Several months' worth of dialogue, at times public and heated, between physician groups like the American Heart Association and the ACCME, has resulted in new guidance from the regulator of continuing medical education: Industry scientists, who had been barred from presenting original product-related research at for-credit talks, may now do so as long as provider controls ensure they have zero control over the content.
The guidance, issued by the ACCME on its website yesterday
, outlines the accreditor's standards for ensuring independence for CME when an accredited provider wishes for the speaker to be an employee of a commercial interest commenting about drug discovery or non-product related research. It comes days after the AHA and ACCME both issued separate statements noting the change in how the ACCME planned to apply its commercial-support policy.
The industry employee cannot deliver the content unless the accredited provider “takes complete control of the content,” the guidance notes, citing two main mechanisms: external validation and peer review, coupled with a provider-driven process for determining research relevance, manner of presentation and the context in which the results will be presented.
“We still say the speaker cannot control content if an industry [employee] is speaking on their drugs or products,” Dr. Murray Kopelow, ACCME chief executive, told MM&M
. “This process takes the control of the content out of their hands…The control is entirely—actively and proactively—in the hands of the accredited provider.”
The new guidance stems from discussions the ACCME has had over the last 18 months with accredited providers, including the AHA, whose president, Clyde Yancy, mounted an aggressive protest this month when he discovered that ACCME's independence policy would bar commercial employees from reporting research at AHA's fall annual meeting.
The issue boiled down to a technicality in ACCME's independence standard that equates speaking at a CME event with controlling the content. The ACCME clarified in March 2009 that employees of commercial interests cannot speak if the CME content they are controlling relates to the business lines and products of their employer.
Several physician leaders, in addition to Yancy, also cried foul
. Among those voicing vehement opposition to the policy were Keith Yamamoto, executive vice dean of the University of California, San Francisco School of Medicine, and Francis Collins, director of the NIH. The disagreement came to a head, appropriately, on the eve of a conference held at Georgetown University Medical Center
debating commercially-supported CME.
Then last week, Yancy met with Kopelow to explain the AHA's independent peer-review process and procedure for accepting abstracts, and Yancy was told that the physician specialty group could allow industry employees to make their presentations and still remain within ACCME's independence standard.
“After thoughtful deliberation, the ACCME agreed that AHA's extensive internal controls assure independence, and are appropriate for CME accreditation for a scientific meeting,” the group noted in a press release Wednesday evening. “Thus, there will be no variance from past Scientific Sessions and CME will be available for all presentations within the scientific program.”
Yancy told MM&M
, “Once we got to a point where we talked with ACCME, what was most important was independence, positioning information and freedom from bias. What's most important to us was unfettered delivery of the science. We realized we were both in the same place.”
The ACCME, in a subsequent press release, noted that “some” accredited providers have both peer review and provider-driven internal processes. “Together, these processes cause the content of the activity to be in the control of the provider—and hence, independent.”
After realizing the spirit of its regulations were embedded in the policies and infrastructure AHA had in place, Kopelow explained, ACCME decided it could be more expansive in applying the independence standard without changing policy. “We said, ‘Okay, we can't do this with a razor-sharp edge but with bit of a line.'”
The guidance means other accredited providers, many of whom have been struggling with the same issue when planning meetings, can include new science that mentions therapeutic options or interventions. CME that includes research addresses professional practice gaps and can contribute to improvements in patient care and quality.
Over the last three years, only about one-half of one percent of abstracts at AHA's annual confabs have been presented by industry scientists. This year's count won't be much different, Yancy said, “which is pretty interesting when you consider all the hand-wringing that's taken place as of late.”
Kopelow said his conversations with other accredited providers revealed similar rates: “Out of 4,000-5,000 abstracts at a meeting, 20-30 of them [typically] are in this kind of domain,” he said. Yet, “You don't know if the cure for cancer is among those or not, and neither they nor we wanted to get in the way of disseminating that information."