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  • Lessons learnt on transparency, scientific process and publication ethics. The short story of a long journey to get into the public domain unpublished data, methodological flaws and bias of the Cochrane HPV vaccines review

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Lessons learnt on transparency, scientific process and publication ethics. The short story of a long journey to get into the public domain unpublished data, methodological flaws and bias of the Cochrane HPV vaccines review
  1. Catherine Riva1,
  2. Serena Tinari2,
  3. Jean-Pierre Spinosa3
  1. 1 Re-Check, Winterthur, Switzerland
  2. 2 Re-Check, Bern, Switzerland
  3. 3 Faculty of Medicine, University of Lausanne, Lausanne, Switzerland
  1. Correspondence to Catherine Riva, Re-Check, Winterthur 8404, Switzerland; catherine.riva{at}re-check.ch

https://doi.org/10.1136/bmjebm-2018-111119

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    Cochrane meta-analyses are considered the gold standard to assess public health interventions’ benefits and risks. Cochrane reviews shall apply evidence-based medicine (EBM) methodology on the best available evidence; they shall adhere to strict ethical guidelines as authors of Cochrane reviews are supposed to not have bias, nor conflicts of interest. Our 6 years’ documented case on the Cochrane human papillomavirus (HPV) vaccines review demonstrates that Cochrane guidelines can fail. According to EBM standards, such relevant methodological and ethical flaws void Cochrane positive conclusions on HPV vaccines efficacy.

    Cochrane published a review of the human papillomavirus (HPV) vaccines on 9 May 2018.1 On 4 June, we submitted a detailed analysis of this review as a comment2 via the Cochrane website. Our comment highlights serious methodological flaws in the review: (A) studies’ quality not properly assessed; (B) post hoc subgroup analyses presented as randomised controlled trial results; (C) reporting bias not acknowledged; (D) selective reporting not taken into consideration; (E) biased trial designs; (F) unpublished data not included; (G) conflict of interests (COI) in the authors’ group; (H) n=7 studies on Gardasil included, n=18 for Cervarix—the latter not being marketed in the USA anymore.

    On 27 July (almost 2 months after submission), while we were still waiting for our …

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    Footnotes

    • Contributors CR and ST wrote the first draft. CR, ST and JPS contributed to the conception, drafting, critical revision for important intellectual content and the final approval of the article.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests CR and ST are freelance investigative journalists. They co-founded Re-Check, a non-profit organisation specialised in investigating and mapping health affairs. JPS is a gynaecologist and a surgeon. He is a lecturer at the University of Lausanne (Faculty of Medicine). CR and JPS are the coauthors of an investigative book on the HPV vaccination (‘La piqûre de trop?’, Xenia, 2010). CR published four investigations in Swiss mainstream media on HPV vaccine. ST is the cochair of investigativ.ch, the Swiss Network of Investigative Journalists, and an advisory board member for www.journalismfund.eu and www.irpi.eu. She authored three investigative TV documentaries on the HPV vaccination (Swiss Public Broadcaster: Falò RSI 2009; Falò RSI/Rundschau SRF 2010; Rundschau SRF 2014).

    • Provenance and peer review Not commissioned; internally peer reviewed.