Medical Education Report: Course Correction
Industry funding of continuing medical education was flat in 2007 at around $1.2 billion, according to the Accreditation Council for Continuing Medical Education (ACCME), and 2008 figures, due later this month, are likely to show a decline. CME providers say manufacturers are spending less on continuing education—due in part to across-the-board budget cuts at drug and device makers.
And then there's the palpable anxiety gripping the CME industry —the fear that Sen. Chuck Grassley (R-IA) will subpoena your employees' toenail clippings for the past five years over a continuing education program you supported, holding up a grant as evidence of the big bad drug companies using CME as a marketing channel.
Not everybody's keeping their heads down. Sanofi-Aventis is still supporting CME unapologetically, if a little less than in years' past, thanks to generalized belt-tightening. Sure, the grants support vague commercial objectives (companies can target grants to therapeutic areas, but cannot influence content in any way). They also serve a greater good, explains Hilary Schmidt, associate VP, independent medical education at Sanofi-Aventis.
“There are so many independently defined healthcare gaps that show patient care is really not meeting some basic standards,” says Schmidt. “And those gaps are often very much related to the interests of our company. So once we understand those gaps, we select gaps that are aligned with our interests and we provide funds for activities designed to close them and improve patient care. Healthcare professionals need to understand the full-range of therapies available and keep abreast of emerging science in order to select the best treatment for each patient. We're in the business of improving patient care, and CME is an important part of that equation.”
Those coverage gaps aren't only in the areas of new science or emerging therapies that companies are looking to introduce to physicians. Take osteoporosis, says Schmidt, where less than a third of women over 65 get a recommended bone density test, meaning many with the disease go undiagnosed. “So, any company that makes a treatment for osteoporosis, it's in their interest that CME be provided to help physicians meet basic standards. It's in the best interest of the nation and women over 65. It will result in improved diagnosis and treatment, and that's in everyone's best interest. That's a win-win.”
Continuing education under scrutiny
It's been an ugly few years for the CME industry. Pilloried by snooping pols and sniffing ethicists, not to mention budget cuts and the seismic policy changes handed down from the ACCME and other parties, CME providers and supporters feel besieged. Critics see a system riddled with conflicts of interest, bias lurking behind every lectern and poisoning the prescribing habits of gullible medical professionals. Advances of recent years in the rules governing accredited providers—and mandating a hands-off approach on content for supporters—are seldom acknowledged.
“I believe many observers are talking about a CME system that they were part of a decade ago,” says ACCME chief Murray Kopelow, MD. “Our providers are doing most of the work behind the scenes in identifying and resolving conflicts of interest, and the learners don't see all of that work.”
Indeed, two groups representing med ed companies felt the need last year to launch a campaign to educate faculty, learners and policymakers on the differences between certified and accredited CME versus promotional med ed. Over the past year, the American Psychiatric Association banned industry-funded CME from its annual meetings, as did Stanford University School of Medicine, joining the five other big medical schools. An Institute of Medicine committee called for the development of “a new system of funding accredited CME … free of industry influence.”
Harvard's Dr. Marcia Angell captured the sentiment when she told the Minneapolis Star-Tribune: “Of all the financial deals between industry and physicians, [CME] is the worst.”
There are, however, signs the worm is turning, as the industry gets behind transparency initiatives, providers reorganize to comply with strict new firewall policies and even critics acknowledge the importance of industry support to continuing education. In June, the AMA's House of Delegates rejected, for the second year in a row, a proposal to crack down on industry-supported CME. The AMA's Council on Ethical and Judicial Affairs (CEJA) had backed down from its 2008 call to ban commercial support, instead proposing to delineate “ethically preferable” and “ethically permissible” CME funding practices. The policy was soundly rejected.
Perhaps that's not surprising in light of polls showing that doctors overwhelmingly approve of commercial support. A Pri-Med poll of 268 physicians last fall found that 92% disagreed with CEJA's hardline stance on CME, expressing concern that a ban on commercial support would make it more expensive to receive CME and that the quality of CME would decline. A more recent poll of 904 physicians, conducted by Manhattan Research, found only 9% opposed to commercial support of CME. Just 8% of those participating in CME said it was biased, and nearly half said that if commercial support were eliminated, they would end up decreasing their use of CME.
Meanwhile, the IOM's Conflict of Interest Committee, while expressing concern about the potential for bias, conceded in its report that there was no evidence of bias. Committee chair Dr. Bernard Lo, MD, told MM&M at the time that evidence of industry bias in CME “is weak in either direction” and acknowledged that ACCME documents indicate high compliance from commercial providers. “We're calling for more evidence rather than empty accusations,” said Dr. Lo. “We were not persuaded that the process now in place really assures a lack of bias. We think the burden should be on the providers to demonstrate independence.”
Counters Kopelow: “It's our expectation that any organization that looks into a new funding mechanism will recognize that what they are describing is exactly what we have: a CME system free of industry influence, that has the public trust, that has integrity and provides a high-quality education.” Proving that is the idea behind the monitoring system ACCME is launching this month.
Kopelow is no softie when it comes to conflicts of interest. The ACCME recently weighed a ban on commercial support of CME before concluding that its Standards of Support, greatly strengthened in recent years, were sufficient to safeguard against commercial bias. Now ACCME is considering an “independent funding mechanism” that would pool funds and disburse them, though many supporters would scoff at the notion of funding an unknown activity if they could not even select the therapeutic area to which it was directed.
“If such a mechanism were to prevent us from identifying the gaps that we believe are aligned with the company's interests, we would likely not support it,” says Sanofi's Schmidt. “We also think in the absence of any evidence to support or refute the claim that industry-supported CME is tainted, it's unwarranted.”
New rules, new standards
In 2004, ACCME revised its Standards for Commercial Support, the code by which all accredited providers must abide, to get tough on conflicts of interest between industry, providers and faculty, ensuring that commercial supporters have no control over content or even faculty selection. A subsequent provision requiring that providers be completely independent of companies handling promotion for pharmas goes into effect this month. The 2006 Standards, boasting the motto “CME as a Bridge to Quality,” aimed to reorient CME towards measurable learning objectives and, as Dr. Kopelow puts it, realize “our opportunity to engage as key change agents in the challenges that the whole healthcare system is being confronted with.”
“They shifted the focus from education for the sake of credits and time and exposure to new information to education that is truly focused on the real goal,” says Schmidt, “improving patient care.”
“The level of quality over the past three to five years has really increased significantly, but the level of regulatory requirements has, as well,” says Stephen Lewis, president of accredited provider Global Education Group. “So, on the good side, these requirements have really pushed the bad apples out of the business among all provider types—med ed companies, universities, hospitals and societies—which is good news for CME's future. However, in order to write quality independent needs assessments and meet all the guidelines that we now face to ensure that education is independent and unbiased, it's more expensive to produce that level of quality CME, while at the same time, it's harder to get funds. Everybody wants to focus on commercial support, but that's really not the issue —quality is the issue.” The increasing cost, says Lewis, is prompting many smaller players, including dozens of hospitals, getting out of CME provision. A number of longstanding commercial providers, too, have gotten out of accredited CME—due to costs, the firewall policy going into effect this month and declining levels commercial support. Lewis forecasts a decrease in commercial support of 15%-30%.
“The change in ACCME criteria has forced some providers to reassess their business models and others to collaborate to gain access to technologies, event management or higher outcome levels,” says Pamela Mason, director of medical education grants at AstraZeneca. As a result, the company has seen an increase in the number of grant submissions involving collaboration between different provider types. In 2008, 55% of AstraZeneca grants were awarded to hospitals, medical schools and healthcare systems, 30% to medical associations and specialty societies and 15% to medical education companies. The company has been receiving around 4,000 grant applications annually in recent years.
“Present-day economics have challenged all CME stakeholders,” says Mason. “Limited and shrinking budgets at academic and healthcare institutions, as well as professional associations, present challenges in the number, type and quality of CME offerings. Pharmaceutical companies are also trying to cope with budgetary restrictions and, consequently, are providing fewer grant awards. As such, the competition for grants is becoming more robust.”
That's led to a tendency for overall grant awards to be smaller, just as the cost of implementing quality and measurement initiatives is driving up the size of grant requests. “The cost of every individual grant per activity type is increasing,” says Schmidt. “So what may have been a $5,000 grant in the past is an $8,000 grant today. And that's not just because the costs are increasing—education is becoming more rigorous and there is outcomes assessment for most grants.”
The conversation within the CME industry is shifting from one about rooting out conflicts of interest to one about promoting quality. Time will tell if the larger policy discussion follows.
“The big concern is not just commercial bias, but whether or not there's a tendency for learners to deliver care that is not necessary as a result of educational activities,” says Kopelow. “We're in a different regulatory and operational environment now. It's clear where the boundaries are. The commercial supporters see them and are respectful of them. The providers see them and know how to manage them. We need this to play out over some years, and ACCME needs to produce data on compliance, and we're going to.”