Coalition of Epilepsy Physicians Calls for Freedom of Expression for Non Accredited Educational Events

Academic neurologists are educators as well as physicians. As educators, academic neurologists, like many physicians who are experts in their field, participate in educational and promotional programs to share their experience and to encourage a dialogue among peers and colleagues in their respective fields. The goal of these educators is simple: advance science and improve patient outcomes and care. 

However, over the past several years, the dynamics surrounding educational and promotional programs have changed. For example, the pharmaceutical industry has decided to strictly enforce rules and regulations requiring faculty to exclusively show company slides without allowing editing. The main reason for these rules is because companies need to ensure that speakers and educators only discuss a products approved use (not off-label), and only discuss data which there is evidence for. These regulations were created to comply with recent Food and Drug Administration (FDA) regulations and recent lawsuits and/or settlements. 

Frustrated with their inability to give their own input when presenting educational or promotional materials, a group of neurologists recently sent a letter to the editor of Epilepsy & Behavior, asserting that a number of neurologists have been “uncomfortable using a pharmaceutical company’s slide deck during educational/promotional programs.” 

The letter was written by Dr. Selim R. Benbadis from the Comprehensive Epilepsy Program, Department of Neurology at the University of South Florida and Tampa General Hospital, Dr. R. Edward Faught Jr. from Emory University, Larry Hirsch from Columbia University, Michael Sperling from Thomas Jefferson University, Jeremy Slater from the University of Texas Medical School at Houston, and Joseph Sirven from the Mayo Clinic. 

In their “Open letter (and invitation) to the pharmaceutical industry: “No, we cannot just present your slide deck,” the neurologists explain that they have “gathered a coalition of nationally known and active epileptologists from large academic epilepsy centers” and have the support of many members of the American Epilepsy Society who participate in speakers’ bureaus.” 

As a result, the authors assert that there is “near-unanimous agreement among this coalition that the present rules for promotional programs are a disservice to our colleagues, trainees, and patients.” 

The authors recognize that “Academic neurologists participate in these programs because they believe that a valuable educational goal is achieved.” They further assert that neurologists “do not participate to promote sales of any drugs, and believe that the pharmaceutical industry supports non-CME programs not only to enhance sales, but to educate physicians for the ultimate benefit of patients.” 

The group of neurologists would like to start a discussion on how to reach a solution that will suit both industry and physician-educators. The creation of this dialogue is critical because as the authors note, “Without discussion and change in policy, reputable and respected faculty will entirely cease speaking in non-CME programs.” 

Several universities or institutions now explicitly prohibit their faculty from using pharmaceutical industry-prepared slides, and allow faculty to participate only in CME lectures. Other leaders in the field have decided on their own to abandon promotional programs altogether and take part only in CME events. 

Many neurologists feel that these “dinner program” talks fill an educational gap for many practicing physicians who cannot regularly attend neurology department grand rounds and would otherwise have no opportunity for informal and personal interaction with subspecialists. Given the value neurologists see in these programs, the authors ask whether there can be a “middle ground.” 

They want to “educate physicians more broadly, and believe it can be done ethically and legally while still delivering a useful message for both sides,” instead of reciting a company’s slides. Despite abuses in the past, they assert that “a few bad apples and lawsuits do not justify the current extreme rules of “compliance.” 

Moreover, they recognize that “Pharmaceutical companies risk throwing out the baby with the bath water if the end result is abandonment of non-CME programs by independent faculty.” Accordingly, the authors offer several options to explore:

• The preferred option is for companies to provide unrestricted educational grants to CME-granting institutions for educational programs for physicians. Most universities, many hospitals, and several national and regional societies are accredited CME providers.
• Make the faculty responsible for the content of their talk. If faculty promote off-label use or make other unfounded claims, they should be held responsible. Faculty could sign waivers exonerating the company, and the company could retain the right to pre-approve presentations for the sole purpose of ensuring that the speaker will make no off-label uses or unwarranted claims for products.
• Create a new type of educational event, somewhere between CME and promotional programs.
• Allow for two-part programs, with a promotional part (slide deck) followed or preceded by a faculty member’s own education program (CME or not). Again, some companies are beginning to do this after approving the speakers’ personal slides and educational message.

 Conclusion

The coalition of neurologists that supported and wrote this letter recognize the need to work with industry to improve promotional and educational programs that will ultimately benefit patients. They also urge other academic faculty to begin these discussions as well. Other medical organizations and specialists should follow this recommendation as soon as possible since physicians find value in these programs and want to educate their colleagues to benefit patients.

These educational and promotional events are voluntary, and those who have problems with them do not need to attend. Nevertheless, eliminating the participation and availability of educational programs and materials offered by industry will only exacerbate gaps in care that physicians in all areas experience today. As medicine and technology advance rapidly, our physicians need to stay up to date on the latest breakthroughs to help treat and diagnose Americans health problems. A dialogue between academia, physicians, and industry will help ensure that physicians continue to receive information that will make Americans healthier.