Cochrane HPV vaccine review severely compromised by conflicts of interest

Independent
Adelaide, South Australia
17 September 2018

 

The recently published Cochrane HPV vaccine review[1] is severely compromised and cannot be trusted due to the conflicts of interest of authors on the original protocol and the final review document.

Due to serious conflicts of interests, Cochrane should withdraw this review.

In February 2016, I challenged David Tovey, Editor in Chief of Cochrane, directly about protocol author Lauri Markowitz’s conflicts of interest.

Catherine Riva et al raised the problem of conflicts of interest in December 2014 in a comment on the original protocol[2], specifically pointing out the failure to properly disclose conflicts of interest by Lauri Markowitz and Marc Arbyn. Arbyn remained an author throughout all stages.

Lauri Markowitz is an employee of the US Centers for Disease Control and Prevention (CDC), and is involved in HPV vaccination promotion.

The US Government benefits from the sale of HPV vaccine products, i.e. a letter to Dr Eric Suba from the US National Archives and Records Administration (November 2010) discusses royalties the US National Institutes of Health (NIH) receives from the sales of HPV vaccines. (See a copy of the letter via this link: http://www.vietnamcervicalcancer.org/dmdocuments/ogis%20suba%2024%20nove…)

Indicating a stunning lack of transparency, it appears the value of these royalties is kept secret, i.e. it is protected from disclosure under the US Freedom of Information Act.

The NIH Office of Technology Transfer (OTT) oversaw the patenting of the HPV vaccine technology and licensed the technology to Merck, the maker of Gardasil, which sought approval for Gardasil around the world, working with the PATH group, with support from the Bill and Melinda Gates Foundation, in distributing the HPV vaccine in developing countries.[3] The HPV vaccine technology was also licensed to GlaxoSmithKline[4].

The Bill and Melinda Gates Foundation has been very influential in promoting HPV vaccination[5]. In regards to the Cochrane HPV vaccine review, Cochrane has a conflict of interest in that it is a beneficiary of Bill and Melinda Gates Foundation funding, i.e. to “support the development of Cochrane’s next generation evidence system, with a specific focus on maternal and child health”.[6] The World Mercury Project has provided critical analysis of Cochrane’s conflicts of interest via the Bill and Melinda Gates Foundation and other organisations[7].

As a matter of urgency, Cochrane needs to consider conflicts of interest in its undertakings, as these are compromising Cochrane’s mission to provide credible and unbiased information to support informed health decision-making.

In regards to the Cochrane HPV vaccine review, it’s alarming that an employee of a US government agency promoting HPV vaccination was involved in the Cochrane protocol to evaluate the immunogenicity, clinical efficacy, and safety of HPV vaccines when there is a clear conflict of interest, i.e. it is in the US Government’s interest to justify and defend the use of HPV vaccine products.

How and why was Lauri Markowitz’s participation in the protocol approved by Cochrane?

In my previous correspondence to Dr Tovey in February 2016, I noted Markowitz is an author on many papers about HPV vaccination, for example Prevalence of HPV After Introduction of the Vaccination Program in the United States[8], a paper which received acclaim in the mainstream media, see for example this article published in Forbes magazine: HPV Infection Rates Plummet in Young Women Due to Vaccine[9].

I also noted Markowitz was on the US Advisory Committee on Immunization Practices’ Human Papillomavirus Vaccine Working group in 2006, and that she is the ‘corresponding preparer’ on the ACIP’s document recommending implementation of HPV vaccination[10].

I queried how Markowitiz could possibly be an objective and independent reviewer of the literature regarding HPV vaccination, and also queried on what basis Lauri Markowitz was engaged to conduct the Cochrane review of HPV vaccines.

Dr Tovey’s response to me on 1 March 2016 included: “We can’t govern the opinions that review authors hold although we are stricter than other journals about conflicts of interests – in that declaration is not always sufficient. We have safeguards in place to avoid bias due to non financial conflicts although I acknowledge these cannot currently be fully controlled – but these include insisting on teams of authors, peer review at both the protocol and review stage, detailed editing by the appropriate Cochrane Review Group plus oversight by my Editorial Unit.”

It appears that Cochrane does not have an effective system to evaluate conflicts of interest either of Cochrane itself or its authors.

Dr Tovey did not clarify on what basis Lauri Markowitz was engaged to conduct the Cochrane review of HPV vaccines.

It is not clear who initiated the HPV vaccine review protocol.

Subsequently Lauri Markowitz was not listed as an author on the title page of the Cochrane HPV vaccine review, so it appears there was recognition that it was not appropriate that she continue as an author of a review on HPV vaccines.

But the fact remains she was influential in the development of the protocol, which was acknowledged in the final review, along with her “invaluable advice and contributions by reviewing the results and discussion sections”.

As a citizen interested in HPV vaccination I had hoped to rely on a review by Cochrane which was untainted by any allegation of bias, but I do not trust this review and do not consider it to be a document of value.

The Cochrane HPV vaccine review is severely compromised. Based on Markowitz’ involvement, at least, it is demonstrably not independent and therefore cannot be trusted.

The Cochrane HPV vaccine review should be withdrawn.

Cochrane also needs to urgently consider its own position in regards to conflicts of interest, and the impact on Cochrane’s credibility, independence and trustworthiness.

References:

1. Marc Arbyn, Lan Xu, Cindy Simoens and Pierre PL Martin-Hirsch. Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors. Cochrane Systematic Review. Published 9 May 2018.

2. Marc Arbyn, Andrew Bryant, Pierre PL Martin-Hirsch, Lan Xu, Cindy Simoens and Lauri Markowitz. Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors. Cochrane Protocol. Published 30 December 2013.

3. NIH Technology Licensed to Merck for HPV Vaccine: https://www.ott.nih.gov/news/nih-technology-licensed-merck-hpv-vaccine

4. HHS-Licensed Products Approved by the FDA: https://www.ott.nih.gov/reportsstats/hhs-licensed-products-approved-fda

5. See for example Summary of Bill & Melinda Gates Foundation-supported HPV Vaccine Partner Activities: http://www.who.int/immunization/sage/HPV_partner_info_gates.pdf

6. Cochrane announces support of new donor: https://www.cochrane.org/news/cochrane-announces-support-new-donor

7. Are Cochrane Reviews Truly “Independent and Transparent”? World Mercury Project. 5 June 2018: https://worldmercuryproject.org/news/are-cochrane-reviews-truly-independ…

8. Markowitz LE et al. Prevalence of HPV After Introduction of the Vaccination Program in the United States. Pediatrics. 2016 Mar;137(3):e20151968. doi: 10.1542/peds.2015-1968. Epub 2016 Feb 22.

9. Tara Haelle. HPV Infection Rates Plummet In Young Women Due To Vaccine. Forbes. 23 February 2016: https://www.forbes.com/sites/tarahaelle/2016/02/23/hpv-infection-rates-p…

10. Quadrivalent Human Papillomavirus Vaccine. Recommendations of the Advisory Committee on Immunization Practices (ACIP): https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5602a1.htm

Competing interests: No competing interests

17 September 2018
Independent
Adelaide, South Australia

Further to my previous comment re the Cochrane HPV vaccine review and the undisclosed conflicts of interest of the CDC’s Lauri Markowitz.

On 17 August 2018, Cochrane Editor in Chief Dr David Tovey responded to me saying “Dr Markowitz withdrew as an author on the review between the protocol and review stage”.

However, under the Contributions of Authors section of the Cochrane HPV vaccine review, Lauri Markowitz is listed for her participation in the conception of the systematic review, writing of the protocol, and critical review of the manuscript. In the Acknowledgements, Lauri Markowitz is specifically acknowledged for “her invaluable advice and contributions by reviewing the results and discussion sections”.

I suggest the Acknowledgements show that Lauri Markowitz has in fact been a very influential participant in this Cochrane HPV vaccine review, if not a listed author.

Questions remain unanswered by Cochrane, i.e.

– How and why was Lauri Markowitz’s original participation in this Cochrane review approved by Cochrane?

– Who initiated the Cochrane HPV vaccine review protocol?

Lauri Markowitz has significant conflicts of interest via her employment with the Centers for Disease Control & Prevention (CDC), her involvement with the promotion of HPV vaccination, and her publication of papers on the subject of HPV vaccination.

In the protocol for this Cochrane review, published in December 2013, Lauri Markowitz formally declared “no conflict of interest” in the Declarations of Interest section. I suggest this was misleading as Lauri Markowitz demonstrably does have conflicts of interest in regards to HPV vaccination.

In their comment on the 2013 protocol, published in 2014 (which now appears to be difficult to access online), Catherine Riva et al pointed out Lauri Markowitz’s conflicts of interest, i.e. her employment with the CDC and her support of HPV vaccination, including via her participation as an author in continuing education programs for medical practitioners, i.e. HPV Vaccine: A Shot of Cancer Prevention, supported by Merck.[1]

It’s notable that Lauri Markowitz’s conflicts of interest have still not been disclosed under Declarations of Interest in the recently published Cochrane HPV vaccine review.

As I argued in my previous comment, this Cochrane HPV vaccine review is severely compromised. It is demonstrably not independent and cannot be trusted.

It’s remarkable that Cochrane have got this so spectacularly wrong. They’ve really undermined their whole ethos, i.e. to provide unbiased information.

As a citizen interested in HPV vaccination, I do not trust this Cochrane review.

It’s unconscionable that an important review so open to suspicion of bias or conflicting interest might influence vaccination policy.

The Cochrane HPV vaccine review should be withdrawn.

Reference:
1. In their comment on the Cochrane HPV vaccine protocol, Catherine Riva et al include reference to CME/CE HPV Vaccine: A Shot of Cancer Prevention, as hosted on Medscape, 2012-2013: https://www.medscape.org/viewarticle/768633_sidebar2

Competing interests: No competing interests

17 September 2018
Independent
Adelaide, South Australia

2 thoughts on “Cochrane HPV vaccine review severely compromised by conflicts of interest

  1. cochrane collaboration:

    ABOUT US.
    Cochrane’s 11.000 members & over 35.000 supporters come from more than 130 countries world wide.

    * rounded up – that’s 85 members coming from each country world wide.
    * rounded up – that’s 256 supporters coming from each country world wide.

    😛 .. my observation .. 😛 .. THAT’S NOT MANY.

    Back to ABOUT US.
    Our global independent network gathers & summarizes the best evidence from research to help you make informed choices about treatment & we have been doing this for 25 years.

    OUR VISION.
    Is a world of improved health where decisions about health & healthcare are informed by high quality, relevant & up-to-date synthesized research evidence.

    * synthesize – meaning – to produce a substance by combining other substances.

    😛 – my observation – sounds dubious.

    OUR FUNDING & PARTNERS
    Our global network of groups – are supported by —>
    1. national governments
    2. international governmental & non-governmental organisations
    3. universities
    4. hospitals
    5. private foundations
    6. & personal donations worldwide.
    The direct income in 2017 for Cochrane Groups was approximately AU$28.000.000.
    Their direct income for 2017 was twenty eight million Australian dollars.

    😛 my observation – government monies come with an expectation of preferential consideration to a preconceived & expected end. = “we want you to see it as we expect it to be seen”
    – of monies given directly from the government – or through universities – or research groups.
    – of monies given directly from private donation – the same expectation applies

    The truth being sought from the Cochrane Group has a BigDollar expected – profit realisation attached to it.

    To discover if the Cochrane Group’s funding is really independent & coming from truth seeking investors – we would have to look at the origins of the money invested / donated from ground zero.

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