June 01, 2008
Market Overview: Lesson Plans
Pharmaceutical companies seem to be holding the line on grants for now, but with intense pressure from officials, academia and increasingly, the medical community, not to mention their own in-house bean counters and cost cutters, they're re-evaluating their support of CME.
In 2006, commercial support for CME rose 8% to nearly $1.2 billion, but 2007 support figures, due from the Accreditation Council for Continuing Medical Education (ACCME) in August, are expected to be more or less flat, and the word on the street is that 2008 could well produce a decline. With funding in question and many medical education and communication companies (MECCs) scrambling to reorganize in order to retain their accreditation, the future of commercially-supported CME seems very much in question.
What began a few years ago as the hobby horse of a few senators has come to a full boil, with an Institute of Medicine inquest into conflicts of interest in CME and legislation making the rounds that could broadly proscribe commercial support. Influential foundations wring their hands over the industry's influence on CME, and scarcely a week goes by when a major medical journal doesn't inveigh against commercial support. Companies are facing their own cost pressures due to looming “patent cliffs” and few new approvals. With little in the way of ROI data to back up the value of CME sponsorship and an increasing number of disincentives to get involved, support is likely to decline this year.
“I think there's going to be a reduction in industry CME funding,” says Marty Cearnal, EVP, chief strategy officer, Jobson Medical Information. “The thing we don't know yet is how much of that reduction will be due to all these regulatory changes and how much is due to the overall slowdown in approval of new drugs. In the past, investments in CME are fairly closely liked to the introduction of new products, where companies are, in fact, using CME to explain new science and breakthroughs to physicians where a three-to-five minute interaction in a detail call is not enough time to get significant information across. CME provided a venue where these more complex messages could be understood.”
Karen Overstreet, president of Indecia Medical Education and past president of the North American Association of Medical Education and Communication Companies (NAAMECC), says that while she hasn't yet seen a decline, companies are putting off approving budgets longer and looking for fat to cut. But Overstreet says some good could come of the tumult. “There are a lot of positive things happening,” she says, citing the policy revisions of the ACCME and the new certification process being worked on by the National Commission for Certification of CME Professionals (NC-CME), of which she is president. “I hope there's time for us to see the effectiveness of all these things before there's another round of regulation,” says Overstreet.
In short, Overstreet believes industry-sponsored CME provides a vital portion of physician education, but has undergone some necessary corrections over the past few years. Now, the danger is that, at a time of scarce resources for the industry, overzealous regulators and pharma-bashing busybodies will eliminate a valuable source of continuing education altogether.
In a summary of a forthcoming report on continuing education in healthcare, the Josiah Macy, Jr. Foundation said commercial support of CME “risks distorting the educational content and invites bias; Raises concerns about the vows of health professionals to place patient interest uppermost; Endangers professional commitment to evidence-based decision making; Validates and reinforces an entitlement mindset among health professionals that CE should be paid for by others,” and “Impedes the adoption of more effective modes of learning.” The full report of the foundation is not due until the end of the year, but the summary, seemingly rushed out to impact the IOM hearings, concluded: “No amount of strengthening the ‘firewall' between commercial entities and the content and processes of [continuing education] can eliminate the potential for bias.”
That's the position of one extreme in the debate over commercially-supported CME in a nutshell: If so much as the potential for abuse exists, the entire system must be trashed. It's maddening to supporters and providers, who see a valuable source of continuing education for healthcare professionals caught up in a witch hunt.
“Nobody is looking at the 99% of programs serving physicians that are in compliance,” Cearnal explains. “It's not just CME but this whole complex of issues about what is the appropriate relationship between industry and medicine—it's also clinical research, medical journals. All of a sudden, what had been a kind of smoothly operating, mutually beneficial structure that also benefits society and science and progress, every aspect of those relationships has come under scrutiny, and as a result, you're getting people saying there should be no commercial support of CME, or if companies want to contribute to CME, they should be putting money in a central fund, much like a charitable contribution. My own view is that the industry is going to have limited interest in those approaches which don't give them any ability at all to at least select an area of medicine where they have an interest and want to be seen making a contribution. Anything that totally breaks that relationship runs the risk of severely limiting the contributions that industry makes to CME.”
The latest round of recriminations for commercial support kicked off with a Senate Finance Committee investigation into pharmaceutical industry influence on CME. The committee's 2007 report concluded that the drug industry “uses education in grants as a way to increase the market for their products,” including promotion of off-label uses. The committee acknowledged that companies had moved to separate grant-writing from marketing, but found ACCME guidelines to be inadequately enforced.
In response to the committee's report, which called for greater transparency about CME support from pharmas, Lilly agreed to make its grants public in May, 2007, posting info on $11.8 million in grants to 495 organizations online. Sen. Chuck Grassley, the former head of the committee and now its ranking Republican member, recently wrote other major grantors demanding that they do the same, and AstraZeneca obliged.
A messy amendment to ACCME rule
The report had major implications for MECCs, as ACCME responded by changing its definition of what constitutes a “commercial interest”—and is therefore subject to guidelines requiring strict separation of science and marketing functions—to include not only companies that sell drugs but also those that market them. That would include marketing companies like WPP or Omnicom as well as medical publishers, which accept pharma advertising, and independent providers that do both accredited certified CME and unaccredited promotional CME.
The MECCs have until 2009 to restructure themselves—in many cases radically.
Much to the chagrin of advocates of commercially supported CME, other types of providers—hospitals, medical schools, insurance companies and specialist societies – are exempt from the rule.
“It sets up a two-tiered system,” says Overstreet. “Any med ed company that does any sort of marketing or that's owned by anybody that does any sort of marketing will have to drastically restructure themselves, or they can't be players in accredited CME anymore.” ACCME rules stipulate that management, faculty and all staff having anything to do with content must be separate from the promotional parents of these companies.
This could result in a significant winnowing of the field. Some could go nonprofit. Others would opt out of accredited CME and stick to non-accredited promotional med ed, says Overstreet. Some might simply fold, as their parent companies find the costs of separating them unbearably steep.
ACCME has been fairly oblique as to what measures would be needed for companies to retain accreditation. “I just wish ACCME was clearer,” says Mark Schaffer, VP, CME compliance at Professional Postgraduate Services, which is currently in the middle of the re-accreditation process.
Getting direction on where the line is with the new policy has been tough, says Schaffer. “If you have to have a separate building or separate floors, you'd think they'd say that. Separate corporate structure doesn't necessarily mean separate legal entity with a separate tax ID. If that's what's required, just tell us and we'll comply. I don't want to tell the boss we have to move without actually knowing that.”
Furthermore, under the new system, those accredited MECCs working in joint sponsorships with other providers are expected to vet them for compliance.
“It leaves a huge gap in the system,” explains Cearnal. “How does a university or a medical school or a teaching hospital or a medical society determine if the MECC they're working with is a commercial interest or not? They don't have the structure to go out and check this.”
Brad Bednarz, chief strategy officer at Visible Productions, says companies will continue to fund education when they have truly groundbreaking science to share and truly innovative products to promote.
“It's a very clear cut decision to fund when a company has a new drug or a new category,” says Bednarz. “Where it becomes hazier is when you have the second, third or fourth drug in the category. That's where the internal debate really happens.”
He expects the pressure on CME will produce more joint sponsorships which “put everybody at less risk” and an increase on compliance in continuing education. However, he notes, increasingly, corporate counsel is calling the shots on grants. “What happens is the debate shifts away from quality medicine to protecting the company,” says Bednarz. “If it gets to the point where it inhibits our ability to fund quality education, we all lose.”