With the increased scrutiny on physician-industry collaboration and relationships, physicians, academic medical centers, and professional medical associations (PMAs) are beginning to feel the pressure to improve their policies and become more transparent. A recent article reviewed the confluence of interest policies for the American Academy of Neurology and its affiliated organizations (AAN).
The article highlights the response of the AAN to the heightened concern about industry COI through an AAN Board of Directors–appointed task force, a review of existing policies, and the implementation of newly revised policies governing AAN relationships with industry.
Background and Summary
AAN has relationships with industry, including pharmaceutical and medical device manufacturers and other medically related commercial product and service companies, which have mutual benefits, but can carry the risk of conflicts of interest (COI). COI may cause unintended harm by creating bias, favoritism, undue influence, and a resulting loss of public and member confidence in the integrity and objectivity of the AAN. In recognition of these risks, the AAN has longstanding policies to prevent and limit COI and their consequences, including strict enforcement mechanisms to guarantee that the policies are followed.
The authors of the article reviewed the AAN′s polices governing its interactions with industry, mechanisms for enforcement, and the recent findings of the board-appointed COI task force, in the context of the 2009 David Rothman and colleagues’ article in JAMA, the Council of Medical Specialty Societies (CMSS) Code for Interactions with Companies (Code), efforts of the American Medical Association in this area, and increased public and Congressional scrutiny of physician/physician organizations’ relationships with industry.
With respect to continuing medical education (CME), AAN policy and practices are congruent with the principles identified in the CEJA Report 1-A-11, “Financial Relationships with Industry in Continuing Medical Education:” minimizing industry influence on programming, transparency for learners, firewalls between industry and program development. H aving zero industry involvement with CME programming is a sound aspirational goal, as noted by CEJA. However, the article recognized that,” having industry support does not present a prima facie unethical situation and the integrity of the AAN can be protected with appropriate measures (as outlined in the Principles, CEJA report, and ACCME Standards).”
The AAN′s Policy on Conflicts of Interest provides four mechanisms for addressing COI: avoidance, separation, disclosure, and regulation. The authors concluded that, “Complete avoidance of relationships between the AAN and industry is not a reasonable strategy because areas of appropriate mutual gain would be sacrificed unnecessarily and because effective and less radical remedies are available.”
Rothman and colleagues identified several guiding principles to consider when addressing relationships with industry, which the AAN supports: transparency, diversification of support, and firewalls to prevent inappropriate influence on programs and publications. However, the AAN disagreed with some of Rothman and colleagues’ recommended methods for enacting these principles. For example, AAN, along with the CMSS Code signatories, believe a complete ban on funding “stifles a mutually beneficial relationship between PMAs and industry in which the two groups share a common interest of supporting patient well-being and medical innovation, with an understanding that these relationships must be highly regulated.”
The AAN′s Principles Governing Academy Relationships with External Sources of Support, including recent amendments proposed by the COI task force, regulate industry interaction with AAN programming, products, and leadership. With the Policy, Principles, and other methods of COI prevention, the AAN meets or exceeds all recommendations of the CMSS Code.
“With its adherence to the Principles since 2004, the AAN has been a leader among professional medical associations in appropriately managing COI related to interactions with industry,” the article concluded. Recent amendments to the Principles maintain the AAN′s position as a leader in a time of increased public scrutiny of physicians’ and professional medical associations’ relationships with industry. The AAN is responsive to the recommendations of the COI task force, and has adopted the CMSS Code.
Study and Review of AAN COI Policies
AAN promotes the highest quality patient-centered neurologic care and enhances member career satisfaction through providing education, information, policy development, and advocacy for AAN members and patients; by setting and maintaining the highest ethical and professional standards for members, staff, and programs; and by upholding the integrity of the AAN and keeping the interests of patients first.
Pharmaceutical and medical equipment manufacturers strive to benefit patients by providing products and services that help physicians diagnose, treat, and rehabilitate patients. To carry out the AAN′s mission, its members prescribe industry-developed treatments that their patients need and use. Therefore, the article recognized, “relationships between the AAN and industry are natural and mutually beneficial.”
The principal risk in AAN–industry relationships is the development of COI that jeopardize AAN′s mission. The article defined COI as “situations in which professional judgment concerning a primary interest such as patient welfare is unduly influenced by a secondary interest such as financial gain.” COI are a serious problem for physicians if they demote the primacy of the patient’s interests and if their presence diminishes the overall confidence that patients and the public have in the medical profession. For medical societies such as the AAN, COI could diminish the confidence of AAN members, patients, and the public in the AAN′s integrity and could jeopardize the AAN′s core value to keep the interests of patients first.
Relationships with industry can produce COI or the appearance of COI, if AAN members, patients, or the public believe that the AAN has sacrificed its credibility and integrity by promoting the interests of industry for its financial gain. The use of industry support to offset costs of AAN programs and offerings makes the issue of maintaining our organizational independence, credibility, and integrity a serious ongoing concern.
This concern is magnified by the national publicity generated by current inquiries by the United States Congress into relationships between physicians and industry, and between medical associations and industry, in which all relationships are suspect, scrutinized, and publicized. This trend of increasing public scrutiny makes even the appearance of COI a liability for the AAN.
The AAN Board of Directors and the AAN Ethics, Law and Humanities Committee previously established policies addressing AAN relationships with industry and COI: the Principles Governing AAN Relationships with External Sources of Support, first published in 2004, and the Policy on Conflicts of Interest, substantially amended in 2008. In response to the article by Rothman et al. and the contemporaneous COI policy formulation by the CMSS, AAN leadership commissioned an ad hoc task force in 2009 to 1) evaluate the extent of AAN-industry relationships; 2) review existing AAN policies that regulate the relationships in the context of policies of other professional medical associations and prevailing ethical standards; and 3) make recommendations to limit COI in such relationships.
The task force made their recommendations from their findings in the form of proposed amendments to the Principles Governing AAN Relationships with External Sources of Support. The revised Principles document was approved by the AAN Board of Directors and adopted by the AAN Foundation Board of Trustees in June 2010.
The task force found many of AAN′s existing policies and practices to be proficient in appropriately preventing or managing COI related to AAN relationships with industry and consistent with prevailing codes and standards (including ACCME standards and aspects of the Rothman et al. article and the CMSS Code).
The article noted that public disclosure of COI is an essential step but only mitigates the COI by making others aware of it. Regulation is a necessary strategy to promote mutual interests while minimizing the possibility of COI. Regulation requires the drafting of effective policies and their vigilant enforcement. The Principles Governing Academy Relationships with External Sources of Support is the AAN′s primary policy in providing such regulation.
In 2004, the AAN Board of Directors approved the Principles Governing AAN Relationships with External Sources of Support, which outline six principles and eight special guidelines to be observed when establishing and maintaining relationships with external sources of support, including industry supporters. The task force also added a section to the Principles specifically outlining special guidelines concerning AAN relationships with industry in particular contexts involving industry (e.g., CME programming, advocacy training, guideline development and dissemination, exhibit hall activities).
The task force identified several goals they felt would be met by their proposed amendments to the Principles. All AAN policies governing relationships with industry must be transparent to members and the public. These policies must assure that any financial support of the AAN by industry is not conditional on any real or implied quid pro quo. Industry monies or representation ought not to influence AAN administration, policies, services, practices, or educational activities.
AAN policies should address the public relations issue of the appearance of COI or undue influence. Such influence grows in magnitude in proportion to the extent of AAN financial relationships with industry. AAN policies governing relationships with industry should be configured to allow appropriate areas of mutual benefit while, most importantly, maintaining the AAN′s high ethical and professional standards and protecting its most valuable and cherished asset, its credibility and integrity as a PMA.
AAN and CMSS regulate through policies that require society control over education programming, transparency of industry funding for programming and publications, disclosure or recusal by faculty and guideline authors, and overall prevention from over-reliance on industry funding for operations. Evidence of AAN enforcement of such policies is AAN′s 2011 reaccreditation with commendation by the ACCME—demonstrating AAN′s compliance with ACCME’s criteria. In addition, AAN support from industry was well below that recommended by Rothman et al.: 18% in 2009 and 17% in 2010 (including journal advertising revenues and meeting exhibits—both excluded from the calculations recommended by Rothman et al.).
The Principles expressly prohibit the AAN from accepting industry funding for development and initial distribution of guidelines. Since adoption of the CMSS Code, the AAN requires a majority of the guideline development panel members to be free of COI relevant to the subject matter of the guideline. In addition, the chair of the panel (or at least one of the chairs, if multiple) is required to be free of COI.
Conclusion
Ultimately, AAN should be encouraged for their approach to maintaining physician-industry relationships, while promoting transparency. The concern is that organizations can engage in group think , often ignoring the benefits of collaboration in attempt to appease their critics.
The statements made in this article reflect their understanding of the important role physician-industry collaboration can have, and the dedication and oversight needed to ensure such relationships continue ethically to benefit patients. Other PMA’s should look to this article and AAN for guidance on how to continue collaborating with industry through thoughtful, reasonable COI policies.