The University of Miami Schools of Business and Medicine held the University of Miami Global Business Forum. The event, entitled “The Business of Health Care: Defining the Future,” included a large attendance, with participants such as Department of Health and Human Services (HHS) Secretary Kathleen Sebelius, Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg, and numerous high officials from the pharmaceutical, device and insurance industries.
The forum was divided into several tracks including Economics & Health Care, the Aging Population, Age of Innovation, Wellness & Prevention, Global Health Issues, and Health Care Delivery 2030, each with a number of panels discussing a variety of issues.
Two of the panels, entitled Managing Conflict of Interest: The Patient-Centric View and Coping with a New Landscape of FDA Regulations: The Patient-Centric View, explored the pitfalls, risks and rewards of conflict of interest policies in health care, including recently enacted regulations that supporters credit with increasing transparency in doctor-industry relations and reducing risks to patients. Participants on this panel included:
– University of Miami Medical School Dean Pascal Goldschmidt
– Dr. Richard Stack, Managing General Partner, Synecor LLC
– Bill Hawkins, Medtronic CEO
– Jon Cohen, Senior VP and Chief Medical Officer at Quest Diagnostics
– Peter van der Goes, director of health care banking at Goldman Sachs
– Dr. Bill O’Neill, Executive dean for clinical affairs at the Miller School
– Thomas P. Stossel, M.D., director of the translational medicine division, Brigham and Women’s Hospital, Harvard Medical School
– John Capek, Executive Vice President, Medical Devices, Abbott Labs
Panel Discussion
In his opening remarks during these panels, Dean Goldschmidt agreed that it is critical for transparency’s sake and for patient protection’s sake to report and manage all relationships with industry. However, he asserted that “we do not believe that all interactions should be proscribed between industry and doctors.”
Since medical advancement depends on interaction between physicians and the
device and drug industries, panel members agreed at the Forum “that there needs to be a careful balance in their relationships, with the patient always coming first.”
Dean Goldschmidt added that, “In effect, taking the patient-centric view, it is clear that industry alone is not poised to develop successful drugs, devices and therapeutic strategies without the opportunity to maintain and foster successful but regulated
interactions with physicians and nurses.” As a result, he warned that “There is a risk
that the pendulum will swing so far as to make industry partnership with physicians impossible.”
Dr. Richard Stack, a professor emeritus of medicine in cardiology at Duke University who co-founded and invested in Synecor and other medical device companies, spoke about his experience at Duke, where he said “device development
was able to thrive under strict standards that required full disclosure for all
faculty and others involved.” Dean Goldschmidt also emphasized the Miller School’s publicly accessible and searchable website that discloses all relationships between
faculty physicians and industry, including all compensation.
Medtronic CEO Bill Hawkins pointed to the incredible advances in medicine, and the need for much more in the age of significant chronic diseases. He asserted that what the US has accomplished in medical advances is remarkable, “citing deep brain stimulation and neurodegenerative disease therapies, and declines in some disability and mortality rates.”
However, he recognized that “the most successful breakthrough therapies have come through interaction in this unique ecosystem that involves academia, hospitals,
regulators, advocacy groups, and many more to ensure we can advance innovation
and bring the technology that makes a difference in people’s lives.” While Medtronic and similar companies must continue to have guidelines, he said innovation requires partnering with people who have the ideas for lifesaving technology.
Dr. Stossel “drew applause when he said medicine is substantially better today than
when he started, primarily because of the tools developed by private industry
through the interaction with physicians.” Nevertheless, he recognized that much is at stake because, “while there is a need for high standards, such policies must allow room for innovation.”
He added that patients need to be more aware of how the system works, and “they should be worried that lawyers are running the show.” He also stated that while transparency is laudable at face value, “we must be sure that it doesn’t divert precious resources from innovation, that it is accurate and that it is not abused by opportunists.”
In both panels, participants, especially Stossel and O’Neill, “spoke passionately
about how FDA regulations are forcing some clinical trials and medical
developments to move to foreign countries with substantial job loss for the US
amongst other casualties.” Panelists gave examples of device trials that moved
to South America and Asia because FDA rules would have significantly prolonged
the timeframe and raised the costs for testing and production. They praised
countries in Europe that had strong but more manageable drug and device
regulations, allowing new therapies to be benefit patients sooner.
While O’Neill said there must be conflict of interest policies and government
regulation, he added, “We have to be careful we are not preventing the next
generation of Dr. Stacks—brilliant doctors who have worked with industry to develop lifesaving technologies and medical advances.
Conclusion
The audience during these panels agreed that the aggressive attacks on conflicts of interest and overzealous FDA regulation are problematic. Moreover, all participants agreed that patients should be prominent participants in future policy decisions regarding conflicts of interest and FDA regulations. This principle is extremely important for Congress and policymakers to consider.
Conflict of interest policies created by agencies, academic medical centers, and institutions are created as a way to ensure that individuals and companies are operating in the public’s best interest. However, the public has largely been neglected from policy changes and decisions at all of these institutions, when by and large, it is the patients who will feel the greatest impact when such policies are fully implemented. If physicians at research centers and medical schools continue to be restricted from collaborating with industry, medical technology and advances will decrease, affecting patients negatively.
Patient groups and advocacy organizations should begin to encourage working with academic medical centers, agencies, and institutions to create a balanced set of guidelines for managing physician-industry collaboration. While it is important that conflicts of interest are adequately managed, the overwhelming majority of Americans would almost certainly rather have new treatments and medications that save their lives and make them healthier instead of piles of conflict of interest policies which cannot help anyone.