Is it appropriate for industry speakers to speak at certified continuing medical education activities if their presentation relates to their employers’ products or business lines? The question created some controversy recently and caused the Accreditation Council for Continuing Medical Education to clarify some rules pertaining to industry speakers presenting at certified CME activities. The discussions specifically related to presentations about industry-sponsored research and discovery.

The controversy erupted at a June National Institutes of Health advisory committee meeting that was attended by several leaders from the worlds of science and medicine, including Clyde Yancy, MD, president of the American Heart Association, and NIH Director Francis Collins. Among the topics the committee discussed was a clarification of the ACCME Standards for Commercial Support that essentially said that employees of commercial interests could not serve as speakers at accredited CME activities “if the content of the CME that the employee of the commercial interest controls relates to the business lines and products of its employer.”

The clarification was spelled out in the question-and-answer section of the Standards for Commercial Support and published on the ACCME’s Web site in March 2009. The Q&As are posted to answer the questions that arise as providers implement the Standards. The Standards were issued in 2004. The Q&As were added, as clarifications, in 2009, explains Murray Kopelow, MD, chief executive, ACCME.

At the NIH meeting, Yancy talked about the impact the stipulation was having on AHA and its annual Scientific Sessions, coming up in November. “As we were planning our 2010 Scientific Sessions, we went back to update the current strategies we’re using and to make certain they were in line with the stated principles and policies of the ACCME,” Yancy told Medical Meetings. AHA leaders discovered that some of the submitted abstracts might be in conflict with the stipulation. Though the abstracts in question equaled less than 1 percent of the total, “That put us in a peculiar spot as the first large meeting to have to operationalize this nuanced, but very significant, interpretation of the ACCME guidelines,” Yancy says. Consequently, AHA made the decision to prohibit the abstracts since they would have been in violation of this guideline.

Ban Bias, Not Scientists

However, it did not sit well with Yancy and AHA, which has rigorous internal reviews and controls to make sure that all science presented at accredited CME is independent and free of bias. “The idea that someone would ban scientists from presenting their data simply because of their source of employment was objectionable,” he says. While there are certainly instances where industry speakers do cross the line and shouldn’t be permitted to speak at accredited CME activities, there are others where the information can be presented appropriately, he says. “The principle ought be that good science, fairly adjudicated during an appropriate peer-review process, ought to be made available for review, comment, and critique to the global science community and shouldn’t be censored or separated or tainted simply because of the origin of the investigator,” he adds.

The impromptu protest against the stipulation at the NIH meeting served as the tipping point, and others—including NIH Director Francis Collins, MD—objected as well. The story was covered in the mainstream press, including The New York Times, spreading the controversy outside of the provider/supporter community to the public at large.

Yancy appealed the stipulation with the ACCME. After discussions, ACCME determined that AHA’s processes were rigorous enough to insure independence even if industry speakers made presentations about the results of research conducted by their companies. “During in-depth discussions with the AHA, and after thoughtful deliberation, the ACCME agreed that AHA’s extensive internal controls assure independence and are appropriate for CME accreditation for a scientific meeting. Thus, there will be no variance from past Scientific Sessions and CME will be available for all presentations within the scientific program,” the association’s leaders said in a statement on June 24. “For those submissions that were withheld, we will reopen abstract submissions shortly and enter the newly submitted material into our ongoing peer review process.”

ACCME’s Kopelow also released a statement, saying “We recognize this policy addresses complex issues and presents challenges for some accredited organizations. We are engaged in ongoing discussions with them to understand their specific circumstances and to provide support as they develop implementation strategies.”

ACCME Updates Guidance

This case as well as the controversy that ensued precipitated a move by the ACCME to further clarify the rules. “We are providing the updated guidance as a result of discussions we have had over the last several months with accredited providers concerning the role of commercial-interest employees in accredited CME about research and discovery,” the ACCME said in a statement on June 28. “The ACCME’s objective is to support the free flow of scientific exchange while safeguarding accredited CME from commercial influence.”

Specifically, ACCME added some further clarifications to the Q&A section of the Standards for Commercial Support, 1: Independence. As a follow-up to the question that sparked the controversy, ACCME explained which topics do not relate to “business lines and products” of employers:
1. teaching about the scientific or discovery process itself,
2. reporting research results that would be considered at the level of biology or physics—but not about products, and
3. participating in CME beyond the scope of the firm (e.g., a person from a device manufacturer who volunteers with a specialty society to develop a program on disaster management).

The Q&A also says that accredited CME can include presentations or reports on scientific research conducted by employees of commercial interests as long as it complies with ACCME criteria and Standards. It adds: “Together, the ACCME and accredited providers have recognized that there are circumstances where an employee of an ACCME-defined commercial interest can make a scientific presentation within accredited CME about their company’s research—and be compliant with the ACCME Standards for Commercial Support.”

Applying the Clarifications

The new clarifications have been well-received by providers. Thomas Sullivan, president and founder of Rockpointe Corp., a medical education company headquartered in Columbia, Md., supports the new guidance from ACCME. “I think this shows the ACCME’s commitment to overseeing high-quality medical education,” says Sullivan, who also writes a blog called Policy and Medicine. “It is encouraging that the ACCME is not only focused on the risk, but also looking at the benefit of industry science which eventually improves patient care.”

Since the initial Q&A was posted in March 2009, ACCME officials have had discussions with several providers about how it applies to their activities and situations, says Kopelow. “It depends on the facts and circumstances of the situation. Everyone’s facts and circumstances are different and every time somebody comes to us with a question and a situation, our answer is applicable to them and their circumstances.” Some societies supported the policy and said their internal rules were stricter than the ACCME’s policy. There was one specialty society that said the policy as explained in the 2009 FAQ was too restrictive and the society decided it was no longer going to offer accredited CME, says Kopelow. There might have been others who didn’t call ACCME with their concerns, but just decided to stop offering accredited CME, he adds.

One organization that decided the policy was too restrictive was Keystone Symposia, an independent nonprofit organization based in Silverthorne, Colo., that organizes more than 50 conferences per year. After reviewing the stipulation, it announced last September that it had decided it would no longer offer certified CME.

“We all need to understand the concepts of independence and control of content and to recognize what constitutes control of content,” adds Kopelow. “That’s something we haven’t articulated explicitly to people up until now and it is valid.”

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