I've heard about a disturbing development: Several pharmaceutical companies may stop their funding of CME because of the current regulatory environment. According to The New York Times, just about every major pharmaceutical company has received federal subpoenas concerning itspractices. And, with the new Medicare drug benefit, the government will pay for almost half of all medicine sold in the United States by 2006 — which means scrutiny of pharma firms is only going to intensify in the near future. So, it's probably no surprise that some companies are questioning whether investing in CME is worth the risk.
The good news is that truly independent CME still has something of a safe-harbor status. The Office of Inspector General will not investigate a good scientific program, said one corporate counsel at a CME conference in June, co-sponsored by the Center for Business Intelligence and.
That opinion was backed up by Thomas E. Kanwit, assistant U.S. attorney, healthcare fraud unit, district of Massachusetts, addressing a June audioconference about the Pfizer case. “I think it would be difficult for the government to be terribly enthusiastic about the prosecution of [off-label discussion at a CME event]” as long as the supporting company didn't have any role in determining the content or speakers, and the discussion was not “a result of any activity by the company.”
But the CME community's system of self-regulation is not effectively protecting CME from pharma influence, say some. Asked via an audience response system for input about the Accreditation Council for CME's new proposed Standards for Commercial Support, the majority of attendees at the CBI/MM conference who responded — 39 percent — said the new Standards will make no difference unless enforcement is increased. That poll reinforces what I've heard from some CME professionals — both on the industry and the provider side — who say that the's system of investigating complaints and monitoring compliance needs to be strengthened.
What can CME providers do to help commercial supporters mitigate the risk of investing in CME? This is what I've heard:
- Measure CME results
Demonstrate that your activities result in physician behavior change and improved patient care.
- Prove it
Evidence-based content is less likely to generate suspicion.
- Go beyond the Standards
Even if you achieve exemplary status with the ACCME, consider the Standards a minimum set of requirements, the basis from which you build your ethical collaboration with pharmaceutical companies.
- Educate doctors
Teach physicians about the regulations and the difference between educational and promotional presentations. Wouldn't it be great if the doctors indicted in the TAP case, for example, could speak to their colleagues about the enormous professional and personal risks of crossing the line?
Finally, speak out. I'll be glad to publish your ideas and concerns about CME self-regulation — anonymously, if necessary — in order to encourage debate about these critical issues.