TRIBUNAL ORDERS RELEASE OF PACE TRIAL DATA (QMUL v the IC and Matthees)
The First-Tier Tribunal judgment in this case (click on that link to read full judgment) has just been published. [Update: the judgment was removed on 1 September for minor corrections. It was reinstated on 7 September but with a different url].
QMUL’s appeal has been roundly dismissed and strongly criticized in a majority decision. The Tribunal has therefore decided that the requested data from the PACE trial should be released.
I have just skimmed the 48 pages of the judgment and so have only taken in a small amount so far. However, it appears that this is a defining moment for the international ME community and the PACE Trial itself. Alem Matthees (the original requestor of the data) has done an extraordinary job. Retraction Watch covered the development here.
However, it is important to remember that, in theory, QMUL could still seek leave to appeal against this judgment to the Upper Tribunal so we cannot yet be certain that this judgment will stand.
[UPDATE September 2016: QMUL is NOT appealing the decision and the data will be released. Retraction Watch linked to Virology Blog article here].
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Background note for new readers
In March 2014, Mr Matthees sought some of the data from the controversial PACE trial, using the process set out in the English Freedom of Information Act (FOIA). This information is held by relevant public authority, Queen Mary University of London (QMUL). QMUL refused to disclose the data.
In due course, Mr Matthees complained to the Information Commissioner (IC) who, in October 2015, ordered that the information be disclosed. QMUL appealed against the IC’s decision; that appeal was heard by the First-Tier Tribunal on 20-22 April 2016 in central London. QMUL and the IC were legally represented and QMUL called witnesses to give evidence. Mr Matthees had been joined as a party to the proceedings. He was not legally represented and did not attend the hearing but made written submissions.
[Note: the PACE trial, which was published in 2011, relates to certain treatments for the condition known as “chronic fatigue syndrome” (CFS). CFS is often conflated (confusingly) with myalgic encephalomyelitis (ME) and referred to as CFS/ME or ME/CFS, to the detriment of genuine ME patients. This is the situation in many countries and has been for decades; it is the cause of significant confusion and distress to many patients. There are an estimated 20 million patients worldwide although conclusive figures do not exist.
The results of the PACE trial promote psychosocial treatments (Graded Exercise Therapy and Cognitive Behavioural Therapy) which many patients find either ineffective or actively harmful. Constructive biomedical research into ME has been sidelined as a consequence (and has been for decades).
Patients have been using FOIA to try to obtain the trial data in order to understand how the PACE results were achieved. However, most requests have been denied, requestors declared vexatious and, five years on, most of the data is still unavailable.]
More detailed information on the history and progress of this case can be found in my series of posts on the PACE Trial (or scroll down right-hand sidebar for “Categories”).
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Disclosure
I have lived with the illness ME since 1981. I currently (2016) have a courtesy academic title at QMUL as Visiting Scholar at the Centre for Commercial Law Studies. I have no connection with the PACE Trial other than as a patient and observer. For more information see About.
Trackbacks
- TRIBUNAL ORDERS RELEASE OF PACE TRIAL DATA | Quick Thoughts
- Tribunal orders release of PACE Trial data (courtesy of Valerie Eliot Smith) | 16 August 2016 | ME Association
- TWiV 403: It's not easy being vaccine | This Week in Virology
- August 2016 Facebook Blog – DGMEFM Network
- Karina Hansen news + a battle with NICE (the UK’s National Institute for Health and Care Excellence) | valerieeliotsmith
- Changing the narrative 4: the QMUL judgment explained and some observations on feedback | valerieeliotsmith
- Prof Malcolm Hooper, Margaret Williams, and the PACE Trial | On Eagles Wings
valerieeliotsmith 
Reblogged this on Short Blogs for the Distracted……… and commented:
Good news in the ME world ..
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superb, thank you so much Valerie.
just in time to include in the August-issue of the MEGC as well
please notify me if you manage to write more before next Monday, so we can include that as well. But mind your health first
best wishes from rob
________________________________ Van: valerieeliotsmith Verzonden: dinsdag 16 augustus 2016 10:48 Aan: karenrssb1@hotmail.com Onderwerp: [New post] TRIBUNAL ORDERS RELEASE OF PACE TRIAL DATA (QMUL v the IC and Matthees)
valerieeliotsmith posted: “The First-Tier Tribunal judgment in this case has just been published. QMUL’s appeal has been roundly dismissed and therefore the Tribunal has decided that the requested data from the PACE trial should be released. I have just skimmed the 48 pages of t”
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Wonderful news. Huge thanks to all who made this possible, but most of all to Mr Mathees.
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Thank you. Great news!
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Every day this is the first website I look at, hoping to see a favorable judgement while very much doubting it would ever happen. This is terrific news! Thank you for keeping us informed about this case.
Ten years ago the UK Parliament Group on Scientific Research into Myalgic Encephalomyelitis (ME) (Gibson Inquiry) [1] called for an investigation into blatant conflicts of interest:
“CFS/ME is defined as a psychosocial illness by the Department for Work and Pensions (DWP) and medical insurance companies. Therefore claimants are not entitled to the higher level of benefit payments. We recognise that if CFS/ME remains as one illness and/or both remain defined as psychosocial then it would be in the financial interest of both the DWP and the medical insurance companies.”
[There are] “numerous cases where advisors to the DWP have also had consultancy roles in medical insurance companies. Particularly the Company UNUMProvident. Given the vested interest private medical insurance companies have in ensuring CFS/ME remain classified as a psychosocial illness there is blatant conflict of interest here.” [2]
I wonder if QMUL will keep paying their legal fees when Professor White et al are finally held to account in a court of law…
[1] http://erythos.com/gibsonenquiry/Index.html
[2] https://en.wikipedia.org/wiki/Controversies_related_to_chronic_fatigue_syndrome#Political
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“Singin’ in the Rain”
I hope this will get resolved soon, but legal isn’t synonyms of fast 😛
Thx for the news!
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Thank you for bringing this news, and also for your longstanding efforts to bring this study into daylight! I hope QMUL does not seek yet another delay – but I imagine they will. Either way, it is good to see the clear-eyed decision of the First-Tier Tribunal. And yes, many thanks to Mr. Mathees – also to the open-data movement within the scientific community, public health journalist David Tuller, Columbia University virologist Vince Racaniello, and so many others who are fighting for transparency with regards to the PACE trials.
The PACE study, billed as the ultimate measure of the validity of CBT/GET as a “cure” for Chronic Fatigue Syndrome and Myalgic Encephalomyelitis, has had enormous influence on the way these patients are perceived and treated internationally. But it was conducted using £6 million in British taxpayer funds. The taxpayer bought it – the taxpayer owns it. Time for a little sunshine on what this study actually found.
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There’s really no such thing as chronic fatigue syndrome. In the United States, the CDC refused to accept the WHO name and definition for the disease (myalgic encephalomyelitis), and opted to call it chronic fatigue syndrome, most likely for political reasons. The definition and diagnostic criteria for CFS in the United States (I have no idea about other countries) is 100% identical to ME. It’s definitely the disease they were describing. It’s been a long, hard fight to get the CDC to admit to this, and the use of ‘ME/CFS’ is an acknowledgement that they knew the disease had a real name all along, and chose not to use it. It’s just been the past couple of years where people in the United States could actually get a diagnosis of ME at all.
Meanwhile, a few other countries decided to call various undiagnosed fatigue conditions ‘chronic fatigue syndrome,’ I guess, even though they didn’t fit the basic diagnostic criteria used by the CDC. I think that’s where a lot of the confusion came from. Basically – depending on where you are, they may be the same thing, OR, all people with ME have CFS, but not all people with CFS have ME. And the confusion, in my opinion, is very much deliberate.
Hopefully they will just drop all of these ridiculous names soon and replace them with one that describes the cause of the disease – we’re SO close to pinning that down, with the incredibly important drug trials going on right now in Norway.
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While I agree that chronic fatigue syndrome was a social construct, dysfunctional to the point of harmful, the history is not quite accurate.
In the 1950s, with polio supposedly conquered by the vaccine, atypical polio was renamed Myalgic Encephalomyelitis in the UK, and ME was adopted throughout the Commonwealth. By 1969 it had an ICD code in neurology, and Melvin Ramsay published a textbook on it in 1968 and 1988.
But M.E. was never adopted in the US. Instead, US specialists adopted the name “epidemic neuromyesthenia.” It did get a code in the ICD’s for a while (in ICD-10-CM, it codes to G93.3), but it disappeared from the medical lexicon in the US by the 1970s.
A series of cluster outbreaks occurred all over the US in the mid-1980s. Many cases began with an episode of EBV (Epstein-Barr Virus, mono, glandular fever), and the US “expert” on EBV at NIH, the late Stephen Straus, soon gave it the name Chronic EBV (CEBV). But many cases had not followed EBV. Doctors on the west coast and in New York were giving it different names, including HIV-negative AIDS or (ugh) AIDS-lite.
Straus suggested the name “the chronic fatigue syndrome” in a funding request in 1986. As the NIH “expert” on the disease, he would have a veto on ALL NIH funding for the disease (something I find appalling, but it was true). When Straus and Gary Holmes held a meeting to come up with a name and definition for this “new and emerging disease syndrome,” Straus immediately put forward his own new favorite name, and he didn’t get many critics. However, Byron Hyde of Canada was there, along with (I am not sure of the number) 2-3 ME experts from the UK, and Alexis Shelekov, who was still researching epidemic neuromyesthenia and believed that was what these outbreaks were. He agreed that ME was more of a living name, and this group of 4-5 specialists suggested to the meeting that these outbreaks were really outbreaks of M.E. and should be accurately named – not re-named. They were voted down, and they walked out of the meeting. I was told this by Byron Hyde, Tony Komaroff, and Meghan Shannon, who was already sick at the time. [If pressed, the excuse I got from CDC and NIH was always that “there is no evidence of “inflammation,” or “-itis,” which I consider a stupid answer. The name had been in existence and used consistently for 30 years at the time of the outbreaks; no need to come up with something new.]
So while it is true that the COMMITTEE did know about M.E. and rejected it, and while it is also true that Stephen Straus most certainly deliberately rejected M.E. for this deliberately vague and insulting new name, MOST of the medical community in the US had never heard of Myalgic Encephalomyelitis. Neither Dan Peterson nor David Bell knew that there was an existing name and definition (beyond CEBV) for the cluster outbreaks that occurred in their practices. They learned about M.E. later.
When Canada adopted its own version of ICD-10 (ICD-10-CA), both M.E. and CFS were placed in the TABULAR (more formal) version at G93.3. We are all familiar with what we call the Canadian Consensus Criteria that was created by a committee of expert researchers and clinicians, brought together by Bruce Carruthers and the ME/FM Action Network of Canada. That document uses the term “ME/CFS” throughout, because one of the purposes was to bring together doctors who had been diagnosing ME, and doctors who had been diagnosing CFS.
In 2004, the Chronic Fatigue Syndrome Advisory Committee (CFSAC) of the US Department of Health and Human Services recommended that the US adopt the Canadian Consensus Criteria, place CFS with ME under neurology in ICD-9-CM (which the US used until last year), and call the disease ME/CFS.
From the perspective of knowing about ME, the name ME/CFS (or CFS/ME, what the psychiatrists use), is obviously a come-down. But in the US, nobody had heard of ME. Using the term given the disease in Canada, ME/CFS, was seen as a chance to educate people about ME (and hopefully jettison CFS once they were used to the alternate). (At the time, NCHS assured us that CFS would go into G93.3 in ICD-10-CM, but CDC did not allow that.)
As we all know, the upshot of all this is a jumble of names and definitions. The PACE trial was based on the Oxford definition of CFS: six months of “debilitating” fatigue, no other physical symptoms, and no psychiatric conditions exclusionary. The result was that most people diagnosed with CFS in the UK actually had primary mood disorders, specifically depression and anxiety. It was a tautology because of the absence of physical symptoms. But even the Fukuda (1994) definition required physical symptoms and excluded primary mood disorders from research.
So it’s somewhat ironic that today, just a couple of hours after I learned of the tribune’s rejection of the PACE investigators’ refusal to release data, I also learned that the US AHRQ (part of DHHS, which also oversees CDC, NIH, and FDA), which concluded last year that the Oxford Definition should be dumped but nevertheless insisted there was quality science research backing CBT and GET, just issued a corrective. Challenged by Mary Dimmock and Jennie Spotila to re-evaluate CBT and GET WITHOUT using studies conducted with the Oxford criteria, they have concluded that there is NO EVIDENCE that CBT or GET helps patients. Period.
Taking a while, but I think we will get there.
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Thank you for your comment, Mary. Yes, that AHRQ correction yesterday was an extraordinary and perhaps heartening shift. As you say – “taking a while but…..”
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You’re doing an extraordinary job too! Deeply appreciated, thanks a million!
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Reblogged this on Utting-Wolff Spouts.
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Your phrasing “genuine ME patients” is unfortunate. It suggests that CFS/ME patients with symptoms mimicking, but caused by some other disease than, ME are malingering or seeking wrongly to benefit from the status of ME as a genuine illness.
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Reblogged this on johnnydme and commented:
Victory for transparency in science, data sharing, and not least(!) ME sufferers if this ruling stands
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Hello Valerie,
The link to the judgement no longer works and there are internet rumors that the judgement is being re-written. Do you have any information about this turn of events?
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Hi jimells – yes, there is a reason for that. I’ve added a note in the post above. Thanks for raising it.
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Thank you for the update once again Valerie, and an extended thank you to anybody involved in bringing about this decision.
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