Queen Mary University of London (QMUL) has released the PACE data to a patient who requested it under the Freedom of Information Act, as ordered by a recent tribunal, on the last possible day to lodge an appeal against the court’s order.
The move follows the publication three days previously of an open letter from a group of scientists including Dr. Ron Davis, Vince Racaniello and Jonathan Edwards, urging QMUL’s principal, Professor Simon Gaskell, not to appeal the tribunal’s decision.
The data was requested in March 2014 by Alem Matthees, in order to allow the calculation of the trial’s main outcomes and recovery rates according to the methods specified in the trial’s original protocol. The original analysis methods were abandoned once the trial was underway and replaced by others, including an analysis in which patients could become more disabled and yet be classed as having “recovered”.
Tom Kindlon, a patient whose criticism of PACE’s analyses has been published in medical journals, said, “This is a great day for patients. We’ve waited years for this. Finally, it’s going to be possible for independent parties to scrutinise the data and, in particular, find out what the results would have been without all the unjustified changes to the study protocol. Looking at how the objective data relate to the subjective outcomes will also be very interesting.”
“This was a publicly funded trial and cost £5 million in taxpayers’ money — the data should never have been kept secret.”
He added, “This was a publicly funded trial and cost £5 million in taxpayers’ money — the data should never have been kept secret. It is very disappointing that both the PACE Trial investigators and QMUL fought the case so hard, forcing Alem Matthees to have to put in so much work when he is not well himself, and dismissing some other requests for basic information.”
The day before the data was released, the PACE authors published online the main results for the trial using the original protocol-specified methods. The new results show that only a third as many patients improved according to the protocol-defined analysis, compared to the numbers reported in The Lancet in 2011.
The results confirm suspicions long-held by patients and scientists who have studied the trial critically that if the PACE investigators had stuck to their own original analysis protocol, PACE would have appeared to be a far less successful trial.
The new results show that only 21% of patients were classed as “improvers” in the graded exercise therapy group, compared to the 61% claimed in the Lancet paper using an analysis developed after the trial was under way. 10% of patients in the group that received no therapy were “improvers”, indicating that, even with the subjective measures used, only one patient in ten reported improvement from the addition of graded exercise therapy. Results for the CBT group were similar to those for the graded exercise group.
These re-interpreted results were released without fanfare on QMUL’s own website. Despite the dramatic fall in improvement rates, the study authors said that the outcomes were “very similar to those reported in the main PACE results paper” and supported their Lancet conclusion that CBT and graded exercise, added to standard medical care, “moderately improve” outcomes for CFS patients.
But journalist and public-health expert Dr. David Tuller, of the University of California, Berkeley, who has criticized the trial in detail, said, “Let’s be clear. These findings are really much worse than those presented in published, ‘peer-reviewed’ papers. If these were the best findings for $8 million, then PACE really will not survive legitimate scrutiny.”
But now, with the original, raw data going to Alem Matthees, a more independent review is sure to follow.
Over the past several months, following the first of Dr. Tuller’s critical articles, patients and scientists have joined together all over the world to put pressure on QMUL to release the data. A petition led by #MEAction with over 12,000 signatures was featured in the Wall Street Journal, and was presented at the tribunal as evidence of the level of public interest in data release; and 24 ME/CFS organisations in 14 countries, representing tens of thousands of patients, wrote open letters to the university. L.A. Cooper, head of #MEAction Network UK said, “Our thanks go out to Alem Matthees, who worked incredibly hard to achieve the release of the PACE data at what was almost certainly enormous physical cost. Thank you, Alem!”