Financial conflicts cloud medical reviews

By STEVE MITCHELL, Medical Correspondent  |  Aug. 14, 2003 at 10:30 AM
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WASHINGTON, Aug. 14 (UPI) -- Financial ties between medical researchers and pharmaceutical companies have been a growing and controversial trend in recent years. Now a new study reveals the arrangements also are pervasive among medical school faculty charged with reviewing medical studies to ensure they do not endanger patient safety unduly.

The findings could intensify the debate about whether monetary ties bias researchers toward the interests of industry over the welfare of study volunteers.

The study, conducted by researchers at Harvard University in Cambridge, Mass., is the first attempt to assess the professional affiliations of members of Institutional Review Boards. These boards, also known as IRBs, are panels comprised of medical school faculty that review research proposals for new medications and therapies to determine if the protocols protect patients adequately and inform them of any inherent risks.

As reported in the August issue of the journal Academic Medicine, the authors surveyed nearly 3,000 faculty members at more than 120 medical schools. They found of those who were IRB members, 47 percent also had served as consultants to the pharmaceutical industry.

"The fact that almost half of all faculty IRB members serve as consultants to industry raises potential conflicts of interest," the authors concluded.

The medical community and the federal government have struggled with ways to deal with potential financial conflicts among researchers, but so far no clear consensus has emerged.

"It's certainly the case that conflict of interest is a problem that has not been solved," Arthur Caplan, director of the center for bioethics at the University of Pennsylvania in Philadelphia, told United Press International. "We simply don't know what to do about it. We haven't figured out how to handle conflicts of interest when researchers have them."

Caplan said he was not aware of any unsafe or unduly risky medical studies that could be traced directly to IRB members having financial conflicts of interest. However, he noted, it "would be hard to pinpoint because there's so little known" about IRBs and how they function.

Still, more and more medical researchers are receiving financial compensation from pharmaceutical and medical companies and "it's an issue that absolutely merits serious attention," Caplan said. "IRBs are supposed to primarily protect human research subjects but if you have a conflict of interest financially it may be that you are not in the best position to protect people," he said.

Eric Campbell, the study's lead author and assistant professor of medicine at the Institute for Health Policy at Harvard Medical School, argued financial ties do not necessarily indicate a researcher has a bias in favor of industry.

"These (ties with industry) are a fact of life today in science and there are good reasons for these relationships," Campbell told UPI. Pharmaceutical companies seek out the most knowledgeable researchers, who also tend to be the ones desired by IRBs because they are most familiar with issues surrounding the protection of human subjects, he explained.

"There's good and there's bad (to financial ties with industry). The issue is to help everyone understand there may be these potential problems and ... the goal is to manage them," Campbell said.

Caplan agreed. Financial ties do not necessarily bias a researcher's judgment, he said, adding one major problem with the IRB system is there is no assurance all ties and potential conflicts are disclosed. He suggested financial ties might be even more pervasive than Campbell's survey indicates. "My hunch is 50 percent is under-reporting. I think it's bigger than that," he said.

Campbell noted the only kind of financial ties surveyed were consultancies by IRB members to industry. "There could be other kinds of relationships, such as receiving research funding, serving on boards of directors, holding equity in a company (and) holding licenses on products," he said.

The Association of American Medical Colleges, which has set up a special task force to assess the issue, does not see a problem with financial arrangements between researchers and industry.

"As long as IRB members declare their financial interests and as along as they are recusing themselves from conflicting proposals I don't see any problem with it," Dr. David Korn, senior vice president for research at AAMC, told UPI.

Korn said AAMC urges researchers to disclose all conflicts, not just those that are financially-related. "It may have nothing to do with money, it may have to do with scientific competition," he said.

The AAMC task force has issued two reports calling for full conflict disclosure among both individual researchers and institutions. The task force also has called for establishment of institutional conflict-of-interest committees to review financial relationships and determine if any conflicts exist. The Association recently launched a survey in May "to see just what affect the reports are having or have had on academic medical centers," Korn said.

Dr. Ross McKinney, vice dean for research at Duke University Medical Center, said the system of voluntarily disclosure that most IRBs currently have in place is adequate to protect human subjects. "It is sufficient, as long as the people who are making decisions are the kinds of people who think about human research protection first," said McKinney, who oversees IRBs at Duke and is responsible for ensuring the policies protect research volunteers

"We're very conservative," he said. "If you think you have any relationship that represents a conflict of interest, you shouldn't be sitting in the discussion."

Others, however, do not think voluntary disclosure goes far enough.

Sheldon Krimsky, professor of urban and environmental policy and planning at Tufts University in Boston, said the mere act of disclosing conflicts would not get people in other professions off the hook if they had conflicts of interest and it should not be acceptable in scientific research.

A judge or government employee with financial conflicts of interest would have to dissolve the arrangement, "they would not be able to get away with disclosure," said Krimsky, who also serves as adjunct professor in the department of family medicine and community health at Tufts Medical School and has written a forthcoming book called Science in the Private Interest that deals with commercial aspects of academic science and its impact on society.

"I don't believe the current system is sufficient," he said "There are too many conflicts of interest that are entering into medicine."

Campbell said the solution should involve more than just disclosure. "That is the minimal," he said. A third party should then review any financial arrangements to determine which are acceptable. This should include mediation so a researcher determined to have a conflict has the opportunity to resolve it and some arrangements may have to be banned, he said.

The federal government is aware of the problem and recently initiated steps to deal with it. In April, the Department of Health and Human Services issued a draft guidance proposing steps that should be taken to deal with financial conflicts of interest among researchers and protect study subjects from potential harm that could result. The guidance has not been finalized but it would apply to IRBs, investigators, and research institutions conducting research funded by the National Institutes of Health, the Centers for Disease Control and Prevention and the Food and Drug Administration.

Krimsky, however, said the guidance is weak and will do little to address problems stemming from conflicts of interest. "A draft guidance document is about as low as you can get without doing anything," he said.

The HHS Office of Human Research Protections was unable to respond to inquiries from UPI before presstime.

Caplan, too, is doubtful there will be a satisfactory solution to the issue any time soon. "The conflicts are so pervasive that it's hard to imagine doing anything except acknowledging them," he said. This is because "IRBs are understaffed and it's hard to get people to serve on them as it is" so eliminating those with ties to industry "would bring the system to a halt."

In addition, other potential conflicts, unrelated to remuneration, have not been addressed.

"Commercial conflicts are important but it's just as problematic to have ambition, promotion and fame in play as sources of conflict," Caplan said. "Everybody from Enron to the New York Times has been grappling with this. It's hard to internally monitor yourself and I don't know if IRBs are any better at it than the editor that doesn't pick up the renegade reporter or the accountant that gets bullied into falsifying documents."

In the meantime, Caplan said, patients considering volunteering for medical research should not merely accept approval by the IRB as proof a study is safe.

"Patients should pay close attention to informed consent forms and ask what's involved in the research and what are the real risks and benefits," he said. "IRB approval is necessary but it's not sufficient," he said.

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