Although the back-to-school season has barely begun, both the pharmaceutical industry and the FDA have already received “could do better” report cards. According to researchers from Mount Sinai School of Medicine, only 18% of 192 pharmaceutical advertisements in biomedical journals were compliant with FDA guidelines. And, over half failed to include serious risks including death. The study, was the first in almost 20 years to provide a systematic assessment of the adherence of US pharmaceutical ads to FDA guidance. Researchers looked at prescription pharmaceutical ads published in nine major peer-reviewed journals, including: the Annals of Internal Medicine, Blood, JAMA and the New England Journal of Medicine, during the month of November 2008. They evaluated adherence to FDA standards and the presence of safety information. Of the 192 advertisements for 82 unique products, only 15 fully adhered to all 20 FDA Prescription Drug Advertising Guidelines. Advertisements contained bias with regard to a wide variety of issues:
- 57.8% of the advertisements did not quantify serious risks
- 48.2% lacked verifiable references
- 28.9% failed to present adequate efficacy quantification
However, despite the high rates of FDA non-adherence, the mean number of biased features in each advertisement was low and most advertisements they reviewed satisfied the majority of FDA guidelines. Part of the problem it seems is that the FDA emphasizes avoiding frankly false information and balancing efficacy and safety information but does little to encourage the presentation of useful and accurate information. For example, an ad containing no specific efficacy claim, no quantification of drug safety and no verifiable references would adhere fully to FDA guidelines, despite presenting no practical information for clinicians.
Dr. Deborah Korenstein, lead author of the study and Associate Professor of Medicine at Mount Sinai School of Medicine is concerned by the lack of adherence. “While the majority of physicians deny that advertisements inform their prescribing marketing research has consistently shown that journal advertising is the most profitable form of drug marketing, with an estimated return on investment of $5 for every dollar spent.” She does however acknowledge that it may be unrealistic to expect ads to inform rational prescribing by presenting complete drug safety and efficacy, since they primarily serve a marketing function and are not designed to train physicians to prescribe. Her advice? “Physicians should ensure that their prescribing is informed by the clinical literature and not by marketing materials.” She also notes that the findings have important policy implications. Although he FDA has already demonstrated a desire to improve the quality of pharma ads, by enlisting doctors to review advertisements through its “Bad Ad” program, Korenstein suggests that the current FDA guidelines are subjective, challenging to enforce and do not emphasize transparency and the inclusion of basic information relevant to prescribing. She suggests that the FDA should update and simplify its guidelines for physician ads. According to her, guidelines should be straightforward and objective. They should ensure that ads present clear risk quantification, absolute benefit information, description of the appropriate population to receive the drug, and verifiable references to published peer-reviewed literature. In other words, the FDA may hold the key to improving the quality of pharmaceutical advertisements rather than the industry itself.