Direct-to-consumer advertising for bleeding disorders: a content analysis and expert evaluation of advertising claims.
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 >or=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 with risks/adverse effects, and the latter was more difficult to read [FRES of 32.0 for benefits vs. 20.5 for risks/adverse effects, a difference of 11.5 (95% CI: 4.5-18.5)]. 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.


CONCLUSIONS
As measured by our methods, print DTCA for bleeding disorders may not reach the FDA's standards of truth and fair balance.
Abel
G A
GA
Center for Outcomes and Policy Research, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA 02115, USA. gregory_abel@dfci.harvard.edu
Neufeld
E J
EJ
Sorel
M
M
Weeks
J C
JC
D000329:Advertising / Q000592:standards*; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use; D001778:Blood Coagulation Disorders / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D033181:Information Dissemination; D014481:United States; D014486:United States Food and Drug Administration
D000925:Anticoagulants