Cochrexit?
Editorial: There were no plans to write a part 5 to a 4-part series but this account by David Hammerstein, a Cochrane board member, clamors to be spread. One more point to mention is if what Cochrane is doing now is junk, then the NICE and all other guidelines are also junk. So there is a lot riding on this clash. Cochrexit refers to the fact this is a curiously British cutting itself off from the rest of the world.
Trusted evidence for the common good of public health
The crisis in Cochrane is about the credibility of Cochrane and not a question concerning the “behaviour” by one individual. What is at stake is the prestige of Cochrane and the public´s faith in its work. It is a major mistake to personalize the crisis in Peter Gotzsche. Instead we should orient our attention to a much broader consideration of the democratic and scientific improvements needed in Cochrane. If the measures taken by Cochrane to overcome this crisis are circumscribed to Gotzsche it will be a missed opportunity for a genuine regeneration of the organization and the defense of the credibility of its work.
It is extremely superficial and probably an act of bad faith to focus the present crisis of the Cochrane Collaboration on one individual´s behaviour. Here “personal behaviour” is being used to avoid a serious debate on the future strategy and policies of the organization. Of course, there are all kinds of people with different characters and different temperaments as in any large organization. Yes, there have been some passionate and sometimes overly heated discussions concerning important policy issues of Cochrane in which both the Cochrane leadership, including its CEO, and Peter Gotzsche have been involved. But this crisis is not about style but substance.
One person´s personality can sometimes be bothersome to some people but, without a doubt, what has moved the Cochrane leadership to take the exceptional decision to expel Peter Gotzsche are his very visible actions in the fields of science, policy and medical ethics. Peter´s positions on unethical practices by the pharmaceutical industry, the harms and overuse of psychiatric drugs, deadly secondary effects of many medicines, the dangers of over-diagnosis of mammography screening, the general inefficacy of influenza vaccines, the concealment of clinical trial data, ADHD, HPV vaccine reviews, EMAs transparency policies and medicine patents, among other issues, have many times caused great discomfort to Cochrane´s leadership. Peter Gotzsche never claimed to represent the whole Cochrane organization (only his Nordic Cochrane Centre) but his great public exposure made his Cochrane affiliation at the Nordic Centre very inconvenient for the Cochrane leadership and its “comfort zone brand” strategy. This deliberate confusion of affiliation with representation has been used by the Cochrane leadership over the past few years to attack and try to erode Gotzsche´s prestige related to his scientific and policy positions. As Gotzsche´s activities generated wider and wider public debate, the Cochrane leadership became more and more worried about being identified with the “radical” views of one of their most famous members.
A collaboration or a “brand”?
Practically all observers of Cochrane, including a number of medical journals, the press and even the so-called “independent Counsel” hired by the Cochrane leadership, have all admitted that there are confronting paradigms of varying degrees concerning what the future of the organization should look like. One stresses the top-priority of “a sustainable business model” based mainly on substantial publishing income(produced by paywalls), capable of maintaining a large central office for editorial and administrative teams. This paradigm held by the CEO and a small majority of the Governing Board deems that the preservation of a unified “brand” and a more centralized and authoritarian “corporate image” is of the upmost importance for the financial growth and stability of the Cochrane central office. In this context the scientific, financial and policy independence of Cochrane centres outside of the UK could pose a threat to the consolidation of this common “brand”. According to this narrative held by the Cochrane leadership all other issues of policy, scientific methodology and ethics are secondary, or are even considered “negative liabilities”, for the maintenance of the central organization. Hence, with the same logic, the present executive team and Governing Board presidency are openly reticent of contact with most public health NGOs and against any visible Cochrane leaders taking clear public positions on transparency, open data, open science or medical innovation policies.
The other paradigm, often held by a number of Cochrane “old-timers” as well as young newcomers, stresses, in varying degrees(totally irrespective of their positive or negative appraisal of Peter Gotzsche), support for much stronger policies to avoid biases and conflicts of interest in Cochrane reviews, much greater visibility of Cochrane in policy debates on health technology evaluation, open access publishing, shared structured data and open models of biomedical innovation. What is essential for this group is where the “evidence” comes from, who pays for it and if all the clinical evidence is publicly available or not. As well, this group values much more than the present Cochrane leadership interactions with civil society organizations, NGOs and progressive policy-makers. Here a more horizontal governance of the organization is often requested with much more input from Cochrane´s regional centres which often feel marginalized from decision making processes. The present Cochrane leadership has become generally conservative, reactive to change and principally driven by its scientific publishing economic interests more than public health concerns.
If we consider the expulsion of Gotzsche and the recent strategic direction of Cochrane from a structural social-economic perspective, the big winner in this conflict has been the pharmaceutical industry, having succeeded in weakening the voice of one of its greatest critics and having consolidated a Cochrane leadership closer to industrial interests with fewer audible critical voices. As far as we know there is no smoking gun of direct industry influence(aside from the permitted conflict of interest of reviewers), but from a cold analytical viewpoint the objective outcome is clear.
Democratic deficits
Any open, internal debate within Cochrane concerning Cochrane policies is considered by the present leadership as dangerous. This is reflected in the lack of democratic efficacy of many of the internal structures from the Council to the Governing Board, from the Annual General Meeting to the Meetings of centre directors. None of these structures have proven satisfactory forums for a fruitful relationship between the Central Executive Team and the Cochrane members that carry out most of the organization´s work around the world. The Cochrane leadership has often shown disdain and impatience with any criticism of their work or proposals. This has created a negative environment for the positive synergy among Governing Board members, members of the Council and many centre directors.
What is specially grievous is that the Governing Board, as a whole, does not govern. It seems to be considered by the central executive team to be a mere rubber-stamp for their decisions. Only the co-chairs of the Governing Board seem to have some fluid input into the decision-making process.
Every six months there is a Governing Board meeting. A few days before each meeting the members are sent dozens of pages of documents of proposals to be voted in the meeting. The response can be “yes, no or abstention” while significant amendments to the proposals are practically impossible. In other words, important decisions are taken on a “take it or leave it” basis. The highly polished proposals presented by the central executive team are not prepared in collaboration with most members of the Governing Board or other important members of the Collaboration, in what could be an enriching inclusive process between Board meetings. Instead, most members of the Board are presented with a series of fait acompli which has created quite a deal of frustration among veteran members of Cochrane on the Board. One of them said that he/she felt like resigning at every board meeting due to being taken for granted by the CEO and the central executive team. Serious discussion of strategic policy, scientific and organizational issues is not common in Governing Board meetings and when it does occur it is not well received by the Cochrane leadership, including the two co-chairs of the Governing Board who never have a public word of discrepancy with anything presented to the Board by the CEO. Despite vocal criticism from veteran Cochrane members concerning the weak role of the Governing Board compared with the decisive role of the central executive team, no measures have been taken to improve the democratic dynamics of the organization. A great deal of the time of Governing Board meetings is occupied by long power-point presentations given by the central executive team about their accomplishments.
There is a general lack of democratic participation and debate among the members in Cochrane For example, the Strategy 2020 adopted by the board has never been broadly discussed debated among Cochrane members. Another illustrative example of this top-down control obsession of the Cochrane leadership is the “webinar” organized a few days ago to theoretically “explain” the current crisis sparked by the expulsion of Peter Gotzsche (though no convincing evidence was provided). All the microphones of the participants were muted who they were not allowed to speak, only to listen passively, and even their written questions sent to the CEO and the Co-Chairs were “re-interpreted” and formulated in different terms. One Cochrane centre director participating in the “webinar” asked in his written question “Would you be ready to offer yourselves for a motion of confidence, that is, resigning from the Governing Board and also applying as candidates to the new elections? This would give Cochrane people the opportunity to explicitly support you.” The question announced to the whole group by the organizers with no respect for the written formulation was: “He asks if the Governing Board should resign”. This is just an anecdotal example of the generally top-down, fearful approach to democratic debate and participation in Cochrane.
The crucifixion of Peter Gotzsche
The whole process against Gotzsche has been anti-democratic and none of the basic tenets of due process, fairness and transparency have been upheld. There has been no attempt at seeking outside neutral arbitration nor the use of techniques of conflict resolution with the aim of reaching a friendly agreement or even a more peaceful modus vivendi concerning disagreements. No time has been given to establish an independent committee of conflict made up of people from outside of Cochrane´s the main institutions. Every step of democratic guarantees that is common in most large organizations has been ignored in this case with the objective of the rapid exclusion and tarnishing of Peter Gotzsche. Any future independent investigation of this question should be centered on the violation of democratic processes by the CEO and the Co-chairs of the Governing Board.
Instead of an open and balanced procedure with the hope of reaching a friendly arrangement or a fair arbitration, the whole process was practically limited to a totally unproductive written back and forth between Cochrane´s CEO and Peter Gotzsche.
Peter Gotzsche has had no chance to defend himself in person before the Board. He was expelled without even knowing what he was accused of, aside from the generic accusation of causing “disrepute” to Cochrane. The only accusation that had been made clearly, that he had violated the spokesperson policy, was not at all confirmed by the so-called “independent counsel” that found the spokesperson policy “ambiguous” and “open to different interpretations”. In fact, the so-called “independent counsel” did not reach any clear conclusions nor did it make any recommendations for disciplinary action against Gotzsche despite this being requested from the Cochrane leadership. The ambiguous phrase used publicly by the Cochrane leadership that the open-ended counsel report – “did not exonerate”- falsely insinuated that Gotzsche was found guilty of wrongdoing on the part of the Counsel, but that did not happen. It is disgraceful that the Cochrane leadership has used such personal defamation tactics without any proof nor transparency.
The decision to expel Peter Gotzsche from membership in Cochrane by a minority of the Board was taken by such a narrow margin (6 in favour and 5 against with one abstention – without the presence or vote of Gotzsche) that any rational consideration of an issue that divides the organization would have called for a postponement, a reconsideration or a new approach of conflict resolution. To move forward with this unprecedented decision “whatever the cost” was a very reckless course to take, to say the least.
What is totally unacceptable and probably illegal is that dark and ominous insinuations have been made about Peter Gotzsche, backed up with absolutely no evidence. Concerning his personal “behaviour”, the Cochrane leadership has publicly and privately used the language of the “me-too” movement and “zero-tolerance” of sexual harassment and abuse.
The exclusion of Peter Gotzsche and the “suggested” resignation of another four members of the Board was a well-planned, pre-determined operation for the elimination of all the critical voices from the Governing Board. Shortly before the Governing Board vote that expelled Gotzsche, one of the six members of the Board that voted in favour of the expulsion, stated that all the members of the Board were obliged to publicly defend the decision and not reveal the details of the close vote that was about to take place. What was also sought by the Cochrane leadership was a concealment of what had happened in the process, debate and vote.
Should up to half of Cochrane authors have conflicts of interest?
At the Governing Board meeting in September 2017 Peter Gotzsche proposed a text, with the support of a number of other members of the Board, to substantially strengthen Cochrane´s conflict of interest policy which today allows up to half of the authors of reviews to have conflicts of interests with the company that makes the product they are evaluating. This proposal was met with considerable resistance and outright discomfort from the Cochrane leadership, one of the Governing Board leaders even said that “without conflicted reviewers we´ll find no-one to do our reviews”. Over the next year no progress was made on this conflict of interest proposal and a long, torturous bureaucratically procedure was suggested by the co-chairs with the intention of burying the whole issue.
Long time Cochrane collaborator Ray Moynihan has insisted that an important improvement of Cochrane´s conflict of interest policy is long over due because it still allows individuals with financial ties to pharmaceutical companies to review evidence about those same companies’ product if they make up less than half of the review team. Moynihan states “it’s an anathema that conflicted individuals should be reviewing what is often conflicted evidence to start with. Cochrane has an opportunity to provide global leadership by cleaning up this mess” [i] Unfortunately, the Cochrane leadership has shown no willingness to clean up the mess.
The International Society of Drug Bulletins has stated it very clearly: “What is at stake is the not the transparency of conflicts of interest or whether or not it is feasible to get rid of conflicts of interest; it is definitely about trust, credibility and scientific integrity. Cochrane is damaging the trust and credibility that doctors, pharmacists, scientists and patients have put in them. Cochrane’s credibility and trust are largely at stake if they do not adequately deal with this issue immediately.”[ii]
It is no coincidence that Peter Gotzsche´s expulsion took place when he had been insisting for over a year on a new, much stricter conflict of interest policy for Cochrane.
No commitment to transparency
The present Cochrane leadership represented by its CEO is very reticent and even allergic to any public interest advocacy despite that it is one of the important elements of the Cochrane 2020 strategy. In fact, the internal auditing of the degree of fulfillment of the established advocacy objectives of the 2020 admits that Cochrane´s public advocacy has been totally insufficient and is marked as a failure with the colour “red”.
As a member of the Board I took the initiative to make a number of concrete suggestions for Cochrane public advocacy by means of mails, phone calls and personal meetings. I requested that Cochrane take positions on the weak application of clinical trial transparency rules in the EU, on the new health technology assessment legal framework of the EU and on public interest innovation proposals at the WHO.
Over the past year the CEO has insisted that they “are not ready” for taking public positions, that it is not a present priority for the staff and expressed in a written reply the need to plan advocacy carefully based on the “products” (systematic reviews) Cochrane develops. When one top member of the Cochrane team was asked about Cochrane´s relationship with the major public health NGOs that often present proposals for access to medicines and new open innovation models before the World Health Organization, he/she said that these organizations held viewpoints “too radical” for Cochrane.
At the Edinburgh meeting in September, 2018 the central executive team presented an advocacy proposal for 2019-2020 without structuring any previous input or dialogue from members of the Governing Board despite the continuous interest in advocacy of a number of members of the Board.
Despite visiting the London office on my own initiative, speaking with members of the executive team and supplying political intelligence in writing, I received no corresponding requests to collaborate, offer ideas or comment on the advocacy strategy or other related issues before it was presented for the consideration and approval by the Board.
What is evident to any observer is that over the past few years Cochrane has not considered it important to influence public policy in areas extremely relevant and necessary for the production of “better evidence”. Apparently, there is a divergent viewpoint over what kind of public advocacy, if any, is based on the needs of its “products”.
Is Cochrane allowing evidence-based medicine to be “hijacked”?
While Cochrane has been considered by many to be the beacon and the best example of “evidence based medicine”, the Cochrane leadership has generally not heeded very qualified and documented calls concerning the perversion and hijacking of EBM. As John Ioannidis has said ““evidence-based medicine” has become a very common term that is misused and abused by eminence-based experts and conflicted stakeholders who want to support their views and their products, without caring much about the integrity, transparency, and unbiasedness of science.”[iv] Some observers feel that many Cochrane reviews are being “misused and abused” in this very manner by the pharmaceutical industry. Especially criticized is the production of many Cochrane reviews based on journal articles without attention given to much of the clinical data which is often either hidden, censored or manipulated by the industry sponsors of the trials. In these journal-based reviews there is often insufficient importance given to the factors of publication bias, the concealment of secondary effects and changes in statistical protocols.
Can a systematic reviews of journal articles, often suffering from publication bias and the lack of accessible raw data or structured data to back them up, supply the “trusted evidence” Cochrane promises? According to Cochrane veteran Tom Jefferson the answer is: “probably not”. Most journal articles have a very high degree of bias that usually exaggerate benefits and hide possible harms. Moreover, many journal articles are based on clinical data that is not available or hidden by the trial sponsors. Because of these reasons Jefferson considers much of the raw material used in Cochrane systematic reviews as “garbage”. Jefferson suggests alternatives to focussing on unreliable journal articles: “They (Journal Articles) can be carefully contrived pieces of marketing, part of a global jigsaw. We can only guess at what their purpose is and what the true results are. We need to stop producing reviews based on articles (or at least solely on articles) and seriously and urgently look at drawing from data sources which allow alternative explanations and conclusions from the data, because the data set is detailed and near-complete.”[v]
The present Cochrane leadership has not reacted proactively to this criticism of how many of Cochrane´s systematic reviews are carried out within a biased and nontransparent context due to the manner a large part of biomedical evidence is generated, evaluated and published. They have even refused to seriously consider other emerging forms of evidence synthesis such as realist reviews, scoping reviews and some kinds of rapid reviews which could be very important for decision makers.
Cochrane has also not been positively responsive to public criticism by many longtime members and supporters of Cochrane that Cochrane reviews often do not include open access to structured data for sharing, re-use and to back up conclusions. [vi] While Cochrane formally supports the clinical data transparency initiative All Trials “it has no similar clear principles on opening full access to the data within Cochrane reviews”. There has been a positive disposition for dialogue on these issues on the part of Cochrane´s chief editor David Tovey but in his response he insists that a “more liberal application of open access” would jeopardize Cochrane´s “financial sustainability”. [vii] Again we see an unresolved conflict between the needs of the prevailing Cochrane business model and its declared public interest objectives of openness and the sharing of data.
Without taking energetic steps to improve the independence, openness, transparency and reliability of the evidence it uses, the credibility of Cochrane reviews will decrease.
David Sackett´s definition of evidence-based medicine is “integrating individual clinical expertise with the best external evidence”. [viii] There are ample examples that this goal has not generally been achieved for a number of reasons. One major reason is what Ioannidis has insisted that clinical evidence is “becoming an industry advertisement tool” and that “much ‘basic’ science [is] becoming an annex to Las Vegas casinos due to a highly competitive, unpredictable mass of aggressive gamblers with enormous economic stakes in play.”[ix] It is has become evident that the present Cochrane leadership has sometimes chosen to ignore overt industry manipulation of clinical evidence and has ocassionally even fallen in the trap of serving as “an industry advertisement tool” with a shiny Cochrane stamp on it that lends this publicity “independent” credibility.
Peter Gotzsche and others in Cochrane have defended the idea that evidence generated by companies with a vested financial interest in the marketing of the “reliability” of that evidence is a great problem for medical researchers and the carrying out of systematic reviews. Most of the Cochrane leadership thinks and acts otherwise in the way it treats the evidence usually used as the “raw material” for systematic reviews. If that is added to the fact of a weak conflict of interest policy that allows up to half of reviewers to have conflicts of interest, Cochrane has a growing credibility problem.
The objective of some Cochrane authors is to produce as many reviews (referred to as “products” by the Cochrane CEO) as possible, often by networked meta-analysis, which according to Cochrane´s own handbooks has significant limitations and weaknesses. But when the principal objective is to turn out a large quantity of reviews by means of collecting the maximum quantity of “evidence”, without much scrutiny of its origin, the protection of patients, the defense of public health and the rational use of medicines can become of secondary importance.
Regenerating Cochrane
In order to overcome the crisis in Cochrane and to defend the prestige of the organization it is crucial to re-establish the the conditions of trust and cohesion necessary to strengthen Cochrane in its work and goals. The Ibero-American centre directors have made a proposal [x] that calls for the election of the posts vacant on the Governing Board that would name an independent investigative commission to investigate the process of the expulsion of Peter Gotzsche.
For many reasons this would be a false closure of the crisis because it leaves out many of the fundamental underlying aspects of this crisis. To exclusively focus the solution to the problems of Cochrane on the personal case of Peter Gotzsche´s “behaviour” while ignoring at the same time the crucial democratic deficits and strategic differences that have led to the conflict, would produce a damaging missed opportunity for the democratic regeneration of the organization and the improvement of its scientific work.
The conditions for the resolution of the conflict must have minimum guarantees which are consistent with democratic demands of impartiality and objectivity, something that cannot occur if the organization of the investigation process remains in the same hands of the same Cochrane leadership that were active participants in the decisions that led to the expulsion of Peter Gotzsche. The people who have actively participated in this conflict, principally the CEO and the co-presidents of the Governing Board, are not credible organizers of a fair and transparent electoral process of new members of the Board of government and much less the establishing of the terms of reference and objectives of an investigative commission.
Below are some of the reasons why this proposal would imply a false closing and at the same time an alternative proposal is made for the broader regeneration of the organization.
1. The small number of people currently members of the Governing Board, who have taken part and adopted decisions in the conflict, must validate and receive the democratic support of the whole organization if they aspire to continue as members of the Board. Consequently, it is neither sensible nor appropriate that elections be held to only fill the vacant positions of the Governing Board, when the coherent and logical in these exceptional circumstances would be the complete renewal of the Governing Board.
2. Any electoral process for the election of positions of responsibility and direction must have conditions of neutrality, objectivity and monitoring. For this reason, an independent commission must be created specifically in charge of guaranteeing the election process. The members of an electoral commission in charge of supervising the election process must enjoy maximum independence and must be elected by a joint meeting of the Council, the Governing Board and the center directors. The electoral commission for the electoral process must assure a public and transparent census of the members of Cochrane. The legitimacy and validity of the voting process and candidacies must be established from the census of Cochrane members existing prior to the current crisis that started in the month June 2018. The electoral commission created must establish sufficient time periods and open forums of debate to provide for a democratic campaign and debate.
- Any proposal to create a commission of inquiry that is appointed and oriented in its tasks by the current leadership of Cochrane, including the remaining Governing Board(5 out of 13) or the executive team, does not offer guarantees of impartiality. Moreover, this inquiry commission should integrate broader objectives beyond the reasons Gotzsche expulsion and also consider the organizational, democratic and strategic issues that are substantially involved in the current conflict.4. An investigation of the conflict focusing exclusively on the process of expulsion of Peter Gotzsche would in fact exclude the necessary evaluation of the democratic deficits of the functioning of the Cochrane governance bodies, those related to the conflict of interest policy of Cochrane reviewers and the consequences of the publishing business model of the organization.5. The selection of a new editor-in-chief of Cochrane to replace David Tovey is a decision of vital importance for the present and future of the organization. This requires a process with broad democratic foundations that cannot be left in the exclusive hands of the CEO and the co-presidents of the Board of Governors who, in turn, have been active protagonists of the current crisis.
David Hammerstein, ex-member of the Cochrane Governing Board, resigned September 13, 2018
Analysis and context of the scientific conflict in Cochrane
Open scientific debate, transparency and advocacy in Cochrane as strategies for improving Cochrane reviews
1) From a meta-scientific perspective, there is a crisis of evidence-based biomedical science that is often being hijacked by commercial interests (Ioannidis)[xi] that Cochrane is not taking charge of and as a result much of the evidence that feeds into its reviews have a high possibility of being biased. Open scientific debate is one way of trying to reduce these dangers. Another way is fighting for open access to all clinical data used in a review and assuring transparency without any limits on access to existing trial data.
2) The high possibility of a priori bias (Stegenga)[xii] should force Cochrane to activate safeguards not only technical (which are usually very good) but also policies of epistemology, methodology, ethics and morality. Transparency, open debate and expanded participation are tools that can help in the reduction of uncertainty and improve the public perception of the democratic scientific process. These are conditions and tools that cannot be eliminated without placing into serious doubt the rigorous scientific undertaking of Cochrane and eroding public confidence in Cochrane´s work. Moreover, the admittance of great uncertainty due to the lack of access to complete data is a key aspect of reducing bias and misleading results.
3) Good governance of science always requires open debates. The prestige of a scientific institution has to do with its ability to manage critical debates, not censor them. As it has been stressed for decades by very diverse theorists of science, as for example Karl Popper, the central difference of the studies and the scientific knowledge in comparison with another type of knowledge resides in the rigorous application of the ” scientific method “in its two paths of inquiry (empirical and rationalist) and also resides in the same” ethos “that characterizes the scientific communities: the open and critical debate that makes possible the continuous revision and testing of the studies, hypothesis, methodology , results and applications. The combination of both types of controls (internal-methodological and external of the strictly scientific debate) on epistemic demands in science allows greater guarantees of objectivity and greater productivity around results, knowledge and scientific truths. Then the prestige of a scientific institution has to do with its capacity to favor and manage the dissemination of information and critical debates in the scientific community, among professionals, experts and researchers, not with one “official point of view” or (self) censorship. Democratic and pluralistic (Kuhnian and “post-normal”) science represents a new perspective, highly advisable in the face of realities and problems of very high risk, possible harms and of very high indeterminacy, which also implies an expanded transparent system of citizen-scientific guarantees. The post-normal paradigm adds a new mechanism of scientific control by not restricting participation and open, critical debate to the scientific-research community but also opening participation to other citizen/consumer/patient actors (affected, responsible, concerned, expert professionals, …). Cochrane could be an excellent example of this paradigm.
4) It is crucial to defend academic and scientific freedom, autonomy and independence in Cochrane. The reviewers of the Cochrane, members and Centre Directors are scientists with their own voice (many do not work exclusively for the Collaboration, have academic careers or independent clinics, get their financing and salaries from other sources,….) and not disciplined members of a political party or a private company that have the obligation of defending “one brand” in the “market” or one point of view.
5) Cochrane members should have the right to express their opinion and criticize publicly unless they say they are representing the whole organization: the quality of the critique must be evaluated by the scientific journals that publish them and should not pass any previous institutional filter. This public criticism by Cochrane members should not be seen as an attack but as an enrichment of a plural organization with different points of view based on evidence. This is the only quality guarantee accepted in science and not whether or not it is in accordance with organizational policies. That is, Cochrane members, besides being an integral part and members of that organization, have the individual right to the freedom to disagree, to publicly criticize and criticize, to contradict methodologies and results of scientific and meta-scientific studies, to question opinions and adopted agreements. by the direction of the organization. The quality and foundation of the critique must be evaluated in any case, by the rest of the members of the organization, by specialized and professional researchers, by the scientific journals that publish the criticisms, etc. In short, the critical public statements that Cochrane scientists-researchers can make as members of the organization should not be subjected to any previous institutional, political, economic or ideological filter, let alone be subject to censorship, repression, or exclusion.
6) Some of the causes of the current crisis of science have to do with conflicts of interest, industrial influence and the capacity of institutions and companies to restrict the freedom of scientists. Cochrane should not continue making the mistake of not taking this issue more seriously. The recovery of public confidence in the scientific process and scientific results means clearly facing these structural problems of conflicts of interest that seriously affect the credibility and public perception of researchers.
7) Criticizing a Cochrane review as a member or a centre representative is not criticizing the entire organization. Affiliation with a Cochrane Centre does not mean representation of the whole Cochrane organization unless that is made explicit. Criticism by a Cochrane member of a Cochrane review should not make someone “an enemy from within”. On the contrary, much of Cochrane’s prestige has to do with the existence of internal (self) criticism and a plural democratic debate. The part never supplants the whole. Much of the prestige acquired by Cochrane has to do with the existence of diversity, flourishing debate and criticism and internal (self) criticism.
This annex was written by David Hammerstein, Mara Cabrejas and Abel Novoa, members of the Editorial Board of No Gracias nogracias.eu Spain
[i]https://blogs.bmj.com/bmj/2018/09/17/ray-moynihan-lets-stop-the-burning-and-the-bleeding-at-cochrane-theres-too-much-at-stake/
[ii]http://www.isdbweb.org/publication/cochranes-sinking-ship-and-conflicts-of-interest
[iii] https://www.bmj.com/content/362/bmj.k3945/rr-0
[iv]https://retractionwatch.com/2016/03/16/evidence-based-medicine-has-been-hijacked-a-confession-from-john-ioannidis/
[v]https://www.bmj.com/content/362/bmj.k3945/rr-0
[vi]Structured data from Cochrane should be fully accessible for download, re-use and review (Box 1). Currently, they are not. Although Cochrane supports transparency initiatives such as AllTrials, and is explicit about this within its policy,22 it has no similar clear principles on opening full access to the data within Cochrane reviews. Cochrane does provide access to results data from reviews but, crucially, these cannot be readily re-used; and the available information is an incomplete set of the data generating these reviews, comes in a technically problematic format and can only be viewed by those with access to the full content of the Cochrane Library.https://www.bmj.com/content/360/bmj.k510/rr-2
[vii]https://www.bmj.com/content/360/bmj.k510/rapid-responses
[viii]Evidence based medicine: what it is and what it isn’t
BMJ 1996; 312 doi: https://doi.org/10.1136/bmj.312.7023.71 (Published 13 January 1996)
[ix]https://retractionwatch.com/2016/03/16/evidence-based-medicine-has-been-hijacked-a-confession-from-john-ioannidis/
[x]http://www.nogracias.eu/2018/10/06/the-cochrane-iberoamerican-network-asks-to-improve-the-governance-of-the-organisation-as-well-as-transparency-participation-and-an-independent-review-of-the-peter-gotzsches-process/
[xi]https://retractionwatch.com/2016/03/16/evidence-based-medicine-has-been-hijacked-a-confession-from-john-ioannidis/
[xii]Jacob Stegenga, Medical Nihilism, Oxford University Presss, 2018
Share this:
COCHRANE WRECKS IT … Sí Gracias
JUNKEXIT
MHRANEXIT..
Gotzsche says the MHRA is “acting like MI5” in its lack of transparency and the policy shows it is on the side of the drug companies.
His criticisms are echoed by David Healy, professor of psychiatry at Bangor University, who accuses the regulator of being as “transparent as the Vatican before Pope Francis”.
Drug regulator destroys Prozac research
George Arbuthnott and Jonathan Leake
March 23 2014, 12:01am, The Sunday Times
https://www.thetimes.co.uk/article/drug-regulator-destroys-prozac-research-z7lqbxpxgfr
BRITAIN’S medicines regulator has destroyed the original scientific data supporting the licensing of Prozac, the antidepressant drug that is provoking growing controversy over evidence that it is linked to suicide.
It means that scientists who have tried to re-examine the evidence justifying its release may now never be able to find out how good the science was. Patients making compensation claims will face the same problem.
It comes amid growing concern over Prozac’s effectiveness in treating depression, with some evidence suggesting it is little better than a placebo. There is also unease over potential side effects ranging from suicidal thoughts to loss of libido.
The decision by the Medicines and Healthcare Products Regulatory Agency (MHRA) to shred the data emerged only after Professor Peter Gotzsche, a Danish medical researcher, asked for it to check allegations that trial data had been rewritten to play down the suicidal feelings that had affected some participants.
Fluoxetine, the chemical name for Prozac, is one of the most widely prescribed antidepressant drugs in Britain. There were 5.8m NHS prescriptions of the drug, costing £12.3m, in England in 2012.
Since the drug was licensed, the MHRA’s records show there have been 9,520 reports of suspected adverse reactions to the drug with 254 fatalities, 100 through suicide.
Lucy Hill, 31, from Eastbourne, East Sussex, claims taking Prozac nearly led to her death. In 2009 she was sectioned and admitted to hospital with “a personality disorder”. There she claims to have been prescribed Prozac which she says led her repeatedly to attempt self-harm. “I’m 99% sure it was the Prozac … because those feelings stopped a week after I finished taking it,” she said.
By 2011 many doctors were aware of such concerns. They prompted Gotzsche — who co-founded the Cochrane Collaboration, a healthcare review body with a seat on the World Health Assembly — to ask the MHRA for the full trial results.
The regulator said it had shredded the detailed information and held only some documents that summarised the findings. The manufacturer retains the data and the MHRA said it can order it to be submitted.
Gotzsche says the MHRA is “acting like MI5” in its lack of transparency and the policy shows it is on the side of the drug companies.
His criticisms are echoed by David Healy, professor of psychiatry at Bangor University, who accuses the regulator of being as “transparent as the Vatican before Pope Francis”.
The drug was first licensed in Britain in 1988, earning the nickname “Bottled Sunshine” with its promise of a cure for depression. Stories of antidepressant-driven redemption soon followed, including the bestselling memoir Prozac Nation, which was later turned into a Hollywood film.
However, concerns over the drug’s effectiveness and safety have grown. The NHS warns that Prozac carries an increased risk of self-harm or suicide in some patients as well as sexual dysfunction. The MHRA warns that its use by women in the first three months of pregnancy may increase the risk of heart defects in their unborn child.
The MHRA said it had “led the way” on antidepressant safety issues, was committed to greater transparency and can ask licence holders to resubmit data. “The recommendation from the National Archives is for a default retention period of seven years for most material; however, the MHRA has extended this to 15 years,” it said.
Eli Lilly, which first put the drug on the UK market, said Prozac was one of the “most studied medicines in history”, had helped millions of people worldwide and no credible evidence had established a causal link between Prozac and suicidal behaviour.
NICEXIT
Prof. Peter Gøtzsche
@PGtzsche1
·
3h
All 31 Cochrane Directors from Spain and Latin America call for an independent investigation of Gøtzsche’s expulsion from Cochrane. The Cochrane leadership ignores the call. (link: http://www.deadlymedicines.dk) deadlymedicines.dk 8 October
@cochranecollab
#sundpol #dkpol
Prof. Peter Gøtzsche
@PGtzsche1
·
3h
Head of Nordic Cochrane Centre complains to Charity Commission about serious mismanagement and moral meltdown in the Cochrane Collaboration. (link: http://www.deadlymedicines.dk) deadlymedicines.dk
@cochranecollab
#sundpol #dkpol
Added 9 October:
Gøtzsche’s complaint to the Charity Commission about serious mismanagement of the Cochrane Collaboration.
Highly important.
In my complaint, I explain that it has become international news that Cochrane, arguably the most important global organisation in science and healthcare, is experiencing a moral meltdown caused by poor leadership.
The organisation has expelled one of its founding fathers from the Board (me), four other Board members have resigned in protest, and now many Centre Directors from around the world are calling for the entire Board to step down in order to save the organisation.
Cochrane is currently imploding and it requires the UK Charity Commission to intervene urgently. Several Cochrane centres are already making moves to sever themselves from the organisation; international protests from thousands of people are mounting; and people have lost trust in the charity.
All 31 centre directors in Spain and Latin America have signed a document, which describes the lack of transparency, accountability and due processes, and proposes the establishment of an ad-hoc commission, without the participation of any person who has been directly involved in the conflict between Cochrane’s CEO and me, that should independently review all the actions related to the conflict. As is characteristic of Cochrane’s leadership, it has ignored the letter.
My complaint is about serious abuse and mismanagement over several years, which has harmed the charity’s services, beneficiaries and reputation. The evidence I provide not only outlines the risk of additional harm to the organisation, but also has broader implications for medical research, policy-makers and most importantly, people’s health and well-being. I have tried to challenge the leadership on these important issues but, as a whistle-blower, I have endured intimidation, bullying and witnessed corruption, by a leadership that is bringing the organisation to its knees. There is a substantial risk that Cochrane will fall apart if nothing is done.
The conflict between Cochrane’s CEO and me was a trivial issue about the interpretation of Cochrane’s Spokesperson Policy in relation to two recent cases. Cochrane’s own Counsel exonerated me from all charges, and in a letter from 3 October, marked Addressee Only. Strictly Private & Confidential and NOT FOR PUBLICATION OR DISSEMINATION, the co-chairs admit, for the first and only time, that I have not broken the Spokesperson Policy. There is therefore no basis for the Board’s expulsion of me from the Board and from Cochrane.
The real reasons why Cochranes CEO, Mark Wilson, and his close ally, co-chair Martin Burton orchestrated my expulsion are that I challenged Cochrane’s business model, with its focus on “brand” and “our product,” with too little attention to getting the science right and keeping the drug industry at arm’s length. Clearly, my very visible advocacy in the fields of science, policy and medical ethics, exposing the unethical practices by the pharmaceutical industry, the harms and overuse of psychiatric drugs, the deadly effects of many drugs, the dangers of overdiagnosis caused by mammography screening, the concealment of clinical trial data, the gross inadequacy of drug regulation, and the harmful effects of patents on public health, among other issues, have many times caused great discomfort to Cochrane´s leadership.
It also plays a role that I: demonstrated that Wilson’s use of the Spokesperson Policy against me has been totally inappropriate; challenged Wilson’s leadership in many aspects and expressed concerns about his ‘management by fear’; demonstrated serious mismanagement in my report to Cochrane’s law firm, on the part of Wilson and the co-chairs, which included tampering with minutes and other essential evidence; and published a scientific critique of Cochrane’s HPV vaccines review, which is encouraged by Cochrane, but people in the leadership felt offended by it. They now claim they did not receive ‘internal’ warnings about our publication, which is demonstrably false.
I demonstrate in my complaint that virtually everything the CEO and the Board presented during a webinar on 4 October about the reasons for my expulsion was mendacious or seriously misleading.
The most important issues I summarise in my complaint are:
1) Serious acts of tampering with evidence to the detriment of the public we aim to serve.
2) Serious mismanagement in Cochrane, committed by its CEO and the co-chairs of the Governing Board.
3) Numerous violations of rules for charities and for Cochrane by the CEO and the co-chairs.
4) Lack of collaborative, democratic, transparent and accountable leadership in Cochrane.
5) Management by fear and bullying by the CEO.
6) An almost total lack of due processes in Cochrane, in stark contrast to other organisations.
7) Fierce resistance from Cochrane’s CEO towards introducing due processes.
8) Favouritism: other rules apply to CEO staff than to Cochrane collaborators.
9) Serious selection bias in the 400-page material sent by co-chair Martin Burton to Cochrane’s law firm, which favours his line manager, CEO Mark Wilson.
10) Serious conflicts of interest.
11) Repeated and serious violations of Cochrane’s core principles of openness, transparency, honesty and fairness by the CEO and the co-chairs.
12) Scientific censorship in Cochrane, although it is a scientific organisation whose whole justification is that the public can trust us, which is even part of Cochrane’s motto: “Trusted evidence.”
13) Repeated, very harmful actions by Cochrane’s CEO, which have favoured industry and guild interests.
14) A show trial against me, where none of the evidence in my favour that I, or Cochrane’s own hired Counsel provided, was taken into account; where I was denied the possibility to present crucial evidence that would have exonerated me; where the charges raised against me were changed on the spot when a report from Cochrane’s law firm had exonerated me; and where I was given five minutes to defend myself, after which the Board deliberated for five hours. The CEO’s and the Board’s total disregard for the evidence is particularly grave for Cochrane because this is an organisation that prides itself for basing its conclusions on “the best available evidence.”
15) Scientific misconduct.
It is not surprising that a growing number of people and organisations, both in- and outside the Collaboration, have come to the conclusion that the CEO and the Board should resign, and that if they are unwilling to do this, it is proof that they are not fit for office.
I guess there’s an awful lot of ‘junk’ floating around whenever the topic is to do with mental health – in the media as well as in companies.
Last night we had a half hour TV programme here in Wales, titled ‘Hooked on Pills’ which covered painkillers etc. as well as antidepressants. Whilst I fully agree with patients’ voices being heard in such programmes I do feel that far too much time was spent last night visiting and revisiting individuals’ stories without proper follow up. One person had suffered a ‘movement disorder’ – an ideal opportunity to introduce akathisia into the mix but this did not happen.
David had been interviewed – had I blinked, then I would have missed his contribution! Two or three sentences was all that was shown of his lengthy interview. We were reminded more than once that ‘these drugs work for many, many people’. In a programme with the title of ‘hooked on pills’ – was this absolutely necessary?
It was so obvious that someone somewhere within ITV Wales had decided that this programme was necessary. It was just as obvious that someone else had set the rules so that ‘patients will not be frightened of taking their medications’.
It’s about time we were allowed to watch a documentary about ADs or painkillers without having to always consider the other side of the coin. When programmes air showing the benefits of a medication, does anyone insist that ‘adverse reactions’ are covered too to provide a balanced view? No, of course not. Restrictions only come into play when the topic happens to criticise the easy access of these drugs and their downfall for so many of us.
Prior to watching this last night, I really felt that the tide was turning in out favour – but now I feel totally deflated again. As Heather says, we must carry on with renewed vigour to make sure that our message reaches more and more people, therefore I shall now stop grumbling about that which has passed and concentrate on what is ahead!
So – today we have a “Minister for the Prevention of Suicide”.
What is needed is a Minister for The Prevention of AKATHISIA.
The BBC Radio 4 – Westminster Hour program (10pm Sunday 7th October 2018) left me with the understanding that an “In-House” M.H. service has been established for politicians.
If this is correct, then it would be even more useful for parliamentarians to have a Minister who understood akathisia.
Back to the future …
And, now, Glaxo says it will largely reverse course — and patients, doctors, and the entire pharmaceutical industry are the losers.
Engaging with healthcare professionals
As a healthcare company, we regularly work with healthcare professionals. From collaborating on clinical trials to providing high quality, balanced information about our medicines and vaccines, in all of our interactions we aim to be transparent about our work, operate with integrity, and always put the interests of patients first.
http://us.gsk.com/en-us/responsibility/operating-responsibly/engaging-with-healthcare-professionals/
One of the world’s largest drug makers is paying docs again — and patients are the worse off
By Ed Silverman @Pharmalot
October 10, 2018
https://www.statnews.com/pharmalot/2018/10/10/glaxosmithkline-paying-doctors-patients/?utm_source=STAT+Newsletters&utm_campaign=63218b02b1-Pharmalot&utm_medium=email&utm_term=0_8cab1d7961-63218b02b1-149674737
Seeking to recover from sensational marketing scandals, GlaxoSmithKline did something unexpected five years ago — the company promised it would no longer pay doctors to promote its medicines, which had been a long-standing industry practice.
The move came not long after Glaxo paid $3 billion in fines in the U.S. for illegal marketing and kickbacks, among other things, and also followed reports the company showered doctors and government officials in China with bribes. With its announcement,
Glaxo won praise for setting a new tone and raised hopes other drug makers would follow suit.
They did not.
And, now, Glaxo says it will largely reverse course — and patients, doctors, and the entire pharmaceutical industry are the losers.
Related:
Glaxo ‘turns back the clock’ and resumes payments to doctors
Here’s why: For years, drug makers tried to goose sales by enticing doctors to write prescriptions. In many instances, this involved juicy incentives, such as fees for speaking or consulting. There were also freebies: meals, event tickets, or paid travel to conferences at luxurious destinations.
This generosity rightfully prompted scrutiny over who really benefited — the patient or the doctor and drug company? The answer was never hard to figure out. And despite indignant protests from some doctors who argued they are not swayed by largesse, studies have shown otherwise.
An analysis in the Journal of the American Medical Association back in 2000 found that interactions between doctors and drug companies appeared to affect prescribing and physician behavior. More recently, a 2016 study in JAMA Internal Medicine found an association between meals and an increased rate of prescribing for medicines that were being promoted.
“The problem has been well-documented over many years,” said Eric Campbell, the director of research at the Center for Bioethics and Humanities at the University of Colorado, who has studied the financial relationships between physicians and pharmaceutical companies.
Over concerns that financial ties were unduly influencing medical research and practice, the federal government created a database of payments to doctors. Drug makers are required to report these payments, and the data are publicly available. The feds also pursued many companies for paying kickbacks. Mindful of the horrible optics, the pharmaceutical industry trade group issued a tougher voluntary code for interactions with doctors.
But Glaxo was the only company to halt payments.
Related:
Doctors who accepted meals from drug makers prescribed more of their pills
The move was part of an effort by former Glaxo chief executive Andrew Witty to remove a growing stain on his tenure. He also changed the system for sales rep compensation to put less emphasis on physician prescribing. And Glaxo committed to disclosing clinical trial data, since the company had also been fined for hiding important information.
But Witty is gone now and his successor, former consumer products chief Emma Walmsley, is trying to remake the drug maker. So far, she has replaced 50 top executives and is reworking pharma R&D. And as she sees it, resuming payments to doctors can only help the bottom line.
In explaining the decision, Glaxo noted it was the only drug maker that halted payments when the policy was put into effect in 2016, and it placed the company at a competitive disadvantage. “We believe this has led to a reduced understanding of our products and is, ultimately, restricting patient access to truly innovative medicines and vaccines,” according to a statement.
Glaxo would not make any executives available to discuss this in detail, but a spokesman told us the new policy pertains to only about a dozen products launched in the last two years, although it could also apply to other new drugs going forward. For now, payments will be permitted for only two years for new medicines or vaccines, and one year following the release of “significant new data.”Privacy Policy
Putting aside any skepticism, Glaxo deserves some credit for trying to nudge an industry known for egregious marketing in a better direction. The fact that its effort failed to catch on says more about other drug makers than Glaxo.
But that shouldn’t mask the real significance of Glaxo’s about-face. The job of any doctor is to provide health care for patients or to do research; the point of payments from Glaxo and other drug makers is to help companies get a foothold in the market.
“If a doctor is being paid to market under the cover of professional or academic standing, it looks like an abuse of entrusted power for private gain,” said Roy Poses, a Brown University professor, who is also president of the Foundation for Integrity and Responsibility in Medicine.
In fact, financial ties between industry and doctors fell over the past 15 years, but a majority of doctors still reported them in 2017, according to a new survey in the Journal of General Internal Medicine.
For all concerned, Glaxo’s decision takes us back to the future. And it will only cement the value of paying doctors to promote drugs.
“…if what Cochrane is doing now is junk, then the NICE and all other guidelines are also junk.”
I disagree with this statement. NICE no longer rely on Cochrane reviews but have their own teams of unconflicted technical systematic reviewers who have no specialised clinical knowledge or contact with clinicians and so cannot be influenced by their biases and preferences. They have true equipoise which is essential in both primary and secondary health research. They also organise meaningful input from large stakeholder groups. I am not saying their processes are perfect, but to say what they do is junk because what Cochrane does is junk doesn’t follow.
PS – I have never worked for NICE, but I have some knowledge of their processes. I used to work for Cochrane so have greater knowledge of theirs.
Caroline
NICE reviewers go by the same ghostwritten literature as Cochrane and are constrained by the same lack of access to the data. The most senior people in NICE refuse to share a platform at meetings with someone like me where statements like this are likely to be made. They were emailed by Chris Van Tulleken when he made his program about kids and meds recently about this very issue and refused to answer.
NICE have known about this problem since 2004 when some of those involved in creating a Guideline for paediatric depression wrote an editorial in the Lancet saying given the lack of data and a ghostwritten literature that says the opposite to what the data shows it now looks like its impossible to do our job. This little rebellion got squashed then and NICE have vigorously refused to engage with the question since
NICE guidelines in so far as they deal with pharmaceuticals cannot accordingly be anything other than junk.
David
Would you still want to work for Cochrane though Caroline?
Regarding NICE – there are enough medics who are so critical of NICE (sometimes anonymously or if they are confident openly ) that they refuse to consume the diet of junk NICE feeds them The blame is currently mainly being put on medics for over prescribing – largely understandably when they are not forced to prescribe harmful treatments — but they are part of a whole web of unreliable groups causing harm. Being more visible and at the hard end of prescribing medics’ reputation is at stake more than that of NICE with the public, Most people have never heard of NICE much less Cochrane.
But NICE is another organisation which. as the fiasco over yet another revision of their draft on guidelines for depression due to ,incredibly, their admission of using out of date evidence incredibly ,is not fit to safeguard public health or to advise medics.. Where were their teams of ‘unconflicted technical systematic reviewers’ here?
Too often people are becoming more interested in promoting their organisations’ survival at the expense of unbiased evidence ,as far as this is humanly possible. It create a ‘you scratch our back we’ll watch yours’ culture where honesty and transparency slide ,critics are silenced more and more and organisations become more and more corrupt ,unless enough people of goodwill get together to activate as is happening with Cochrane. Some do operate like cults , the high priest/esses are adept at creating a culture of fear where those doing their rightful job by at times providing uncomfortable evidence even difference of opinion are bullied and trashed. Others seeing this could happen to them play along – It is sad that some of those who have been at the top of all kinds of organisations only speak out when they have retired, such is the fear of retaliation. At it’s worst it can seem as though we are slipping back from the age of enlightenment into a dark time when people can be again, persecuted for dissent .
E. Fuller Torrey does not ring many bells, certainly not under the cat-collar, so I looked him up..
With a result, ting a ling …
Robert Whitaker has written a post on MIA
The Cochrane Collaboration Has Failed Us All
By
Robert Whitaker
October 11, 2018
https://www.madinamerica.com/2018/10/the-cochrane-collaboration-has-failed-us-all/
The most “recent issue” related to psychiatry, Grant wrote, was a complaint from E. Fuller Torrey. Gøtzsche had written to Torrey requesting information about deaths in the Norwegian TIPS study, which had been funded in part by the Stanley Medical Research Institute, where Torrey is associate director of research, and Torrey responded by filing a formal complaint against Gøtzsche. Torrey stated that Gøtzsche had presented himself as a “Protector for the Hearing Voices Network in Denmark,” an organization that—according to Torrey—promoted numerous false beliefs. As a result of Gøtzsche’s relationship with this organization, Torrey wrote, “I would personally not find any Cochrane publication on mental illness to be credible.”
https://crazywisefilm.com/2014/04/23/interview-with-e-fuller-torrey-biological-disease/
We started the interview on a point that he and Robert Whitaker completely agree. Pharmaceutical medications used to treat mental disturbances are being over prescribed – especially in children! They both believe this presents an extreme danger to our society.
Where they differ is in the way they believe pharmaceutical treatment should be applied. Whitaker’s findings lead him to believe that medication should be used sparingly and mainly to relieve acute symptoms in the early stages of severe distress. In his analysis of the scientific literature he has found that long term use of psychopharmaceuticals is mostly ineffective and has side effects that are extremely harmful. He quotes the results of programs like ‘Open Dialogue’ in Northern Finland that have shown very favorable results by minimizing the use of medication and placing an emphasis on healing the social network of the distressed individual.
Dr. Torrey does not mince words. It is his belief that psychosis is a physical disease that at this time is best managed by medication. He hopes one day to isolate the physical causative agent(s) of psychosis that he suspects are carried by household cats.
As we get further into this project we are finding this debate over the definition and treatment of ‘mental illness’ to be heating up more and more – fueled by the disarray and crisis of our mental health system.
Wendy Burn
@wendyburn
Did ANYONE see
@Number10cat?
Well maybe I have been slow on this … but I finally found the source of the complaint that led Cochrane to “investigate” and then expel Peter Gotzsche. David Hammerstein is exactly right. This ain’t about Gotzsche. It’s about our most basic rights as patients, scientists and citizens.
Gotzsche was trying to get ahold of the raw data from the “TIPS Study” of antipsychotic drug use – specifically, the numbers and causes of deaths in that study. The limited information in the official report just didn’t add up. He sent this request as director of the Nordic Cochrane Center, and put it on the NCC’s stationery. Well, getting information of this kind is a core mission of the Cochrane Collaboration – or at least you’d hope so. “When young people who are receiving antipsychotics die, we need to know why they died in order to reduce the risk of death in future,” Gotzsche wrote. He added that “patients with psychotic disorders” shared this view, and mentioned in passing his role as a “Protector” or medical advisor to the Hearing Voices Network in Denmark.
One of the people he wrote to was E. Fuller Torrey of the Stanley Research Institute in the USA, which funded the TIPS study. Dr. Torrey, however, didn’t even bother to deal with the request for data. Instead, he sent a memo to Cochrane HQ expressing his outrage that Cochrane would include any scientist in its ranks who dared to collaborate with the Hearing Voices Network!
“This organization promotes the belief that auditory hallucinations are merely one end of a normal behavioral spectrum,” Torrey wrote, “thus casting doubt on whether schizophrenia actually exists as a disease.” He also accused them of believing that “hearing voices are caused by trauma in childhood, for which there is no solid evidence.” Cochrane should exclude any researcher who collaborated with a group that would express such forbidden ideas. Otherwise, Torrey warned, “I personally would not find any Cochrane publication on mental illness to be credible. I thought it important to make you aware of the problem.”
The arrogance is breathtaking – and the attitude is more suitable to an archbishop than a scientist. Especially given that Stanley is the privately-funded project of a single wealthy family, and campaigns aggressively (through its “Treatment Advocacy Center”) for laws to expand forced pharmaceutical treatment in all fifty states. A strange group to lecture Cochrane about the need for “objectivity” in research!
Cochrane could have politely explained that Dr. Gotzsche’s opinions were his own – and politely repeated the demand to share the data. Instead, they helpfully reformulated Dr. Torrey’s hissy-fit into a “complaint” that Gotzsche had misused his title and letterhead to portray his views as those of Cochrane! It wasn’t at all what Torrey had said – but he was delighted to endorse the complaint.
McCarthyism is too gentle a term for the witch-hunt Torrey and others in US psychiatry seek to impose on medical research. The Spanish Inquisition comes a lot closer. And clearly the greatest heresy, in their eyes, is to ask a patient for his or her opinion. If Cochrane wants to follow the dictates of a psycho-pharmaceutical Vatican, fine. But it should share Torrey’s correspondence with the rest of the scientific community, so they can see what they are signing up for. Here it is:
http://www.deadlymedicines.dk/wp-content/uploads/2018/09/1-Wilson-to-G%C3%B8tzsche-about-complaints-by-Torrey-and-Pottegaard-15-March.pdf
Thanks very much for the link Johanna. I notice that The last sentence in Torrey’s e mail Subject ‘Cochrane’s Credibility’ written and signed as a director of the Stanley Institute stated that ‘I PERSONALLY would not find any Cochrane publication on mental illness credible. I thought it important that I make you aware of the problem’. So Torrey is writing in a personal capacity not as a spokesperson for the Institute…thought he had a problem with that as he used it conjure up trouble for Peter G and Cochrane. He not the Institute ‘thought it important to make (you) aware of the problem’.
I wonder if Cochrane receives any of the massive amounts of dosh held by the Stanley Institute – the last phrase has a strangely sly tone. Why should his personal anger with what one member of an organisation promotes lead to not finding Any publication by Cochrane credible…Fact is as Torrey welll knows P G’s stance is held and has been developed for decades by other researchers, psychiatrists, and most importantly people with mental health conditions themselves. Hearing Voices Network started off as a grass roots ‘user’ movement combating the lack of understanding and harmful treatments by institutions and has now been accepted by them . The Stanley Institute itself needs to give a response , doubt if they will though, there doesn’t seem to be a P Gotzsche among them.
The Institute has a collection of brains , researchers can apply for samples – broken down into ; white, black, Asian.Hispanic, male,female. no mention of transgender, other diverse ethnic inheritance or social factors but maybe these are included in detailed publications somewhere other than on the Institute’s site .
Susanne
I agree: the tone of the letter is not only arrogant, it is menacing – it means there will be repercussions. I recall when the Observer withdrew its article about the rise in autism in 2007 (the editor, Roger Alton, eventually losing his job) there was a very similar letter written by Fiona Fox of Science Media Centre, saying that SMC was unable to support the article – ie any article that SMC does not support must not be published. Subsequently, Fox was appointed to head an inquiry into the future of science journalism by the Department of Business.
John
Did you know
Fiona Fox OBE was accused of genocide denial following the report she published in Living Marxism on violence in Ruwanda She wrote under a pseudonym of Fiona Foster. (Wikipidia)
Susanne
I think Fox’s intervention in medical science has been deplorable, arrogant, manipulative and worse. I wouldn’t like to condemn her reporting of Rwanda out of hand and is certainly insufficient to call her a Holocaust denier.
http://web.archive.org/web/20000308064904/www.informinc.co.uk/LM/LM85/LM85_Rwanda.html
John
Guess you meant genocide denier not holocaust denier. we would have to disagree on this one though
Susanne
I don’t know all the answers. When I tried to look at the background FF’s article some years ago I came up with some very interesting discussions, not less interesting today as NATO beats the drum towards another big war with the MSM (Peter Hitchens apart) in lockstep.
https://mronline.org/2011/09/02/george-monbiot-and-the-guardian-on-genocide-denial-and-revisionism/
http://www.medialens.org/index.php?option=com_content&view=article&id=637:a-malign-intellectual-subculture-george-monbiot-smears-chomsky-herman-peterson-pilger-and-media-lens&catid=24:alerts-2011&Itemid=68
That said it is also hard to imagine with FF that there wasn’t some agenda.
My thoughts, out of thin air:
“If you want to discredit someone, have someone else do it for you”
That summarizes what could be behind an intricate story of how the expulsion of Prof. Goetzsche came to be.
“Shroud it in an endless stream of vague accusations” – is another!
Ove2018
Torrey’s opinions seem to carry a lot weight, for some inexplicable reason. We have belonged for many years, to a Mental Health Carers Support Group. They have a website. When we first read Robert Whitaker’s ‘Anatomy of An Epidemic’ four years or so ago, we were so impressed with it that we wanted to share it with all the members and asked the Secretary to put a reference to it on the website. She wouldn’t, citing Torrey who we’d never heard of again, till now, who apparently pronounced the book as containing a lot of misguided views, or words to that effect. His word seemed important enough to override the evidence that that magnificent book contained. Why?
Extra saucer of milk …
‘I am interpreting your message of yesterday as a formal complaint…
Might be handy to have Peter Gotzsche, his reply
http://www.deadlymedicines.dk/wp-content/uploads/2018/09/1d-Gøtzsche-suggested-replies-to-Fuller-Torrey-and-Pottegaard-18-March.pdf
Response to Fuller …
Stark, bare and truthful ..
18 October. The moral meltdown of the Cochrane Collaboration: Interview with Peter C Gøtzsche. Interview in Danish, subtitles in English. Duration: 15:24.
https://www.youtube.com/watch?reload=9&v=UVHSpQ9PbSs&feature=youtu.be
Just Peter
An ‘ALERT 62’ from Peter Breggin MD to Peter Gotzche
‘We are honoured by your acceptance of our invitation to become a member of the Advisory Council for the Centre for the Study of Patient Orientated Psychiatry’. The unintended consequences of the Cochrane attack on Peter G are very hopeful especially in the counter attack on the bullying and attempts to silence critics,
Disappointed at seeing the Council’s choice of title though – many find ‘patient’ orientated disempowering preferring eg ‘client’ and how far does ‘orientated’ go..being picky here but giant steps are needed to change relationships and their impact on how individuals are treated.
hopefully and optimistically if more ethical and trustworthy studies are defended and made public they will help to shame the colleges and regulators to change studies into realities which change practice. Whether they admit the influence of activism or not. Many of those on the list of the Council though practice in USA privately , a few are members of the Critical Psychiatry Network in UK but a very few people can get an NHS consultation with a psychiatrist of choice in UK without going private..and knowing they exist in the first place. GP’s could be given a list as they don’t always know of client centred psychiatrists either/ In reality though I’ never met anyone who was given a choice of who they get referred to or who were given any prior information about the psychiatrist or other health worker-counsellor;psychologist whoever. In a vet’s office certificate and qualifications and experience are pinned to the wall or on information leaflets , a consultation about a dog including any emotional problems will take longer than most consultations with a GP or psychiatrist, explanations about treatment possibilities ond possible side effects are more thorough. Vets tend to have a lot of empathy both for the animals they treat and their owners – medic s could learn a lot from vets.
Good bless Peter G, I say.
Cantankerous maybe AND we need many more like him.
I am so glad I no longer find myself with pen in hand and script pad on desk wondering whether I am doing more harm than good.
The book Overdo$ed America and others were huge warnings and all were ignored.
What a story mess.
Letter to Danish Minister of Health against dismissal of Peter Gotzsche
https://www.ipetitions.com/petition/letter-to-danish-minister-of-health-against
Dear Minister of Health of Denmark Ellen Trane Nørby:
We are writing to express our concern over the possible dismissal of Peter Gøtzsche from his job at the Rigshospitalet in Copenhagen. We feel that Dr. Peter Gøtzsche´s work at the Nordic Cochrane Centre has been an important service to patients, taxpayers and the scientific community in Europe and globally. For many years the prestigious activity and publications of Dr. Gøtzsche have played a pivotal role in favour of the transparency of clinical data, the priority of public health needs and the defence of rigorous medical research carried out independently of conflicts of interest. The recent crisis within the
Cochrane Collaboration that involved Dr. Gøtzsche and many other prominent long-time members of Cochrane should be seen in this light.
We ask you to reconsider this possible dismissal due to the great benefits taxpayers, patients and health-care professionals reap from his work aimed at studying the efficacy and safety of medical treatments. We also fear that the dismissal of Dr. Gøtzsche from the Rigshospitalet could harm the international reputation of Danish medical research and could seriously weaken Denmark´s traditional support for open scientific debate.
We hope this issue can be resolved amicably and fairly for the sake of public health, robust scientific debate and the wise spending of public money.
Thank you very much,
David Hammerstein, Former Member of the Cochrane Governing Board (2017-2018) and former Member of the European Parliament (2004-2009)
Tom Jefferson MD MRCGP FFPHM, Senior Associate Tutor, University of Oxford, Oxford OX2 6GG Member, Cochrane Collaboration (1994 – current)
http://www.deadlymedicines.dk/
24 October. Rthorat: Authoritarianism at Cochrane