Cochrane Cock-up

September, 17, 2018 | 15 Comments

Comments

  1. Its really a tragedy. I really admire your work Peter, and respect you and the 4 board members that left with you, for standing up for the good for mankind!

  2. A million peer-reviewed articles confirming the safety of the HPV vaccine does not hide the fundamental fact that our healthy daughters have developed SAEs after the Vaccine. No tests = no proof. I am so sorry PG et al that you have paid the price for your integrity.

  3. I am afraid what remains of the Cochrane Board have not put themselves in a good light. If the sacking wasn’t over Peter Goetzsche’s censure of the ridiculous review of HPV vaccines (as they now claim) it was certainly not a clever time to make an issue of his behaviour. They might be in danger of being misunderstood, or even look foolish.

    The point I have tried to make as the debacle has progressed is that it is being reported if at all as a matter of institutional warfare, but it is the public who being asked to trust these products. Frankly, they should be told the truth.

  4. Disturbing on many levels.

    I admire and respect Dr. Gotzsche for all of his work and fight to right the wrongs in medical research. I had no idea until today who had become involved in the….Dictatorship. Scary, quite frankly. If there’s a silver lining, it is that this has been exposed.

    Thank you, Dr. Gotzsche, for showing how it’s done. You have a legion of supporters behind you.

  5. David,

    What is taking place here is nothing new. The Cochrane Collaboration took British government money and published reviews contrary to the science, facts and evidence but favouring the interests of their government funders.

    I wrote about it back in 2006 in a peer reviewed paper [more below]. But there had been prior scandals also. The Cochrane Collaboration is to science what Wikipedia is to encyclopedias in my evidence-based view.

    And there is little doubt that this expulsion of Professor Gøtzsche is illegal if the account you link to of Dr Maryanne Demasi can be relied upon. Cochrane appears to have a history of behaving above science. Here we see they behave above the law.

    Dr Maryanne Demasi’s account suggests The Cochrane Collaboration hierarchy disregard science and evidence when they choose. It shows how compelling commercial interests are to them. They want to rid themselves of someone, Professor Gøtzsche, who is trying to make them act with integrity and do what they are meant to do.

    Not only is the pharmaceutical industry out of control but the influence extends deeply into government and the medical industry [“medical professions” is a misnomer]. There are regulators but not safety regulators.

    Is Professor Gøtzsche justified regarding the HPV vaccine?

    Without any doubt he is.

    The UK’s Medicines and Healthcare Products Regulatory Agency falsified the adverse reaction analyses of the HPV vaccine administered to millions of British Schoolgirls. In preparing the published analyses the MHRA split up the symptoms reported for each report and separated them under five headings. That way no one could tell what the underlying condition was the British schoolgirls were suffering from.

    Not a single case was followed up and that includes serious cases.

    You can find the MHRA’s scandalously crooked 2012 analysis here:
    “MHRA PUBLIC ASSESSMENT REPORT – Cervarix HPV vaccine: update on UK safety experience at end of 4 years use in the HPV routine immunisation programme
    December 2012”
    https://assets.digital.cabinet-office.gov.uk/media/547307f540f0b6131200003d/con213228.pdf

    And how clear is the evidence The Cochrane Collaboration has done the same before?

    This is the title of a 2006 peer reviewed paper “Questions on the Independence and Reliability of Cochrane Reviews, with a Focus on Measles-Mumps-Rubella Vaccine”
    http://www.jpands.org/vol11no4/millerc.pdf

    The paper examines and reports on how Cochrane’s policies on conflicts of interest were even then in 2006 ineffective; how they become flexible when faced with funding shortages; how they expose themselves to undue influence and how they readily accept funding from sources with conflicting interests.

    In this case the British Government first put Cochrane’s existence under threat by withdrawing funding. They then bailed Cochrane out with Cochrane having visibly set science aside to publish a review favourable to UK Government policy and financial interests.

    The changes Cochrane made were described thus by Cochrane author Professor Sir John Grimley Evans:

    “Over the next five years, the money to be provided to British Cochrane Groups by the Department of Health, ominously now called “core funding”, will not be enough for survival. We will all therefore be looking for additional money from people or agencies interested in what we do.To put it in terms familiar to the shopkeepers who, as Buonaparte observed, rule this unhappy country, we have to sell our product.”

    Today it is the HPV vaccine. In 2006 it was the MMR about which Professor Sir John Grimley Evans also wrote:

    “As the witch-hunt over MMR illustrates, the mob goes for the
    man, not the ball. Government research money is now heavily
    under political influence; it would be a brave academic hoping for
    future grants who used government funds to conclude that the latest
    Downing Street-trumpeted health service initiative was garbage.”

    The only criticism the Director of The Cochrane Collaboration in Oxford had about the paper was that Cochrane was not part of Oxford University. But The Cochrane Collaboration had deliberately chosen to remain based at Oxford thereby benefiting from the kudos associated with the University.

    Not a single one of the substantive assertions were challenged.

    Here is the Abstract of the paper:

    “The Oxford University-based Cochrane Collaboration had previously been dependent on British government funding. A change in funding completed by 2004 appears to leave Cochrane now more vulnerable to undue influence from commercial and government funding sources. Cochrane’s 2005 published policies on commercial conflicts of interest do not address and appear ineffective to prevent conflicts over government funding and undue political interference.”

    “The 2005 Cochrane review of measles-mumps-rubella (MMR) vaccine safety and effectiveness was published against a background of litigation in the UK over vaccine damage claims. The British government appears to have substantial financial interests in those litigation claims failing. There is evidence the British government was involved directly in a media and political campaign to discredit the expert medical evidence underlying those claims. There is also suggestive evidence that the British government may have used undue influence to stop statutory funding of the claims.”

    “The conclusions of the Cochrane MMR review are not supported by, and contradict, the evidence presented in the “review.” Having found inadequate evidence of safety in the papers studied, the review’s conclusion that the millions of doses of MMR vaccine administered worldwide are safe is not science based. It is based on the circular assertion without cited evidence that the vaccine is safe because millions of doses are administered.”

    “The review also shows that studies into the extent of the adverse effects are too limited to say how extensive these adverse effects may be, and consequently to say whether the vaccine is ‘safe.’ The review provides no comparative evaluation of MMR vaccine safety and effectiveness against other measures, such as single vaccines, placebo, no vaccine, or modern treatment options. It provides no evidence to refute theWakefield hypothesis of an association between MMR vaccine, regressive autism following previously normal development, and a novel form of inflammatory bowel disease.”

    “The Cochrane review duplicates an almost identical paper published in 2003 by members of the same team, yet contains no reference to the earlier paper. According to a separate publication by one of the authors, duplicated publication can be considered unethical or fraudulent when the authors attempt to conceal the existence of duplicated publication from editors and readers.”

    • Yes, of course, the three Cochrane reviews of MMR safety (2003, 2005, 2012) were interesting fudges – they repeatedly reported that safety studies were “largely inadequate” but recommended that the policy should continue (perhaps the quid pro quo for reporting truth). In 2005 the Plain Language Summary (which was anything but plain) made claims that seemed to be unrelated to the publication. One mainstream journalist, Melanie Phillips, cottoned on that there was a major problem, and was given a unjustified and ad hominem drubbing by Ben Goldacre, when actually she had just read more carefully than anyone else. However, we know that all six studies related to autism in 2005 were seriously flawed, and the review anticipated the William Thompson revelations of 2014 regarding DeStefano 2004 among other things. But it is interesting that there was a yawning gap between the science and the recommendations, and the health officials continued to bluff their way.

      • John,

        The truth is far worse. Cochrane does not know what shame is but there is much for Cochrane to be ashamed of and much for the British public to be ashamed of Cochrane.

        Cochrane claimed in its reviews of MMR and without any evidence whatsoever that the MMR vaccine must be safe because millions of doses had been administered.

        In fact under-reporting was on a massive scale.

        The Pluserix MMR scandal provided data showing the extent of vaccine adverse reaction under-reporting.

        The confidential UK Government reports into meningitis caused by the MMR vaccine revealed that there was 100% under-reporting of adverse reactions suffered by children in 70 countries in which 26 million MMR doses had been administered.

        That was of a then 26 million of a total of 35 million doses administered.

        Only in 6 European countries were adverse events reported.

        Of 35 million doses GSK received only 96 reports of meningitis itself or from the other sources referred to in the reports.

        If the UK was used as a reference, and taking a most conservative position on estimates, relative AEFI under-reporting was:
        100% outside 6 European countries;
        99.7% in the UK

        Colville and Pugh, writing in the Lancet in 1992, reported that it was their findings in the Public Health Laboratory, University Hospital at Queen’s Medical Centre, Nottingham found a close correspondence in the UK to the Japaneses experience of adverse meningitis vaccine reactions of up to 3 per 1000 doses. [786:VOL 340: SEPT 26, 1992]

        Nottingham was the only UK PHL to carry out lumbar puncture all children suffering febrile convulsions [Item 7 CSM/92/8/32P].

        This meant that just for that one adverse vaccine reaction of meningitis caused by the MMR vaccine there should have been not 96 reports in 35 million but 105,000.

        And it was not just meningitis. There were manifold adverse reactions. Several deaths were reported as attributable to the vaccine.

        Now if you are starting to think that The Cochrane Collaboration is corrupted and untrustworthy then I could not blame you. And you could not blame me for holding that view.

        Cochrane’s MMR reviews are worthless junk science in my view.

  6. I find this disturbing. I always viewed Peter Gotzsche as a vital part of Cochrane and Cochrane as an integral bastion of ethics in medicine. He was the gate-keeper, he kept the wolves from devouring ethics completely -Sorely needed in this climate of optics, PR, and the creepy corporate capture of all of our lives. Sad.

    • To me, this is the most disturbing part:

      “Insiders say a ‘possible concern’ might be that Cochrane fears that Gøtzsche’s criticism of the HPV vaccines review would negatively impact its sponsorship from the Bill & Melinda Gates Foundation.”

  7. Yes this is outrageous. No way for me to know each detail, but from what I’ve gathered from Goetszche, from videos of lectures, and articles he has written, there is no doubt he tried to help the end user, the patient.

    And yes, he was probably a bit to blunt and outspoken. For ‘Academia’ that is.

    Because I have come to learn that Academia is a sandpit full of intelligent “kids”, instead of
    measure whose “daddy is the strongest”, they throw latin phrases at eachother. It sounds better than the “daddy contest”, but makes as little sense.

    The fight is rigged from the start, and truth has no place in it.

    Cochrane was probably founded with the best intentions, just like BMJ or NEJM. Nowadays they turn slowly into “Astroturfing” fronts for whatever opinion is most financially benefitial.
    With a slick surface and a polished past, they can function well as foundations for ‘credible claims’.

    Peter Goetzsche is to me just an intelligent and sound-minded person. He is not really critical unless you are on the side that thinks that: “quantity of drugs is better than quality of drugs”.

    Oh, and yes, to miscredit the person rather than his claims, has a well known latin phrase!

    Ove 2018

  8. They have lost the right to call themselves the Cochrane Collaboration – it’s not a collaboration when a cabal can squeeze out those who expose fake evidence or refuse to collaborate with an agenda which can and has caused harm to the uninformed or insist on making their views public so that people have at least a minimal chance to weigh up, if not the evidence as that is not available, whether to take a risk.

    there needs to be a module added to those dished up on higher education courses to highlight not just the ‘mistakes’ and abuses of power of the past but those of the present so that students can be forewarned that they will not only have to deal with the academic side of practice (not only in medicine) but also the potential corruption; power games; nepotism and cronyism; the politicking; the self serving networking and so on which will test their personal moral values as well as careers. When the shenanigans begin for anyone caught up in it for the first time the main reaction is shock .The Cochrane scandal would be a useful case study – from beginning to …?

  9. For an account of the Cochrane affair, please see the following article published in Science yesterday:

    http://www.sciencemag.org/news/2018/09/evidence-based-medicine-group-turmoil-after-expulsion-co-founder

    He has often been critical of Cochrane as well. In a statement written for his 2017 election to the board, Gøtzsche listed a litany of “pretty widespread concerns” he wanted to address, including the concentration of power at the Central Executive Team in London and the fact that “collaboration” had been dropped from the group’s name. “The Cochrane Collaboration is now run much more as a business with a brand than it was just a few years ago,” he wrote.

    The review didn’t constitute the “trusted evidence” promised in Cochrane’s official motto, they said.

    “Academic freedom means communicating ideas, facts and criticism without being censored, targeted or reprimanded,” they argued.

    Within a scientific organization such as Cochrane, discussion and dissent should be possible, says David Hammerstein Mintz, a consumer advocate, former member of the European Parliament from Spain, and one of the four departing board members. “If they can’t tolerate a few disagreements or a few headaches, that is a problem,” he says.

  10. This article and the comments below it contain outrageous slurs on a vibrant, transparent, evidence based enterprise, made by people who know little of the facts or have axes to grind, and particularly dangerous anti-vaxers. Instead of trashing an organisation of 37,000 selfless and principled contributors, examine your own motives, biases and rush to judgement.

  11. In regards to the recently published Cochrane HPV vaccine review[1], this review 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.

    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%20november%202010.pdf)

    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 this Cochrane review 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 be 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 an objective and unbiased review by Cochrane, 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. It is demonstrably not independent and 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-independent-and-transparent/

    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-plummet-in-young-women-due-to-vaccine/#17973c732d85

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

    • 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”.

      Saying that Lauri Markowitz is not an author of this review is a sleight of hand.

      I suggest Lauri Markowitz has in fact been a very influential author of this Cochrane HPV vaccine review.

      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, (which now appears to be inaccessible 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. The ‘scientific expert reaction’ lined up to support this Cochrane review is also tainted by conflicts of interest.[2]

      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 and I do not trust Cochrane.

      It’s unconscionable that this obviously biased review might influence vaccination policy.

      The Cochrane HPV vaccine review should be withdrawn.

      Reference:
      1. 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
      2. Scientific expert reaction to new Cochrane Review on HPV vaccine for cervical cancer prevention in girls and women: https://www.cochrane.org/news/scientific-expert-reaction-new-cochrane-review-hpv-vaccine-cervical-cancer-prevention-girls-and

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