Is public health safety at risk?
Is public health safety at risk following expulsion of Cochrane Collaboration founder member, Professor Peter C. Gøtzsche?
The medical research community is in turmoil following the expulsion of Professor Peter C. Gøtzsche from the Cochrane Collaboration, an organisation long respected for its independent review of public health interventions, including vaccines and whose work is trusted globally to inform government legislation.
At a meeting in Edinburgh last week, Cochrane’s Governing Board first considered “the findings of an independent review and additional complaints related to the conduct of a Member” that he was “causing disrepute”. Professor Gøtzsche, one of the co-founders of Cochrane and who has been on the 13 strong Governing Board since early in 2017, issued a statement saying he has been stripped of his membership following a vote of 6 in favour, 5 opposed and 1 abstention.
In protest, four board members resigned en-mass and two appointed trustees also volunteered to step down. According to a statement released by the four – they are protesting that the removal of an “inconvenient member” goes against the Cochrane ethos. It is also considered by some to be reflective of the shift away from well-founded research and public health protection. The Cochrane Board also issued a statement earlier this week accusing Gøtzsche et al of a “public and media campaign of misinformation” and that “at this point in time [Gøtzsche] remains a member of the Cochrane Collaboration”. They also amended the reason for the disciplinary to “bad behaviour” and notably: “This 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.” From online posts, not everyone agrees. I spoke to Gøtzsche briefly this morning: unable to give a full interview due to other time pressures, he confirmed that the Cochrane board “removed his membership”.
This is a storm that has been brewing for some time. Over the last few years Gøtzsche has been raising difficult questions of Cochrane and others about the HPV Vaccine, which is marketed as an anti-cancer vaccine. A statement released by Gøtzsche, following the vote, focuses on the move by Cochrane to commercialisation over “getting out independent, ethical, and socially responsible scientific results … my centre, and others, have been confronted with attempts at scientific censorship, rather than promotion of pluralistic, open scientific debate … There is stronger and stronger resistance to say anything that could bother pharmaceutical industry interests.”
Cochrane on the other hand states that there has been “repeated bad behaviour over many years” from Gøtzsche. Having met him a couple of times, and spoken to a number of people he works with there is no doubt that Gøtzsche has a very firm way of expressing his opinions. He is passionate about scientific integrity. It is also curious that, if such “bad” and “repeated” behaviour was known to Cochrane why was Gøtzsche appointed to the board in early 2017 with the most votes of the 11 candidates? If his (alleged) behaviour was known and acceptable enough to allow him to be voted onto the Cochrane board in line with the Cochrane “zero tolerance policy” then what changed?
If it is the man, and not the science, that is at issue then Cochrane, as an organisation that prides itself on objectivity, should still (objectively) investigate his claims in full. After all, he raises important questions about how scientific research has been conducted in relation to the safety of our children. When asked about this, Cochrane responded that they could not provide any more information than their earlier statement. Surely, responding to a scientific challenge however uncomfortable, should be a given.
Time for Action, a group of parents turned vaccine safety campaigners, agree: "Gøtzsche publicly questioned the evidence base for antidepressants and the HPV vaccines, two mainstays of the pharmaceutical industry … This is what we expect from Cochrane scientists; to ask difficult questions, to follow the science and to have total disregard for industry interests … Cochrane have lost the very scientists who appear to be true to the ethos and principles of Cochrane.”
The Nordic Cochrane centre, headed up by Gøtzsche, had also raised a complaint against the European Medical Agency’s (EMA) handling of a 2015 review of two, of the many, suspected serious harms reported following the HPV Vaccine. The EMA is responsible for the protection of public health through the scientific evaluation and supervision of medicines and is one part of the European Union that MPs have voted to remain part of post-Brexit. While Cochrane lost the complaint, and, on appeal, the Medical Ombudsman agreed with the EMA; many questions raised by Gøtzsche et al remain unanswered particularly around the scientific basis used by the EMA to determine vaccine safety, and the fact that internal documents differ from publically available information.
With a preventative vaccine that is given to healthy girls and boys, the standard of safety should be second to none. Yet, despite a growing body of evidence from abroad, and internal safety figures of suspected HPV Vaccine harms in the UK (held by the regulator but not available to the public) the NHS and UK regulators (and much of our media) continue to promote the HPV Vaccine without question.
There is also much debate in the scientific community about the basis on which safety decisions are being analysed and made. Gøtzsche has led the charge along with some other scientists. In recent months they’ve gained public traction. Time for Action comments: “Gøtzsche recently highlighted flaws in a systematic review of HPV vaccines published by other Cochrane affiliated scientists. The take-home message from Cochrane's decision to expel Gøtzsche is that some areas of medicine are out of bounds for independent critical analysis”.
History provides many examples, including Thalidomide or more recently, Swine Flu vaccine and narcolepsy, or vaginal mesh that questions should always be asked, taken seriously, and answered. History also shows, (as repeatedly so in my documentary Belonging The Truth Behind the Headlines) that people are often incorrectly ousted for spurious claims of “bad behaviour” when their approach no longer fits the planned new direction of an organisation.
Doctors and scientists complain that questioning vaccine safety after the MMR scandal is very difficult. The International Federation for Injured Children and Adults (IFICA) who work to foster dialogue, compassion and understanding by all stakeholders around the HPV Vaccine say: "This [Gøtzsche expulsion] is just another example of scientific censorship where people with integrity and honesty are punished for speaking the inconvenient truth".
We interviewed Gøtzsche in Denmark in May 2017, on vaccine safety regulation. He initially presented as a man who carries righteous pride well. In person, on and off camera, he is actually a considered, kind man who likes the facts to speak. He believes not just in science, but in science done well. He has an exceptionally clever mind and wants the right questions to form the debate. He has a reputation of being direct with an unorthodox and firm way of expressing his opinions, but that does not mean his scientific facts are wrong. I asked him then why regulators are apparently not listening to scientific experts, he concluded: “The whole debate has become vulgarised, often to a level where you are asked, are you for or against the vaccines?”
Those campaigning for a review of HPV Vaccine Safety tell us that they are being ignored, vilified and accused of being anti-vaccine, even though they consented to their daughters receiving the vaccine. Karen Smyth, mum of Laura, who fell ill after the HPV vaccine in 2010 and member of Irish parent led support group REGRET (Reactions and Effects of Gardasil Resulting in Extreme Trauma) says: “In 2016 the head of the Irish Health Service Executive; Tony O'Brien launched a scathing attack on the parents of girls affected, labelling them ‘Emotional Terrorists’. The incitement of hatred and abuse targeted at anyone daring to speak out in Ireland, including some of our sick girls, is unprecedented"
The expulsion of Gøtzsche may serve to drive home the wall of silence, despite scientific facts. The concern should be that if there is a problem with a vaccine’s safety and regulators ignore the signals, which are subsequently proven correct, public trust in all vaccines will be implicated – particularly if the regulators fail to ask the questions that Gøtzsche et al are asking. Today, and despite the storm which he centres, Gøtzsche told me: “In science the crucial thing is to get the facts right, no matter if the results are not welcome”.
His removal from an organisation that purports to promote “trusted evidence” and “informed decisions” may be reflective of the internal battle within Cochrane over its future direction. It may also reflect the wider ability to question vaccine safety without fear and maintaining public health concerns over commercial interests. Turmoil indeed. Not just for Cochrane.
By Morag Livingstone whose vaccines are up-to-date.
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