More from the NAAMECC session at the National Task Force on CME Provider/Industry Collaboration conference: There was lots of great discussion after the member and audience survey portion was done.
One audience member brought up this intriguing question: "The law and logic don't necessarily equate sometimes. If we're talking off-label at an oncology activity, the grantor would have to say that that is off-label and you can't talk about it. So they'd be controlling the content. We're supposed to do independent education. It's clear in the ACCME Standards that it's my concern to deal with mistakes in the content. [Letting supporters review content] puts ourselves and grantors in jeopardy."
Lawrence Sherman, Chief Executive Officer with the Physicians Academy for Clinical and Management Excellence in New York and moderator of the discussion, asked, "Does any level of peer review coopt independence?"
Panelist Sondra Moylan, RN, President, American Academy of CME, said, "The ACCME recognizes that commercial supporters can be held accountable, so they may feel compelled to ask for review, and for the provider to let them review. However, it's up to the provider to decide to make a change, to control the content." It also makes a difference who is asking to do the review, and why (to check the science, or to approve the content), who the comments come back to, and who decides what to do with them. "I send it back to the faculty member and ask them to check their references. I like to involved the faculty chairperson too, and I like to go to an independent review. I don't tell the faculty that the comment came from the commercial supporter. The idea was floated about adding another disclosure that the content was reviewed by pharma for scientific accuracy, but no one picked up and ran with it.
Someone else asked if the products of six companies were included in the content, does that mean you should let all six review, or just the commercial supporter?
Moylan said to have a policy in place and follow it: "Exceptions will get you in trouble."
Panelist John Kamp, PhD, JD, Executive Director, Coalition Healthcare Communication, added, "I'm going to make sure every t is crossed, and I'm going to ask for a review. I wouldn't want to deal with anyone who wouldn't agree. I have to sign that report that goes to the OIG—I already know Jim Sheehan all too well, and I don't want to get to know him any better."
When asked if he would want to see all the data, or just that which is related to his company, the attorney said, "If you see an accident and stop to help, you may be liable. It's best to drive by. But that's a terrible way to be. I want to review everything."
What about if the content is all off-label? "I'm not here to review on- or off-label just that it's scientifically correct. If I ask for you to bias it in my direction, just as a test, and you do, I'll never work with you again." But wouldn't that be taken as your company marketing off-label? "I'd say, 'Jim, I did exactly what I said I'd do in our corporate integrity agreement and reviewed it for scientific accuracy."
Lawrence wrapped up the session with a great sports analogy (and I really don't like sports analogies, but this one was too perfect): "In baseball, the umpire makes the final call. In football, they now allow instant replay booth review. We're moving from a baseball model to a football model. The question is: Who's in the booth looking at the instant replay?"
