Author Affiliations: Program in Medical Ethics (Dr Lo), Department of Medicine (Drs Lo and Grady), and Department of Epidemiology and Biostatistics (Dr Grady), University of California, San Francisco; Office of the Executive Vice President for Medical Affairs Emeritus, University of Michigan, Ann Arbor (Dr Kelch); and San Francisco VA Medical Center, San Francisco (Dr Grady).
Sunlight is said to be the best of disinfectants, declared Justice Louis Brandeis in 1913.1 The 2010 Affordable Care and Patient Protection Act contains sweeping sunshine provisions including the development of a searchable public Web site that will list payments from drug, device, biological, and medical products companies to physicians by name.2 Public disclosure of payments from companies will allow verification of disclosures that individuals are required to make to journals, professional societies, continuing medical education (CME) audiences, and academic medical centers (AMCs). Using publicly available information, recent and present articles in the Archives show that undisclosed financial relationships between medical companies and members of cardiology practice guideline panels are widespread and that authors of journal articles and medical school deans may, in some cases, underreport or not report substantial relationships that involve more than $100 000 in annual payments (Chimonas et al,3 Freshwater and Freshwater, and Mendelson et al4). These articles illustrate the value of information that will be available to the public under federal sunshine provisions, as well as challenges to its accurate interpretation.
Disclosure may deter physicians, researchers, and administrators from engaging in financial relationships they would not be comfortable explaining. It also helps reviewers and readers of journal articles or practice guidelines, potential participants in clinical trials, and institutional review boards that oversee clinical research to assess the risk of undue influence. Addressing several problems with current and planned public disclosure would enhance its value.
Inconsistent disclosure requirements may lead to overestimates of failures to disclose financial relationships. For example, some financial relationships identified by Chimonas et al3 that were not disclosed by authors may have fallen outside the disclosure policy of the journal. Developing uniform disclosure policies is highly desirable to minimize unwarranted suspicions of impropriety and to reduce reporting burdens on physicians.5 The International Committee of Medical Journal Editors has taken an important first step toward harmonization by recommending uniform standards for disclosure to journals.6 However, it remains to be seen if these guidelines will be widely adopted by journals or in other settings.
Disclosure policies may not lead to transparency if relationships of greatest concern cannot be readily identified. First, the nature of the relationship needs to be specified. Reporting payments for “consulting” or “honoraria,” as in medical journals and under federal sunshine law, fails to distinguish providing scientific from marketing advice. Legitimate scientific collaboration, which can benefit academic institutions and future patient care, should be encouraged. To avoid misunderstandings, grants, or contracts from a company to an academic medical center to support research should be distinguished from personal payments to an individual physician or researcher. Also, payments for participation in speakers' bureaus are often reported as “consulting” or “honoraria.” Presenting slides and text prepared by companies for product-related talks violates academic integrity.5 Hence, payments for serving on a speakers' bureau should be in a separate category from other honoraria or consulting activities or should be prohibited, particularly for faculty at academic medical centers. Second, the exact amount of payment should be disclosed, as will be done on the federal sunshine law Web site. Although even small gifts may lead to undue influence,7 very large personal payments raise more serious concerns. Third, the type of compensation should be clarified. Fixed dollar payments, such as a contract or grant to carry out a clinical trial, generally are less problematic than compensation whose value may increase sharply if results of a clinical trial are favorable to a product, such as royalties on the intervention being tested or stock options in the company sponsoring a clinical trial. Fourth, the relevance of a relationship to the topic under consideration may be unclear. In the practice guidelines analyzed by Mendelson et al,4 the names of companies that had financial relationships with members of guidelines development committees were disclosed, without naming the company products that are relevant to the guidelines. Readers who do not know what products a company makes cannot judge how the product might be affected by the guideline.
Beyond requiring faculty and leaders to report outside financial relationships to the institution, AMCs should also disclose these relationships on institutional Web sites. Such disclosure provides public access to this information and places physicians' and researchers' relationships with companies in the context of their clinical and scientific expertise, which is also presented on the Web sites.8
Disclosure is necessary but may be just a first step. Some relationships need to be managed or even prohibited. It is not clear that a dean of an AMC can responsibly serve on the board of a for-profit pharmaceutical or biotech company. At a minimum, leaders of AMCs serving on boards of directors should recuse themselves on issues for which responsibility to the AMC conflicts with their fiduciary responsibility as director.9 Directors' payments that are on the same order of magnitude as academic salaries as documented by Freshwater and Freshwater raise serious concerns about undue influence, even if these payments are donated to the medical center. For practice guidelines, under the 2010 Council of Medical Specialty Societies code, the chair of the panel should be free of conflicts of interest, and a majority of the panel should be free of relevant conflicts.10 A 2009 Institute of Medicine panel recommended that members with significant conflicts should not vote on recommendations.5 Furthermore, members of speaker's bureaus, who are spokespersons for a company, should not be allowed to serve on practice guideline committees where critical judgment and independent appraisal of evidence are essential.
In conclusion, increased public disclosure of financial relationships between physicians and medical companies offers unprecedented opportunities to analyze the impact of these relationships on physician decisions and the benefits and burdens of conflict of interest policies. The value of public disclosures would be enhanced if disclosure requirements were standardized.
Correspondence: Dr Lo, Program in Medical Ethics, University of California San Francisco, 521 Parnassus Ave, Box 0903, Room C-126, San Francisco, CA 94143-0903 (email@example.com).
Financial Disclosure: None reported.
Funding/Support: This commentary was supported by National Institutes of Health (NIH) grant 1 UL1 RR024131-01 from the National Center for Research Resources (NCRR), NIH grant MH062246, and the NIH Roadmap for Medical Research and by the Greenwall Foundation.
Disclaimer: The contents of this commentary are solely the responsibility of the authors and do not necessarily represent the official view of the NCRR of the NIH.
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