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A Word From the President: From Perceived Conflict to Principled Research Partnerships

AAMC Reporter: April 2012

Imagine you have been diagnosed with a disease. After consulting with your physician, you decide to enroll in a clinical trial. There is some hope that the experimental product she is testing will be at least as effective as known therapies, and your participation could help advance science. At a time like this, you need to be able to trust that your physician is making decisions based on your best interests, not on a financial stake in the research.

Sustaining the public’s trust in medical research is essential to the very core of the research process. Since serious breaches of that trust were first reported several years ago, major stakeholders—academic medicine, industry, and government—have worked to strengthen the integrity of the research process, outlining a clear path forward for the principled partnerships essential to research advances.

Partnerships between academic medicine and industry have led to important medical breakthroughs over the years, and our ability to engage in them must be preserved. For example, in the 1970s investigators at AAMC-member medical schools and teaching hospitals worked with the private sector to develop the first implantable, rechargeable pacemaker for cardiac disorders. More recently, public-private partnerships at our institutions have led to the development of a device that can tell if a colon polyp is cancerous before removing it. These are only a few of the many examples of the truly remarkable benefits of collaboration between academic medicine and industry.

But in this age of skepticism, academic medicine is justifiably being asked to prove it is worthy of the significant trust and resources Americans place in our research institutions. A few even have gone so far as to suggest that somehow we must “wall off” academic medicine from any relationship with industry. I am gratified to hear a growing consensus among AAMC constituents across the country that maintaining the primacy of the patient at the center of our research through principled partnerships with industry is a top priority. We all agree that even the perception of financial conflicts of interest (COI) can erode public trust in our work.

Working with our member institutions, the AAMC has a long history of leadership on this issue. Over the last several years, Dr. Ann Bonham, AAMC chief scientific officer, and her scientific affairs team have been deeply engaged in discussions with federal agencies, industry representatives, and our member institutions about how we can work together with integrity. Through active participation in crosscutting working groups at the Institute of Medicine and the National Dialogue for Healthcare Innovation, the AAMC is ensuring that the academic medicine perspective is at the forefront of these national COI conversations.

In addition, the AAMC has been working closely with the federal government to refine two new regulations in this arena.

The first is a regulation from the Centers for Medicare and Medicaid Services (CMS) that sets out to fulfill the important “physician payment sunshine” provision of the Affordable Care Act. This proposed rule, issued in December 2011, requires that manufacturers of drugs, devices, and other products covered by Medicare, Medicaid, or the Children’s Health Insurance Program report any payments made to a physician or teaching hospital, including research grants made to the institution. The reported information will be available in a public database starting in September 2013. The AAMC supports CMS’s efforts to increase transparency and has provided feedback to CMS to ensure the information collected and reported is accurate and meaningful.

The second major regulation came last summer when the Department of Health and Human Services (HHS) issued the final rule on financial conflicts of interest in Public Health Service–funded research, representing the first change to its COI regulations since they were issued in 1995. These substantial changes require entities that receive funding from the Public Health Service (which includes the National Institutes of Health [NIH]) make changes to the collection and review of information from investigators about their financial interests related to the research they are conducting. Most AAMC-member institutions are subject to this new rule, which also requires that certain information about identified and managed financial conflicts of interest be made public beginning in August.

We recognize that the HHS rule will have broad implications for our institutions’ COI policies and processes and have been working to solicit your input. We convened a series of meetings across the country late last year to collect practical suggestions on implementation strategies for the new rule. Representatives from more than 50 institutions—large and small, urban and rural, public and private—provided feedback about how they and their institutions are thinking about implementing the new rule. The results of these generative discussions appear in a new AAMC report, Implementing the Final Rule on Financial Conflicts of Interest in Public Health Service Funded Research (available at www.aamc.org/coi2012).

More than merely complying with federal regulations, however, academic medicine is leading the charge to ensure the integrity of the research process. Every year, hundreds of leaders from our medical schools and teaching hospitals gather at our annual Forum on Conflict of Interest in Academe meeting to share strategies to promote the highest ethical and professional standards of conduct at their institutions. For instance, the Cleveland Clinic began disclosing publicly all physician ties to industry in 2008 on a dedicated website and has received praise and recognition in the media, from patients, and from the government. This is just one example, and I continue to be impressed by the innovative approaches I see at your institutions to prevent and manage potential COI.

As NIH Director Francis Collins, M.D., Ph.D., has said, “The public trust in what we do is just essential, and we cannot afford to take any chances with the integrity of the research process.” The AAMC and I are proud to help you demonstrate to patients and research subjects that we are indeed the trusted advisers they deserve.

Darrell G. Kirch, M.D.
AAMC President and CEO