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.
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).
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).
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.
Publication trends of the benefit/risk profile of medications might differ in time and during a drug safety case.
We analysed the long-term dynamics of publication trends in the context of the SSRIs and suicidality controversy.
The number of articles (in terms of positive, negative and neutral, as well as the type of article and age groups) were analysed in scientific journals and the Netherlands and the UK dailies from January 2000 to December 2009.
We found a positive publication tendency in scientific journals that did not influence the dissemination of negative news in newspapers in the Netherlands and the UK.
The negative tendency in newspapers was predominant in paediatrics and during the warnings.
The public was informed on time about this drug safety controversy, although the information conveyed was not uniform (from scientific journals to newspapers).
Strengths and limitations of this study
Definition of the categories is limited by the researchers' criteria.
Two independent scorers reviewed the articles to avoid subjectivity during scoring.
More than 95% agreements between both research scorers were documented.