The Alliance for Continuing Medical Education (The Alliance) representing over 2,500 CME professionals from medical schools, hospitals, medical specialty societies, state medical societies, medical communication companies, pharmaceutical and medical device companies and related organizations. Issued a statement to refer back to committee the current (CEJA Report 1-A-09) Financial Relationships with Industry in Continuing Medical Education
Despite the laudable objective of the CEJA report, the specific ethical guidance provided to physicians and the profession on pages 8 & 9 of the report is vague and open to multiple interpretations. The Alliance strongly recommends that this report be referred back to CEJA for reconsideration and clarification.
The Alliance offers the following comments concerning CEJA's proposed "ethical framework to guide professional practice with respect to financial relationships in the context of continuing medical education."
The Differentiation Between Ethically Preferable and Ethically Permissible:
• The distinction presented between ethically preferable and ethically permissible implies a value judgment that educational activities with commercial support or speakers with financial relationships with industry are somehow less evidence-based or less ethical than activities with no commercial support or speakers with no financial relationships. The report from CEJA provides no current data to support this potential judgment. Indeed, the report fails to acknowledge the one current study by Cervero that found no evidence in support for or against this premise! Further research needs to be conducted in this area before new ethical standards are established.
• The delineations between ethically preferable and ethically permissible can be subjective and confusing and will be interpreted differently by physicians and the public alike. We believe there is no value in suggesting shades of gray as to whether or not a practice is ethical. Both "ethically preferable" and "ethically permissible" are, in fact, ethical.
• Ethically preferable CME, as defined by this document, places undue pressure on all organizations that provide continuing medical education to eliminate commercial support. Business models may well have been established that rely upon industry support. As long as these models comply with the ACCME Essentials, Standards, and Policies there is no evidence that industry support represents an ethical issue.
• There are circumstances when individuals having relationships with industry are the best potential faculty for a CME activity. This is particularly true when a new a pharmaceutical product or device is made available either in clinical trials or after FDA approval. The Alliance would argue that it is ethically preferable to have knowledgeable faculty with a financial relationship with industry in this instance rather than the CME provider selecting a "good enough" speaker simply because he/she lacks a relationship with industry.
• In its effort to clarify how a program can be ethically permissible while accepting commercial support or utilizing speakers with relationships with industry, the report specifies several conditions that lack clarity. The report should:
o Define what "overly reliant" means in regards to CME provider dependence on funding from industry sources.
o Define "modest financial interests" with regard to individuals involved in programming for, developing content for, and teaching in CME activities. Note that the ACCME's Standards for Commercial Support require that any amount of financial interest must be disclosed and managed. Does CEJA propose that CME providers collect information on specific financial amounts? If so, CEJA should clearly state where the tipping point is between "modest financial interests" and unacceptable financial interests.
o Define "demonstrably uniquely qualified" as it relates to the involvement of individuals with significant, unavoidable financial interest. This is a subjective description that would be very hard to defend or prove if the uniquely qualified expert had a "substantial" financial interest in the educational recommendations or content. Providing evidence of such a selection could become onerous. A focus on the overall process of faculty selection and evidence of the process for the CME provider's management of conflict of interest policy is more appropriate.
Finally, we note that the report does not recognize the value of the safeguards that are currently in place to address conflicts of interest. Accredited CME providers must uphold the ACCME's Standards for Commercial Support and already adhere to the conditions being recommended in the description of ethically permissible, so we contend that there is no ethical dilemma to be addressed.
Furthermore, there are no data available to suggest that the Standards for Commercial Support are not effectively mitigating potential conflicts of interest.
CEJA needs to take these recommendations very seriously; the Alliance represents almost everyone who works in the educational process and design of CME courses.
The bottom line comes to this is commercial support or any other support (commercial, governmental, insurance, hospital paid for) CME is either ethical or not, perhaps CEJA is looking at the wrong equation, regardless of who pays for the CME it is in the patients best interest for the physician to be as well educated as possible, this is epically true when life saving medications are involved.
AMA CEJA (CEJA Report 1-A-09) Financial Relationships with Industry in Continuing Medical Education
Alliance for Continuing Medical Education: Response to AMA CEJA Report 1-A-09