There is trouble for the pharmaceutical industry in CME City.

The ACCME (Accreditation Council for Continuing Medical Education), which sets national standards for accredited CME activities, has tightened up its requirements for commercial support, which is giving drug companies, private medical education firms, and assorted hired guns a collective case of indigestion.

Before we give you the gory details, here’s some of the historical background.

Up until about 1990, most doctors got their Category 1’s by going to meetings or grand rounds. Industry influence was either non-existent or barely visible, and you usually had to pay your own way. But over the past 15 years, a huge new industry has arisen--the for-profit “medical education and communication companies” (MECCs). These are the companies with vaguely academic-sounding names on the return addresses of the free CME activities that bombard our mailboxes. MECCs are hired by drug companies to put on these seminars, and the ACCME has by now accredited over 100 of these companies to provide continuing medical education. Between 1998 and 2003, pharmaceutical support of CME has tripled, from $302 million to $971 million (N Engl J Med 2005; 352:534-535), and now the majority of education received by American physicians is drug-company supported, a fact that might not be too surprising but is still a little spooky.

The potential problem with all this, of course, is that commerciallysponsored CME programs are likely to be biased. The small body of research that has evaluated this issue is highly consistent: industry sponsored CME programs are effective in altering prescribing behavior in favor of the sponsored drug, even when this drug presents no clear advantages to cheaper alternatives already present (for a thorough review, see JAMA 2000; 283:373-380).

Which brings us back to the ACCME. In September 2004, the ACCME announced the culmination of a three-year soul-searching process: the final approval of its Updated Standards of Commercial Support for CME activities. While ACCME has always tried to separate obvious promotional activities from educational activities, in the past the main tools to achieve this were forbidding drug companies from directly planning the activity and requiring financial disclosure. Well, as any careful consumer of CME activities has discovered, this didn’t work very well, at least in psychiatry. Reach into your mailbox today, and chances are that you will find a CME activity that is glaringly slanted toward the sponsor’s product (see accompanying article: “How to Sniff Out Bias in CME Programs: A Primer”).

But beginning in May 2005, any new accredited CME activity will be held to a Higher Standard. Financial disclosure is no longer enough--in fact, it’s only the beginning. If the presenter has had any financial arrangements with drug companies over the past year, the CME provider is now required to actively prevent commercial bias. The ACCME suggests various mechanisms for providers as safeguards against the insertion of commercial bias, including finding a different speaker, changing the focus of the talk, or finding non-financially conflicted experts to review the activity and give it their stamp of approval.

All this is very heartening. However, the perpetual cynic in TCR sees plenty of opportunity for loopholes, so caveat emptor! We predict that MECCs will hire experts who don’t have any drug funding to review all of their commercially- sponsored CME activities. The MECCs will pay these experts well but since they are not directly paid by drug companies they will meet formal criteria for having no conflict of interest. Looking into our crystal ball, we worry that these experts will consistently err on the side of approving activities with subtle pro-sponsor bias, which is, after all, exactly what they will be paid for.

Of course, the ACCME is not naïve enough to believe that such things will not occur, and has set up a system of screening these activities for compliance. But with a staff of only 14, it may be tough for them to police the estimated 140,000 CME activities that occur each year.

TCR VERDICT: MECCs vs. ACCME: Let the battle begin!