Source: www.medscape.com
Author: Deborah Brauser

Current guidelines on conflicts of interest between industry and professional medical associations (PMAs) should be updated with stronger recommendations and adopted by all PMAs, according to an article published in the April 1 issue of the Journal of the American Medical Association.

“PMAs play an essential role in defining and advancing health care standards,” write David J. Rothman, PhD, president of the Institute on Medicine as a Profession and Bernard Schoenberg Professor of Social Medicine at the College of Physicians and Surgeons at Columbia University, New York City, and colleagues. “Their conferences, continuing medical education courses, practice guidelines, definitions of ethical norms, and public advocacy positions carry great weight with physicians and the public. Because many PMAs receive extensive funding from pharmaceutical and device companies, it is crucial that their guidelines manage both real and perceived conflicts of interests.”

However, the authors write, the current PMA policies are not uniform and “lack stringency.” The authors have identified several conflict-of-interest areas and have suggestions for new short- and long-term guidelines to address them. “The recommendations are rigorous and would require many PMAs to transform their mode of operation and perhaps to forgo valuable activities. To maintain integrity, sacrifice may be required.”

10 Recommended Guidelines
The 10 recommended guidelines cover general budget support from industry, national and regional conventions, industry funds for research by PMAs and members, industry funds for fellowships and training programs, guidelines committees, industry support of PMA publications, product endorsements, affiliated foundations, conflicts of interest for PMA presidents and board members, and guidance for PMA members.

In the area of industry support, the authors recommend working toward a complete ban on pharmaceutical and medical device funding, except for the income that comes from journal advertising and exhibit hall fees. “How can the public and the profession be certain that a PMA dependent on industry for support is being faithful to its mission of conducting educational programs and setting practice guidelines that reflect only the best scientific knowledge?” write the authors. “Such a dependency inevitably creates the perception and reality of conflicts of interest and jeopardizes public trust.”

Recognizing that the goal of $0 will not be quickly attainable, Dr. Rothman and colleagues recommend an interim policy of working toward restricting support to no more than 25% of the PMA’s operating budget.

For conferences and annual meetings, the recommendations include establishing additional safeguards for industry sponsorship of conference programs, having strict conflict-of-interest standards for program committee members, keeping exhibit hall space separate from scientific and educational areas, and discontinuing the practice of allowing branded items and other gifts to be distributed to members.

“Physicians ought not to be billboards for industry,” said Dr. Rothman in an interview with Medscape Medical News. “Industry gives small gifts because they think that they have impact on physician decision-making. They’re in the marketing business, and the reason why they give these gifts is that they want their name prominent in your world.”

For PMA publications, the authors write that revenue from industry advertising can be acceptable as long as it is clearly identified as such, and that it should possibly be kept separate from scientific and educational content.

Strictest Recommendation: Boards Should Be Conflict-Free
One of the strictest recommendations is that an organization’s president, officers, and board of trustees should all be conflict-free during their tenures, and not just disclose their conflicts. “The reputation of a PMA is often based on the quality and integrity of its leaders,” write the authors. “They speak for the organization and are most visible to the public and the profession. Therefore, it is essential that [they] be held to the highest standards in avoiding conflicts of interest.”

They explain that this means that no personal income and no research support should be derived from industry for a 2-year period before the president, officers, and board of trustees officially take office and through the duration of their tenure. “This may require would-be office holders to delay assuming the leadership position until an already existing and multi-year grant expires,” explain the authors. In addition, they recommend that all PMA executives and staff should be prohibited from accepting any gifts or favors, including travel.

Overall, “These proposals are likely to generate controversy and claims that they are too restrictive,” the authors conclude. However, “These changes are in the best interest of the PMAs, the profession, their members, and the larger society. [PMAs] have such an important role to play in speaking for medicine, defining best practices, and promoting evidence-based decision making that they cannot allow relationships with industry to diminish the public’s trust.”

Dr. Rothman told Medscape Medical News that any medical association that issues practice guidelines should follow these recommendations. “This is not going to be a cake walk to go down to 25% of your funding and then to zero, and we don’t expect it to happen overnight. But the first critical point is that [PMAs] have got to begin disentangling themselves from industry. Not because industry is a demon or bad, but because inevitably the marketing interests of industry can have a negative impact on the work that PMAs have to do. Our 2 main stands and what we’re looking at are integrity in medical decision-making and public trust.”

General Agreement With Recommendations
The current president of the American Academy of Family Physicians, Ted Epperly, MD, FAAFP, program director and chief executive officer of the Family Medicine Residency of Idaho, in Boise, told Medscape Medical News that overall, there are several good points in the article. “It’s certainly a well-thought-out, well-written article that tackles a very important issue. And I think we can all certainly agree that we want to ensure for the good of the American public that there is transparency and openness in regard to how the profession of the pharmaceutical industry and the device manufacturers, etc, interface with the profession of medicine.” Dr. Epperly and the AAFP were not involved with the designing the recommendations.

He agreed that separating journal advertising and marketing exhibits at conventions makes sense, as does stopping the giveaways. “There shouldn’t be confusion of what’s marketing and what’s education. And we have actually made the correction at our meetings so that posters have been taken away from the promotional areas. As for the free items, it’s a perception issue. Doctors don’t need pens or tote bags with logos on them. I would agree that those ought to go.”

Dr. Epperly also said he agrees that officers and committee members should not have any conflicts. “I have no problem with that, and I’m happy to say that I have been conflict-free. It’s very important for someone in my position to not be taking any pharmaceutical or device money or any other money, quite frankly, while representing my academy and our members. I don’t think it’s asking too much for that to be the general direction everyone moves towards.” However, he said that there may be room on boards for those who disclose stock information as long as they recuse themselves from any discussions or decisions having to do with a particular conflict.

As for industry funding, Dr. Epperly said, “I can’t speak for other associations, but our academy is well below 25%. So I’m glad we’re already in compliance with that number. And I know that we will continue to ratchet that down to be as small an amount as we possibly can.”

Zero Funding Goes “Too Far”
However, he does not agree with the recommendation of working toward zero funding. “Quite honestly, to say that you can never collaborate in any way in which money exchanges hands for [continuing medical education] programming or things like that — ie, the zero that they want to get to — I think has gone a bit too far. It takes the potential for management of this interface between the 2 professions totally off the table. It just says that that won’t be done. And I’m not quite sure that the academy agrees with that stance. The issue for us is that we believe that this can be managed. And we would not agree that commercial support is inherently negative and that it intrinsically creates conflict of interest.”

Dr. Epperly continued, “I think it’s okay to take pharmaceutical money as long as there are policies and procedures on how that’s done and standards that are followed in how that money is utilized. For example, that the pharmaceutical companies can’t direct who the speaker is, or the content has to pass through a program director who has to make those decisions following guidelines and standards.

“If the money was appropriately managed, I don’t see it as a conflict of interest,” Dr. Epperly said. “I see that as something being done to try to educate professionals for the patient’s good in an appropriate way that is disclosed and monitored. I just think it’s important to find the right balance, and anything that’s too extreme on either end is probably not the right answer.”

In addition to Dr. Rothman, the article’s authors included physicians in leadership positions at the Council of Medical Specialty Societies, the American Medical Association, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American College of Cardiology, the American Psychiatric Association, and the American College of Physicians. These authors participated as individuals and not as representatives of their organizations.

Note:
The work for the article was funded by the Pew Charitable Trusts. The authors and Dr. Epperly have disclosed no relevant financial relationships.

Source:
JAMA. 2009;309:1367–1372.