9
Role of Supporting Organizations

Physicians, researchers, and the institutions that carry out medical research and education, provide patient care, and develop practice guidelines do not act in isolation but, rather, as part of complex intersecting systems. These systems can support or interfere with the adoption, implementation, and improvement of sound conflict of interest policies and can amplify or reduce the probability that financial relationships with industry may undermine primary professional or institutional obligations. Within these systems, a variety of organizations—public and private—can influence the policies and practices of institutions and uphold norms of professional integrity.

Chapter 1 distinguished between institutions that carry out medical research, education, clinical care, and practice guideline development and supporting organizations. Supporting organizations include accreditation and certification bodies, health insurance plans, membership groups such as the Association of American Medical Colleges (AAMC) and the World Association of Medical Journal Editors (WAME), and government agencies such as the National Institutes of Health (NIH). These entities may be seen as supporting organizations because they are in a position to influence the conflict of interest policies of the institutions that are the primary subject of this report. They can establish incentives for academic and other institutions to create more effective responses to conflicts of interest, including adopting and implementing the recommendations presented in this report. Some supporting organizations can also create incentives for individual physicians and researchers to follow conflict of interest policies and related codes of conduct. They can, more broadly, help create a culture of accountability that supports the integrity of professional judgment and sustains public confidence in that judgment.



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9 Role of Supporting Organizations Physicians, researchers, and the institutions that carry out medical re- search and education, provide patient care, and develop practice guidelines do not act in isolation but, rather, as part of complex intersecting systems. These systems can support or interfere with the adoption, implementation, and improvement of sound conflict of interest policies and can amplify or reduce the probability that financial relationships with industry may undermine primary professional or institutional obligations. Within these systems, a variety of organizations—public and private—can influence the policies and practices of institutions and uphold norms of professional integrity. Chapter 1 distinguished between institutions that carry out medical research, education, clinical care, and practice guideline development and supporting organizations. Supporting organizations include accreditation and certification bodies, health insurance plans, membership groups such as the Association of American Medical Colleges (AAMC) and the World Association of Medical Journal Editors (WAME), and government agencies such as the National Institutes of Health (NIH). These entities may be seen as supporting organizations because they are in a position to influence the conflict of interest policies of the institutions that are the primary subject of this report. They can establish incentives for academic and other institu- tions to create more effective responses to conflicts of interest, including adopting and implementing the recommendations presented in this report. Some supporting organizations can also create incentives for individual physicians and researchers to follow conflict of interest policies and related codes of conduct. They can, more broadly, help create a culture of account- ability that supports the integrity of professional judgment and sustains public confidence in that judgment. 0

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 ROLE OF SUPPORTING ORGANIZATIONS The opportunities for supporting organizations to exert influence arise in different ways, depending on the roles and authority of the organization. Accrediting organizations set standards for medical schools, residency and fellowship programs, and institutions that provide health care. State agen- cies establish rules for the licensing and relicensing of individual physicians, and specialty boards design rules to certify and recertify physician special- ists. The National Guidelines Clearinghouse sets conditions for the posting of clinical practice guidelines developed by professional societies and other groups. Public and private health insurers use a variety of financial and other incentives to influence the practices of institutions and individual phy- sicians. The U.S. Department of Justice and the Office of Inspector General of the U.S. Department of Health and Human Services enforce antikickback and self-referral laws that prohibit or limit certain conflicts of interest. NIH promotes and oversees adherence to U.S. Public Health Service (PHS) regulations on conflict of interest for grantees. Professional societies and as- sociations of health care and educational institutions articulate norms and ethical standards for their members. (Some professional societies are both organizations in this sense and also institutions that carry out research, education, and practice guideline development.) Although the Pharmaceuti- cal Research and Manufacturers of America (PhRMA) and the Advanced Medical Technology Association (AdvaMed) represent companies, they establish codes of conduct for their members that may indirectly support medical professionals and institutions by discouraging member companies from interactions that create a risk of undue influence. (As described in Chapter 6, PhRMA and AdvaMed have indicated that they will publicly report on the companies that adopt their recently revised codes.) Previous chapters have identified various shortcomings in the policies and practices of academic and other institutions. For example, as discussed in Chapter 3, some research institutions have been slow to adopt or ad- equately implement PHS requirements for conflict of interest policies, some academic medical centers have not adopted key AAMC policy recommen- dations, and some medical journals have not followed recommendations on conflict of interest from WAME and the International Committee of Medical Journal Editors (ICMJE). Furthermore, it may be difficult to de- termine a particular institution’s policies. Postings on institutional websites may be incomplete or not up to date, and some institutions choose not to reveal their policies. Such a lack of transparency makes it difficult to assess whether an institution’s policies are consistent with regulations or with recommendations of groups such as AAMC and WAME. As a result, oppor- tunities to strengthen the institution’s accountability for conflict of interest policies may be lost. Supporting organizations may promote consensus on the content of policies and also, in some situations, draw attention to the

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 CONFLICT OF INTEREST failure of institutions to adopt and implement the policies, which may then stimulate corrective action. This chapter discusses ways in which these diverse supporting organiza- tions can cooperate with and influence the academic and other institutions that have the primary responsibility for dealing with conflicts of interest in medical research, education, and practice. The chapter begins by consider- ing some of the productive forms that support and cooperation can take. The discussion emphasizes the roles of collaboration, consensus building, and incentives in making conflict of interest policies more effective and compliance with them less burdensome. It also recognizes that policies need to be backed by enforcement and sanctions. The chapter concludes with two recommendations that supplement the mostly mission-specific recom- mendations of earlier chapters. The first calls on supporting organizations to develop incentives for medical institutions to become more accountable for preventing, identifying, and managing conflicts of interest. The second calls for more research to provide a stronger evidence base for evaluating and improving conflict of interest policies. HOW SUPPORTING ORGANIZATIONS CAN INFLUENCE MEDICAL INSTITUTIONS Consensus Building and Collaboration Consensus building and collaboration can operate within the institu- tions that are the focus of this report. Such efforts seek to engage those affected by policies in the process of developing them to improve the poli- cies (e.g., by identifying and understanding obstacles to the success of the policies) and to win acceptance or buy in by those affected. Supporting organizations may likewise be more successful if they engage research, educational, and other institutions in the process of designing incentives and setting standards and if they give those institutions some discretion on how to reach specific performance goals. The leaders of those institutions are often in the best position to identify barriers to accountability (including burdensome or confusing administrative procedures) and to suggest ways to overcome those barriers. They are also well situated to identify and reduce the unintended negative consequences of proposed policies or procedures. Some lessons for collaborative efforts that can be made to improve conflict of interest policies and practices are suggested by quality improve- ment initiatives within health care organizations. The typical quality im- provement program in health care actively engages frontline caregivers and managers in an interdisciplinary process of identifying and analyzing problems in the quality of care, devising preventive or corrective interven- tions, monitoring outcomes, and modifying interventions on the basis of

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 ROLE OF SUPPORTING ORGANIZATIONS the observed outcomes (Berwick, 1998). In this approach, the gathering and monitoring of outcomes data are crucial to identifying and reducing inappropriate variations in outcomes. In some cases, cross-institutional collaborations have helped institutions develop effective quality improve- ment programs. Some programs use transparency—the public reporting of organizational performance in relation to benchmarks—as a means of en- hancing accountability and promoting competition to improve the quality of care. Accreditation agencies and voluntary groups have also encouraged this quality improvement process, and some universities have applied qual- ity improvement models to university administration. The University of Wisconsin, for example, has an office of quality improvement that supports process improvement activities in administrative as well as academic areas, and its website showcases examples of activities that are potentially relevant for conflict of interest programs (University of Wisconsin, 2008). There are, of course, significant differences between quality improve- ment procedures and conflict of interest policies. Nonetheless, the mecha- nisms of collaboration, consensus building, and outcome measurement can usefully guide the relationships between outside supporting organiza- tions and institutions directly involved in medical research, education, and practice. Some supporting organizations have been able to promote a consensus on important and often contentious aspects of conflict of interest policies. As described in earlier chapters, AAMC convened a broad group of af- fected parties that made recommendations about financial ties with indus- try in medical education (AAMC, 2008c). The parties included academic medical centers, teaching hospitals, industry, professional organizations, government agencies, and consumer groups. AAMC and the Association of American Universities convened another consensus development process to develop recommendations for improving the adoption and implementation of conflict of interest policies in human subjects research (AAMC-AAU, 2008). Over time, these and other initiatives have forged agreement on goals and recommendations regarding a number of controversial issues. Such collaborative consensus-building activities can address the practical concerns of individuals and institutions affected and make recommenda- tions more credible and acceptable. Incentives Supporting organizations can devise incentives for institutions to adopt and implement conflict of interest policies. An example of an incentive for change in institutional policies and practices is the policy of the National Li- brary of Medicine mentioned in Chapter 3. It will not cite or index articles from certain types of company-sponsored journal supplements unless they

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 CONFLICT OF INTEREST include specific disclosures about any financial relationships that guest edi- tors and authors have with the company or with the commercial products discussed in the supplement. Just as the Medicare program and private health insurers have turned to pay-for-performance programs to provide incentives for quality improve- ment, so could insurance organizations offer incentives to institutions to adopt and maintain effective conflict of interest policies and to individuals to refrain from engaging in undesirable relationships with pharmaceutical, medical device, and biotechnology companies. For example, if preferred provider organizations publicly identified those participating physicians who agreed to decline gifts and marketing payments from industry, many physicians might decide that the benefits of being so identified outweigh the benefits of accepting such gifts and payments. Particular incentives can have both positive and negative aspects. For example, when it rated medical schools on aspects of their conflict of inter- est policies, the American Medical Student Association used the “sunshine” of publicity in ways that were positive for the schools that it viewed as hav- ing good policies and possibly embarrassing for the schools that it viewed as having deficient policies (AMSA, 2008b). Although public reporting should enhance transparency and motivate policy change, it is also possible that it could merely promote the documentation of policies rather than meaningful oversight or change. Furthermore, public reporting could discourage rela- tionships with industry that appropriately promote institutional missions and professional goals. Enforcement and Sanctions On the basis of the literature reviewed for Chapters 3 and 6, the actual imposition of penalties does not seem to figure prominently in the enforce- ment of conflict of interest policies, except for cases that involve offenses such as violations of anti-kickback and self-referral laws. NIH surveys and site visits have uncovered shortcomings in the content and application of PHS conflict of interest regulations for research grantees, and it appears that federal officials have penalized institutions or required quality im- provement or remedial programs only rarely and only in cases in which problems have been identified in other ways (e.g., congressional or media investigations) (see Kaiser [2008]). As described in Chapter 3, NIH opposed a recommendation from the Office of the Inspector General that it require additional information from grantees about identified conflicts of interest and the means for their resolution. Although they should be applied thoughtfully, sanctions have impor- tant roles in limiting and managing conflicts of interest. For example, at the most basic level, a process needs to be in place for institutions to determine

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 ROLE OF SUPPORTING ORGANIZATIONS who has and who has not submitted the required financial disclosure forms. Usually, reminders should be sufficient for those who have not submitted forms, but penalties may also be needed, at least for blatant violations. Recent highly publicized incidents of significant underreporting of financial relationships to academic institutions call attention to the need for mecha- nisms to verify that the information disclosed is complete and accurate (e.g., through public reporting by industry of payments to physicians; see Recom- mendation 3.4). Again, sanctions may be appropriate for blatant cases of inaccurate disclosure. In addition, journal editors could take a stance more aggressive than they generally have thus far toward authors who violate their journals’ disclosure and conflict of interest policies. When noncompliance is egregious, penalties such as public censure or the suspension of individuals from certain positions (e.g., a principal investigator or department chair) may be necessary. Even accrediting agen- cies such as the Joint Commission (formerly the Joint Commission on the Accreditation of Healthcare Organizations) that have shifted from using more negative strategies to using more positive and cooperative strategies (e.g., acknowledging high performers and helping struggling performers improve) retain a range of sanctions for use against persistent or egregiously poor performers. Sanctions are, however, neither sufficient nor desirable as the sole instruments of accountability. They must be combined with a more ambitious and effective compliance strategy that employs collaboration, consensus building, and positive incentives. RECOMMENDATIONS Creating Incentives for Institutional Action As this report has described, some institutions that carry out medical research, education, clinical care, and practice guideline development have no or inadequate conflict of interest policies. Some institutions may not even fully meet the requirements of current federal regulations, and others fail to undertake monitoring and enforcement activities. This report has also described shortcomings in adherence by individual physicians and re- searchers to academic medical center, journal, and other conflict of interest policies. Ideally, physicians, scientists, and medical institutions should voluntarily adopt conflict of interest policies as a matter of professional responsibility and professional ethics. A commitment to patient well-being, valid scientific research, and evidence-based education would naturally lead professionals to voluntarily adopt strong measures to minimize the negative impact of conflicts of interest on objectivity and trust. No doubt many professionals have such an attitude and act on it. Realistically, however, the committee

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6 CONFLICT OF INTEREST is aware that behaviors are shaped not only by personal commitments but also by cultural and social forces. The environment in which health care professionals carry out research, teach, provide clinical care, and develop practice guidelines should promote and reinforce a professional’s internal tendency to avoid relationships that pose an unacceptable risk of improp- erly influencing his or her judgment. The same is true for institutions. Their commitment to improve the content and application of conflict of interest policies is more likely to be effective if strong and consistent support from multiple independent organizations exists alongside government regula- tions. Thus, Recommendation 9.1 calls for an array of public and private groups (that is, supporting organizations) to create incentives to promote the widespread acceptance of policies to limit and manage conflicts of interest. RECOMMENDATION 9.1 Accreditation and certification bodies, private health insurers, government agencies, and similar organiza- tions should develop incentives to promote the adoption and effective implementation of conflict of interest policies by institutions engaged in medical research, medical education, clinical care, or practice guideline development. In developing the incentives, these organizations should involve the individuals and the institutions that would be affected. A number of specific suggestions about incentives were discussed above and in the earlier chapters on medical research, education, and practice and practice guideline development. Box 9-1 summarizes these and other BOX 9-1 Examples of Methods That Supporting Organizations Can Use to Strengthen Conflict of Interest Policies Oversight bodies that oversee or regulate medical education and practice • Accreditation and specialty certification bodies could set standards for the adoption of conflict of interest policies by organizations that offer undergraduate, graduate, and continuing medical education. These bodies could also collect and make public information on the educational institutions that follow those standards. • State licensing boards could require that the continuing medical education courses required for relicensure be provided only by institutions that have adopted conflict of interest policies and other relevant recommendations presented in this report.

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 ROLE OF SUPPORTING ORGANIZATIONS BOX 9-1 Continued Membership organizations • AAMC, PhRMA, and AdvaMed could collect and make public information on which of their member organizations have adopted their recommended conflict of interest policies or codes of conduct. (Note that the last two organizations have announced that they will post the names of companies that have pledged to follow their recently revised codes.) • WAME could collect and make public information on which medical journals have adopted the authorship, ghostwriting, and conflict of interest policies consis- tent with its policy statements and those of ICMJE. • Professional societies and associations of professional organizations could set standards for conflict of interest provisions in professional codes and member- ship criteria, make their policies public, and establish awards for groups that have exemplary conflict of interest policies and procedures. Private health insurance plans • Private health insurance plans could establish incentives for hospitals and individual physicians to adopt conflict of interest policies, as recommended in this report. For example, the adoption of such policies could be a criterion for an institu- tion to be a center of excellence or for a physician to be a member of a preferred provider program. Alternatively, the lists of physicians in a plan could include infor- mation on whether a physician has agreed to certain conflict of interest provisions. Health insurers could also establish similar incentives for other institutions that provide health care, such as skilled nursing facilities or dialysis units. • Business coalitions, such as the Leapfrog Group, the National Business Group on Health, and the Pacific Business Group on Health, could encourage employers who purchase health insurance to provide financial incentives for health care plans and health care providers to adopt the relevant recommendations presented in this report. Government agencies • NIH could collect and make public information on research institutions that have policies that are not in full compliance with 1995 PHS regulations. It could expand its recent efforts to provide more guidance to grantee institutions covered by the PHS regulations, and it could also analyze a sample of grantee conflict of interest reports to understand and evaluate how grantees eliminate or manage those conflicts of interest that are identified. • The National Library of Medicine could identify in its online databases those journals that have adopted the authorship guidelines of ICMJE or WAME. For example, a symbol could be placed near the name of the journal when it appears in the listing of an article. • The National Guidelines Clearinghouse could include only clinical practice guidelines that follow the recommendations presented in this report, including the provision of information about the sponsoring group’s conflict of interest policies, the sources and amounts of industry funding for the guideline, the steps taken to identify participants without conflicts of interest, and the limits placed on participa- tion in decision making by members with conflicts of interest.

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 CONFLICT OF INTEREST examples of what supporting organizations can do. Many involve collect- ing and making public information about which institutions have adopted and applied the recommended policies. The committee expects that the prospect of such reporting would motivate institutions to close the gaps and loopholes in their conflict of interest policies or to provide a vigorous justification of why their policies depart from the recommendations. If voluntary measures to deal with conflicts of interest are perceived to be weak or ineffectual, then calls for additional legislation or regulation or the more intrusive or punitive enforcement of existing laws will likely grow. The opportunity to preempt sweeping and potentially burdensome legal requirements should give a sense of urgency to voluntary efforts to estab- lish and implement conflict of interest policies that reassure the public and those who make public policy. Government directives and prohibitions can be blunt instruments for dealing with conflict of interest problems, which often call for subtle judgments of risks and benefits and which involve many uncertainties. They also may not be as sensitive as voluntarily adopted measures to the administrative burdens of compliance or the possibility of unintended adverse consequences. This caution should not be interpreted as an endorsement of lax agency oversight or the lax application of existing conflict of interest rules. Building the Evidence Base for Policy Improvement As has been observed throughout this report, little systematic informa- tion about conflict of interest policies is available. This lack of information extends from basic descriptive information about policies to evaluations of the effects of different kinds of policies and implementation strategies. RECOMMENDATION 9.2 To strengthen the evidence base for the design and application of conflict of interest policies, the U.S. Depart- ment of Health and Human Services should coordinate the develop- ment and funding of a research agenda to study the impact of conflicts of interest on the quality of medical research, education, and practice and on practice guideline development and to examine the positive and negative effects of conflict of interest policies on these outcomes. Within the U.S. Department of Health and Human Services, NIH, the Agency for Healthcare Quality and Research, and the Food and Drug Administration should be involved in defining a research agenda that ad- dresses questions and concerns about implementing, enforcing, and possibly refining conflict of interest policies. The research agenda not only should investigate government policies, however, but also should investigate the

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 ROLE OF SUPPORTING ORGANIZATIONS policies that academic medical centers, professional societies, and other private groups have adopted. Research on the characteristics and outcomes of conflict of interest policies would be desirable for several reasons. First, research could clarify which relationships are associated with higher or lower risks of undue influence or loss of trust, as well as the magnitudes of such associations. Second, such research may identify which conflict of interest policies and procedures are effective in achieving the desired outcomes and under what circumstances various policies are likely to be more effective. These data could then guide modifications in policies and procedures. Third, research on conflict of interest policies may identify unintended adverse conse- quences of well-intentioned policies and, in turn, inform corrective policy changes. Unintended negative consequences might include disproportionate administrative burdens and the inhibition of constructive collaborations be- tween academia and industry. Strengthening the evidence base should allow institutions to improve their conflict of interest policies to better protect the integrity of their missions and to maintain the trust of the public.