THE APPROVAL OF THE

Accreditation Council for CME's new Standards for Commercial Support was the biggest news announced at the American Medical Association's 15th Annual Conference of the National Task Force on CME Provider/Industry Collaboration, held in late September in Baltimore. The conference attracted a record 511 attendees and 21 exhibiting companies.

In his session explaining the new Standards, Murray Kopelow, MD, chief executive, ACCME, addressed not only the packed crowd at the conference but also, via a live feed, the attendees at the Pharmaceutical Marketing Congress, which was being held at the same time in Philadelphia.

The thrust of the new Standards is to ensure that CME is in the public interest, he said, with independence, transparency, and the separation of promotion from education as basic principles. “Certified CME is professional education for the medical profession, by the medical profession. That's what differentiates CME from promotion.”

However, that doesn't exclude pharmaceutical companies from contributing. “For example, if a pharmaceutical company has information that needs to be included in a CME activity because that's what's in the public's best interest — it would be wrong for any of us to say we want that quieted because it also serves to benefit a commercial interest. This is about the public interest, not censorship.”

While the old Standards were about the management of money, he said, the new Standards also talk about independence. Those are two different concepts, he underscored. “Even in the absence of commercial support, independence is still an issue.”

To ensure independence, the new rules state that faculty disclosure of financial relationships with industry is no longer enough — providers must now identify, manage, and resolve those conflicts of interest. “Standard 2 is about the resolution of personal conflicts of interest — not about the removal of people with commercial interest,” Kopelow said.

The ACCME considers financial relationships to cause a conflict of interest when the person has a current (during the previous 12 months) financial relationship with a drug or device company and the opportunity to control content about that company's products. There is no minimum dollar amount specified. That's because “no matter how well-intentioned, well-meaning, or professional someone is, the potential for increasing the value of the financial relationship with the commercial interests creates an incentive to influence the content of CME,” said Kopelow. While salaries, royalties, and intellectual property rights are among the benefits that constitute financial relationships, the honoraria that faculty receive for teaching CME activities do not constitute a financial relationship with the grantor.

Kopelow also discussed a document, which had just been released by the ACCME, outlining strategies for resolving conflicts of interest. This document created a firestorm at the conference, as it appeared to preclude people with financial relationships with industry from speaking or to limit what they could discuss. A second document released on October 20 offered more options and received a much more favorable response from providers.

Definitive Answers

Ending his talk, Kopelow drew cheers from the audience when he said, “We're going to do something new at the ACCME. We're going to answer questions directly.” He did add that sometimes the answer would have to be “mostly yes or mostly no.” Kopelow fielded questions from attendees at the AMA conference and the Pharmaceutical Marketing Congress. Here are some excerpts :

Q: Are you concerned about indirect control; for example, if an accredited provider has a very deep relationship with a company, perhaps not in the area of the current program, but in other areas, and they understand what the company wants to do because they've done a lot of programs in the past?

Kopelow: Yes. We are concerned about anything that introduces commercial bias into the activity when that bias is not in the best interests of the public. It's not like a police action where this amount of activity is something that we are going to regulate out.

Q: How can commercial supporters hold accredited providers accountable to these Standards for Commercial Support?

Kopelow: There are two parts to being accountable. One is that accredited providers spend the money according to the written agreement. The other, more interesting, part is that the commercial supporters say, “You will not accept suggestions from any commercial interest, you will not pick teachers who are on the speakers bureau of our programs.” If an accredited provider does what I call “nudge, nudge, wink, wink” — what we want is the commercial supporters to say, “This is a provider who doesn't understand or respect the rules and will only get us all into trouble.”

Q: As a result of the OIG pharmaceutical marketing compliance guidance, some companies' legal departments are becoming much more engaged in grants, and are much more interested in [learning about] the details of planning activities during the grant application process than ever before. Some of us on the provider side are feeling pinched between some of the companies' exuberance — they want to know everything to prove how independent they are — and our own process to demonstrate meaningful independence. [We believe] the less the company knows about what we are doing during the planning phases the better off we are. What are your comments?

Kopelow: If the commercial interest knows everything, it may contribute to transparency rather than compromise independence. With the updated Standards we can create bright lines of behavior that can stand up to scrutiny. If we can get the OIG and the FDA to say that [our system] meets their standards, then pharma legal departments won't have to be so afraid. That may be naive and optimistic, but I've been accused of that before.

Q: If a pharma company gives a grant to a for-profit accredited provider, couldn't the grant be an incentive to influence content?

Kopelow: Yes, it could be. I believe there are some accredited providers and some business models that will be more challenged by this system than others. The for-profit providers are not commercial interests in our minds. They are accredited providers regardless of the business model they use. But the organizations that have an incentive to keep doing a certain type of activity or content in order for the cash to flow — that's a real concern. But all accredited providers have incentive — there's a lot of money [involved].

In response to another attendee who expressed concern about MECCs (medical education and communication companies), Kopelow said that some of the best strategies for managing conflict have been implemented by communication companies, and that some MECCs have received exemplary six-year compliance from the ACCME. He continued: “Our system wasn't created to have that community of CME provider. Our system wasn't created to have $1 billion of commercial support. This is a very different world, and we are working hard to manage the circumstances. These problems are also present in for-profit hospitals within academic medical centers. The fact that not-for-profit organizations hold patents is incredibly complicated. Our approach is not to ghettoize, but rather to integrate.”

As for implementing the new Standards, a transitional period will extend into May 2005, Kopelow said. The first accreditation decisions based on the new Standards will be made in November 2006. “We will do the best we can in the next 18 months to offer constructive advice and resources,” he added.

For more on the new Standards, see “Choice, Not Censorship,” page 23.
Tamar Hosansky

From the Trenches

Winnie Brown, CME director, Truman Medical Center, Kansas City, Mo., outlines two attempts her office made to manage conflicts under the new Standards for Commercial Support:

Case 1: Indignation The speaker had been confirmed prior to the effective date of the new Standards. We had obtained his disclosure information and were planning to “grandfather” him in under the old SCS. We thought we'd let him know about the new Standards for Commercial Support, so he wouldn't be surprised when he heard about them from someone else. The course director who selected him had also completed a form attesting that he (not the pharma supporter) had chosen the speaker. Both the speaker and course director had financial relationships with the commercial supporter.

The speaker sent an e-mail to the course director indicating that he “rarely participated in a promotional program.” He went on to say that our letter to him told him that since he had a relevant financial relationship with a particular pharma company that in the future he would not be able to speak under the new guidelines. While our letter did not elaborate on other ways that the conflicts might be managed, the intent was just to alert him to the new SCS. After saying that he felt it in the best interest of our institution to find a speaker less biased than he, he finished his letter stating that “someone needs to think about some of the interpretation of these rules before implementation.”

The course director proceeded to send a letter to our chief medical officer with a copy to our affiliated medical school dean, and the chair of the department, indicating that this situation was embarrassing and offensive to invited speakers. He suggested that our “policies be looked at and revised so that we can attract speakers with national and international reputations.”

Case 2: Cut the Ties We advised the course director (a different person than in case 1) of the new Standards for Commercial Support. He was planning to have his department chair give a presentation at a conference that had not yet been finalized. We weren't a party to the discussion that ensued between the course director and department chair, but later received an e-mail from the course director stating that the department chair had decided to terminate his relationship with the pharma company that will be asked to provide an educational grant for the conference. The department chair was a member of that pharma company's speakers bureau.