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Spring/Summer 2009 Vol. 9 Number 1

Table of Contents

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Unbiased Care

Report Lays Out Path to End Medical Conflicts of Interest

Does it make a difference in a patient’s care if his doctor writes a prescription with a pen featuring a pharmaceutical company’s logo? What if the physician accepts lunch from a company sales representative? Or gives a presentation noting the virtues of a medical-device maker’s product?

These scenarios illustrate the uncertainties about when and how relationships with the medical industry affect practitioners’ habits. Some contend that documented harms to patients as a result of health care providers’ or researchers’ industry ties are few and that such cases are aberrations. Others argue that any ties to industry are inherently fraught with potential for creating biases and point to a number of conflict-of-interest cases that have come to light in just the past year.

Revelations of undisclosed financial relationships between the medical community and companies could have a corrosive effect on people’s trust in medicine, says a new report from the Institute of Medicine. And some relationships pose risks for bias while offering little or no societal benefits.

©Comstock/PunchStockAmericans have traditionally placed great trust in physicians and clinical researchers, granting them considerable leeway to regulate themselves. And collaborations with companies have advanced medical knowledge and yielded new diagnostic tests, more options for therapy, and better approaches to care. But in light of growing concerns among policymakers, medical leaders, and the public about medical conflicts, the report lays out a blueprint for voluntary and regulatory measures that can strengthen protections against inappropriate relationships without hindering patient care or the advancement of medical knowledge.

“Responsible and reasonable conflict-of-interest policies and procedures will reduce the risk of bias and the loss of public trust while avoiding undue burdens or harms,” said Bernard Lo, chair of the committee that wrote the report and professor of medicine and director of the program in medical ethics at the University of California, San Francisco.

Most medical institutions have conflict-of-interest policies of some kind, but they vary considerably. Compliance also varies widely as does institutional oversight and management, the committee found.

The report encourages enhanced requirements for all physicians, scientists, and medical institutions to disclose their links to companies. The format for disclosure and categories of relationships that must be revealed should be standardized to make it easier to judge the nature of relationships and to ease the burden for individuals who must report to multiple organizations. In addition, Congress should require pharmaceutical, biotechnology, and medical 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.

Disclosure is only one part of the solution, however. The report also calls for individuals and institutions to simply refuse to accept industry gifts, sign their names to industry-written articles or materials, and engage in other inappropriate relationships.

Industry involvement in continuing medical education (CME) stirs significant debate. Company sponsorship has helped make CME more widely accessible, but has increasingly led to concerns about the objectivity of the information being presented. To remove even the appearance of slanted information, CME should be free from industry influence, the committee said. It did not rule out the possibility of industry support, however, noting that it may be possible for financial assistance from firms to be channeled through a mechanism that allocates it in a neutral fashion.

The report emphasizes the role of voluntary efforts as more likely to reinforce professional values and foster policies that minimize unintended consequences and administrative burdens. However, if the industry and the medical community fail to strengthen their conflict-of-interest policies, practices, and enforcement, policymakers may turn to legislative solutions.  — Christine Stencel

 Conflict of Interest in Medical Research, Education, and Practice. Committee on Conflict of Interest in Medical Research, Education, and Practice, Board on Health Science Policy, Institute of Medicine (2009, approx. 392 pp.; ISBN 0-309-13188-X; available from the National Academies Press, tel. 1-800-624-6242; $54.95 plus $4.50 shipping for single copies).

The committee was chaired by Bernard Lo, professor of medicine and director of the program in medical ethics, University of California, San Francisco. The study was funded by the National Institutes of Health, Robert Wood Johnson Foundation, Greenwall Foundation, ABIM Foundation, Burroughs Wellcome Fund, and Josiah Macy Jr. Foundation.

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Copyright 2009 by the National Academy of Sciences