Adding to the growing crowd of criticism against new proposals from Accreditation Council for Continuing Medical Education (ACCME) regarding continuing medical education (CME) and industry, the Council on Ethical and Judicial Affairs (CEJA) of the American Medical Association (AMA) recently submitted a report titled “Financial Relationships with Industry in Continuing Medical Education.” This report, given to a reference committee of the AMA, is being considered for submission to the AMA House of Delegates in mid-June. Below are some of the recommendations:
“It is ethically preferable that CME providers accept funding only from sources that have no direct financial interest in a physician’s clinical recommendations and that those involved in CME have no … direct financial interest in the subject matter …”
“It is ethically permissible that CME providers accept funding from industry sources if the educational activity is planned by the provider based on needs identified independent of, and prior to, solicitation or acceptance of the funding; the use if funding is not restricted in any way; the source … is clearly disclosed; and the CME provider is not overly reliant on funding from industry sources…”
“CME activities that involve financial relationships that cannot be addressed through any of these mechanisms are “ethically prohibited.”
Lewis Miller, the founder of the Alliance for Continuing Medical Education has outlined some of his concerns in a recent white paper.
The Quality of Research and Ethics of the Report
The section titled “Industry Support for CME,” suggests that industry support now accounts for more than half of all income to accredited CME providers because of “uncertain funding from other sources” is problematic. The report ignores benefits for companies, physicians, and their patients from the use of industry funding, such as:
– Disseminating research findings that benefit patient care;
– Identifying best practices in diagnosis and treatment in therapeutic areas of interest to supporters;
– Informing physicians of off-label uses, and
– In some cases, discharging a social responsibility.
In addition, the section on “Disclosure” mentions the ACCME requirement to disclose conflicts of interest, goes on to criticize the value of disclosure itself, and yet fails to disclose that the ACCME standards require resolution of the conflict. Further, the value of the ACCME standards on independence are apparently dismissed under “Firewalls,” because CEJA believes they are insufficiently specific.
Furthermore, one of the most important papers not referenced is that by Cervero and He. This study, commissioned by the ACCME, could find no evidence that commercial support did — or did not — influence doctors inappropriately, nor could they find any evidentiary link between commercial support of CME and patient care outcomes.
In addition, the report does not reference updated industry standards on gifts to physicians, venues for meetings supported by industry, and awareness of the need for independence of CME. Ironically, many of these practices have been prohibited within academic medical schools and professional associations.
As a result, there is a lack of fair balance, and thus, the report reflects a bias against industry support of CME.
The Gap Between Results, Conclusions and Recommendations
Accordingly, within the report, there is no evidence presented that commercial support prevents the profession from safeguarding the independence of CME. Moreover, there is no evidence that control of the educational enterprise has passed from the hands of the profession to the hands of industry.
Ethically Right or Wrong?
Lastly, there is a contradiction. On one side, it is unethical for CME providers to accept funding from industry and for faculty, organizers, and participants who have a financial interest in the subject matter to avoid taking part in such CME.
However, it also appears that it is ethical for providers to accept such support, and for individuals to take part, if certain conditions are met. As a result, several critics believe that the report should be sent back to the CEJA reference committee for further examination.
Similarly, Peter Rheinstein, M.D., J.D., and former Director of the Division of Drug Marketing, Advertising, and Communications at the FDA, also provides a similar perspective. Dr. Rheinstein specifically noted that “the use of the funding is not restricted in any way” and insertion of language from the ACCME Standards of Commercial Support as shown below:
– It is ethically permissible that: CME providers accept funding from industry sources if the following conditions are met:
– The use of funding is not restricted in any way.
This definition can cause real problems for the FDA and other regulatory agencies in that:
– A truly “unrestricted grant or gift” from a pharmaceutical or device company to an accredited provider that is also a hospital, physician, clinic, or other organization that may use or potentially use the grantor’s products and that bills Medicare, Medicaid, or other government agencies for patient care could be seen as a bribe or illegal kickback.
– The other problem is that companies are held responsible for CME that is off-label, if the companies cannot restrict what general topics the funding is being used for they may not fund projects based on the potential liability as seen in several important legal cases.
The ACCME language is perhaps more clear “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.*” (*footnote omitted.)
This ACCME language expresses the intent of requiring that funding not be restricted, and would preserve the right of grantors to condition a grant on the grantee’s commitment that funds be used in compliance with applicable requirements and provide grantors the ability to avoid an inadvertent violation of anti-kickback laws.
The other element of concern in the recommendations is the section on:
– 3.D. The CME provider is not overly reliant on funding from industry sources.
– The statement overly reliant is “overly vague,” and can be used against CME providers who accept funding from industry. In a court of law, “overly” can be considered as little as $1.00.
– There is no evidence that commercially supported CME is not scientifically valid. When we produce educational programs for physicians, we do extensive needs assessment, and attempt to raise funds from whatever sources are available to us (industry, government, private foundations and managed care). Outside of industry, there are very few sources of funding for education.
The Reference Committee on Constitution and Bylaws, which hears CEJA reports, is scheduled to meet from 1:30 pm until 6:00 pm on Sunday, June 14 at the AMA House of Delegates Meeting in Chicago.
In conclusion, while Physicians should share some of the financial burden of their CME, it is necessary to address the legal and ethical principles associated with these financial burdens.
While it would seem more appropriate for a physician to pay for his own professional training, many doctors are already overwhelmed with expenses, insurance, loans from medical school, and so on. As a result, many would be discouraged away from these programs, if it were not for the funding made possible by industry. Although CEJA has laid out some good ideas, the lack of evidence is troublesome. Instead of looking for the extreme of giving the burden to doctors, we need to be the ones taking care of them first, before it becomes too expensive for them to care for us.