“AS CME PROVIDERS, we should be able to use the best and the brightest to develop educational content. If we are to disqualify these physicians based on “perceptions” of conflicts of interest, we fail to provide the highest quality CME to physicians while impugning the integrity and honesty of many of the finest physicians and educators in the world.
“Based on this draft document, accredited providers would be required to be the “Conflict of Interest Police,” making judgments on the possible commercial bias of a proposedmember before a word of the content has been written. Where are the data to support such a significant change in policy?”
The above paragraphs, excerpts from the North American Association of Medical Education and Communication Companies' (NAAMECC) response to the draft revision of the Standards for Commercial Support, express the views of many in the CME industry that the Accreditation Council for CME has gone too far in attempting to curtail bias in CME activities.
The draft Standards maintain that disclosure of faculty relationships with industry is no longer enough to protect CME, and stipulate that speakers/teachers should be excluded from serving if their relationships with commercial interests, such as drug firms, constitute a conflict of interest. Those who fail to disclose would also be disqualified.
Under the current Standards, CME sponsors as well as faculty are required to disclose. The new Standards strengthen that concept, saying that those who control the content of CME — not only providers but also planners or managers (third parties hired to manage a CME activity) — should disclose their relationships. And, if their relationships constitute conflicts of interest, they should also be precluded from controlling CME activities.
Since ongoing debate of these complex issues is crucial to the successful creation of a practical and effective set of Standards, we have reviewed responses from three organizations — NAAMECC, the Alliance for CME, and the Pharmaceutical Research and Manufacturers of America (PhRMA), and we have also spoken with numerous CME providers. We are presenting here excerpts from their critiques of the draft Standards and their suggestions for reworking it. In the third section of this article, we present the views of three CME professionals who bring additional — and quite different — perspectives to the debate.
Who Is the Judge?
While there is some support for expanding and strengthening disclosure, there seems to be consensus that the solution of disqualifying people or organizations based on their relationships is problematic.
“These policies are going to be pretty tough to interpret, they are going to be very difficult to monitor, and they're going to be almost impossible to enforce,” says Melinda Steele, director, CME, Texas Tech University Health Sciences Center, Lubbock. As with many providers, one of her main concerns is the distinction between conflict of interest and vested interest — a critical point, as under the draft Standards, those with a conflict of interest will be excluded from CME, while those with a vested interest can participate.
“That's a nuance that's subject to interpretation. If you brought 10 people in a room to discuss one particular issue of conflict of interest or vested interest, you might get 10 different opinions. Who's qualified to make that call? As a CME provider I'm not sure I'm qualified to make it. My CME committee members said, ‘We can't make those calls. We're not willing to do it.’”
The Alliance for CME agrees with many areas of the draft Standards, including the expansion of the disclosure requirements, pointing out, however, as Steele does, that in actual practice it will often be difficult to distinguish vested interest or perceived conflicts of interest from true conflicts of interest. In fact, the Alliance says that learners are often better qualified than providers to discern bias, and suggests that complete disclosure to learners should be the principal means of managing conflicts. In addition, the Alliance recommends that therequire providers to employ more comprehensive disclosures, using forms such as those developed at the National Institutes of Health; and mandate that providers evaluate the effectiveness of their efforts to ensure balance in their activities. Further, the Alliance asks the ACCME to identify relationships where control of content should be prohibited, to ensure that application of such prohibitions will be equitable and uniform.
Without more specific criteria, “providers are placed in a position of potential liability when excluding faculty,” says NAAMECC. Further, “providers may be penalized for the implementation of standards that are higher than those of their competitors. Faculty and grantors would be more willing to work with those perceived to have fewer barriers.”
PhRMA also opposes disqualification of faculty, stressing that CME providers should have the opportunity to use the most qualified presenters. “Any process that suppresses the sharing of truthful medical information in CME is ultimately detrimental to the CME enterprise, particularly when that process deprives CME participants of the results of the most current medical research,” states PhRMA's response. “However, because many of the most qualified experts have relationships with pharmaceutical companies that may appear to raise issues of bias, the goal of the Standards for Commercial Support should be to help experts manage such potential conflicts, not automatically exclude the experts from participating in CME.”
PhRMA also points out that “the proposition that pharma speakers should be disqualified from presenting at CME when a potential conflict of interest exists directly contradicts the approach that the FDA took in its 1997 final guidance on industry-supported scientific and educational activities. It is the FDA's position that meaningful disclosure is one factor that should be considered in evaluating CME activity and determining independence.”
In developing guidelines to help root out commercial bias in CME, some providers assert that the ACCME developed guidelines that are in themselves biased. The area of contention is the definition of commercial interests: “Firms or persons, including FDA regulated firms and their representatives, who are in a position to gain financially through the sale of products, devices, or services that physicians use.…” The memorandum that accompanied the draft added: “We expect that the ‘interests’ of hospitals, medical schools, and academic medical centers in delivering healthcare education will not be considered ‘commercial interests.’”
Lewis Miller, corporate editorial director/chairman, Dowden Health Media Inc./Intermedica Inc. Darien, Conn., and a founding member of the Alliance for CME, takes issue with those exemptions. “In this era of aggressive competitiveness for patients, these institutions often spend tens of thousands of dollars to get referrals from practicing physicians. They should be held to the same standards as any contributor.”
NAAMECC also took exception to the memo. “The only major provider group that is not included in this broad “benefit of the doubt” provision is the medical education and communications companies (MECCs). This is particularly offensive given that clear and poorly managed commercial interests of other provider groups have been documented in the literature.”
For instance, in the systematic review, “Scope and Impact of Financial Conflicts of Interest in Biomedical Research,” published in the January 22, 2003 issue of the Journal of the American Medical Association, “Bekelman and colleagues reveal that more than two-thirds of universities hold equity in biomedical start-up firms that fund research at the same institutions. The investigators also found that university investigators conducting industry-funded research tend to choose research designs that would be more likely to produce positive results.…”
PhRMA also felt unfairly singled out. “The ACCME has only identified funding of CME by FDA-regulated firms and their representatives as a source of potential bias.” Agreeing with others in the CME community, PhRMA observes that a variety of relationships might affect the independence of CME presenters, planners, or accredited CME providers. People may be involved in clinical trials, or work at “an institution that has an ownership interest in a drug being discussed at the CME session; or at an institution hoping to receive funding, from either a government agency or a for-profit source, for research…in the area addressed in the CME session.”
Another problem area is section 2.3, which states that accredited providers will not produce or disseminate CME in a clinical area in which they have a commercial interest. “This is written so broadly that many, if not most, providers could be prohibited from producing CME,” states the Alliance. While the ACCME did attempt to address this complication by providing the exemptions mentioned above, “such exemptions are problematic and appear to give special status to some providers.” Instead, “the breadth of 2.3 should be narrowed by the ACCME to achieve its specific prohibitions and applied equally to all providers.”
NAAMECC adds that “providers perceived by the ACCME to have a conflict of interest continue to have the opportunity to demonstrate that the CME entity maintains adequate separation from the parent company through the use of effective organizational structure, firewalls, policy, and oversight.”
Joint Sponsors Suspect
Another area that causes confusion is element 1.5, which states that the nonaccredited partner in a joint sponsorship relationship cannot be a commercial interest. This appears to single out MECCs, some of whom have parent or sibling companies involved in promotion for drug firms. Asks PhRMA: “Does this involve ACCME inappropriately in determining what types of internal organizational structures are and are not acceptable for companies?”
Again, Miller observes that the provision may be unfair. “If it is OK [for Eli Lilly, an accredited pharma firm, to produce CME], why should a commercial entity which is not accredited be prevented from joint sponsorship, so long as the accredited provider controls the activity?”
Back to the Drawing Board
What can be done to address these complex issues? Here are suggestions.
STANDARDIZE DISCLOSURE “We suggest that the ACCME establish a common form for eliciting disclosure information and a standardized format for the presentation of disclosure information. This would be far more reasonable than disqualification.”
ASK ATTENDEES “We recommend that the ACCME mandate that every evaluation of every CME activity include a question regarding the participant's perception of commercial bias. Faculty who provide commercially biased presentations would be identified through participant evaluations and could be eliminated from further development of CME activities.”
SEND IN AUDITORS “NAAMECC supports the creation of an external monitoring system for the purpose of randomly auditing live activities and enduring materials/journal-based CME produced by all accredited provider groups.”
ONE SET OF RULES “Currently, there are too many documents addressing the gifts to physicians issues: FDA, ACCME, AMA [American Medical Association], PhRMA. Invite the leaders of all organizations to a meeting to generate a uniform set of policies that apply across the organizations.”
Alliance for CME Ideas
GLOSSARY NEEDED “The clarity of the proposed new SCS would be further enhanced by incorporation of a glossary or set of definitions. Definitions for conflict of interest may come from a variety of sources. For example: ‘A conflict of interest occurs when an individual's [or organization's] objectivity is compromised by a desire for prominence, professional advancement, or financial gain.…Financial interests include employment, consultancies, stock ownership, honoraria, expert testimony, royalties, patents, grants, and material or financial support from industry, government, or private agencies.’ (American Medical Association Manual of Style: A Guide for Authors and Editors, 9th edition, 1998. Note: Bracketed words added). The ACCME should also consider relationships that are included in National Institutes of Health disclosures (e.g., relationships of immediate family members that may be a source of influence).”
SPECIFY SANCTIONS “Conflicts that warrant preemptive exclusion should be specifically identified in the new Standards for Commercial Support and the nature of the sanction clearly stated. In particular, exclusion could be associated with one of two sanctions: complete prohibition from participation at any level or exclusion from control of program content.”
NONDISCLOSURE PENALTIES “Faculty presenters may be tardy in responding. Do we preemptively disqualify them if they do not respond by a certain date? Rather than requiring providers to treat all failures to disclose in the same manner, we recommend requiring providers to have sanctions, including the length of time sanctions are to be in force, for individuals who do not disclose. Information on incomplete or absent disclosures should be communicated to the audience.
“Policies regarding sanctions for failing to disclose should be required by and remain in the purview of providers,” the Alliance continues. “In return for that flexibility, the Alliance suggests that the ACCME require providers to evaluate and improve those policies as needed.”
Pro and CON
NEXT: A HISTORICAL PERSPECTIVE, a wider world view, and a voice in favor of the draft Standards.
Enough of Uncle ACCME
Kevin Bunnell, EdD, a CME consultant based in Boulder, Colo., former Alliance for CME president, and the chair of the working group that drafted the original Standards, sent the following letter to the ACCME:
“I'm sorry you are accepting comments only from those who are willing to fit in the Procrustean Bed of your downloadable response form. What I have to say doesn't fit well in a rectangular box.…I am centering my comments on two key principles that this revision violates. First, the draft says that a person with duality of interest between a commercial entity and an educational enterprise “Should not, therefore have control of or responsibility for the development, management, presentation, or evaluation of CME that is relevant to that conflict of interest.” This statement violates one of the most firmly established principles of American democracy that if one has a duality of interest, one is [not necessarily] guilty. [This concept was] discussed thoroughly by the broadly representative group who drafted the 1992 Standards. We were all perfectly clear that duality of interest was not, in itself, bad. Only if duality of interest were abused were sanctions to be imposed. This new statement is an unnecessary preemptive strike, which in my view will do great harm to the carefully nurtured and essential working relationship between commerce and the education of physicians.
Second, the 1992 working group of medical, educational, commercial, and government interests agreed that beyond some guiding principles suggested by the FDA, no amount of words could fully define or interdict all of the perils of duality of interest. We believed that the medical/educational community is among the best educated, most honorable, and committed groups in the country. Of all people, they should be able to recognize abuses of dual interests and deal with them. In the 25 years I have been doing accreditation site surveys I have seen all the evidence anyone should ever need that physicians and medical educators are quick to recognize bias and scientific inexactitude and very effective at squelching it. Our physicians and medical educators already have enough of Uncle ACCME peering over their shoulders to “guide (them) in the management of their interaction with commercial interests.” It's time for the Accreditation Council to trust the medical education community to do what it has always done — [manage] duality of interest [situations] as they occur.”
The Right Direction
But some providers say it's time for the rules to change. “The draft Standards for Commercial Support are just the most recent step in a larger movement in the world of medicine,” says R. Van Harrison, PhD, CME director, University of Michigan School of Medicine, Ann Arbor. While CME is important, when it comes to conflict of interest and potential bias, the first lines of fire in terms of public interest are in research and publications, he says. And while ACCME is just beginning to tackle what is acceptable in terms of conflict of interest, its parent organizations already have taken a stand on it in those areas. “The ACCME is just catching up with changes that are already happening elsewhere in medicine,” he says. “For those who say the existing disclosure rules don't need to change, well, they're out of date with what's already happened in the bigger picture.”
For example, on the research end, the Association of American Medical Colleges has released two reports: Report on Individual Financial Interest in Human Subjects Research in December 2001; and the Report on Institutions' Financial Interests in Human Subjects Research in October 2002 (full text of the reports are available at www.aamc.org). “Under these AAMC policies, relationships that you would simply disclose under the previous ACCME rules could now prohibit you from being involved in research activity funded by a commercial entity,” Harrison says. “If people with conflicts of interest can't participate in research, why should people with the same conflicts be allowed to participate in formal, fully accredited CME?”
Another national trend regarding conflict of interest emerged when the editors of major medical journals established detailed policies regarding relationships between journals, authors, and industry, Harrison posits. These policies, as outlined in a statement of the International Committee of Medical Journal Editors regarding sponsorship, authorship, and accountability, include a stipulation that editors may have no conflicting relationships. They also may take author disclosures into account when making decisions about whether or not to publish an article. (For details, go to www.icmje.org.)
“The ACCME is aware of these changes. I think they are looking at how they can bring the educational enterprise into a position that parallels the standards that have already been articulated in the research and publications arenas,” says Harrison. The difference, though, is that the AAMC and the ICMJE aren't accrediting bodies, and ACCME is. That means that it's not enough to publish guiding principles, as ACCME did with its draft Standards. “ACCME has to go beyond articulating the principles to providing clear operational guidelines so people can be fairly and uniformly judged on their compliance. Until ACCME provides that operational guidance, no one can move forward.”
Asked what he thinks of the draft Standards, Harrison laughingly answers, “If I knew what they were, I'd tell you. The principles ACCME outlines are a well-intentioned and appropriate attempt to bring CME to the new level that has already been put into place in other areas of the medical world. With commercial sources funding more than 50 percent of the out-of-pocket financial expenditures of the 674 nationally accredited CME providers, we are required to react, just as those in research and publications have been. If CME does not recognize that larger world change, we will be scorned and marginalized.”
Sharing the Burden
Winnie Brown, MPA, leader of the hospital special interest group of the Alliance for CME, and director of CME, Truman Medical Center, Kansas City, Mo., is one provider who approves of the new proposed Standards — although she worries that she might be the only one. “The new Standards may actually take some of the burden off CME providers,” she says.
Because her department is not required to be self-sufficient financially, she is not forced to rely on commercial support to a great extent. But many providers are in a different boat. “With so many CME programs dependent on commercial support for their existence, there is a built-in potential for bias at the CME provider level,” Brown says. When her department joint-sponsors programs with some CME providers and program directors, “Sometimes there's that little suspicion that they could be influenced because of a relationship they have that they're not currently required to disclose to us,” she says. “That's something that's not been addressed in the past and will be under the new Standards. The new rules can make it easier for us, because we don't have to be the bad guys. We can let the Standards be the bad guys for us and just point out we can't allow someone to do something” that has the potential for bias, she says.