PROFESSIONLawsuits over clinical trials have doctors wary, but not quitting research yetAlthough the potential for high awards in recent litigation has heightened attention to the clinical trials process, the long-term effect on medical research is unclear.By Vida Foubister, amednews staff. April 16, 2001. Alan Milstein is quickly becoming a household name among physicians involved in medical research. In less than seven months, the Pennsauken, N.J.-based lawyer has filed three lawsuits on behalf of clinical trial participants that name physician investigators as defendants. His most recent target is the Fred Hutchinson Cancer Research Center in Seattle. Two previous cases were filed against the University of Oklahoma Health Sciences Center in Tulsa and the University of Pennsylvania in Philadelphia. And he told AMNews that more cases will follow. "I'm hoping to achieve a focus on the [oversight] system that's in place now that's not working," he said. Milstein believes that neither institutional review boards nor the federal Office for Human Research Protections are doing an adequate job of protecting human subjects. Instead, the ethical nature and safety of clinical trials "depends solely" on the doctors and scientists who conduct them. "In our major institutions, where you've got Nobel scientists and Nobel doctors and well-regarded professors, the IRBs more or less simply rubber-stamp whatever protocol one of these men put before them," he said. To many involved in medical research, Milstein's statements smack of a "plaintiff's lawyer looking for business." "I'm not saying the system is perfect," said David Korn, MD, senior vice president for biomedical and health sciences research at the Assn. of American Medical Colleges. "But there's an extraordinary degree of oversight right now and great scrutiny of what you're going to do and how you're going to do it."
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