We are aware the list of the initiatives we took since 2008 is long, but we believe transparency is important; looking at this list might be fruitful if you are very interested in what happened with Cochrane and its HPV vaccines review an the way HPV vaccines have been approved.
March 2008: Catherine Riva published an investigation in the Swiss newspaper Le Matin dimanche (“Vaccin contre le cancer du col de l’utérus: nous a-t-on tout dit?”, in French) on the launch of Gardasil®, revealing the existence of an innovative marketing apparatus, selective reporting of the RCTs results, and conflicts of interest among the Swiss Federal Vaccines Commission (EKIF/CFV)
August 2008: Serena Tinari documentary on HPV vaccines broadcasted by Swiss TV program Falò RSI (“Una speranza e qualche dubbio”, in Italian)
March 2010: Catherine Riva and Jean-Pierre Spinosa published the investigative book on HPV vaccines La piqûre de trop? (in French, Xenia 2010).
October 2010: Serena Tinari documentary on HPV vaccines broadcasted by the Swiss TV programs Falò RSI (in Italian: “Dalla parte delle bambine”) and Rundschau SRF (in German: “Umstrittene Impfung”).
May 2011: Jean-Pierre Spinosa and Catherine Riva published with Jérôme Biollaz a letter to the editor of Cancer Letters, responding to the article of Luisa Lina Villa “HPV prophylactic vaccination: The first years and what to expect from now”. They signaled the results listed in the unpublished VRBPAC background document, showing that Gardasil® failed to demonstrate the expected efficacy in preventing CIN 2+ irrespective of HPV type. doi: 10.1016/j.canlet.2011.01.024
June 2011: After a three-year procedure, the Swiss Federal Administrative Court ruled in favor of Catherine Riva and ordered the Swiss Federal Office of Public Health to grant her access to the conflicts of interest disclosures of the EKIF/CFV that had been kept confidential.
October 2011: Catherine Riva and Jean-Pierre Spinosa were invited by the independent medical association Med’Ocean to participate to a roundtable on HPV vaccination at the Assemblée Nationale (French Parliament) in Paris, France. They tackled efficacy issues in the case of Gardasil® and concerns about the way its approval was managed by the FDA (fast track, outcomes’ choice, selective reporting).
November 2011: Catherine Riva published an investigative article in the Swissmagazine Femina (“Les jeunes filles cobayes d’un vaccin qui n’a pas fait ses preuves”, in French) that included unpublished data she obtained from the FDA through Freedom of Information Act (FOIA) request. These data indicate that outcome switching, an highly controversial practice as it may change the study results, affected Gardasil® Phase III trials. The article also showed that the Swiss Vaccines Commission (EKIF/CFV) changed its conflicts of interest disclosure policy, a decision that led to less transparency.
December 2012: Catherine Riva, Jean-Pierre Spinosa, Abby Lippman, Neil Arya, Pierre Biron, Geneviève Rail, Lyba Spring, Anne Taillefer and Fernand Turcotte signaled in a referenced comment sent to Cochrane their concerns about undisclosed conflicts of interest among the authors of the planned Cochrane HPV vaccine review. Cochrane, contrary to its own policy, didn’t publish it.
July 2013: The journal Prescrire published a letter Catherine Riva and Jean-Pierre Spinosa had sent in March 2012 that addressed, among other issues, Prescrire’s statements in favor of HPV vaccination and the lack of evidence to support it. The authors considered the journal response unsatisfactory, in their further reply to the journal they underlined undisclosed conflicts of interest of the Prescrire editorial board.
October 2013: Jean-Pierre Spinosa, Lucija Tomljenovic and Christopher Shaw published the article “Human papillomavirus (HPV) vaccines as an option for preventing cervical malignancies: (how) effective and safe?” in the journal Current Pharmaceutical Design. doi: 10.2174/1381612811319080014
December 2013: Catherine Riva, Jean-Pierre Spinosa, Abby Lippman, Neil Arya, Pierre Biron, Geneviève Rail, Lyba Spring, Anne Taillefer and Fernand Turcotte sent to Cochrane an email with 3 attachments: a new letter; and again the December 2012 comment and the analytical listing on the Cochrane review authors conflicts of interest. Cochrane replied and reassured that the review authors’ panel had changed.
Summer 2014: In July 2014 Catherine Riva received from Prof. Ingrid Mühlhauser (Hamburg University) the detailed protocol of the planned Cochrane HPV vaccines review. In August 2014 Catherine Riva, Jean-Pierre Spinosa, Abby Lippman, Neil Arya, Pierre Biron, Geneviève Rail, Lyba Spring, Anne Taillefer and Fernand Turcotte did submit to Cochrane a new comment with detailed suggestions to improve the review protocol. In this comment they made the Cochrane review authors aware about the unpublished data Catherine Riva obtained from the FDA through a FOIA request regarding Gardasil® efficacy in preventing all CIN 2+ irrespective of HPV type and of the outcome switching in the Gardasil® Phase III studies.
September 2014: Catherine Riva and Jean-Pierre Spinosa sent a rebuttal to Michèle Rivasi and Prof. Henri Joyeux who were disseminating flawed information on vaccines’ efficacy, Pap test, aluminum toxicity and observational studies’ results in social and mainstream media.
October 2014: Serena Tinari authored for the Swiss TV program Rundschau SRF a story on HPV vaccines reported adverse events. Catherine Riva published on the Swiss media Sept.club an extensive comment about the issues tackled in the documentary.
December 2014: Catherine Riva published on Sept.club a critical comment on the WHO HPV Handbook methodological flaws and conflicts of interest among its authors. Four months after submission, the comment on Cochrane HPV vaccines review protocol still hadn’t been published on the Cochrane dedicated website. Catherine Riva, Jean-Pierre Spinosa, Abby Lippman, Neil Arya, Pierre Biron, Geneviève Rail, Lyba Spring, Anne Taillefer and Fernand Turcotte wrote again to Cochrane.
February 2015: The comment on Cochrane HPV vaccines review protocol submitted in August 2014 was finally published on the Cochrane dedicated website. The comment on the protocol and the review authors’ reply is no more available, since Cochrane erased all comments on the HPV vaccines review protocol after the review was published in May 2018.
December 2017: Catherine Riva and Jean-Pierre Spinosa published on Swiss media Sept.club an open letter on HPV vaccination, tackling methodological issues during approval and conflicts of interest.
Mai 2018: Cochrane published its HPV vaccines review Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors. doi : 10.1002/14651858.CD009069.pub3.
June 2018: Catherine Riva, Serena Tinari and Jean-Pierre Spinosa did submit to Cochrane a critical comment on its HPV vaccines published review. It highlights methodological flaws in the review: (a) studies’ quality not properly assessed; (b) post-hoc subgroup analyses presented as RCT results; (c) reporting bias not acknowledged; (d) selective reporting not taken into consideration; (e) biased trial designs; (f) unpublished data not included; (g) COIs in the authors’ group; (h) n=7 studies on Gardasil® included, n=18 for Cervarix® – the latter not being marketed in the U.S. anymore. The comment was published over three months after submission and without the tables.
July 2018: Lars Jørgensen, Peter C Gøtzsche, Tom Jefferson published on BMJ-Evidence-Based Medicine the Analysis The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias. doi: 10.1136/bmjebm-2018-111012.
August 2018: Catherine Riva and Serena Tinari presented at the Preventing Overdiagnosis Conference (PODC) 2018 a poster in conversation on “Ghost Management in Medicine and Public Health” that included two maps on the HPV vaccines. The abstract was published in a special edition of BMJ-EBM. doi: 10.1136/bmjebm-2018-111070.105. Catherine Riva and Serena Tinari participation to the conference was supported by the Center for Evidence-Based Medicine Oxford (CEBM) and by the Fondation pour l’Encouragement de la Recherche en Pharmacologie Clinique (Lausanne, Switzerland).
September 2018: Cochrane published a rebuttal of Jørgensen, Gøtzsche, Jefferson critics.
December 2018: Catherine Riva, Serena Tinari and Jean-Pierre Spinosa published the complete correspondence with Cochrane, including tables and data, on the open-access platform Zenodo.org. They submitted a Letter to the editor of the BMJ-Evidence-Based Medicine. It was published online first on December 6, doi:
December 2020: Catherine Riva and Jean-Pierre Spinosa published on the Journal of Scientific Practice and Intergrity the original research and commentary “Has the HPV vaccine approval ushered in an era of over-prevention?”, doi: