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
