Reprinted with the kind permission of Alex Anderssen and MEAction.
By Alex Anderssen
A tribunal panel has ordered Queen Mary University of London (QMUL) to release anonymised data from the PACE trial to Mr. Alem Matthees, a patient who requested it. The ruling has important implications for CFS patients both in the UK and worldwide.
The David-vs-Goliath outcome represents the first successful attempt to begin to counter the PACE authors’ claims — believed by many scientists and thousands of patients to be highly questionable — that the PACE trial showed graded exercise and cognitive therapy to be effective treatments for CFS.
The tribunal was held in April in London, and the panel heard three days of evidence on QMUL’s appeal against the UK Information Commissioner’s decision that they must release the data. Mr. Matthees had requested the data in March 2014 under the Freedom of Information Act, to allow him to conduct main outcome and recovery analyses specified in PACE’s own protocol but abandoned during the trial.
Mr. Tom Kindlon, a patient who has published criticism of the PACE trial in medical journals, said, “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 they claimed, due to the dramatic changes they made to the criteria.”
The tribunal’s decision-document summarises the evidence given at the hearing and includes the tribunal panel’s commentary. For example, the document notes Mr. Matthees’s concern that QMUL were restricting the researchers to whom they would provide data upon request, and states, “The evidence before us is not clear but if QMUL are cherrypicking 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”.
The document summarised the Information Commissioner’s comments on the testimony of Professor Ross Anderson, one of QMUL’s witnesses, who gave evidence on data security. The tribunal panel noted that the Commissioner had referred to Professor Anderson’s “wild speculations” that “young men, borderline sociopathic or psychopathic” would attempt to identify trial participants from the anonymised data, and said that his views “do him no credit”.
The panel wrote that Professor Anderson’s assessment of activist behaviour was “grossly exaggerated and the only actual evidence was that an individual at a seminar had heckled Professor Chalder”. The report noted the Information Commissioner’s view that Professor Chalder, who is one of PACE’s principal investigators, “accepts that unpleasant things have been said to and about PACE researchers only, but that no threats have been made either to researchers or participants”.
The panel added, “The identity of those questioning the research, who had signed an open letter or supported it, was impressive.”
QMUL spent over £200,000 in making the appeal. A further appeal is possible but only on the grounds the law has been interpreted incorrectly or the wrong law applied, rather than on the facts of the case.
Science blogger Simon McGrath said, “The State, and taxpayers, ultimately fund clinical research for the benefit of patients, so it’s important patients get accurate, reliable information on the effectiveness of any tested treatments. And researchers should not, in my view, go to such lengths to hide their data from scrutiny: it might be in their interests, it’s not in the interests of patients.”
Trevor Butterworth, the Director of Sense About Science USA, said in response to the news, “The PACE trial is a fault line between the way we did medicine (secretive, clubbable) and the way we should do medicine (transparent, shared).”
The PACE paper, as it stands in The Lancet, includes an analysis in which patients’ physical function could worsen during the trial to approximately the average level of Class II congestive heart failure patients and yet they would be considered to have been effectively treated. The Lancet has ignored requests to issue a correction notice.
However, independent analysis of the released raw data would allow researchers to bypass The Lancet and publish the more appropriate, protocol-specified analyses elsewhere. Such reanalyses are likely to revise estimates of the effectiveness of graded exercise and cognitive behavioural therapy considerably downwards. This would also put pressure on the UK’s National Institute for Healthcare and Clinical Excellence (NICE) to review its NHS treatment guidelines, which currently recommend these therapies for CFS.
In related news, in response to requests by US patient organizations and advocates, the Agency for Healthcare Research and Quality (AHRQ) has issued an Addendum to its 2014 ME/CFS evidence review. This Addendumdowngrades the conclusions on the effectiveness of cognitive behavioral therapy (CBT) and graded exercise therapy (GET) to state that there is not good evidence of effectiveness in ME or ME/CFS patients. Read more about this development here.