April 10, 2009

Physician Leaders Call for Ban on Industry Funding of Professional Medical Association Activities

Holland & Knight Alert
Michael J. Werner

In an article published in this week’s Journal of the American Medical Association (JAMA), a group of 11 influential clinicians that includes leaders and former leaders of national medical specialty societies as well as the Journal’s editor-in-chief, called on Professional Medical Associations (PMAs) to eventually ban all pharmaceutical and medical device industry funding of operations and activities, except for income from journal advertising and exhibit hall fees.

Although they acknowledged the large role of the pharmaceutical and device industries in the development of new diagnostics and therapies, the authors expressed concerns over the real and perceived conflicts of interest that stem from financial links between industry and medical practitioners and institutions.

The authors propose a set of guidelines to help PMAs develop policies to address these conflicts. A sampling of their guidelines are as follows:

General Budget Support

PMAs should work toward a complete ban on pharmaceutical and medical device funding, except journal advertising and exhibit hall fees. These activities are “marketing” and therefore are easily distinguishable. Recognizing that a complete ban is not feasible in the short term, the guidelines offer a few interim steps for PMAs:

a. All industry funds should be unrestricted and not for a specific activity. They should be pooled and administered by a central repository.

b. PMAs should immediately move to ensure that total support from industry is no more than 25 percent of their operating budgets.

National Conferences and Regional Meetings

a. PMAs should consider establishing a Continuing Medical Education (CME) committee whose members are free of all industry ties to distribute unrestricted, educational grants from industry. This group would select program topics and speakers.

b. Program committee members should adhere to strict conflict-of-interest guidelines. Though at a minimum these committee members should disclose any financial ties to industry, PMAs should strongly consider selecting committee members who are completely free of financial ties to industry.

c. No company logos should appear on “tote bags, lanyards, pens, notebooks, and publications” distributed to conference attendees.

d. A PMA may choose to permit industry representatives to purchase exhibit space, but these should not be “in the obligate path” to a scientific or educational session and must be clearly delineated as a “marketing site.”

Industry Funds for Research by PMAs and Members

PMAs must be solely responsible for determining their research priorities and which research teams to support. Industry should not be allowed to provide a grant for a project of its choosing or be associated with a specific project. Rather, research funds from industry should go to a central repository, and awards should be given out through peer review without industry involvement.

Industry Funds for Fellowships and Training Programs

Industry supports fellowships and training programs for residents and fellows. However, decision-making about which residents or fellows are chosen must be made by PMAs alone. Fellowships should not be named after the pharmaceutical or device company sponsor. In addition, no conditions may be attached to the gift, and the recipient should not be told which company underwrote their fellowship. PMAs should also not allow industry payment for journal subscriptions or books.

Committees That Formulate Practice Guidelines or Outcomes Measures

The establishment of guidelines and performance and outcome measures must be independent of all industry influence, actual or perceived. “Under no circumstances” should PMAs accept funding from industry to develop practice guidelines or outcomes measures. In addition, PMAs must exclude from the relevant committees any persons with any conflict of interest ($0 threshold) involving “direct salary support, research support, or additional income from a company whose product sales could be affected by the guidelines.” To address a situation in which these restrictions would exclude the most qualified individuals, draft guidelines can be widely circulated for comment, but the writing of the final document should be done by knowledgeable professionals who are free from conflicts.

Industry Support of PMA’s Publications

Both the creation and distribution of guidelines and other advisory materials should be independent of industry funding. No PMA publication should bear the logo of a drug or device company. Also, PMAs should not accept industry funding for journal supplements.

Conflicts of Interest Among PMA Presidents, Officers and Board Members

The president and officers of the PMA should be conflict free ($0 threshold) during their tenure. No personal income and no research support should be derived from industry. Members of the PMA board of trustees should be asked to sever all financial ties to industry during their term of service. The PMA executive and operational staff should have no financial ties to industry and should be prohibited from accepting gifts or other favors. Industry should not be permitted to fund any board activity. All travel and meeting costs, including food, are the financial responsibility of the PMA.

The JAMA article details guidance for other situations as well, including product endorsements, affiliated foundations and satellite meetings.

It is not mandatory that any PMA adopt all or part of these guidelines. Nonetheless, the article is another criticism of the role of industry in medical research and practice, as well as of the relationships between industry, physicians and institutions. As a result, it is likely to provide new momentum for legislative and regulatory efforts.

The article can be found at JAMA. 2009;301(13):1367–1372.

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