Healthy Skepticism Library item: 14027

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Abel GA, Neufeld EJ, Sorel M, Weeks JC.
Direct-to-consumer advertising for bleeding disorders: a content analysis and expert evaluation of advertising claims.
J Thromb Haemost 2008 Jul 18;
http://www3.interscience.wiley.com/journal/120835477/abstract

Abstract:

Objective: In the United States, the Food and Drug Administration (FDA) requires that all direct-to-consumer advertising (DTCA) contain both an accurate statement of a medication’s effects (“truth”) and an even-handed discussion of its benefits and risks/adverse effects (“fair balance”). DTCA for medications to treat rare diseases such as bleeding disorders is unlikely to be given high priority for FDA review. Methods: We reviewed all DTCA for bleeding disorder products appearing in the patient-directed magazine HemeAware from January, 2004 to June, 2006. We categorized the information presented in each advertisement as benefit, risk/adverse effect, or neither, and assessed the amount of text and type size devoted to each. We also assessed the readability of each type of text using the Flesch Reading Ease Score (FRES, where a score of >/= 65 is considered of average readability), and assessed the accuracy of the advertising claims utilizing a panel of five bleeding disorder experts. Results: A total of 39 unique advertisements for 12 products were found. On average, approximately twice the amount of text was devoted to benefits as compared to risks/adverse effects, and the later was more difficult to read (FRES of 20.45 for risks/adverse effects versus 32.08 for benefits; difference of 11.56 [95% CI: 4.52, 18.60]). Only about two-thirds of the advertising claims were considered by a majority of the experts to be based on at least low-quality evidence. Conclusion: As measured by our methods, print DTCA for bleeding disorders may not reach the FDA’s standards of truth and fair balance.