Continuing Medical Education
On-Label and Off-Label Usage of Prescriptions Medicines and Devices, and the Relationship to CME
National Task Force on CME Provider/Industry Collaboration | 05-Apr-2010
Fact Sheet states “A presentation of an off-label indication within the context of a CME activity is intended to provide healthcare providers with the most current clinical evidence for all available treatment options and when other therapies are not available or have not benefited the patient. Such discussion must be evidence-based, should be strictly limited to the discretion of the accredited provider within the activity, and cannot be positioned to encourage or promote off-label use for commercial purposes. Sufficient evidence and a balance between a product’s safety and efficacy must be presented to permit providers to make informed decisions when considering off-label drug use.”
NEJM Letters to the Editor: Underplaying the Value of Industry Support of CME
Thomas Sullivan, President, Rockpointe Corporation
Policy and Medicine | 19-Mar-2010
“An article last year in the New England Journal of Medicine (NEJM) focused on “The agenda for continuing medical education - limiting industry’s influence.” The article, written by Lewis Morris, J.D., and Julie K. Taitsman, M.D., J.D., of the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS), created a large discussion about the proper role of industry in continuing medical education (CME). As a result, comments were sent to NEJM, and are summarized below, along with a summary of the author’s response.”
Harrington Relationships with Industry: Research, CME, Focus on Solutions
Thomas Sullivan, President, Rockpointe Corporation
Policy and Medicine | 18-Mar-2010
“Citing the executive summary of the Institute of Medicine (IOM) Conflict of Interest report [Dr. Harrington] highlighted that ‘an effective and principled partnership between academic medical centers and various health industries is critical in order to realize fully the benefits of biomedical research and ensure continued advances in the prevention, diagnosis, and treatment of disease.’ … he feels that the alternative of “no engagement” with the industry in research and education would be bad for the public health. As a result, he believes that while it may be easy to point out the problems, and to vilify and demonize, it is a lot harder and less newsworthy to offer up solutions and a path forward.”
ACC: Both Sides See Red During Industry Funding Debate
Peggy Peck, Executive Editor, MedPage Today
MedPage Today | 16-Mar-2010
“A red dress jauntily displayed on cans of Diet Coke has become the latest symbol in the ongoing debate about pharmaceutical company support of research or CME…. The controversy over the dress became a flash point in a debate about industry influence on the academic process presented here at the American College of Cardiology meeting.”
On the Stump: When Academics Are Out of the Picture
John Fauber
Milwaukee Journal Sentinel / MedPage Today | 13-Mar-2010
“In this special report by MedPage Today and the Milwaukee Journal Sentinel we examine the forces behind the recent increase in the use of non-academic physicians on the 'dinner speaker' tour and the arguments used to support it and criticize the practice.”
Using a Pfizer Grant, Courses Aim to Avoid Bias
Duff Wilson
The New York Times | 11-Jan-2010
“Stanford University ... will announce plans to develop new continuing education programs for doctors that will be devoid of the drug industry influence that has often permeated such courses. The work is being done with a $3 million grant - from the drug maker Pfizer.”
Pharmaceutical, Biotechnology and Medical Device Company Support of Continuing Medical Education
National Task Force on CME Provider/Industry Collaboration | 25-Mar-2009
Fact Sheet states “CME should address the documented educational needs of healthcare professionals and should support evidence-based quality improvement and performance improvement initiatives. Continuing medical education support comes from a variety of sources, with the substantial majority of CME providers utilizing industry funding to help fulfill their missions.... Progress to ensure the complete separation of promotional activities from the support of independent certified CME has been recognized and acknowledged.
Continuing Medical Education: Addressing Conflict of Interest (COI)
National Task Force on CME Provider/Industry Collaboration | 16-Mar-2009
Fact Sheet acknowledges that the potential for conflict of interest exists in the medical education, research and publishing environments and adds that this “must be recognized, mitigated and negated to protect the independence of the environment.” For CME planners, presenters and authors, the key is recognizing when an entity has both a current financial relationship with a commercial interest and the opportunity to affect the content of a CME activity. The fact sheet lays out the steps for resolving such conflicts, should they arise, so that physician-learners can be assured that the information they are receiving is free from bias.
Continuing Medical Education: Providing Valid and Independent Evidence for Clinical Decisions
National Task Force on CME Provider/Industry Collaboration | 16-Mar-2009
Fact Sheet points out that physician-learners rely on “valid and independent evidence that is recognized within the medical profession as being the result of generally accepted practice, personal knowledge, technical skills, standards of experimental design, data collection and analysis” for clinical decision-making. Even when practice decisions are not made on the basis of such evidence, the fact sheet notes, “they must not be dangerous or proven ineffective.” The expectation is that the information CME providers present in their educational activities will reflect these tenets.
Continuing Medical Education: The Importance of Compliance in the Current Climate
Thomas M. Gallagher, Partner, Pepper Hamilton LLP
Pepper Hamilton LLP | 01-Oct-2008
“Any improper remuneration … or improper promotion of products manufactured by [commercial] supporters may violate the Federal Anti-Kickback Statute (AKS) or the Federal Food, Drug and Cosmetic Act (FDCA)…. The AKS protects patients and the federal health care programs from fraud and abuse by curtailing the potential corrupting influence of anyone knowingly and willfully receiving or granting anything of value, with the intent to influence the referral of federal health care program business. In the CME context, value can include the payment of tuition for courses; funding physician expenses such as travel or lodging; or providing entertainment, meals or gifts.... For CME to comply with the FDCA, all discussions of off-label uses for FDA-approved products must be solely attributed to physicians, and may not be influenced by manufacturers.”
Industry Funding of Medical Education
Association of American Medical Colleges | 01-Jun-2008
“Substantive, appropriate, and well-managed interactions between industry and academic medicine are vital to public health, but they must be conducted in a way that is principled and upholds the public trust.”
ACCME Standards for Commercial Support
Accreditation Council for Continuing Medical Education
Accreditation Council for Continuing Medical Education | 24-Aug-2007
Standards to ensure the independence of CME activities.