AAMC Reporter: March 2007

Conflicts of Interest Targeted in Research, Medical Education

When the academic world comes in contact with the business world, good things often happen. New pharmaceuticals, medical devices, and other treatments and technologies reach the market—and help patients—every day as a result of their teamwork.

However, people in the academic world agree the system is not perfect. Conflicts of interest that arise from industry gifts and remuneration—from small tokens to trips to paid speaking engagements—can cloud judgment, sometimes with disastrous consequences, including recent instances in which new drugs found to harm patients were released to the public despite faulty or incomplete reporting of research findings.

These conflicts are at the heart of several recently completed or ongoing local and national efforts to better ensure the integrity of medical education and biomedical research and help bolster public trust in these national institutions.

"Fundamentally, I think the issue is to respect the importance of relationships between academic medicine and the industries they interact with, but at the same time ensure that the relationships remain principled, protective of the integrity of medical education, research, and clinical decision-making, and capable of withstanding intense public scrutiny," said David Korn, M.D., senior vice president in the AAMC's Division of Biomedical and Health Science Research, which is responsible for the association's Task Force on Industry Support for Medical Education.

Scenarios for potential conflicts of interest in medical education literally begin as soon as the education process itself.

"The issue is so broad that it affects the entire continuum of a physician's career, from the moment you set foot in medical school all the way to a physician's outpatient practice or CME," said Erick Cheung, a task force member, fourth-year student at Albany Medical College, and immediate past chair of the AAMC's Organization of Student Representatives. "The feeling among the students I've spoken with nationally is that interactions with industry are variable in nature but pervasive in frequency. It is really common for students to have these kinds of interactions."

The task force plans to review policies and procedures in place at medical schools and teaching hospitals for managing industry support of educational activities and industry practices of presenting gifts to students, residents, faculty, and staff. After the review, the task force plans to develop and recommend general principles and guidelines for academic medical institutions.

According to task force member Michael Friedlander, Ph.D., the Wilhelmina Robertson Professor and Chair in the Baylor College of Medicine's Department of Neuroscience and chair of the AAMC's Council of Academic Societies, the industry presence in education initially sprang from a relative shortage of resources in specific subject areas.

"With education in pharmacology and with medical devices and other areas, there has been a sort of vacuum created, and industries have filled that vacuum," he said. "There is a need in medical education to have informed and up-to-date education and information in therapeutics. We don't have enough invested in that, so that's where the companies come in."

Funded by the Josiah Macy, Jr. Foundation, the AAMC Task Force on Industry Support for Medical Education hopes to release its findings by the end of 2007. Several other groups are creating or updating their own guidelines for industry interaction in biomedical research and education. Several medical schools including the University of Michigan Medical School, the University of Pennsylvania School of Medicine, Stanford University School of Medicine, Yale University School of Medicine, and the University of California, Davis, have recently beefed up or instituted new standards. The American Society of Clinical Oncology (ASCO) and the American College of Neuropsychopharmacology (ACNP) recently wrote new codes of conduct for industry-related interactions for society members. The Association of American Universities recently formed an advisory committee with the AAMC that is developing supplemental policy recommendations and implementation guidance to assist academic institutions in addressing conflicts of interest in clinical research.

A widely read article co-authored by then-AAMC President Jordan J. Cohen, M.D., which appeared in the Jan. 25, 2006, issue of the Journal of the American Medical Association, provided a strong impetus for these discussions. The article authors called for sweeping changes in policies governing the academic medical community's interactions with industry, especially in the area of medical education.

Government Mulling Action

Along with professional groups and individual institutions, conflict-of-interest policy is drawing federal agency and congressional attention, according to Diane Dean, director of the Division of Grants Compliance and Oversight in the National Institutes of Health's (NIH) Office of Policy for Extramural Research Administration. In comments reported by the Medical Research Law & Policy Report, Dean said policy changes governing financial conflicts of interest in research could affect the administration of medical research grant funding. The White House National Science and Technology Council's Research Business Model Subcommittee is expected to issue proposed changes as early as March in order to harmonize federal requirements for reporting research conflicts of interest.

A central issue is which members of a research team should report potential conflicts of interest. An NIH summary report expected to be released soon could question who on a research team should report potential conflicts, Korn said.

Federal agencies that support clinical research currently stipulate only that research institutions have policies and procedures in place that are compliant with federal regulations, and enforce those policies and procedures diligently.

"It is not black and white," Korn said. "Maybe the AAMC and other groups can play a role in bringing leaders together to have a conversation about what the regulation really intends, and what is reasonable. AAMC believes this reporting and disclosure responsibility is not solely that of the principal investigator, but it need not extend to every member of a research team, either."

The Science of Reciprocity

Many educators and researchers in academic medicine have traditionally contended that smaller gifts or compensation affect decision-making less than larger ones, or that they can resist the influence of such gifts. But now, emerging science in two relatively new fields of study—neuroeconomics and behavioral economics—are uncovering the scientific bases for human decisionmaking and bias.

Read Montague, Ph.D., director of the Human Neuroimaging Laboratory at Baylor College of Medicine, said his lab is currently using functional MRI to study the impact of favors on the brain.

"It is a study of cultural messaging,"Montague said. "Entity X does you a favor. How does it affect you? The answer is, pretty dramatically. The reciprocity instinct is deep-seated, and it does not seem to be too susceptible to modification."

Montague said the lab's findings on the subject are expected to be presented in June at a symposium organized by the AAMC and the Baylor College of Medicine Program in Neurosciences.

Dan Ariely, the Alfred Sloan Professor of Behavioral Economics at the Massachusetts Institute of Technology, said there is evidence that relationships grow and are strengthened through gift giving regardless of conscious intentions.

"Reciprocity is a very strong human motive, both in positive and negative ways," he said. "It doesn't mean a person is evil. There are levels of grayness and all kinds of mechanisms that make us feel it is not improper." Ariely said that no study has shown definitively whether the brain reacts differently to large gifts versus smaller ones, but added that even "a meaningless gift" does make an impression.

The Future

Overall, there seems to be growing sentiment that now is the time to act with respect to all of these conflicts—albeit prudently. In the meantime, various groups continue to codify the nature of their own relationships with industry, while recommending new practices to members.

The ACNP's code, which they hope will serve as a model to other academic societies, stipulates that all clinical trials should be registered and the data (including those from studies with unfavorable results) be published; that ACNP meetings contain no industry-sponsored booths or off-site excursions; that research abstracts or posters will no longer be accepted unless sponsored by an ACNP member or fellow who has a significant role in the project; and that the results be submitted to a peer-reviewed journal within a specified period. The code also includes enforcement provisions. It encourages members to report potential violations to the ACNP's ethics committee, which is empowered to investigate the matter. If the committee finds that a violation has occurred, members would report its findings to ACNP leadership for further action, up to and including banning the participation of the supporting corporation from further activity with ACNP.

According to ASCO Executive Vice President and Chief Executive Officer Allen Lichter, M.D., his organization reminds members of the potential criminal ramifications of releasing research findings to the private sector ahead of the public.

"Some kinds of industry interactions flirt with insider trading. It is potentially legally risky, and we want our members to remember that."

Cheung suggested several forums for educating medical students on the issue, such as medical ethics and professionalism discussions, journal clubs, and pharmacology curricula.

"Students lean toward the idea that education about how to navigate these conflicts of interest is important," Cheung said. "It is crucial not to shelter students; we don't want to be isolated from these interactions. "There are industry interactions that are necessary and productive, but there are other parts as well. The tricky part is determining what is beneficial and what is not."

—By Scott Harris

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