HPV vaccination

Cette page est disponible uniquement en anglais

Since 2008 Re-Check investigates the HPV vaccination case. It’s an issue of public interest, as these vaccines are recommended to millions of healthy individuals.

You’ll find below all details about our publications, open letters, a poster we presented at the 2018 Preventing Overdiagnosis conference (PODC), and the regulatory documents we obtained from the FDA through a Freedom of Information Act (FOIA) request.

In December 2018 with the MD Jean-Pierre Spinosa we published an analysis of the Cochrane HPV vaccines review on the British Medical Journal publication 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 The short story of a long journey to get into the public domain unpublished data, methodological flaws and bias of the Cochrane HPV vaccines review”

Read our press release here

The access to our paper is free, its doi is: 10.1136/bmjebm-2018-111119 (https://ebm.bmj.com/content/early/2018/12/05/bmjebm-2018-111119)
Don’t forget Re-Check favorite tool to read the full text version of every science and medicine study, regardless of its copyright status – Sci-Hub is currently available under this URL, all changes are as usual communicated by its Twitter account.


What’s the point?

 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 supporting the claim this vaccine is safe and effective.

Cochrane’s 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 happy Cochrane worked on it.

But the first Cochrane 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 brilliant Canadian public health researchers. Our efforts didn’t bring many results though.

Six years later, the Cochrane published review is disappointing, because it carries way too many methodological and ethical flaws. According to evidence-based medicine, such problems void Cochrane’s positive conclusions on HPV vaccine’s efficacy. The conflicts of interest are not solved.

Our experience with Cochrane shows that regarding HPV vaccines this organization failed to respect its basic principles.

We ultimately decided to publish on the open source platform Zenodo.org our exchanges with Cochrane as the collection provides the evidence that the organization had many opportunities to make use of our findings. We put in our BMJ-EBM paper and on Zenodo.org all data and tables to support our conclusions. At least this way they are finally in the public domain, for the scientific and medical community and for the public to read.

Disclosures

Catherine Riva
Catherine Riva
Catherine Riva is a freelance investigative journalist and the co-founder of Re-Check. Catherine wrote with MD Jean-Pierre Spinosa the investigative book La piqûre de trop? (Xenia 2010) and authored four articles published on Swiss media (Le Matin Dimanche 2008; Femina 2011; Sept.club October and December 2014). In 2011 Catherine got access through a FOIA request to FDA regulatory documents concerning Gardasil® approval.
Serena Tinari
Serena Tinari
Serena Tinari is a freelance investigative journalist and the co-founder of Re-Check. Serena authored three TV documentaries on the HPV vaccination for the Swiss National TV: they were broadcasted by Falò RSI 2009 ; Falò RSI and Rundschau SRF 2012; Rundschau SRF 2014. Serena is the co-chair of investigativ.ch, the Swiss Network of Investigative Journalists, ICIJ.org member and an advisory board member with journalismfund.eu and irpi.eu.
Jean-Pierre Spinosa
Jean-Pierre Spinosa
Jean-Pierre Spinosa, a gynecologist and surgeon, is a lecturer at the University of Lausanne (Faculty of Medicine and Biology). Spinosa specialises at oncological gynecology and breast medicine. He co-authored with Catherine Riva the investigative book La piqûre de trop? (Xenia 2010). JP Spinosa does not have conflicts of interest to declare.

The work we have done

Chronology

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.

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:

Cochrane HPV vaccines review

Between December 2012 and September 2018, Catherine Riva, Serena Tinari (since June 2018) and Jean-Pierre Spinosa had a correspondence 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 vaccines review publicly presented intermediate results at a congress (here)

• exposé (2015*) summarizing all concerns and correspondance 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
The letters to Cochrane (December 10th, 2012 – December 8th, 2013 – December 23rd, 2013 – August 19th, 2014 – April 17th, 2017) are available here

*also 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 review

Book

La piqûre de trop? (One Injection Too Many?)

Xenia publishing, Vevey, March 2010

The HPV vaccine – also known as “vaccine against cervical cancer“ – was celebrated as a remarkable medical breakthrough. But is cervical cancer really 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 price? This book examines a shocking success story. It takes stock of today’s state of knowledge, reveals existing studies and unanswered questions. And exposes the tremendous extent of the influence maze set in motion by the vaccines manufacturers.

Re-Check Monography on HPV vaccines is coming soon. Interested? Contact us, we’ll keep you posted as soon it is out.

CONTACT