HPV Vaccination
Since 2008 Catherine Riva and Serena Tinari are investigating the case of HPV vaccination. It’s an issue of public interest, as these vaccines are recommended to millions of healthy individuals.
You’ll find below all our publications, open letters, posters, and the regulatory documents we have obtained from the US Food and Drug Administration (FDA) through a Freedom of Information Act (FOIA) request.
Recent publications
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In December 2020, Catherine Riva and MD Jean-Pierre Spinosa published on the Journal of Scientific Practice and Integrity the article “Has the HPV vaccine approval ushered in an era of over-prevention?”.
The article analyzes unpublished documents from the US Food and Drug Administration (FDA). This original research, published on December 2, 2020 in the open access Journal of Scientific Practice and Integrity, highlights the cascade of problematic decisions that led to the approval of Gardasil®, Merck’s quadrivalent HPV vaccine. The article is part of a long-term investigative effort that began in 2008 and shows that under the pressure of an unjustified fast-track procedure, US regulatory authorities failed to comply with the methodological guidelines that are supposed to be applied in drugs and vaccines approval (ICH guidelines). As a result, almost 15 years after its approval it is impossible to know what the true benefit-risk ratio of HPV vaccination is. Furthermore, in industrialized countries Gardasil® approval has generated a constellation of “over-prevention” that allows Merck to be freed from the burden of proof, while generating huge profits. Meanwhile, health authorities promote these products, and the society bears the costs of both the vaccination campaigns and the vaccine’s potential health risks.
Article for lay person available here | Publication available here
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In December 2018, Catherine Riva, Serena Tinari and MD Jean-Pierre Spinosa published an analysis of the Cochrane HPV vaccines review on the British Medical Journal’s BMJ-Evidence-Based Medicine: “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 The short story of a long journey to get into the public domain unpublished data, methodological flaws and bias of the Cochrane HPV vaccines review”.
The news in 2012 that Cochrane was going to review the evidence on HPV vaccines made us hopeful – finally, we thought, someone will set the records straight about the flawed science behind the claim that this vaccine is appropriate, safe and effective. Cochrane meta-analyses are indeed considered the gold standard to assess public health interventions’ benefits and risks. Its reviews are supposed to apply evidence-based medicine methods on the best available evidence, and adhere to strict ethical guidelines. So yes, we were really glad Cochrane was working on this review.
However, the first review protocol in 2014 was riddled with methodological flaws and the authors’ panel had many conflicts of interest. You can read in our Chronology the details of how many times we took contact with Cochrane, through the established platforms, to share our concerns about these shortcomings. Our communications were co-signed by several Canadian public health researchers. Our efforts didn’t bring a result though.
The Cochrane review was finally published six years later, and it comes with many methodological and ethical flaws. According to evidence-based medicine, such issues void Cochrane review’s positive conclusions on the efficacy of HPV vaccines. The conflicts of interest in the authors’ panel weren’t addressed, nor resolved.
Our experience shows that on HPV vaccines Cochrane has failed to respect its basic principles. We ultimately decided to publish on the open-source platform Zenodo.org our correspondence with Cochrane, as the collection provides the evidence that the organization had many opportunities to make use of our findings. In our BMJ-Evidence-Based Medicine paper and on Zenodo.org all data and tables to support our conclusions are available. At least they are in the public domain, for the scientific and medical community and for the public to read.
Chronology of the work we have done
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2008
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. Cervical cancer vaccine: have we got all the available information?) on the launch of Gardasil®, revealing the existence of an innovative marketing apparatus, selective reporting of the RCTs results, and conflicts of interest within the Swiss Federal Vaccines Commission (EKIF/CFV).
August 2008: Serena Tinari documentary on HPV vaccines was broadcasted by Swiss public TV program Falò RSI (“Una speranza e qualche dubbio”, in Italian. A shred of hope, and some doubts).
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2010
March 2010: Catherine Riva and MD Jean-Pierre Spinosa published the investigative book on HPV vaccines “La piqûre de trop?” (in French, Xenia 2010. One Injection Too Many?).
October 2010: Serena Tinari documentary on HPV vaccines was broadcasted by the Swiss public TV shows Falò RSI (in Italian: “Dalla parte delle bambine”. On the girls’ side) and by Rundschau SRF (in German: “Umstrittene Impfung”. A controversial vaccine).
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2011
May 2011: Jean-Pierre Spinosa and Catherine Riva published with Clinical pharmacology Professor Emeritus 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 an 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.2011.01.024ISTEX
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 Swiss Federal Commission for Vaccination (FCV) that were kept confidential.
October 2011: Catherine Riva and Jean-Pierre Spinosa were invited by the independent medical association Med’Ocean to a roundtable on HPV vaccination at the Assemblée Nationale (french Parliament) in Paris, France. Their presentation focused on efficacy issues in the case of Gardasil® and on concerns about the way its approval was managed by the US Food and Drug Administration FDA (fast track, outcomes’ choice, selective reporting).
November 2011: Catherine Riva published an investigative article in the Swiss magazine Femina (“Les jeunes filles cobayes d’un vaccin qui n’a pas fait ses preuves”, in French. Girls as Guinea pigs of a vaccine that hasn’t been yet properly assessed) that included unpublished data she obtained from the FDA through Freedom of Information Act (FOIA) request. The data indicate that “outcome switching”, a highly controversial practice as it may impact the study results, affected Gardasil® Phase III trials. The article also showed that the Swiss Federal Commission for Vaccination (FCV) modified its conflicts of interest disclosure policy, a decision that has ultimately led to less transparency.
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2012
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 vaccines review. Cochrane, contrary to its own policy, didn’t publish the comment on its website.
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2013
July 2013: The journal Prescrire published a letter Catherine Riva and Jean-Pierre Spinosa had submitted to the journal in March 2012 that addressed, among other issues, Prescrire’s statements in favor of HPV vaccination and the lack of evidence to support them. The authors considered the journal response unsatisfactory, and in a further reply underlined undisclosed conflicts of interest in the Prescrire editorial board.
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; once more, their December 2012 comment and the analytical listing of the Cochrane review authors’ panel conflicts of interest. Cochrane replied to the group and reassured them, that the review authors’ panel composition had changed.
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2014
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 submitted to Cochrane a new comment with suggestions to improve the protocol. In the 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 in social and mainstream media flawed information on HPV vaccines’ efficacy, Pap test, aluminum toxicity and observational studies’ results.
October 2014: Serena Tinari authored for the Swiss public TV show Rundschau SRF a story on HPV vaccines reported adverse events. “Umstrittene Impfung” (A controversial vaccine) is available in German. Catherine Riva published on the Swiss magazine Sept.club an extensive comment about the issues featured in the documentary.
December 2014: Catherine Riva published on the Swiss magazine Sept.club a critical comment on WHO’s HPV Handbook methodological flaws and the conflicts of interest among its authors. Meanwhile, 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.
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2015
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.
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2017
April 2017: Re-Check published a piece on the lucrative market of HPV testing, that is being expanded with the new era of the HPV vaccines marketing. This technique comes with a false-positive rate almost five times higher than cytology screening, leading to an increased demand for additional testing, and potentially causing overdiagnosis.
December 2017: Catherine Riva and Jean-Pierre Spinosa published on the Swiss magazine Sept.club an open letter on HPV vaccination, focusing on methodological shortcomings in the approval process, and conflicts of interest.
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2018
May 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 submitted to Cochrane a critical comment on its HPV vaccines 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) conflicts of interest in the authors’ panel; (h) n=7 studies on Gardasil® included, n=18 for Cervarix® – the latter not being marketed in the US anymore. The comment was published over three months after submission and without the tables.
August 2018: Catherine Riva and Serena Tinari presented at the 2018 Preventing Overdiagnosis Conference (PODC) a poster in conversation on “Ghost Management in Medicine and Public Health” that included two maps about the HPV vaccines. The abstract was published in a special edition of BMJ-Evidence-Based Medicine. doi: 10.1136/bmjebm-2018-111070.105. Catherine Riva and Serena Tinari participation to the conference was supported by the Oxford Center for Evidence-Based Medicine (CEBM) and by the Fondation pour l’Encouragement de la Recherche en Pharmacologie Clinique (Lausanne, Switzerland).
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 that was published online first on December 6, doi: 10.1136/bmjebm-2018-111119
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2019
January 2019: Catherine Riva was featured in the article “Rien ne justifie de recommander le vaccin Gardasil contre les papillomavirus” (In French. Nothing justifies recommending Gardasil vaccine against HPV). Published by Paris-Match.
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2020
December 2020: Catherine Riva and Jean-Pierre Spinosa published on the open access Journal of Scientific Practice and Integrity the original research and commentary “Has the HPV vaccine approval ushered in an era of over-prevention?”, doi: 110.35122/001c.18180
Cochrane HPV vaccines review
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Between December 2012 and September 2018, Catherine Riva, Serena Tinari (since June 2018) and Jean-Pierre Spinosa corresponded with Cochrane (CGNOC) and Cochrane Library on the Cochrane systematic review on HPV vaccines. It entailed:
- Comments (2012-2014 */**) addressing undisclosed conflicts of interest among the Cochrane review authors and making suggestions to improve the review protocol (here)
- Email (2015*) about the concerning fact that the lead author of the Cochrane HPV vaccine review had publicly presented intermediate results at a congress (here)
- Exposé (2015*) summarizing concerns and correspondence 2012-2015 (here)
- Comment (2018) on methodological flaws in the HPV vaccines review and unresolved conflicts of interest in the authors’ panel (here and here). Especially, this comment entails:
- tables showing how in the Gardasil® studies the definition of the subgroup “negative to 14 HPV types” population (RMITT-2) changed several times between 2006 and 2010 (here and here)
- the two versions of the Statistical Data Analysis Plan (DAP) setting the frame for Gardasil® approval (here and here)
- the 2006 VRBPAC background document on Gardasil® Phase III studies’ results (here)
The complete email correspondence with Cochrane (2012-2018) is available here.
All letters to Cochrane (December 10th, 2012 – December 8th, 2013 – December 23rd, 2013 – August 19th, 2014 – April 17th, 2017) are available here.
*co-signed by Abby Lippman, Geneviève Rail, Lyba Spring, Anne Taillefer, Neil Arya, Pierre Biron, Fernand Turcotte.
** these comments are no more available on the dedicated website of the Cochrane HPV vaccines review.
Book: La piqûre de trop? (One Injection Too Many?)
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The HPV vaccine – also known as “vaccine against cervical cancer“ – was celebrated as a remarkable medical breakthrough. But is cervical cancer a public health threat in industrialized countries? What kind of clinical records do actually exist? And first and foremost: how did this vaccine manage to become accepted so quickly despite its record-breaking price? The book analyses how a stunning success story came to life and features today’s state of knowledge, the published studies and the unanswered questions. It exposes the tremendous extent of the influence maze created by the vaccines’ manufacturers. Xenia publishing, Vevey, March 2010.