Commentary & Perspective

Commentary & Perspective on
"The Validity of Claims Made in Orthopaedic Print Advertisements"
by Timothy Bhattacharyya, MD, et al.

Commentary & Perspective by
Roy Crowninshield, PhD*,
Zimmer, Inc., Warsaw, IN

This article addresses an important subject that is central to the goals of both orthopaedic surgeons and the industry in partnering to provide optimal patient care. Although the authors' method of evaluating the validity of these advertising claims, which involved the random selection of advertisements and a blinded review by senior orthopaedists, has inherent limitations, the conclusions drawn by the investigators should be useful to the profession and embarrassing to the industry. The orthopaedic industry should be disappointed to learn that, in a representative sample of fifty print advertisements in professional orthopaedic publications, only 14% of claims made were judged to be "well supported" by the supporting data provided by the companies that placed the ads. It should be further disappointing that 34% of claims were judged to be "possibly supported" by scientific data and that the majority of claims were judged by two out of three reviewers as unsupported.

In advertising its products to orthopaedic surgeons, the industry is responsible to be truthful and to comply with Food and Drug Administration (FDA) and Federal Trade Commission (FTC) requirements for substantiation of advertisements. Basic truthfulness is essential to the development and maintenance of the trust that must exist between the profession and the industry to ensure quality patient care. Advertisements for medical devices and pharmaceutical products are included in the category of product labeling that is regulated by the FDA. Claims made in product labeling are required to be consistent with claims that have been approved or allowed in the appropriate FDA product-approval or clearance process. The FDA and the FTC can judge inaccurate advertising as "misbranding" or "false and misleading labeling."

This publication by Bhattacharyya et al. should serve as a reminder to the orthopaedic industry to review their prepublication process of advertising design. Before being distributed, advertising should be subject to internal review processes that include validation of the content, including performance claims or implications, by scientific experts and a check for adherence to the regulatory guidelines of the FDA and the FTC. The orthopaedic profession should not bear a "readers beware" responsibility. Rather, it is the responsibility of the orthopaedic industry to be accurate in its advertising and other efforts to promote products. Orthopaedic surgeons have a right to expect that the information in print advertisements such as those evaluated by Bhattacharyya et al. is, in fact, accurate and truthful. This article unfortunately demonstrates that this expectation is not always fulfilled.

*In support of the research or preparation of this manuscript, the author received grants or outside funding from Zimmer, Inc. In addition, the author received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity (Zimmer, Inc.). No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the author is affiliated or associated.