A recent lecture from Robert A. Harrington MD, FACC, focused on the "Relationships with Industry: Effects on the Academic Process and Education of Physicians.”
Dr. Harrington, who is a Professor of Medicine at Duke University Medical Center, is also the Director of the Duke Clinical Research Institute (DCRI). In this role, he is responsible for reporting directly to the Dean of the Medical school.
Introduction
Dr. Harrington opened his presentation by acknowledging and disclosing that DCRI receives grants and contracts from government sources, professional societies, foundations and private industry. Specifically, he noted that industry funding accounts for approximately 60% of annual research funding through the DCRI. He noted that full details on his relationships with industry are available here.
His presentation then went on to frame the current debate regarding physician relationships with industry, and used as examples the headlines of various medical journals, newspaper articles, and other media sources. He portrayed the media outlets as largely for-profit corporations who depend revenues from advertisements and subscription fees. As a result of this dependence, advertisers sell their point of view, which ends up being simple: Bad news sells better than good news (as is evident by the sensational headlines regarding this issue).
Industry and Physicians: The Right Approach
The obvious problem with selling bad news is that the press does not have any social responsibility for “getting it right” beyond the sound bite and easy story. Instead, as we have constantly written, media sources like to use big numbers and dollar signs to distract readers and the public away from the real issue. Consequently, one person who always seems to make it into the limelight for such headlines is Dr. Steve Nissen, of the Cleveland Clinic. Dr. Harrington goes on to portray Dr. Nissen, and his crusade to portray physician-industry relationships as inappropriate by showing some of the stories and headlines he’s made.
Although Dr. Harrington agrees with his debate opponent Dr. Nissen about the egregious behavior by industry, and equally egregious behavior by clinicians
and academics, he disagrees with his approach. Specifically, he believes that since society has rightly taken notice and demands better management of such relationships, the approach to solving these problems deserves thoughtful and deliberate discussions.
Dr. Harrington also disagrees with Nissen because he feels that the alternative of “no
engagement” with the industry in research and education would be bad for the public health. As a result, he believes that while it may be easy to point out the problems, and to vilify and demonize, it is a lot harder and less newsworthy to offer up solutions and a path forward.
Industry-Physician Relationships
Citing the executive summary of the Institute of Medicine (IOM) Conflict of Interest report as evidence of the importance of industry and academia, Dr. Harrington noted the importance of industry-physician collaboration. Specifically, he highlighted that “an effective and principled partnership between academic medical centers and various health industries is critical in order to realize fully the benefits of biomedical research and ensure continued advances in the prevention, diagnosis, and treatment of disease.”
These relationships are especially important because the Medical products industry creates plays an important role in society and for public health. Such partnerships are charged with discovering, developing, manufacturing, and distributing products to practitioners who use them. These relationships also:
– Educate practitioners in product use;
– Educate consumers (advertise);
– Are highly regulated activities (FDA, SEC, other); and
– Create responsibilities for shareholders and profit motives
Consequently, these critical relationships are appropriate and productive to patients and society because they create useful products that improve health and make quality of living affordable. In addition, such partnerships help the health industry by creating useful products that maximize market shareholder value, which ends up leading to more investment in research, development and clinical studies. This relationship is also equally important to clinicians, scientists and PMAs because it helps patients understand diseases and creates opportunities for grants, publications and education for physicians and the public.
Although the reasons and examples listed above show how important physician-industry collaboration is to patients and doctors, questions still need to be addressed in clinical research to avoid bias and conflict. Places that bias could exist and potential areas for real or perceived conflicts of interest include: educational meetings; Annual Scientific Sessions; live programs; Publishing; JACC and related journals; Professional recommendations; Guidelines; CECD; appropriateness; performance; as well as others. To help address this potential, Dr. Harrington notes that in clinical research the following questions should be asked to prevent these kinds of issues:
– What is the question that is being asked?
– What are the design elements of the trial?
– How are the data being managed; how are key decisions made about definitions of key variables; how are the data being collected?
– How is the analysis being done? Who sees the full analysis output? Who has freedom to query the database?
– How is the manuscript written? Who has the right to review? Who has the right to approve?
In addition to these questions, partnerships must also use the following standards and protocol to ensure that clinical research agreements are unbiased:
– Independent Executive/Steering Committee;
– Independent access to data;
– Publication rights and oversight of analyses;
– “Reasonable” duration of confidentiality; and
– Intellectual property protection
CME
Accordingly, Dr. Harrington also discussed the important role physicians and industry play in CME to identify learning gaps among doctors and health care providers. In fact, the role of industry in CME has helped programs and accredited CME providers to:
– Focus on physician performance competencies;
– Involve individual learners by sharing personal performance data and requiring: interaction with faculty and content and commitment to change;
– Train program planners to use assessment to design activities from desired results backwards;
– Provide faculty development activities to involve physicians in using education as a quality improvement tool; and
– Collaborate with other groups or organizations as needed to link to physician quality and performance data
Recommendations
In response to these potential issues, Dr. Harrington puts forward recommendations for appropriate engagement with industry in medical education.
1. Medical education should be treated as a social benefit: Groups who benefit from a well-educated health care community (e.g., medical professionals, medical products industry, government, private foundations, academic medical centers (AMCs), insurance industry) should contribute to the funding of medical education.
2. Medical schools, health systems, hospitals, and practices should establish rules of behavior for faculty, staff and students interacting with industry. These rules should include methods for accepting funds for educational support that are highly transparent and free from commercial control and bias.
3. Firewalls should ensure independence of content development, faculty selection, and delivery methods when AMCs receive industry funds for CME programs.
4. Conferences held in a training environment should follow a standard set of rules regardless of whether or not these are formal CME events.
5. Practitioners should learn more about key issues in decision making when considering technology applications, including the regulatory system, understanding of clinical research, and use of quantitative, probabilistic reasoning.
6. Professional medical associations (PMAs) should provide high-quality training on new knowledge. AMCs should create and invest in first-rate CME offices. Both entities should create explicit guidance for transparency of funding, selection of topics, faculty, and methods of delivery. They should also have clearly defined methods of disclosing relationships with industry (RWI) and managing conflicts
7. Additional formal research on optimal CME models is needed and should be coordinated through AMCs with support/collaboration from the PMAs.
Conclusion
In the end, Dr. Harrington appropriately chose a quote from a report issued by the Royal College of Physicians, which acknowledged the “long and proud tradition” of doctors and the pharmaceutical industry working together. Moreover, the report asserted how this relationship “has resulted in a number of benefits, principally those of new drug discovery, better patient care and improved clinical outcomes. Accordingly, as the Standing Committee of European Doctors and the European Federation of Pharmaceutical Industries Associations declared:
“Cooperation between the medical profession and the pharmaceutical industry is important and necessary at all stages of the development and use of medicines to secure safety of patients and efficacy of therapy.”
As a result, such an “uncontroversial” statement clearly demonstrates why the “need for solid collaboration” between physicians and industry “is universal.”