“In today's climate, the field of medicine will be better served by clearer rules that more strictly separate education from promotion. The Standards for Commercial Support now represent a too subtle set of expectations that seem to invite pushing the envelope. The relentless commercialization of medicine and the overly aggressive promotion of some commercial interests compels us to raise the bar higher, so that physician learners and the public can be best assured that CME is unbiased.”
Gerald Holzman, MD, ex-pressed the views of many CE providers when he presented his thought-provoking testimony during the July hearing convened in Chicago by the Accreditation Council on CME's Task Force on the Standards for Commercial Support. Holzman, who is secretary, Council of Medical Specialty Societies; and vice president, education, American College of Obstetricians and Gynecologists, Washington, D.C., was one of about 20 CME leaders who shared their organizations' suggestions for revising the rules.
It's been a decade since the CME community staved off outside regulation by deciding to regulate itself, and theissued the Standards for Commercial Support to protect education from pharmaceutical industry influence. While most of those testifying agreed that commercial support of CME was necessary, and that the Standards were basically sound and effective, they also noted that the health care landscape is becoming increasingly complex, with many more players than there were before. Relationships between physicians, pharmaceutical companies, and medical educators are once again facing intensive media and public criticism — raising the specter of government regulation. Although the Food and Drug Administration is not about to police industry-supported education — the agency sent a letter to the hearing asserting its noninterference policy — the CME industry is concerned about maintaining its credibility.
Everyone at the hearing concurred that it was time to revise the rules — and, interestingly, there was much agreement about which areas needed updating. Some of the suggestions are relatively simple to implement — changing all the “shoulds” to “musts,” for instance. Other recommendations will require a lot more thought.
“I'm concerned that the more one pays a speaker or contributor, the more likely they are to introduce — perhaps unwittingly — bias. People can be bought.”
— Gerald Holzman, MD
The Gift Horse
One speaker called it “influence peddling.” Another called it a “marketing campaign that is rocking the very foundation of medicine.” Whatever you call it, the escalating trend of pharmaceutical companies lavishing gifts on physicians is a huge concern for CME leaders and for the public, and generated much discussion at the hearing. The ideas presented by speakers break down into four areas:
Should the Standards incorporate the AMA's Ethical Opinions on Gifts to Physicians and CME? Currently, the Standards don't address the issue of social events or gifts to physicians in much detail — only saying that commercially supported social events at CME activities should not interfere with education.
It's the American Medical Association's Ethical Opinion on Gifts to Physicians that addresses the issue more specifically, saying physicians should only accept gifts that relate to patient care and are of minimal value (usually defined as less than $100); and that industry-funded meals should be “modest.” The AMA's Ethical Opinion on CME states that doctors should attend CME conferences for the education, not the amenities.
Many of the presenters felt that the Standards needed to be more explicit as well. “The policy is entirely too vague and gives little direction to accredited providers,” said Morton Morris, D.O., representing the American Osteopathic Association, Davie, Fla. “It should be clear enough that providers will know that physicians are attending because of the quality of the program — not for the location or quality of the food.” To help providers, “the ACCME Web site should contain descriptions of circumstances which are acceptable and not acceptable.”
Others suggested that the Standards stipulate that CME activities must adhere to the AMA's Ethical Opinion, a guideline that many providers have already implemented.
Should the Standards include dollar limits? But how can the Standards define limits without becoming too prescriptive? In an interview following the hearing, Murray Kopelow, MD, executive director, ACCME, said that one approach would be to set per diems by location. “It's not lavish to spend $250 per day for hotel and meals in New York, but in Salt Lake City we could have a different per diem. We could find benchmarks.”
Should gifts be disclosed? Commercially supported events and gifts offered in conjunction with CME activities should be disclosed in conference materials, suggested Bruce Bellande, PhD, Alliance for CME, “with the intent of achieving full disclosure to the CME audience.”
But will physicians comply? CME providers are in the untenable position of trying to get doctors to comply with ethical guidelines they may not be aware of — or accept. Educating physicians is a major challenge, presenters acknowledged. The ACCME's partners, such as the Alliance for CME and specialty societies, will have to play a role, said task force chair Norman Kahn Jr., MD, in an interview following the hearing. (Kahn is also vice president, science and education, American Academy of Family Physicians, Leawood, Kan.)
As for how to make that education effective and palatable: “We know that ‘just-in-time’ education has the most impact,” said Robert J. Cullen, PhD, representing the National Task Force on CME Provider/Industry Collaboration, and the Department of Veterans Affairs Employee Education System. Rather than holding special sessions for physicians about commercial support or the Ethical Opinion, he thought it would be more effective “to incorporate bits of [ethics education] into other right-on-target programs.” And that education needs to go beyond the physician, he added, and extend to all the people involved in the commercial support of CME. No arguments there.
Off-Label Is OK
Under the current Standards,must inform participants when they discuss uses or products that are unapproved by the FDA. Many presenters felt that the rule was not useful.
“It creates considerable confusion for providers and for presenters,” said Deborah Danoff, MD, representing the Association of American Medical Colleges, Washington, D.C. “Many physicians are not actually sure if the therapeutic use of a drug is label or off-label because it's the standard use of the drug.”
And because faculty are unaware of labeling, they may not comply with the rule, increasing the risk of litigation against the provider, said Bellande. “Any time there is a standard where no mechanism exists to ensure compliance, the risk of litigation increased.”
And just because a product or use is off-label, it doesn't mean discussion about it is biased, added Bellande. The important criteria is whether the use is evidence-based, agreed Danoff.
No More Faculty Police
Faculty are also supposed to disclose their relationship with industry and give balanced presentations. But what happens when — despite all your efforts to apprise faculty of the rules — a speaker launches into a product promotion? In a reversal of its long-held position that providers are accountable for faculty misbehavior, the AMA now says that although providers should be diligent in educating faculty, “they are not expected to be policemen,” said Dennis Wentz, MD, director, division of continuing physician professional development.
Of Honor and Honoraria
One reason faculty may bend the rules is because they feel beholden to the commercial supporter who is paying their speaking fee. Payments to faculty should be reasonable, according to the Standards. Like the social events rule, the honoraria stipulation is just too vague, providers said. While technically the funding goes through the provider, speakers know where the money is coming from and thus may feel obligated to the commercial supporter.
“I'm concerned that the more one pays a speaker or contributor, the more likely they are to introduce — perhaps unwittingly — bias,” said Holzman. “People can be bought.”
One person took exception to the idea that the more someone is paid the more likely he or she is to skew their presentation. And some providers argued that setting specific figures might create problems, too. Such rules would be “difficult to set and worse to enforce,” said Dorothy Bell, American Nurses Credentialing Center, Washington, D.C. “It would have implications for a whole industry of consultants and speakers bureaus.”
“We have never come down with a specific dollar amount and I can't imagine doing so in the future,” Kahn said. “But folks need additional clarification.”
Faculty aren't the only players who can inject commercial influence into CME. Members of the CME planning committee should also be considered agents of the provider, and thus subject to disclosure rules, commented Cullen. “Providers should demonstrate that their planning processes are designed to detect and address inappropriate influences in activity planning.”
Keep the Slides
Another gray area is industry's role in providing technical assistance with graphics, slides, handouts, and other ancillary materials. Refusing to allow supporters to provide help with program materials can place a burden on small providers with limited resources, and thus do a great disservice to physician learners, observed Kahn. Morris added that technical support is particularly important with Internet CME, which is so costly to produce. “But there should be a caveat, said Holzman. Any materials should become the property of the CME provider or the speaker, not the commercial supporter. Others agreed.
Ask the Audience
But no matter how strict the rules, or how vigilant the provider, things do go wrong at CME activities. One suggestion, endorsed by many of the presenters, is that providers ask participants in their evaluations whether they perceived bias, and whether there was full disclosure regarding the provider and faculty's financial relationships with industry.
“Feedback from participants is one of the hallmarks of the entire CME process,” said Greg Thomas, vice president, clinical affairs and education, American Academy of Physician Assistants, Alexandria, Va. “[Audience evaluations] are the key to guaranteeing that programs provide balanced, accurate information, and appropriate disclosure of commercial support.”
Web of Influence
But to really protect education from bias, the ACCME needs to expand the definition of commercial interests to include more players than the drug and device companies regulated by the FDA.
“Health care is an extremely complicated industry with as complicated a web of commercial influences,” Cullen testified. Not only does a manufacturer have a vested interest in sales of a medical device — but the institution that has purchased the device may also have a vested interest in seeing that utilization increases, Cullen pointed out. Or, the provider's parent organization might have a risk-sharingthat rewards physicians for conserving use of a drug or device. Complicating matters further, Cullen noted, there is a new set of vendors — technology companies that have vested interests in physician education.
“We have to decide who we put under the umbrella [of commercial interests],” said Kopelow, “and how we characterize those relationships.”
Ain't No Standard High Enough.
Since neither the FDA nor commercial supporters sent representatives to the hearing (although the FDA did submit written comments), Kahn said the task force would seek a meeting with those groups to “make sure they have an opportunity to contribute input, and to respond and react to others' input.”
The task force has also gathered comments from internal ACCME committees, will put a draft out for comment, and, if needed, do subsequent revisions. Kahn says he hopes to disseminate the new Standards by Summer 2002.
Many Professions — One Standard
Organizations that educate doctors aren't the only ones being courted by pharmaceutical companies these days. Commercial supporters are now showing much more interest in funding the education of pharmacists, nurses, and physician assistants, as those health care practitioners are more empowered than ever before to make or influence prescribing decisions. In addition, health care education is becoming much more interdisciplinary. As Murray Kopelow, MD, executive director, Accreditation Council for CME, puts it: “Health care professionals are learning the way they are working — as a team.”
For those reasons, the ACCME invited other accrediting organizations to its hearing on the Standards for Commercial Support in July. As speakers from the American Council on Pharmaceutical Education, the American Nurses Credentialing Center, and the American Academy of Physician Assistants pointed out, it would be in everybody's best interest to collaborate on developing ethical standards and learn from each other's experiences. In fact, the ACCME and the other organizations are working on developing unified standards for commercial support and accreditation.
“Although the professions are different, the ethics and values shouldn't be very different,” says Kopelow. “The opportunity is there for commonality.”