At last week’s American College of Cardiology annual meeting In Washington D.C., Murray Kopelow, President and CEO of the Accreditation Council for Continuing Medical Education (ACCME), spoke to the ACCME’s conflict of interest (COI) requirements. His presentation was part of a larger COI session entitled “Let the Sunshine in: Research and Education in an Era of the 24-Hour News Cycle.”
Kopelow noted that continuing education has been proven effective in assisting professionals in modifying and improving their practice. But in certain cases, promotion and education can become intertwined. ACCME’s presentation examined the 2007 Senate Finance Committee’s quotes regarding potential conflicts in the CME sphere: “There is a risk that physicians will allow favorable drug messages learned in an educational context to change their clinical practices to favor use of those drugs, without critically appraising the evidence or fully assessing information from other sources.”
“Accredited” continuing medical education (CME), therefore, is grounded in whether the educational content is valid, and if it is independent of the control of ACCME-defined commercial interests.
The ACCME is “very precise” about the circumstances that cause a conflict of interest, stated Kopelow. They look at whether a person: (1) has a financial relationship with an ACCME-defined commercial interest AND (2) has an opportunity to control the content of CME relevant to that relationship. ACCME is concerned with these “relevant financial relationships” because presenters may have an incentive to maintain or increase the value of that relationship. The undesirable outcome of this relationship would be for CME learners to, for example, inappropriately prescribe a drug, or prescribe more than is necessary.
ACCME’s Standards for Commercial Support are intended as a tool to resolve potential conflicts. Kopelow admitted that while ACCME seeks to only regulate as much as necessary, they may fall into what Anthony Downs calls the “Law of Ever Expanding Control.” The Law states: “The quantity and detail of reporting required by monitoring bureaus tends to rise steadily over time, regardless of the amount or nature of the activity being monitored.”
ACCME provides three layers of requirements using a “public health model” to protect against unnecessary or inappropriate use of products.
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ACCME ensures that the education is based on professional need, not the availability of money. Professional practice gaps, Kopelow notes, drive what the education will be. Educational providers then must deduce the need that underlies a professional practice gap. Furthermore, industry has not been allowed to pay physicians directly in the United States for over 20 years.
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ACCME requires that the education be truthful, evidence-based, and “by the profession, for the profession.” Thus, ACCME disallows any commercial bias in its education programs, including even “nuanced” guidance from industry. “There must be evidence for the recommendations in the accredited continuing medical education,” Kopelow states, and “the profession must agree that evidence supports the recommendation.” ACCME requires explicit independence—industry has no role in the educational program.
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The third layer ACCME uses in protecting against unnecessary or inappropriate use of products involves revealing and resolving relationships with industry. “Conflict of interest isn’t moral, unethical, or unprofessional,” Kopelow notes. “It is a fact of life, and it is a result of the world in which professionals operate.” Thus, ACCME has tools to manage these situations in its conflicts resolution procedure.
Kopelow worries about the perception that ACCME’s rules stifle innovation. A number of years ago, the National Institutes of Health (NIH) noted their concern that some critical discovery by industry couldn’t be reported in accredited continuing medical education because the ACCME said it couldn’t be done. He also offered an example of an article which stated: “one day someone is going to say ‘we cured cancer three years ago but we couldn’t tell anybody because the ACCME wouldn’t let us.'”
These circumstances were “not what [ACCME] intended,” Kopelow stated, so they “created special guidance for those working in discovery.” He noted that “just because the data was generated from industry doesn’t mean they control the content…of what gets published.” Kopelow hopes that new discoveries are getting reported, and believes they are. He concluded his presentation by quoting Raynard S. Kington, M.D., Ph.D., Deputy Director of the National Institutes of Health, who stated: “We applaud the Accreditation Council for Continuing Medical Education’s efforts to provide additional guidance for ensuring research independence and a free flow of scientific exchange, while safeguarding accredited CME from commercial interest. Your vigilance in this important matter contributes to the best practices of unbiased information-sharing and will benefit, ultimately, the health of the American public.”