AAMC Reporter: December 2008

Institutions Expand Conflict of Interest Policies

Medical schools and teaching hospitals nationwide are creating new financial conflict-of-interest (COI) policies in response to increasing calls for action from inside and outside the academic medical community.

Earlier this year, when the AAMC released two reports urging the medical community to firm up their COI guidelines, only a handful of medical schools and teaching hospitals already had far-reaching measures in place, said David Korn, M.D., the AAMC's former chief scientific officer. Although Korn is uncertain of the specific number of schools changing their policies, he is optimistic that the tide is turning.

"By 2010, institutions without comprehensive policies will be outliers," Korn said. "The AAMC's actions reinforced what work had already been done, and brought attention to all members to do something more."

In the medical community, a COI can occur when professional or patient interests clash with industry's goals or objectives. In the research setting, an investigator receiving funds for a project may be disinclined to report negative results. An educational COI occurs when impressionable students think more favorably of a company after receiving a gift.

The first report, created by the AAMC and the Association of American Universities (AAU) and titled "Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research," calls on academic centers and universities to refine their policies on individual COI in human subjects research and to implement institutional COI policies within two years.

The second report, titled "Industry Funding of Medical Education, Report of the AAMC Task Force," urged medical schools to implement by July 2009 a full plan to govern student and faculty interactions with industry in the context of medical education.

"Even though doctors vehemently deny that gifts from industry affect their decisions, the fact is that they do," Korn said. "There is abundant evidence that companies' marketing techniques do work, and work very effectively, but the evidence is proprietary and tightly guarded by industry. As one former CEO asked me, why else would companies spend billions of dollars every year promoting their products to physicians? It becomes a problem when physicians' prescribing patterns are not based on sound scientific evidence and are driven more by the physician's self-interest than the patient's interest."

Not everyone thinks that conflicts of interest are corrupting the medical community. Thomas Stossel, M.D., a professor at Harvard Medical School, said that everyone involved in medical education—from professors to textbook editors—introduces, intentionally or otherwise, some bias to the process, and that the idea of a purely impartial learning environment is a myth. Furthermore, trying to create this unattainable ideal can actually do more harm than good.

"Medicine is infinitely better today than when I started 40 years ago, and I argue it's because of conflict of interest," said Stossel. "The competition among companies for access to health care professionals fosters production."

Harvard Medical School officials said Stossel's views do not reflect those of the school.

Funding for continuing medical education (CME), which has long relied heavily on commercial support for events, was the focus of a new COI policy introduced at Stanford University School of Medicine, said Harry Greenberg, M.D., Stanford's senior associate research dean. The concern with industry CME support, Greenberg said, is that companies may only fund programs in which they can showcase their own products.

To solve this problem, as of Sept. 1 the school prohibited all new industry funding for specific CME courses or programs. All commercial support not specific to a particular field will be directed to the CME office, which will distribute it in accordance with institutional judgments about educational priorities.

"I'm hoping any academic-industry relationships where continuing medical education was used as a marketing device will decrease substantially," Greenberg said. "Our intent is to remove the marketing influence from CME, and I think it will happen."

Industries are also responding. The Pharmaceutical Research and Manufacturers of America (PhRMA), the association representing pharmaceutical research companies, recently adopted measures to strengthen PhRMA's Code on Interactions with Healthcare Professionals. This updated code, said Diane Bieri, J.D., PhRMA's general counsel and senior vice president, is an effort to ensure that pharmaceutical marketing practices comply with the highest moral standards.

"We are proud of our relationships with academia, and hope this enhances the level of trust," she said.

Among its changes, PhRMA's revised voluntary policy, which will take effect Jan. 1, prohibits industry from giving out noneducation items such as pens, mugs, or restaurant meals. It also requires companies to make sure their employees are trained in COI laws and regulations.

Bieri said she is already aware of around 35 PhRMA members who are supporting the code.

"We have a list of companies that have plans to abide by it, who have embraced the code as their own."

As the University of Kentucky College of Medicine expands its policy to cover institutional COI, it is looking to the AAMC-AAU report for guidance, said James Tracy, Ph.D., the school's vice president for research.

"The report lays out expectations," Tracy said. "It talks about what should be in a policy, and provides case studies. We are looking for best practices so we don't have to reinvent the wheel."

—By Elissa Fuchs