Mr. Paul Smallcombe
Records & Information Compliance Manager
Queen Mary University of London
Mile End Road
London E1 4NS
Dear Mr Smallcombe:
The PACE study of treatments for ME/CFS has been the source of much controversy since the first results were published in The Lancet in 2011. Patients have repeatedly raised objections to the study’s methodology and results. (Full title: “Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome: a randomized trial.”)
Recently, journalist and public health expert David Tuller documented that the trial suffered from many serious flaws that raise concerns about the validity and accuracy of the reported results. We cited some of these flaws in an open letter to The Lancet that urged the journal to conduct a fully independent review of the trial. (Dr. Tuller did not sign the open letter, but he is joining us in requesting the trial data.)
These flaws include, but are not limited to: major mid-trial changes in the primary outcomes that were not accompanied by the necessary sensitivity analyses; thresholds for “recovery” on the primary outcomes that indicated worse health than the study’s own entry criteria; publication of positive testimonials about trial outcomes and promotion of the therapies being investigated in a newsletter for participants; rejection of the study’s objective outcomes as irrelevant after they failed to support the claims of recovery; and the failure to inform participants about investigators’ significant conflicts of interest, and in particular financial ties to the insurance industry, contrary to the trial protocol’s promise to adhere to the Declaration of Helsinki, which mandates such disclosures.
Although the open letter was sent to The Lancet in mid-November, editor Richard Horton has not yet responded to our request for an independent review. We are therefore requesting that Queen Mary University of London to provide some of the raw trial data, fully anonymized, under the provisions of the U.K.’s Freedom of Information law.
In particular, we would like the raw data for all four arms of the trial for the following measures: the two primary outcomes of physical function and fatigue (both bimodal and Likert-style scoring), and the multiple criteria for “recovery” as defined in the protocol published in 2007 in BMC Neurology, not as defined in the 2013 paper published in Psychological Medicine. The anonymized, individual-level data for “recovery” should be linked across the four criteria so it is possible to determine how many people achieved “recovery” according to the protocol definition.
We are aware that previous requests for PACE-related data have been rejected as “vexatious.” This includes a recent request from psychologist James Coyne, a well-regarded researcher, for data related to a subsequent study about economic aspects of the illness published in PLoS One—a decision that represents a violation of the PLoS policies on data-sharing.
Our request clearly serves the public interest, given the methodological issues outlined above, and we do not believe any exemptions apply. We can assure Queen Mary University of London that the request is not “vexatious,” as defined in the Freedom of Information law, nor is it meant to harass. Our motive is easy to explain: We are extremely concerned that the PACE studies have made claims of success and “recovery” that appear to go beyond the evidence produced in the trial. We are seeking the trial data based solely on our desire to get at the truth of the matter.
We appreciate your prompt attention to this request.
Sincerely,
Ronald W. Davis, PhD
Professor of Biochemistry and Genetics
Stanford University
Bruce Levin, PhD
Professor of Biostatistics
Columbia University
Vincent R. Racaniello, PhD
Professor of Microbiology and Immunology
Columbia University
David Tuller, DrPH
Lecturer in Public Health and Journalism
University of California, Berkeley
Comments
28 responses to “A request for data from the PACE trial”
Thank you so much for doing this.
Maybe this will be the action that finally makes Queen Mary University of London understand that all that everyone wants is good scientific practice applied to this trial.
I hope they do the right thing while they still have some shreds of reputation left as a serious academic institution.
Richard Smith, the former editor of the BMJ, is supporting Professor James Coyne’s request for release of PACE data, after King’s College London treated his request for PLOS One PACE data as an FOI request and dismissed it as “vexatious”:
http://blogs.bmj.com/bmj/2015/12/16/richard-smith-qmul-and-kings-college-should-release-data-from-the-pace-trial/
yes it seemed like the right request to make at this point, following up the rejections of Alem Matthees request for similar data and James Coyne’s request for the PLoS data.
Thank you … Surely it is soon going to be inevitable that they MUST share their data? How can they possibly stand over their claims without doing so?
I’m very grateful for the added pressure this brings to bear on QMUL (and by implication, I’d like to presume, to KCL) to release the raw dated as requested. I agree with others: the tipping point must surely have arrived? The rejection of these requests must now be untenable if they wish to retain any sense of their institutions having any sort of rigour or respect for the scientific process.
It is an offense against every ill person, including those naive enough to go on the trial. Its very assumptions prior to trial are ridiculous in the extreme. Just promotes the ongoing saga of an illness that was created and the consequence attempts to deny its true origin.
Glad there are folk with gravitas and intelligence to put this nonsense to bed……no pun intended…… Sufferer for 15 yrs……after 30 yrs of extreme fitness and good health. There is some cognitive intelligence required a degree of objectivity and a whole lot of assumed nonsense to dismantle……Jolly good for bastians of sanity.
Thank you for sending this request.
Partnership with South London and Maudsley NHS Foundation Trust is beyond academic embarrassment for KCL should the data relied upon within the PLOS One paper fail.
Very sincere and heartfelt thanks to all you great doctors and academics who are applying yourselves to this matter. I cannot express just how much it means – the relief of knowing that there really is a very public effort by some of the most incisive minds to bring the truth about PACE into the fresh, open air.
So many people have suffered for so long, and continue to suffer as a result of the fall-out of this trial and the policies associated with its theories. This despite the volume of excellent biomedical evidence of physiological damage in ME. I have had this god-awful illness for 30 years, during which the behavioural psychiatrists’ stranglehold on how it is treated just got stronger.
Catherine Hale’s excellent blog is demonstrative of how attitudes have been shaped by the flawed theories, and the impact this has had on desperately ill people with ME who need, but are not getting any help from the UK social care system.
http://limitedcapability.blogspot.co.uk/2015/12/the-politics-of-stigma-with-mecfs.html
Thank you all for the continued pursuit of this on behalf of all patients who have suffered due to the harmful GET & CBT that the PACE trial and the PACE Principal Investigators have been forcing on sick patients and who are ignoring all biomedical evidence (including post-exertional malaise) and the harms from GET due to their serious conflicts of interest with the insurance industry and the UK DWP.
Patients have been ignored, ridiculed, and stigmatised as militants and vexatious to silence them for far too long when they have been challenging the bad science of the PACE trial.
We now need more UK scientists and doctors to speak out on behalf of the patients and science who are being harmed by this very bad science and not just leave it to the US scientific community to examine and expose this.
The request may not be vexatious as defined under UK FOI legislation, but that does not remove the authors’ capacity to judge it as such. Until such time as the current appeal to the FOI Tribunal receives judgement, it seems unlikely that the PACE team (Principal investigators Professors Chalder, Sharpe and White plus 16 other team members) will want to release any material that is covered by the appeal. Merely having more people requesting the same data that has notably already been refused would have no bearing on the principles being judged by the Appeal Tribunal. Multiple requests may of course persuade the authors that the weight of scientific opinion is against them – however if they consider that their appeal is based on principled arguments, weight of opinion is unlikely to feature in their thinking.
The current UK Government looks unfavourably on what it sees as an overly permissive FOI law and the PACE data requests can not be separated from the present fragile state of freedom of information in the UK. Concerns about harassment of researchers (accurate or otherwise), inter specialism jealousies, and trans-Atlantic differences in perspective make this issue more than usually problematic. Even with the clearest judgement of the Appeal Tribunal in favour of release of data, resolution of this issue is unlikely to be a simple affair.
Thank you for all your efforts. Its very appreciated and means so much to us patients.
Queen Mary University London has to accept the consensus in the science and patient communities. They can’t continue to only listen to the word of the authors and stand in isolation against the rest of the academic community. The flaws that area already apparent from PACE mean that no one is willing to accept the authors conclusions blindly without seeing the full data to check their conclusions.
Refusal of this requst, whatever the excuse, will just make this bigger news and alert more people in science to what has already happened and the methodological problems we already know about in the PACE trial. It really isn’t worth the reputational damage to QMUL to do that over one trial when all that is being requested is access to the data so that the conclusions can be scrutinised as part of standard scientific method.
Thank you for submitting this FIO request. Hopefully it will help jolt the PACE researchers out of their defensive stance, dismissing any criticism and requests for their dataset as vexatious harassment by irrational activists, and encourage them to engage in rational debate.
Thank you for submitting this request. Patient voices have spoken out since the PACE trial (and others) were published, but we have not been heard. My hope is that the addition of respectable, and academic (non ME) voices, will be able to add enough weight to this matter, to allow genuine and honest scientific investigation.
I cannot begin to describe the impact that this study has had on my medical “treatment”, and the attitudes of the medical professionals that I have been subjected to. Everything that I have tried to share with my medical team was always silenced because “scientific evidence” “proved” me wrong. If I complained about the study, then I was told how it was “peer reviewed”. At my worst, I couldn’t argue as I was struggling for breath because my body was too exhausted to breathe.
Thank you for attempting to apply genuine scientific rigor to this “research”. So far, the evidence does speak for itself. Even if the researchers have more shame hide, it is time for the truth to be told.
The impact of this trial has ruined and cost lives. With this in mind, I feel less worried about the reputations of the people involved in this “study”.
“At my worst, I couldn’t argue as I was struggling for breath because my body was too exhausted to breathe.”
Powerful words which should shame all those in the medical profession who have promoted the psychosocial model of ME to the detriment of so many.
Thanks for the informative post. It certainly seems like a “vexatious” situation. From what you say, it sounds as though the role of the scientific journals in promoting – or failing to promote – open access becomes even more important in an environment where FOI laws are under threat and/or imperfectly enforced.
It is worth repeating here that James Coyne’s request for the PLOS data was not made as a FOI request, but it was unilaterally treated as such by the university. If the data is never voluntarily shared, and if laws may not force its release, the scientific journals can still withdraw their imprimatur on papers where the underlying data have not been made available for scrutiny.
It is probably time for the people at Queen Mary University, the Lancet to make their parachutes. The Richard Smith already has.
It’s a slightly sad commentary that the PACE trial merely being acknowledged by the scientific mainstream as “controversial” feels like such progress. For too long, it has stood as an officially unchallenged piece of “best available evidence,” with the seemingly inexplicable prejudices of patients being at best a footnote that might serve the narrative of patients being irrational and perverse. It seemed there were few or no scientists or professionals of independent reputation (that is, without a stake in the matter already) who were willing to look critically at the PACE trial or say anything publicly critical about its possible flaws.
I first discovered Prof. Racaniello’s work and the Virology blog and podcasts when the XMRV debate was underway. I was recently recalling to mind September 2012, when Ian Lipkin spoke at a press conference announcing the findings of the NIH study that found XMRV to be a lab artifact and not an infectious virus at all.
A number of patients had hoped that XMRV would be found to be the cause of ME/CFS, and that new recognition of the disease and treatments would follow soon. I think it’s safe to say that all of us really, really, REALLY wanted the lead to be thoroughly followed up by the best available science. It wasn’t clear at the outset that that was going to happen.
But after that press conference many of us, including me, joined in sending our public thanks to Ian Lipkin – not for having destroyed our hopes, but for the way in which he presented the findings: with respect and compassion for patients whose lives were directly impacted, and with promises that he and other researchers would continue to search for the real answers.
I’m mentioning this now, more than three years later, because I think it’s a story that illuminates the difference that it makes to patients when we are treated with empathy and honesty by the science community. And it puts the lie to the claim of the PACE researchers that activist patients are a potentially dangerous, anti-science “minority” who simply don’t like to hear the truth.
Thank you Vincent Racaniello, David Tuller, Ronald Davis and Bruce Levin for embodying the opposite attitude toward patients, and for being willing to go out on a limb with your own reputations and say in public “We think something’s not right here.” Even if that elusive data never appears in public, and even if not all the scientific journals show leadership on the issue of data transparency, the question mark next to the PACE trial’s findings will remain, because you cared enough to ask the questions.
Thank you all for your support.
This is an issue of transparency in science, which is increasingly moving towards open-access and data sharing. The PACE authors have often dismissed patient concerns out of hand. Given the influential nature of the PACE trial results on treatment guidelines in many countries, scientists expressing concern about serious flaws in the trial and seeking the data for reanalysis should be allowed to do so. To deny such access (by tarring all claimants as vexatious) is inappropriate and unjustifiable. For science to have credibility, it must be robust and it must be independently verifiable. To continue to hide behind FOI laws, to protect either the trial’s or the authors’ reputations, is no longer acceptable.
I’m thinking the decision by the authors here is just as much as adding another voice to the conversation as an attempt to acquire data. Weight if opinion may not figure into PACE authors’ appeal motivation, but no matter how principled they feel they are, as you say, reputation doesn’t happen in a vacuum. Even if they succeed, the journals, the university, the people who hand out money, etc., are likely all taking note of this emerging controversy.
The difficulty is that the role of scientfic journals is inevitably circumscribed by national laws. Consider the situation where an institution says: “the legal code bywhich we are governed does not recognise the legitimacy of releasing X type of data, in consequence we consider ourselves vulnerable to civil and/or criminal action if we release X type of data, therefore we can not risk making the data available.” Is a journal then to refuse all submissions from countries that have restrictive FOI legislation ? Or where data is requested and not given, to retract an article on grounds that a national law is a source of inhibition, rather than upon any actual established failings in the submitted article ?
It is not surprising that while the Appeal Tribunal process is underway the article authors (QMUL is in effect acting as agent for the lead authors one of whom is a Professor at QMUL) are treating all requests for data, as FOI requests. This will almost certainly be as advised by lawyers acting either for QMUL or the authors, in the Appeal Tribunal case, and I think it will be very surprising if Prof. Davis et al’s request is treated any differently (though one can aways hope). My own view is that QMUL and the PACE authors are in danger of promoting a wholly unnecesary legal crisis in open data sharing, and that this case should be of great concern far beyond ME/CFS research.
Thank you, thank you, thank you, thank you.
Infinite thanks for sending this request!
Great to see that Ronald Davis et al have made a Freedom of Information request for the PACE data from QMU. QMU previously denied a similar request from an individual complainant which was later overturned by the Information Commissioner’s office. QMU cited the vexatious exclusion clause but the Commissioner rightly disagreed and ordered QMU to release the information. This was in it’s decision letter FS50565190 dated October 2015. A similar outcome could happen here.
Thank you…There are people, like Malcom Hooper, Margaret Williams and Countess of Mar who I believe also questioned the validity of the trial…not just patients. Just FYI
Unfortunately, the last I heard, QMU were appealing the Information Commissioner’s October decision.
I have seen that too. Let’s see how far they get – the ICO’s decision was very well-reasoned. I think its only a matter of time before the growing tide of criticism forces QMU to cave in
Fingers crossed!