“We need to lower the heat on the rhetoric,” said the Cleveland Clinic’s William Carey, MD, during his opening keynote at the American Medical Association’s National Task Force on Continuing Medical Education Provider/Industry Collaboration conference in Baltimore in September. He centered his talk around one of the key recurring themes when it comes to collaboration between healthcare professionals and industry: The perception that something fishy must be going on whenever there’s a financial relationship between industry and a healthcare professional.
His thesis was that a well-regulated industry/CME relationship benefits patients, healthcare professionals, and the public. And yet, because so much of the discussion around CME and industry occurs under the media and political circus tent among players who don’t (and for the most part don’t care to) understand all the regulatory nuances and the firewalls already in place, CME providers still have to deal with misperceptions about what it is they do, and why. The University of Pittsburgh, University of Pennsylvania, Stanford, University of California at Davis, and Yale are just some of the institutions that already have put strict limits on how their can interact with industry. He pointed out that some of the strongest objectors to collaboration—journal editors—accept advertising from pharmaceutical companies. “They say their firewalls are sufficient—why can’t they accept that the same is true of CME?”
One hot topic at the meeting was the latest report from the AMA Council of Ethical and Judicial Affairs, the 1-A-11 report, which in its fifth iteration the House of Delegates passed this summer. Carey asked the audience several questions and used an audience-response system to gauge where they stood on the controversial report, which asks that CME providers try to avoid “support or the participation of individuals who have financial interests in the educational subject matter.”
More than half of the audience believed that the CEJA report would cause minor changes in the CME industry, with 34 percent predicting it wouldn’t change anything, and 10 percent expecting it to have a big impact on the CME community. This lines up with answers to the next question, which asked what they thought the intent of the report was. Forty-one percent thought that it was to reduce commercial support (20 percent thought the intent was to eliminate it, while 39 percent said neither was the case). More than half agreed that the Accreditation Council for CME shouldn’t respond to the report by further refining its Standards for Commercial Support, while 31 percent said it should make some minor adjustments to the SCS.
The AMA’s Bette-Jane Crigger, PhD, also discussed the report, focusing on what she called the “10 myths about CEJA Report 1.” Among these are that it prohibits industry support of CME. It does allow commercial support under certain circumstances, she said, though it requires that providers be able to explain why support is necessary or why it is essential to the activity to have faculty who have financial ties to industry. She said that the report does not require CME providers to collect and disclose new kinds of information; the goal is to “set robust standards for disclosure” that include the magnitude, source, and nature of the relationship.
As for the common complaint that much of the report is unnecessary because it mirrors the ’s Standards for Commercial Support, she said that while some of the recommendations may be similar, the SCS is geared toward CME providers, while the CEJA report is for docs, and the ACCME’s requirements address operational aspects, where the CEJA report outlines “fundamental principles.” She also said the two differ in that “ACCME thinks conflicts can be resolved. CEJA 1 is predicated on understanding that conflicts of interest can only be eliminated, not managed.”
Another common complaint is that it will be an undue burden on those who have the fewest resources. Crigger said that CEJA 1 provides guidance on when to make exceptions based on factors including budget and locale. When asked about any possible impact the report might have on AMA PRA Category 1 credit, she said that the Council was considering what, if any, changes would need to be made to the criteria.
One topic at the meeting that was so hot that panel members came back for an unscheduled Q&A during a break was the FDA’s new take on Risk Evaluation and Mitigation Strategies. The Food and Drug Administration can require drug manufacturers to provide REMS to ensure that the benefits of its products outweigh their risks. Many consider this a potential new avenue for CME now that FDA has included prescriber training as part of the REMS for opioids. A panel made up of representatives from the AMA, the American Academy of Family Physicians, the FDA, and two pharmaceutical companies talked about the possible risks and benefits of getting involved in REMS.
Theresa Toigo, RPh, Assistant Director, Drug Safety Operations, FDA, pointed out that this type of risk management on drugs is not new; it stems from a 2005 guidance to industry on risk mitigation action plans. In most cases, labeling has been sufficient. (You can find a list of all the approved REMS by going to the FDA’s Web site and searching for “REMS.”)
An industry working group of both generic and brand-name opioid manufacturers now is trying to develop standardized REMS to reduce the burdens on the system. The group has submitted a large collection of documents to the FDA, which is now synthesizing all the information to come up with a blueprint providers can use to develop clinical applications that will be meaningful to individual practices. (To get an idea of what might be in the blueprint, Toigo said to read Appendix A of the letter sent to opioid manufacturers outlining opioid REMS implementation, which also can be downloaded from the FDA’s site. Update: A draft of the blueprint has been released, and the FDA is seeking feedback. Ccomments on the draft version are due by December 7, 2011. Comments can be submitted electronically to Docket No. FDA–2011–D–0771 at www.regulations.gov.) The group, and the FDA, is confident that REMS training can be done in compliance with the ACCME rules, Toigo said. A representative from pharma said the reason the accrediting bodies are comfortable with REMS is because the content is controlled by the FDA.
In terms of outcomes, Toigo said the FDA will want to know how many prescribers complete the training. But, she added, “We want people to learn, not just take the training.” When the blueprint is ready, it will be posted on the FDA’s Web site. As to whether more REMS will follow the opioid format and include a CME element, Toigo couldn’t really say. “We’ve never done this before.”
Blog Posts from the 2011 Task Force Meeting:
More on the Keynote Address (including a very funny video used by the speaker to illustrate a point)
Photos and Writeups from Day 2 of the Conference
Thoughts from the First Day of the Conference
Other Articles You May Want to Read:
AMA Approves CEJA Commercial Support Recommendations