Medical leaders call for curbs on conflicts of interest

Apr 1 2009

Calling professional medical associations' (PMAs) dependence on funding from pharmaceutical and medical device manufacturers a threat to quality patient care and professional integrity, a group of influential medical leaders today urged these organizations to reduce and eventually eliminate industry contributions.

In an article appearing in the April 1 Journal of the American Medical Association (JAMA), the authors, which includes past and present leaders of medical societies, said PMAs need to "work toward a goal of $0 contributions from industry," excepting revenues from journal advertisements and exhibit hall fees. The authors put forth a detailed package of recommendations to guide PMAs in this effort.

This represents the first time that such a distinguished group of leaders in medicine has uniformly sought to restrict ties between industry and medical specialty organizations. Writing as individuals, not as representatives of their organizations, the authors include physicians who have been or are now at the helm of a number of the major PMAs.

PMAs are critical in both defining and advancing health care standards. Many of these groups help to formulate practice guidelines, to conduct continuing medical education (CME) courses, and to advocate on health policy issues at the state and federal levels.

"Because they are so very important, they must be free of industry funding," says lead author David Rothman, Ph.D., president of the Institute on Medicine as a Profession at Columbia University. Rothman and co-author Walter McDonald, MD, past CEO of the Council of Medical Specialty Societies, convened the group publishing in today's JAMA two years ago. The project was supported by a grant from the Pew Charitable Trusts to address conflict of interest in medicine. "We are not trying to put unreasonable burdens on PMAs but they should be building much sturdier firewalls," says Rothman.

"PMAs play a pivotal role in educating physicians and advancing the practice of medicine but they must be scientifically objective and avoid even the appearance of commercial bias. Only a policy that precludes acceptance of outright financial support from industry can meet the most rigorous standards for independence and integrity," adds co-author Steven Nissen, MD, who chairs the Department of Cardiovascular Medicine at the Cleveland Clinic Foundation.

The goal of $0 contributions is a rigorous one for most PMAs. In the absence of transparency and legal reporting requirements, no one knows for certain what percentage of PMAs budgets come from industry. But it is likely that eliminating drug and device company support, write the JAMA authors, may "require PMAs to transform their mode of operation and perhaps even give up activities of considerable value." Nevertheless, they insist that organizations that educate must erect an impenetrable barrier between their activities and industry marketing actions that could inappropriately influence the practice of medicine.

"We must develop a new model for our relationship with industry - one that is both transparent and clearly separates education from marketing," adds co-author James Scully, MD, medical director and CEO, American Psychiatric Association. "Physicians need the best unbiased evidence about treatments to provide better care for our patients," he says.

"Society will always face controversial issues on which the judgment of physicians and the best interests of patients may not align with the interests of the pharmaceutical industry," adds co-author David Wofsy, MD, a professor of medicine at the University of California San Francisco. "PMAs need to be able to respond to these issues without allowing financial ties to undermine their credibility and without fearing that an independent political position might jeopardize their revenue stream," he adds.

Achieving the group's recommended $0 support (excluding journal advertising and exhibit hall fees) will inevitably take time. Meanwhile, the medical leaders say, PMAs should act "immediately" to restrict total industry support to no more than 25 percent of their operating budget. This interim goal would "begin to wean PMAs from industry support without putting their survival into jeopardy," says the group.

"Budgets for the coming year are set for the most part but we would like to see this principle employed in setting next year's budgets. We believe it is both achievable by most PMAs and an important first step," says McDonald.

The JAMA authors lay out 10 rigorous recommendations for PMAs to follow in the short- and long-term to prevent the appearance or reality of undue industry influence. The recommendations identify and address a number of industry conflict-of-interest areas including leadership, practice guideline development, product endorsement, and conference sponsorship. Here are some key highlights of this groundbreaking effort:

• PMA Leadership. PMA leaders and officers must be completely conflict free during their tenure. This means that no personal income or research support should be derived from industry. Because their election or selection typically occurs at least two years before they take office, they should be conflict free from that starting point. The same rules would apply to the Board of Trustees during their term of service.
• Practice guidelines committee. Formulating practice guidelines is one of the most important things that PMAs do but "under no circumstances" should PMAs accept funding from industry for this purpose. Disclosure of industry relationships by guideline committee members is not sufficient. At a minimum, PMAs "must exclude from guideline committees those with any conflict of interest involving direct salary, support, research support, or additional income from a company whose product sales could be affected by the guidelines."
• Product endorsement. The group says that endorsement contracts with industry "sullies" the reputation of a PMA. A PMA should never solicit or accept any offer that would attach the medical societies name or logo to a commercial product, service or activity, they say.
• Conference sponsorship. PMAs should make sure industry does not influence choice of meeting speakers or content of programs that they support. In addition, because of their ability to influence the content of educational programs, PMA program committee members should disclose financial ties with industry to the committee, chair or other leaders. Drug and device makers should not be allowed to distribute branded items to PMA members such as company logos on tote bags, lanyards, room keys, or publications at conferences. And, while PMAs can let industry purchase and occupy booths at medical conferences, they should not be in the sole path to the scientific or educational session and must be clearly delineated as a marketing site.
• Research and fellowships. Industry should not be allowed to provide a grant for a research project of its choosing or be linked with a specific project. Research funds from industry, like educational support from industry, should go to a central PMA repository or committee. In addition, fellowships should not be named after the drug or device company sponsor. No conditions should be attached to the gift and fellows should not know which company's funds underwrote their grant or travel so they are not under a sense of obligation.

The recommendations for PMAs come slightly more than three years after JAMA published a similar call to action related to industry conflict of interest for academic medical centers (www.imapny.org). Since that effort, which IMAP's Rothman also co-authored with a group of medical luminaries, at least 25 percent of AMCs, including many leading institutions, have enacted policies that keep industry at arm's length from clinical practice.

PMAs recognize that the glare of spotlight is now falling on them as well. Sens. Charles Grassley (R-IA) and Herb Kohl (D-WI), and Rep. Henry Waxman (D-CA) are leading congressional efforts for greater transparency and more stringent limits on pharmaceutical and device industry relationships with medicine.

"PMAs understand fully that they are at a turning point and the rules of the game have changed," says IMAP's Rothman. "Medicine has got to start taking leadership. If they don't do it themselves, it will be done to them," he warns.

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