One of the medical world’s most respected expert bodies is in turmoil as its annual meeting gets underway in Edinburgh, Scotland, after its governing board voted to expel a member.

The Cochrane Collaboration, which reviews the scientific literature in areas of clinical research and produces widely cited analyses that help guide clinical practice, kicked out a member who has been an outspoken critic of certain vaccines and has blasted the profession of psychiatry for pushing unsafe drugs on unsuspecting patients.

The expulsion of Peter Gøtzsche sparked accusations that the Collaboration is too friendly toward the drug industry. Four other members of the organization’s governing board resigned in response, citing concerns that the action “goes against Cochrane ethos.”

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The vote appears to have been 6 of 13 in favor of the move, according to statements from the board members who resigned and Gøtzsche — short of a majority but enough to pass because only 11 voted.

“This unprecedented action taken by a minority of the Governing Board is disproportionate and damaging to Cochrane, as well as to public health interests,” Gøtzsche said in a letter he circulated on Friday.

The Collaboration posted a statement on its website Saturday, saying, “Cochrane’s Governing Board considered, as planned, the findings of an independent review and additional complaints related to the conduct of a Member.” The complaints were not specified, but the statement said the board’s co-chairs will provide more details “once this process is complete.”

In a longer response posted Monday, Cochrane’s governing board said that it finds itself in “an extraordinary situation” and that the four board members who resigned “actively disseminated an incomplete and misleading account of events.”

The decision, the board said, “is not about freedom of speech. It is not about scientific debate. It is not about tolerance of dissent. It is not about someone being unable to criticize a Cochrane Review.”

Instead, the board said, “It is about a long-term pattern of behaviour that we say is totally, and utterly, at variance with the principles and governance of the Cochrane Collaboration.” Although the board did not describe the behavior, the pattern, it claimed, dated back to complaints since 2003, and included three new complaints in March of this year. “All our staff, and our members, have the right to do their work without harassment and personal attacks,” the statement said.

Gøtzsche, the director of the Nordic Cochrane Center, in Copenhagen, Denmark, has cast doubts about the safety of a vaccine against human papillomavirus (HPV), a cause of cervical cancer, and says psychiatry has “gone astray” by coercing patients into taking medication, such as antidepressants, they don’t want to use and that cause “brain damage” over the long run. “The way these drugs are used today cause[s] more harm than good. So it would be better for us if the drugs didn’t exist.”

Gøtzsche, Cochrane member Tom Jefferson, and another colleague ruffled feathers at Cochrane with a July 2018 article that criticized a recent paper from the Collaboration on the safety of the HPV vaccine. The paper prompted a rebuttal from Cochrane that dismissed the concerns and stood behind the original findings.

Hilda Bastian, a founding member of the Cochrane Collaboration and an influential writer about science, called the review “a manufactured controversy — a hatchet job by people with such strong intellectual and ideological biases, that they didn’t even pick up that some of their most implausible allegations were based on their own analytical and investigative slip-ups.”

Complaints about the review that Gøtzsche co-authored came late in the process, according to the board’s Monday statement, and were not the initial trigger of the investigation.

As of now, the board said, Gøtzsche remains a member of the organization. He was given seven days to respond to the board’s vote.

In an email Wednesday, Gøtzsche did not directly address a question on the complaints about his behavior, instead forwarding a colleague’s appeal for the matter to be turned over to a mediator. Asked whether he would submit a response to the board within seven days, he replied, “that is my secret.”

Gøtzsche, who was elected to the group’s board of governors in 2017, blamed the vote on his stance on the drug industry. “As most people know, much of my work is not very favourable to the financial interests of the pharmaceutical industry. Because of this Cochrane has faced pressure, criticism and complaints. My expulsion is one of the results of these campaigns.”

Jefferson, speaking from a reception at the Edinburgh meeting, told Retraction Watch and STAT that people he’s spoken to are outraged. “I’ve been in Cochrane 25 years, this is not how we do things,” he said. “Peter Gotzsche was a democratically elected member of the board. It’s really unheard of.”

At least one prominent scientist expressed alarm that the move to jettison Gøtzsche was an assault on free speech. John Ioannidis, of Stanford University, said he is “disturbed” by Gøtzsche’s expulsion and stressed the importance of heterodox views in science.

“I adore Peter for his courage and I highly value his major contributions to evidence-based medicine … even if I don’t agree with all of Peter’s views and inferences,” Ioannidis wrote Sunday in an email to a group of more than 100 experts in evidence-based medicine. “I think it is important to make sure that people who disagree with us will get the most opportunity to express and support their views with arguments and evidence and, of course, not get expelled.”

But at least one other expert defended Cochrane. Allen Frances, chair of the Department of Psychiatry at Duke University, in Durham, N.C., dismissed the notion that Gøtzsche was being unfairly muzzled.

“This has nothing to do with freedom of speech,” Frances wrote in the thread that included Ioannidis. Rather, he said, Cochrane is justifiably concerned about remaining an “impartial evaluator of evidence” and providing reliable information to doctors and their patients.

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“At least in psychiatry, Peter is anything but impartial,” Frances wrote. “He consistently expresses the most extreme views in the most dramatic and misleading way. His role at Cochrane lends its legitimacy to opinions that are dangerous to patients with severe mental illness. As an individual, Peter has total freedom to express extreme opinions, but he has no inherent right to cloak them with Cochrane’s hard won mantle of neutrality.”

The four board members who resigned in the wake of the vote said in a statement Saturday that “the expulsion of inconvenient members from the Collaboration goes against Cochrane ethos and neither reflects its founding spirit nor promotes the Collaboration’s best interests. We are concerned that these actions might cause great damage to the reputation of the Collaboration.”

In its own statement, the governing board said that two other members had resigned because the “situation required further changes in the composition of the Board in order to comply with Cochrane’s Articles of Association.” Neither of the board’s co-chairs immediately responded to requests for comment.

“There appears to be no confidence in the management board at this point,” Jefferson said. “I think the only honorable thing for the rest of the board to do is resign.”

This story has been updated with a statement from Cochrane’s governing board and an email response from Gøtzsche. The story is a collaboration between STAT and Retraction Watch.

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  • Response to David Bahar. David, you don’t even know me. I am certainly no “denier”. I have to wonder about the use of immediate labels to counter a point as opposed to a friendly dialog. It’s obvious and sad that you don’t even want to know how I came up with my conclusions. I would ask you how you came up with your conclusions, but you have already answered that with “femnist” “denier”. What does that even mean and how does it pertain to the subject?

  • 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

    • Elizabeth,

      An employee of CDC has no interactions with NIH, never mind any fiduciary interests at NIH. Merely being a CDC employee does NOT lead to a conflict of interest here, nothwithstanding the many irrelevant citations in your replies. The US government is very large and its agencies are independent. (The bigger problem at CDC and HHS today is that they are controlled by partisans, who won a minority of votes, whose party’s goal is to destroy the government to cut taxes on the rich.)

      Sounds to me like there are no issues here for Cochrane.

  • I applaud Peter Gotzsche. Science has become so closed-minded in it’s assumption of facts. Science does NOT know how or if psychiatric drugs work and ignores all the overwhelming damage that has been caused. Tardive dyskonesia is now considered a “side effect”. Uncontrollable rage in patients who take antidepressants we are told has no correlation to the medications. Nagalase in vaccines and the autism epidemic. Do any of them care to ask why the tremendous increase in damaged children and young adults with a host of traditional and new diseases. Yes, I think Peter Gotzsche was the only one in the room with a brain. It wouldn’t have hurt them to consider a differing view. This kind of news has become standard staple in the science world as their agendas are bought and paid for by special interests.

    • “Overwhelming damage?” Irresponsible denier garbage. Exception fallacy, nitpicking side effects seen in all remedies, no exception. Water, at a certain dose causes swelling of brain cells, crushing against the skull, convulsions and death. Ban water, Honey.

    • David, you might try making your points without dismissive sexism. Whatever those views are – you seem to denounce and embrace evidence-based medicine in random turns. At any rate, misogyny is not an argument. It is merely a way of “winning” by relying on a reader’s potential hatred of women.

    • Hi, Lori. Are you now or have you ever been a feminist?

      Alice is a denier. All feminists are deniers.

      Deniers do not argue in good faith. Argument in good faith means, views are influenced by facts. In denial, facts do not influence the hate filled, political agenda. Almost all deniers are also anti-Semites.

      Respect of deniers is unnecessary and serves no purpose.

  • No mention of the legal review team that found he had not breached Cochrane policies but was ousted anyway? Reminds me of chemical weapons accusation in Syria, bombed before any independent transparent investigation can occur. the bombers control the narrative… Very concerning .

  • Dr. Francis certainly is more mainstream than Dr. Gøtzsche in his support of psychiatry and the pharmaceutical industry (in spite of some of his criticisms). But his attempt to silence someone with whom he disagrees by claiming he is an extremist does him no credit. To some of us mainstream psychiatry with its drug centered approach harms more people than it helps. Disagree, but let’s hear all points of view.

    • Allen Frances hardly has clean hands in this debate. It’s been kept very, very quiet somehow, but back in the ’90s, he and two of his psychiatrist colleagues were paid more than half a million dollars by Johnson & Johnson to write practice guidelines that favored their product Risperdal. His corruption is detailed in a paper by Dr. Paula Caplan entitled “Diagnosisgate: Conflict of Interest at the Top of the Psychiatric Apparatus”, but it’s received surprisingly little attention. One has to ask, if he isn’t upfront about his past unethical behavior, why should we trust him now?

  • This is the first I’ve read about the situation, however I think Cochrane has the right and responsibility to disassociate from people who loudly proclaim views that are contrary to evidence. Manufactroversies about vaccines are particularly insidious and irresponsible coming from a respected medical institution that is all about evidence. There is a real body count that results from vaccine fear mongering. If there’s an issue with safety of a vaccine, you better be damned sure of your evidence, especially as someone with credentials and a platform.

    • Where do you get the idea that Dr. Gotzsche’s opinions are contrary to evidence? Have you read what he’s written? As for vaccine fear mongering, are you claiming that no one can question the safety of a new vaccine without being attacked. I haven’t heard that Dr. Gøtzsche is criticising all vaccines.

    • Marie, if he expresses strong concern of adverse events relating to HPV vaccines, he is not on the side of the medical consensus about the evidence. These are hardly “new”. HPV vaccines have been on the market for over a decade and administered to millions – likely tens of millions – of people.
      I also did not say he is criticizing all vaccines. However there is a lot of vaccine fear mongering in the world, and any criticism of any vaccine is seized upon. When a vaccine prevents several common forms of cancer, the bar for raising concerns should be very high.
      My understanding is that the Cochrane review brand is about the weight of collective evidence. He has every right to speak out, but Cochrane also has the right to not provide a platform to him.

    • Among other things, the “medical consensus” once had it all wrong about ulcers and advocated radical mastectomies for breast cancer that is now treated much more conservatively. The HPV vaccine is new in the US. Just because some people abuse legitimate criticisms is no reason to demand that no criticisms be made. I am not a vaccine critic, but I have had some concerns about the HPV vaccine. Cochrane can do what it wants, but it should be careful what it does if it expects to command respect.

    • Cochrane was established and has since received a lot of bequests FOR its challenging ill founded consensus, especially where biased and conflicted research casts its spell over medical consensus. These deceased benefactors would be rolling in their graves to hear corporate sponsored research, conflicted as it continues to be, now has the final say in Cochrane. It is a totally misusing those bequests. As to Gates Money, his having millions invested in markets including pharmaceuticals should alert Cochrane to only accept the money with no strings attached. Instead it seems the money has bought the brand and the remaining board.
      As to being damned sure about evidence, that is exactly what Goetzsche has been trying to do of late with the HPV papers and with their hidden datasets and with no real placebo and with all the studies done that dont prove favourable so dont get published.
      Did you hear that the first HPV trials had injuries that didnt make it into the research papers? see Slate. Do you think that there was only one trial that obfuscated for profit? Medical consensus! or herd naivety?

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