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By Maryanne Demasi, PhD<\/em><\/p>\n A scandal has erupted within the Cochrane Collaboration, the world\u2019s most\u00a0 prestigious scientific organisation devoted to independent reviews of health care interventions. \u00a0One of its highest profile board members has been sacked, resulting in four other board members staging a mass exodus.<\/p>\n They are protesting, what they describe as, the organisation\u2019s shift towards a commercial business model approach, away from its true roots of independent, scientific analysis and open public debate.<\/p>\n There are concerns that Cochrane has become preoccupied with \u201cbrand promotion\u201d and \u201ccommercial interests\u201d, placing less importance on transparency and delivering \u201ctrusted evidence\u201d.<\/p>\n It began as a simmering personality clash, between the CEO and a board member, but now has boiled over into a spectacular war of words, where the underlying issues of Cochrane have bubbled to the surface, with many insiders predicting the beginning of the end of Cochrane.<\/p>\n The dispute<\/strong><\/p>\n A meeting of the Trustees of Cochrane was convened in an effort to resolve an ongoing dispute between the CEO of Cochrane Collaboration, Mark Wilson and one of the founding fathers of the Cochrane Collaboration in 1993, Director of the Nordic Cochrane Centre, Peter C. G\u00f8tzsche.<\/p>\n It began with, what might be perceived as, fairly trivial issues. Wilson accused G\u00f8tzsche of using Cochrane\u2019s letterhead on a complaint to the European Medicines Agency about its evaluation of possible harms of HPV vaccines and testifying in a court case without overtly declaring his expert testimony was expressing \u2018personal\u2019 not \u2018Cochrane\u2019 views.<\/p>\n Wilson alleged that it constituted a breach in the \u2018Spokesperson Policy\u2019, a claim denied by G\u00f8tzsche. The dispute intensified after several people complained to the Board about G\u00f8tzsche\u2019s \u2018take no prisoners\u2019 approach to critiques of industry-funded science.<\/p>\n G\u00f8tzsche is well-known for his blunt criticisms over the harms of breast cancer screening programs, the overuse of psychiatric drugs, and has referred to the drug industry as \u2018organised crime\u2019.\u00a0 But his most recent article, with co-authors Lars J\u00f8rgensen and Tom Jefferson, was a stinging critique of the quality and methodology of Cochrane\u2019s HPV vaccines review. [1]<\/p>\n Immediate backlash ensued and the Cochrane leadership, accused G\u00f8tzsche\u2019s team of causing reputational damage to the organisation, fuelling anti-vaxxers and risking \u201cthe lives of millions of women world-wide by affecting vaccine uptake rates\u201d, according to a complaint by the editor of the Cochrane group that published the HPV review.<\/p>\n G\u00f8tzsche stood by his group\u2019s paper, sparking an urgent, internal review at Cochrane.\u00a0 On 3 Sept 2018, Cochrane\u2019s Editor in Chief, David Tovey, and his Deputy, Karla Soares-Weiser, issued a statement<\/a> claiming that the criticisms of the HPV vaccine review had been \u2018substantially overstated\u2019 and \u2018inaccurate and sensationalized.\u2019<\/p>\n \u201cPeople all over the world have interpreted the Cochrane editors\u2019 criticism of us as being the \u2018final word\u2019\u201d said G\u00f8tzsche in frustration. \u201cThe editors did not even address our most important concern that the harms of the HPV vaccine had been greatly under-reported and that much of the clinical data is not included in the review\u201d.<\/p>\n Legal Review<\/strong><\/p>\n The Board of Trustees agreed to engage the services of an external law firm to independently assess the dispute between G\u00f8tzsche and Wilson.\u00a0 In July 2018, G\u00f8tzsche was presented with 400 pages of documents, containing allegations that he had breached Cochrane policies and damaged its reputation.<\/p>\n G\u00f8tzsche retaliated by submitting a 66-page dossier outlining, in painstaking detail, allegations that Wilson\u2019s leadership team was \u2018destroying\u2019 Cochrane by treating it like it was a \u201cbrand or product\u201d, accusing Wilson of \u201cserious abuse and mismanagement of Cochrane\u201d, \u201ctampering with meeting minutes\u201d and \u201cmanagement by fear\u201d.<\/p>\n The lawyers poured over the mountain of documents and were expected to deliver a verdict in time for the 13 Sept Governing Board meeting.\u00a0 Twelve hours before the meeting started, the Counsel\u2019s report was delivered to the Board with a caveat that inadequate time was granted for a thorough review of all the issues.<\/p>\n Nonetheless, the report found that none of the serious allegations against the Cochrane executive could be substantiated, nor did it find that G\u00f8tzsche had breached the Spokesperson Policy or had acted inappropriately in his role as Trustee.<\/p>\n The Board Meeting<\/strong><\/p>\n Co-chair, Marguerite Koster, allowed G\u00f8tzsche \u2018five minutes\u2019 to state his case.\u00a0 Witnesses in the room say G\u00f8tzsche was constantly interrupted before being asked to leave the room while the other Board members discussed the situation. G\u00f8tzsche was given no further opportunity that day to defend himself.<\/p>\n After more than 6 hours of deliberation, the remaining 12 Board members voted on whether G\u00f8tzsche could remain as their 13th<\/sup> Governing Board member and continue to practice under the Cochrane license.<\/p>\n Five voted to remain, six voted to remove and one abstained.\u00a0 In the end, a \u2018minority\u2019 vote [6 out of 13] saw G\u00f8tzsche vacated from his position and lose his Cochrane membership. After 25 years of service to Cochrane and author of 17 Cochrane reviews, G\u00f8tzsche would officially learn of his fate by an email.<\/p>\n \u201cNo clear reasoned justification has been given for my expulsion aside from accusing me of causing \u2018disrepute\u2019 for the organization\u201d, claims G\u00f8tzsche. \u201cThis is the first time in 25 years that a member has been excluded from membership of Cochrane\u201d.<\/p>\n Several board members were shocked over the treatment of G\u00f8tzsche.<\/p>\n \u201cThe legal assessment essentially exonerated Peter of breaching the Spokesperson Policy so his enemies spent the day inventing new excuses to get rid of him\u201d, said one member. \u201cTo expel Peter is totally disproportionate,\u201d said another of G\u00f8tzsche\u2019s supporters. \u201cIt was like looking for any behavioural pretext to fire him.\u201d<\/p>\n The following day, 14 Sept 2018, four members resigned from the Governing Board in solidarity for G\u00f8tzsche and because they felt something drastic had to happen in order to save the organisation.<\/p>\n \u201cWhat should happen now, is that entire Board should resign and start again\u201d, said one member after their resignation.<\/p>\n On 15 Sept 2018, a statement to Cochrane Directors, from the co-chairs of the Governing Board, mentioned that four members resigned and that changes to the board were afoot, but did not mention G\u00f8tzsche\u2019s expulsion from the Board.<\/p>\n \u201cI don\u2019t understand why they are sticking they\u2019re head in the sand\u201d, said one board member. \u201cThey should do something now to address everyone\u2019s concerns\u201d.<\/p>\n Cochrane\u2019s sinking ship<\/strong><\/p>\n The events that have unfolded in the last few days have consequences for Cochrane far beyond dealing with the public embarrassment of losing more than a third of its Governing Board.<\/p>\n Much of G\u00f8tzsche\u2019s scientific work at the Nordic Cochrane Centre, has focused on exposing the flaws in clinical trials and the undue influence of the drug industry on medical research.<\/p>\n In addition, there are the issues raised in a recent editorial<\/a>, co-authored by Dr Tom Jefferson from Centre for Evidence-Based Medicine, Oxford. It explains the problems behind the reliance of data from published journal articles, many of which are likely to contain \u2018unfathomable bias\u2019.<\/p>\n \u201cWe know that the biomedical journals publish articles which are neutral at best, but are mostly positive and tend to emphasize benefits and downplay or even ignore harms,\u201d says Jefferson.<\/p>\n \u201cWhat you end up within the medical journals is a shoe-horn version or a summarized version and you don\u2019t know what criteria go into choosing which bits goes into the print version. So that introduces unfathomable bias\u201d.<\/p>\n Jefferson\u2019s answer to whether we should ignore evidence from journal articles was \u2018probably\u2019 unless urgent steps aren\u2019t taken to address the issue of reporting bias: cherry picking and spin of research findings<\/p>\n This presents Cochrane with an enormous problem. The lifeblood of the organisation is in carrying out systematic reviews.\u00a0 The basic evidence, upon which these reviews are founded, is largely at risk of bias, especially for interventions where there is a huge market.<\/p>\n \u201cThe contention that Cochrane has been publishing reviews that are mainly beneficial to the sponsors of these interventions is probably a fact,\u201d says Jefferson.\u00a0 \u201cIf your review is made up of studies which are biased and in some cases are ghost written or the studies are cherry picked and you don\u2019t take that into account in your review, then its garbage in and garbage out \u2013 its just that the \u2018garbage out\u2019 is systematically synthesised with a nice little Cochrane logo on it\u201d.<\/p>\n As for the data behind the HPV vaccines, it\u2019s a question of whether anyone has seen the full data set. \u201cThe answer is no-one outside the vaccine manufacturers.\u00a0 Not the drug regulators and certainly not, independent scientists\u201d says Jefferson.\u00a0 \u201cSo if you were to ask me what I think of HPV vaccines, I would say \u2018I don\u2019t know\u2019 because I haven\u2019t seen the full data set\u201d.<\/p>\n Furthermore, G\u00f8tzsche says that Cochrane\u2019s policy regarding the conflicts of interest of the authors of reviews is inadequate.\u00a0 \u201cI proposed a year ago that there should be no authors of Cochrane reviews that have financial conflicts of interests with companies related to the products considered in the reviews,\u201d says G\u00f8tzsche \u201cBut Cochrane did nothing about it\u201d.<\/p>\n Currently, Cochrane allows up to half of the authors on a review to have conflicts of interest, a policy that is widely criticized by insiders, and largely unknown to the public.<\/p>\n So why hasn\u2019t Cochrane done anything about it?<\/p>\n \u201cCochrane has become too sensitive to criticism of the pharmaceutical industry\u201d, says one board member. Insiders say a \u2018possible concern\u2019 might be that Cochrane fears that G\u00f8tzsche\u2019s criticism of the HPV vaccines review would negatively impact its sponsorship from the Bill & Melinda Gates Foundation.<\/p>\n Scientific censorship<\/strong><\/p>\n Cochrane has been accused of \u2018scientific censorship\u2019 and is now in \u2018damage control\u2019 to contain the PR nightmare.<\/p>\n Publicly, Cochrane has always maintained it encourages debate about scientific issues, including controversial ones.\u00a0 \u201cCochrane values constructive criticism of its work and publicly recognises this through the Bill Silverman Prize … with a view to helping to improve its work, and thus achieve its aim of helping people make well-informed decisions about health care\u201d, states Cochrane.<\/p>\n However, the reality is very different. \u201cThey don\u2019t believe in democratic plural science\u201d, said one outgoing board member.\u00a0 \u201cGood governance of science always requires open debates.\u00a0 The prestige of a scientific institution has to do with its ability to manage critical debates, not censor them\u201d.<\/p>\n \u201cScience needs to be challenged, it should not be politically correct, it is not consensus seeking,\u201d says G\u00f8tzsche. \u201cYou cannot call a public challenge to science \u2018controversial\u2019, it\u2019s a pejorative term.\u00a0 It\u2019s simply what our job as scientists requires of us\u201d.<\/p>\n The future of Cochrane<\/strong><\/p>\n Cochrane is in a moral crisis and many say it has lost a democratic leadership. \u201cOn dozens of issues, the Board can only vote yes or no with very little opportunity to amend or modify the executive team \u0301s proposals,\u201d says G\u00f8tzsche.<\/p>\n The entire US Cochrane Centre has already closed down in the spring of 2018, in frustration over management and other centre directors are also contemplating leaving Cochrane.\u00a0 Whereas those who\u2019ve been critical of Cochrane\u2019s direction, have simply withdrawn, G\u00f8tzsche spoke out publicly and has borne the consequences.<\/p>\n \u201cA recovery from this dire situation would call for the dissolution of the present board, new elections and a broad-based participatory debate about the future strategy and governance of the organization\u201d, says G\u00f8tzsche.<\/p>\n The Annual General Meeting on Monday (17th<\/sup> Sept) might shed light on Cochrane\u2019s future.<\/p>\n DISCLOSURE<\/u><\/strong>:\u00a0 \u00a0Maryanne Demasi is a\u00a0science reporter and<\/em>\u00a0a researcher working with Prof Peter C. G\u00f8tzsche, the Nordic Cochrane Centre, and was present in Edinburgh at the time of the meeting, but not present in the discussion room.<\/p>\n Reference:\u00a0The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias<\/a>.\u00a0
\nSee here: Why we resigned<\/a><\/h6>\n
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