Editor’s Note: Over the next several months, Mad in America is publishing a serialized version of Peter Gøtzsche’s book, Mental Health Survival Kit and Withdrawal from Psychiatric Drugs. In this blog, he explains how the Cochrane Collaboration, which he co-founded, denied his findings, refused to publish his work, and ultimately expelled him, all in service of protecting guild interests and blocking information on antidepressant withdrawal. Each Monday, a new section of the book is published, and all chapters are archived here.

The Cochrane Collaboration doesn’t want to help patients withdraw

The biggest roadblock was provided by the Cochrane Collaboration. As noted, my criticism of psychiatric drugs was the direct reason why I was considered by Cochrane’s CEO, Mark Wilson, to be in bad standing, as they say in gangster circles, in the organisation I co-founded in 1993. I wrote the book Death of a Whistleblower and Cochrane’s Moral Collapse7 about Cochrane’s recent history and my expulsion from its Governing Board, to which I had been elected with the most votes of all 11 candidates, and from the Cochrane Collaboration. Wilson even got me fired in October 2018 from my job in Copenhagen, which I had held since I established the Nordic Cochrane Centre in 1993.7

Cochrane’s actions against me were widely condemned and there were articles in Science, Nature, Lancet and BMJ.7 Child and adolescent psychiatrist Sami Timimi reviewed my book,12 and here is an excerpt:

This book chronicles how an upside-down world is created when marketing triumphs over science; where the actual target of a years-long campaign of harassment gets labelled the guilty party … Gøtzsche’s compelling account includes quotes and documentation from written and oral sources, including transcripts of what was actually said in various meetings.

The book stands as a detailed study in how organisations become corrupted unless they have carefully formulated processes that guard against anti-democratic forces taking control, once that organisation has been successful and reached a certain size. This is a book exposing how Cochrane fell into the clutches of a hierarchy more concerned with finances and marketing than the reasons it was created for.

The death of its integrity, means that the most important institution left that could be trusted when it came to medical science, has disappeared down the same marketisation rabbit hole that captures so much of modern (so-called) medical science. Indeed it was because Professor Gøtzsche was prepared to call out the lowering of scientific standards in Cochrane that the hierarchy felt compelled to plot his demise.

Gøtzsche … created many of the methodological tools used by Cochrane reviews and has never shied away from letting the data speak for itself, however unpopular the findings might be with some doctors, researchers, and in particular with pharmaceutical and other medical device manufacturers. Cochrane under the influence of Gøtzsche, and others like him, became known as a source of credible, reliable, and independent reviews … helping doctors understand what worked and to what degree, but just as importantly what didn’t work and what harms treatments may cause.

It is these latter issues that meant that Gøtzsche was, and is, an inspiration to those of us who want medical practice to be as objective, free from bias, and safe as possible; but a threat to those who put commercial matters, marketisation, and image as their primary concern.

Gøtzsche’s brilliance and his fearless approach earned him many enemies. He is one of Denmark’s best-known researchers and is respected in research circles all over the world. But, for years he has documented how many products promoted by pharmaceutical industry and medical device manufacturers, can cause more harms than benefits; with detailed analysis of how the research from these companies misleads, obfuscates, or sometimes straightforwardly lies in order to protect and promote their products …

His work on psychiatric drugs showing how poor they all are at delivering better lives for those who take them, at the same time as causing enormous harms to millions, has earned him the ire of the psychiatric establishment at large, including some Cochrane groups … Instead of congratulating Gøtzsche for ensuring the integrity of the science produced by Cochrane, they began a challenge to this truth seeker for being “off message.”

This book carefully recounts this dark period in medical science where a once trusted institution carried out one of the worst show trials ever conducted in academia. The CEO and his collaborators went about their task in a manner that mirrors how the drug industry operates. Its employees are obliged to protect the sales of drugs and therefore cannot criticise the company’s research publicly.

There are many examples in the book of how once you label someone, their actions can be interpreted as fulfilling that label. For example, after being kept waiting for hours outside a room where a meeting about his potential expulsion is being discussed, an understandably frustrated Professor Gøtzsche, decides to knock on the door and go in to ask if it is OK if he goes back to the hotel rather than carry on waiting. He is reprimanded for entering the meeting and a brief altercation ensues, before Professor Gøtzsche leaves. This then becomes the only actual example of his alleged “bad behaviour” and part of the “evidence” for why he should be dismissed.

After his expulsion from Cochrane, through a majority vote of board members of only 6 against 5, with one abstention, a further four members of the board walked out in protest. Leading medical scientists from all over the world expressed their solidarity with Gøtzsche and outrage at what Cochrane had done. They universally praised Gøtzsche as a tireless advocate for research excellence, a fearless critic of scientific misconduct, and a powerful opponent of the corruption of research by industry interests, and criticised the unsupportable actions of Cochrane.

History will recount this as the death of Cochrane rather than the whistleblower.

It was a direct consequence of Cochrane’s moral collapse that Anders and I failed when we tried to get a protocol for a Cochrane review on depression pill withdrawal approved.13 The Cochrane depression group sent us on a two-year mission that was impossible to accomplish, raising their demands along the way to absurd levels with many irrelevant requirements, including demands of inserting marketing messages about the wonders depression pills can accomplish, according to Cochrane dogma.

Cochrane has no interest in a review about safe withdrawal of depression pills but did its utmost to defend the psychiatric guild, its many false beliefs, and the drug industry, forgetting that Cochrane’s mission is about helping patients, which is why we founded it in 1993, and the reason why we called it a collaboration.

In 2016, I contacted psychiatrist Rachel Churchill, the coordinating editor of the Cochrane depression group, who showed great interest in my proposal to do a review. I employed Anders, a newly qualified psychologist, but when we submitted a protocol for the review, it was not welcomed. It took nine months before we got any feedback. We responded to the comments and submitted two revised versions, but the demands on our protocol just increased and the editorial delays were so pronounced that we concluded that the editors deliberately obstructed the process to wear us out hoping we would withdraw the review ourselves while the group would not be seen as being unhelpful.

At one point, Churchill attached a 30-page document with 86 item points that no less than four editors and three peer reviewers had contributed to, with individual, named comments. The document took up 12,044 words including our replies to earlier comments, which was seven times longer than our original protocol from 2017. Anders wrote to me that our review was quite simple, as we just wanted to help people wishing to come off their drugs but weren’t allowed to do so: “What kind of world is this?”

When Churchill sent the eighth and final peer review to us, her invitation to address the feedback had suddenly metamorphosed into an outright rejection. Cochrane reviews on drugs are about putting people on drugs, not about getting off them again, and the eighth peer review is one of the worst I have ever seen. It is as long as a research article, 1830 words, and provided the Emperor’s New Clothes the group needed to get rid of us. In contrast to the other seven reviews, the hangman was anonymous. We asked for the identity of the reviewer, but this was not granted.

We appealed Churchill´s rejection, responded to the comments and submitted the final version of our protocol. We uploaded all eight reviews, our comments to them, and our final protocol, as part of the article we published about the affair.13 This allows independent observers to conclude for themselves whether Cochrane or we are to blame for the fact that the patients do not get the Cochrane review on withdrawal they deserve.

Very few changes to the protocol were needed. The eighth reviewer had denied a long array of scientific facts and had used several strawman arguments accusing us of things we had never claimed.

We were accused of “painting a picture” about avoiding using depression pills, which did not represent the scientific consensus, a totally irrelevant and misleading remark for a review about withdrawing these drugs. The reviewer wanted us to, “Start with a statement as to why antidepressants are considered by the scientific community to be beneficial … in treating a broad range of highly disabling and debilitating mental health problems” and accused us of being unscientific because we had not mentioned the beneficial effects. We responded that our review was not an advertisement for the drugs and that it was not relevant to discuss their effect in a review about stopping using them. Furthermore, a Cochrane review should not be a consensus report.

Also, the Cochrane editors had asked us to write about the benefits and to mention that “some antidepressants may be more effective than others,” with reference to a 2018 network meta-analysis in Lancet by Andrea Cipriani and colleagues.14 However, even though there is a Cochrane statistician among its authors, Julian Higgins, editor of the Cochrane Handbook of Systematic Reviews of Interventions that describes in over 636 pages how do to Cochrane reviews,15 the review is seriously flawed. I demonstrated this in the article, “Rewarding the companies that cheated the most in antidepressant trials,”16 and a re-analysis by my colleagues from the Nordic Cochrane Centre showed that the outcome data reported in Lancet differed from the clinical study reports in 12 of the 19 trials they examined.17

A Cochrane editor asked us to describe how depression pills work and what the differences are between them, and a reviewer wanted us to explain when it was appropriate and inappropriate to use depression pills. However, we were not writing a textbook in clinical pharmacology, we were just trying to help the patients come off their drugs.

We wrote in our protocol that, “Some patients refer to the discredited hypothesis about a chemical imbalance in their brain being the cause of their disorder and therefore also the reason for not daring to stop.” The eighth reviewer, who clearly believed in the chemical imbalance nonsense, opined that we dismissed many decades of evidence of neurochemical changes observed in depression and accused us of having suggested with no evidence that prescribers perpetuate untruths to justify drug prescription.

They surely do, but Cochrane used the familiar tactic of blaming the patients for the psychiatrists’ wrongdoing and lies. Responding to the same sentence, coordinating editor Sarah Hetrick asked us to write: “People on antidepressants may believe that this is necessary because they have a belief that the difficulties they are experiencing are due to a chemical imbalance in the brain.” The patients didn’t invent this lie; the psychiatrists did!6

The eighth reviewer asked us to explain the concept of ongoing prophylactic depression pill treatment, “a well-accepted clinical strategy,” but this was outside the scope of our review. Furthermore, as noted in Chapter 2, all randomised trials comparing maintenance therapy with withdrawal of the drug are flawed because of cold turkey effects in the latter group.

We were wrongly accused of having conflated disease reappearance with withdrawal symptoms, and the reviewer even argued that most people who had taken depression pills for extended periods could stop safely without problems, which is blatantly false.

The reviewer wanted us to remove this sentence: “the patients’ condition is best described as drug dependence” referring to the DSM-IV drug dependence criteria. We replied that, according to these criteria, no one who smokes 20 cigarettes every day is dependent on smoking cigarettes.

The level of denial, obfuscation, and confusion was really high in the two-year process. We were asked by a reviewer to give references on rates of dependency but had already done this to such an extent that an editor asked us to shorten it.

Our long-held suspicion that Cochrane wasn’t interested in helping patients come off their psychiatric drugs had now turned into certainty. But we wouldn’t give up and filed three appeals, one to Churchill, one to Chris Eccleston, Senior Editor for the Cochrane Mental Health and Neuroscience Network and a professor of medical psychology, and finally, to Cochrane’s Editor-in-Chief, Karla Soares-Weiser, who is a psychiatrist.

We emphasized that the Cochrane Collaboration should not mount ever increasing obstacles along the way for those who volunteer to do the work to help suffering patients but should be forthcoming and helpful. Earlier, we had written to the editors that they “are making something, which is very simple, highly complicated. Our review has a very simple aim: to help patients come off drugs they want to come off.”

An editor wrote to us that our primary outcome of “complete cessation of antidepressant drug use” should be more clearly defined, as it might not be cessation for life. Perhaps not, but no studies in psychiatry have ever followed all patients till they are all dead.

Our first appeal was not handled by Churchill but by the coordinating editor from the Cochrane Airways group, Rebecca Fortescue. According to her, “a reader can be left in little doubt about the review authors’ stance on the relative harms and benefits of psychiatric drugs, which does not fully reflect the current international consensus and could cause alarm among review users who rely on Cochrane’s impartiality.”

We responded with a British understatement: “We are a bit surprised about this comment.” Cochrane should not be about consensus but about getting the science right, and unfortunately it is very far from being impartial.6,7 Furthermore, assessing the harms and benefits of psychiatric drugs was outside the scope of our review. We had not written about this issue in our protocol or offered any “stance.”

Even though we had pointed this out repeatedly, Fortescue, the other Cochrane editors and the peer reviewers didn’t understand that “types of participants” were people taking pills who wanted to come off them. As the withdrawal symptoms are similar for any type of patient, disease, or drug, this broad approach is the right one, which I had explained already in 2000 in BMJ in the article: “Why we need a broad perspective on meta-analysis: It may be crucially important for patients.”18

Fortescue requested a clearer description of the population, intervention, and comparators (e.g. if we would include trials in migraine prophylaxis, chronic pain, or urinary incontinence), and another editor asked for details about which ages, sexes, settings, diagnoses of depression, and types of depression pills we would include, as if we were planning to do a randomised trial. HELP! These demands were totally absurd and amateurish. We included everything!

Although we explained to Eccleston that there was very little that separated us and the Cochrane Common Mental Disorders group after our latest revision, which Fortescue had not seen, he—although being a psychologist—joined the Cochrane ranks and summarily rejected our appeal in just 56 words:

“I am very sorry that this title did not succeed because I agree with the importance of the question. I sincerely hope that you will both take what is done and complete it in another outlet. We need to stimulate a discussion on this important topic and it has become more important over time not less.”

Cochrane’s Editor-in-Chief, Karla Soares-Weiser, rejected our appeal in 72 words:

“I have had a chance to look carefully at the protocol, the editorial and the peer-review comments, together with your replies and the email exchanges between your team and the Review Group editors. The comments obtained from the open peer review process consistently indicated a lack of clarity regarding the review methods proposed and, despite more than one opportunity to address this, the protocol did not show sufficient evidence that this progressed.”

We wonder how it can be an “open peer review process” when the hangman was deliberately disguised. We cannot even check if that person had unacceptable conflicts of interest. It was not correct either that there was a lack of clarity about our methods. Even though we found many of the demands unreasonable, we did our best to live up to them, and, being an author on about 20 Cochrane reviews and countless other systematic reviews, having defended what might be the first doctoral thesis about meta-analyses in the world in healthcare, and having developed several of the methods Cochrane use, I think I know what I am doing, in contrast to the Cochrane editors.

The fact that patients are organising themselves in survivor groups and various withdrawal-related initiatives around the world is a clear sign that the psychiatric guild ignores them, which Cochrane also does. Although it is true that “some people get terrible withdrawal symptoms,” a reviewer wanted us to trivialise totally this harm by writing that, “some people get withdrawal symptoms that can negatively impact the quality of life of the patient.” This must be at the top end of British understatements. We changed “terrible” to “severe,” since withdrawal has been documented using exactly this word.8

Cochrane protected psychiatry’s guild interests, the drug industry’s commercial interests, and the specialty’s false beliefs in 2015 as well, when I explained in a BMJ paper why long-term use of psychiatric drugs causes more harm than good and that we should therefore use these drugs very sparingly.19

The same day, Cochrane’s then Editor-in-Chief, David Tovey, who is not a psychiatrist but has a background as a family physician, and the three editors in charge of the three Cochrane mental health groups, Rachel Churchill included, attacked my scientific credibility in a rapid response to my article.7 Several editors of other Cochrane groups told me they were dismayed that these editors had tried to denigrate my research by appealing to authority rather than reason, which they felt shouldn’t happen in Cochrane.

We will publish our review of withdrawal in a journal whose editors are not morally corrupt and who have the patients’ interests as their first priority.

 

 

To read the footnotes for this chapter and others, click here.

***

Mad in America hosts blogs by a diverse group of writers. These posts are designed to serve as a public forum for a discussion—broadly speaking—of psychiatry and its treatments. The opinions expressed are the writers’ own.





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