Department of Medicine, Mount Sinai School of Medicine, New York, New York, United States of America.
PLoS One. 2011;6(8):e23336. doi: 10.1371/journal.pone.0023336. Epub 2011 Aug 17.
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.
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.
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.
美国食品和药物管理局（FDA）监管医生指导的药品广告；目前尚不清楚是否遵守 FDA 指南。我们的目的是确定生物医学期刊中医生指导的印刷广告对 FDA 指南的遵守率，并描述安全处方的重要内容。
对 2008 年 11 月美国顶尖生物医学期刊上发表的原始研究的药品广告进行横断面分析。我们排除了设备、非处方药物和疾病意识的广告。我们利用 FDA 指南项目来识别独特形式的广告偏见，将广告分类为符合 FDA 指南、至少有 1 项不符合或至少有 1 项不符合的广告。我们还评估了安全处方的重要广告内容，包括效益量化、风险信息和可验证的参考。所有广告均由 2 名或更多研究人员进行评估，意见分歧通过讨论解决。12 种期刊符合纳入标准。其中 9 种含有药品广告，包括 82 种不同产品的 192 种广告；每种产品中位数为 2 个（范围为 1-14 个）。6 个“广告噱头”只提供了药物名称，留下了 83 个完整的独特广告。15 个广告（18.1%）符合所有 FDA 指南，41 个（49.4%）至少有一种 FDA 描述的偏见形式不符合，27 个（32.5%）由于信息不完整可能不符合。安全处方的重要内容往往不完整；57.8%的广告没有量化严重风险，48.2%的广告缺乏可验证的参考，28.9%的广告没有充分呈现疗效量化。研究局限性包括其仅关注一个月的广告、FDA 指南本身的主观性以及对遵守情况的必要主观性。
很少有医生指导的印刷药品广告符合所有 FDA 指南；超过一半的广告没有量化严重风险。FDA 通过创建新的更客观的广告指南，要求透明呈现基本的安全性和疗效信息，可以更好地保护公众健康。
