- The Washington Times - Thursday, October 24, 2002

The drug companies that pay for major testing of most new medicines give the participating university researchers little or no say in how the studies are designed and how the findings are handled, a survey found.
The survey of 108 medical schools highlights growing concern about conflicts of interest between those doing scientific research and the pharmaceutical companies sponsoring it.
"What the institutions have told us is they feel almost powerless in these contracts," said Dr. Kevin Schulman, a Duke University Medical Center professor who led the survey published in today's New England Journal of Medicine.
While federal agencies sponsor much early research, large-scale studies of drugs' safety and effectiveness are usually paid for by the manufacturers. Typically, the companies hire medical school faculty members to carry out the studies.
But some scientists worry their lack of control could threaten the integrity of research and the safety of the volunteers participating. Among other things, pharmaceutical companies have sponsored research that found a drug didn't work or was dangerous, then suppressed the results.
Concerned about the problem, the International Committee of Medical Journal Editors in 2001 published guidelines for research contracts between medical schools and the pharmaceutical industry.
Among the study's findings:
Researchers rarely were allowed a say in the design of the clinical trials, with only 10 percent of contracts covering how data are collected and monitored and only 5 percent covering how data are analyzed and interpreted.
Less than 1 percent of contracts guaranteed that results would be published and that an independent committee would have control over that. But 40 percent of contracts addressed editorial control of manuscripts.
Only 1 percent of contracts required an independent board to monitor patient safety. Such boards can stop a study early if the treatment is found to be harming participants.

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