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Conflicts of Interest in Continuing Medical Education

December 16, 2008

In professions as wide-ranging as law, accounting and speech therapy, licensed practitioners are expected to keep up with new developments and periodically refresh their training. Usually, the costs of such activities lie with the lawyers, accountants and therapists themselves.

Medicine, however, stands apart. Longstanding practice holds that part of the expense for doctors' continuing education is covered by the pharmaceutical industry, a reality that has invited the kind of scrutiny into potential conflicts of interest that led this year to several high-profile investigations and a renewed focus on oversight in medical research.

Providers of continuing medical education (CME) voluntarily adhere to disclosure guidelines enforced by the Accreditation Council for Continuing Medical Education (ACCME). Critics have argued that no matter how publicly industry funding is advertised, influence on the content of educational sessions is inevitable -- conscious or not, overtly or covertly -- much as scrutiny on certain scientists has focused on the effect of industry support on research conclusions.

Partially to dispel that kind of attention, Stanford University's medical school announced a new policy on CME funding several months ago that goes further than existing ACCME standards. Companies can still donate to the CME office, but they cannot specify individual subjects or programs they'd like to support. While other medical schools consider whether to adopt similar rules, many involved in the practice worry that stricter regulations could scare off industry funding altogether, and with it the financial viability of continuing education.

People are "scared to death of the prospect of losing industry funding for a particular program," said Clarence Braddock III, a professor at the Stanford Center for Biomedical Ethics and course director for the practice of medicine at the Stanford School of Medicine, who helped the institution develop its new guidelines as part of a CME task force.

As the medical establishment considers these questions, critics insist that it's possible to organize a system of continuing education that does not require serious commercial support. To prove themselves right, many have created or called attention to alternative models, from mail-order services to scaled-down seminars.

The Medical CME Landscape

CME is traditionally offered in two ways: by medical institutions or through private medical education and communication companies, both of which receive substantial industry support. The total CME budget approaches $3 billion; over half that amount originates from pharmaceutical companies. Since Pfizer announced in July that it would stop directly supporting CME through contracts with medical education companies -- reportedly to reduce the appearance of any conflict of interest -- there has been a shift from the companies to medical institutions as the dominant continuing education providers. That hasn't removed conflicts of interest as a cause for concern, either real or perceived, and the shift could actually intensify criticisms as medical institutions -- themselves constantly under scrutiny for ties to commercial interests -- administer a growing share of continuing education.

"They're both largely funded by industry," said Adriane Fugh-Berman, a researcher at the Georgetown University School of Medicine and a frequent critic of pharmaceutical companies' influence, referring to CME offered by medical education companies (up to 75 percent funded by industry, she said) and medical schools (two-thirds).

The profession has been grappling with the issue for some time. Two reports released this summer strongly opposed any marketing of pharmaceuticals at medical institutions and rejected the kind of overt gift-giving that has invited criticism from many quarters. Illustrating the debate over how strict new restrictions should be, however, one of the reports, from the Association of American Medical Colleges, suggested that industry support of CME be handled through central offices rather than prohibited.

But the other, from the American Medical Association's Council on Ethical and Judicial Affairs, said that "the profession must obtain more noncommercial funding of professional education activities" and stop relying on pharmaceutical support. The AMA's House of Delegates voted not to support the report's conclusions.

"Continuing medical education need not be as expensive as it now is, and physicians attending CME programs ought to be willing and able to pay something for their continuing education," Arnold S. Relman, professor emeritus of medicine and social medicine at Harvard Medical School, wrote in the September 3 issue of the Journal of the American Medical Association. "As part of their job, full-time salaried clinical faculty at schools and teaching hospitals should be expected to teach in the CME programs sponsored by their institutions, just as they teach in medical student and residency programs."

ACCME, too, has responded with more scrutiny and calls for comment on pending accreditation policy changes. "The ACCME is implementing stricter regulation and oversight of all steps of CME activity development," according to a document issued this summer.

Earlier this year, the accreditation council went so far as to argue that "due consideration be given to the elimination of commercial support of continuing medical education. Many stakeholders inside and outside the CME enterprise have expressed their views on this subject. The ACCME recognizes that although CME exists in a data-driven, evidence-based world, many are motivated by firmly held personal beliefs about propriety and professionalism. The ACCME values both perspectives and now seeks input on this matter."

"It is not ‘business as usual’ at ACCME," Murray Kopelow, the council's chief executive, said in an e-mail, referring to the seriousness with which he said the organization is responding to conflict-of-interest issues.

Preserving Independence

Stanford's task force, Braddock said, began by "trying to think about a way that we could extricate industry influence from CME to the greatest extent possible." After consulting with various groups, including industry, the task force recommended essentially what the medical school ended up adopting as its new policy in September.

Now, pharmaceutical companies can provide funds, but they must go through the central Stanford CME office and be designated for what the medical school calls "broadly defined" fields of study, rather than individual sessions or procedures, such as diagnostic and imaging technologies and disciplines; health policy and disease prevention; and medical, pediatric and surgical specialties.

Among other issues, the task force grappled with the belief that if attendance fees were raised too much, partially to offset diminished industry support, fewer people would come -- or they'd complete their CME requirements in some other way that didn't cost as much. Schools are left with a sort of prisoner's dilemma in which a decision to cut off industry funding and raise individuals' fees would simply benefit those that don't.

Even adjusting fees from $250 to, say, $700 shouldn't be too much of a financial burden, Braddock said, considering doctors' salaries. Still, it would be difficult to compete as long as cheaper alternatives -- likely those with more industry support -- exist. Braddock added that what "nobody really wants to discuss" is that if CME were funded only through registration fees, there is a "generally held assumption that nobody would come."

Stanford considered keeping its standards in line with those currently endorsed by ACCME or, at the other extreme, banning industry support altogether. "[E]ssentially it was viewed to be unrealistic to the extent that there’s not a well-recognized, easy way to think about financial support for CME without some involvement of industry," Braddock said, summarizing the consensus. The task force went with a recommendation that was somewhere in the middle.

"They don’t believe that industry will go along with providing basically a no-strings-attached support that we outlined," he said, referring to worries about what would happen if all schools adopted policies similar to Stanford's. But if many schools were to shift toward a model in which industry could donate funds, but only in generalized pools, "that old model of direct support for CME programs, and at least the perception about the reality of direct influence ... that goes away," Braddock said, adding that one industry group the task force spoke to recognized that they might have to accept a different funding paradigm in the future.

Ultimately, he said, the industry as a whole would have to make shifts in the kinds of programs it funds.

Fugh-Berman, of Georgetown, said she still worried that Stanford's policy could allow for indirect influence, especially in cases in which there's only one drug accepted as treatment for certain conditions. She is the principal investigator of PharmedOut, an online resource funded through a public settlement against a division of Pfizer that was charged with running an illegal drug marketing campaign. The site provides links to free, Web-based CME modules and industry-free CME sources. (Fugh-Berman also criticizes the pharmaceutical industry for using CME to indirectly promote off-label drug use -- in other words, encouraging prescriptions for use in situations other than those they were approved for.)

"We're used to continuing medical education being done in nice hotels with nice meals and speakers from out of town with slides," she said.

Industry funding might not be necessary if those kinds of luxuries are no longer seen as part of the package, she suggested. Braddock agreed that local, regional programs -- rather than large, big-city gatherings -- can subsist at much lower cost.

At the Brody School of Medicine at East Carolina University, the Office of Continuing Medical Education operates its programs with less than ten percent support from the pharmaceutical industry. "We have never relied on commercial support, so we've gotten kind of a culture that allows us to do without it," said Stephen E. Willis, the associate dean for CME and a member of ACCME's Committee for Review and Recognition. He said much of the support comes from the university itself.

"There's no magic" involved, he added -- it's simply a "meat-and-potatoes, bread-and-butter sort of operation" that operates regionally. Although the university is fairly big, the area is mainly rural, another factor in the relatively low meeting costs at local hotels. For most one-day sessions, visitors don't spend the night, Willis said.

But CME doesn't have to be tied to a specific geographic location. Daniel J. Carlat, assistant clinical professor of psychiatry at Tufts University School of Medicine, founded his own monthly newsletter supported entirely by subscriptions. That publication, The Carlat Psychiatry Report, functions as an independent source of CME, free from industry support. Subscribers pay $79 to $109 a year and receive 12 hours of ACCME-approved continuing education if they pass a five-question test every month.

"It’s kind of a model that I think is going to be increasingly prevalent, sort of a model of the physician paying for [his or her] own education," Carlat said. "I hope, anyway."

Carlat, who once gave promotional talks for drug companies until he realized he was a "glorified pharmaceutical representative," said he doesn't believe it's possible for financial interests to support the CME enterprise without biasing it.

"One could argue I have a financial interest in this, as well as an ethical interest, in believing that there has to be some island of pure medical education that is absolutely trustworthy and unbiased."

 

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