If Industry-Funded CME Goes, What Exactly Goes With It?

The Carlat Psychiatry Blog points to the recent Chairman’s Summary of the Conference on Continuing Education in the Health Professions from the Josiah Macy, Jr., Foundation—a privately endowed organization that, among other objectives, supports “[p]rojects to improve medical and health professional education…” One the most dramatic recommendations from the conference participants is the 5-year phaseout of all continuing medical education (CME) funded by pharmaceutical or medical-device companies. By the chairman’s own reckoning, this means the elimination of a $1.45-billion facet* of the CME industry by 2013.

For now, I will catalog 3 general problems that I have with recommendations from organizations like the Josiah Macy, Jr., Foundation—and I’m really directing my objections more to related bureaucracies like the American Council for CME (ACCME):

1. They don’t appear to entertain the limitations or repercussions of their recommendations;
2. They provide no concrete examples of how to attain really difficult-to-understand-much-less-attain ephemeral goals (for example, “align continuing education efforts with quality improvement initiatives at the level of health systems”); and
3. They seem to love to bandy about eye-rolling and arguably obfuscating terms like “change agent” and “stakeholder,” when “interested party” or even “physician” will do just nicely, thank you.

Stylistic sensibilities aside, my comments to excerpted assertions or recommendations (in italics) from the Chairman’s Summary are as follows:

[T]he health professions…threaten the ethical underpinnings of professionalism by participating in a multi-billion dollar CE enterprise so heavily financed by commercial interests. This arrangement, which evolved over the years, distorts continuing education. It places physicians and nurses who teach CE activities in the untenable position of being paid, directly or indirectly, by the manufacturers of health care products about which they teach. At the same time, commercial support of CE places learners in an obligatory position because they are often given free meals and small gifts. Independent judgment of how best to care for patients is compromised. Bias, either by appearance or reality, has become woven into the very fabric of continuing education.

The important point here is not so much whether bias exists among paid health care professionals who deliver CME programs or within the programs themselves (those stipulations require different arguments), but whether this bias is transferred to learners at the time of delivery and thus to their practices. The Chairman’s Summary concludes that bias is, prima facie, part and parcel of a pharma-supported CME program. However, delivery of all certified CME programs is accompanied upfront by information defining program support and by divulging the commercial relationships of the health care educator(s). The Chairman’s Summary unfairly removes the ability of the independent thought of learners, who know—in many cases before even electing to attend a program—its provenance. It is also the assumption that this bias, if it exists and is transferred to learners, adversely affects practice and consequently patient outcomes. But just as there are limited concrete data regarding the positive effect of CME programs on patient outcomes, there is little information (to my knowledge) regarding the negative effect of pharma-supported CME on practice or patient outcomes.^‡ In fact, it is just as probable as not that those health care professionals who attend pharma-supported CME programs have superior medical knowledge and provide superior health care, when compared with their colleagues, owing to the likelihood that the former group is more apt to seek out medical education in all its various forms.

In a free-market system, commercial entities…have a clear responsibility to shareholders to gain market advantage and generate a profit, while health professionals have a moral responsibility to provide safe, high quality care for their patients, based on valid scientific findings. The two responsibilities are fundamentally incompatible. Even if bias could be avoided, the potential, and the perception, are ever-present. No amount of strengthening of the “firewall” between commercial entities and the content and processes of CE can eliminate the potential for bias.

There are 2 assertions here that I believe are just plain wrong. First, the market advantage or profitability of a pharmaceutical or medical-device company is not incompatible with state-of-the-art evidence-based health care. This is especially true in the case of innovative medications (and I do not own direct stock in any of these cited companies)—for instance, the use of trastuzumab (Herceptin; Genentech) in HER2-positive breast cancer, the use of imatinib (Gleevec; Novartis) in CML, and the prophylactic vaccination for cervical cancer (Gardasil; Merck). Second, the placement and fortification of the so-called firewall between commercial entities, in my experience, has considerably reduced or even eliminated the potential for bias in CME content. This is especially true in the case of many large pharma companies (which now have taken a near-complete or complete hands-off approach to CME development thanks to the recent history of heavy penalties exacted by the OIG) that work with professionally staffed medical-education communications companies (MECCs). By definition, health care professionals employed by MECCs are necessarily content savvy and are capable of developing accurate and balanced CME programs in conjunction with faculty educators, who are (again, in my experience) extremely mindful of educational independence.

New metrics…should be based on assessment of process improvement and enhanced patient outcomes.

No one, to my knowledge, has figured out exactly what these “new metrics” should be or how they should work. There are independent entities (eg, MECCs and similar companies) attempting to make a business out of defining how higher-level CME outcome measures (ie, measures that go beyond assessing the retention of information) should be created and implemented. My understanding is that health care organizations with access to patient-outcome data, like Kaiser Permanente, are attempting to correlate the effects of their own CME programs with patient data.

New metrics are needed…[t]o automate credit procedures for point-of-care learning.

Even beyond the reference to “new metrics,” this small bullet point is packed with assumption, lack of foresight, and a disregard for practicality. “Point-of-care learning” (POCL) as the Chairman’s Summary defines it, is “providing access to information and answers to questions at the time and place of clinical decision-making.” It is assumed that POCL is preferable to other forms of learning. Automation of credit procedures for POCL learning, a not-insignificant job, seems unlikely to be met any time soon by major academic health care systems; although I could be ignorant of institutionally based programs currently in use. A quick Google search reveals that online POCL programs are being offered in a kind of ad-hoc fashion (a program from the Electronic Education Documentation System, or eeds, which has partnered with UCDavis, costs $35 per year). The elective uptake of these programs, which may be viewed by the already overworked professional as consuming even more weekly time or effort than is available, is unknown to me at present. Although I can imagine that there is little incentive for the average practicing physician to participate, particularly if the physician can still acquire sufficient CME credits by attending weekly grand rounds or the annual specialty meeting. Also there is the issue of what appears to be the more-or-less blind provision of credit for logged activities and the selection of sources used for patient care, not to mention the currently unknowable effects of the logging of these activities on physician liability and patient outcomes.

Federal and state policymakers should provide financial support for the further development of information technology tools that facilitate practice-based learning and should strongly encourage all clinicians to use these tools.

All I can say (write) is…there’s a lot that Federal and state policy makers should do.

A national inter-professional CE Institute should be created to advance the science of CE.

So the conference participants of the Chairman’s Summary have fallen into the bureaucratic trap of recommending the formation of another committee, more or less.

The Institute should…[p]romote the discovery and dissemination of more effective methods of educating health professionals over their professional lifetimes and foster the most effective and efficient ways to improve knowledge, skills, attitudes, practice and teamwork.

Evidently we need yet another organization, aka über-committee, aka Institute, to perform these tasks. I was operating under the assumption that this was the reason for the existence of the ACCME or, for that matter, dozens of other CME/CE organizations.

The Institute should…[b]e independent and composed of individuals from the various health professions.

The clarification of “independent” here is lacking. If the answer is independent of commercial interests, then how is this independence to be defined or established? It is difficult, if not impossible, to identify medical leaders (assuming the Institute wants medical leaders) who do not have some relationship—either in the form of grants received or advisory-board services—with a commercial supporter. (Ad-board services are to be distinguished from serving on speakers’ bureaus.) It is also arguable that these very relationships—by enabling clinical-trial investigation and providing access to proprietary information—are part of what make these professionals leaders in their respective fields.

The Institute should…[p]romote and fund evaluation of policies and standards for CE.

And said funds come from…?

The Institute should…[d]evelop mechanisms needed to assess and fund research applications from health professional groups and individuals.

At the risk of repeating myself…

The Institute should…[a]cquire financial resources to support its work and provide funding for research. Possible funding sources include the Federal government, foundations, professional groups, and corporations.

Ok, here we go. Aside from the specification of “Federal government,” which hardly qualifies as a specification, the suggested possible sources of funding are frustratingly vague. “Foundations” may include the privately endowed Josiah Macy, Jr., Foundation itself, but what other endowed organizations would be interested in supporting such as endeavor? “Professional groups” are very likely organizations that already rely on the current commercial support of pharmaceutical and medical-device companies. And last, what corporations would have an interest in supporting CME research and be acceptably pristine to the committee?

The financial resources to support CE should derive entirely from individual health professionals, their employers (including academic health centers, health care organizations, and group practices), and/or non-commercial sources.

In other words, MECCs that currently rely on commercial support to offer free CME should transition to a pay-for-CME-program model. I contend that a transition to this business model would likely wipe out most small-scale MECCs (and in my estimation, most MECCs are small scale), who may or may not salvage their business by turning to the production of promotional, non-CME educational programs.

Organizations authorized to provide CE should be limited to professional schools with programs accredited by national bodies, not-for-profit professional societies, health care organizations accredited by the Joint Commission, multidisciplinary practice groups, point-of-care resources, and print and electronic professional journals.

If the absence of commercial support doesn’t wipe out most MECCs, this recommendation most assuredly will (as it is intended to). However, I would argue that the very organizations that the committee would authorize to provide CME are not staffed or equipped to do so—especially if CME is to move away from the lecture-based format, as the committee also recommends. Creating programs that emphasize practice-based learning requires the considerable time, planning, tech savvy, beta testing, and delivery of and by knowledgeable individuals—individuals that are typically found at MECCs and certainly not within professional societies or academic-based CME offices. The committee also falls to recognize the support, both in the form of fees and otherwise, that accredited MECCs and their staff provide to various CME organizations, like the ACCME, or to professional societies or academic-based CME offices in the form of CME grant proposals and certification fees. Initial and reaccreditation fees requested by the ACCME are $6500 each, and the annual ACCME accreditation fee is $2000. According to the available roster at the ACCME web site, at least 155 MECCs are accredited to independently provide certified CME; this tabulation does not consider nonaccredited MECCs that work with accredited partners, such as academic CME offices, to provide certified CME. Not counting initial or reaccreditation ACCME fees (along with fees for the necessary site visits of ACCME staff), the loss of annual fees from these 155 accredited MECCs would amount to a yearly loss of at least $310,000 for the ACCME.

The Chairman’s Summary notes that "A more detailed account of the proceedings, along with the background papers, will be included in a monograph to be published by the Macy Foundation late in 2008." Rest assured, I will comb the documents for "change agent" and "stakeholder."

*An industry that provides jobs, that helps people pay their mortgages, pay for their health care coverage, etc.

†To the Chairman’s credit, the objectionable terms were not used in the summary, but I’ve seen and heard them aplenty elsewhere.