CME has a public image problem. So said 84 percent of the attendees polled via audience-response system at an opening panel discussion at this year's Annual Conference of the National Task Force on CME Provider/Industry Collaboration, held October 24 to 26 in Baltimore. When asked why the public is concerned about CME, 35 percent said it was because CME is tied to perks for docs, and 35 percent said it was because of negative media coverage, while just 9 percent said it was because CME adds to the cost of medicine. Twenty-one percent said there is no public concern about CME. The question of how the CME community should respond to its public image problem fueled contentious debate from the meeting's start.
“The challenge for you is to convince people like me that there really is a free lunch. Explain to me why CME/industry collaboration is helpful to patients,” said Gardiner Harris, science correspondent with The New York Times, during the opening panel. Both the panelists and the audience of 650 CME providers and pharmaceutical company representatives were eager to take on his challenge.
Attendees spent much of the meeting looking for ways to repair the reputation of CME/industry collaboration, defending the integrity of CME/pharma relationships, and exploring other possible options for funding CME. On the last point, however, while the discussion was fiery at times, most seemed to agree with keynote speaker, former Accreditation Council for CME public representative, and 35-year CME veteran Rosalind Whitehead's summation: “Get real. Without commercial support, there is no CME.”
Ties That Bind
“Why are there so many critics of CME?” asked Dennis Wentz, a principal in WentzMiller & Associates, LLC, Darien, Conn., and formerly the American Medical Association's director of continuing physician professional development, when introducing the opening panel, whose members discussed whether industry/provider collaboration is a problem or a solution. Charles Sanders, former CEO of Glaxo-SmithKline, recalled that 18 years ago, Merck was the most admired company in the U.S. — not just among pharma companies, but among all of corporate America. The slide in pharma's reputation over the past two decades has been spurred by several factors: the improprieties noted in the press — such as the recent Serono case, which included accusations that the company sent physicians who prescribed its drugs to a meeting in the south of France; companies pulling drugs off the market due to safety problems; and the increasing costs of prescription drugs. “The Pharmaceutical Research and Manufacturers of America tries to advertise the importance of research but is undermined by the direct-to-consumer ads that emphasize lifestyle drugs, which do nothing to improve health,” he said.
“Pharma is sinking fast in public opinion, and they're taking you with them if you have ties [to industry],” said Harris, adding that some pharma companies are investing in CME that encourages physicians to use drugs for non-FDA — approved uses.
But Sanders defended CME that includes discussion of off label/unapproved uses, saying, “To provide information on off-label usage raises antennae, no doubt about it. But there are many research studies that should be disseminated prior to FDA approval. CME, properly carried out, provides information that is essential to the prescribing public. ‘Properly carried out’ is, of course, the key phrase.”
Harris didn't seem convinced, but after an audience member asked if it would be better to change the process so that a public organization such as the National Institutes of Health would peer-review grant proposals as a quality check before releasing funds for a specific activity, the reporter had a change of heart. “If you would have a national foundation, [funded by pharma], and the foundation then would fund activities with no control over speakers, that'd be great,” he said.
Panelist Herbert Pardes, MD, president and CEO of New York Presbyterian Hospital, agreed that “it is to everyone's advantage to have industry involved in CME, since many of the advances come from industry.” He added that things have changed in the years since he had to withdraw as course director for a series of symposia because there were too many strings attached by the funding company. “The rules and regulations help enforce the role of a course director, and [help ensure that] industry can support CME appropriately.” He also called for pharma to increase its support of research into CME's effectiveness in changing physician behavior and improving patient care, a point seconded by an audience member, who said he would call for more federal government — funded research on gaps in public health as well.
Marcia Jackson, PhD, senior advisor, education, with the American College of Cardiology in Bethesda, Md., took a different tack: “We need to look to alternative funding sources,” she said, quickly discounting a federal government role in CME funding as “not likely, given [the government's] current situation.” Asking physicians to pay for their own education, another oft-discussed option, “would take a large reorientation effort,” she said. “The ultimate downside would be if doctors didn't get as much CME as they needed. The number of CME providers also would go down, and only those who provide good value would be left.”
Arnold Relman, MD, professor emeritus of medicine and social medicine with Harvard Medical School and emeritus editor-in-chief, New England Journal of Medicine, Boston, piped up from the audience with a comment that would become his recurring theme over the conference, up to and including a final shoot-out with Murray Kopelow, MD, chief executive of the Accreditation Council for CME, Chicago, at the conference's end. If it's appropriate for the profession to find resources to educate medical students, residents, and fellows (all of which costs more than CME), he said, why doesn't the profession have the responsibility to educate physicians in practice?
Whitehead countered that there are 650,000 practicing physicians, a much larger number than there are undergraduates or residents, and it wouldn't be practical or possible to pay for CME for all of them without commercial support from industry.
MECCs Under Fire
It wasn't just the pharma industry that came under fire at the meeting: Medical education and communication companies took a fair amount of heat as well. At the opening panel discussion, Relman lit the first of his many matches when he said, “TheStandards are an improvement over the previous version, but they still need improvement. They say that the content, etc., ought to be [controlled independently of] commercial interests. The problem is that a lot of these programs are done by medical education and communication companies that rely solely on industry for their income. It seems to me that you have to have guidelines for them as well as pharma.”
Jackson, who sits on the board of a MECC in addition to working with a specialty society, said that many of theand committee members the American College of Cardiology uses for its activities are the same people the MECC uses. “I think medical education companies are actually more actively involved in monitoring the process,” she added.
But an audience member echoed Relman's point when she said, “There's always a relationship with commercial supporters when it comes to third parties. This always gives me doubt since they get most of their money from industry.” Derek Dietze, executive director of CME with Veritas Institute for Medical Education Inc., Queen Creek, Ariz., replied, “The question pre-supposes that medical education companies are different in their relationship with commercial supporters [than are other types of educators]. There is a body of commercial support available to us, but other types of providers have the same thing. Two years ago, commercial supporters weren't interested in funding outcomes measurement. Now they are more willing to support it, and they understand that it's not about tracking prescriptions.”
This discussion was sparked by Dietze's presentation during a panel discussion revolving around case studies of commercially supported projects in a MECC, a medical school, and a medical society. Dietze reported on an initiative his office did that involved measuring knowledge acquisition and retention, both immediate and longer term. The initiative was supported by an educational grant from Sanofi-Aventis, but Dietze repeatedly emphasized that the outcomes being measured were educational: “It's important to remember,” he said, “that the questions we asked were not market research questions. It was all about education and educational results.” He also outlined the needs assessment and planning process, and the safeguards put into place to avoid bias and conflict of interest, and stressed that all the data was reported in aggregate, not individual, format. Still, the audience member found it difficult to believe that a MECC can provide independent education by virtue of being a MECC.
Panelist George Mejicano, MD, assistant dean for CME with the University of Wisconsin Medical School, Madison, countered with, “I can make money by being a physician and make good decisions for patients, even though I'm part of a for-profit entity.” He added that early on in his medical career, a student had asked him if he was worried about getting HIV from a needle stick when working with HIV patients. “I responded that I assume everyone is HIV-positive — the danger comes from those who you assume aren't HIV positive. I feel the same way about CME: I have more suspicion about those [CME providers] who are not for profit.”
OIG Investigates CME
Although there have been no indictments of CME organizations by the Office of Inspector General yet, there have been investigations. Chief Counsel to the Inspector General Lewis Morris, Esq., while a humorous and a captivating speaker, also represents the one agency that CME providers are most worried about, according to an audience poll taken earlier at the meeting. He started off by saying you don't have to worry if you've done nothing wrong. “We strongly favor educating doctors. What we are against is using kickbacks to sway doctors to use a particular drug.”
He explained which CME practices might raise red flags with the OIG. In particular, his office looks for CME providers that accept commercial support that is conditional on the activity covering specific content, and those who receive “knowing and willful remuneration for a specific service.” He explained that the OIG has a board that will render a summary judgment on whether a particular scenario does or does not violate the anti-kickback statute, but warned that it takes time to gather all the necessary materials and to render a judgment. He pointed to the pharmaceutical compliance guide on the OIG's Web site as a good resource for CME-specific questions.
“Is OIG the Darth Vader of healthcare?” he asked. It's not the OIG per se you need to worry about, he said, rather “the biggest threat is from the employees and contractors who work in hospitals, pharmaceutical companies, etc., who know what's going on and see the memos. When the news comes out on something like Serono, those folks have the papers to prove something similar is happening in their situation, and they still have the papers to prove it.
“It's just as illegal for pharma to pay a CME provider to pay a physician to fly to Boca Raton for a fishing trip as it is for the company to pay the physician directly,” he added. “In one case I've been working on, they thought if they couldn't pay the person directly, they could pay his wife. That case goes to court next month.” So, with recent pharma settlements reaching into the millions and more investigations on the horizon, what does he think about companies that just want to wash their hands of CME altogether? He said it just made him wonder what they've been up to.
Shootout at the CME Corral
In the meeting's final session — head-to-head presentations from Relman and Kopelow — Relman reiterated his call for ACCME guidelines specific to MECCs because, in his view, these organizations have an inherent conflict of interest that are not addressed in the revised Standards. The basic problem, he said, “lies in trying to manage a conflict of interest that shouldn't even be allowed to exist.”
One solution, he said, would be to have pharma just provide funds for general education, and have no part in choosing which specific certified activities the monies given to the general education fund would support. “I doubt that the industry would be much interested in that kind of really unrestricted assistance, but such a restriction would be an instructive test of industry's claim simply to be interested in supporting medical education without any commercial motives.” He added, “Does anyone here really believe that industry would continue to support CME (directly, or indirectly through MECCs) at anywhere near present levels if that support had no effect on sales?” The only real solution, he said, is to put the funding onus on physicians, and provide CME only through schools and teaching institutions.
Kopelow said he and Relman share the belief that medical education needs to be by and for the profession of medicine, and that it should be independent and bias-free. And he also said, “The idea of a general fund may be acceptable, and may eventually happen. But the profession and the public have to want that,” he said.
When it comes to MECCs, Kopelow stood by the ACCME Standards, but left the door open to further revision — not just in regard to MECCs, but to all types of CME providers. “In 1980, ACCME felt that if a provider could meet our Standards, we would accredit them. [The 2005 revised Standards] are addressing individual conflicts of interest, and now we have to look at organizational conflict of interest.” While he stated that he doesn't believe any provider type inherently has an organizational conflict of interest, he also said, “We're being asked to adapt. We always have, and we always will.”
Conflict or Confluence?
In an impassioned address during the American Medical Association Task Force meeting, J. Patrick Kelly, president of Pfizer Pharmaceuticals, Cambridge, Mass., and La Jolla, Calif., called on attendees to ensure that science prevailed over the hysteria surrounding the CME/pharma relationship. Referencing the Talking Heads rock group's lyrics to one of its big hits, he said, “Where does the CME path go? Are we right, or are we wrong? Will we say, ‘My God, what have we done?’ We need to start making sense.
“The very guidelines that were developed to protect CME actually threaten the future of CME,” he said. “We need a more balanced discussion.” Citing a recent book blasting the pharmaceutical industry and its ties to CME, Kelly summarized the prevailing viewpoint as one that “starts with the presumption of conflict, not confluence. This in spite of pharma doing more to help human health than any other industry.” He pointed out that many other entities involved in healthcare have a potential conflict of interest, such as health insurance companies, for-profit practices, and for-profit hospitals. “The health insurers might want to encourage generics over brand medicine, not because they're better, but because it's in their financial interest to do so,” he said. “If we were to eliminate all bias, we'd have no CME because bias and conflict of interest are ubiquitous. At the very least, we'd eliminate the use of all experts at the top of their fields. These processes should be applied to all, not just FDA-regulated industry.”
His suggestions for improving CME and the CME/pharmaceutical industry relationship include:
Apply conflict-of-interest standards consistently to both FDA- and non-FDA — regulated members of industry, such as health insurance companies
Improve accountability across the system by enforcing the ACCME rules.
Improve transparency by having all CME policies published on the Internet.
Have full peer review of all CME materials.
“Together, let's make sure science, with the free flow of information, does prevail,” said Kelly.
Taking the Temp of Collaboration
A series of audience-response questions were designed to take the temperature of today's collaborative climate during the opening panel discussion of the Annual Conference of the National Task Force on CME Provider/Industry Collaboration, held October 24 to 26 in Baltimore.
Interestingly, the number of responders who thought CME/pharma collaboration was increasing was about the same as the number who thought it was decreasing. Forty-two percent said they thought the ethical guidelines issued by industry, the PhRMA and AdvaMed codes on interactions with healthcare professionals, were having a positive impact on collaborative efforts, compared to 31 percent who thought they had a negative effect.
More than half, however, agreed that the Office of Inspector General's recent efforts were having a negative impact on CME/industry collaboration (33 percent cited a positive impact). The response was flipped when attendees were asked the same question in regard to the Accreditation Council for CME's Standards for Commercial Support, with 39 percent saying the new guidelines had a positive effect, compared to 36 percent who thought the effect was negative.
When asked what effect the PhRMA and AdvaMed codes have had on ensuring unbiased, independent CME, the positive impact vote shot up to 72 percent, with just 3 percent voting that they have had a negative effect, and 25 percent saying they had no effect. And 72 percent of the same audience voted that the OIG efforts have had a positive impact on unbiased, independent CME. The ACCME Standards for Commercial Support scored as working positively toward the creation of unbiased education with 75 percent of the voters.