Conflicts of interest threaten public’s trust in medicine: IOM report

“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,” according to a new report issued today by the Institute of Medicine. [Here is a link to a free PDF of the Executive Summary.]

The report calls for “all academic medical centers, journals, professional societies, and other entities engaged in health research, education, clinical care, and development of practice guidelines” to “establish or strengthen conflict-of-interest policies.” Furthermore, “disclosure by physicians and researchers not only to their employers but also to other medical organizations of their financial links to pharmaceutical, biotechnology, and medical device firms is an essential first step in identifying and managing conflicts of interest and needs to be improved.”

The report calls for legislation that would “require pharmaceutical, biotechnology, and device firms to report through a public Web site the payments they make to doctors, researchers, academic health centers, professional societies, patient advocacy groups, and others involved in medicine.” In addition, physicians should decline gifts of any amount and refuse to publish ghostwritten material, according to the report. Consulting arrangements, interactions with sales reps and accepting free drug samples also would be severely limited.  “Groups that develop guidelines should not accept direct industry funding for this work and generally should exclude individuals with conflicts of interest from the panels that draft guidelines.”

Regarding continuing medical education, the report compared physicians to other professionals, including accountants, architects, engineers, and lawyers (lawyers!) and notes that the cost of continuing professional education in these other fields is generally paid by the individual professional or his or her  firm or employer.

But the ACC CEO Jack Lewin, while generally approving of the report, defended the value of industry-funded CME. Here is his response to the report:

“Most of the recommendations made in this report are appropriate and reasonable; however, it would be wrong to say that industry-funded CME cannot be carefully managed to prevent conflicts. Twenty years ago we were only using a fraction of the science we use today, and it is necessary for doctors to keep up with the latest technologies in order to continue to provide patients with the best evidence-based care available. It would be a shame to alleviate industry from their responsibility to physician education, freeing up more funds for direct to consumer advertising.

The report includes 16 concrete recommendations, as follows:

Overview of 16 Recommendations

General policy:

  • Adopt and implement conflict of interest policies
  • Strengthen disclosure policies
  • Standardize disclosure content and formats
  • Create a national program for the reporting of company payments

Medical research

  • Restrict participation of researchers with conflicts of interest in research with human participants


Medical education

  • Reform relationships with industry in medical education
  • Provide education on conflict of interest
  • Reform financing system for continuing medical education


Medical practice

  • Reform financial relationships with industry for community physicians
  • Reform industry interactions with physicians


Clinical practice guidelines

  • Restrict industry funding and conflicts in clinical practice guideline development
  • Create incentives for reducing conflicts in clinical practice guideline development


Institutional conflict of interest policies

  • Create board-level responsibility for institutional conflicts of interest
  • Revise PHS regulations to require policies on institutional conflicts of interest


Supporting organizations

  • Provide additional incentives for institutions to adopt and implement policies
  • Develop research agenda on conflict of interest

Here is the press release from the Institute of Medicine:

Date:  April 28, 2009

Contacts:  Christine Stencel, Senior Media Relations Officer

Alison Burnette, Media Relations Assistant

Office of News and Public Information

202-334-2138; e-mail <[email protected]>

FOR IMMEDIATE RELEASE

VOLUNTARY AND REGULATORY MEASURES NEEDED TO REDUCE

CONFLICTS OF INTEREST IN MEDICAL RESEARCH, EDUCATION, AND PRACTICE

WASHINGTON — New voluntary and regulatory measures can strengthen protections against financial conflicts of interest in medicine without hindering patient care or the advancement of medical knowledge, says a new report by the Institute of Medicine.  The report tackles conflicts of interest across the spectrum of medicine, from biomedical research to clinical care and from the training of new doctors to the continuing education of physicians.  It recommends several actions to improve disclosure of financial ties between the medical community and industry, limit company payments and gifts, and remove industry influence from medical education and the development of practice guidelines.

“It is time to end a number of long-accepted practices that create unacceptable conflicts of interest, threaten the integrity of the medical profession, and erode public trust while providing no meaningful benefits to patients or society,” said Bernard Lo, chair of the committee that wrote the report and professor of medicine and director of the program in medical ethics, University of California, San Francisco.  “We also need more specific disclosure of the financial relationships that doctors and researchers have with medical industries.  This report spells out a strategy to protect against financial conflicts while allowing productive relationships between the medical community and industry that contribute to improved medical knowledge and care.”

All academic medical centers, journals, professional societies, and other entities engaged in health research, education, clinical care, and development of practice guidelines should establish or strengthen conflict-of-interest policies, the report says.  Disclosure by physicians and researchers not only to their employers but also to other medical organizations of their financial links to pharmaceutical, biotechnology, and medical device firms is an essential first step in identifying and managing conflicts of interest and needs to be improved.  The committee noted substantial variations in institutions’ conflict-of-interest policies and shortcomings in physicians’ and researchers’ adherence to policy requirements.  The format for disclosure and categories of relationships should be standardized to help institutions judge the risk that a relationship poses and to ease the burden for individuals who must report information to multiple organizations with different policies.

In addition, Congress should require pharmaceutical, biotechnology, and device firms to report through a public Web site the payments they make to doctors, researchers, academic health centers, professional societies, patient advocacy groups, and others involved in medicine.  A public record like this could serve as a deterrent to inappropriate relationships and undue industry influence.  It also would provide medical institutions with a way to verify the accuracy of information that physicians, researchers, and senior officials have disclosed to them.

The report calls on researchers, medical school faculty, and private-practice doctors to forgo gifts of any amount from medical companies and to decline to publish or present material ghostwritten or otherwise controlled by industry.  Consulting arrangements should be limited to legitimate expert services spelled out in formal contracts and paid for at a fair market rate.  Physicians should limit their interactions with company sales representatives and use free drug samples only for patients who cannot afford medications.  Several professional organizations and industry groups have set new limits on gift giving and other relationships between industry and the medical community, but it is too soon to gauge the effects these changes, the committee noted.

Greater transparency and accountability are needed in the development of clinical practice guidelines, which advise physicians on how to best provide care.  Groups that develop guidelines should not accept direct industry funding for this work and generally should exclude individuals with conflicts of interest from the panels that draft guidelines, the report says.  In addition, the current system for financing accredited continuing medical education relies too heavily on industry support and needs to be overhauled to be free of industry influence and provide high-quality education.

Professional societies, government agencies, and the groups that accredit medical schools can encourage adoption and implementation of conflict-of-interest policies by publicizing which institutions have adopted the recommended policies and which have not.  This publicity could motivate institutions to close gaps in their conflict-of-interest policies or to justify why they disagree with the recommendations.  For example, groups that accredit and certify medical schools could set standards for the adoption of conflict-of-interest policies and publicly list the institutions that follow those standards.  Similarly, the World Association of Medical Editors could publicize which journals have adopted authorship and other policies consistent with its conflict-of-interest statements.  The report also calls for more research on the impact of conflict-of-interest policies so that future policies can be based on more rigorous evidence.

Although the report calls for some new legislation and regulations, it also emphasizes the role of voluntary efforts by medical groups, industry, and individual professionals.  Voluntary action is more likely to reinforce professional values and foster policies that minimize unintended consequences and administrative burdens.  However, the report warns, if the industry and the medical community fail to strengthen their conflict-of-interest policies, practices, and enforcement, more policymakers may turn to legislative solutions, as officials in some states have.

Interactions between industry and the medical community have evolved over decades, becoming commonplace today and producing both benefits and concerns.  Research collaborations have yielded new cancer drugs, HIV/AIDS therapies, prosthetic heart valves, tools to monitor anesthesia, and many other advances in the prevention, diagnosis, and treatment of illness, the report notes.  At the same time, legal and media investigations into relationships between industry and the medical community have led to embarrassing revelations about lack of disclosure and dubious relationships, congressional legislative proposals, and prosecutions.  Although data are limited on the extent to which conflicts result in biased decision making or harm, such conflicts can erode trust in doctors and the research enterprise, the report concludes.

The study was sponsored by the National Institutes of Health, Robert Wood Johnson Foundation, Greenwall Foundation, ABIM Foundation, Burroughs Wellcome Fund, and Josiah Macy Jr. Foundation.  Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public.  The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies.  A committee roster follows.

Copies of CONFLICTS OF INTEREST IN MEDICAL RESEARCH, EDUCATION, AND PRACTICE are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at HTTP://WWW.NAP.EDU.  Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).  In addition, a podcast of the public briefing held to release this report is available at HTTP://NATIONAL-ACADEMIES.ORG/PODCAST.

#       #       #

[ This news release and report are available at HTTP://NATIONAL-ACADEMIES.ORG ]

INSTITUTE OF MEDICINE

Board on Health Sciences Policy

COMMITTEE ON CONFLICT OF INTEREST IN MEDICAL RESEARCH, EDUCATION, AND PRACTICE

BERNARD LO, M.D. (CHAIR)

Professor of Medicine, and

Director

Program in Medical Ethics

University of California

San Francisco

WENDY H. BALDWIN, PH.D.

Director

Poverty, Gender and Youth Program

The Population Council

New York City

LISA BELLINI, M.D.

Associate Dean for Graduate Medical Education, and

Associate Professor of Medicine

Pulmonary, Allergy, and Critical Care Division

Department of Medicine

University of Pennsylvania

Philadelphia

LISA BERO, PH.D.

Professor

Department of Clinical Pharmacy

School of Pharmacy and Institute for Health Policy Studies

University of California

San Francisco

ERIC CAMPBELL, PH.D.

Associate Professor

Institute for Health Policy

Department of Medicine

Massachusetts General Hospital

Boston

JAMES F. CHILDRESS, PH.D.

John Allen Hollingsworth Professor of Ethics, and

Professor of Medical Education, and

Director

Institute for Practical Ethics and Public Life

University of Virginia

Charlottesville
PETER CORR, PH.D.

Co-Founder and General Partner

Celtic Therapeutics

New York City

TODD DORMAN, M.D.

Nursing Vice Chair for Critical Care, and

Associate Dean and Director of Continuing Medical Education

Departments of Anesthesiology and Critical Care Medicine

Johns Hopkins University

Baltimore

DEBORAH G. GRADY, M.D., M.P.H.

Professor of Medicine, and

Associate Dean for Clinical and Translational Research, and

Director

Women’s Health Clinical Research Center

School of Medicine

University of California

San Francisco

TIMOTHY STOLTZFUS JOST, J.D.

Robert L. Willett Family Professor of Law

School of Law

Washington and Lee University

Lexington, Va.

ROBERT P. KELCH, M.D.

Executive Vice President for Medical Affairs

University of Michigan

Ann Arbor

ROBERT M. KRUGHOFF, J.D.

Founder and President

Center for Study of Services

Washington, D.C.

GEORGE LOEWENSTEIN, PH.D.

Herbert A. Simon Professor of Economics and Psychology

Department of Social and Decision Sciences

Carnegie Mellon University

Pittsburgh

JOEL S. PERLMUTTER, M.D.

Professor of Neurology, and

Professor of Radiology

Washington University

St. Louis

NEIL R. POWE, M.D., M.P.H., M.B.A.

Director

Welch Center for Prevention, Epidemiology and Clinical Research, and

Professor of Medicine, Epidemiology and Health Policy and Management

Johns Hopkins Medical Institutions

Baltimore

DENNIS F. THOMPSON, PH.D.

Professor of Public Policy and Alfred North Whitehead Professor of Political Philosophy

John F. Kennedy School of Government

Harvard University

Cambridge, Mass.

DAVID A. WILLIAMS, M.D.

Leland Fikes Professor of Pediatrics

Harvard Medical School; and

Chief

Division of Hematology/Oncology, and

Director

Clinical and Translational Research

Children’s Hospital Boston

Boston

INSTITUTE OF MEDICINE STAFF

MARILYN J. FIELD, PH.D.

Study Director

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