Robert W. Doyle, vice-president of marketing operations
"The worst thing in the world that any of us could do would be for one part of our CME enterprise to interfere with either the professional or legal obligations of other parts of the enterprise," Murray Kopelow, chief executive
of the Accreditation Council for Continuing Medical Education (ACCME), said in his opening remarks as he addressed an initially
antagonistic—if not hostile—crowd on the second day of Pharmaceutical Executive's Second Annual Med Ed Forum last month in Philadelphia. Facing an audience of more than 150 medical education providers
and pharma company executives waiting for his session, Kopelow did an admirable job of assuaging the audience's distress over
an ACCME staff-written Q&A (released a few weeks before the conference) that attempted to clarify stipulations of the organization's
newly updated "Standards for Commercial Support (SCS)." At the end of his presentation, even the most belligerent attitudes
seemed tamed. The following comments have been excerpted from Kopelow's comments during his formal presentation and the subsequent
questions.
"The Q&A The ACCME board of directors charged the staff with the responsibility, and gave us the authority, to interpret and explain
its positions in the context of what we knew from the process of developing the SCS. The resource materials were created,
I promise you, as educational resources to help bracket the landscape—not as instructions to say, 'Do this and you're going
to be OK, and if you don't do these four things you are going to be out of compliance.'
Novartis; Mary L. Lacquaniti, CAE, executive director, Healthcare Marketing and Communications Council, with Susan Torroella,
CEO of Columbia MedCom Group
I've tried over the last 10 years not to give specific examples of what a provider should do because the facts and circumstances
for each provider are unique. We were asked at this time to take a different role. Resolving conflict of interest is something
that we've never asked CME providers to do before. In the educational resources we tried to give examples of what providers
could do.
But providers need to understand that those are just educational resources. If they stay on our website or if they disappear,
if they get edited or changed, it doesn't mean we are changing policy, and it doesn't mean we are changing accreditation criteria.
The decision-making criteria will be established over the next few years, as providers come forward with their approaches
to compliance.
John Kamp, PhD, partner, Wiley Rein & Fielding
We are telling providers that context matters. The context in which they operate—who their audience is, what their educational
objective is, what their facts and circumstances are—will dictate their strategy. It's up to the provider to pick strategies
to address these issues. It's up to the provider to decide what can be done to ensure that commercial bias is not inserted."
"Validity The standards are a key part of ACCME's overall strategy to ensure the credibility and validity of CME. Credibility and validity
are, to a great extent, determined by who is in front of the audience teaching. It is important that the best and the brightest
are teaching and that CME is independent of commercial interests. Transparency through disclosures is a large part of the
credibility of CME.
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
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