The majority of pharmaceutical advertisements in biomedical journals fails to quantify serious risks including death, a US study has shown.
The study, led by the Mount Sinai School of Medicine in New York, found that of 192 pharmaceutical adverts, only 18% were compliant with the US Food and Drug Administration guidelines and 57% did not identify serious health hazards.
In addition, 48.2% of advertisements lacked verifiable references, and 28.9% failed to present adequate efficacy quantification.
Lead author of the study Dr Deborah Korenstein said, “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.”
The associate professor believes that “limited resources” of the FDA’s Division of Drug and 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,” Korenstein added.
Researchers at the medical school performed a cross-sectional analysis of prescription pharmaceutical advertisements published in nine journals in November 2008 and evaluated adherence to FDA standards and the presence of content that is important for physicians to use when safely prescribing the drugs.