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Policy Loopholes Don't Protect Patients in Clinical Studies Many medical schools have policies that do not protect patients against doctors profiting from positive research results, a new study says. (ArtToday) By Daniel Q. Haney The Associated Press B O S T O N, Nov. 29 — University rules to prevent researchers from putting their own financial interests ahead of the well-being of patients in medical studies are often weak and easy to sidestep, an analysis concludes. Most medical schools have regulations that limit financial conflicts of interest by doctors who perform experiments on human volunteers. However, these vary widely. A report in Thursday's New England Journal of Medicine reviewed the rules from the 10 medical schools that receive the most research money from the National Institutes of Health. Many Loopholes in Guidelines "We were surprised that there were so many loopholes in the guidelines," said Dr. Bernard Lo, who directed the review. "If we said, 'How would someone invest who really wanted to cash in?' we found that all but one of the universities gave them scope to do that in ways that were very troubling." Drug companies routinely pay medical school physicians to conduct clinical trials, or human studies designed to test the safety and effectiveness of drugs and medical equipment. Can Positive Results Increase Income? "We have no problem with paying people for the effort they put in," said Lo, a researcher at University of California at San Francisco. "It's a problem when their income increases if the trial turns out to be positive." The most obvious way this can happen is when researchers are paid in company stock or stock options rather than a set fee. If the study shows the treatment works, the stock increases in value. Only Harvard Medical School among the top 10 universities categorically prohibits researchers from holding stock or options in companies that may be affected by the results of the research. Lo noted that three other universities place limits on stock but allow a variety of exceptions that undercut their potency. For instance, one university allows stock ownership but bars researchers from trading stock while research is going on. Another allows researchers to hold stock that they inherit. All 10 universities require researchers to disclose their financial interests in companies whose products they study, including stock and income from salaries, honorariums and consulting fees, at least if these total more than $10,000. All also require disclosure of financial interests of spouses and dependent children. Besides Harvard, the schools reviewed were Baylor College of Medicine, Columbia University, Johns Hopkins University, the University of Pennsylvania, the University of Washington, Washington University, Yale University and the University of California at San Francisco and Los Angeles. Some Lack Policies A second report in the journal by S. Van McCrary and others from Baylor surveyed all 297 medical schools and research institutions that get more than $5 million a year from the NIH or National Science Foundation. It found that 15 of the 250 that responded had no policies on conflict of interest. Federal regulations give universities responsibility for managing conflicts of interest. However, these conflicts must be reported to the government if researchers get more than $10,000 in annual pay or stock from a company or own more than 5 percent of the company. McCrary found that 9 percent had guidelines that exceeded this federal standard. Last May, Harvard Medical School decided not to ease its tough conflict of interest rules. "Just as we expect elected officials and governmental appointees to be free from any appearance of bias, so should we expect academic scientists to adhere to the highest standards of intellectual integrity," Harvard medical Dean Joseph B. Martin wrote in a separate report in the journal. In an editorial, New England Journal of Medicine editor Jeffrey M. Drazen said medical schools should adopt uniform policies on stock ownership.