CME: Points of view	December 2007

Critics of Industry-supported Certified CME Ignore Value to Prescribers and their Patients

By Brad Bednarz, Marty Cearnal, and Mark Schaffer
Brad Bednarz is chief strategic officer, Visible Productions (visiblep.com). Marty Cearnal is executive VP & chief strategy officer, Jobson Medical Information (jobson.com). Mark Schaffer is VP, CME compliance, Professional Postgraduate Services (ppscme.org). Mr. Bednarz, Mr. Cearnal, and Mr. Schaffer are co-chairs of the CME Committee of the Coalition for Healthcare Communication (cohealthcom.org).

The current controversies over industry-supported certified continuing medical education so cloud the landscape these days that it’s almost easy to overlook the most important fact: Clinicians continue to flock to these programs to learn about new and better ways to diagnose and manage disease and return to their practices better prepared to treat their patients. The pharmaceutical and medical device industries support nearly half of all certified CME. Patients are the primary beneficiaries.

Unfortunately, even careful readers of the popular and professional press could get the impression from the pronouncements of politicians as well as academic and citizen critics that industry-supported certified CME is flawed or even corrupt and in need of wholesale reform and restructuring. These critics of industry support are getting the most attention from the pharma blogs, the leading medical journals, and the most popular news outlets. 

Make no mistake about it, the Coalition for Healthcare Communication believes in robust discussion, free expression, and everyone’s right to participate in public policy debates. But this debate seems one sided, focusing mostly on kicking around the industry and ignoring many important facts. This is the time for all involved with certified CME to pull together, reform what needs reforming, clarify what needs clarifying, and, most importantly, tell the real story about the value of industry-supported education for health-care professionals.

Recently the Coalition teamed up with the North American Association of Medical Education and Communication Companies to highlight the difference between certified CME and other forms of continuing medical education. This campaign recognizes that, while prescribers gather important information from many sources, certified CME is different because of rigid third-party oversight in selecting content, topic, and faculty. Providers accredited by Accreditation Council for CME (ACCME) and activities approved by the American Academy of Family Physicians and other organizations must meet process and quality standards before prescribers can receive credit for participating.

Other organizations, including the Alliance for Continuing Medical Education, the National Task Force on CME Provider/Industry Collaboration, and the National Commission for the Certification of CME Professionals, are taking actions to further enhance the value of certified CME for physicians. The Alliance has developed a program focusing on the key competencies required of CME professionals, including, of course, a full understanding of all laws, regulations, guidelines, policies, and standards that govern the provision of certified CME. A subcommittee of the Task Force is developing a series of fact sheets on important issues that will help inform policy makers, the press, and all who participate in certified CME. The NC-CME is developing a certification program that will set definitive standards and require successful completion of a validated examination in order to allow an individual to be recognized as a certified CME professional.

Meanwhile, much of the criticism of the industry is unfair or misses the most important points. Consider, for example, the criticisms driven by Senator Charles Grassley, one of the powerful leaders of the Senate Finance Committee. The April 2007 Senate Finance Committee staff report, “Use of Education Grants by Pharmaceutical Manufacturers,” correctly focused on many of the important historical abuses and emerging reform actions by industry, ACCME, and others. But the report ignored the value of industry funded CME. Indeed, the report spoke skeptically about off-label education, skipping the fact that off-label uses are critical to patient care, particularly in critical areas where few on-label options exist, such as oncology, pediatrics, and psychiatry.

The now famous cases brought by federal and state enforcers and much of the current criticism are based on historical events, not recent transgressions. Over the past decade, the provision of CME funded by industry has undergone a profound transformation. Consider the dramatic effect of just six major documents in the past decade: the FDA’s 1997 Guidance on Industry-Supported Activities; the OIG Compliance Program Guidance; the ethical codes from PhRMA, AdvaMed, and the AMA; and the 2004 Standards of Commercial Support from the ACCME. Quite simply, the world has changed for the vast majority of players in this industry. And, for those who have not yet gotten the message, the HHS-IG and other law enforcers stand ready to bring those few outliers in line.

Other criticism is well taken. Continuing reform is a job that may never be completed. For example, for far too long, many faculty and others failed to fully disclose potential conflicts of interest. But transparency is the watchword today, written in industry codes and the standards of accreditation for providers. Indeed, earlier this year Lilly voluntarily published all its grants for the world to see. Many other pharmaceutical companies are following that lead and may make similar announcements soon.

So, what’s the future of industry sponsored CME?

More controversy for sure, including further investigations by HHS-IG, and more calls for reform by academics and other critics. But also expect further improvements in the system driven by pharma company grantors, leading commercial education companies, and the ACCME.

But, if the efforts of the Coalition and other industry leaders get your support and that of the entire industry, expect more focus on the facts, more focus on the distinctions between certified CME and other forms of education, and much more focus on the value of certified CME for physicians and the patients they treat.

Best of all, expect even better certified CME programs, driven by clinical needs, compelling content, and better outcomes measurement. Expect more health professionals than ever to flock to industry funded certified CME activities to better support patient care.

More information on the CME and other activities of the Coalition for Healthcare Communication can be found at: www.cohealthcom.org or by contacting John Kamp, executive director, at jkamp@cohealthcom.org