Over the past decade, the continuing medical education (CME) and the medical writing industry have undergone a “sea of change.” This change was met with some challenges, which led “not only to a complete reassessment of how we design, develop, and execute physician education, but also required that we reexamine how we fund it.”
While the relationship between medicine and commercial entities dates back as early as 1900, much has changed in the world of medical writing. Nevertheless, stakeholders are still debating the relative merits of the relationship between commercial support and those who develop and implement CME programs needed by health care practitioners to improve the performance of their craft and maintain their certification and licensure.
Although much has changed in the world of medical writing, over a century later, we have seen significant progress in writing and publishing, contributing to the progression of advanced practices and treatments.
At the core of the debate are two issues: whether CME that is commercially funded allows for bias of CME content and whether without commercial support the development and availably of CME will be so impeded that the quality and quantity of continuing education available to health care professionals will be diminished and erode our nation’s health care.
These issues have spurred government investigations; voluntary regulatory and guideline changes by government agencies, trade associations, and accrediting bodies; and research into the impact of commercial support on CME and its participants. In keeping with the theme of ethics and medical writing, the American Medical Writers Association (AMWA) recently published CME Rising: Point-Counterpoint: Industry Sponsorship of CME by two prominent thought leaders who hold opposing views on the subject of commercial support and CME.
In Support of Commercial Funding of CME
Thomas Sullivan, author and editor of Policy and Medicine, defended industry support of CME. He noted how the Affordable Care Act (ACA) did not provide funding or support for CME and that without such a focus, many of the programs and initiatives that the ACA hopes to realize will be extremely challenging and difficult to achieve.
With all the recent changes in health care, and ones coming in the near future, Sullivan asserted that, “now is not the time to take away resources from the CE system that are necessary to accomplish health care reform.”
He recognized how CME today is vastly distinct from CE of the past. Its historical reputation for ineffectiveness has been dispelled with a strong emphasis on outcomes and meeting educational gaps, and new standards of commercial support create a principled firewall that prevents undue industry influence.
Sullivan explained how CE providers that accept commercial support are committed to transparency, accountability, and independence in producing CE programs and strictly follow codes and guidance’s including the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support, HHS-OIG Guidance, FDA Guidance, and the PhRMA and AdvaMed Code of Conducts, to reduce any kind of appearance of potential bias or “conflict of interest.” Even more recently, the CME Coalition announced a CME Code of Conduct, to bring clarity to the rules governing CME.
Sullivan also pointed out how commercially supported CE programs have positively affected ICU patients, as well as patients being treated for COPD, Hypertension, Sepsis, and hospital acquired infections. Furthermore, concerns about commercial support of CE are misplaced considering three very large studies from 2010 produced substantial data that demonstrate a complete lack of commercial bias in industry-sponsored CME (Cleveland Clinic; Medscape, and UCSF).
“The Obama Administration, and federal health agencies expect that doctors and health professionals will be able to work together across disciplines, use health information technology (HIT), update their coding to ICD-10, “meaningfully use” electronic health records (EHRs), without offering the kind of high quality CE necessary to change and improve health professionals clinical practices and patient outcomes. But our healthcare workforce needs additional training and CE to achieve these promising goals.”
The article recognized how, “neither the administration nor the federal health agencies have provided a direct mechanism, let alone funding, to educate health professionals about these expectations while commercial support of CE funding has decreased significantly over the past several years.”
Since 2007, commercial support of CME has declined $297 million or 31.4%. In 2010, total commercial support for CME was $856 million, which made up 37% of total CME revenue. The continued decline in funding for CE programs, both from industry and government, will have an adverse impact on medical writers because CE providers will have fewer resources and funding to hire medical writers for their programs and grants.
Moreover, the impact on the decrease of commercial support of CME has affected hospitals, state-accredited CE providers, universities, and even the federal government.
For example, the Department of Defense (DOD) announced that its Continuing Education Office (CHE) will be disestablished in FY12. Similarly, the University of North Carolina School of Medicine, decided to close its CME Office on campus, as a result of state budget reductions.
In addition, between 2003 and 2010, the number of CE providers accredited by state medical societies fell by 18.7% to 1,450. As the AMA’s Council on Medical Education noted, unabated, this trend could “impede the delivery of cost-effective, quality, accessible certified CME” dealing with local health issues.
CME is needed “to educate our doctors in practice now, the next generation of our medical students, and the health care system as a whole.” He noted that, “The health problems our country faces today will only continue to grow exponentially with an aging population and a growing epidemic of chronic diseases such as diabetes, obesity, and heart disease. CE is critical to facilitate the continued integration of new advances in medicine and technology into patient care and curtailing commercial support for CE will only dramatically diminish access to education and negatively affect patient care.”
Sullivan noted that stakeholders “must stop focusing on who supports providing CE, because the proper firewalls are in place to ensure quality, integrity and independence.” Instead, the CME community and healthcare stakeholders “must focus on making sure that this country’s physicians have the highest quality continuing education, before it is too late.”
Against Commercial Support of CME
Daniel J. Carlat, MD, an Associate Clinical Professor of Psychiatry at Tufts University School of Medicine, and Director of the Pew Prescription Project, argued that CME should be devoid of commercial support so that doctors have unbiased CME. He recognized that if everyone followed ACCME’s Standards for Commercial Support, which are intended to ensure independence in CME activities, then all CME, industry supported or not, would be unbiased. He noted how Standard 5.1 states the crucial criterion for unbiased CME: “The content or format of a CME activity or its related materials must promote improvements or quality in health care and not a specific proprietary business interest of a commercial interest.”
Carlat, however, asserts that “these standards are enforced laxly, and extraordinary financial incentives have ensured that that rule-breaking has become the norm rather than the exception.” Yet he points to no concrete evidence to support this claim. Instead, he only relies on anecdotal conversations he has had with other medical writers.
Contrary to his assertion, the incidence of commercial bias is quite low with only 12 inquiries concerning commercial bias (out of over 100,000 activities) from 2008 – 2009 and only five of the activities were found to be bias. In addition, recent updates from the ACCME show that providers have been placed on suspension, had accreditation revoked, and other penalties with non-compliance with ACCME standards.
Nevertheless, Carlat tells of stories he heard from CME writers about abuse in programs with commercial support. In light of these stories, he qualifies his support for AMA CEJA rules that called for extremely limited commercial support of CME. Interestingly, Carlat recognizes that there are “no multisite double-blind trials proving that commercial support of CME adversely affects medicine.”
Instead, he points to the fact that there are studies (social science), which show that physicians can be influenced by industry salesmanship of various kinds. However, these studies did not use patient outcomes. Moreover, Carlat recognizes that “there are no adequately designed studies proving that under current ACCME standards, commercial support is pernicious.”
Ultimately, Carlat uses a metaphor to support his claim why CME should be void of industry support. He notes how judges, baseball umpires, and newspaper reporters may not participate in any professional activities with which they may have an interest in. Because these parties must recuse themselves, he asserts that CME funded by industry should similarly be prohibited. There are three simple reasons why this analogy, particularly to lawyers and judges, fails, and should not be applied to CME.
First, the volume of information in medicine is vastly greater than law. More than 400,000 medical journal articles are published each year, making the practice of medicine much more dynamic than that of law. The sheer volume of new scientific data and changes in medicine requires as many appropriate avenues for funding certified CME as possible. If commercial support of CME was to evaporate or be severely restricted, how could our physicians learn about the findings and results from these 400,000 journal articles? There is not enough time in the day to read these articles let alone gain an insight into the implications of the results.
Second, the changes to practice in medicine occur at a much faster rate than law. The nature of medicine involves constant advancement, testing, and application. Medicine features landmark breakthroughs, such as the discovery and testing of a new therapeutic agent. The legal system is based on the tradition of stare decisis, or precedent. In short, changes in the law are evolutionary while changes in medicine often are revolutionary. Patients and society demand that our physicians receive information instantaneously, and that updates in treatment, diagnosis, and prevention are disseminated to physicians as soon as practically possible. Commercial support of CME enables a smooth process to ensure that health care practitioners get the most recent and up to date advances so that physicians can begin implementing new breakthroughs sooner and improve patient outcomes before it’s too late.
Finally, mistakes in medicine can lead to death, whereas mistakes in law can be corrected through other, less life threatening processes. Continuing professional education is necessary for physicians, partially because a drug used incorrectly is a poison. A failure to diagnose or prevent a disease or illness can lead to further complications and spreading of the disease. A physician’s inability to adopt new guidelines or practices can result in thousands of medical issues. When a lawyer makes a mistake in practice, parties can appeal to a higher court. A physician mistake with prescriptions or on the operating table can mean serious illness or even death, a situation for which no appeal process exists.