The ACCME’s Standards for Commercial Support require that accredited continuing medical education be independent from commercial interests. The hallmark of independence is that the control of content lies with the accredited continuing medical education provider. In the world of continuing medical education there are faculty and planners who are involved in both the device manufacturers and pharmaceutical industries as well as in accredited continuing medical education. And our Standards for Commercial Support allow for the movement of these people back and forth between industry as advisors or consultants, researchers, scientists and the practice of medicine — the profession of medicine. And the Standards for Commercial Support allow for this under Standard 2, the identification and resolution of conflict of interest.
But, those people who are employees of Industry, who have a fiduciary responsibility to Industry, who teach and develop new information in Industry, have been prohibited from participating in accredited continuing medical education. And this ban is appropriate when the content that they wish to teach about is about products. That’s a hallmark of accredited continuing medical education, is to separate promotion from education. And we’ve been able to have a fine line, a bright line, a sharp line, a demarcation, between promotional activities and accredited continuing medical education.
But, we have found over the last year or two that that thin line, that sharp line, may need to be widened somewhat, because involved in the discovery process and in the early phases of translation of new information into first use and regular use of products, are a wide number of people that are employees of Industry. And that the accredited providers can retain control of the content of accredited continuing medical education that involves the reporting of the discovery phase of product development ‑ by virtue of having the opportunity to look at the results, to vet the results and the conclusions, to ensure the validity of the process whereby those results and conclusions were developed, and by ensuring that the placing of the reporting inside accredited continuing medical education is in their control. And they make independent decisions as to whether or not this content is relevant to accredited continuing medical education and that it should be reported. And taken together, the proper construct ‑ the accredited provider can retain control of the continuing medical education and the content and at the same time allow employees of Industry to do the reporting of the science.
There’s also other examples where it’s less problematic for the review and for the internal controls. For example, when an industry scientist is reporting on biology or the physics of devices — not on devices — but rather on that basic science, that isn’t the separation of Industry and accredited continuing medical education that the Standards for Commercial Support were designed to ensure. So, in that case it would be allowed for an industry employee to teach.
Another is when an employee of a device manufacturer wants to teach in a topic of continuing medical education that has nothing to do with that firm. For example, an employee of a company that makes sutures wants to help a specialty society develop continuing education on the management of disasters ‑ that that person should not be prohibited from the development of education on disaster management or in the planning or the presentation of it, because who she works for has nothing to do with that content. But, everyone needs to be apprised of his or her employment and when any planning gets to an area that is relevant to the products or services or business lines of that commercial interest. That all would put into proper place the safeguards.
Applications to Practice
As we look at the issues of independence in accredited continuing medical education and ensuring that the content of accredited CME is free of the control of commercial interests, we need to reflect and recognize that there’s a spectrum of what kind of educational activities we can talk about now in accredited continuing medical education. At one end, there’s the traditional oral or live presentation, or enduring materials, about optimum use of certain products, certain interventions or the health care of people. Further along, there’s journal-based continuing medical education where discussions by professionals about material that has been recently published or has been present for some time in the literature, to arrive at a consensus or an understanding of why we approach patient care in a certain way. And moving further along on this continuum, we find our self at the discovery phase or the translation of the discovery into first use, where there’s the first oral presentations of the science, the written abstract of that science, the first publication of that science. That we want to ensure that there is a good flow of that kind of information into the hands of the people who can make decisions about how best to use that new information. A lot of that is now included in accredited continuing medical education. And if you look across that spectrum, and you look at the potential role of the employees of commercial interests, it’s clear that there isn’t a role for the employees of commercial interests in the development of the enduring material or the oral presentation on therapeutics, on clinical examination, on physical diagnosis, on the care of patients — that’s not where the employees should participate. That’s where it should be education by the profession for the profession.
As you move further along right to the very end, when discovery is occurring inside Industry and the profession wants those results to be disclosed either in an abstract or in an oral presentation or in an article — our profession has traditionally had internal controls put into place to ensure that the profession is in control of that content. And that’s true at the live presentations of academic societies or specialty societies where new research wants to get translated. You can look at our Web Site for frequently asked questions and more information on the attributes of the accredited provider and the features of the presentation and the content that predispose to our independence and the control of that continuing medical education being in the hands of the accredited provider.