James M. La Rossa Jr. built a medical publishing empire and knows a thing or two about industry-funded CME. He founded CNS Spectrums and Primary Psychiatry in 1997, and sold them to its current publisher in 2003. Aside from publishing the journals T.E.N. and Mental Fitness, he recently rescued the journal Psychopharmacology Bulletin from oblivion by buying it from NIMH, which wanted to get out of the medical journal business. He got out of the commercial CME business in 2001 because he couldn't stand what it was becoming.I spoke with La Rossa, who had commented on a recent posting on unsavory CME manipulation.
Dr. Carlat: As publisher of various psychiatric journals, you could have made a ton of money publishing commercial CME articles. Why didn't you?
La Rossa: First of all, I am in media, which I love. I did not want to be in the CME business. Going from venue to venue to put on the exact same CME programs -what I refer to as the dog-and-pony show-had no attraction for me. I gave up a potential law career to be a journalist and publisher. The most important job of any publisher is to influence a field of interest, make your publications an indispensible part of that field, and, most importantly, play the game while keeping your third party credibility. Once you lose that independence, it is next to impossible to regain it.
Dr. Carlat: Do you think it’s possible for publishers take industry money for CME material in an ethical way?
La Rossa: I don’t think so. In my experience, the publisher inevitably becomes nothing more than an agent of the sponsoring pharmaceutical company. Rather than producing true medical education content, they are customizing intellectual material for pharmaceutical companies. While there is nothing inherently wrong with this, where it gets sticky is when the publication runs the customized project as a CME activity in the journal, which automatically implies that the project is sanctioned by the journal's editors, board of advisors, etc.
Dr. Carlat: The scale of the CME enterprise has certainly mushroomed over the past several years. Why?
La Rossa: Several reasons. First, of course, is that people began to see how much money there was to be made, and that has attracted many companies in itself. But another driver of this enormous CME problem can be traced back to about 5 years ago when the APA began to get very aggressive about retaining exclusive rights to any and all symposia. What they were doing was trying to prevent sponsors and/or outside CME companies from profiting off of these symposia. These companies responded by inviting the APA speakers to a hotel near the meeting, for example, to give the same talk. They changed the title, said it was in "conjunction with the APA meeting," or language like that. In other words, as the APA tightened controls to the dissemination of CME materials to psychiatrists, a CME free-for-all started as private content providers started coming out of the woodwork. It sounds like I am putting most of the blame at the APA's door, which is unfair. Universities-who view CME as a profit center-are getting in on the action as well. But I do think that the APA should stick to what they do best: Make excellent journals and books. Isn't that the very heart and soul of psychiatry?
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See Final Guidance on Industry-Supported Scientific and Educational Activities. Federal Register; Vol. 62, No. 232. 64073-64092 at...
http://www.fda.gov/opacom/morechoices/industry/guidedc.htm
http://www.fda.gov/opacom/morechoices/
industry/guidedc.htm
CME regulator issues plan for shoring up oversight
BY Marc Iskowitz, Medical Marketing & Media
Placing trained observers in audiences, making faster compliance decisions and eliminating commercial funding altogether are some of the steps the main regulatory body in CME said it will consider taking in response to recent criticism levied by senators.
The regulatory body, the Accreditation Council for CME (ACCME), will also consider imposing tougher penalties on accredited providers who break the rules and more closely scrutinizing content for commercial bias. The enhancements were contained in a five-part list of areas to be studied, issued late Friday afternoon by ACCME chief executive Murray Kopelow, MD.
The plan comes in response to perceived weakness in ACCME's rules of commercial support—the rules for ensuring the independence of educational activities—and the group's compliance-checking system. The Senate Finance Committee blasted both in its April report on the use of educational grants by drug firms.
The list of possible steps, which ACCME calls an “action plan,” was drafted by the group at its July board meeting as it felt pressure to appear responsive to the Senate report. The fact that the plan contains a variety of proposed steps highlights the difficulty in getting to the root of the Senate concerns.
“The big problem is nobody knows,” said Van Harrison, PhD, an ACCME board member and director of the Office of CME at the University of Michigan. “There's a lack of clear data on how big the problem is and how much effort and resources should be put into it.”
The response will have to occur in multiple ways and address two main areas. First involves dealing with the Senate's complaint of very slow turnaround times to correct problems. It can take years after a non-compliant activity for the group to impose a penalty. Second involves the need for stronger monitoring of specific providers and enforcement of the current standards.
Cost-effectiveness will be another challenge, as Sens. Baucus (D-MT) and Grassley (R-IA), the ranking members of the Senate Finance Committee, will be loathe to add a whole new layer of costs to the healthcare system. Currently ACCME inspects and audits only a percentage of activities that are provider certified; the Senate said that that's not enough. Kopelow's plan shows the ACCME is committed to beefing up its monitoring but needs to do so in a way that doesn't increase costs for everyone.
“That's going to be tough. At every CME activity, you're going to have a physician complain about something,” said Stephen Lewis, who headed an accredited medical education company for several years.
As far as taking measures to improve the integrity of CME, the Senate report was quite complimentary to actions taken by the pharmaceutical manufacturers, most of which have moved education out of the marketing department over the last few years. Nevertheless, among other steps ACCME said it will look at are alternate funding models, like pooled funding and limits.
This will involve “discussions on the value, or impact, of no commercial support,” Kopelow wrote. While receiving financial support from industry doesn't mean content or faculty is influenced, “the future role of industry in CME, including that of a funder, will be evaluated in the context of independence,” he noted.
In the months since the senators issued their report, ACCME released data showing that drug company funding accelerated 8% last year compared to 2005 to nearly $1.2 billion. Funding to medical schools and societies increased faster than funding to medical education and communication companies (MECCs), a possible sign that pharma wants to be seen writing checks to providers that appear safer from a compliance standpoint (although compliance data show MECCs are just as compliant with ACCME rules on handling commercial support, if not moreso, than these other groups).
Additional education for physician learners, faculty, drug firms and providers are also among the steps being explored, as is collaboration with other organizations to help ensure bias-free CME. The ACCME staff must now develop a narrower list of priorities, which the board will discuss when it meets next November.
“The boundaries between promotion and CME need to be clarified for all participants in the system,” Kopelow wrote.
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