PHARMA-SUPPORTED CME is in an increasingly precarious position — subject to government investigation under new regulations and under attack in the media for being marketing disguised as education. To foster debate and help generate solutions, MM published a proposal put forth by CME veteran Lewis A. Miller in the December 2003 issue, calling for your responses. Here is Miller's idea, followed by your colleagues' opinions.
The Office of Inspector General is looking for intent to defraud the Medicare and Medicaid programs in every act that might inappropriately influence prescribing, including payment to [CME] speakers, program content, and spending on attendees. And, as pointed out at [many CME conferences], pharma tends to support product-related programs and ignore CME proposals in areas that may benefit care but aren't related to major drug categories.
How can the industry change its image among the regulators, the public, and physicians under these negative pressures? Form a CME foundation supported by pharma, which would be controlled by an independent board, responding to grant proposals from accredited providers, regardless of product category. The rules for grant-making would be related to demonstrated need, a program designed to meet those needs, and an evaluation plan related to some measure of outcome — behavior change, performance, or patient health.
The industry could start by setting aside 15 percent of the roughly $720 million it spends on accredited CME (each company applying that percentage to its spending). This would provide an initial pool of $100 million of nondirected pharma support for accredited CME, to be renewed at a level of 10 percent of such spending for the following four years. This would be a voluntary and tax-deductible contribution on the part of each company, whose names would be prominently associated with the foundation as members of an advisory donor panel. The board would be instructed to distribute at least 75 percent of the assets annually, and to report to pharma, ACCME, and the CME community at large on the results of its activities.
Such a move would gain tremendous positive support for the industry, would benefit physicians and their patients, and could reduce the scrutiny by federal agencies — especially related to activities conducted by the foundation.
Lewis A. Miller is corporate editorial director, Dowden Health Media; chairman of Intermedica Inc.; and founder and director of the Global Alliance for Medical Education.
I like Miller's proposal very much. It removes the onus from pharma, which we know clearly exists and must change; it provides the much-needed financial boost to increasingly diminished med ed [internal] funding; it potentially offers a means of distributing donor funds in an even-handed fashion. My only concern is that the “independent board” not become a weighty bureaucracy, siphoning off undue portions of the grant monies. On the other hand, the quiet but potent MECCs will (justifiably, I opine) lose their function to a more open, transparent mode.
Byron D. Roseman, MD
Director of Medical Education
Lowell General Hospital
Lowell, Mass.
My comment regarding Miller's proposal concerns appointment of the “independent board.” I fear that the small CME provider will be overlooked in disbursement of funds, in favor of large university medical schools and communications companies. I'm not opposed to the proposition with appropriate safeguards to ensure equitable distribution and, if possible, a board composed of individuals without bias toward any one category of accredited CME providers. A mechanism for electronic submission of requests similar to that used by Merck would be helpful.
Winnie E. Brown, MPA
Director, Continuing & Graduate
Medical Education
Truman Medical Centers
Kansas City, Mo.
I find it interesting that someone who has been so closely associated with the evolution of Accreditation Council for CME guidelines through the past 10 years would think that we need more regulation in the form of a foundation. This endeavor would lead to unnecessary work. The standards and guidelines that all CME-accredited sponsors abide by have changed and improved and are more than sufficient to safeguard that grants are used to improve the health of patients in the community. Many small independent CME providers, such as CME of Acadiana, have the freedom to decide what continuing medical education topics are needed in our communities, and a national foundation would jeopardize that.
A much more beneficial and less expensive approach would be to improve communication and training for CME providers and industry representatives.
This view is solely mine as a CME coordinator and does not represent the opinions of the organization of CME of Acadiana or its board of directors. See, I know how to disclose.
Lisa Hidalgo
Director of CME
Continuing Medical Education
Committee of Acadiana
Lafayette, La.
Mr. Miller's proposal for a pharma-supported CME foundation is well-intentioned. However, by focusing on pharmaceutical companies, the proposal diverts attention from a more fundamental issue: Physicians and medicine as a profession are not fulfilling their obligation to assure an adequate, unbiased system of CME.
As noted in the American Medical Association's education modules on gifts to physicians, industry is only responsible for informing physicians about the availability and appropriate use of products. The profession of medicine is responsible for assuring that funding and arrangements are in place for an adequate, unbiased system of CME that serves the best interests of patients and the entire population. Ongoing concerns about inappropriate influence of commercial companies on CME represent a failure of medicine to provide sufficient guidance and control over individual CME activities and the overall national curriculum of CME offerings, as I noted in my article “The Uncertain Future of Continuing Medical Education: Commercialism and Shifts in Funding,” Journal of Continuing Education in the Health Professions, Volume 23, No. 4.
With 58 percent of funding for national CME providers coming from commercial sources, concerns are increasing about both intended and unintended commercial distortions of the professional CME system. The availability of huge amounts of commercial funding is resulting in CME providers, presenters, and participants shifting their focus to commercially related CME topics. Within the CME system, norms of professionalism are giving way to norms of commercialism. Solutions to ongoing concerns about inappropriate commercial influence should focus initially on reforms within and by the medical profession.
R. Van Harrison, PhD
Professor of Medical Education
Director of Continuing Medical Education
University of Michigan Medical School
Ann Arbor, Mich.
The concept of a “CME foundation supported by pharma” ignores the existing responsibility of accredited CME sponsors, as well as the ability of industry and providers to self-regulate their ethical collaborative relationship. In my opinion, such a foundation would be just another example of overreaction to the 2003 OIG [pharma marketing] guidance.
OIG's looking at “every act that might inappropriately influence prescribing” has actually had a positive influence on the CME enterprise, because it has forced industry to look seriously at appearances — especially payment to speakers and spending on attendees. It is appropriate that industry provide funding to “support product-related programs and ignore CME proposals in areas that may benefit care but aren't related to major drug categories.” With public pressure to eliminate prescription errors, yet reduce overall drug costs, pharmaceutical companies cannot justify funding CME outside of their vested areas of therapeutic interest, where they are ethically obligated to ensure that physicians learn to prescribe the companies' products correctly. Company stockholders agree.
But, Miller rightfully identifies a key outage for pharma: changing “its image (in CME) to the regulators, the public and physicians.” To wit, take the funding allocation proposed for an unnecessary foundation and apply it to a public relations campaign. It's unfortunate that the current image of pharma's role in CME differs with each stakeholder.
A “CME foundation supported by pharma, which would be controlled by an independent board”? I thought that was the responsibility of the accredited sponsors of CME: to function independently from commercial bias, yet seek funding and other assistance from multiple sources, including industry, as allowed by the ACCME Standards for Commercial Support.
If only ACCME would devote as much attention to deviations from the existing Standards for Commercial Support as it does to the multiple levels of compliance in the complicated system of accreditation launched in 2000. If only all PhRMA [Pharmaceutical Research and Manufacturers of America] member companies voluntarily complied with the 2002 Code on Interactions with Healthcare Professionals. And, if only physicians would follow the Code of Ethics written years ago by the American Medical Association and similarly by the American Osteopathic Association.… Then, the funding saved not creating a CME foundation could be used to inform the public that the pharmaceutical industry is providing support to ensure that their physicians will continue to learn lifelong.
My last concern over Miller's suggested CME foundation is that it might inadvertently stratify commercially supported CME, by inferring that only those activities vetted by the foundation would be truly independent of industry control. Then, those CME activities independently supported by a pharmaceutical company would be viewed by physicians as second-rate. To think so would denigrate most accredited CME providers.
Frederic Wilson
Manager of CME
Procter & Gamble Pharmaceuticals
Mason, Ohio
Members of the North American Association of Medical Education and Communication Cos. have heard similar ideas recently from different venues — perhaps the independent foundation concept is a trend in the making. These proposals are particularly intriguing because the foundations they discuss could potentially ensure funding for non-product-specific activities, such as educational programs to teach communication skills and informatics, thereby obviating one of the major criticisms of commercially supported CME.
The NAAMECC Board of Directors believes that if this proposal is to be seriously considered, a number of issues must first be resolved to help ensure its success. Issues to be considered include:
How will the grants be awarded?
Will there be any limits on how the grants can be used?
Will there be a limit to the number of or dollar amount of grants per organization?
Who will be eligible for grants from the foundation? Should grants be awarded based on merit rather than on the type of organization that submits a proposal? Will the grants be awarded to both accredited providers and nonaccredited organizations that work with accredited providers? Would each type of CME provider (i.e., academia, hospitals, professional associations, education/communication companies, etc.) be offered equal access to funds?
Who would sit on the independent board, and how would the board members be “elected”? Would individuals rotate on and off the board? Would the group be representative of all types of CME stakeholders? Would supporters of the foundation have representation on the board?
Should individuals having a financial interest in any organization seeking a grant be excluded from serving on the board? Should the board members recuse themselves from voting on any proposals in which they have a financial interest? What constitutes a conflict of interest for a board member?
Should there be grant “pools” focused on therapeutic areas or only one general overall pool? Would commercial supporters of the foundation be expected to offer blanket corporate support or could they offer support for specific therapeutic areas?
Who would seek the funding for the foundation? Would potential supporters perceive this foundation to be of value to them? Should the foundation seek grant funding not only from biopharmaceutical and device manufacturers but also from other organizations such as specialty societies, governmental agencies, etc.?
Should grantees provide reports to the foundation and its supporters to demonstrate that the funds were used as proposed and show the outcomes of the activities?
We encourage and look forward to hearing responses from all stakeholders to the issues we have brought forth.
NAAMECC Board of Directors:
Karen M. Overstreet, EdD, RPh (President);
Eric D. Peterson (President-Elect);
Mark H. Schaffer, EdM (Secretary);
Richard F. Tischler, Jr, PhD (Treasurer);
Jacqueline N. Parochka, EdD (Past President);
Kurt J. Boyce; Deborah Correnti, RN;
James T. Magrann; Rick Rodes;
Jane Ruppenkamp
What strategies do you suggest for ensuring independent CME and creating a more positive public image? Do you have solutions for the questions NAAMECC raises? MM will continue this forum in future issues. Please contact MM> Editor Tamar Hosansky at (978) 466-6358 or thosansky@primediabusiness.com.