Under pressure from one member of Congress the American Medical Association (AMA) Council of Judicial and Ethical Affairs (CEJA) proposed another report CEJA Report 1-1-09: Financial Relationships with Industry in Continuing Medical Education to be voted on at the 2009 Interim Meeting of the American Medical Association House of Delegates.
The meeting is being held from Saturday, November 7 – Tuesday, November 10 at the
Houston Hilton and George R. Brown Convention Center, in Houston, Texas. Below is a summary of the report.
The report appears to be yet another attempt by CEJA to restrict speakers and CME funding.
Background
While their proposal is an improvement from previous CEJA Reports (June 2009, June 2008) which were rejected by the House of Delegates, the report is still built on the same extremely weak scientific structure of largely editorials, and opinion papers and little science (3 original papers out of 57 references).
In fact, CEJA itself admits that the process it proposes is “arbitrary” and the “available data by no means demonstrates conclusively that commercial funding unduly biases continuing professional education.” Yet without scant evidence to support their claims, CEJA goes on to use commentary, conjecture, opinion and mostly a non-scientific framework to embellish that CME cannot be objective if industry is involved.
“to date there is no empirical evidence to support or refute the hypothesis that CME activities are biased.”(p 3 48-49) and The available data by no means demonstrate conclusively that commercial funding unduly biases continuing professional education. (p 4 11-12)
The report as in other CEJA reports and recommendations are still based on the belief that “Financial and in-kind support of continuing medical education (CME) by pharmaceutical, biotechnology, and medical device companies puts that ethical obligation (to ensure objectivity) at risk by creating conditions for conflict of interest. Medicine’s ethical aspiration should be to avoid this potential.” (p 9 14-15)
They then go on in the very next sentence to outline that: In some circumstances, however, refusing support from industry entirely could significantly undermine the profession’s capacity to ensure that physicians have access to appropriate, high quality CME. (p 9 19-21)
There premise holds that: Medicine should seek to minimize such occasions when they cannot be avoided; medicine must act vigorously to protect the interest of patients and the integrity and independence of the educational exercise. (p 9 21-23)
Financial Relationships with Industry in Continuing Medical Education
CEJA’s report is seeking to provide ethical guidance for physicians and the profession with respect to industry support for continuing medical education. After surveying various literatures, CEJA found that relationships with industry—i.e., pharmaceutical, biotechnology, and medical device companies—can offer enormous benefit to the profession and the patients it serves.
Contrary to this finding however, CEJA is concerned that commercial funding for professional education can pose significant ethical challenges to medicine’s ability to focus primarily on the needs of patients and ensure quality education for physicians.” As a result, CEJA stated that there should be “no direct financial interest in a physician’s clinical recommendations.” Specifically:
“Those involved in CME should have no current, recent, or potential direct financial interest in the subject matter and should not currently be or recently have been involved in a compensated relationship with a commercial entity that has a financial interest in the educational subject matter.” (p9 31-39 summarized)
Avoiding Conditions that Can Compromise the Integrity of CME
CEJA proposes that physicians will have to decline to accept or seek support for professional education activities from commercial funders who have significant financial interests in physicians’ clinical decisions. By totally eliminating industry, CEJA asserts that it would eliminate the administrative and resource costs that must otherwise be devoted to mitigating influence. If doctors are required by law to already disclose such information publicly, what kind of administrative cost is CEJA really eliminating? It sounds more like CEJA is eliminating of ways for doctors to learn about new treatments for patients, which will end up costing ten times as much in administrative and resource costs once patients go without proper care.
The report calls for CME providers to avoid financial relationships with industry by cultivating alternative sources of support; designing and conducting educational activities independently; and identifying content developers and faculty members who do not have problematic ties with industry.
Where exactly is CEJA going to find such people? How much is that going to cost? While the Institute of Medicine has called for development of a new system of funding CME that is free of industry influence, who is going to pay for it? For the most part the federal government does not see supporting CME as part of their mission and states are broke. Insurance companies and academic medical centers have reduced funding for CME over the last ten years.
What CEJA’s plan sounds like is a waiting list for doctors to be able to talk about new medicine and research. Hypothetically, CEJA would prefer to let studies for breakthroughs in medicine and devices to wait around until a doctor who has no experience with the material reads the article. This is problematic for two reasons: first, it prevents patients and physicians from learning about lifesaving and altering technologies; and second, it harms rural communities, as CEJA notes, because they “may not always be able to obtain the services of experts who do not have problematic ties to industry” based on the local conditions.
Mitigating Potential Influence That Cannot Be Avoided
CEJA does acknowledge “that not all relationships with industry are equally problematic. For example, having once conducted sponsored research or accepted a modest honorarium for speaking on behalf of a company would not necessarily create such clear potential for bias as to preclude an individual with the appropriate expertise developing content or serving as a faculty member for a given CME activity.”
Who determines what ‘appropriate expertise’ is? Any physician who conducts clinical studies on a particular device or medicine successfully would certainly have more expertise then a doctor who just read the outcome. So then why is payment for such research, which represents the legal work product of physicians, such a problem?
If examples like cadavers and sophisticated equipment to train physicians in new surgical procedures or the use of new technologies “are not feasible without financial support from industry,” then why is CEJA trying to take such broad strokes eliminating industry funding? Perhaps CEJA would revise such claims if they read a recent scientific study from the Journal of American Medicine which found that an overwhelming majority of physicians found it appropriate to work with industry.
CEJA is also seeking to create additional “firewalls” between industry funders and decisions about educational goals, content, faculty, pedagogical methods and materials, and other substantive dimensions of CME activities. Ideas include using multiple, competing funders for CME programs, and creating a “blind trust” model where funders have no knowledge of which programs their grants or gifts supported, nor are CME providers, content developers, or faculty aware of which funder supported their activities;
Exceptional Cases: Conflicted But Essential Expertise
CEJA’s ethical considerations are even more confused by the fact that they support using physicians paid by industry “in the earliest stage of adoption of a new medical device, technique, or technology, because they are the only individuals truly qualified to train physicians in its use, and are often those who developed the innovation.”
Although CEJA feels these are the very individuals who often have the most substantial and direct interests at stake, this is irrelevant: these experts are morally and ethically obligated to teach doctors how to use such devices, techniques and technologies, and it is legal for them to do so. These breakthroughs and innovations, which require physician education, have one priority: saving lives. Whether such relationships are ongoing or through employment with manufacturers, or other direct financial interests in the adoption and dissemination of the new device, technique, or technology is of little importance compared to saving a life.
Still, CEJA wants to make such experts wait in line with the other ‘conflicted’ physicians while the committee tries to arbitrarily define whether the:
– Dissemination of the device, technique or technology will be of significant benefit to patients, and to the public and the professional community;
– That the individual is uniquely qualified as an expert in the relevant body of knowledge or skills; and
– That there is demonstrated, compelling need for the specific CME activity;
RECOMMENDATIONS
Accordingly, CEJA recommends that financial and in-kind support of continuing medical education (CME) by pharmaceutical, biotechnology, and medical device companies should be:
1. Provided only by sources that have no direct financial interest in a physician’s clinical recommendations; and
2. Individuals who develop content for or teach in CME activities should:
a. Have no current, recent (within the preceding 12 months), or potential direct financial interest (e.g., royalties or ownership interest) in the educational subject matter; and
b. Not currently be and not recently have been (within the preceding 12 months) involved in a compensated relationship (e.g., direct employment, service on a speakers bureau, service as a consultant or expert witness) with a commercial entity that has a financial interest in the educational subject matter.
CEJA recommends that CME can be funded by industry sources if declining such support would significantly undermine the capacity to ensure that physicians have access to appropriate, high quality professional education. If such circumstances are established, then industry can fund CME 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 CME provider can articulate compelling reason(s) to accept industry support;
· The CME provider declines industry support that is conditioned on the provider’s acceptance of advice or services concerning educational content, faculty or content developers, or other educational matters;
· The source and magnitude of support are clearly disclosed; and
· The CME provider routinely audits the level of industry support it receives to ensure the independence and integrity of its educational mission and programs
CEJA recommends that CME providers may permit involvement of individuals with “modest financial interests” if the nature and magnitude of those interests are disclosed and steps are taken to eliminate or mitigate the potential influence of those interests.
CEJA recommends that CME providers may permit involvement of a uniquely qualified expert who has a direct, substantial, unavoidable financial interest if:
· There is a demonstrated, compelling need for the educational activity in the professional community that cannot otherwise be met;
· The CME provider demonstrates that the individual has unique expertise in the relevant body of knowledge/skills;
· The CME provider takes steps to mitigate the potential influence of the unavoidable financial interest;
· The nature and magnitude of the specific interest are clearly disclosed; and
· CME activities that use such experts should contribute overall to the timely development a pool of qualified, independent experts in the relevant field.
Summary
The ethical considerations of CEJA’s report are at best confusing. The report itself even admits that because “there are no specific, publicly agreed on understandings of the key criteria proposed above, trying to create concrete definitions would be an essentially “arbitrary exercise.”
The recommendations include several italicized words (modest, uniquely qualified, direct, substantial, and unavoidable) which provide more examples of the ambiguous language surrounding this report. And lack of definition will in the end cause even more confusion for those seeking to regulate and understand CME.
This report summarizes a conflict of interest on one hand CEJA clearly sees the benefit of commercial support of CME in high quality programs, on the other hand they are scared that somehow subtle bias will prevail. “Our concern is not with egregious lapses of judgment or with corruption, but with the subtle bias that financial ties create.” (p 4 21-22)
Disregarding their own admission, CEJA would rather force patients to wait for a new therapy to become available, rather then let your doctor even learn about such therapies in advance of FDA approval.
CEJA also wants to make patients wait for new treatments to find a “uniquely qualified” expert (or one of only a very few) who has significant knowledge about or experience in treating a rare disease or who was involved in the early development or testing of a new treatment, device, or technology.” Ironically, this premise is a contradiction in itself because the only experts who could meet such expectations would have absolutely worked with industry.
What this report suggest for patients is that waiting for new treatments and medicine from CEJA’s perspective is about waiting for arbitrary definitions to be created out of thin air—which is essentially what CEJA’s entire report was based on—to determine who can teach our doctors about such breakthroughs.
If the AMA House of Delegates allows CEJA or even Congress tell your doctor who can teach them about medicine and treatments for their patients, next time your doctor tells you something, how will you know if it’s based on education and experience?
Hopefully, you can ask your doctor, and they can tell you “I learned it from CME.”
Twice now the AMA House of Delegates has sent this report back for more work, until they build it on a framework of evidence one can only expect them to continue to do the same.