In an online study published today in the journal PLoS, lead researcher at the Mount Sinai School of Medicine revealed that only 18% of the total 192 pharmaceutical advertisements in biomedical journals adhered to FDA guidelines, and more than 50% did not enumerate adverse events including fatalities.
Lead author of the study and Associate Professor of Medicine at Mount Sinai School of Medicine, Dr. Deborah Korenstein, said: “Marketing research has consistently shown that journal advertising is the most profitable form of drug marketing, with an estimated return on investment of five dollars for every dollar spent. Our study, the first in nearly 20 years to provide a systematic assessment of the adherence of US advertisements to FDA guidance, shows that the current system is not in the best interest of the health of the public.”
A cross-sectional analysis was conducted on prescription pharmaceutical advertisements appearing in nine journals in November 2008. Researchers assessed two aspects: Compliance to FDA standards as well as the existence of pertinent content that was significant to physicians for safe prescription of medications.
They found that only 15 out of the total192 advertisements listed for 82 exclusive products were compliant to FDA Prescription Drug Advertising Guidelines. Furthermore, 28.9% had insufficient efficacy data, 48.2% failed to have authentic references, and huge 57.8% of the advertisements failed to present adverse risks associated with the treatment.
Dr. Korenstein added: “The limited resources of the FDA’s Division of Drug Marketing and Advertising are a major barrier to successful regulation of the pharmaceutical industry’s multi-billion dollar marketing budget. We are hopeful that an update in FDA regulations, with increased emphasis on the transparent presentation of basic safety and efficacy information, might improve the quality of information provided in physician-directed pharmaceutical advertisements.”