Charles Caution, MD, PhD, medical director for a small medical education and communication company in New Jersey, has been a longtime advocate of transparency with safety data. His company has been awarded a large educational grant to conduct a dinner meeting series funded by the manufacturer of a blood thinner recently approved by the Food and Drug Administration. Stories about adverse effects of similar products have been published in the popular press and have been discussed on television talk shows.
Dr. Caution's needs assessment for this activity, including a thorough literature review and input from thought leaders and focus group participants, indicated a significant “opportunity gap” for education about the role of new agents in the armamentarium, as well as a comparison of the risks and benefits of other therapies. Just as he starts to schedule a planning committee conference call, colleagues bring him a newspaper article about serious adverse events associated with the newly approved product. Startled, Dr. Caution calls Dr. Effa Casey, medical affairs director at ABO Health Inc. (the commercial supporter) to determine how he can validate the data in the news story. He is shocked when Dr. Casey informs him that her compliance officer and regulatory attorneys won't let her provide safety data because it could affect CME content. (According to Accreditation Council for CME rules, as specified in a FAQ document released in October 2007, CME providers cannot ask commercial supporters for any advice or guidance related to content, including a review for accuracy.)
First, Do No Harm
Shouldn't patient care come first?
Parochka: Karen, the idea that newly emerging safety data cannot be validated by commercial supporters is ludicrous. What insurance carrier would want accurate findings withheld at a CME activity because of an accreditation regulation?
Overstreet: This case presents a real conundrum because providers want to be compliant withrules and policies, but patient care should be the ultimate goal. As a patient myself, I want my caregivers to have the best, most up-to-date, relevant, and valid data.
Does patient safety trump accreditation regulations?
Parochka: Too often CME professionals cower at the thought of questioning accreditation practices. Will we remain complacent in order to achieve compliance — at the risk of harm to others? Let us hope not.
Overstreet: You're right, Jackie. In the interest of protecting the public, providing accurate information that can assist clinicians in effective decision-making should be most important. In addition, supporters that are under a Corporate Integrity Agreement (many of them are), may be required by the government to notify the public of emerging safety information. How does this jive with accreditation rules?
Should providers avoid citing “data on file” as a reference for important new information? Where can they find up-to-date data?
Overstreet: Just as with all content, providers should seek credible sources of information to help validate emerging information. Askingand advisers for recommendations and obtaining abstracts presented at recent conferences may help. I'm generally against citing “data on file,” but this is perhaps the one instance where I might allow it to be used. (“Data on file” refers to clinical study reports that the manufacturer has not published. This data has not been peer-reviewed and participants who want to learn more will not be able to find information.)
Parochka: I agree, Karen. Given the long lag time for presentation and publication of clinical data, CME planners need to rely on the experts.
Karen Overstreet, EdD, RPh, FACME, is president, Indicia Medical Education LLC, North Wales, Pa. Reach her at Karen.Overstreet@indiciaed.com.
Jacqueline Parochka, EdD, FACME, is president and CEO, Excellence in Continuing Education Ltd., Gurnee, Ill; and partner, PTR Educational Consultants. Reach her at JacquelineParochka@comcast.net.