Camilleri, Michael MD; Parke, David W. II MD
A recent joint policy statement from the Association of American Medical Colleges (AAMC) and the Association of American Universities1 offers a detailed roadmap for academic institutions to protect patients and preserve integrity as they identify, evaluate, and manage financial conflicts of interest (COIs) that arise when individuals or institutions conduct research involving human participants. Research organizations, granting agencies, the National Institutes of Health (NIH), and the U.S. Food and Drug Administration (FDA) have all recently experienced increasing scrutiny from the media, Congress, and the public regarding COI issues that impact research involving human participants. The American Medical Association (AMA), through its Council on Ethical and Judicial Affairs (CEJA), also has drafted new guidelines dealing with COI for physicians,2 and final recommendations are expected soon. In contrast to the extensive coverage of individual and institutional COIs in the literature, little attention has been given to the somewhat unique COI issues faced by professional membership organizations. Such organizations function principally to serve the professional interests of their members and the patients they serve by providing advocacy, management, and professional education—the latter commonly through peer-reviewed journals, newsletters, and meetings involving a “trade show” component.3
In this article, we address COI issues within these professional organizations. Thus, we focus on organizations that serve as the “public faces” of specific professions. These organizations have responsibilities to their members, must be sensitive to societal expectations, and (in the absence of federal policy) may serve as role models for members who function outside of entities with formal COI policies. A review of such professional organizations' scope of activities typically reveals a robust menu of significant relationships with corporate sponsors.
The diversity of professional organizations dictates that one size cannot fit all; COI management is predicated, at least in part, by the activities conducted by individual professional organizations. We propose general principles that our combined experience suggests may serve as a starting point for others to develop customized COI management strategies.
Addressing COIs Within a Professional Membership Organization
We have considered nine principal questions regarding COIs within professional membership organizations: (1) What makes COI management different in professional membership organizations? (2) What COI challenges are specific to professional organizations? (3) What are potential impacts of perceived or real COIs involving professional organizations and the management of COIs? (4) Is regulation necessary, or should professional organizations proactively resolve COI issues independently? (5) Are guidelines portable from academic medical centers to professional organizations? (6) What approaches may be considered for managing COIs of the organization's leaders? (7) What approaches are reasonable for managing COI issues at professional meetings? (8) What approaches are important for ensuring the integrity of educational programs, publications, and products? and (9) What approaches are reasonable for managing and enforcing COI guidelines on an ongoing basis?
What makes COI management different in professional membership organizations?
List 1 summarizes typical functions and activities of a professional membership organization. The organization depends on the active involvement and voluntary leadership of its members to accomplish its mission and to maintain its credibility as a valued resource. Any real or perceived “commercial taint” or COI of the professional organization or its leaders might imperil its membership enrollment, credibility as a source of continuing education, certification by the Accreditation Committee for Continuing Medical Education, and effectiveness as a “professional voice” to the public.
Unlike academic medical centers, which have multiple revenue streams including patient-care income, grants and contracts, state or institutional support, and philanthropy, professional membership organizations typically depend on membership dues and revenue generated by their meetings for the largest proportion of their budgets. Professional membership organizations are, therefore, economically and organizationally vulnerable to any activity that compromises their credibility as an independent voice representing a profession in service to its members or the public.
What COI challenges are specific to professional organizations?
No COI challenges are unique to professional membership organizations: COIs in governance, educational products and programs, meeting sponsorship and conduct, endowment growth, public programs, and journal editorship are shared with other entities. However, certain opportunities for conflict are more visible in a professional organization. Industry visibility at meetings and public statements made by the organization regarding industry products may both be perceived as endorsements. Thus, a professional organization must design and implement not only policies dealing with conflicts arising from research funding and subsequent presentations at its meetings and in its publications but also policies that address wide-ranging issues of clinical conduct, sponsorship of programs, adherence to federal regulations, and diverse industry activities at meetings.
The purpose of exhibitor booths at meetings is to sell products. Product samples for professionals, kiosks for Internet access, coffee, snacks, and meals enable industry to use a meeting as a venue for marketing products. Exhibitor marketing extends beyond the booths, to hotel, airport, and bus banners, to attendees' hotel rooms and public spaces, to social and educational events outside meeting hours, and to the physical space devoted to the activities of the professional organization. Selling the rights to display sponsorship on bags, lanyards, hotel keys, buses, meeting “newspapers,” and elsewhere may generate hundreds of thousands of dollars of important revenue to the professional organization—in addition to revenue generated from the rental of exhibitor space.
Materials and activities endorsed by pharmaceutical and device companies during organizations' meetings are conspicuous, constant advertisements for the sponsors.
What are potential impacts of perceived or real COIs involving professional organizations and the management of COIs?
Professional membership organizations have two primary constituencies: their members and the public, which includes patients served by the members, health care policy makers, and the general population. Perspectives among different stakeholders regarding real or perceived COIs of professional organizations may differ.
Members require their organization to be an effective, trusted voice and to advocate on behalf of their profession and its practitioners. When a professional organization is recognized as the “voice of the profession,” it draws credibility and support from industry, payers, news media, other professional organizations, federal and state agencies, and elected officials. COIs within an organization compromise its legitimacy as the voice of the profession. Loss of this prestigious position may result in an exodus of members to competing organizations, resulting in negative impacts on finances, operations, and governance.
Members also expect programs sponsored or conducted by the organization to be of high quality and scientific credibility; COIs that taint the credibility of these educational offerings risk losing the support of the membership.
Tolerating commercial intrusions into a professional organization's “core mission” risks sending a message to members and to the public regarding “true” versus “actual” value, promotes a sense of organizational dependency (financial or other), reinforces an “entitlement mindset,” and may impede development of other, more effective learning modes.
Is regulation necessary or should professional organizations proactively resolve COI issues independently?
There are presently no consensus regulations or recommendations regarding management of COIs for professional organizations. Report 1 of the CEJA of the AMA made recommendations2 on Industry Support of Professional Education in Medicine. The three main recommendations were, first, that “individual physicians and institutions of medicine... not accept industry funding to support professional education activities, except when new diagnostic or therapeutic devices and techniques are introduced; second, that medical schools and teaching hospitals . . . limit industry marketing and promotional activities on their campuses; and third, that the profession . . . identify the most effective modes of instruction and evaluation for physician learners . . . and obtain more noncommercial funding of professional education activities.”4
On June 16, 2008, the AMA House of Delegates rejected these recommendations despite the proposal that compliance would be voluntary. The AMA's CEJA and Council on Medical Education are collaborating to develop complementary companion reports.5 Rothman et al3 recommended numerous specific COI management points for physician membership associations including an upper limit on industry support as a percentage of operating budget and an absence of any COIs for key organization leadership (among others).
Given the dearth of regulatory commentary regarding management of COI for professional organizations, the federal government may intervene (as evidenced by the Draft: Physician Payments Sunshine Act of 2009 championed by Senators Grassley and Kohl6) and develop regulations addressing the breadth of physician–industry interactions. The Council of Medical Specialty Societies has commented on the specific language in the bill regarding certified continuing medical education, the need to distinguish direct payments to physicians versus indirect benefits to physicians, and the unintended consequence of disclosure potentially leading to the use of physicians' names for marketing purposes.7
We believe that professional organizations would be better served with self-regulation. Many members, leaders, and representatives in these organizations consider the status quo unacceptable; they clamor for the medical profession to take the high road—to preserve and enhance societal trust of physicians and their organizations. Many organizations have crafted and enforced codes of ethics that directly address COI issues.8
Thoughtful and well-articulated COI principles constitute an important value proposition for the members of a professional organization, enabling protection of the organization's brand, conservation of public trust, and validation of educational programs sponsored by the organization. At the same time, COI policies may pose an operational and financial burden if they cause the organization to forego revenue opportunities or enact practices considered intrusive or onerous by a portion of the membership. Indeed, competing physician organizations may capture revenue and member loyalty by enacting less stringent policies than those of their counterparts.
We suggest that professional organizations in the same specialty should collaborate (while not violating Federal Trade Commission regulations9) on COI policies and guidelines, such that similar policies become active simultaneously in multiple organizations. This will create interorganizational congruency for members and for industry, and it will present a unified philosophy to the public. The Council of Medical Specialty Societies is currently engaged in just such an effort.10
Are guidelines portable from academic medical centers to professional organizations?
Leadership at academic health centers are employed by these institutions to further specific missions pertaining to direct patient care, research, and education. On the other hand, leadership of professional organizations have a strikingly different governance relationship within the organizations they lead, resulting in incomplete portability of guidelines originating at academic centers into the professional organization milieu. Nevertheless, among the seven principal recommendations by Brennan et al11 for academic medical centers to manage institutional COI, we perceive that all except the seventh recommendation8 generally pertain to professional organizations:
* Prohibit direct provision of drug samples to physicians.
* Disqualify physicians from participating in speakers' bureaus, which are regarded11 as marketing maneuvers of the corporate sponsor and should be differentiated from independent-content educational CME events that may be sponsored by industry; further guidelines will prove necessary to further define what constitutes a speakers' bureau.
* Prohibit publishing anything ghostwritten by industry employees.
* Ban all gifts (large and small) from drug and device makers, including free meals, which is consistent with PhRMA guidelines in 20098 and AdvaMed guidelines.12
* Prohibit direct support of CME programs (including travel) by industry.
* Establish a central fund, pooling unrestricted grants from multiple sources to be distributed by the organization.
* Prohibit formulary committee members' direct financial relationships with drug or device companies.
The first six recommendations are simply a starting point in developing effective COI policies. The main threats to the integrity of a professional organization are the endorsement of clinical guidelines (discussed below) that favor the product of an industry that supports the organization, and the presumption that members' and organizations' relationships with industry are significantly conflicting, even when they may support mission-related activities of the organization. Ties to for-profit corporations may foster certain agendas within a professional society and disadvantage others. A COI may be perceived if “unrestricted” grants received from for-profit corporations for research and education lack complete transparency, if the organization partners with sponsors in credentialing members' competencies (e.g., with devices) in educational programs for the lay public, or if the organization allows cobranding. The presumption that the COI in such situations is unmanageable is rebuttable, and our proposed management approaches in such events are summarized in List 2.
What approaches may be considered for managing COIs of the organization's leaders?
When identifying and managing COIs, elected or volunteer leadership and employed leadership both deserve scrutiny, and similar rules should apply to both groups. Each organization must define the term “leadership” for itself; for this purpose, leadership may be limited to the president, president-elect, and immediate past-president (the Presidential trio) and to the executive leaders employed by the organization. In accordance with responsibilities in some organizations, leaders may include the board of trustees, certain committee chairs, and participants in clinical guideline development. General recusal from all activities with industry involvement is not a practical option for managing COIs, and it risks excluding some of the best clinicians, scientists, or administrative leaders. COIs must be recognized and managed “sensibly and effectively.”13 This requires a code of ethics, disclosure, an honor system, and general principles to manage relationships of a professional organization with industry.
Policies perceived to be unduly onerous may reduce members' willingness to serve in volunteer leadership capacities. Similarly, a complex process of COI disclosure and management for the hundreds of volunteer members called to serve their organization may be unreasonably resource-intense for the organization. It seems unnecessary to manage the business activities of nonexecutive employees in their conduct of the business of the organization with corporate entities, including medical education companies, hotels, or transportation companies. Such business does not seem to pose potential COIs for the professional organization. In principle, any member speaking at an organization-sponsored event must, however, be familiar with and act in compliance with the policies of the organization.
We recommend that the Presidential trio and the staff executive leader of the organization members should have no financial COIs during their terms of office. In addition, those charged with selecting “influential” presentations at professional meetings (e.g., state-of-the-art lectures, plenary sessions, clinical symposia), and the majority of members of clinical guidelines committees, should have no financial COIs during the conduct of these specific responsibilities. This principle applies to direct or indirect conflicts. Indirect conflict occurs when the individual has a relationship with a commercial interest that is in competition with the issue under consideration.
What approaches are reasonable for managing COI issues at professional meetings?
The potential for COI is high at any professional organization's annual meeting, a point of convergence of the organization, industry, and a large number of physician members who depend on the meetings for high-quality education and exposure to new drugs and devices. All of these parties (and patients) are best served not by rigid avoidance of all situations that might engender COIs but, instead, by interaction and collaboration governed by clear policies of disclosure, management, and enforcement. However, some activities must necessarily be eliminated or curtailed.
In coordinating annual meetings, professional organizations must work with industry to communicate any policy regarding what constitutes a COI and determine how that conflict can be managed. Nevertheless, the organization's scope of responsibility and authority is limited by a number of factors, including time, geography, and the heterogeneity of physician members. For example, it is difficult for the organization to control what goes on before and after the meeting dates or to control events occurring outside the meeting space for members. If societies and corporate sponsors can agree on principles in a spirit of cooperation, the influence of those principles may extend beyond the confines of the convention halls or the annual meeting.
The heterogeneity of physician members typically ranges from solo private practitioners with little direct exposure to COI issues to academicians already functioning in a highly regulated environment. Some members value participation as student and/or teacher in industry-sponsored events during society meetings. Draconian changes in meeting structure and operation are, therefore, likely to meet with as much disapproval as approval from the membership—with tangible impacts on the organization. Therefore, substantive changes must involve all major stakeholders and should be communicated to all in advance of the meeting.
What approaches are important for ensuring the integrity of educational programs, publications, and products?
Despite increasing disclosure in publications and presentations, there are still problems managing COIs in industry-sponsored programs and products of professional organizations. There are still misperceptions as to what constitutes a conflict, and policies dealing with COIs, including those of the AAMC and the International Committee of Medical Journal Editors,14 are implemented differently, even by the same journals.15 Physicians have not historically received formal education on identifying and managing COIs in their training, and there is no requirement for certification or CME in COI issues (in contrast to the requirements of “responsible conduct of research” and “protection of humans” for eligibility to conduct NIH-funded or FDA-governed research). Doctors are also confused by the mixed messages found in the Bayh–Dole Act, legislation dealing with intellectual property arising from federally funded research. This act gives U.S. universities, small businesses, and nonprofits the ability to own and license intellectual property that resulted from the federal funding. The act fosters the belief that it is in the interest of the public and economic good of the country to commercialize intellectual property; on the other hand, federal regulations imply that it is desirable that investigators should be free of any personal financial interest.
Another challenge to the integrity of professional organizations arises in overt forms of industry advertising in society journals and annual meetings. The sale of these ads provides revenue necessary for the society's missions, but it is important to disclose this support and to avoid covert ways in which the organization may directly endorse the companies' products by association. Examples of perceived endorsement include an organization's selection of state-of-the-art topics and speakers for lectures at the annual meeting or society-endorsed “consensus guidelines” that may be tainted by the conflicts of individual members participating in guideline development.
When clinical practice guidelines receive the endorsement of a professional organization, there is need for even greater transparency about individual COIs and the perceived COIs arising from relationships of the professional organization and the company whose products are appraised or recommended in the guidelines. In one example, several pharmaceutical, diagnostic, and device companies' financial support of the European Crohn's and Colitis Organization was disclosed in the organization's consensus guidelines on the diagnosis and management of Crohn disease.16 The journal required the authors of an editorial about the guidelines17 to disclose their personal, potentially competing interests. Interestingly, the personal interests of the authors of the consensus guidelines were not provided. Such inconsistency is also demonstrated by another example. Clinical guidelines on Crohn disease management in adults18 were developed under the auspices of the American College of Gastroenterology, which publicly disclosed support from several companies in a capital campaign in 2007.19 Therapeutic or diagnostic products of those companies are featured in the guidelines. Appropriately, the authors of the guideline disclosed very thoroughly their personal financial or research interests with the corporate entities. Conversely, the potential COI of the professional organization in light of the previously disclosed industry support is not addressed in the publication. The perception of potential for bias in consensus guidelines extends to the professional organization as well as the authors.
So, is disclosure an effective strategy for managing COIs in professional organizations? The best financial disclosure policy for presentations at meetings or contributions to enduring materials or Web sites is only as good as the mode in which it is communicated to the audience or readership. All too often, disclosures are made but are structured or presented in a fashion that does not allow the audience to determine whether the potential conflict is meaningful or not. This may taint the content or the entire educational event. Bias may be perceived where it is not present, or overlooked when it is relevant.
There are no universal principles to manage conflicts arising from personal financial interests other than the federal government's pronouncement of $10,000 as the threshold for significant financial interest. One institution applies a sliding scale according to the grade of financial interest to manage COIs in clinical practice.20 A similar graded approach may apply to managing financial COIs for professional organizations. With such an approach, industry relationships could be managed by the administrative staff with oversight by the ethics committee, and full disclosure in appropriate venues by the professional organization, as in annual meetings, journals, and annual reports that are available to the members and the public. For example, in cases of sponsorship of more than $10,000, the organization would acknowledge COIs by public disclosure in its annual report, as well as at the individual activity (e.g., annual meeting). If sponsorship were more than $50,000, the organization's administrative staff would manage the COIs (e.g., oversight and independent appraisal of decisions involving the sponsors' products at meetings) and report to the ethics committee. For amounts above $100,000, the ethics committee specifically would impose strategies to manage the COIs, including review of content and speakers selected. All of this assumes, first, that it is possible to establish an honor code through education and example, and, second, that the professional organization actually has an ethics committee vested with final authority, not just an advisory capacity. Among four national organizations pertaining to gastroenterology and hepatology—the subspecialty of one of the authors (M.C.)—two have standing ethics committees, and both of these committees serve in an advisory capacity. There is a need to educate societies and leaders about the importance of awareness of COIs and to implement mechanisms through which it can be managed.
Some rebut the value of an honor code, of sliding scales, and of disclosure.21 Large corporate marketing and physician gifting programs are used as evidence that most industry–physician relationships cannot be managed and that “there do not seem to be deliverables that meet the ethical and moral test for justifying industry involvement in legitimate CME.”21 We believe, however, that there are real deliverables in appropriate relationships with industry that are of value to members and, ultimately, to society. These deliverables include a broad spectrum of organization activities, such as education programs and peer-reviewed research, that can best be enhanced by a well-crafted and monitored series of policies and operational procedures that recognize the genuine desire of the organization to responsibly guide the profession and the public it serves. We appreciate that, as the public and its representatives recommend or demand “zero tolerance,” more stringent management strategies may be required for individuals and organizations. There is need to ensure that the restrictions do not hinder the greater interest of the public, which is best served by educated professionals practicing evidence-based medicine.
What approaches are reasonable for managing and enforcing COI guidelines on an ongoing basis?
Following the development and issuance of policies pertaining to COIs comes the very substantive task of management and enforcement of these policies. Ideally, if similar policies are taking effect in multiple organizations within a profession, the tasks of management and enforcement should ideally be handled in a similar fashion across organizations.
Effective COI policy management will require some degree of central coordination of sponsorship opportunities, negotiation, and resolution. All appropriate organization staff and volunteer leadership must be trained in the organization's policy. Regular adherence to issues such as disclosure and recusal must become a part of the organizational culture. Databases of industry relationships with the organization and its leaders must be established and maintained to ensure a current COI disclosure registry that is widely accessible and regularly reported, such as in the annual report to members and the public. Potential conflicts, when identified, must be subject to a standardized review and management process. Policy violations must be reviewed and guidelines enforced, with sanctions imposed as necessary.
For a large organization, such an approach would probably necessitate a special standing committee. Though this committee would be autonomous and would ultimately report to the senior governance body, the responsibilities described likely should reside with the organization's ethics committee.
This review of the current state of management of COIs in professional organizations reveals a lack of regulation and a paucity of discussion on this topic in the published literature. We have examined common experiences as members in numerous different professional organizations in our respective specialties and explored ways in which the principles of management of individual and institutional COI may lead to strategies for a professional organization. Some principles are worthy of emphasis: First, there must be a code of ethics governing the general behavior of members and safeguarding the interest of patients; second, the actions of leaders need to be monitored, managed, and, in some cases, may even require recusal from certain industry relationships; third, unrestricted grants from corporate sponsors have to be carefully and consistently managed; and fourth, members and society at large expect that professional organizations scrutinize the appropriateness of industry marketing efforts at membership meetings and in all industry relationships. Some professional organizations already have developed principles governing corporate support of their programs. An example of the set of principles enacted by one organization is provided in List 3.
We believe it is possible to manage unrestricted industry “donations” to professional organizations in a manner analogous to that recommended by Brennan et al11 for academic medical centers. Professional organizations should develop overarching principles; emphasize ethical principles, transparency, and clarity over “purity”; focus on the long-term need to protect the “brand” of the professional society over short-term gains; and adapt the concept of “rebuttable presumption”22 applied in research in academic centers to the activities of the professional organization.
Educating members and emphasizing the long-term benefits of having a COI management policy are key objectives of the professional organizations. Although we offer initial recommendations for management of professional organizations' COIs, further study and commentary by others are needed as this issue evolves.
We conclude that professional organizations have similar missions as those of academic institutions with regard to serving members and providing public education. Industry relationships with these organizations and with member physicians are not necessarily bad or riddled with irresolvable conflicts. We do not perceive that fewer, less frequent, or more modest gifts from industry to professional organizations will affect the existence or perception of COIs.23 If the risks and benefits are appraised and the relationships are properly managed, physicians and industry can relate in ways that will benefit the organization, its members, and the public. If COI issues are ignored or improperly managed, the trust of members and the public will be forfeited, and the organization may suffer irreparable harm.
The authors thank Dr. Robert Sandler, past president, and Mr. Robert Greenberg, executive vice president, of the American Gastroenterological Association Institute for permission to use the information in List 3. They also thank Ms. Marianne Hockema, administrator in the Office of Conflict of Interest Review at Mayo Clinic, for helpful discussions, and Mrs. Cindy Stanislav for excellent secretarial assistance.
Funding/Support: Dr. Camilleri reports the following industry support: Industry research grants for single-center pharmacodynamic or diagnostic validation studies in the past year: ABDiagnostics, Bristol-Myers Squibb, Theravance; Consulting for drug development: Albireo, GlaxoSmithKline, Ipsen, SK Biopharma, Takeda, Tioga, Wyeth; Royalty: Enteromedics (device for obesity).
Other disclosures: Dr. Camilleri's current organizational relationships are president of the American Neurogastroenterology and Motility Society and chair of the Publications Committee and member of the Governing Board of the American Gastroenterological Association. Dr. Parke reports the following industry relationships: Board of Directors: Ophthalmic Mutual Insurance Company; Dr. Parke's organizational relationship is executive vice president and CEO, American Academy of Ophthalmology.
Ethical approval: Not applicable.