February 1999 Bulletin

New policy on commercial support of CME materials

The Academy has adopted a new policy on commercial support for enduring continuing medical education (CME) programs which formalizes the Academy's approach to multimedia and video CME programs. The new policy is consistent with the Accreditation Council for Continuing Medical Education's "Standards for Commercial Support."

The policy states that enduring educational materials-printed, recorded or computer-assisted instruction materials-sponsored and distributed by the Academy must be free of commercial bias for or against any product. If the enduring education materials are concerned with commercial products they must present objective information about those products, based on scientific methods generally accepted in the medical community.

The policy requires authors, developers, producers to disclose to any audience any and all potentially biasing factors including in-kind or financial support, as well as financial or professional interests of the producer/developer with the commercial products used in the educational presentation.

Enduring materials must provide a balanced view of therapeutic treatment options for the treatment of musculoskeletal patients. The use by authors of generic names to describe a device or pharmaceutical increases a sense of impartiality and is strongly encouraged.

If a medical device or pharmaceutical is discussed or described in an enduring education program, the author or presenter is responsible for including the Food and Drug Administration clearance status. If applicable, the policy mandates the disclosure of the investigational status of devices and pharmaceuticals.

Some medical devices or pharmaceuticals not cleared by the FDA or cleared by the FDA for a specific use-only may be used "off-label," if in the judgment of the treating physician, such use is medically indicated to treat a patient's condition. "Off label" uses of a device or pharmaceutical may be described in the enduring educational materials as long as the lack of FDA clearance for such uses is also disclosed at the time it appears in the program. Results from published scientific studies known to the author relating to the described intended use should be discussed, if so doing will not adversely affect the study or violate some other regulatory requirement.

The policy also mandates complete and explicit disclosure of conflict of interest on an application form. If financial support was provided for the creation of a video or multimedia program, it must be disclosed to the viewing audience at the beginning of the program.

A conflict of interest may be considered to exist if a program author is affiliated with or has financial interest in any organization(s) that may have a direct interest in the subject of the presentation. While situations involving a potential conflict of interest are not inherently bad or wrong, the prospective audience must be made aware of the affiliation/financial interest.

The intent is not to prevent an author with an affiliation or financial interest from making a program. It is intended that any potential conflict be identified openly so that the viewers/ users have the full disclosure of the facts and may form their own judgments about the program.

A reasonable test to guide decisions about what to disclose is whether any particular affiliation could cause embarrassment to the individual or institution involved, or lead to questions about the author's motives, if such affiliation(s) were made known to the general public.

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