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Drawing Lines on Conflicts of Interest

June 11, 2009

Unlike many membership groups that sometimes fight any attempt to regulate their industries, the Association of American Universities and the Association of American Medical Colleges have generally been seen as leaders, not laggards, on the combustible issue of conflicts of interest in biomedical research. The two groups published a series of reports in 2001, 2002, and 2008 urging research institutions to adopt policies and practices to combat both individual conflicts of interest (those involving scientists and others who are directly involved in research) and institutional conflicts, those involving the financial interests of a college or school itself and of officials there who are not directly involved in research.

Adoption of such policies has been inconsistent, and in recent years external pressure -- from a vocal cohort of critics and one very powerful member of Congress, Sen. Charles Grassley of Iowa -- has built not only for greater enforcement of existing policies but for much tougher laws and federal oversight of institutions and researchers. As that pressure has mounted, the AAU and AAMC have sought to strike a balance between continuing to recognize conflicts of interest as a problem and discouraging the overinvolvement of the federal government in the affairs of their members.

That tension is very much in evidence in the two groups' response Tuesday to May's announcement by the National Institutes of Health that it was contemplating toughening the regulations that govern financial conflicts of interest in research financed by the Public Health Service.

In the letter, they generally embrace the agency's assertion that the government and the institutions that conduct research on its behalf must ensure the "absolute necessity of complete and timely disclosure of financial interests and effective management of conflicts." They also endorse recommendations that would require more researchers to report more information about their financial entanglements to their universities than they do now, and lower the thresholds at which research institutions have to disclose information about investigators' conflicts to the federal government.

But the two associations also express their opposition to several proposals that would step up federal involvement and oversight, arguing against them for both practical and philosophical reasons. The groups, for instance, discourage the NIH from mandating specific types of responses that institutions must take to certain kinds of conflicts, from requiring accreditation of conflict of interest programs, and from trying to regulate institutional (as opposed to individual) conflicts of interest. And they generally urge the agency to strike a balance in responding to the inevitable conflicts that will arise no matter the regulatory scheme.

"But reacting by imposing overzealous regulations could disrupt productive partnerships to the detriment of science and the public," the groups write. "The Associations believe that the active and committed partnership among the NIH, the awardee institutions, and the Associations collectively can achieve the necessary and appropriate level of oversight and the requisite degree of accountability while still fostering productive and principled relationships among universities, academic medicine, and industry."

The associations framed their responses around the major questions that the NIH posed in its Advance Notice of Proposed Rulemaking last month, which included: Should researchers have to report more information about their sources of income to the institutions, even if they do not believe it is germane to their work? Should the minimum threshold of payment that is perceived to be a financial conflict of interest be raised? Should research institutions be required to establish committees to review their employees' financial disclosures?

On balance, the two groups took an expansive view of the information that researchers should be required to report to their employers, endorsing the prospect of requiring more categories of scientists to inform institutions about potential conflicts and lowering (from $10,000 to $5,000) the financial threshold deemed to be "significant" and about which such reports must be made.

While the associations say they do not oppose requiring institutions to disclose all financial interests of grant recipients to the Public Health Service agencies that fund them, they warn that doing so would "create a huge volume of disclosures and would diminish PHS’s ability to focus on conflicts with the potential to affect PHS-funded research. A zero disclosure threshold will generate an enormous volume of noise in the system rather than focus on the important signals."

Instead, the associations recommend that institutions disclose to federal agencies any ownership interest that researchers have in non-publicly traded companies, but income or ownership valued at more than $5,000 (or 0.1 percent) in a publicly traded company.

The associations say they are open to an NIH proposal that would require grant recipients with more than 50 employees to create an institutional committee to review researchers' potential financial conflicts. But they balk at the idea that the government might dictate what steps a university should take when they identify conflicts and decide to try to "manage" rather than eliminate them, as is commonly the case.

"Prescribed standards could not possibly anticipate the myriad facts and circumstances encountered by Associations’ members," the groups write, adding: "Because of the large contextual variation in circumstances in which conflicts of interest may arise, such an approach would almost always be either excessive, misdirected, or inadequate, depending on the circumstances."

Regarding regulatory changes aimed at their own compliance with federal rules, the associations note that they have supported Congressional legislation that would require drug and medical device companies to disclose their payments to scientists, and say that such a system would "have an immediate and salutary effect on conflicts of interest programs," to give them a source with which to compare the reports that individual researchers are already required to file with them.

And while many research universities are voluntarily participating in an accreditation system for human subjects research that examines conflicts of interest, they say they are "strongly opposed" to any requirement that they participate in such a system.

They also discourage the government from wading into the issues surrounding institutional conflicts of interest. "The Associations believe that the complexity of the issue of institutional conflict of interest, the extensive differences among grantee institutions in administrative structure, and the level of difficulty institutions have faced in putting these policies into place while still complying with national, state, and local imperatives for economic development and active partnerships with industry all suggest that institutional conflict of interest is not a matter for federal regulation at this time," they write.

The associations' statement was welcomed by Senator Grassley, the Iowa Republican who has been conducting what is virtually a one-man campaign against biomedical conflicts of interest, through a series of revelations of alleged wrongdoing and various legislative proposals. "These two associations have been real leaders for their professional communities in trying to establish transparency and, in turn, build public confidence," the senator said in a prepared statement via e-mail. "My focus for reform is full disclosure of financial relationships, but the National Institutes of Health ought to consider everything the Association of American Universities and the Association of American Medical Colleges have to say in this comment letter.

"The research community could have avoided a lot of the problems we see today with great discrepancies and disregard for policies, if it had listened to the AAU and the AAMC in 2001, when they made recommendations along the same lines.”

Nothing in the groups' letter surprised Thomas P. Stossel, the American Cancer Society Professor of Medicine at Harvard Medical School and a rare, outspoken critic of the stampede to condemn researchers' corporate and other financial entanglements. "It's not at all surprising that when the NIH asks, 'What should we do?' on conflicts of interest, the AAMC responds, 'You should do what we said you should do' "in 2001," Stossel said. He said that he is not opposed to the idea of greater financial disclosure -- "Let's just disclose everything; I'm fine with that" -- but argues that the main people who will benefit are tort lawyers who will use the information to file specious lawsuits against doctors.

"No one has proven there are any damages from not disclosing this information," Stossel said. "Patients don't care, they're not interested in it. So I just would like someone to tell me what good is going to come from this."

 

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