The AAMC Released today a comprehensive set of recommendations concerning conflict of interest and interaction with medical faculty at Universities. The opponents of commercially supported CME (the Prescription Project, and Institute of Medicine as a Profession) took this report as an opportunity to bash our industry in the New York Times. The report itself is significantly more balanced than the Gardner Harris Article.Group Urges Ban on Medical Giveaways
Unlike previous reports on similar issue, this report starts out with the following pre-amble:
“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. Appropriate management of this partnership by both
academic medical centers and industry is crucial to ensure that it remains principled, thereby sustaining public trust in the proposition that both partners are fundamentally dedicated to the welfare of patients and the improvement of
public health”.
There was a section devoted to CME, and this is a summary of their recommendations.
For Continuing Medical Education (CME)
• Academic medical centers offering CME programs should develop audit
mechanisms to assure compliance with the standards of the Accreditation
Council for Continuing Medical Education (ACCME), including those with
respect to content validation and meals.
• Academic medical centers should establish a central CME office through which
all requests for industry support and receipt of funds for CME activity are
coordinated and overseen.
• To the extent that educational programs for physicians are supported by any
commercial entity, including pharmaceutical, device, equipment, and service
entities, the programs should be offered only by ACCME-accredited providers
according to ACCME standards.
In respect to CME these are all very reasonable recommendations, and most universities have already undertaken significant effort to achieve these goals.
The document covers many other things not directly related to CME including:
· Gifts to individuals (Prohibiting)
· Pharmaceutical samples, (Central Distribution)
· Site access by pharmaceutical representatives, (Limited to appointment or invitation, student participation limited, more MD’s, PhD’ and PharmD’s)
· Site access by device manufacturer representatives, (credentialing, appointment or invitation, disclosure and consent of patients, student participation limited)
· Participation in (Non CME) industry sponsored programs. (Discourage faculty, transparency of payment and fair market value, prohibit attendance, paying for attendance, accepting personal gifts)
· Industry Sponsored Scholarships and other Educational Funds for Trainees (Giving Centrally, no Quid pro quo, selection sole responsibility of the university)
· Food (only for ACCME-Accredited Events)
· Travel (only for legitimate reimbursement or contractual services.
· Ghostwriting (transparency of all involved in the process)
· Purchasing (Disclosure of interest, and recuse from purchasing decisions in COI cases)
· Boards of Directors, Advisory Boards and Consulting (Valuable and Compensation to Reflect Fair Market Value)
The report was accompanied by letters from the CEO’s of Pfizer, Eli Lilly stating that:
· They support all but one of the recommendations,
· But do so without supporting all the arguments in the body of the report,
· Issues addressed reflected perceptions rather than proven consequences
· “We cannot agree with the report’s suggestion that AMCs actively discourage academic physicians from participating in the defined speakers programs”
An additional letter from David Beier, President from Amgen stated:
Support of the explicit recommendations of the taskforce
“Our experience is that medical professionals who work in academic settings are dedicated professionals focused on the delivery of patient care and have not been inappropriately influenced in the manner, or to the degree represented in this report.
· Engage healthcare professionals in appropriate fair-market value contractual relationships to participate in FDA Approved Speaker Programs.
· Engage healthcare professionals as consultants with appropriate fair market value contractual relationships for defined interactions
· Provide funding for Independent Medical Education to qualified recipients and, per a new policy, disclosing all Independent Medical Education and Healthcare Donations Publically
· Deliver appropriate product and disease information to healthcare professionals via field based Representatives and Medial Liaisons.