Chapter 205 Conflicts of Interest and Conflict Management
Background on Conflict of Interest
As U.S. federal government funding for research and development has diminished, academic researchers and innovators have become increasingly dependent on industry for financial support. An analysis from 2007 reveals that industry remains the largest contributor to biomedical research at 58%, followed by the National Institute of Health (NIH) (27%), state and local government (5%), non-NIH federal sources (5%), and nonprofit groups (4%).1 Although more money is spent on pharmaceutical research, the rate of research spending growth increased the most for the medical device sector.1 In addition to funding research, industry currently spends $7 billion on promotion to medical professionals in the United States.2 Industry also provides nearly $850 million in funding for continuing medical education (CME), which in 2009 accounted for 39% of total funding.3
Even though much of this money goes toward research and education, companies providing funding are inherently in conflict as they have a fiduciary responsibility to their shareholders to make decisions that will maximize returns on investments. Therefore, it is left to the individual physician to appropriately structure relationships with industry to pursue research and innovation while simultaneously minimizing and appropriately managing conflicts of interest. Unfortunately, many physicians have been inappropriately influenced by such associations. The media has highlighted numerous questionable and sometimes clearly unethical physician–industry relationships.4 Scrutiny has become so tight that the mere appearance of a conflict may be enough to publicly indict a physician. Hence, the public demands greater transparency and honesty in physician–industry interaction.
In addition to these media reports, a growing body of evidence indicates that interactions with industry bias physician practice. A systematic review published in 2000 highlights a large body of evidence that pharmaceutical gift giving is associated with increased company drug formulary requests, decreased generic prescribing, more rapid prescribing of new medications, and prescribing patterns inconsistent with medical teaching.5 Because of the increasing influence of industry, many regulatory bodies have spent significant effort studying COI in physician–industry interaction.
Defining Conflict of Interest
According to the Institute of Medicine (IOM), a conflict of interest is a “set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest.”6 The primary interest for the physician is patient care with indirect interests in research and education. Secondary interests include financial gain, career advancement, and recognition. Even though nonfinancial conflicts can be equally influential, they are difficult to regulate. Therefore, current guidelines primarily focus on financial COI.
Current Guidelines
In the last 2 years, a flood of commissioned reports have been issued by various medical and surgical organizations. In 2008, the Association of American Medical Colleges (AAMC), which represents accredited U.S. medical schools, major teaching hospitals, and many scientific societies, released its new physician–industry guidelines. This was released shortly after the American Board of Internal Medicine (ABIM) in conjunction with the IOM issued a similar report. Both reports call for distancing industry from medical professionals and eliminating practices likely to inappropriately influence physicians and provide little patient benefit. This included a “zero dollar limit” on gifts from industry, restricting industry access to physicians to appointment and invitation only, eliminating speaker bureaus with industry-controlled content, and centralizing industry distribution of product samples and CME funding via central offices to minimize industry influence or advertising.7
Since the release of these reports, there has been a strong movement by leaders at academic medical centers to enact these changes. There has also been a growing emphasis on increasing transparency of physician–industry financial arrangements. Several medical centers, such as the Cleveland Clinic, now maintain public databases that list self-disclosed physician–industry financial arrangements.8 The Duke Clinical Research Institute created a similar online site and in 2009, the Commonwealth of Massachusetts began to mandate online disclosure of industry ties in its own online site.9 In 2009, the IOM committee called for Congress to create a national program for reporting industry payments to physicians similar to one proposed by the Medicare Payment Advisory Committee.6,10 Such legislation recently took shape in the Patient Protection and Affordable Health Care Act passed on March 23, 2009. The new legislation contains “the Sunshine Provisions,” which require drug and medical device companies to publicly report gifts and payments made to physicians and teaching hospitals.11
Managing Conflicts
In any potential COI, the intricacies of the social, professional, and financial relations are often too varied for generic management algorithms. Therefore, we emphasize the importance of applying principles of COI management to each situation. Ultimately, effective COI management requires education more than regulatory steps. We have simplified the principles of COI management into four primary principles (Box 205-1). The most important and often missed step is the recognition of COI. One must not only have knowledge of the different types of COI that may occur in patient care, research, and education, but must also have the skills to recognize these conflicts when they occur. The second principle is to avoid conflict when possible. Although avoidance is often not feasible, there are clinical instances in which this principle can be applied. For example, gifts to physicians, which provide no patient benefit, should be avoided completely. Industry access to physicians in the clinical setting should be minimized to only what is necessary (e.g., intraoperative device assistance) and should otherwise be limited to appointment or invitation only. Arrangements permitting industry control in research trials or CME content should also be restricted. Third, interaction with industry must be made as clear and explicit as possible. Contracts are created where possible to clarify duties, define expectations, and detail any exchange of funds. Finally, proper COI management requires appropriate disclosure to maintain full transparency. Disclosures can be made in research publications, educational or CME presentations, institution or state databases and to patients when applicable. Box 205-2 provides examples of techniques to manage COI in patient care, research, and education.
Being Involved in the Debate
On the other hand, pharmaceutical innovation places less of a burden on the clinician. There is no skill to be learned or instrument to be mastered. Moreover, outcomes and adverse events are often entirely independent of an individual operator. These differences require that COI-related regulations or policies must reflect the unique relationship between the surgeon–innovator and industry.
Association of American Medical Colleges. Industry funding of medical education: report of an AAMC task force. January 7, 2009.
Brennan T.A., Rothman D.J., Blank L., et al. Health industry practices that create conflicts of interest: a policy proposal for academic medical centers. JAMA. 2006;295:429-433.
Institute of Medicine. Conflict of interest in medical research, education, and practice. April 21, 2009.
. Medicare Payment Advisory Commission: Report to the congress: Medicare payment policy. March 17, 2009.
Steinbrook R. Online disclosure of physician-industry relationships. N Engl J Med. 2009;360:325-327.
Transparency rules at the cleveland clinic. Lancet. 372, 2002. 2008
Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA. 2000;283:373-380.
1. Dorsey E.R., de Roulet J., Thompson J.P., et al. Funding of US biomedical research, 2003–2008. JAMA. 2010;303:137-143.
2. Brennan T.A., Rothman D.J., Blank L., et al. Health industry practices that create conflicts of interest: a policy proposal for academic medical centers. JAMA. 2006;295:429-433.
3. . Accreditation Council for Continuing Medical Education (ACCME): ACCME annual report data. 2009.
4. Abelson R. Financial ties are cited as issue in spine study. New York Times. January 30, 2008.
5. Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA. 2000;283:373-380.
6. Institute of Medicine. conflict of interest in medical research, education, and practice. April 21, 2009.
7. Association of American Medical Colleges. Industry funding of medical education: report of an AAMC task force. January 7, 2009.
8. Transparency rules at the Cleveland Clinic. Lancet. 372, 2002. 2008
9. Steinbrook R. Online disclosure of physician-industry relationships. N Engl J Med. 2009;360:325-327.
10. Medicare Payment Advisory Commission. Report to the congress: Medicare payment policy. March 17, 2009.
