Hernandez J F, Mantel-Teeuwisse A K, van Thiel G J M W, Belitser S V, Raaijmakers J A M, Pieters T
Department of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, the Netherlands.
BMJ Open. 2011 Dec 6;1(2):e000290. doi: 10.1136/bmjopen-2011-000290. Print 2011.
Background In the period 2003-2008, the regulatory authorities issued several warnings restricting the use of selective serotonin re-uptake inhibitors (SSRIs) in paediatrics, in reaction to safety concerns regarding the risk of suicidality. In this study, the SSRIs and suicidality controversy serves as a template to analyse the long-term publication trends regarding the benefit/risk profile of medications. The aim is to ascertain differences (in terms of numbers, categories and timing) between negative and positive newspaper and journal articles on SSRIs and suicidality and to ascertain correlations between changes in the reports and regulatory warnings. Methods A systematic review of scientific articles (Embase) and the Netherlands (NL) and the UK newspapers (LexisNexis) was performed between 2000 and 2010. Categorisation was done by 'effect' (related treatment effect), 'type of article' and 'age group'. The articles' positive-to-negative effect ratio was determined. Differences in distribution of effect categories were analysed across sources, type of article and age group using the Mann-Whitney (two subgroups) or Kruskal-Wallis test (three or more). Findings In total, 1141 articles were categorised: 352 scientific, 224 Dutch and 565 British newspaper articles. Scientific articles were predominantly on research and were positive, whereas newspaper articles were negative (ratios=3.50-scientific, 0.69-NL and 0.94-UK; p<0.001). Articles on paediatrics were less positive in scientific journals and more negative in newspapers (ratios=2.29-scientific, 0.26-NL and 0.20-UK; p<0.001), while articles on adults were positive overall (ratios=10.0-scientific, 1.06-NL and 1.70-UK; p<0.001). In addition, negative-effect reporting trends were exacerbated following regulatory warnings and were generally opinion articles, both in scientific journals and in newspapers (2003/2004 and after 2007). Interpretation The authors found a positive publication tendency inherent in journal research articles. This apparent positive publication bias present in scientific journals, however, does not seem to prevent the dissemination of 'bad' news about medications. The negative tendency present in Dutch and British newspapers was perceivable in the paediatrics group and during the warnings, indicating that national news media have informed the public about this international drug safety controversy on time.
在2003年至2008年期间,监管机构发布了多项警告,限制选择性5-羟色胺再摄取抑制剂(SSRI)在儿科的使用,以应对有关自杀风险的安全担忧。在本研究中,SSRI与自杀倾向争议作为一个模板,用于分析有关药物效益/风险状况的长期出版趋势。目的是确定关于SSRI与自杀倾向的负面和正面报纸及期刊文章之间的差异(在数量、类别和时间方面),并确定报道变化与监管警告之间的相关性。方法:对2000年至2010年间的科学文章(Embase)以及荷兰(NL)和英国报纸(LexisNexis)进行系统综述。分类依据为“效应”(相关治疗效应)、“文章类型”和“年龄组”。确定文章的正面与负面效应比率。使用Mann-Whitney检验(两个亚组)或Kruskal-Wallis检验(三个或更多亚组)分析效应类别在不同来源、文章类型和年龄组中的分布差异。结果:总共对1141篇文章进行了分类:352篇科学文章、224篇荷兰报纸文章和565篇英国报纸文章。科学文章主要是关于研究的,且呈正面态度,而报纸文章则呈负面态度(比率分别为:科学文章3.50、荷兰报纸文章%0.69、英国报纸文章0.94;p<0.001)。儿科方面的文章在科学期刊中正面性较低,在报纸中负面性较高(比率分别为:科学文章2.29、荷兰报纸文章0.26、英国报纸文章0.20;p<0.001),而关于成人的文章总体呈正面态度(比率分别为:科学文章10.0、荷兰报纸文章1.06、英国报纸文章1.70;p<0.001)。此外,在监管警告之后,负面效应报道趋势加剧,且在科学期刊和报纸中(2003/2004年及2007年之后)通常为评论文章。解读:作者发现期刊研究文章存在正面的出版倾向。然而,科学期刊中这种明显的正面出版偏差似乎并未阻止关于药物“负面”消息的传播。荷兰和英国报纸中的负面倾向在儿科组以及警告期间是明显的,这表明国家新闻媒体及时向公众通报了这一国际药物安全争议。