Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.
PLoS Med. 2012;9(8):e1001280. doi: 10.1371/journal.pmed.1001280. Epub 2012 Aug 7.
Litigation documents reveal that pharmaceutical companies have paid physicians to promote off-label uses of their products through a number of different avenues. It is unknown whether physicians and scientists who have such conflicts of interest adequately disclose such relationships in the scientific publications they author.
We collected whistleblower complaints alleging illegal off-label marketing from the US Department of Justice and other publicly available sources (date range: 1996-2010). We identified physicians and scientists described in the complaints as having financial relationships with defendant manufacturers, then searched Medline for articles they authored in the subsequent three years. We assessed disclosures made in articles related to the off-label use in question, determined the frequency of adequate disclosure statements, and analyzed characteristics of the authors (specialty, author position) and articles (type, connection to off-label use, journal impact factor, citation count/year). We identified 39 conflicted individuals in whistleblower complaints. They published 404 articles related to the drugs at issue in the whistleblower complaints, only 62 (15%) of which contained an adequate disclosure statement. Most articles had no disclosure (43%) or did not mention the pharmaceutical company (40%). Adequate disclosure rates varied significantly by article type, with commentaries less likely to have adequate disclosure compared to articles reporting original studies or trials (adjusted odds ratio [OR] = 0.10, 95%CI = 0.02-0.67, p = 0.02). Over half of the authors (22/39, 56%) made no adequate disclosures in their articles. However, four of six authors with ≥ 25 articles disclosed in about one-third of articles (range: 10/36-8/25 [28%-32%]).
One in seven authors identified in whistleblower complaints as involved in off-label marketing activities adequately disclosed their conflict of interest in subsequent journal publications. This is a much lower rate of adequate disclosure than has been identified in previous studies. The non-disclosure patterns suggest shortcomings with authors and the rigor of journal practices. Please see later in the article for the Editors' Summary.
诉讼文件显示，制药公司通过多种途径向医生付费，以推广其产品的标签外用途。目前尚不清楚是否有存在此类利益冲突的医生和科学家在他们撰写的科学出版物中充分披露了这些关系。
我们从美国司法部和其他公开来源收集了举报人指控非法标签外营销的投诉（日期范围：1996-2010 年）。我们在投诉中识别出被描述为与被告制造商存在财务关系的医生和科学家，然后在 Medline 上搜索了他们在随后三年中撰写的文章。我们评估了与所涉标签外用途相关的文章中所做的披露，确定了充分披露声明的频率，并分析了作者的特征（专业、作者职位）和文章的特征（类型、与标签外使用的关系、期刊影响因子、引用计数/年）。我们在举报人投诉中确定了 39 名存在利益冲突的个人。他们发表了 404 篇与举报人投诉中所涉药物相关的文章，只有 62 篇（15%）包含充分的披露声明。大多数文章没有披露（43%）或没有提到制药公司（40%）。充分披露率因文章类型而异，与报告原始研究或试验的文章相比，评论更不可能有充分的披露（调整后的优势比[OR] = 0.10，95%CI = 0.02-0.67，p = 0.02）。在 39 名作者中，有一半以上（22/39）在其文章中没有充分披露。然而，在有≥25 篇文章的 6 名作者中，有 4 名作者在大约三分之一的文章中进行了充分披露（范围：10/36-8/25[28%-32%]）。
在举报人投诉中确定的参与标签外营销活动的作者中，有七分之一的作者在随后的期刊出版物中充分披露了他们的利益冲突。这一充分披露率远低于之前研究中确定的水平。这种不披露的模式表明了作者和期刊实践的严谨性存在缺陷。请在文章稍后部分查看编辑摘要。
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