Summary

ABSTRACT

Patients and the public benefit when physicians and researchers collaborate with pharmaceutical, medical device, and biotechnology companies to develop products that benefit individual and public health. At the same time, concerns are growing that wide-ranging financial ties to industry may unduly influence professional judgments involving the primary interests and goals of medicine. Such conflicts of interest threaten the integrity of scientific investigations, the objectivity of professional education, the quality of patient care, and the public’s trust in medicine.

This Institute of Medicine report examines conflicts of interest in medical research, education, and practice and in the development of clinical practice guidelines. It reviews the available evidence on the extent of industry relationships with physicians and researchers and their consequences, and it describes current policies intended to identify, limit, or manage conflicts of interest. Although this report builds on the analyses and recommendations of other groups, it differs from other reports in its focus on conflicts of interest across the spectrum of medicine and its identification of overarching principles for assessing both conflicts of interest and conflict of interest policies. The report, which offers 16 specific recommendations, has several broad messages.

  • The central goal of conflict of interest policies in medicine is to protect the integrity of professional judgment and to preserve public trust rather than to try to remediate bias or mistrust after it occurs.

  • The disclosure of individual and institutional financial relationships



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Summary ABSTRACT Patients and the public benefit when physicians and researchers collab- orate with pharmaceutical, medical deice, and biotechnology companies to deelop products that benefit indiidual and public health. At the same time, concerns are growing that wide-ranging financial ties to industry may unduly influence professional judgments inoling the primary interests and goals of medicine. Such conflicts of interest threaten the integrity of scien- tific inestigations, the objectiity of professional education, the quality of patient care, and the public’s trust in medicine. This Institute of Medicine report examines conflicts of interest in medi- cal research, education, and practice and in the deelopment of clinical practice guidelines. It reiews the aailable eidence on the extent of indus- try relationships with physicians and researchers and their consequences, and it describes current policies intended to identify, limit, or manage conflicts of interest. Although this report builds on the analyses and rec- ommendations of other groups, it differs from other reports in its focus on conflicts of interest across the spectrum of medicine and its identification of oerarching principles for assessing both conflicts of interest and conflict of interest policies. The report, which offers 6 specific recommendations, has seeral broad messages. • The central goal of conflict of interest policies in medicine is to protect the integrity of professional judgment and to presere public trust rather than to try to remediate bias or mistrust after it occurs. • The disclosure of indiidual and institutional financial relationships 

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 CONFLICT OF INTEREST is a critical but limited first step in the process of identifying and responding to conflicts of interest. • Conflict of interest policies and procedures can be strengthened by engaging physicians, researchers, and medical institutions in deeloping policies and consensus standards. • A range of supporting organizations—including accrediting groups and public and priate health insurers—can promote the adoption and implementation of conflict of interest policies and promote a culture of accountability that sustains professional norms and public confidence in medicine. • Research on conflicts of interest and conflict of interest policies can proide a stronger eidence base for policy design and implementation. • If medical institutions do not act oluntarily to strengthen their conflict of interest policies and procedures, the pressure for external regula- tion is likely to increase. Physicians and researchers must exercise judgment in complex situ- ations that are fraught with uncertainty. Colleagues, patients, students, and the public need to trust that these judgments are not compromised by physicians’ or researchers’ financial ties to pharmaceutical, medical device, and biotechnology companies. Ties with industry are common in medicine. Some have produced important benefits, particularly through research col- laborations that improve individual and public health. At the same time, widespread relationships with industry have created significant risks that individual and institutional financial interests may unduly influence profes- sionals’ judgments about the primary interests or goals of medicine. Such conflicts of interest threaten the integrity of scientific investigations, the objectivity of medical education, and the quality of patient care. They may also jeopardize public trust in medicine. Surveys show the breadth and diversity of relationships between indus- try and physicians, researchers, and educators in academic and community settings. For example, • gifts from drug companies to physicians are ubiquitous; • visits to physicians’ offices by drug and medical device company representatives and the provision of drug samples are widespread; • many faculty members receive research support from industry, and industry funds the majority of biomedical research in the United States; • many faculty members and community physicians provide scien- tific, marketing, and other consulting services to companies; and some serve on company boards of directors or on industry speakers bureaus; and • commercial sources provide about half of the total funding for ac- credited continuing medical education programs.

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 SUMMARY Although certain of these financial relationships may be constructive, recent news reports, legal settlements, research studies, and institutional an- nouncements have documented a variety of disturbing situations that could undermine public confidence in medicine. These situations include • physicians and researchers failing to disclose substantial payments from drug companies, as required by universities, government agencies, or medical journals; • settlements with the U.S. Department of Justice by medical device and pharmaceutical companies to avoid prosecution for alleged illegal pay- ments or gifts to physicians; • companies and academic investigators not publishing negative re- sults from industry-sponsored clinical trials or delaying publication for over a year after the completion of a trial; • academic researchers putting their names on manuscripts, even though they first became involved after the data were collected and ana- lyzed and after the first drafts were written by individuals paid by industry; and • professional societies and other groups that develop clinical prac- tice guidelines choosing not to disclose their industry funding and not to reveal the conflicts of interest of the experts who draft the guidelines. Although the causes of these situations are various and their extent is unclear, they highlight the tension that may exist between financial relation- ships with industry and the primary missions of medical research, educa- tion, and practice. In addition to these examples, research on industry gifts and other financial relationships has generated troublesome findings. For example, systematic reviews of the evidence sponsored by a pharmaceutical company are more likely than other reviews to present conclusions favor- able to the company, even when the actual findings of the analysis are not favorable. In addition, articles based on company-sponsored clinical trials are more likely to draw conclusions favorable to the company’s product than articles trials not sponsored by industry. Although these findings do not necessarily show that the research is biased and other explanations can be offered (e.g., companies do not fund trials unless they see a reasonable likelihood of success), they do raise legitimate questions about possible undue influence. To cite another example, the availability of drug samples may be associ- ated with the prescription of new brand name drugs when they are not rec- ommended by evidence-based practice guidelines or when appropriate but less expensive drugs or generic equivalents are available for the same indica- tion. Although one argument for the use of drug samples is that they help low-income patients, research suggests that these individuals are not the

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 CONFLICT OF INTEREST primary recipients of such samples. Also, although small gifts to physicians may seem to be inconsequential, some research suggests that small gifts can contribute to unconscious bias in decision making and advice giving. It also seems unlikely that companies would give such gifts to physicians if they did not believe that they would benefit the company in some way. In addition to information that raises concern about the scope and con- sequences of industry financial ties in medicine, surveys and other studies have reported inconsistencies in the adoption and implementation of con- flict of interest policies by medical institutions. Relationships and practices that are forbidden by one institution may be allowed and even encouraged by others. Reports also have described shortcomings in the oversight of con- flicts of interest in research by federal agencies and medical institutions. Unfortunately, the empirical evidence relevant to financial relationships and conflicts of interest is limited. On many topics related to conflicts of interest, no systematic studies are available. For other topics, data are suggestive rather than definitive. The studies that have been conducted have primarily been observational rather than interventional, in large part because the issues cannot be investigated using randomized controlled tri- als of the effects of different kinds of relationships or different approaches to identifying and managing conflicts of interest. A number of academic medical centers, professional associations, and other institutions have taken steps to strengthen their conflict of interest policies, but few data that can be used to assess the consequences—positive or negative—of these changes are available. Some prominent physicians and researchers have argued that concerns about conflicts of interest are far out of proportion to the evidence that they exist or are harmful, and some contend that measures designed to address conflicts of interest have interfered with beneficial collaborations with industry. Critics of conflict of interest policies have also charged that the great majority of individuals who have not acted in an unethical manner may be subjected to onerous regulations and tacit conclusions that they are culpable of misconduct until proven otherwise. Responding to the situations and concerns outlined above, the Institute of Medicine appointed a committee to investigate and develop a consensus report on conflicts of interest in medical research, education, and practice and in the development of clinical practice guidelines. Consistent with its charge, the committee • examined conflicts of interest in medical research, education, and practice and in the development of clinical practice guidelines and • developed analyses and recommendations to inform the design and implementation of policies that identify and manage conflicts of inter- est in these contexts without damaging constructive collaborations with industry.

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 SUMMARY Because the evidence on many issues is limited, the committee had to rely on its experience and judgment in evaluating the analyses and arguments presented in the literature and in statements submitted to the committee. During its work, the committee kept in mind the core goals of medical research, education, and practice and practice guideline devel- opment, which include serving the best interests of patients and society through the generation of valid scientific knowledge, the independent evalu- ation of evidence and the application of critical thinking, and the creation and use of evidence-based recommendations for patient care. Reflecting concerns that were raised during the planning of the project and the central issues in debates and policies on conflicts of interest in medicine, the committee focused on financial relationships involving phar- maceutical, medical device, and biotechnology companies. Although it did not investigate in depth the conflicts of interest associated with different physician payment arrangements or with physician referral of patients to facilities in which they have an ownership interest, the committee recog- nized the seriousness of those types of conflicts and the difficulties that policy makers have encountered in trying to eliminate or manage them. It also recognized other sources of conflicts of interest, for example, desires for professional advancement and recognition. After examining a wide array of evidence, analyses, and perspectives on conflicts of interest, the committee reached several overarching conclusions. They are as follows: • The goals of conflict of interest policies in medicine are primarily to protect the integrity of professional judgment and to preserve public trust rather than to try to remediate bias or mistrust after they occur. • The disclosure of individual and institutional financial relationships is a critical but limited first step in the process of identifying and responding to conflicts of interest. • Conflict of interest policies and procedures can be strengthened by engaging physicians, researchers, and medical institutions in developing conflict of interest policies and consensus standards. • A range of supporting organizations—public and private—can pro- mote the adoption and implementation of conflict of interest policies and help create a culture of accountability that sustains professional norms and public confidence in professional judgments. • Research on conflicts of interest and conflict of interest policies can provide a stronger evidence base for policy design and implementation. • If medical institutions do not act voluntarily to strengthen their conflict of interest policies and procedures, the pressure for external regula- tion is likely to increase.

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6 CONFLICT OF INTEREST PRINCIPLES FOR IDENTIFYING AND ASSESSING CONFLICTS OF INTERESTS Chapter 2 presents the principles and conceptual framework for iden- tifying and assessing conflicts of interest. Conflicts of interest are defined as circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest. Primary interests include promoting and protecting the integrity of research, the quality of medical education, and the welfare of patients. Secondary interests include not only financial interests—the focus of this report—but also other interests, such as the pursuit of professional ad- vancement and recognition and the desire to do favors for friends, family, students, or colleagues. Conflict of interest policies typically focus on finan- cial gain because it is relatively more objective, fungible, and quantifiable. Financial gain can therefore be more effectively and fairly regulated than other secondary interests. The severity of a conflict of interest depends on (1) the likelihood that professional decisions made under the relevant circumstances would be unduly influenced by a secondary interest and (2) the seriousness of the harm or wrong that could result from such an influence. The likelihood of undue influence is affected by the value of the secondary interest, its duration and depth, and the extent of discretion that the individual has in making important decisions. Conflict of interest policies generally emphasize prevention and man- agement rather than punishment. They do not assume that any particular professional will necessarily let financial gain influence his or her judgment. Likewise, a judgment that someone has a conflict of interest does not imply that the person is unethical. Such judgments assume only that some situa- tions are generally recognized to pose an unacceptable risk that decisions may be unduly influenced by considerations that should be irrelevant. Chapter 2 presents criteria, described in the list that follows, that can be used to evaluate conflict of interest policies. • Proportionality. Is the policy effective, efficient, and directed at the most important and most common conflicts? Conflict of interest policies and procedures may create harms or burdens as well as benefits. Do the policies and their implementation unnecessarily interfere with the conduct of legitimate research, teaching, and clinical practice? • Transparency. Is the policy comprehensible and accessible to the individuals and institutions that it may affect? Such transparency is es- sential to determine if conflict of interest policies are reasonable and are being implemented fairly. Transparency can also help institutions learn

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 SUMMARY from each other about more and less successful ways of handling particular situations. • Accountability. Does the conflict of interest policy indicate who is responsible for monitoring, enforcing, and revising it? Leaders of ac- countable institutions explain institutional policies and monitor and accept responsibility for the consequences, both beneficial and harmful. • Fairness. Does the policy apply equally to all relevant groups within an institution and in different institutions? In an academic medical center, the relevant groups would include faculty, medical staff, students, residents, fellows, members of institutional committees (e.g., institutional review boards, formulary committees, panels developing practice guidelines, and device purchasing committees), and senior institutional officials. POLICIES ON CONFLICTS OF INTEREST: OVERVIEW AND EVIDENCE Concerns about conflicts of interest in medicine have a long history, and responses to these conflicts have evolved as relationships with industry have grown more frequent and more complex and as different responses to such relationships have been tried and found in need of modification. Government regulations and voluntary codes of conduct often follow the discovery of instances of questionable or inappropriate relationships and conduct. Government scrutiny of financial relationships and conflicts of interest may also stimulate private, voluntary efforts by academic and other institutions to deal with problems and avoid regulation. The conflict of interest policies of academic medical centers, profes- sional societies, medical journals, and other institutions vary on many di- mensions. It is not clear that all medical institutions have conflict of interest policies. Those that do have such policies vary in what they ask physicians and researchers to disclose about their financial relationships with industry. Such variations may create additional administrative burdens for physicians and researchers who act in multiple roles and make multiple disclosures of their financial relationships with industry to different institutions for vari- ous purposes related to medical research, education, and clinical care and clinical practice guideline development. Institutions also vary in what relationships they prohibit because they view them as creating unacceptable risks of undue influence on primary interests, and they also differ in how they manage conflicts of interest that are not prohibited. The National Institutes of Health (NIH) has identified variations and deficiencies in how research institutions implement the 1995 U.S. Public Health Service (PHS) regulations on conflict of interest, and it has advised institutions on steps that they can take to strengthen their poli-

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 CONFLICT OF INTEREST cies. Similarly, the Association of American Medical Colleges (AAMC) and the Association of American Universities (AAU) have developed recommen- dations and guidance on conflict of interest policies governing research with human participants, but surveys indicate that research institutions have not fully implemented these recommendations. Although the disclosure of financial interests or conflicts of interest is a necessary part of conflict of interest policies, it is not sufficient in itself to safeguard the integrity of professional judgment or to maintain public trust. For example, when a relationship or conflict of interest is disclosed to individual patients, students, or research participants, they often lack the knowledge and perspective to assess the relationship and may have no sat- isfactory options if they have concerns about it. Conflicts that are disclosed but not eliminated or managed can continue to pose risks to judgment and undermine public trust. The recommendations in Chapter 3 establish the fundamental elements of an effective policy response to conflicts of interest in medical research, education, and practice. Recommendation 3.1 calls on all institutions en- gaged in these activities to establish conflict of interest policies and create conflict of interest committees to evaluate and manage conflicts. Recom- mendation 3.2 focuses on the essential policy step of requiring physi - cians, researchers, and senior officials to disclose to their institutions their financial relationships with industry. Unless institutions are informed of these relationships, they cannot identify conflicts of interest or determine whether additional steps—such as the elimination or management of the conflict—are needed to reduce the risk of bias or a loss of public trust. Recommendations 3.1 and 3.2 are similar to the recommendations made in other reports on conflict of interest; but they extend to all institutions that carry out medical research, medical education, clinical care, and practice guideline development. The disclosure of financial relationships can be effective only if it pro- vides sufficient information for others to use in assessing a relationship and judging the severity of a conflict. At the same time, disclosure can be bur- densome, particularly for physicians who must make multiple disclosures for different activities. Recommendation 3.3 calls for the standardization of disclosures with the goals of providing institutions with the specific infor- mation that they need to assess relationships while reducing the reporting burdens on physicians and researchers. Such standardization is best pursued through a consensus development process that involves a broad array of concerned parties (e.g., academic medical centers, professional societies, public interest groups, and NIH and other public agencies). On the basis of the agreements resulting from this process, the next step would be for soft- ware developers to produce computer programs that allow an individual to fill out a standard questionnaire and then format the information for differ-

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 SUMMARY ent institutions and purposes. This should reduce the burden on individuals and increase the consistency of the information disclosed. Even with further policy development and standardization, institutions will still face questions about the completeness and accuracy of the infor- mation disclosed to them. Recommendation 3.4 calls for the U.S. Congress to create a national program that requires pharmaceutical, medical device, and biotechnology companies and their foundations to publicly report payments to physicians, researchers, health care institutions, professional societies, patient advocacy and disease-specific groups, providers of con- tinuing medical education, and foundations created by any of these entities. Although many details will need to be worked out, the information should be readily available on a secure, searchable public website that allows the identification and aggregation of all payments that an individual or institu- tion receives from all companies. Such a program of company reporting will enhance accountability by allowing universities, journals, and others to verify the disclosures that have been made to them. It may also discourage the formation of questionable relationships that individuals or companies would prefer not be widely known. CONFLICTS OF INTEREST IN BIOMEDICAL RESEARCH Research partnerships among industry, academia, and government are essential to the discovery and development of new medications and medi- cal devices that improve the prevention, diagnosis, and treatment of health problems. Chapter 4 reports on evidence that relationships between aca- demic researchers and industry are widespread and are associated with ben- efits, for example, greater research productivity. At the same time, evidence suggests that these relationships have risks, including decreased openness in the sharing of data and findings and the withholding of negative results. These kinds of risks justify additional requirements and incentives, as rec- ommended in this report, for institutions to adopt and implement policies to identify and eliminate or manage conflicts of interest. Consistent with the recommendations of AAMC and AAU, Recommen- dation 4.1 calls for a general rule that researchers may not conduct research involving human participants if they have a financial interest in the outcome of the research, for example, if they hold a patent on an intervention being tested in a clinical trial. Exceptions should be allowed only if an individual’s participation is judged to be essential for the safe and appropriate conduct of the research. An example might be the inventor of a complex new im- planted medical device who has unique expertise and technical skills that are essential for the safe implantation of the device during pilot or early- phase studies. If a conflict of interest committee approves the involvement of such a researcher, it should take advantage of the full range of options

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0 CONFLICT OF INTEREST for managing the conflict, including placing restrictions on the researcher’s role in the study. Although Recommendation 4.1 does not cover nonclinical research, financial relationships in this arena may also create risks of undue influ- ence that institutions should assess and manage as appropriate to protect the integrity of the science. Additional studies on financial relationships in nonclinical research, their risks and consequences, and the ways in which institutions identify and respond to these relationships would help establish an evidence base that could be used to guide judgments about policies in this area. CONFLICTS OF INTEREST IN UNDERGRADUATE, GRADUATE, AND CONTINUING MEDICAL EDUCATION Chapter 5 presents strong evidence that relationships with industry are pervasive in undergraduate, graduate, and continuing medical education. Most medical students and residents are exposed to lunches, gifts, and other interactions with pharmaceutical company representatives on a frequent basis. Faculty members have extensive relationships with these individuals as well. In analyzing relationships with industry in the context of medical edu- cation, the focus should be on the learning environment, the development of core competencies, and consistency between the formal curriculum and the informal or hidden curriculum. The key goals of medical education include helping learners at all levels develop the ability to think critically and appraise the evidence for clinical decision making. In controlled situa- tions, some interactions with representatives of medical device companies may foster the goals of appropriate training, patient safety, and device evaluation. Otherwise, the committee found no bases for concluding that educational goals are promoted by other relationships involving gifts, most visits by pharmaceutical company representatives, service as a marketing consultant, participation in an industry speakers bureau, or acceptance of credit for a ghostwritten article. Indeed, the evidence suggests that some of these relationships are associated with undue influence and thus undermine the goals of medical education. Overall, the risks of these relationships outweigh any possible benefits. Recommendation 5.1 therefore calls on academic medical centers to prohibit faculty, students, residents, and fellows from accepting gifts (in- cluding meals), making presentations that are controlled by industry, and claiming authorship for ghostwritten publications. This restriction is not intended to exclude the acceptance of scientific materials from industry scientists under appropriate material transfer agreements or the payment of reasonable honoraria to speakers who present their own material. Recom-

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 SUMMARY mendation 5.1 also calls for restrictions on the acceptance of drug samples and visits by drug and medical device sales representatives. For academic medical centers and community physicians, drug samples present difficult issues. Caring for indigent patients who cannot afford needed drugs is frustrating for physicians who are trying to act in their patients’ best interests. Many physicians believe that drug samples allow some patients access to drugs that they could otherwise not obtain. None- theless, research suggests that most samples are not in fact given to patients who lack financial access to needed medications and that physicians who have access to samples may change their prescribing habits, for example, by not prescribing the drugs that they would prefer their patients to use or by prescribing drugs in ways that are not consistent with evidence-based recommendations. The committee concluded that the lack of access to af- fordable medications is serious and disturbing but that drug samples are not a satisfactory answer to this societal problem. Academic medical centers should, at a minimum, oversee and restrict their use. Because faculty, students, residents, and fellows may not understand the risks posed by conflicts of interest and the rationale for conflict of interest policies, Recommendation 5.2 calls on academic medical centers and teach- ing hospitals, as part of their educational mission, to provide education on the avoidance of conflicts of interest and the management of relationships with pharmaceutical and medical device industry representatives. Organiza- tions that accredit medical schools and residency programs should develop standards to reinforce this recommendation. Questions about conflicts of interest have been particularly visible in continuing medical education. Most physicians are required to participate in accredited continuing medical education as a condition for relicensure, specialty certification, or granting of hospital medical staff privileges. Many commercial and academic providers of accredited continuing medical edu- cation receive half or more of their funding from industry, which raises concerns about industry influence over the selection of educational topics, the content of presentations, and the overall scope of educational offerings (e.g., whether they provide sufficient coverage of such issues as prevention and physician-patient communication). Although individual continuing medical education providers and the accrediting organization for continuing medical education have taken steps to limit industry influence, the dependence of many programs on industry funding raises doubts about how successful these steps can be. Recom- mendation 5.3 calls for a broad-based consensus development process to propose a new system of funding accredited continuing medical education that is free of industry influence, enhances public trust in the integrity of the system, and provides high-quality education. Some members of the commit- tee supported a total end to industry funding, but others were concerned

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 CONFLICT OF INTEREST about the potential for unintended harm from such a ban. The committee recognized that changes in the current system likely would substantially reduce industry funding for accredited continuing medical education. Even if education providers trim their expenses, the costs of accredited continu- ing medical education would likely increase for many physicians, which could be an economic burden for some physicians, for example, those in rural areas. CONFLICTS OF INTEREST AND MEDICAL PRACTICE As is the case in medical research and education, evidence shows that relationships with industry are widespread among physicians in practice. Physician acceptance of gifts and meals from industry representatives is commonplace, as are visits with company sales representatives. Company marketing strategies are sophisticated. As part of these strategies, physi- cians may be used as marketing agents, physicians’ prescribing habits may be tracked through commercial databases, and companies may sponsor so-called seeding trials that are primarily designed to market products to participating physicians. Published studies of these strategies are limited but suggest the risk of undue industry influence on physician prescribing behavior with little or no benefit to patient care. Many physicians may view drug representatives as useful, but reliance on individuals whose charge is to increase sales is not a satisfactory solution to practitioners’ need for valid, reliable, and up-to-date medical information. Several recent policy changes may affect the relationships between industry and physicians in practice. Several drug and device companies are voluntarily making public information on their payments to physicians by physician name and the purpose and the amount of the payment; other companies have been required to do so as part of legal agreements with federal prosecutors. The Pharmaceutical Research and Manufacturers of America also recently revised its code on interactions with health care pro- fessionals to prohibit the use of certain marketing tools and gifts (including well-paid speaking engagements) as inducements or rewards for prescribing or recommending a course of treatment. Compliance is voluntary, but the organization says that it will ask member companies to declare whether they have adopted its provisions and will then post the information on its website. The Advanced Medical Technology Association has included simi- lar provisions in its revised code for medical device companies. In addition, some professional societies have recently revised their conflict of interest policies to restrict or manage certain relationships with industry and to make their policies public. Taking into account the weight of the evidence and the recommen- dations and actions of other groups or institutions, the committee rec-

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 SUMMARY ommended the elimination of some problematic relationships between practicing physicians and industry. In broad terms, Recommendation 6.1 calls on physicians in clinical practice not to accept gifts, including meals, from companies; to enter only into bona fide consultation arrangements with written contracts; to avoid presenting or publishing material whose content is controlled by industry or is ghostwritten; to set restrictions on meetings with company sales representatives; and to use drug samples only for patients who lack financial access to medications. This recommendation is generally parallel to Recommendation 5.1 (for faculty, students, residents, and fellows). Independent assessment of the evidence and the practice of evidence-based medicine are core competencies for physicians in clinical practice as well as academic practice; relationships with industry should not undermine those competencies. Because recommendations directed to physicians are more likely to be adopted if other incentives are aligned with those recommendations, Rec- ommendation 6.1 also calls on professional societies and institutions that provide health care (and that employ physicians or grant them staff privi- leges) to take actions to support physician acceptance of changes in their re- lationships with companies. Recommendation 6.2 calls for further revisions to industry practices to be consistent with those outlined in Recommenda- tion 6.1. It is a separate recommendation to emphasize that relationships between physicians and industry are bilateral and that the expectations for givers and receivers in financial relationships should be parallel. CONFLICTS OF INTEREST AND DEVELOPMENT OF CLINICAL PRACTICE GUIDELINES Financial relationships with companies affected by clinical practice guidelines are common both for groups convening expert panels to develop guidelines and for the individuals serving on those panels. Groups often do not make public their conflict of interest policies, their sources of funding for guideline development, or the financial relationships of the panel mem- bers. This lack of transparency makes it difficult for the readers and users of guidelines to assess the potential for undue influence and bias. The committee found examples of alleged undue industry influence on the development of clinical practice guidelines but little systematic research. The risks that result from the acceptance of industry funding and the in- clusion of individuals with industry ties on guideline development panels include possible bias in the recommendations made in guidelines and pos- sible harm to patients because guidelines may influence physician practice behavior, quality improvement measures, reimbursement incentives, and insurance coverage decisions. Recommendation 7.1 calls on groups that develop guidelines not to

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 CONFLICT OF INTEREST accept direct funding for guideline development from industry and gener- ally to exclude individuals with conflicts of interest from guideline develop- ment panels. Because it may be impossible in some situations to obtain the needed expertise from individuals who have no conflicts, the recommen- dation also includes measures to limit the likelihood of undue influence if panels include members with conflicts of interest. These measures include requiring that chairs of guideline development panels have no conflicts of interest, limiting members with conflicts of interest to a small minority of the panel membership, and precluding such members from voting on topics in which they have a financial interest. The committee also calls for groups that develop guidelines to involve the public in attempts to identify experts without conflicts of interest, to make such efforts public, and to disclose publicly any conflicts of interest of those selected for membership on panels. Recommendation 7.2 calls for organizations that have an interest in the use of evidence-based clinical practice guidelines to establish incentives to encourage the developers of guidelines to adopt the committee’s recommen- dations. For example, the National Guideline Clearinghouse could require that the guidelines that it posts include information about the sources of funding for a guideline, the sponsor’s conflict of interest policy, and the fi- nancial interests of the expert panel members. Similarly, public and private health plans and accreditation and certification bodies could avoid the use of clinical practice guidelines that lack information that allows users to identify conflicts of interest and assess the risks that they pose. INSTITUTIONAL CONFLICTS OF INTEREST Institutional conflicts of interest arise when an institution’s own finan- cial interests or the interests of its senior officials pose risks to the integrity of the institution’s primary interests and missions. Institutional conflicts typically appear when research conducted within an institution could affect the value of equity that the institution holds in a company or the value of a patent that the institution licenses to a company. Institutional conflicts of interest have not received as much attention as individual conflicts of inter- est, but their consequences can also be damaging. If they are not properly identified and managed, institutional conflicts can undermine the work and reputation of an entire institution, including employees or members who are themselves strictly avoiding individual conflicts of interest. Recommendation 8.1 calls for the boards of trustees of institutions to establish a conflict of interest committee to make judgments about insti- tutional relationships with industry, including the relationships of senior officials. In their fiduciary role, members of the board oversee the long- term interests of the institution. They stand at a greater distance from the

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 SUMMARY day-to-day pressures of decision making, which should help them assess more judiciously the potential risks posed by a particular financial interest to the institution’s core missions. This committee of the board of trustees could be supported by staff committees on institutional conflict of interest. Recommendation 8.2 calls for NIH to develop regulations requiring institu- tions covered by the 1995 PHS regulations to adopt institutional conflict of interest policies. THE ROLE OF SUPPORTING ORGANIZATIONS In carrying out medical research and education, providing patient care, and developing practice guidelines, physicians, researchers, and the institu- tions in which they work are part of complex intersecting systems. These systems can amplify or mitigate the pressures that individuals and institutions may experience to expose their primary professional obligations or social missions to undue influence from secondary interests, such as financial gain. Within these systems, a variety of organizations—public and private—can influence the policies and practices of institutions and support the norms of professional integrity. For example, accreditation and certification organiza- tions set standards for medical schools, residency and fellowship programs, and individual physicians. State agencies license and relicense individual physicians, and specialty boards certify and recertify them. Journals publish medical research. The National Guideline Clearinghouse posts clinical prac- tice guidelines. Public and private health insurers use a variety of financial and other incentives to influence the practices of institutions and individual clinicians. The U.S. Department of Justice and the Office of the Inspector General of the U.S. Department of Health and Human Services enforce laws limiting or prohibiting certain conflicts of interest, and NIH is responsible for overseeing compliance with PHS policies covering its grantees. In addition to discussing incentives for policy adoption and implemen- tation, the final chapter of the report discusses the roles of collaboration and consensus building in building conflict of interest policies that win ac- ceptance and avoid needless burdens. Although the emphasis should be on preventing problems, policies should also be backed by enforcement and appropriate sanctions as well as assessment of their effectiveness. Recommendation 9.1 proposes that groups such as accrediting orga- nizations, public and private health insurers, and associations of medical journal editors develop incentives to make institutions more accountable for preventing, identifying, and managing conflicts of interest. The accom- panying discussion gives examples of such incentives. The final recommen- dation, Recommendation 9.2, calls for more research to assess the positive and negative consequences of conflict of interest policies and provide a

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6 CONFLICT OF INTEREST stronger evidence base for improving conflict of interest policies and their application. Society has traditionally granted the medical profession considerable autonomy to regulate itself. Society may be willing to continue do so in the case of conflicts of interest; but concern is growing in the U.S. Congress, state legislatures, federal agencies, and elsewhere that stronger measures are needed. Physicians and researchers can play a vital role in designing responsible and reasonable conflict of interest policies and procedures that reduce the risks of bias and the loss of trust while avoiding undue burdens or even harms. They and the institutions that carry out medical research, education, clinical care, and practice guideline development must recognize public concerns about conflicts of interest and take effective measures soon to maintain public trust. OVERVIEW AND LIST OF RECOMMENDATIONS TABLE S-1 Report Recommendations in Overview Recommendation Number and Topic Primary Actors General policy 3.1 Adopt and implement conflict of Institutions that carry out medical research and interest policies education, clinical care, and clinical practice guideline development 3.2 Strengthen disclosure policies Institutions that carry out medical research and education, clinical care, and clinical practice guideline development 3.3 Standardize disclosure content Institutions that carry out medical research and and formats education, clinical care, and clinical practice guideline development and other interested organizations (e.g., accrediting bodies, health insurers, consumer groups, and government agencies) 3.4 Create a national program U.S. Congress; pharmaceutical, medical device, for the reporting of company and biotechnology companies payments Medical research 4.1 Restrict participation of Academic medical centers and other research researchers with conflicts of institutions; medical researchers interest in research with human participants

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 SUMMARY TABLE S-1 Continued Recommendation Number and Topic Primary Actors Medical education 5.1 Reform relationships with Academic medical centers and teaching hospitals; industry in medical education faculty, students, residents, and fellows 5.2 Provide education on conflict of Academic medical centers and teaching hospitals; interest professional societies 5.3 Reform financing system for Organizations that created the accrediting continuing medical education program for continuing medical education and other organizations interested in high-quality, objective education Medical practice 6.1 Reform financial relationships Community physicians; professional societies; with industry for community hospitals and other health care providers physicians 6.2 Reform industry interactions Pharmaceutical, medical device, and with physicians biotechnology companies Clinical practice guidelines 7.1 Restrict industry funding and Institutions that develop clinical practice conflicts in clinical practice guidelines guideline development 7.2 Create incentives for reducing Accrediting and certification bodies, formulary conflicts in clinical practice committees, health insurers, public agencies, and guideline development other organizations with an interest in objective, evidence-based clinical practice guidelines Institutional conflict of interest policies 8.1 Create board-level responsibility Institutions that carry out medical research and for institutional conflicts of education, clinical care, and clinical practice interest guideline development 8.2 Revise PHS regulations to require NIH policies on institutional conflicts of interest Supporting organizations 9.1 Provide additional incentives Oversight bodies and other groups that have a for institutions to adopt and strong interest in or reliance on medical research, implement policies education, clinical care, and practice guideline development 9.2 Develop research agenda on NIH, Agency for Healthcare Research and conflict of interest Quality, and other agencies of the U.S. Department of Health and Human Services

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 CONFLICT OF INTEREST RECOMMENDATION 3.1 Institutions that carry out medical research, medical education, clinical care, or practice guideline development should adopt, implement, and make public conflict of interest policies for indi- viduals that are consistent with the other recommendations in this report. To manage identified conflicts of interest and monitor the implementation of management recommendations, institutions should create a conflict of interest committee. That committee should use a full range of management tools, as appropriate, including elimination of the conflicting financial interest, prohibition or restriction of involvement of the individual with a conflict of interest in the activity related to the conflict, and providing ad- ditional disclosures of the conflict of interest. RECOMMENDATION 3.2 As part of their conflict of interest policies, institutions should require individuals covered by their policies, including senior institutional officials, to disclose financial relationships with phar- maceutical, medical device, and biotechnology companies to the institution on an annual basis and when an individual’s situation changes significantly. The policies should • request disclosures that are sufficiently specific and comprehensive (with no minimum dollar threshold) to allow others to assess the severity of the conflicts; • avoid unnecessary administrative burdens on individuals making disclosures; and • require further disclosure, as appropriate, for example, to the con- flict of interest committee, the institutional review board, and the contracts and grants office. RECOMMENDATION 3.3 National organizations that represent aca- demic medical centers, other health care providers, and physicians and researchers should convene a broad-based consensus development process to establish a standard content, a standard format, and standard procedures for the disclosure of financial relationships with industry. RECOMMENDATION 3.4 The U.S. Congress should create a national program that requires pharmaceutical, medical device, and biotechnology companies and their foundations to publicly report payments to physicians and other prescribers, biomedical researchers, health care institutions, pro- fessional societies, patient advocacy and disease-specific groups, providers of continuing medical education, and foundations created by any of these entities. Until the Congress acts, companies should voluntarily adopt such reporting.

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 SUMMARY RECOMMENDATION 4.1 Academic medical centers and other research institutions should establish a policy that individuals generally may not conduct research with human participants if they have a significant finan- cial interest in an existing or potential product or a company that could be affected by the outcome of the research. Exceptions to the policy should be made public and should be permitted only if the conflict of interest committee (a) determines that an individual’s participation is essential for the conduct of the research and (b) establishes an effective mechanism for managing the conflict and protecting the integrity of the research. RECOMMENDATION 5.1 For all faculty, students, residents, and fellows and for all associated training sites, academic medical centers and teaching hospitals should adopt and implement policies that prohibit • the acceptance of items of material value from pharmaceutical, med- ical device, and biotechnology companies, except in specified situations; • educational presentations or scientific publications that are con- trolled by industry or that contain substantial portions written by someone who is not identified as an author or who is not properly acknowledged; • consulting arrangements that are not based on written contracts for expert services to be paid for at fair market value; • access by drug and medical device sales representatives, except by faculty invitation, in accordance with institutional policies, in certain specified situations for training, patient safety, or the evaluation of medical devices; and • the use of drug samples, except in specified situations for patients who lack financial access to medications. Until their institutions adopt these recommendations, faculty and trainees at academic medical centers and teaching hospitals should voluntarily adopt them as standards for their own conduct. RECOMMENDATION 5.2 Academic medical centers and teaching hospi- tals should educate faculty, medical students, and residents on how to avoid or manage conflicts of interest and relationships with pharmaceutical and medical device industry representatives. Accrediting organizations should develop standards that require formal education on these topics. RECOMMENDATION 5.3 A new system of funding accredited continuing medical education should be developed that is free of industry influence, en- hances public trust in the integrity of the system, and provides high-quality education. A consensus development process that includes representatives of the member organizations that created the accrediting body for con-

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0 CONFLICT OF INTEREST tinuing medical education, members of the public, and representatives of organizations such as certification boards that rely on continuing medical education should be convened to propose within 24 months of the publica- tion of this report a funding system that will meet these goals. RECOMMENDATION 6.1 Physicians, wherever their site of clinical prac- tice, should • not accept of items of material value from pharmaceutical, medical device, and biotechnology companies except when a transaction involves payment at fair market value for a legitimate service; • not make educational presentations or publish scientific articles that are controlled by industry or contain substantial portions written by someone who is not identified as an author or who is not properly acknowledged; • not enter into consulting arrangements unless they are based on written contracts for expert services to be paid for at fair market value; • not meet with pharmaceutical and medical device sales represen- tatives except by documented appointment and at the physician’s express invitation; and • not accept drug samples except in certain situations for patients who lack financial access to medications. Professional societies should amend their policies and codes of professional conduct to support these recommendations. Health care providers should establish policies for their employees and medical staff that are consistent with these recommendations. RECOMMENDATION 6.2 Pharmaceutical, medical device, and biotech- nology companies and their company foundations should have policies and practices against providing physicians with gifts, meals, drug samples (ex- cept for use by patients who lack financial access to medications), or other similar items of material value and against asking physicians to be authors of ghostwritten materials. Consulting arrangements should be for necessary services, documented in written contracts, and paid for at fair market value. Companies should not involve physicians and patients in marketing projects that are presented as clinical research. RECOMMENDATION 7.1 Groups that develop clinical practice guide- lines should generally exclude as panel members individuals with conflicts of interest and should not accept direct funding for clinical practice guide- line development from medical product companies or company founda- tions. Groups should publicly disclose with each guideline their conflict of

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 SUMMARY interest policies and procedures and the sources and amounts of indirect or direct funding received for development of the guideline. In the exceptional situation in which avoidance of panel members with conflicts of interest is impossible because of the critical need for their expertise, then groups should • publicly document that they made a good-faith effort to find ex- perts without conflicts of interest by issuing a public call for members and other recruitment measures; • appoint a chair without a conflict of interest; • limit members with conflicting interests to a distinct minority of the panel; • exclude individuals who have a fiduciary or promotional relation- ship with a company that makes a product that may be affected by the guidelines; • exclude panel members with conflicts from deliberating, drafting, or voting on specific recommendations; and • publicly disclose the relevant conflicts of interest of panel members. RECOMMENDATION 7.2 Accrediting and certification bodies, health insurers, public agencies, and other similar organizations should encour- age institutions that develop clinical practice guidelines to adopt conflict of interest policies consistent with the recommendations in this report. Three desirable steps are for • journals to require that all clinical practice guidelines accepted for publication describe (or provide an Internet link to) the developer’s conflict of interest policies, the sources and amounts of funding for the guideline, and the relevant financial interests of guideline panel members, if any; • the National Guideline Clearinghouse to require that all clinical practice guidelines accepted for posting describe (or provide an Internet link to) the developer’s conflict of interest policies, the sources and amounts of funding for development of the guideline, and the relevant financial inter- ests of guideline panel members, if any; and • accrediting and certification organizations, public and private health plans, and similar groups to avoid using clinical practice guidelines for performance measures, coverage decisions, and similar purposes if the guideline developers do not follow the practices recommended in this report. RECOMMENDATION 8.1 The boards of trustees or the equivalent gov- erning bodies of institutions engaged in medical research, medical educa- tion, patient care, or practice guideline development should establish their

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 CONFLICT OF INTEREST own standing committees on institutional conflicts of interest. These stand- ing committees should • have no members who themselves have conflicts of interest relevant to the activities of the institution; • include at least one member who is not a member of the board or an employee or officer of the institution and who has some relevant expertise; • create, as needed, administrative arrangements for the day-to-day oversight and management of institutional conflicts of interest, including those involving senior officials; and • submit an annual report to the full board, which should be made public but in which the necessary modifications have been made to protect confidential information. RECOMMENDATION 8.2 The National Institutes of Health should de- velop rules governing institutional conflicts of interest for research institu- tions covered by current U.S. Public Health Service regulations. The rules should require the reporting of identified institutional conflicts of interest and the steps that have been taken to eliminate or manage such conflicts. RECOMMENDATION 9.1 Accreditation and certification bodies, private health insurers, government agencies, and similar organizations 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 de- veloping the incentives, these organizations should involve the individuals and the institutions that would be affected. RECOMMENDATION 9.2 To strengthen the evidence base for the de- sign and application of conflict of interest policies, the U.S. Department of Health and Human Services should coordinate the development 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.