More MS news articles for November 2000

Without Clear Guidelines, Sponsorship Money Can Color Medical Research

http://healthwatch.medscape.com/medscape/p/gcommunity/HNews/hnews.asp?RecID=226251

By Jennifer Warner

Oct. 31 (CBSHealthWatch)--As financial ties continue to grow between university researchers and industry sponsors, vague conflict-of-interest policies at America's top research institutions may jeopardize the quality of medical research as well as the public's trust, according to a new report.

Pharmaceutical companies far outspend the government in providing funds for clinical research conducted at centers across the country, and last year the nation's top ten drug makers spent $22.7 billion, primarily on clinical research. But a collection of articles published in the Nov. 1 issue of The Journal of the American Medical Association (JAMA) suggest that accepting sponsorship or other assistance from biotech and pharmaceutical companies should come with specific guidelines from the research institution.

Federal law requires research centers to have some type of financial disclosure policy on the books, but a survey of the 100 top-funded research institutions in the United States found only about half of the centers require disclosure from all faculty. In addition, most policies are not specific about the kinds of relationships with industry that are permitted or prohibited.

"There should be a national stimulus for institutions to come up with at least some baseline monitoring mechanisms," says JAMA editor Catherine DeAngelis, MD, who wrote an editorial on the issue. "We've got to be constantly vigilant to make sure that the scientific research process is secure and safe.

"The issue is: How do you best prevent a researcher from becoming involved with a pharmaceutical company in a way that the decision-making process is altered?" says DeAngelis. "When the funding agency interferes with the natural process and the natural integrity of the scientific process, that's when it crosses the line."

Researchers say financial ties between a researcher and corporation can come in a variety of forms beyond direct sponsorship of studies. For example, a case study done at the University of California at San Francisco found 34% of disclosed relationships involved paid speaking engagements, 33% involved consulting agreements between the researcher and sponsor, and 32% involved the investigator holding a position on scientific advisory board or board of directors.

"It's difficult for academic institutions to make policies because the nature of academic-industry ties is changing so rapidly," says Mildred Cho, PhD, senior research scholar at Stanford University. "It's been difficult for institutions to know what's going on with their faculty."

Cho and her colleagues surveyed the major research institutions and found there were few specific prohibitions or limits on activities related to research and teaching. Nineteen percent of policies specified limits on faculty interests in corporate sponsors of research, 12% had limits on permissible delays in publication, and 4% prohibited student involvement in sponsored research in which the faculty member had a financial interest.

Cho says one of the biggest hazards of the lack of public disclosure at the university level is the potential loss of public trust if they find out after the fact that there were a number of financial relationships between researchers and companies. "I don't think the public is aware of the extent to which that occurs in biomedical research," says Cho.

Experts say having a financial interest in research can also affect the quality of the research, the outcome of it, the type of research questions asked, and the likelihood of the findings being published. Cho says the effects of bias can be subtle and psychological, which makes it difficult to tell in any one case if the outcome was influenced, but overall it is clear that financial interests have an impact.

DeAngelis says it is in the best interests of research institutions to have companies fund research, and it is important that the research is carried out by the most qualified people (many of whom are at academic centers). But, she adds, "The research institution has a requirement, I believe, to oversee, understand, and know what kind of interests their faculty and staff has with pharmaceutical companies and that they have rules to oversee it."
 

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