Tuesday, May 16, 2006

 

Drug firms control medical studies

Thursday, October 24, 2002 - 12:00 a.m. Pacific

Drug firms control medical studies


By Linda A. Johnson
The Associated Press

Drug companies that pay for major testing of most new medicines give participating university researchers little or no say in how studies are designed and how findings are handled, a survey found. The survey of 108 medical schools, published in today's New England Journal of Medicine, is the latest sign of growing concern about conflicts of interest between those doing scientific research and 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.

While federal agencies sponsor much early research, large-scale studies of drugs' safety and effectiveness usually are funded by manufacturers. Typically, companies hire medical-school faculty members to carry out studies.

But some scientists worry their lack of control could threaten the integrity of research and the safety of participants. 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. Researchers at Duke University interviewed officials at U.S. medical schools last winter and reviewed some of their research contracts to determine how many complied with the new guidelines. Only a minority did.

Schulman said researchers have less and less control over patient trials as more and more studies include dozens of medical centers, a strategy meant to bring results faster.

Among the study's findings:
. Researchers rarely were allowed a say in the design of clinical trials,
with only 10 percent of contracts covering how data is collected and
monitored and only 5 percent covering how data is analyzed and interpreted.

. Fewer 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 harmful.

Financial ties between academic researchers and industry sponsors already are under scrutiny for apparent conflicts of interest, as when researchers receive stock in a company testing an experimental drug.

The Pharmaceutical Research and Manufacturers of America last summer established voluntary guidelines for clinical research, but they are "basically toothless," said Dr. Jeffrey M. Drazen, editor of the New England
Journal. "The system would be better served if there were universally accepted contractual language," he wrote.

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