AMA CEJA: Council on Medical Education (CME) Conflict of Interest and Bias In Continuing Medical Education

In addition to the CEJA Report the AMA Council on Medical Education (The Council) issued proposed guidelines for CME providers, presenters and participants of CME events to help them implement the CEJA report guidelines:

Their discussion follows the lines of Ethically Preferable and Ethically Permissible and is designed to serve as a guide for implantation of the CEJA report. The Council’s recommendations are designed to re-enforce the ACCME Standards for Commercial Support and the AMA Guidelines on Medical Education (CME – PRA Credit). They specifically did not add any new guidelines other than offer recommendations for implementation of the current rules in the framework of the CEJA Report.

Providers

For Ethically Preferable CME Providers Should:

• Ensure that the certified CME activities are balanced, with faculty members presenting a broad range of scientifically supportable viewpoints related to the topic at hand.
• Educational materials that are part of a CME activity, such as slides, abstracts, or handouts cannot contain any advertising, trade name, or a product-group message.
• The content or format of a CME activity or its related materials must promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.
• Presentations about pharmaceutical choices must give a balanced view of available therapeutic options. Use of generic names will contribute to this impartiality.
• If the CME educational material or content includes trade names, where available, trade names from several companies should be used, and not trade names from just a single company.
• Academic medical centers should prohibit physicians, trainees, and students in their role as faculty from allowing their professional presentations of any kind, oral or written, to be ghostwritten by any party, industry, or otherwise.
• CME Providers also must be able to show, in keeping with the tenets CEJA proposes for what is ethically preferable, (i.e., no commercial support and no individual financial relationships with industry) that everyone who is in a position to control the content of an education activity has disclosed all relevant financial relationships with any commercial interest to the provider.
• An individual who refuses to disclose relevant financial relationships will be disqualified from being a planning committee member, a teacher, or an author of CME, and cannot have control of, or responsibility for, the development, management, presentation, or evaluation of the CME activity.
• For an individual with no relevant financial relationship(s), the learners must be informed that no relevant financial relationship(s) exist.
• Providers must ensure that this information is disclosed to learners prior to the beginning of the educational activity.

For Ethically Permissible certified CME the Providers Should:

In addition to the duties of CME Providers described under the ethically preferable framework, the further obligations of the CME Providers under the ethically permissible framework, where there may be commercial funding and individuals may have financial interests, are as follows:

• Funding from industry or others may be accepted in accordance with Opinion 8.061, “Gifts to Physicians from Industry”.
• Such financial support for CME is intended to support education on a full range of treatment options and not to promote a particular medicine.14
• The CME providers must make all decisions regarding the disposition and disbursement of commercial support.
• Providers cannot be required by a commercial interest to accept advice or services concerning teachers, authors, or participants or other educational matters, including content from a commercial interest, as conditions of contributing funds or services.13
• All commercial support associated with a CME activity must be given with the full knowledge and approval of the CME Providers.13
• The terms, conditions, and purposes of the commercial support must be documented in a written agreement between the commercial supporter that includes the Providers and their educational partner(s).13.
• No payments from commercial funders shall be given directly to the director of the activity, planning committee members, teachers or authors, joint sponsor, or any others involved with the supported activity.
• When companies help fund medical conferences or lectures other than their own, responsibility for and control over the selection of content, faculty, educational methods, and materials should belong to the organizers (CME providers) of the conferences or lectures.

CME Providers should ensure that representatives of industry or other financial contributors do not exert control over the choice of moderators, presenters, or other faculty, or modify the content of faculty presentations.

The company should not provide any advice or guidance to the CME Providers, even if asked by the regarding the content or faculty for a particular CME program funded by a grant from the company.

The CME Providers must have implemented a mechanism to identify and resolve all COI prior to the education activity being delivered to learners. Strategies that CME Providers may use to resolve COI or mitigate the potential influence of the financial interests may include, but are not limited to:

(a)  Having content reviewed and revised as necessary by experts that do not have relationships with the commercial entity;

(b)  Limiting the presentation to pathophysiology and mechanisms of disease rather than therapeutic recommendations;

(c)  Selecting another speaker to present clinical implications after the primary speaker that has a COI has reported a scientific discovery;

(d)  Changing the focus of the presentation so that the content is not about products or services of the COI;

(e)  Limiting the presentation to research results and assigning another speaker with no COI to address the broader implications of clinical care when an individual with a COI is a principal investigator on a project funded by industry; or

(f)   Limiting the sources for recommendations that the speaker with a COI may use such as the AAFP Evidenced-Based CME Requirements.

In addition to these strategies to resolve COI in advance, CME Providers may also assign clinical practitioners to monitor educational activities so that they may be able to address any perceived commercial bias during a live presentation immediately if it occurs.

CME Providers must also assure that arrangements for commercial exhibits or advertisements do not influence planning or interfere with the presentation, nor can they be a condition of the provision of commercial support for CME activities.

Product-promotion material or product-specific advertisement of any type is prohibited in or during CME activities. The juxtaposition of editorial and advertising material on the same products or subjects must be avoided.

Live (staffed exhibits, presentations) or enduring (printed or electronic advertisements) promotional activities must be kept separate from certified CME.

CME Providers must further ensure the disclosure to learners of any individuals’ relevant financial relationship(s), including the following information:

(a)  the name of the individual;

(b)  the name of the commercial interest(s);

(c)  the nature of the relationship the person has with each commercial interest.

In addition, the CME Providers must also disclose to learners the source of all support from commercial interests.

Further, when commercial support is “in-kind,” the nature of the support must be disclosed to learners

Disclosure must never include the use of a trade name or a product-group message.

Presenters

For Ethically Preferable Certified CME Faculty:

Physicians serving as presenters, moderators, or other faculty at a CME conference should ensure that:

a)    Research findings and therapeutic recommendations are based on scientifically accurate, up-to-date information and are presented in a balanced, objective manner;

b)    The content of their presentation is not modified or influenced by representatives of industry or other financial contributors, and they do not employ materials whose content is shaped by industry.

Educational materials that are part of a CME activity, such as slides, abstracts, and handouts, cannot contain any advertising, trade name, or a product-group message.

In addition, professional presentations of any kind, oral or written, should not be ghostwritten by any party, industry, or otherwise

For Ethically Permissible Certified CME the Faculty:

In addition to the same responsibilities in ethically preferable CME faculty must be aware of and abide by the Providers’ written policies and procedures governing honoraria and reimbursement of out-of-pocket expenses for planners, teachers, and authors.

Faculty should only accept honoraria or reimbursement of out-of–pocket expenses in compliance with the Providers’ written policies and procedures and directly from the Providers, joint sponsor or designated educational partner. At no time should the faculty accept direct payment from the commercial funder.

Physician Learners

Duties of physician learners in all CEJA categories

For physician learners, the same duties apply whether the activity falls into either the ethically preferable or ethically permissible frameworks. These duties start with the CEJA report’s recommendation that physician-learners should seek out CME activities that indicate their adherence to the CEJA ethical framework.

The physician choosing among CME activities should assess the activities’ educational value and select only those activities which are of high quality and appropriate for the physician’s educational needs.

When selecting formal CME activities, the physician should, at a minimum, choose only those activities that:

(a)  Are offered by sponsors accredited by the Accreditation Council for Continuing Medical Education (ACCME), the American Academy of Family Physicians (AAFP), a state medical society (or the American Osteopathic Association as referenced in the body of the CEJA report);

(b)  Contain information on subjects relevant to the physician’s needs;

(c)  Are responsibly conducted by qualified faculty; and

(d)  Conform to Opinion 8.061, “Gifts to Physicians from Industry.”

The educational value of the CME conference or activity must be the primary consideration in the physician’s decision to attend or participate.

Though amenities unrelated to the educational purpose of the activity may play a role in the physician’s decision to participate, this role should be secondary to the educational content of the conference.

Subsidies from industry should not be accepted directly or indirectly to pay for the costs of travel, lodging, registration fees, or other personal expenses of physician learners attending conferences or meetings, nor should subsidies be accepted to compensate for the physicians’ time.

From the Council on Medical Education’s perspective, the learner has an ongoing obligation to understand the sources of funding and the methods by which the CME activity was developed.

Physician learners should critically review the scientific information that is presented to determine whether any bias can be detected.

The funding information should be transparent to the learner but if it is not, the learner has an ethical obligation to seek it.

These guidelines apply to the learner in all of the categories proposed by CEJA. Learners, as part of the evaluation process of the CME activity, are usually asked to assess the presence or absence of bias, and they should be prepared to make this judgment routinely.

At all times, the learner must be ready to understand and judge the extent of the separation of content and funding and assess the value of the content accordingly.

The Council on Medical Education acknowledges that some of the CEJA recommendations are aspirational and there may not be existing guidelines or regulations to guide physicians and the CME community on how to demonstrate compliance.

Additional interpretations, time, and experience will be needed before clarity in application and eventual compliance with these recommendations can be demonstrated.

Specifically, the CEJA recommendations and terms requiring clarification are as underlined below:

3d. the CME provider is not overly reliant on funding from industry sources.

5a. the individual is demonstrably uniquely qualified as an expert in the relevant body of knowledge or skills.

5c. there is a demonstrated, compelling need for the specific CME activity in the professional community that cannot otherwise be met.

5e. every effort is made to develop a pool of qualified, independent experts as quickly as possible.

In addition, recommendation 4 allows CME providers to permit individuals who have “modest” financial interests in the educational subject matter to program, develop content for, or teach in CME activities if certain conditions are met, but the term “modest” is not defined and therefore subject to interpretation.

Prohibited Activities

This report has described the inextricable link between the CEJA ethical opinions and the AMA PRA credit system; therefore, activities that do not conform to the CEJA ethical framework or other pertinent CEJA opinions by using the mechanisms outlined above and/or other mechanisms to reach the stated CEJA objectives, may not be certified for AMA PRA Category 1 Credit™.

It should be noted that neither the CEJA report nor this report addresses promotional or industry designed, Food and Drug Administration-regulated events. Promotional events, as already stated in previous CEJA opinions, should be clearly indicated as such. There cannot be AMA PRA Category 1 Credit™ given for those activities. All physicians should be aware of the difference between purely promotional and certified CME activities.

Summary

From reading both reports, their ideas presented are in the right direction, of encouraging the continuation of commercial support for Continuing Medical Education.

Unfortunately, the rhetoric presented in CEJA and the reliance on older evidence are causes for concerns.   We are also concerned with some of the conflicting language in both reports, which leave one unclear of the final outcome if adopted.

We applaud the Council on Medical Education for undergoing an analysis and proposed implementation of the CEJA Guidelines.

AMA CEJA: Full AMA CEJA Report

AMA CME: Conflict of Interest and Bias in Continuing Medical Education