Tom Larrañaga, group publisher of Pharmaceutical Executive magazine, with Steven Mankofsky, strategic account director, Advanstar
Medical Economics, and Jerry Silverman, RPh, president of Bimark Medical Communications;
Most important, of course, is that in order for CME to serve the public's interest, what is taught needs to be true. There
is promotional education that is valid and has face validity. But what distinguishes continuing medical education from promotional
education is that CME is by and for the profession. The content has been created independently from any commercial interest.
I am not saying that education dependent on commercial interest is wrong, or invalid, or not true. It is just education created
by commercial interests and not by the CME system."
Andy Bender, principal of Polaris Management Partners
"The Big Picture The content or format of a CME activity or its materials must promote improvements or quality in healthcare. That is the most
important goal of CME, and we need to focus on that because that is what ACCME's member organizations, the public, and the
learners expect."
Eric D. Peterson, MEd, president of the National Alliance of Medical Education and Communications Companies (NAMECC), and
vice-president and general manager of Bimark Center for Medical Education.
"Mechanism One of the big new issues with these updated standards is resolution of personal conflicts of interest. Here, the most important
things to the ACCME are the word 'mechanism' and that providers are engaged in the process of managing, or resolving, conflicts
of interest. This has two major components—the identification and the resolution. Resolving conflict of interest means taking
steps to ensure that the content of the activity is aligned with the interest of the public. When a relevant financial relationship
exists and the content is relevant to that commercial interest, providers must insert safeguards against bias. Providers can,
for example, address conflict of interest through managing a person's role or assignment in CME, or through external validation
of content. We are moving away from just disclosure of relationships and raising the bar. A disclaimer saying, 'I know this
is a biased presentation because I firmly believe it,' is not a standard that we use for managing conflicts of interest. External
validation can be accomplished by reference to the scientific literature. There are evidence-based reviews and meta-analyses
and syntheses for almost everything that we do as physicians. We need to recognize that quoting the literature, citing four
articles that support what is being said, is very different from referencing a meta-analysis or meta-synthesis as the best
available evidence. This expectation has been articulated in ACCME's 2002 Content Validation statements.
Another example of external validation is the circumstance where the educational space contains the world's experts. When
someone brings new information from his or her own research or offers personal thoughts of what should be done, it is effectively
being subjected to a peer-review process because the room contains peers who can judge what they are being asked to learn.
They can say, 'this is biased,' 'this is only because of your commercial interest,' or 'the data don't support that conclusion.'
That process, that mechanism, resolves conflicts of interest. There are safeguards in place. This is the way professionals
and clinical scientists interact, at the expert level."
"Enduring Materials The 1992 SCS said a commercial interest could distribute enduring materials, and the provider was responsible for their use
as a CME activity. In element 4.5 of the 2004 Updated SCS, ACCME says providers must not use commercial supporters as a distribution
vehicle for a CME activity. The goal of this [SCS] element is to separate detailing from the physician's participation in
CME. 'Let's sit down and do this activity together while we are detailing the product,' fails to separate education from promotion.
But it's not up to ACCME to say what commercial supporters can buy or do. ACCME does not regulate commercial supporters; they
are accountable to other organizations or institutions."
Sibyl Shalo, senior editor, manages the editorial direction and content of Media Mix, Pharmaceutical Executive's marketing and media section. Sibyl's extensive healthcare experience includes writing, editing, media and government relations, medical education, and marketing communications. Her career has taken her from Washington, DC, where she wore many hats at the National Alliance for the Mentally Ill, to her hometown of New York, where she worked as a freelance medical writer and media liaison for leading public relations agencies. She held positions at New York University Medical Center and Memorial Sloan-Kettering Cancer Center before freelancing with Reuters Health. She made the full-time switch to journalism with Pharmaceutical Executive in September 2000.
Articles by Sibyl Shalo
PharmExec Blog
Follow Us
RSS
Bookstore
