“Is thetrying to put itself out of business?” commented one CME provider during the American Medical Association's conference on CME Provider/Industry Collaboration, held in September in Baltimore. During the conference, Murray Kopelow, MD, chief executive, Accreditation Council for CME, announced that at long last the new Standards for Commercial Support had been approved. Since the Standards had garnered widespread support in the CME community, that didn't seem a controversial announcement — until Kopelow released accompanying documents, with recommendations for resolving conflicts of interest. One strategy, explained Kopelow, is for speakers to alter or sever their relationships with drug firms — a recommendation that drew “Are you serious?!” laughter from attendees. Or CME providers can restrict the content of speakers' presentations, Kopelow said. For instance, a doctor who is a paid researcher for a drug firm could discuss the research results — but not make any recommendations.
The ACCME's solutions were unrealistic and constituted censorship, contended many CME professionals at the conference. Since “the best and the brightest” physicians have relationships with the pharmaceutical industry, it would ultimately hurt patient care to limit their participation in CME programs, they said.
The firestorm was similar to the one unleashed at the 2003 Alliance for CME conference, when the first draft of the Standards was released saying that speakers with a conflict of interest would automatically be disqualified from serving as. But it was déjà vu with a difference — in this case, within weeks of the conference, the ACCME released additional FAQs, which calmed the storm by providing more options for resolving conflict of interest, including putting together a peer-review process to approve presentations, and ensuring that presenters reference the best available evidence in their talks. Responding directly to the CME community's concerns, the new implementation document specifically says that conflicts of interest can be resolved while preserving the participation of experts with financial relationships.
We interviewed Kopelow the day after the new FAQs were released, and asked him to clarify some points.
MM: How were the implementation guidelines developed?
Kopelow: The board authorized staff to act for ACCME in providing interpretations and explanations about implementing the Standards. These documents are resources and aids; they are not a new or additional set of acceditation requirements. They are not compliance criteria. Only the ACCME accreditation process establishes such criteria.
Providers have already said that the updated Standards represent a new culture; for example, senior CME staff have told me that this presents an important faculty development issue for them. We've had the Standards in place for 12 years and 30 percent of our providers cannot verify that faculty are disclosing financial relationships. The member organizations, the specialty societies, the schools of medicine, the academic medical centers can enhance their faculty development programs. This can be an important CME contribution to professionalism and education.
Why isn't it enough to resolve a conflict of interest to add someone who does not have a conflict, for example a point-counterpoint presentation?
It might be, depending on the facts of the situation. Conflict of interest is a personal thing; it's imbued in a person. Adding someone without a conflict contributes to the overall balance of the activity but it doesn't resolve the other person's conflict of interest. If I have a financial relationship with a firm and I want to make claims about the firm's product, then putting you beside me to do the counterpoint doesn't necessarily do anything to validate my claims about the product.
Will the clinical trials registry make a difference in providing more evidence to draw from?
In our content validation policy it says CME should not include recommendations [about treatment or therapies] known to be ineffective. Up until now there has not been a comprehensive source of data on what is ineffective. I believe absolutely that the registry is going to be a very powerful tool for providers and teachers. If there are studies to prove that one antibiotic is no better than the other one, if those studies were stopped because after six months it was obvious there was no difference — that's important negative data. It also needs to be incorporated into CME.
If a faculty member has relationships with multiple pharma companies, does that mitigate a conflict of interest if the person is presenting at an activity supported by only one of those commercial interests?
The ACCME does not have a policy on that. At the moment you still need to disclose to the provider and to the learner that these relationships exist. There certainly is a sense from some people that many relationships [mitigate conflicts of interest].
How do providers resolve conflict of interest dealing with the first drug in a new class?
This is an important and complicated situation and it has to be treated with a great deal of care by the teachers who find themselves in these circumstances. Cures and new important clinical implications need to be shared in CME. The most prevalent current approach to this enormously important task of translating new information into practice is for faculty to incorporate perspectives on what the best evidence says, and answer questions based on what they know, explaining that the rest is speculative.
I'm sure you've seen the press release from the American Society of Cataract and Refractive Surgery, which said that the initial implementation documents would suppress truthful speech. What are your comments in light of the additional FAQs document?
What we released yesterday actually requires more speech — the literature, the comments of peer reviewers. The ACCME has no policies on limiting what can be discussed. Policies are about how to prevent commercial bias. ACCME is sensitive to issues concerning censorship.
Some providers say there needs to be more enforcement of the Standards.
Yes, that observation was made throughout the process of updating the SCS. The ACCME [and CME professionals] have said that there should be a system of observation and surveillance and we are looking into that. Do we need to have observers in the field to get prevalence of commercial bias data? [With that data] we could report that we have measured [compliance] with a valid and credible tool and 99 percent of the activities are free of commercial bias, that our system is effective.
Is the ACCME concerned about MECCs' ability to comply with the Standards?
ACCME knows that compliance with the Standards for Commercial Support is a challenge for all providers. The education companies are a diverse group of providers. The business model creates challenges, but as a group the education companies have always been able to address these challenges.
What are the ACCME's plans for addressing providers' concerns and questions in the future?
This is a very high priority. For example, I just talked with all of our communication companies [via an audioconference organized by the North American Association of Medical and Communication Cos. for its members]. It is a challenge to meet the diverse needs of the providers. Often we are accused of being too reticent to give examples or suggestions and sometimes, when we give examples, they are perceived to be new or unrealistic requirements. I believe we have a good relationship with the provider community — a community that is working very hard to provide excellent CME. We will continue to provide support to them as we always have.
Taking a Public Stand
“New Rule Limits What Physicians Say in Classes,” read The Wall Street Journal headline of September 29. The WSJ article and others picked up by wire services across the country, said that the Accreditation Council for CME's new Standards for Commercial Support would limit what faculty members with financial ties to the pharmaceutical industry could talk about during CME activities. While many in the CME community were up in arms about the new Standards' implementation documents, which outlined those limitations on presenters, the American Society of Cataract and Refractive Surgery, Fairfax, Va., took public action. It issued a press release charging that the implementation documents accompanying the new Standards “would suppress truthful speech and hurt patient welfare.”
“We felt that we needed to make a public statement, because the steps required to adhere to [the implementation strategies] would absolutely end up with censorship and absolutely negatively impact medical education,” says Laura Johnson, director of education, ASCRS. “We also felt that the tone of the [ACCME's comments in the press] was a strong condemnation of the education we worked hard to put forth. We felt we needed to make a public response to that.” While the organization did not expect widespread media response to its press release, it did achieve one of its goals, says Johnson. “Within a short period of time, if you searched on the Web for ACCME, you came up with our response to that original article. So [the initial coverage] was not standing alone.”
Like many others in the CME community, Johnson says the second set of FAQs released by the ACCME addressed many of her concerns. “First and foremost, they specifically note that financial interest does not mean automatic exclusion. We do have a peer-review process in place for the majority of our meetings; a lot of CME providers already have that process in place or could put it in place relatively easily. We're very glad to see that peer review coupled with full financial disclosure will be acceptable so that we can continue to provide cutting-edge information. Even though this started out on a negative, I feel much more positive about the health of the CME community and the future.”
There are still a few sticking points. Under the new Standards, anyone in the position to affect the content of CME must disclose not only their relationships with pharma firms, but also the financial relationships of their spouse or partner. While Johnson says they will probably add that requirement as a line item in their financial interest statement, the organization is reviewing “whether or not it's appropriate for us to be gathering that from a legal point of view. We don't necessarily feel that it's appropriate for us to have a large dossier on our faculty.”
While Johnson has a peer-review process in place for her larger meetings, she doesn't have “quite as many layers” for her smaller meetings. “I think I'm going to be challenged to ensure that the smaller meetings can continue to be effective without being overwhelmed with additional paperwork that slogs down the process. But I don't feel that it's unworkable.”
She adds that the ACCME's review process will make the transition easier. “One of the things that's the biggest positive about the ACCME is that they look for improvement and self-analysis and review — and they don't fault you if you get it wrong once. They only fault you if you fail to recognize a failing or if you recognize a failing but don't do anything to fix it. They're going to continue to recognize us if we're working toward the goal.”
As for helping providers comply with the new Standards, she says, “My wish list would be that maybe once a month the ACCME would publish two or three concrete examples [of implementation strategies]. That would help us think creatively.”
She also says the ACCME needs to do more monitoring of activities. “I hope they will be able to find something that isn't a big brother system but that is more effective than the current system in ensuring that CME providers really are making the effort and that something happens to those providers that are not adhering to those rules.”