Successes, Challenges Emerge From Efforts to Shift Away From Industry-Funded CME

A growing number of medical institutions and organizationsare responding to concerns about potential biases in industry-funded continuing medical education (CME) by working to limit industry sponsorship of and influence in this realm. So far, such efforts are proving that industry-free CME is feasible, but not without challenges.

Several medical schools and medical centers are in the process of reducing or phasing out industry funding of CME at their institutions, including the University of Michigan Medical School in Ann Arbor, Memorial Sloan-Kettering Cancer Center in New York City, and East Carolina University Brody School of Medicine in Greenville, NC. In addition to these institutional efforts, the Accreditation Council for Continuing Medical Education (ACCME) has developed more stringent standards to limit commercial influence on accredited CME programs.

The efforts aim to prevent marketing messages from being delivered as part of continuing education for clinicians. But individuals involved with the efforts have faced funding and other challenges, such as determining where to draw the line on industry involvement.

A substantial amount of continuing education for clinicians—$1.5 billion in 2007—is funded by companies that make pharmaceuticals or other medical products. But such investments have raised concerns about potential conflicts of interest because the clinicians targeted by these educational programs are the individuals who will ultimately decide whether to use the products. In fact, the Institute of Medicine issued a report in 2009 calling for the creation of a public-private institute to revamp CME to address problems with the way it is funded, regulated, and conducted.

In the meantime, some institutions have begun developing their own industry-free CME programs. In 2007, for example, Memorial Sloan-Kettering Cancer Center ceased accepting industry funding for CME.

“There is life in CME after you do something like this,” said Robert Wittes, MD, physician-in-chief at Sloan-Kettering's Memorial Hospital during a conference at Georgetown University in June. “But you have to be willing to prioritize the activity, such as putting institutional funds toward the balance [previously covered by commercial funds] and/or charge registration fees for CME activities that involve outside physicians.”

Physicians have been willing to pay the registration fees, Wittes said, and attendance at the programs has not suffered. But, he noted, it is critical for organizations to control or cut costs of CME programs through such measures as hosting them on site or soliciting bids for catering.

“We don't have these things in hotels in mid-Manhattan anymore; we have them on our own premises,” Wittes said.

Wittes, who formerly served as the senior vice president of cancer research at Bristol-Myers for 16 months, explained that the center has not banned all consulting or collaborations between staff and pharmaceutical companies. However, since 2002, Wittes, Memorial Sloan-Kettering Cancer Center president Harold Varmus, MD, and Thomas J. Kelly, MD, PhD, director of the Sloan-Kettering Institute, have chosen to decline any industry consulting to avoid the appearance of conflicts of interest among key decision makers at the center. Wittes said that the center would never completely ban collaborations between faculty and industry because such interactions help to improve commercial science, products, and product testing. But he noted that physicians and institutions that work with pharmaceutical companies must recognize that the companies have commercial interests that may differ from the interests of the physicians or investigators and must take steps to deal with nonoverlapping goals.

“For the public good, it doesn't make sense not to work with companies,” Wittes said.

Other institutions are looking to noncommercial partners for CME. For example, East Carolina University's Brody School of Medicine has partnered with North Carolina's Eastern Area Health Education Center (AHEC), a state- and locally funded program that promotes health quality in the region by attracting and training health care professionals.

“We are working toward eliminating industry support from all of our CME,” said Stephen Willis, MD, executive director of eastern AHEC and also the associate dean for continuing medical education at the Brody School of Medicine, during the conference.

In addition, the program bars individuals with financial ties to companies that may create a conflict of interest from presenting related CME. Willis said this decision was made because the organizations did not have the resources to ensure the objectiveness of presentations by researchers with potential conflicts.

The budget for the joint CME program is about $650 000, according to Willis. Of that total, $5000 comes from industry grants, $17 500 from commercial exhibits, and $94 000 from registration fees. The medical school provides $185 000 and Eastern AHEC provides $164 000 and an additional $93 000 in administrative services for the CME programs. The remaining $85 000 comes from contracts with state agencies and regional hospitals. Between 2008 and 2009, the joint program hosted more than 100 sessions with nearly 25 000 attendees.

Willis explained that it makes sense for the school and center to work together rather than compete but acknowledged that the partnership may be unusual and might not work in every setting.

Officials at the University of Michigan Medical School also recently announced a plan to eliminate commercial funding for CME as of January 2011. James O. Woolliscroft, dean of the medical school and Lyle C. Roll Professor of Medicine, explained that the shift is part of a larger effort at the school to revamp medical education to better meet the needs of clinicians and patients and to take advantage of emerging knowledge and technology.

There is growing recognition that traditional lecture-based CME often doesn't have the desired effects on patient outcomes, explained Woolliscroft. The University of Michigan's leadership has been discussing ways to address this disconnect. He said leadership at the school wanted to ensure that such education is free from bias or the perception of it and that it is balanced and evidence based.

Currently, corporate interests provide about 40% to 45% of the funding for the school's CME programs. To make up for the lost funding, departments at the school will be contributing more funds to CME. In addition, costs will be cut by shifting to less glamorous venues, and attendees will be asked to pay higher registration fees.

Internet-based courses may also play a larger role in the future, Woolliscroft said. For example, such programs would allow physicians to look up information from a course they had taken whenever they encounter a patient with a relevant condition, he said, rather than trying to rely on their memory of the lecture. Additionally, mobile technologies may allow physicians using a cellular phone or mobile device to access course information from virtually anywhere.

“Technology has opened up new venues for providing information to clinicians not constrained by geography or time,” he said.

Murray Kopelow, MD, chief executive at ACCME, said that the organization periodically evaluates and updates its standards as CME evolves. One such revision took place in 2004 when the ACCME adopted new standards for the involvement in CME of pharmaceutical companies and manufacturers of medical device and other medical product makers. Among other things, these standards prohibited commercial interests from directly controlling the content of CME.

The new standards required substantial changes in the way some CME providers were structured and how they managed potential conflicts of interest. To help CME providers better understand the standards, the organization issued a guidance document in 2009 further explaining the rules. Among these was a rule prohibiting employees of commercial interests from presenting CME related to their company's products (http://www.accme.org/index.cfm/fa/faq.detail/category_id/667b72cf-6277-4317-99f9-1e476b621e76.cfm).

The rule prohibiting industry employees from presenting CME recently drew criticism from the American Heart Association (AHA), which argued that the measure barred the organization from permitting industry scientists to present research findings during CME sessions at its annual meeting. Subsequent discussions between the ACCME, AHA, and other providers led the ACCME to clarify its position on such presentations on June 28.

Kopelow explained that both professional societies and the ACCME agreed that industry should share its research results with the profession. The professional societies felt strongly that such data should be presented by the individuals who conducted the research, he said, even if they are company employees, rather than by a “ghost presenter” or stand-in without industry ties who did not produce the data. But when such presentations are allowed, the CME providers have agreed that they should completely control the content to prevent bias.

To clarify its position, the ACCME revised its guidance document. It now notes that accredited organizations may exclude product-related presentations by industry employees during CME courses and may restrict such presentations to non-CME sessions. In addition, if they choose to have an industry employee present, they must institute measures to independently vet the content of such presentations. Such safeguards would include establishing a rigorous peer review of the research and its results and conclusion, changing content on presentations to ensure appropriate balance, and ensuring that the selection of content for presentation is made by individuals free from relevant financial relationships.

The revised guidance notes that some organizations' internal controls already meet these standards. For example, the ACCME has concluded that the AHA internal controls meet these standards, according to a statement from the AHA.

“Thus there will be no variance from past [meetings] and CME will be available for all presentations within the scientific program,” the AHA statement said. “This will ensure the flow of science will remain unfettered as it always has been.”

“Instead of a razor-thin line where if you are [industry] staff, you are out, we had to widen the line,” Kopelow said. “In certain circumstances [employees] can speak—if you completely control the content.”

This article was corrected online for typographical errors on 9/17/2010.