Parting of the Ways: A Sea Change in Business as Usual

A collaborative effort of prominent medical leaders seeking to wean professional medical associations (PMAs) from pharmaceutical and device industry funding serves as a major step toward building best practice models for managing conflicts of interest (COI), said the president of the Institute on Medicine as a Profession (IMAP).

David J. Rothman, PhD, Bernard Schoenberg Professor of Social Medicine at Columbia University in New York, explained that the group (which included current and former medical society officers) debated proposals for some 2 years before publishing its recommendations in JAMA.¹ James Scully Jr, MD, medical director and CEO of the American Psychiatric Association, was among the 10 coauthors who assisted lead author Rothman in developing the recommendations. The views presented in the article represent their own perspectives and not those of their organizations. Pew Charitable Trust funded the work.

The authors offered 10 recommendations for PMAs to follow to prevent what they termed “the appearance or reality of undue industry influence.”

They covered general budget support from industry, national and regional conventions, industry funds for research by PMAs and members, industry funding for fellowships and training programs, practice guidelines committees, industry support of PMAs’ publications, product endorsements, affiliated foundations, COIs for PMA presidents and board members, and guidance for PMA members.

PMAs have enormous influence through their practice guidelines, CME courses, and physician education at the annual meetings, Rothman said. They also play a major role in advocating health policy issues at state and federal levels. “We want to make certain that practice guidelines, medical education, and physician advocacy are based on best medical practices and are not a response to industry that may be supporting those activities financially,” Rothman told Psychiatric Times.

The recommendations are the initial step in creating best practices, similar to a pattern followed for aca­demic medical centers (AMCs). In 2008, JAMA published a similar call to action related to industry COI issues for AMCs.² Subsequently, COI policies from 125 AMCs have been posted on the Institute on Medicine’s Web site .

We plan to compile COI policies from leading PMAs and, with permission, make them available on the Web site, Rothman said. Then, we will begin to identify best practices, using the recommendations in the recent JAMA article as the criteria for best practices.

Rothman acknowledged that the COI recommendations were published during a time of economic downturn.

“Many PMAs have lost money in their endowments . . . so this is not the easiest time in the world to build greater firewalls that might cost PMAs industry support. On the other hand, we do think it is necessary that they begin to think imaginatively about how to wean themselves from industry money,” he said.

The most controversial of the proposals, Rothman said, was the recommendation of working toward a complete ban ($0) on pharmaceutical and medical device funding, except for income from journal advertising and exhibit hall fees.

As an interim step, Rothman and colleagues recommended that PMAs restrict total support from industry (except for revenues from journal ads and exhibit hall fees) to no more than 25% of their operating budgets, with no single industry source responsible for the majority of total industry funding to the PMA.

Another contentious topic involved industry funding of research by PMAs and members. Opinions ranged from banning any industry funding for PMA research to only allowing funding if it were deposited into a central repository of funds and were used to support genuine research that the PMA was eager to do rather than for research in response to an industry request or carrying an industry identifier.

It was recommended that PMA officers receive no personal income and no research support from industry for 2 years before they take office and throughout their tenure, and that the board of trustees sever all financial ties to industry during their term of service. The PMA’s executives and staff would be prohibited from accepting any industry gifts or favors, including travel.

Scully’s view

Asked about his experience serving as a coauthor of the JAMA article, Scully responded: “The point of the article was to provide a think piece of recommendations. None of us had standing to force anybody to do anything. But there was collaboration and a good deal of debate across various points of view, ranging from absolutism to relativism. The goal was to get the discussion on these issues further along and let people react.”

PMAs must develop a new model for their relationship with industry-one where there is transparency and a clear separation between marketing and education, he added.

Some of the group’s recommendations Scully felt were too strict.“There are places where the pharmaceutical industry can properly and transparently contribute to professional associations,” he said, citing as examples, public education campaigns, fellowships, and journal advertising.

APA, he added, has been at the forefront of changes in COI policies, such as requiring 3 years ago that DSM-V taskforce and workgroup members agree not to receive more than $10,000 annually in aggregate from industry sources (excluding unrestricted research grants) and agree not to participate in any capacity in industry-sponsored symposia (ISS) at an APA annual meeting during their taskforce and/or workgroup tenure.

More recently, Scully said, APA’s Board of Trustees decided to phase out ISS along with industry-supplied meals at its annual meetings. Workgroups are also reevaluating fellowship programs and the relationships between psychiatrists and medical industries.

For calendar year 2008, according to an APA spokesperson, an estimated 24% of the association’s $64 million budget came from industry funding. Of that $15,360,000, 42% is advertising and exhibit hall fees, 23% is meeting-related (ISS) and 35% is grants and fellowships for education or research.

To offset declining funding from industry, Scully said APA plans to offer additional high-quality continuing medical education (CME) programs at its meetings and CME credit and maintenance of certificate programs on its Web site, as well as possibly raising meeting registration fees.

“We still have revenue from dues, publications, our meetings, and educational programs. So we will cinch up, cut some expenses, and we will be fine,” he said.

Scully emphasized the importance of self-regulation for APA and other PMAs. “We don’t need the government and others coming in to regulate us. When allegations are made and there is all this controversy [around COI], we need to take a hard look at things and see if we can do them better . . . we followed all the rules of the accrediting agencies, but maybe we need to do more than that . . . because our mission . . . is to get the best possible and latest clinical information to our members so they can practice high-quality medicine.”

Hendren’s reaction

According to Robert Hendren, DO, president of the American Academy of Child and Adolescent Psychiatry (AACAP), most recommendations in JAMA represent policies that AACAP has already independently implemented.

Several recommendations are more challenging than others. One, he said, involves eliminating industry support for fellowships and training programs, which allows residents and fellows, “who don’t have financial means,” to attend meetings or engage in special training programs. He explained that such fellowships and grants are awarded on a competitive basis. Selection panel members receive no pay for their service, and industry is required to take a hands-off approach throughout the process.

AACAP, like APA, had already begun addressing COI issues before the JAMA article appeared, according to Hendren.

“The academy has always been very up-front with our operating principles for extramural support,” Hendren said.

At the annual meetings, he said, AACAP has never allowed satellite symposia. When the academy has accepted industry support for its meetings or research programs, there is a firewall preventing industry from having any influence on topic or speaker selections.

In the past year, according to Hendren, the organization has developed or updated guidelines on COIs for child and adolescent psychiatrists and guidelines for researchers. The appendix in the clinicians’ guidelines contains a sample “Statement for Parents” to be used to inform parents about COI situations, and some AACAP members, according to Hendren, have displayed it in their offices.

The various guidelines are posted on AACAP’s Web site, as is AACAP’s revised code of ethics, emphasizing transparency issues, and its annual budget, revealing non-exhibit funding provided by pharmaceutical companies by purpose and amount.

“Industry and professional organizations have a shared mission in educating physicians about the products they use and how to make good decisions,” said Hendren. There are ways, he added, that industry and PMAs can “work together to manage conflict-of-interest issues” through being transparent and letting people know when COIs arise.

Other COI efforts

Shortly after the recommendations by Rothman and colleagues were published, the Institute of Medicine (IOM) issued a 353-page report recommending far-reaching changes to prevent industry gifts and payments from influencing patient care and treatments. The details appear in a press statement.

For example, the report calls on clinicians, researchers, and medical school faculty to forgo gifts of any amount from medical companies and to decline to publish or present material ghostwritten or otherwise controlled by industry.

It also calls on professional societies, academic medical centers, and other entities to establish or strengthen their COI policies.

Some academic medical centers have already begun. Stanford University School of Medicine announced recently that by year-end, it will post on its Web site the medical- and research-related consulting activities of some 1200 physicians and faculty affiliated with the medical school.

Faculty members will have to reveal payments of $5000 or more per year from a single commercial entity and also any companies from which the researcher or clinician has the right to receive royalties for inventions or discoveries; in which the person holds equity as a result of activities as a founder, inventor, or consultant; and for which he or she serves as a director or holds other fiduciary office.

Similarly, Johns Hopkins University’s Medical School as well as Massachusetts General Hospital and Brigham and Women’s Hospital have adopted new COI guidelines.

Bernard Lo, chair of the committee that wrote the IOM’s report and professor of medicine and director of the program in medical ethics, University of California, San Francisco, provided a perspective on recent COI changes. “It is time,” he said, “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.”

References:

1. Rothman DJ, McDonald WJ, Berkowitz CD, et al. Professional medical associations and their relationships with industry: a proposal for controlling conflict of interest. JAMA. 2009;301:1367-1372.2. Rothman DJ. Academic medical centers and financial conflicts of interest.

JAMA.

2008;299:695-697.