Eliminating CME Conflicts Worth the Cost, Says Scully

“The fact that the relationship between the industry and the medical profession is facing increasing scrutiny is not a bad thing,” James H. Scully Jr., M.D., APA's medical director and CEO, told the Senate Special Committee on Aging at a hearing in late July. He was one of the medical leaders who testified at the hearing to express their knowledge and opinions about continuing medical education (CME)—specifically, whether funding from pharmaceutical and device companies, currently accounting for half of all funding for all CME programs in the United States, leads to biased information for physicians.

The committee chair, Sen. Herb Kohl (D-Wis.), asked everyone who testified:“ Are the drugs and device industries getting a return on their annual billion-dollar investment in continuing medical education?”

Several people testifying at the hearing said yes—industry-funded CME poses either a real problem or at least a serious threat to the objectivity and quality of continuing education that physicians are required to obtain and maintain. Others argued that the current system is effective and sufficient in protecting CME from the commercial interest of sponsors.

APA and the American Medical Student Association were the only medical associations testifying at the hearing.

As a CME provider for tens of thousands of psychiatrist members, APA has been closely examining the potential conflict of interest in the education it provides, Scully testified. “We've taken considerable pains to implement policies to reduce the conflict of interest in the provision of continuing medical education,” he told the senators.

In March APA's Board of Trustees voted to phase out all industry-supported symposia at APA's scientific meetings, the first medical professional society to implement this policy, Scully told the committee.

“This action is not without real cost.... For example, this year we'll lose a million and a half dollars in revenue that we would have had,” said Scully. However, he noted that “in the long run, we believe the elimination of even the perception of undue influence and maintaining or regaining the public's trust is well worth the cost.”

In March 2008 the AMA rejected a proposal to ban commercial support for CME presented by its Council on Ethical and Judicial Affairs (CEJA). CEJA softened its stance in its 2009 report and suggested guidelines for “ethically permissible” commercially supported CME. In June AMA delegates again declined to adopt the recommendations.

At the hearing, Sen. Kohl expressed his disappointment about the AMA's continued lack of policy on the acceptance and management of industry funding.

Credibility of Accrediting Body Questioned

From 1998 to 2007, industry-funded CME activities that were accredited by the Accreditation Council for Continuing Medical Education (ACCME) increased by more than 300 percent. The industry funding reversed this upward trend in 2008, when it declined by $200 million, to total approximately $1 billion.

The independent ACCME is the primary overseer of CME providers, and its accreditation is recognized by medical boards throughout the country. However, its effectiveness in safeguarding the quality and objectivity of CME content was questioned by several panelists at the hearing. Lewis Morris, chief counsel of the Office of Inspector General (OIG) at the Department of Health and Human Services, told the committee that the “ACCME's role in mitigating commercial bias is limited. Oversight is complaint driven and occurs after the fact.” He cited federal lawsuits in which pharmaceutical companies were accused of promoting off-label use of prescription drugs that is disguised as independently provided CME. Several such lawsuits filed by the OIG and the Justice Department in the past decade have been settled for hundreds of millions of dollars.

“The current environment tolerates industry sponsors' preferential funding of programs that serve the business needs of the funders,” Morris said.

Steven Nissen, M.D., chair of the Department of Cardiovascular Medicine at the Cleveland Clinic, told the committee that the current oversight by the ACCME is “largely ineffective” and that the organization“ appears uninterested or incapable of enforcing [its rules].” He recommended that the medical profession needs an independent board to replace the ACCME.

Murray Kopelow, M.D., M.S., chief executive of the ACCME, vehemently disputed the criticism at the hearing. He told the committee that in 2007 the ACCME began a public discussion on whether commercial support for CME should continue or be eliminated. In March 2009, the ACCME board decided that it would not be taking any action to end commercial support for accredited CME at this time. Kopelow noted that the ACCME has been tightening its standards for CME providers in the past few years to ensure their independence from commercial interest.

In 2008 and 2009, the ACCME investigated and closed 17 inquiries of CME providers, 12 of which related to commercial support. Of the 12 inquiries, five were found noncompliant and seven compliant with the ACCME standards. Kopelow also pointed out that the number of CME providers put on probation by the ACCME increased from 1 percent before 2008 to the current rate of 10 percent.

Kopelow insisted that the current oversight works: “The ACCME is the firewall between promotion and education. Accredited CME is independent from commercial interests.”

Benefits of Industry Funding Argued

Thomas Stossel, M.D., director of the Translational Medicine Division and senior physician of the Hematology Division at Brigham and Women's Hospital, Harvard Medical School, testified to the committee that modern medical advances owe much to the close relationship between industry and physicians.

“Of course companies are trying to sell products,” Stossel acknowledged, but that is not a bad thing. He believes that the industry's interest is consistent, not in conflict, with patients' own. He urged the committee to examine “the quality of the product, not... the motive of the producer.” Industry involvement in CME is beneficial to physicians and patients, he maintained, as nonprofit organizations cannot rapidly disseminate the latest research and information about new drugs and technologies to clinical practice.

At the hearing, the committee's ranking member, Mel Martinez (R-Fla.), asked why physicians cannot all be required to pay for their continuing medical education, thus eliminating the need for industry subsidies.

Eliminating industry funding would negatively affect physicians with limited resources such as rural physicians and residents, Stossel and Kopelow argued. These physicians would have less access to information on the newest products and research.

An independent grant organization that pools and distributes industry funding may serve as a firewall between commercial interests and CME content, but this mechanism seems to have little prospect, Morris told the committee. He gave an example of such a grant recently established by the American Academy of Orthopaedic Surgeons. The organization's board members who distribute the grants are prohibited from relationships with device or pharmaceutical companies. So far, major device manufacturers in the field have declined to contribute to this organization and elected to make grants directly to CME providers. ▪