title: Adherence of pharmaceutical advertisements in medical journals to FDA guidelines and content for safe prescribing.
abstract: BACKGROUND
  Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA); adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing.
  
  
  RESULTS
  Cross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1-14). Six "teaser" advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1%) adhered to all FDA guidelines, 41 (49.4%) were non-adherent with at least one form of FDA-described bias, and 27 (32.5%) were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence.
  
  
  CONCLUSIONS
  Few physician-directed print pharmaceutical advertisements adhere to all FDA guidelines; over half fail to quantify serious risks. The FDA could better protect public health by creating new more objective advertisement guidelines requiring transparent presentation of basic safety and efficacy information.
authors.affiliation: Department of Medicine, Mount Sinai School of Medicine, New York, New York, United States of America. deborah.korenstein@mssm.edu
authors.forename: Deborah
authors.initials: D
authors.lastname: Korenstein
authors.forename: Salomeh
authors.initials: S
authors.lastname: Keyhani
authors.forename: Ali
authors.initials: A
authors.lastname: Mendelson
authors.forename: Joseph S
authors.initials: JS
authors.lastname: Ross
mesh_terms: D000329:Advertising / Q000592:standards* / Q000706:statistics & numerical data; D003430:Cross-Sectional Studies; D004345:Drug Industry / Q000379:methods / Q000592:standards*; D011307:Drug Prescriptions / Q000592:standards / Q000706:statistics & numerical data; D004358:Drug Therapy / Q000592:standards; D019983:Guideline Adherence / Q000592:standards* / Q000706:statistics & numerical data; D017408:Guidelines as Topic / Q000592:standards*; D006801:Humans; D010506:Periodicals as Topic; D004364:Pharmaceutical Preparations / Q000592:standards; D011634:Public Health / Q000379:methods / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations