Life Science Compliance Update

November 16, 2015

ACCME: Accreditation Rules Safeguard Continuing Medical Education from Commercial Influence

Continuing medical education courses have been under attack lately, with skeptical writers making unsubstantiated claims that CME courses have "become a key marketing tool for increasing clinician receptivity to new products." Those writers make bold claims, but are unable to back their claims up with concrete evidence.

Graham T. McMahon, a physician and the president of the Accreditation Council for Continuing Medical Education (ACCME), has been working diligently to set some of these unsupported claims straight, reminding medical professionals and others that organizations such as the ACCME exist to "set and monitor the standards that, among other goals, ensure that educational programs offered by organizations that we accredit are independent and free of commercial bias."

Dr. McMahon continues to reiterate that promotion and marketing do not have a place in accredited CME courses. Accredited education is designed to offer physicians and health care teams a space to learn, teach, discuss emerging science, and debate ethical or controversial issues without any commercial influence. Non-accredited CME does exist, however, and Dr. McMahon cannot speak to the rigorous standards that might be applied to those courses, but states that if the authors making allegations against CME courses are referring to non-accredited CME being infiltrated with marketing tactics, then they should specify that and not apply such a broad brush against all CME courses.

The authors of the most recent article, including Adriane Fugh-Bermann, a known CME critic and director of PharmedOut, suggest that providers of CME activities have allowed commercial support to include marketing messages to increase awareness and understanding of hypoactive sexual desire disorder, and implies that the ACCME Standards for Commercial Support are either inadequate or ignored by accredited organizations. The authors, however, do not provide any support or evidence of actual courses that have been given accreditation with such "marketing messages."

As we have previously written, the standards that accredited CME courses must follow cover a wide range of topics including "independence from commercial interests; resolution of any personal conflicts of interest; appropriate use of commercial support; and content and format without commercial bias." A course will not be accredited if it does not follow the standards required by the ACCME.

Dr. McMahon reviewed the ten key points the critical authors presented as being "marketing messages," and concluded that all ten points appeared to be "appropriate elements to describe the epidemiology, diagnosis, and impact of an established disorder on affected patients," not "marketing messages" as were alleged.

Dr. McMahon reminds readers that two important functions of accredited CME courses are to both "creat[e] awareness of newly identified diseases and facilitat[e] the translation of new research into practice." He continues on to state that physicians and health care teams need evidence-based disease-awareness education so they can learn how to efficiently and quickly respond to public health priorities, and know how to diagnose and treat their patients appropriately.

In addition to the strict rules the ACCME has in place regarding the management of funds and conflicts of interests for CME providers, the activities of CME providers are subject to routine audit by the ACCME. These audits are performed on a randomized basis and Dr. McMahon also highlighted the fact that only 11% of accredited CME providers receive commercial support.

Dr. McMahon ended his written response by reminding everyone that accredited CME is part of the solution to the health needs of our country, "there is considerable evidence to show that accredited CME has a positive impact on physicians' ability to deliver high-quality care, and is one of the key resources that enables physicians and teams to deliver safe, ethical, effective, cost-efficient, and compassionate care that is based on best practice and evidence – and not on promotion."

Confirming Dr. McMahon's position is a synthesis of systematic reviews, done earlier in 2015 and focused on the impact of CME on physician performance and patient health outcomes. That synthesis identified eight systematic reviews of CME effectiveness published beginning in 2003. Five of the eight reviews directly addressed the question of "Is CME Effective?" by using primary studies that employed randomized controlled trials or experimental design methods, and concluded that CME courses and requirements do improve both physician performance and patient health outcomes.

July 21, 2015

JAMA: Advancing Continuing Medical Education

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In an article issued Online First in The Journal of the American Medical Association (JAMA), the Accreditation Council for Continuing Medical Education (ACCME) authored "Advancing Continuing Medical Education," by Graham McMahon, MD, MMSc, President and CEO of the ACCME. Dr. McMahon articulates the importance of accredited CME in supporting physicians' continuing professional development and the evolving healthcare environment. He explains the evolution of CME over the past 15 years, as increasingly CME has been designed to create meaningful change in healthcare professionals' skills and performance and to affect patient outcomes.

Today, educational partners base activity construction and pedagogy on assessment of needs underlining problems in practice and are required to measure outcomes. However, not all changes are visible to learners. For example, CME is often considered to encompass only lectures and knowledge but now increasingly is designed to improve skills and performance, and many activities aim to specifically affect patient outcomes. Dr. McMahon writes that of the more than 140 000 learning activities offered by accredited organizations each year, approximately 60% are designed to achieve improvements in physician performance, with 40% measured for those changes. Thirty percent are designed to improve patient outcomes; 13% measure those changes.

Stressing the need for independence of content, Dr. McMahon states that resources used to support CME, including commercial support, deserve scrutiny and stewardship so the independence of content from any external support is protected. He cites data from a 2010 report suggesting that physicians perceive low rates of commercial bias in CME and that there is no association between the extent of commercial support and the degree of perceived bias in CME activities. The importance of ensuring that CME activities are free of commercial bias is a critical priority for ACCME and is under continual review. To review accreditation, 3 sources of data—randomly selected activity files, interviews conducted by trained surveyors, and self-study reports—and a complaint process, is employed by the ACCME. However, while the entire medical community needs to take responsibility for preventing and detecting commercial bias, it is imperative that regulation does not impede the rapid dissemination of discovery and research into clinical practice.

Dr. McMahon continues his theme of shared responsibility, outlining that private/public partnerships provide a vehicle for responding to emerging health issues and accelerating research into practice. He cites the FDA's use of accredited continuing education to deliver prescriber education for opioid abuse and the agency is considering other opportunities for collaboration. Providing value is important, and Dr. McMahon calls upon the CME system to highlight "educational deserts" in which important public health issues are receiving inadequate attention.

Describing continuing education accreditors, Dr. McMahon calls them "service organizations," highlighting their mission to reflect and meet the public's needs and maintain the integrity of the system for educational providers and their learners. Accreditors have a role in promoting engagement among stakeholders, such as ACCME's proposed menu of Accreditation with Commendation Criteria. It is designed to respond to emerging issues and award commendation status to CME programs that address the integration of health data, interprofessional collaborative practice, individualized learning activities, CME research, and higher levels of outcomes measurement.

Concluding his article, Dr. McMahon states: "Effective CME programs have the capacity to help physicians and healthcare teams learn how to improve practice and patient care; how to intervene in health behaviors, social and economic factors, and the public's physical environment; and how to improve the health of the nation." Ultimately, this will meaningfully improve health, but it demands the cooperation of educators, health system leaders, and engaged learners.

We are perhaps in the "Golden Age" of CME with the emphasis on education focused on improved patient outcomes and tremendous innovation in the delivery of educational content. It is encouraging that the ACCME along with other stakeholders are speaking up about the tremendous activities that CME providers are producing. It is essential that the contribution that CME makes towards improving healthcare here and around the world is publicized, and it is promising that JAMA and other journals are beginning to take notice.

April 10, 2014

JAMA Opinion Article Looks for Bias in Academic Health Systems and Board Membership

The Journal of the American Medical Association (JAMA) recently published an opinion piece entitled "Conflict of Interest Policies for Academic Health Systems Leaders Who Work with Outside Corporations." As we have come to expect from JAMA, the article was packed with generalizations, but low on real facts and relevant data to support their claims.

JAMA has been active in the past few months, recently taking aim at continuing medical education (CME). There, the authors so desperately rummaged for "conflicts of interests" that they failed to differentiate between promotion companies and accredited medical education companies. The article ignored the firewalls, standards, and oversight that have been in place for several years to prevent the alleged bias the authors claimed.

Apparently JAMA has moved on. The new article focuses on academic health system leaders – presidents, vice presidents, deans, CEOs – who work for outside corporate entities. The authors argue that these higher-ups who are involved in financial and business decisions have fiduciary responsibilities that "preclude a paid relationship with an outside entity…unless a case can be made that there is a compelling institutional interest in the leader's service in such a role, or if the role with the outside organization is outside the scope of the leader's role at the academic health system."

JAMA provides an interestingly specific illustration of such a carve-out from their calls for an end of all corporate relationships. The article notes, that an "example of a compelling institutional interest" would be "the leader's role as a founder of an academic health system start-up company based on his or her intellectual property."

The lead author, Etta D. Pisano, Vice President for Medical Affairs Dean, College of Medicine; Professor of Radiology, Medical College of South Carolina, ironically fits neatly into her exception:

"Recently Dr. Pisano co-founded her own company, NextRay, Inc., which will commercialize a device she and the other cofounders invented, a technology which creates medical images using x-rays through diffraction enhanced imaging which provides superior image quality at a dose that is substantially lower than is currently available" (available here).

While her efforts in the medical device arena are laudable, it begs the question: who does Dr. Pisano expect to buy her company, and how is this not a commercial interest? She speaks to the "very difficult" issue of conflict of interest in the article, but enjoys one with her own company.

This is not the first time that JAMA has been engaging in the very behavior it spends an article decrying. In the JAMA CME piece, JAMA criticized medical education companies' policy of sharing data, when JAMA's own policy includes sharing data with undisclosed third parties.

It is tough to take an article too seriously when the authors are actively doing the opposite of what they are writing. In the most innocuous case it suggests that JAMA does not have a full grasp on the material it offers. The fact that the article includes the specific carve-out, however, would tend to imply that the authors knew the deal.


The article looked at the 50 largest pharmaceutical companies and compiled data on the prevalence of AMC leaders on the companies’ boards of directors. The study found that 19 of the 47 companies with public data on governance had at least one board member who concurrently held a leadership position at an AMC, including “16 of 17 (94%) US companies.” In total, “[f]orty-one board members had AMC leadership positions in 2012, receiving a mean financial compensation for board membership of $312,564 (excluding the 6 industry executives).” 

Jama pics

Putting aside the issues of credibility, the main issue with the opinion piece is that it raises questions, but does not attempt to answer them. The article states: "Having a fiduciary responsibility to 2 separate entities is at best a very difficult situation. Will the leader direct business inappropriately to the outside company on whose board he or she sits? Will the leader inappropriately use information about the institution he or she leads to influence decisions by the outside corporation?"

Questions about someone's personal conflict of interest are easy to raise, but the article provides no real-world context. Furthermore, the authors fail to include any evidence of academic institutions ever being harmed by an executive's roles with corporate entities.

We argue that there are actually many benefits to such a relationship with outside entities:

  • The current landscape for academic medical centers is bleak. Many academic centers cannot compete in efficiency with local for-profit medical centers. An academic leader who understands the private sector could provide industry practice to an otherwise inexperienced entity.
  • Relationships could help academic centers recruit and retain faculty members by providing them with the opportunity to engage in outside interests, enabling them to identify new research scholarship topics and apply their theories.
  • Relationships can increase the potential outside financial support for the institution—either directly or indirectly—through joint ventures and the activities and networking of faculty members in the larger community, including the business community.
  • Often companies are crucial to translate academic research into actual medication that can benefit patients.



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