Life Science Compliance Update

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April 12, 2010

CME Providers Have Suitable Oversight to Ensure Compliance

A recent interview about Continuing Medical Education (CME) with Steven Kawczak, MA, associate director for the Center for Continuing Education (CCE) at Cleveland Clinic, highlighted a study he conducted this year regarding industry support of CME.

The interview noted that “until recently there have been no scientific studies proving—or disproving—that pharma or device makers’ support of CME inherently introduces bias into the activity.” That is, until Kawczak and his colleagues at the clinic—William Carey, MD, director, CCE; Rocio Lopez, MPH, MS, member, qualitative health sciences, Cleveland Clinic; and Donna Jackman, associate director, CCE—decided to analyze the CCE’s database of evaluations collected from 346 CME activities of all types for the year 2007.

As we previously wrote, the results, which were published in the January issue of Academic Medicine, showed that there was no correlation between the perception of bias and the commercial support status of an activity.


What prompted Kawczak and his colleagues to look for evidence that commercial support does or does not introduce bias into CME activities was the heated public debates about commercial support and CME over the past few years.” He also thought it was problematic that “without any studies being done specifically on whether the presence of commercial support creates bias,” the Senate Finance Committee and the Macy Foundation’s analyses and conclusions “make very strong assertions and recommendations about changing the whole paradigm of CME [because of inherent bias caused by commercial support of CME]. In response to this “glaring gap,” Kawczak and his colleagues set out to narrow it with actual data.

Despite their initial assumptions, the study found that commercial support did not result in a perception that the activity was biased. Most surprising to Kawczak was that activities that had absolutely no funding associated with them—activities for which the Cleveland Clinic as a CME provider absorbs the cost within its operations—had a higher level of perceived bias than the other two categories. It was surprising because 1) it indicates that perceived bias is not associated with industry support; and 2) it points to bias in content being caused by something other than the funding source of the activity.

Even using a higher degree of scrutiny for activities that are single-funded than ACCME, the study ranked single-funded activities as being most free of bias. The study guidelines included institutional approval of the project concept, an independent review panel to ensure content integrity, and close monitoring of activity implementation. Kawczak asserted that it is because of this process that CME activities were produced with a very low level of bias.

Kawczak recognized the need for “policymakers to use this sort of data because it shows that bias is not coming from the pharmaceutical industry’s provision of educational grants.” Instead, policymakers must realize that what this “funding is doing is allowing CME providers to produce great education.” Consequently, he recommended that policymakers “review what good CME providers do and emphasize their best practices as examples to follow.” With over 70 percent of physicians completing the evaluation process for an array of activities produced (live courses, online CME, enduring materials, and journal CME), Kawczak’s data is extremely influential and a great place to start.

Two similar studies—one from the University of California, San Francisco, the other from Medscape (1,000,000 participants) —also found evidence that there was no correlation of bias in CME with the presence of commercial support. As a result, the data so far shows that commercial support of CME has not had a negative impact on learners.”

Ultimately, because “the effect of industry support on participants’ perception of bias within CME activities is minimal, and since “CME providers have suitable oversight to ensure compliance with the ACCME’s SCS, we agree with Kawczak’s research that “the prohibition of commercial support is not needed.”

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