Conflict of Interest in Medical Research, Education, and Practice (2009) / Chapter Skim
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1 Introduction
1 Introduction
Pages 23-43
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From page 23... ...
The risks are that individual and institutional financial interests may unduly influence professional judgments involving these primary institutional missions. Such conflicts of interest threaten the integrity of scientific investigations, the objectivity of medical education, the quality of patient care, and the public's trust in medicine.
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From page 24... ...
In medical education, it is particularly troublesome when a faculty member is a promotional speaker for a pharmaceutical, medical device, or biotechnology company or agrees to be listed as an author for a ghostwritten publication. This is because faculty members are expected to present unbiased information and objective assessments of the scientific literature and to help medical students, residents, and fellows develop life-long habits of exercising independent judgment and critically evaluating scientific evidence.
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From page 25... ...
Another area of concern is clinical practice guidelines. Clinical practice guidelines influence patient care, quality and performance standards, and reimbursement for health care professionals and institutions.
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For example, eliminating industry support for accredited continuing medical education might
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From page 27... ...
In contrast, the costs of conflicts of interest and the benefits of mitigating or eliminating them tend to be less tangible, less immediate, and more diffuse. Eliminating direct industry funding of continuing medical education, for example, could increase evidence-based physician prescribing practices, which over time could reduce wasteful health care spending and improve the quality of patient care, but demonstrating such causal relationships could be difficult or impossible.
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From page 28... ...
Institutions that carry out medical research, medical education, patient care, and practice guideline development depend on individuals' disclosure of their financial relationships with industry. Without such disclosure, institutions will lack the information they need to identify and assess conflicts of interest and determine what additional steps -- such as eliminating or managing the conflicting interest -- may be necessary.
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From page 29... ...
Institutions that carry out medical research, medical education, clinical care, and practice guideline development have the primary responsibility for addressing conflicts of interests in these activities. These institutions do not, however, act in isolation.
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In response, the IOM proposed a broad-ranging study that would examine conflicts of interest across medical research, medical education, clinical practice, and practice guideline development. The IOM appointed a 17-member committee to oversee the study and develop the study report.
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This report generally uses the term institutions to refer to academic medical centers; professional societies; patient or consumer groups; and other entities that carry out medical research, provide medical education and clinical care, or develop clinical practice guidelines. The report also distinguishes (particularly in Chapter 9) supporting organizations, such as accrediting agencies and state licensure boards, that may create incentives For the purposes of this report, the committee distinguished companies that produce com mercial medical products from other mostly noncommercial medical institutions (and their personnel)
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From page 32... ...
Reflecting the discussions that led to this study and the emphasis of much research, press coverage, and public and professional debate, this report emphasizes financial interests and relationships involving pharmaceutical, medical device, and biotechnology companies that make -- or that are developing -- medical products used in patient care. (For convenience, the report sometimes refers to these companies as "industry" or "medical product companies," although some start-up biotechnology and other companies may not yet have products approved for marketing.)
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From page 33... ...
Third, when these efforts are found to be wanting and government acts, legislators and administrators may still delegate to regulated institutions many of the details of policy development, implementation, and monitoring. Expanding Relationships Between Industry and Medicine Relationships between physicians, medical researchers, and medical schools and companies that produce medical products have a long history, as have efforts to encourage such relationships.
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From page 34... ...
Between 1998 and 2007, the share of continuing medical education provider income accounted for by commercial sources, excluding advertising and exhibits, grew from 34 to 48 percent, with higher rates for some providers, such as for-profit education and communication companies and medical schools (ACCME, 2008a)
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From page 35... ...
They have also raised concerns that such relationships can -- if they are not properly managed -- threaten the objectivity of medical research, education, and practice and undermine public trust in critical American institutions. Table 1-1 lists some notable events in the emergence of relationships with industry and conflict of interest as a concern in medicine.
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From page 36... ...
issues Grants Policy Statement, which states that grant recipients should have written guidelines on conflict of interest Accreditation Council for Continuing Medical Education (ACCME) adopts Guidelines for Commercial Support (revised and issued as standards in 1992)
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From page 37... ...
) recommends the development of PHS regulations that "clearly restrict financial ties for researchers who conduct evaluations of a product or treatment in which they have a vested interest" Association of American Medical Colleges publishes Guidelines for Dealing with Faculty Conflicts of Commitment and Conflicts of Interest in Research American Medical Association (AMA)
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From page 38... ...
Department of Justice announces deferred prosecution or nonprosecution agreements that allow five orthopedic device companies to avoid criminal prosecution for providing financial inducements for surgeons to use their products 2008 The Pharmaceutical Research and Manufacturers of America releases revised Code on Interactions with Healthcare Professionals and recommends an end to some gift-giving practices The Advanced Medical Technology Association issues revised Code of Ethics HHS issues regulations requiring physician-owned hospitals and physician owners of hospitals to disclose physician ownership interest to patients Massachusetts limits gifts and payments to physicians from pharmaceutical and device companies and requires companies to publicly disclose certain payments 2009 Federal legislation proposed to require disclosure of company payments to physicians and others and reporting of physician ownership interests in health care facilities SOURCES: This timeline draws on a variety of materials, including the websites of the organizations cited above. Other resources include Johnson (1982)
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From page 39... ...
Nonetheless, the adoption of policies has expanded as the scope and complexity of relationships with industry have increased and instances of questionable or illegal behavior have accumulated -- with the attendant negative publicity. In 1984, the Association of American Universities declined to propose conflict of interest policies for its members, but it did undertake a survey of university policies (OTA, 1984; McNeil and Roberts, 1991)
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From page 40... ...
. In recent years, members of Congress have raised questions about industry support for continuing medical education, industry payments to physicians, and faculty member disclosure of such payments.
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. The Advanced Medical Technology Association has also revised its Code of Ethics for medical device manufacturers (effective July 2009)
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From page 42... ...
Senate Manufacturers 2007 Federation of American Call to Action: Managing Financial Societies for Experimental Relationships Between Academia and Biology Industry in Biomedical Research 2007 National Institutes of Health Targeted Site Reviews on Financial Conflict of Interest: Observations 2008 American Council on Working Paper on Conflict of Interest Education 2008 Association of American Industry Funding of Medical Education Medical Colleges 2008 Association of American Protecting Patients, Preserving Integrity, Medical Colleges/ Association Advancing Health: Accelerating the of American Universities Implementation of COI Policies in Human Subjects Research NOTE: These reports do not include organizational codes of conduct or institutional policies. Full citations for these reports are included in the References at the end of the main text of the report.
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From page 43... ...
Chapters 4 through 7 are devoted to examinations of industry relationships and conflicts of interest in the domains of medical research, medical education, clinical practice, and practice guideline development, respectively. Chapter 8 discusses the importance of policies on conflicts that arise at the level of the institution.
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