On August 16, the First Tier Tribunal (UK) ordered the release of the PACE Trial data to Alem Matthees, marking the end of a two-year battle. (You can read the order HERE
Mr. Matthees is an Australian researcher, and ME/CFS patient, who has made repeated attempts
under the Freedom of Information Act to obtain anonymized data from the PACE trial. Queen Mary University of Londom (QMUL) has managed to quash every request - until now.
In this historic ruling, the tribunal determined that:
1) The information Mr. Matthees requested is not personal, and therefore an exemption based on the possibility that people in the trial could be identified does not apply.
2) Because data are anonymized, invasion of privacy does not apply.
3) There is no indication that the release of anonymized data would discourage future research.
4) There is a strong public interest in releasing the data.
This last point is especially important, as it directly addresses the issue of transparency in research, a topic that has been much in the news lately.
In a 2005 article
published in PLoS ONE, Stanford professor John Ionnides claimed that most published research findings were false. There are a number of reasons why research is falsified, including outright plagiarism, conflict of interests (especially true in cases where research is being paid for by pharmaceutical companies), poor methodology, scientific malfeasance, false premises, and general incompetence.
In the case of the PACE trial, conflict of interests led directly to scientific malfeasance. The conflict here stemmed from the unwillingness of NHS to pay for treatment for ME patients. In comparison to treatments such as Ampligen, IVIG, and other immunotherapies, cognitive behavior therapy (CBT) and graded exercise (GET) are relatively cheap to administer.
The PACE trial is not the first trial to make the claim that CBT and GET are beneficial for ME/CFS patients. Trudie Chalder, one of the principals in the PACE study, has been publishing articles since 1989 touting the benefits of CBT and exercise for ME/CFS patients. Nor is she a stranger to faulty methodology as the statistics on some of these studies were questionable.
The PACE trial was the crowning glory to over two decades of research for Chalder, as well as for several other psychiatrists involved in the study. While it is unlikely QMUL will spend any more money on challenging the tribunal's decision, it is equally unlikely that the PACE trial group will abandon its "research" into CBT and GET. In fact, a second PACE study involving adolescents is already under way.
Press Release from ME Action
Thursday, 18th August 2016, London, UK - A tribunal has ruled that data from a treatment trial into
Chronic Fatigue Syndrome (CFS) must be released, rejecting an appeal from Queen Mary University
of London (QMUL).
PACE was a £5 million, publicly-funded clinical trial of exercise and cognitive behavioural therapy for CFS. It has been highly influential in determining treatment in the UK and abroad, but has been
controversial. Academics and patients have both voiced concerns over “misleading” claims. Dr
Richard Smith, former editor of the British Medical Journal, said in December 2015 of QMUL’s failure to release the data, “…the inevitable conclusion is that they have something to hide”.
QMUL spent over £200,000 on legal fees in this case, to appeal the Information Commissioner’s
decision that they should release anonymised data from the trial. The request for data was made
under the Freedom of Information Act by Mr Alem Matthees, to allow analysis of the data according
to the study’s original published protocol.
QMUL made several arguments why the data should not be released, their main claims being that
the data was personally identifiable information, and was not sufficiently anonymised. However, the
tribunal rejected these arguments, noting that QMUL had already shared the data with a small
selection of other scientists, stating, "In our view, they are tacitly acknowledging that anonymization
is effective, or else they would be in breach of the consent agreement and the DPA principles."
The tribunal was satisfied that the data “...has been anonymised to the extent that the risk of
identification is remote.” The tribunal also noted the "strong public interest in releasing the data
given the continued academic interest" and "the seeming reluctance for Queen Mary University to
engage with other academics they thought were seeking to challenge their findings."
In his correspondence with the court, Mr Matthees expressed “concerns that QMUL are restricting
the registered researchers to whom they disclose the data upon request.” The tribunal said, “The
evidence before us is not clear but if QMUL are cherry-picking who analyses their data from within
the recognised scientific research sphere to only sympathetic researchers, there could be legitimate
concerns that they wish to suppress criticism and proper scrutiny of their trial.”
In its submissions QMUL made a number of accusations of harassment from patients, while QMUL’s
expert witness characterized PACE trial critics as "young men, borderline sociopathic or
psychopathic", remarks the Information Commissioner dismissed as "wild speculations".
When pushed to provide evidence of these threats and harassment under cross examination,
witnesses speaking for QMUL were unable to do so, and ultimately conceded that "no threats have
been made either to researchers or participants."
The tribunal found QMUL's assessment of activist behaviour to be, “grossly exaggerated” stating
that “the only actual evidence was that an individual at a seminar had heckled Professor Chalder.”
[Professor Chalder is a leading researcher in the PACE trial and a key witness for QMUL.]
Expert reaction to the decision
Jonathan C.W. Edwards, MD
Emeritus Professor of Medicine
University College London
“I think this is the right decision and I congratulate Mr Matthees on persevering with a very
reasonable request. The report indicates that the Tribunal considered arguments from both sides
very thoroughly. It has become clear that the reasons given for not providing the information
requested are essentially groundless. It is also clearly appreciated that critics of the PACE trial are
not young sociopaths - they include senior medical scientists like myself, concerned about poor
Bruce Levin, PhD
Professor and Past Chair
Department of Biostatistics
Mailman School of Public Health
722 West 168th Street
MSPH Box 12, Room 647
New York, NY 10032
“I am heartened by the Tribunal’s finding that the Commissioner had reached a correct decision in
ordering release of anonymized data for the PACE trial. The Tribunal’s assessment that the
perceived risks of data release were neither substantiated nor demonstrated in the evidence before
them and that such minimum risk as had been expressed to them would not in their view outweigh
the public interest in disclosure of the disputed information is quite important, not only for patients
in this trial and around the world, but also because it underscores how essential transparency and
open, critical review of clinical trials are to the scientific method.”
Keith Geraghty, PhD
Honorary Research Fellow
University of Manchester
"I read the tribunal decision with great interest. I was surprised that the PACE authors declared in
evidence that they had shared their trial data with other researchers. I contacted lead author Prof.
Peter White to request access to PACE data to run an independent analysis, but my request was first
ignored, then later refused. I now understand that the authors shared the data with a select few
academics who they picked to co-write papers, but they have failed to share the data with the
broader scientific community. Selectively sharing this publicly-funded data with collaborators but
refusing to share data with anyone else, is not in the best interests of patients or science, and it
creates a perception that the PACE team do not want independent critical analysis of this trial. I find
it regrettable that the Medical Research Council, who partly funded this very expensive study, did
not specify that the trial data be made available to other researchers.”
Dr Charles Shepherd
Hon Medical Advisor, ME Association
“The tribunal decision to firmly reject the QMUL case for not releasing anonymised PACE trial data
will be widely welcomed by the ME/CFS patient community.
This means that there can now be an independent analysis of data from the PACE trial that has been
used to support a number of conclusions and recommendations regarding the benefits of CBT and
GET in ME/CFS that are just not consistent with patient evidence for these interventions
Having attended the hearing, where a number of unsubstantiated and serious accusations were
made against the patient community, I am pleased to see that this 'red herring' was also rejected by
the tribunal. I hope that QMUL will now accept this judgement to release the data and do so without further delay and that they will not spend any more public money on an appeal.”
David Tuller, DrPH, Investigative journalist and public health expert
University of California, Berkeley
"This decision is a thorough repudiation of the efforts by the PACE investigators to protect their
claims and findings from being exposed as utter nonsense. You don't actually need the data to
determine that the trial is a piece of garbage, but having the data at last will make it clear to
everyone. They will likely appeal, but they will ultimately lose."
Patient and Second Respondent
I am very pleased with this outcome. Both the Tribunal’s decision and commentary are a long
overdue victory for the patient community, as well as for advocates of clinical trial transparency and
open data sharing. I want to thank everyone who gave support, advice or assistance, as well as
anyone who engaged in debate over the PACE trial and the sharing of clinical trial data. This case
ended up costing me greatly in time, energy, and health (currently bedridden).
I utilised the FOIA to loosen the vice grip control over the data and allow truly independent and open
analyses that do not rely on the approval of QMUL or the PACE trial investigators. All this came
about largely because of their refusal to publish or release the protocol-specified outcomes, and
their generally questionable and poorly or erroneously justified changes to the published trial
protocol, i.e. outcome switching, after the trial was over and/or after seeing trial data. Claims of
clinically significant improvement may be open to interpretation, but false or misleading claims of
recovery or remission from debilitating illness simply have no place in the scientific literature.
Irish ME/CFS Association
I hope Queen Mary University of London won't appeal again and cause more public money and
resources to be spent on the case. Now that a court has ruled that the data is non-identifiable and
that releasing it will not contravene agreements with trial participants, there is no good reason to
continue to withhold it. If QMUL appeal, people may suspect this case was at least partly about
trying to hide inconvenient results. Indeed, the tribunal decision notice itself raised the question of
whether QMUL may wish to avoid proper scrutiny of their trial.
Patients want nothing more than to recover from this condition, so misleading claims about recovery
rates are a particularly serious matter. Many are very sceptical of suggestions they can recover with
talk therapy or by steadily increasing their levels of exercise. This is not their experience.
Extraordinary claims require extraordinary evidence but the researchers have not yet released such
evidence: they revised all four aspects of the recovery criteria to make it much, much easier to be
classed as recovered and have so far failed to provide valid justifications for these changes. Some of
the PACE Trial investigators have conflicts of interest, such as doing work for insurance companies,
which can make people concerned about bias.
This is a huge victory for patients, who have a right to examine the evidence for the treatments that
affect their lives. I expect that the recovery rate will only be a small fraction of what the PACE
researchers claimed, due to the dramatic changes they made to the criteria.
Tymes Trust Executive Director
"Tymes Trust is pleased at the judge's ruling. We believe that, pending independent analysis of PACE
data, the MAGENTA (PACEstyle) study in children should be suspended immediately."
Leonard A. Jason, PhD
Professor of Psychology and Director
Center for Community Research
990 W. Fullerton Ave.
Chicago, Il. 60614
“I believe that an independent analysis of the controversial trial would be in the best interest of
scientists, clinicians and patients.”