The federal government, foundations, associations, and the Institute of Medicine (IOM) are examining the relationships between physicians and “commercial interests,” particularly biotechnology, medical device, and pharmaceutical companies (Table 1). Discovering a lack of “systematic information” about conflicts of interest (COI) and commercial bias, IOM recently recommended that the federal government study the effect of such conflicts “on the quality of medical research, education, and practice.”1
;)
Table 1: Recent activity concerning COI and commercial bias
The American Society of Nephrology (ASN) shares IOM's concern over the lack of data related to COI and agrees that more research is needed. However, even in the absence of concrete information, it is the responsibility of a professional society to try to understand the extent to which COI interface with its missions. Perhaps no single aspect of COI for societies and those who represent them is as visible and subject to scrutiny as continuing medical education (CME).
The longest phase of the educational continuum for physicians, CME is also a critical element of the country's health care system. “Given the accelerating pace of change in clinical information and technology, continuing education has never been more important,” observed the Josiah Macy, Jr., Foundation.2 By providing a preponderance of CME, professional societies such as ASN improve the quality of health care.3
In addition to CME, societies like ASN provide access to new knowledge by publishing peer-reviewed journals, support basic and clinical investigation through research grants, and advocate for the development of national health policies. To support these missions, many societies—including ASN—solicit funding from commercial interests.
Although some have argued that professional societies should begin to eliminate such funding, others have suggested that such a restriction “would marginalize critical roles that industry, and many physicians working in industry, play in critical medical research alliances.”3,4 Prohibiting industry support could limit the educational offerings provided by societies newly hampered by budget shortfalls. Completely eradicating any semblance of a conflict—and any individual with a corporate relationship—might diminish the pool of qualified speakers a professional society is able to recruit, thus reducing the quality of CME offered, which is the opposite of what such restrictions are meant to produce.4
To assess its mechanisms for managing relationships with commercial interests and to consider new approaches for protecting its members from perceived bias, ASN created a committee on corporate relations in 2008. The ad hoc committee (chaired by John B. Stokes, MD, FASN) was charged with developing policies for governing ASN's interactions with the biotechnology, medical device, and pharmaceutical industries—or any group with which ASN, its leaders, employees, or other individuals whom the review identified might have COI or bias.
The committee reviewed existing interactions between ASN and commercial interests, evaluated relevant literature, and considered COI policies of similar professional and medical organizations. Through a series of interviews with Society leaders and staff who manage ASN's educational, publications, and fundraising programs, the committee identified areas where the Society effectively restricted industry influence as well as gaps in ASN's COI policies.
The committee on corporate relations developed ten recommendations on how to design, monitor, and enforce regulations that improve the Society's interactions with industry. These recommendations are based on the premise that ASN can develop beneficial partnerships with commercial interests as long as the Society's leaders, staff, and members appropriately and responsibly manage their relationships with these entities.
The ASN Council unanimously approved all ten of the committee's recommendations, which relate to industry participation, disclosure, evaluation, standardization, and transparency. The implementation of these policies—including programs that improve transparency and documentation—and past initiatives to separate the development of program content from the Society's interactions with corporations and their representatives, should assure ASN members that the Society is taking the proper steps to prevent bias in the educational and scientific programs in which it participates. ASN is committed to these recommendations and will work in a timely fashion to modify the Society's existing processes and databases to implement these proposals.
Industry Participation
Legislators, policy-makers, patients, and physicians have reasonable concerns about the influence of commercial interests over CME. As cited in numerous reports, industry-funded CME has the potential to influence clinical decision-making.3,5 However, the mere presence of commercial interests does not indicate influence. Rather, certain behaviors—such as corporate involvement in speaker selection—are associated with potential bias.
To insulate the Society, ASN has created a firewall that limits all engagement between industry representatives and education planners. The firewall effectively—yet not onerously—protects the integrity of CME and ensures that industry support enhances, but never dictates, the programs ASN provides for its members.
Recommendation 1
Only personnel not involved in planning or implementing educational content or ASN public policy should conduct fundraising activities for the Society. From time to time, it is in the best interests of ASN to participate with corporate sponsors in the areas of health policy, research, and program development, to name a few. Thus while fundraising activities should be separate from program development, the Society should not avoid interactions with corporations that serve to advance the missions of the Society.
A firewall allows ASN leaders to create educational programs without considering which company will sponsor its costs, avoiding the danger of considering how program decisions might encourage greater company funding. The Society is opposed to eliminating industry support completely because it would likely diminish the quality and quantity of CME, in turn reducing physicians' knowledge of new technologies and practices and impacting overall patient care.
Recommendation 2
ASN should maintain its policy of prohibiting corporate influence in the planning of its educational symposia, which are accredited by the Accreditation Council for Continuing Medical Education (ACCME). The specific planning and identification of speakers for all symposia should be the sole responsibility of the relevant planning committee. ASN should not accept planned programs proposed by educational companies on behalf of corporations.
The Society recognizes the hidden influence industry has through medical education and communication companies (MECCs). As reported by the Senate Finance Committee in April 2007, “the use of third-party CME providers makes it difficult to demonstrate that the educational programs' favorable product messages should be attributed to the sponsoring drug company.”6
In response to the finance committee's concerns, ASN established strict rules for MECC collaboration on industry-sponsored symposia that prohibit any engagement with industry before contact and programmatic discussion with the Society. ASN intends to track its involvement with MECCs to ensure its policies are effective, but believes an outright ban on their involvement may be against the Society's best interest because MECCs can be “innovative, they're efficient, and they have competencies that other provider groups often lack.”7
Although some groups have called for professional medical associations to stop “endorsing…industry's programs, facilitating their operation, or profiting from them,” ASN has found that the quality and effectiveness of associated symposia have improved drastically since the Society became involved.3 Rather than returning to a model in which the quality of these programs is in question, ASN plans the programs with heightened scrutiny.
Disclosure
In considering its policies, ASN had to differentiate between organizational relationships and its members' individual relationships with commercial interests. By virtue of nephrology's expansiveness, many members have numerous opportunities to collaborate with, and benefit from, industry. These opportunities include participating in trials, sitting on boards, and speaking on a company's behalf. Recognizing this fact, ASN requires its leaders, members, and speakers to disclose all information related to financial and professional conflicts; yet the Society is unwilling to prevent qualified nephrologists from participating in its activities solely because a relationship is cited.
To maintain and benefit from the involvement of these leaders, the Society supports processes that effectively review, document, track, and respond to concerns about potential conflicts.
Recommendation 3
The Society should rename the present disclosure form as “the Financial Disclosure and Potential Conflict of Interest Form.” The revised form should include disclosure of two kinds of information: (1) activities related to other societies with similar missions and (2) financial interests related to private corporations (including royalties): ASN leaders and staff must collaborate to manage the formalized review, whereas the Society believes a second-level of review is necessary to adjudicate any conflicts as well as ensure consistency and fairness. The guiding principles articulated by the Federation of American Societies for Experimental Biology for its researchers extend to all aspects of medicine: Individuals “must operate with transparency…[and] must be accountable to stakeholders.”8 ASN's leaders will identify when conflicts require further action and will either prohibit those individuals from participating in Society activities or require them to disqualify themselves from pertinent discussions.
- The Financial Disclosure and Potential Conflict of Interest Form should include a level of financial involvement with private corporations.
- ASN should develop a process for reviewing the Financial Disclosure and Potential Conflict of Interest Form and taking action in cases where further information is needed or where a potential conflict exceeds a threshold.
- The Society should educate its group leaders about their responsibility to review the revised Financial Disclosure and Potential Conflict of Interest Form, and discuss with their groups the need for additional information specific for each group's activity. Furthermore, the information included on these forms should be considered confidential.
ASN typically requires those members participating in a committee or in one of the Society's educational programs to complete a disclosure form. However, the Society now feels that disclosure should be required of all individuals involved in any activity promoted or supported by the Society.
Recommendation 4
Individuals who review manuscripts submitted to the Society's journals should complete an annual COI disclosure form that can be updated. ASN will develop software to integrate submission and review of manuscript reviewer disclosures into the peer review process. The relevant editor or associate editor should review the forms for any potential COI. Identified potential conflicts should be subject to action by the editor or associate editor. Actions taken by the editor should be recorded in the journal's review documentation.
Recommendation 5
The ASN Program Committee (which helps plan the Society's annual meeting) should review the process of disclosure required for abstract reviewers. Specifically, the primary reviewers should avoid grading an abstract if (1) there is a potential conflict with an institutional affiliation with an author (as currently exists) or (2) if the reviewer has a financial involvement with a product or the competitor of a product mentioned in the abstract. Program committee members should excuse themselves from voting on a presentation if they have a financial involvement with a product, or competing product, mentioned in the abstract.
ASN believes that professional societies must offer additional consideration to the role of review on the dissemination of scientific knowledge. Undeclared corporate bias in one reviewer may greatly influence the acceptance of a manuscript or abstract, which may then influence clinical opinion and practice. In terms of abstract review, the Society is especially conscious of the financial implications associated with presentation. There are many examples in which an individual company's stock value fluctuated based on the presentation of the results of a clinical trial. Any attempt to improve disclosure must start at the beginning of the educational process and must include all participating individuals.
In terms of speaker disclosure, ASN believes current provisions fail to truly inform the participant of what conflicts may exist. For example, the Society maintains that it is vital for the moderators of educational sessions to highlight the potential conflicts for each speaker in that session.
Recommendation 6
ASN should require its moderators to clearly and completely declare the speakers' relationships (financial and other) at the beginning of sessions. While ACCME regulations require speakers to disclose all financial interests, the moderator is responsible for highlighting specific information about financial ties to organizations that make products that are relevant to the subject discussed in the session. The Society should consider creating a threshold value necessary for declaring “significant” financial involvement. The ASN Education Committee should develop a system for evaluating the extent to which speakers comply with the instituted policies.
ASN, like many other professional societies, represents a broad membership of physicians and investigators with varying degrees of understanding about the products created by commercial interests, such as industry. Therefore, ASN believes meeting participants should learn how disclosed relationships relate in the context of the speakers' discussions.
By charging the moderator with improving disclosure, the Society is encouraging greater moderator involvement in preventing, tracking, and responding to bias. New requirements could include increasing moderator participation in premeeting presentation review, educating moderators on how to manage bias arising during a presentation or question and answer period, and restricting moderators from serving as presenters during the session in which they are moderating. Clear policies that inform and direct moderators on responding to bias concerns will enhance the Society's ability to provide high-quality, bias-free CME in the future.
In addition, mechanisms to support documentation—such as a centralized database—will allow ASN to track potential conflicts and document any transgressions among its speakers, reviewers, and leaders. Such a system will allow the Society to better understand individuals' financial and professional backgrounds before they are invited to serve.
To further protect the integrity of CME, ASN agrees with previous reports that marketing and educational activities must remain completely distinct, with no opportunity for overlap (even if such crossover is coincidental rather than manipulative). As such, the Society believes that a second firewall should be built between advertisers and educators.
Recommendation 7
ASN should prohibit individuals involved in corporate-sponsored exhibits or marketing activities from participating in educational activities (such as CME) during ASN Renal Week (the Society's annual meeting) and vice versa.
Evaluation
Although encouraging the implementation of numerous processes to prevent bias, ASN maintains that the best mechanism for protecting educational programming in the long term is to require broad evaluation. To date, the Society is disappointed by the response rate for meeting surveys and the quality of these instruments.
Recommendation 8
ASN should institute a more thorough process for evaluating the appearance of commercial bias in educational presentations. Currently, participants seeking CME credits respond to the question of whether they “perceive[d] commercial bias; defined as the obvious appearance of skewed material which has been influenced by commercial support.”9 Yet responses appear random at best, and anecdotal evidence suggests that the mere presence of industry—whether in the exhibit hall or recognized on signage—leads to responses of perceived bias.
- The Society should require “educated” reviewers to monitor all major presentations at its educational meetings. ASN believes that the session moderators are the most logical people for this task. The meeting planners should provide reviewers with appropriate instructions on how to identify commercial bias. They should also assess evaluations from the assigned reviewers.
- The Society should require participants who complete evaluation forms to be specific about why they detected commercial bias in a meeting or presentation. Asking participants if they detected bias or commercial bias will require education of the audience.
To collect accurate data, ASN must question a broader selection of meeting participants, educate respondents on what constitutes bias in the educational arena, and require participants to thoroughly explain where they perceive bias. Once the Society properly understands where there are concerns—and where perceived corporate influence is not actually impactful—it will create a system to evaluate and address issues of bias after its educational meetings.
Standardization and Transparency
Long-term evaluation will require continual review and update to ASN's policies related to COI and bias. This effort will require a substantial, but necessary, investment in ASN's infrastructure.
Recommendation 9
ASN should develop a group or committee to review the Society's COI activities and policies as well as its instituted documentation processes.
Such a committee is essential to review current policies and practices on an annual basis and recommend changes accordingly. Recommendations might be based on changing national standards and ideas or operational and practical matters within ASN. This committee can also serve as the second level of review of perceived COI and bias and as an arbiter for actions taken in response to conflicts or allegations; serve as a core cog in the Society's machinery for standardizing and communicating policies to its membership and the Society's corporate partners; and help ensure that everyone associated with ASN (including the Society's staff) continue to understand the rules in a fluid, ever-changing environment.
Recommendation 10
ASN should develop clear guidelines for informing the Society's representatives (members and staff) and commercial interests of its expectations and policies. Selected ASN staff should be expected to know (or have access to) the policies of ASN, IOM, the Association of American Medical Colleges (AAMC), the Pharmaceutical Research and Manufacturers of America (PhRMA), the American Medical Association (AMA), and ACCME. In addition, ASN should begin a process to communicate to its members the steps being taken to ensure objectivity in its programs and policies. The Society might consider developing an electronic forum where members can raise questions and concerns about the relationship of ASN's programs with commercial interests.
In an era of increased scrutiny of industry partnerships, myriad organizations are offering recommendations for how best to manage potential conflicts. ASN leaders must be aware of requirements that affect the implementation of educational programming and consider the ways in which national guidelines—put forth by the medical community rather than dictated by external entities—could improve the provision of the Society's services.
ASN considered various options for interacting with commercial interests and purposely chose to direct its attention to managing its relationships with these entities.10 Some of the Society's policies closely follow the recommendations of other organizations (such as IOM), whereas others rest on the other side of the spectrum (such as AAMC). However, regardless of the ultimate decision made on resolving COI and bias, all parties appear to agree on the broad issues that require attention (Table 2).
Table 2: Organizational recommendations for addressing concerns about COI
ASN's policies are strict to the extent that the Society is intolerant of corporate influence on its activities. However, ASN recognizes and appreciates that industry support is vital to the Society's ability to provide its members with the premier tools and opportunities necessary to be successful in an ever-expanding medical field.
The management of COI is a long-term process, and ASN encourages ongoing discussion, input, and guidance from the Society's members on how best to interact with commercial interests. ASN is acutely aware that concerns about conflicts and bias are leading federal and state governments to intervene in what has always been a self-regulating profession.
Although individual actions are necessary first steps in the process, ASN calls on other professional societies to join together to articulate national standards for managing relationships with commercial interests. There are many interpretations of “ethical guidance” for interacting with commercial interests, and if physicians do not articulate their own standard, a disparate one will likely be forced upon them.11
Disclosures
None.
Committee and Council
ASN Committee on Corporate Relations.
Arnold S. Berns, MD, FASN; William L. Henrich, MD, FASN; T. Dwight McKinney, MD; Dr. Molitoris; Biff F. Palmer, MD, FASN; and Dr. Stokes.
ASN Council.
Sharon Anderson, MD, FASN; Peter S. Aronson, MD, FASN; Joseph V. Bonventre, MD, PhD; Thomas M. Coffman, MD, FASN; Ronald J. Falk, MD, FASN; Sharon M. Moe, MD, FASN; Dr. Molitoris; and Donald E. Wesson, MD.
