Changing Tides
by Ingrid Schaefer Sprague
October 2007
Pharmaceutical companies and academic institutions are looking for ways to offer continuing medical education programs free from conflicts of interest.
Continuing medical education (CME) is big business. In 2005 alone, the pharmaceutical industry spent US$1.12 billion to fund CME, with the majority of funds slated to go to more than 700 accredited CME providers. In response to the ever-increasing public scrutiny regarding pharmaceutical industry-sponsored activities, many academic medical centers and professional associations are drafting codes and guidelines to ensure that their CME programs are free from any perceived conflicts of interest. Coupled with an April 2007 report by the U.S. Senate Committee on Finance that investigated the practices of the Accreditation Council for Continuing Medical Education (ACCME), many of these guidelines are signaling a sweeping change in how CME is conducted.
The U.S. Senate report is not the first time that the CME providers’ relationship with industry has been scrutinized. In 2003, more than US$6 billion in government fines—which were partly the result of the U.S. Office of Inspector General’s (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers — were paid by those in the biopharmaceutical industry who blurred the line between marketing and education. Indeed, finding the line between education and marketing often is challenging, particularly for academic medical centers whose continuing education budgets are supported in part by pharmaceutical industry grants.
Centralized Funding
At the University of California at San Francisco School of Medicine, industry supports one-quarter to one-third of the overall CME budget, says Dr. Robert B. Baron, professor of medicine and associate dean for graduate medical education and continuing medical education at UCSF, in San Francisco, Calif., USA. “If we did not have that support, we would have to raise the fees to learners by about a third,” he says. “Although it’s not the end of the world, there would be certain topics we would no longer be able to teach, such as highly specialized topics relevant to small groups of physicians.”
Although industry grants provide for a significant portion of UCSF’s CME activities, Baron says that a “strong firewall” exists between industry and the school’s CME department. In addition to the structure provided by the ACCME, UCSF has created its own guidelines to regulate CME funding. Some of these guidelines include not sponsoring “free” CME or activities funded by a single industry grantor through central mechanisms (instead of individual industry representatives); conducting a careful needs assessment for each educational program; and requiring speakers to use only peer-reviewed, evidence-based information in presentations and asking learners to assess evidence of commercial bias in each and every presentation. Nonetheless, “loopholes that allow seepage between marketing and education do exist,” Baron says. “Even though our learners report that our activities are 96 percent ‘free of bias’ that does mean a small percent of information may have evidence of commercial bias despite our protective systems.”
UCSF is part of a consortium that represents the University of California medical schools with regard to continuing medical education activities. The consortium brings together representatives from all five medical schools in the University of California system to discuss CME policy. Each school has a slightly different approach to programming and regulation, says Pam Stotlar-McAuliffe, manager of the office of continuing medical education at the University of California at Davis, in Sacramento, Calif., USA. According to Stotlar-McAuliffe, UC Davis does not accept sole company support for CME activities, and all funding comes from unrestricted grants that currently support about one-fifth of the school’s program budget. “I think there is a move away from industry-supported CME activities as a trend,” she says, “and I think regulatory issues have caused this.”
David O. Matson, Ph.D., professor of health professions and pediatrics and director of the graduate program in public health at Eastern Virginia Medical School and Old Dominion University, in Norfolk, Va., USA, says there has been a shift away from industry-supported CME activities at his institution. “CME funding does continue to occur, but through indirect mechanisms. For grants, there are now a number of hoops that have to be jumped through before a presentation which is functionally equivalent to a tax on education,” Matson says. “Big pharma is an easy target for some people, just like big oil. But when you look at new discoveries and who applies at-risk capital to research, there are no substitutes.”
At the University of Michigan School of Medicine, industry provides less funding to CME activities as compared with six or seven years ago, says R. Van Harrison, Ph.D., professor of medical education and director of continuing medical education at the University of Michigan, Ann Arbor, Mich., USA. Harrison says the OIG guidance “appreciably altered” the way funding is provided. Most major pharmaceutical companies now provide funds through a centralized source in the company’s education or regulatory unit instead of from the marketing unit. Although Harrison acknowledges the benefits of this transition, he also points out the problems with this structure. “The cost of organizational transition and operations may have somewhat reduced remaining funds available for distribution to support CME activities,” he says.
On the Level
Pharmaceutical companies also are responding to new compliance guidelines and greater public scrutiny. According to the Senate report, most pharmaceutical companies have established, or are working to establish, a centralized grant process with designated review. For the purpose of that report, 23 companies provided information on their grant funding, and most had written policies and procedures for grants. Since the report, Eli Lilly and Company announced it was the first to post all information about its grants on a public Web site, and other companies are taking similar steps to ensure transparency regarding their CME activities.
In compliance with guidance from the OIG, AstraZeneca has established a medical education grants office, says Pamela Mason, director of medical education grants at AstraZeneca, in Wilmington, Del., USA. To give a sense of the demand for industry funding, Mason says “in 2006, we received more than 4,500 educational grant applications and we funded approximately 40 percent of them.”
Although Schering-Plough does look at whether the proposed CME activity is relevant to any therapeutic area in which the company has an interest, Vemer says that they evaluate a scientific program to assure that it is adding knowledge to the field and really helping patients. “We are asking to provide insight about the program before we sponsor,” he says. “We don’t tell the organizers or the speakers at a CME event ‘we want you to talk about this,’ and [we are] definitely not telling them to discuss a particular drug.” Vemer says that Schering-Plough doesn’t do a lot of online courses or dinner entertainment. In organizing conferences, however, sometimes the company will provide a modest meal or give money to a CME provider to fly in a desired speaker of their choosing, he says. “The majority of our money, though, is going to CME activities outside of the conferences at the university, association, or smaller hospital level,” he says. With regard to professional associations, governing and regulating industry funding is no small matter, and almost all professional associations have their own guidelines in place.
Undue Influence
Clearly, most, if not all, medical associations have been in compliance with the guidelines set forth by the ACCME and other organizations, as well as with the Code on Interactions with Health Care Providers established by the Pharmaceutical Research and Manufacturers of America. Many association Web sites post rules governing product promotion, grants, gifts, publications and CME activities, including the American Medical Association, American Society of Anesthesiologists, American College of Obstetricians and Gynecologists and the American College of Cardiology. In association documentation of meeting materials for speakers, there are rules and requests for financial disclosure information, the use of generic drug names, and statements regarding off-label use in association registration materials.
The OIG guidelines apply more to the pharmaceutical companies and how they advertise their medications, than to the medical associations, says Dr. Deborah J. Hales, director of the division of education and career development for the American Psychiatric Association (APA) in Arlington, Va., USA. Hales says that the APA has a six-year accreditation from ACCME with commendation—the highest rating—and that the association also has its own set of guidelines in addition to those from the ACCME. During the Annual Meeting, the APA audio-tapes sessions for evaluation of bias. Scientific program committee members randomly attend sessions to listen for undue advertising influence, Hales says. Speakers and presentations not in compliance are reported to the APA’s committee for commercial support. “Then they listen to the transcript and look at slides to decide whether to sanction the presenter,” she adds.
Despite public perception surrounding the issue of separating marketing and educational objectives in CME, Hales does not believe there has been a shift away from industry-sponsored support by the APA. Nevertheless, the percentage of CME activity by the APA that is supported by industry is relatively small at approximately three to four percent of our annual meeting sessions, she says.
Clear Distinctions
Although marketing and medical education can coexist, they need to be clearly distinguished from one another, says Dr. Alastair J.J. Wood, managing director of Symphony Capital and professor of medicine and pharmacology at Weill Cornell Medical College, both located in New York, N.Y., USA. “The question is: ‘What are a physician’s options for drug information that does not come directly from industry?’” Wood gives several examples of CME opportunities that are independent of pharmaceutical company support, including review articles in major medical journals such as the New England Journal of Medicine (NEJM) and written courses from the American College of Physicians and other professional societies. “Physicians ought to be getting their information from unbiased sources, like NEJM or whatever it is,” Wood says. “People want to say that advertising and CME are the same, but they’re not. We have a problem if we’ve reached a point that we [as doctors] are only educated by advertising.”
Wood is not alone in his desire to separate medical education from pharmaceutical marketing. A recent opinion on the “assorted activities that essentially amount to marketing under other rubrics, such as continuing medical education” is noted in a column by William B. Millard, Ph.D. in the June 2007 issue of Annals of Emergency Medicine. In a similar vein, the U.S. Senate report from April 2007 states that “it seems unlikely that this sophisticated industry would spend such large sums on an enterprise but for the expectation that the expenditures would be recouped by increased sales.”
What the Future Holds
Harrison says companies with the best new products will continue to support CME activities that address conditions relevant to the company’s products. “This relationship will continue until something fundamentally structural in our health system changes,” he says.
The format of future CME activities also is being modified, Stotlar-McAuliffe says. She suggests point-of-care learning and online activities as some alternatives to the traditional live conference.
Matson embraces a change in strategies for CME. “The fact is that I’m obliged to attain CME,” he says. “If I’m not mandated by regulation or law to obtain CME to practice, the entire [CME] industry would collapse. I know that family physicians have received accreditation by conducting chart reviews. Maybe that’s a smarter way to retain a medical license rather than what lecture I go to.”
Hales also supports this idea of improved CME activity. “The future may in fact be in the technology that allows physicians to review their practice patterns, rather than to participate in current CME activities,” Hales says. “The real goal of CME is not the number of hours a doctor sits in a lecture hall, but providing excellent modern patient care. The goal is to assure the public that physicians will meet practice guidelines; the proof is in the pudding or the practice.”
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