August 2008 VIEW on Medical Education THE FORUM News of Pfizer’s decision to eliminate all direct funding for physician CME programs provided by medical education and communication companies (MECCs) — the first such move by a major pharmaceutical company — has rattled even this most dynamic of sectors. Pfizer’s official statement on the decision, released in July, says the company’s new approach “reflects its goal of meeting the highest standards for medical education,” adding that “academic medical centers, hospitals, associations, and medical societies best meet these standards.” Pfizer’s announcement has been applauded by a number of academic institutions and medical societies. The company’s July statement quotes Dave Davis, M.D., VP, continuing education and improvement at the Association of American Medical Colleges, as saying the decision “represents a significant advance in the profession’s ability to address the complex issue of conflict of interest.” “Pfizer’s new criteria for providing educational grants to CME providers is yet another indicator that the entire healthcare community is committed to assuring the highest quality of independent CME,” Joseph Green, Ph.D., senior VP, professional development and education at the American College of Cardiology, said in the statement. But many CME executives and advocate groups have been less enthused. In a statement on its Website, the Coalition for Healthcare Communication calls the Pfizer decision “an honest but misguided attempt to blunt public criticism of commercial support” of CME, and warns that the move “may reduce the robust innovation” contributed by MECCs. “Unfortunately, this decision supports much of the misinformed criticism of the industry, flies in the face of objective evidence, and does not address the true challenges facing healthcare providers and patients today,” the statement says. (For the full text of the coalition’s statement, please turn to page 10.) John Kamp, Ph.D., executive director of the Coalition for Healthcare Communication (CHC), says the coalition drafted the statement at the request of senior CME executives at other pharmaceutical companies who disagreed with Pfizer’s CME funding shift. “They wanted a summary to help them answer any internal questions as to why it wouldn’t it be a good idea for their companies to follow Pfizer’s lead,” Dr. Kamp says. He adds that although the statement is critical of Pfizer’s CME policy, it isn’t meant as an indictment of Pfizer itself. “We think Pfizer made an honest attempt to resolve a problem, but we think it was misguided and wrong,” he says. “I am not sure that Pfizer’s policies regarding CME are going to eliminate all perception of bias,” says Karen Roy, director of medical education at Cephalon, noting that Pfizer’s decision could have the unintended effect of reducing transparency in tracking medical education funding. “I do believe that third party medical education communications agencies will still be recipients of Pfizer’s support, albeit indirectly,” Ms. Roy says. “Institutions and medical societies are not necessarily equipped to take on some of the educational challenges that a company like Pfizer would put forward, and they would potentially have to partner with some commercially driven companies to do that. think this would potentially make things less transparent. We hear about `follow the money’ in pharma all the time, and I think this move makes the money harder to follow.” Cathryn Clary, M.D.,VP of U.S. external medical affairs at Pfizer, says the misgivings expressed by many in the medical education and communications companies segment of the by Carolyn Gretton The Rules Change AGAIN With Pfizer’s decision to end funding of programs produced by commercial medical education and communications companies, THE CONTINUING MEDICAL EDUCATION FIELD SITS ON THE CUSP OF YET ANOTHER TRANSFORMATION. he one constant in continuing medical education (CME) is change. CME providers and pharmaceutical and medical device companies have worked hard to keep pace with the continual flux of compliance rules and content standards, such as the revised guidelines put in place by the Accreditation Council for Continuing Medical Education (ACCME) earlier this year. VIEW on Medical Education August 2008 THE FORUM CME field about her company’s revised policy are understandable. “I think people have mistaken our decision — and I can understand why they would — as a blanket disavowal of medical education and communications companies; it’s not that at all,” she observes. “We have seen many creative, high quality programs come out of medical education and communications companies. And we’re very hopeful that the medical societies and academic centers that we are going to continue to directly fund will be availing themselves of the resources of the MECC community.” (For more of Dr. Clary’s perspective on Pfizer’s CME decision, please turn to page11.) MUDDYING THE CME WATERS The Association of American Medical Colleges added to the chorus of voices demanding better separation of industry and medical education by issuing a report in June outlining a number of recommendations made by a specially charged task force to maintain appropriate interactions between academic institutions and pharmaceutical and medical device companies. In addition to bans on industry gifts, food, and travel, the AAMC report advises medical schools to “strongly discourage” faculty participation in industry sponsored speakers’ bureaus, which compensate doctors for promoting the benefits of particular pharmaceuticals and medical devices. “Interactions between industry and academic medicine are vital to public health,” says AAMC President and CEO Darrell G. Kirch, M.D. “But they must be principled partner ships effectively managed to sustain public trust in both partners’ commitment to patient welfare and the improvement of health care.” Implementing the AAMC’s recommendations “will help ensure that medical education occurs in settings in which individual and institutional behaviors continuously inculcate and reinforce the highest standards of professionalism,” the report concludes. The AAMC also recommends that industry voluntarily discontinue practices that compromise professionalism and public trust. In July, the Pharmaceutical Research and Manufacturers of America (PhRMA) released a revised set of guidelines on the Code of Interactions with Healthcare Professionals to take effect in January 2009.Among the recommendations was that companies should separate their CME grant making functions from their sales and marketing departments. In addition, companies should take care to ensure the programs they are sup porting are bona fide educational programs. For many critics, any pharma funding of CME programs Karen Roy Cephalon THOUGHT LEADERS # CATHRYN M. CLARY, M.D. VP, U.S. External Medical Affairs, Pfizer Inc., New York; Pfizer is a global pharmaceutical company committed to helping people improve their health by discovering and developing medicines. For more information, visit pfizer.com. # JOHN KAMP, PH.D., J.D. Executive Director, Coalition for Healthcare Communication, New York; the Coalition for Healthcare Communication defends the rights of health professionals and consumers to receive truthful information regarding pharmaceuticals and medical products, and works to assure the free exchange of scientific information without undue government interference. For more information, visit cohealthcom.org. # KAREN ROY, M.SC. Director, Medical Education, Cephalon Inc., Frazer, Pa.; Cephalon is an international biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative products in four core therapeutic areas: central nervous system, pain, oncology, and addiction. For more information, visit cephalon.com. The recent changes in the CME landscape reflect the need for more guidance from the ACCME, the AMA, and others who are committed to medical education to train their constituents and memberships on the differences between promotional and independent medical education. automatically makes them promotional in nature, even though the company has little to no input in the program’s format or content. “I think CME has become a lightning rod for some critics of the pharmaceutical industry, and for most of those critics CME is misunderstood,” Dr. Kamp says.“As with virtually every other controversy, 30second sound bite discussions are being had; a sophisticated understanding and discussion cannot be had in these kinds of exchanges.” According to Ms. Roy, while high profile physician thought leaders are usually clear on the differences between promotion and education, some physicians have trouble distinguishing the two. She describes meeting with a physician who introduced himself as a “speaker for Cephalon” at a CME meeting, when in fact he was speaking at an independent medical education event supported by Cephalon — a seemingly small but vitally important distinction. “I would like to see more efforts by the ACCME, the AMA, and all of the appropriate parties to put more effort into training on good practices around independent medical education,” she says. By the same token, Dr. Clary says there remains a significant gap in the monitoring and auditing of commercially sup ported CME programs that needs to be addressed in a more consistent manner. “We hear from physicians all the time who tell us they can tell instantly in some settings, such as satellite symposia, which commercial supporter is supporting a CME program, either through the identity of the speakers or the content of what’s being said,” she says. “A CME program on the treatment of high cholesterol — whether it’s funded by Merck or Pfizer — should basically have the same content, because the evidence out there is the same. “I do think there needs to be a national and consistent plan to audit and spot check CME programs; this will be critical if commercial support of CME is going to continue,” Dr. Clary adds. A PLACE FOR MECCS Pfizer may no longer fund MECCs directly, but Dr. Clary believes MECCs will continue to play a vital role in the CME sector as a partner to local and regional academic and medical institutions providing CME activities. “Academic institutions and medical societies vary in terms of how much CME expertise they have,” Dr. Clary notes. “It would be natural that they would work in partnership with some of the organizations that have expertise or resources that are needed to fill a particular gap they may have in pro viding high quality educational methodologies.” While not in agreement over Pfizer’s move, Ms. Roy says the company’s announcement could result in an across the board improvement in CME quality. “If all the media attention attracted by the announcement prompts academic institutions and medical societies to raise the standards for the medical education that they provide, then it’s a good thing,” Ms. Roy says. “I am happy to see the comparative data on compliance and standards also being discussed, as this effort will raise the bar, and that’s always good.” Dr. Clary agrees that many of the changes happening in the CME field are driving institutions and medical societies to improve their capabilities as well. “We’ve met with some prominent medical centers that are in the process of retooling their CME departments as a way to achieve the higher quality standards of the new ACCME guidelines,” she says. “In some ways, I think many of the ongoing changes are driving these institutions and medical societies to improve their capabilities as well.” Dr. Clary says from her observations, CME programs developed in partnership between different providers tend to be the most effective, offering Pfizer’s funding of the California Academy of Family Physicians’ Cease Smoking Today program as an example. “This program is made up of a consortium of different types of providers — academic institutions, medical societies, and MECCs — that are working together to create the most innovative program with the highest impact to improve physician performance through a variety of methods to help their patients successfully quit smoking. For example, this initiative will address improving provider smoking cessation counseling skills to improve the success of the patient encounter,” she says. CME GOING FORWARD John Kamp CHC I think CME has become a lightning rod for some critics of the pharmaceutical industry, and for most of those critics CME is misunderstood. As with virtually every other controversy, 30second sound bite discussions are being had; a sophisticated understanding and discussion cannot be had in these kinds of exchanges. “There is an active debate as to whether pharmaceutical companies have a role in supporting continuing medical education, and I think we have a challenge to prove the legitimacy of our support and define an appropriate role for our companies,” she notes. “I think we should all stand up and be counted, be prepared to do the right thing, put policies in place, and be open to having those policies audited or scrutinized to demonstrate that we can be stakeholders in the independent medical education world without compromising the credibility of that education.” Maintaining the integrity of the content is paramount not only to those who support the programs but to those who prepare the programs. According to experts at Innovia Education Institute, a comprehensive needs assessment is the first critical step in planning a CME/CE certified activity, because it becomes the foundation on which every step in the planning process is built. Discussions at recent industry meetings, such as the Alliance for CME’s annual meeting and this spring’s Pharmaceutical Alliance for CME (PACME) Summit touched upon the potential of “global” or “universal” needs assessments for all educational activities in a particular disease state across all supporters. While many important questions on this concept remain to be answered, the universal or broad needs assessment can still be applied at the individual CME provider level. It exemplifies the CME planning process, as educational needs and gaps are gleaned from a larger view and under standing of a clinical area and not developed narrowly in response to a particular grant request or to “fit” a particular activity. (For more information on how to incorporate universal needs assessments into CME planning, please turn to page 18.) Ms. Roy says she hopes that CME’s future includes a higher level of transparency regarding practices and support, a standardized interpretation of CME guidelines across various organizations, and a greater emphasis on CME outcomes research. “I’d like to see all of the stakeholders involved share a common mission to improve patient healthcare through the CME mechanism,” Ms. Roy says. “Greater emphasis should be placed on monitoring and evaluating how our efforts are achieving that. I hope that supporters are more willing to put more money into outcomes studies, because I think we all have to demonstrate the contribution of the CME enterprise to improved healthcare.” Experts at CME2 agree that patient outcomes are an important part of the CME continuum. And while CME providers face many obstacles, by providing focused, credible, and relevant information that physicians can use; fielding appropriate program experts and thought leaders; and pro viding physicians with workable strategies to apply the information, they can ultimately influence a physician’s behavior in line with his or her self assessment and improve patient care and outcomes.(For more information about delivering evidence based CME, please turn to page 16.) Dr. Clary says the community as a whole is working to crack the nut of how to provide high quality performance improvement CME. The goal is to ensure that it’s not just a one and done lecture, where a doctor hears the program Insights From the Insiders PHARMAVOICE ASKED EXPERTS IN THE CME ARENA TO IDENTIFY THE BIGGEST CHALLENGE THEY ARE CURRENTLY FACING. Addressing the Critics The biggest challenge we face is demonstrating to the critics of our industry the incredible work that is being done to improve patient care. As an ACCME, CBRN, and ACPE accredited organization, we take great pr de in developing educational activities that are compliant and that improve knowledge, competency, and performance in ways that are both innovative and based on proven adult learning principles that address the difference learning styles of physicians resulting in an enhanced and engaging learning experience. We witness the changes in immediate learning, and its retention and application in practice. At the same time, we have to deploy precious resources to defend our efforts — resources that would be better used toward program development and execution. Scott Weber CoCEO Med-IQ MedIQ For more information, please turn to page 14. Under the CME scope CME providers face many obstacles: increased scrutiny by ACCME, increased scrutiny by the commercial supporters, and increased scrutiny by the general public. But by pro viding focused, credible, and relevant information that physicians can use; fielding appropriate program experts and thought leaders; and providing physicians with workable strategies to apply the information, CME providers can ultimately influence physician behavior and improve patient outcomes. Cathy Pagano Executive Director CME2 For more information, please turn to page 16. THE FORUM STATEMENT OF THE COALITION FOR HEALTHCARE COMMUNICATION ON THE VALUE OF INDEPENDENT COMMERCIAL PROVIDERS OF CME and the creation of innovative long term educational programs specifically designed to meet those needs. 3. A heightened focus on fostering measurement of clinical outcomes derived from educational activities. 4. The development of Web based learning platforms and programs designed to address the immediate needs and time constraints facing clinicians. Indeed, as a result of the recent focus on the management of conflict of interest, commercial providers are uniquely qualified, staffed, committed, and funded to create and implement compliance and reporting functions demanded by policymakers and the public. Because conflict of interest compliance has largely focused on commercial support from the private sector, commercial providers have aggressively addressed this issue and currently lead the industry in compliance. By contrast, other accredited providers, including medical schools, hospitals, and professional societies are often less equipped to effectively deal with transparency and other compliance issues. Shifting the burden of regulatory compliance to institutions that often lack the necessary resources such as staffing, adequate funding, and mature compliance management systems will not accomplish the desired results. Instead, the likely outcome will be fewer high quality CME activities, which will negatively impact patient care. Moreover, it should be noted that Pfizer’s preferred group of CME providers are also among their most important direct customers. For example, these groups employ prescribers and over see many of the formulary decision makers that are critical to the financial health of the pharmaceutical industry. Thus, Pfizer’s decision — made in the absence of any objective scientific evidence — may generate more controversy around conflict of interest, increase oversight by federal and state regulators and lead to further calls for additional restrictive legislation. In summary, we stand proud of the record of accredited medical education companies and continue to believe that patients are best served when all provider types — including private sector providers — are allowed to fully participate in the enterprise and are subject to the same oversight by government and regulatory bodies. Moreover, these providers have led the way in meeting or exceeding the standards of support set by these regulatory bodies. We respectfully disagree with Pfizer’s decision and urge other grantors to work with the Coalition to develop better long term solutions aimed at maintaining public confidence in industry supported education with tactics that truly resolve these issues. Sincerely, Brad Bednarz, Marty Cearnal, Mark Schaffer CoChairmen, CME Committee Coalition for Healthcare Communication W HILEA STRONG SUPPORTER OF SELFREGULATION IN THE CME ENTERPRISE, the Coalition for Healthcare Communication believes that Pfizer’s recent decision to eliminate direct funding of CME through “independent commercial providers” is an honest but misguided attempt to blunt public criticism of commercial support. Unfortunately, this decision supports much of the misinformed criticism of the industry, flies in the face of objective evidence, and does not address the true challenges facing healthcare providers and patients today. In the midst of recent public criticism of industry supported CME, accredited medical education companies have an unequaled record of compliance with conflict of interest rules and provide much of the best CME available today to the nation’s physicians and other healthcare providers. Indeed, the Coalition believes accredited medical education companies should continue to receive strong support from the industry and the public given their leadership in improving patient care with CME through innovation, excellence, and entrepreneurship. ACCME’s 2006 Accreditation and Compliance Report documents that commercial providers achieved the highest ratings of compliance (94.8%) of any group surveyed for all elements relating to the ACCME’s Standards for Commercial Support (i.e. 3.3A 3.3D). These data clearly demonstrate that accredited medical education companies lead all other accredited providers in the top two categories: Compliance and Exemplary Compliance, for standards of commercial support — calling into question Pfizer’s logic for excluding them. Furthermore, ACCME’s recently commissioned report, The Relationship between Commercial Support and Bias In Continuing Education Activities: A Review of the Literature, failed to find “any objective evidence or studies documenting that commercially supported CME activities are biased. ”The report recommends that further “rigorous scientific studies” be conducted before conclusions are drawn. It also recommended answering the question: does commercially sponsored CME lead to better patient care? Addressing these questions with needed research offers significant opportunities to advance patient care. Favoring one group of providers over another in an effort to mitigate the risk of bias does not. Instead, the Coalition and many others believe that patient care is best served when accredited medical education companies are allowed to compete in the education marketplace because their entrepreneurship spurs innovation and competition for excellence in education as well as regulatory compliance. Many further believe that patient care is best served by quality education from multiple qualified and regulated providers. Meanwhile, there is broad agreement that conflicts of interest are best managed by full disclosure, robust reporting, and transparency. In addition, leading providers have incorporated three important additional components designed to manage conflicts of interest: reassignments, peer review. Unfortunately, Pfizer’s decision to redirect its education grants may reduce the robust innovation commercial CME providers bring to medical education. Historically, independent commercial providers have been the first to introduce new techniques and educational formats to the medical community. They have demonstrated willingness to take financial and other risks needed to move beyond the boundaries of traditional education in at least four key areas: 1. Development of interactive and multimedia techniques that actively involve the learners in programs and outcomes. 2. The undertaking of comprehensive clinical needs assessments Source: Coalition for Healthcare Communication, New York. For more information, visit cohealthcom.org. Schools Associations Nonprofit Publishing/Education Hospitals Government Insurance Not classified 94.8% 89.3% 90.8% 89.5% 92.3% 83.6% 87.8% 91.3% COMMERCIAL CME PROVIDERS RANKED BY COMPLIANCE and maybe picks up a pearl or two, but there’s really no consistent follow up. “It’s not clear whether this approach actually translates into a change in a physician’s behavior as he or she treats his or her patients,” she says. “Ultimately, the best programs are going to be ones where there is direct measurement of patient outcomes based on that CME.” Another development Dr. Clary expects to see in the near future is point of care CME. “For example, if a doctor is in his or her office and doesn’t know how to diagnose a patient or has a question, he or she can go online, do some research, read about the condition, get some quick answers, and go back to the patient; at the same time potentially pick up CME micro credits,” she explains. “That’s point of care CME. It’s completely relevant to the doctor’s practice.” According to thought leaders at MedIQ, one way to make CME relevant to a physician’s practice is to develop a blended educational strategy of knowledge based and patient case based material that maximizes the participant experience and offers multimedia formats to meet the varying learning needs of healthcare professionals. They believe that it is also important to employ an outcomes assessment tool that quantitatively and qualitatively measures the effect of CME activities, from immediate knowledge gain to applied behavior change to patient outcomes. (For more information about blended learning techniques and the value of CME, please turn to page 14.) In Dr. Clary’s view, the future likely also will include multi source funding of CME programs. “We really would prefer to fund programs that are being supported by more than one commercial entity, and I think that will help the providers as well,” she says. Dr. Kamp says while he expects a near term pullback in pharma funding of MECC generated CME, he believes it will be short lived. “In the long term, clinicians are going to continue to want to attend compelling CME programs, and some of the most compelling CME out there is for new drugs and new uses of old drugs,” he says. “CME is one of the places under our strange and complicated regulatory scheme where there can be a free exchange of ideas among researchers and clinical doctors and others about off label uses. It’s one of the best possible places to have that conversation, and companies are going to want to continue to support it for that reason.” PHARMALINX LLC, publisher of the VIEW, welcomes comments about this article. Email us at [email protected]. PFIZER’S VISION FOR CME “On the third point, we noticed that when most of the big pharmaceutical companies began to do online grant applications, everything became centralized. This disrupted a whole web of relationships that occurred at the local and regional levels. We heard from many regional and state medical societies and hospitals that they weren’t getting nearly as much funding. We know that since most care is local, education needs to be local. So another one of our goals is to ensure that we are continuing to fund high quality local and regional education.” Dr. Clary says the decision that was made in July on CME funding was a natural outgrowth of ensuring that the entities that are making the decisions about CME content were the ones that had patient care at the heart of their missions. “We believe that academic institutions and medical societies are better able to provide content,” she says. “There are some pretty powerful forces stating that pharma companies should exclude commercial support altogether. And if this is eventually what the community decides to do, we’ll accept that. But we wanted to try to find a different way; a way that mitigates the perception of conflict of interest as much as possible in a way that is responsible and that promotes patient care. We wanted to take a leadership role in this area.” D R. Cathryn Clary, Pfizer’s VP of U.S. External Medical Affairs, talks about the process leading up to Pfizer’s decision to stop funding CME produced by medical education and communications companies (MECCs): “[Pfizer’s decision] is actually very much in the context of over all changes we’ve been making in how we support CME over the past two years,” she says. “Looking back to when our medical affairs group began, we took over the organization that supported the CME grant process, and we’ve been in the process of bringing in staff who have med education and CME expertise. That was the first part. Next, we developed the online grant application process, we brought in the staff, and we looked at all of our policies and procedures and where we wanted to take this process.” Dr. Clary identifies the three goals that Pfizer has worked toward over the last two years. “First, we want to ensure that we’re funding providers that meet the highest standards of compliance and independence,” she says. “The second goal is to move toward performance improvement education with demonstrable outcomes in physician behavior and patient care. That’s easier said than done; this is an issue that the CME community is struggling with. We wanted to be a leader in directing our support to these types of grants. A CME program on the treatment of high cholesterol — whether it’s funded by Merck or Pfizer — should basically have the same content, because the evidence out there is the same. — Dr. Cathryn Clary, Pfizer
t, we developed the online grant application process, we brought in the staff, and we looked at all of our policies and procedures and where we wanted to take this process.” Dr. Clary identifies the three goals that Pfizer has worked toward over the last two years. “First, we want to ensure that we’re funding providers that meet the highest standards of compliance and independence,” she says. “The second goal is to move toward performance improvement education with demonstrable outcomes in physician behavior and patient care. That’s easier said than done; this is an issue that the CME community is struggling with. We wanted to be a leader in directing our support to these types of grants. A CME program on the treatment of high cholesterol — whether it’s funded by Merck or Pfizer — should basically have the same content, because the evidence out there is the same. — Dr. Cathryn Clary, Pfizer
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The Rules Change Again
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