious effects on the treatment of patients. This week at a federally organized conference, scientists and medical ethicists discussed ways to handle conflicts of interest in research. At the close of the conference, Dr. Greg Koski, the government's new biomedical research ethics chief, said he expected some new regulations to come down, probably next year. The soul searching in biomedical research began soon after Jesse Gelsinger, a photogenic 16-year-old with a rare inherited liver disease, died during a gene therapy experiment at the University of Pennsylvania last September. Gene therapy researchers, according to FDA and NIH investigations, had failed to report adverse reactions to their treatments and inadequately warned patients about the risks of the experiments they would participate in. But the grubbiest fact to surface from the subsequent investigation was that James Wilson, the University of Pennsylvania researcher in charge was a founder and major stockholder in the company sponsoring the trial. Which meant that when deciding whether the therapy could succeed, he had a major conflict of interest. A scientist conducting a clinical trial is supposed to be Solomonic in his objectivity, like a judge settling a dispute. Yet while we'd never tolerate a judge who owned a liquor store ruling on whether beer or treadmills were better for the heart, academic researchers have generally been off the hook. They can own stock in companies whose products they test. They can accept consulting fees and attend conferences in warm tropical locales at the companies' expense. They can even be officers in the companies. Some universities have restrictions, some don't. There is no federal law controlling conflict of interest in human subjects research. Scientists have historically been untouched by conflict-of-interest rules because of the widespread assumption that they were devoted, intellectually driven people who didn't care about money. That has all changed. In 1980 the Bayh-Dole law required federally funded universities to work more closely with industry to develop products that resulted from the research. But the total blurring of academic and industrial medical research didn't occur until the mid-1990s, when the biotech boom hit just as managed care and Medicare reform combined to shred the finances of university medical centers. Today, clinical research is increasingly conducted on uninsured patients by cash-strapped physicians and universities funded by drug companies. Should we be worried that practically every biomedical researcher worth his or her salt is now a co-founder of a biotech startup or a consultant to one or more pharmaceutical companies? That more than half the human testing of drugs developed by American companies is either done overseas or contracted out to private physicians who generally know nothing about the drugs they are testing? It depends on who you talk to. For most of the 700 people attending the conference this week in Bethesda, Md., financial conflicts are a thorny ethical issue that can be managed -- which in practice means it can be talked to death without doing anything fundamental to stop it. "Conflicts of interest," said William Raub, a top official in the Department of Health and Human Services, which sponsored the conference, "have become an inescapable part of the research scene." He and other speakers intimated that we don't really need to worry about scientists acting unethically just because they own parts of the drugs they are testing -- that the profit motive can enhance responsible research. The only worry, most of these speakers seemed to be saying, is the danger that in the unwashed masses‚ mistrust of science will be deepened by perceived conflicts of interest.
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