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.

October 27, 2015

CME Back to the Future

It is unusual to read an article that critiques CME activities based on evidence that came out after the courses were produced and rehashes old reports.  However, this is essentially what MedPage Today did with CME providers last week. MedPage Today ran a series of articles about the industry-funding of Continuing Medical Education (CME) courses.

The first article, Slippery Slope: Testosterone Muscles its way to Profits, the most excoriating and least-researched part, references testosterone courses and claims that a majority of faculty experts providing CME courses "were on the payroll of drug companies as speakers, consultants, and advisors." Not only did the author fail to reach out to two of the CME course providers referenced in the article for their comments and defense of CME courses, but the cited CME provider who was painted in a negative light was bullied and pestered with misleading and difficult questions.

The second article, Slippery Slope: Academia Takes a Step Back from Industry CME, begins with attacks on pharmaceutical companies who help to fund CME courses, and highlights the University of Wisconsin. The University of Wisconsin received $3.5 million in grants for CME courses in 2010; today, the program is decimated – receiving only $60,000 in 2014. The author of the article believes the reduction of industry funding of CME courses is because of a perceived conflict – that pharmaceutical companies were giving CME providers funding in return for the advertisement of their pharmaceuticals. The author somehow misses the great CME programs that took place back several years ago, when the University of Wisconsin had a robust program. They also seemed to go out of their way to bring back every negative report they could think of.

CME: Controversial Curricula Draw Fire focuses on CME courses on obesity. The author claims that hypoactive sexual desire disorder is an "invented" condition that was designed to sell drugs. Adriane Fugh-Berman believes that the free CME courses provided in 2010 for educating doctors on hypoactive sexual desire disorder were nothing more than a marketing ploy to increase "doctor acceptance of the condition."

The Dark Money of Medicine, the last part of the article, is an infographic that aims to compare total income for course providers and the income from the pharmaceutical industry.

The Truth About CME Activities

Continuing medical education courses are a necessity in the medical field, where new innovations are made daily. CME content is developed, reviewed, and delivered by faculty who are experts in their individual clinical areas. Similar to the process used in academic journals, any potentially conflicting financial relationships for faculty members must be disclosed and resolved.

Graham McMahon, MD, President and Chief Executive Officer of the ACCME, cleared the air by stating, "CME activities are not promotional. They're required to be evidence-based. They're required to be independent of commercial support." Dr. McMahon pointed to more published or web-based courses rather than live events as the impetus behind the decline in medical schools providing less CME courses.

For a crash-course in accreditation requirements, the author of the MedPage Today article should have visited the ACCME website, which lists thirty different standards CME courses must meet. Those standards 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.

New Data and Old Courses

A careful look at the references provided by the Medpage Today in the article titled Slippery Slope Testosterone Muscles its Way to Profits to support their argument that the CME courses on testosterone were biased, shows they were largely from science published after the CME courses were produced. The studies they reference were published in 2010, 2013, 2014 and the summer of 2015. The CME courses they referred to in their article were from 2011-2012.

CME providers should not be held to a standard of promoting science that does not exist. There is no course on telepathic medicine in which you can predict the outcome of future clinical trials.

A cursory review of the MedPage Today website lists articles both promoting and discouraging the use of testosterone. Several of the titles promoting the use of testosterone on MedPage Today, all which encompass CME Credit examples include: Revisiting Testosterone Treatments In Prostate Cancer: men with low-risk prostate cancer and symptomatic hypogonadism had no evidence of disease progression during long-term testosterone therapy, results of a small clinical trial showed (04/25/2011), No VTE Risk Seen With Testosterone Therapy: findings may help men make benefit-risk assessment for treating testosterone deficiency (07/27/2015), Review Finds No Evidence of Testosterone Harm Testosterone: defenders found "no convincing evidence" of heart risks (01/30/2015). This small sampling of articles is further confirmation that the use of testosterone is by no means a scientifically settled issue.

The Problem with Numbers

The numbers they used to describe this "dark side of medicine" were selected out to match their narrative. It should also be noted that this "original investigation" used the same set of numbers and conclusions that an equally biased Boston Globe article covered. Both of these articles ignore the fact that commercial support for CME has dropped by more than 45% since 2007. This represents a stabilization of the industry, not a huge rise as the articles attempt to imply. After facing such a significant depression in commercial support, CME providers should not be bludgeoned by the media for finally recovering.

Legal Troubles

Often, stories like this are driven by trial attorneys promoting class action cases in an attempt to discredit potential witnesses and companies. When filing a class action complaint, attorneys tend to throw in the kitchen sink. In one section of the story, the authors dedicated space for information on their class action suit, which is essentially fishing for clients. If they can help lead the readers think that since they took testosterone and also had a problem with "x," they too can join the class action suit, making a larger class of plaintiffs for the attorneys.

The physician they interviewed fell into a trap by the reporter by backpedaling on his previous statements and confessing, "I am not an expert," which gives credence to those discrediting anything he may have said in any courses or statements.

The Dangers of Public Databases

The data on which the MedPage Today article is based was collected through public information, such as the Lilly Grants database and the Open Payments database.

This article outlines the problem with taking payments out of context. The fact that some of the faculty of the CME activities taking place from 2010-2014 that discussed testosterone have according to the Open Payments database in 2014 financial relationships with companies that manufacturer testosterone therapies. This provides no context on nature of those relationships or that those relationships even existed when they participated as faculty. CME providers go through extensive work to ensure that faculty with disclosed conflicts of interests are excluded from content that may help the companies they have an interest with.


The articles chooses selective quotes largely taken out of context to demonstrate bias, but perhaps were unaware of the existence of large studies ((Cleveland ClinicMedscape, and UCSF)) and a report in which bias in CME was determined not to be an issue.

The article was written by John Fauber, a reporter who has long been critical of the industry, who has seemingly made a career out of writing leading articles and bashing the industry. Mr. Fauber spent a good portion of time in 2009 and 2010 attacking the University of Wisconsin system to reduce their spending. We wrote about those attacks as they happened. (For a refresher, you can find the articles here, here, and here.) Those articles resulted in the University of Wisconsin School of Medicine and Public Health stepping away from some educational opportunities that would have not only benefitted the school, but the community at large. Several years ago the head of the CME department an important thought leader in CME packed his bags and moved to another university. Perhaps it is kismet that the school now only receives $60,000 in commercial support versus the $3.5 million they earned before Mr. Fauber went on the offensive.

This article is just one of a series entitled, "Slippery Slope." All articles within the "Slippery Slope" series tend to paint a wide brush against innovative and largely effective therapies for diseases such as leukemia and lymphoma, obesity, diabetes, and atrial fibrillation.

Biting the Hand that Feeds?

Oddly enough, the primary advertisers on the MedPage Today website in this "Slippery Slope" series are CME providers and Life Science Advertisers. Not only do the authors of the series make unsubstantiated claims, but they are also biting the hand that feeds them. If MedPage today truly thinks payments from industry is the "Dark Money of Medicine" than we encourage them to either give up asking for commercial support and advertising dollars from those CME providers and Life Science Companies or disclose to the world how much they receive in funds from each company. A quick look at the second quarter earnings for Everyday Health, the parent company of MedPage Today, reported advertising and sponsorship revenue of $50.2 million, a 36% increase from the prior year period. Extrapolated out for the full year, that is somewhere in the range of $200,000,000 dollars--equivalent to approximately 1/3 of the total commercial support for all CME providers combined.


As has been made clear from many years of research and education, science is constantly changing, and advocating for less research and fewer new drugs, as the authors of the "Slippery Slope" series are wont to do, is a dangerous pastime. We cannot use yesterday's science on today's problems. Medical research and continuing medical education are two important factors in making sure our healthcare providers are as up-to-date and efficient as possible.  

The CME Coalition has issued a strong response to the MedPage Today/Milwaukee Journal Sentinel Slippery Slope articles and gracefully MedPage today published them.


Rockpointe, publisher of Policy and Medicine owns a medical education company and accredited CME provider in addition, they are members of the CME Coalition.  We believe that CME plays an important role in educating our healthcare providers on important aspects of medicine.  


September 29, 2015

Improving Diagnosis in Health Care


When providing health care to patients, it is crucial to get the proper diagnosis as soon as possible to help the patient make the best decisions for their health and long-term goals. Recognizing that diagnostic errors have been around for decades, affecting the accuracy of patient diagnoses, the National Academies of Sciences, Engineering, and Medicine convened a committee of experts to research and better understand how diagnostic errors occur and to propose recommendations on how to improve patient diagnosis.

The committee defined diagnostic error as “the failure to (a) establish an accurate and timely explanation of the patient’s health problem(s) or (b) communicate that explanation to the patient.” The committee determined that while diagnostic errors stem from a variety of causes, the definition of diagnostic error should be defined from the patient’s perspective because they hold the ultimate risk of harm from diagnostic errors.

The committee understood that since diagnostic errors stem from multiple causes, a singular, narrow focus on reducing diagnostic errors would not achieve the extensive change the committee believes to be necessary. Instead, the committee developed a conceptual model to better articulate the diagnostic process and to identify eight goals to reduce diagnostic error and improve diagnosis.

Those eight goals centered around the importance of the continuous improvement of teamwork, education and training, technology, and research. For example, one particular goal was to enhance healthcare education and training in the diagnostic process. "Getting the right diagnosis depends on all health care professionals involved in the diagnostic process receiving appropriate education and training," the article stated. "Improved emphasis on diagnostic competencies and feedback on diagnostic performance are needed." Education to improve diagnoses is especially important as health care delivery has gotten increasingly complex, the authors note.

The committee concluded with a reminder that nearly everyone has a responsibility in working to reduce diagnostic error: “just as the diagnostic process is a collaborative activity, improving diagnosis will require collaboration and a widespread commitment to change among health care professionals, health care organizations, patients and their families, researchers, and policy makers.”

In addition to the recommendations made to physicians, the National Academies of Sciences, Engineering, and Medicine also put out a pamphlet geared toward patients. The pamphlet’s purpose is to help patients better understand how diagnostic errors occur and what they, as the ultimate risk-bearers of diagnostic error, can do to avoid them. The pamphlet emphasizes how important effective communication and collaboration with medical providers is. It provides a checklist for patients to ensure that they are doing their part in communicating with their medical professionals, including items like: be clear, complete and accurate when describing their illness; keep track of helpful treatments; and keep good medical records.

Overall, there are many factors that contribute to diagnostic error, and many possible solutions that have the potential to reduce the number of misdiagnosed patients. Effective education, collaboration, and continuous improvement are key components of the solution. 


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