Queen Mary University of London (QMUL) have issued a statement in response to Tuesday’s tribunal ruling that they must release anonymised PACE trial data to a patient who requested it under the Freedom of Information Act.
The data would allow the calculation of main outcome and recovery figures using analyses that were specified in PACE’s original protocol but abandoned during the trial. The protocol-specified results are expected to reduce estimates of recovery in PACE very considerably, in what is likely to be an embarrassing outcome for the authors and the journals who published their work.
QMUL said, “This has been a complex case and the Tribunal’s decision is lengthy. We are studying the decision carefully and considering our response, taking into account the interests of trial participants and the research community.”
Over forty scientists and clinicians from the ME/CFS research community signed an open letter to The Lancet in February asking for independent reanalysis of the PACE data, but QMUL’s statement makes no reference to it.
QMUL added that they had “shared data from the PACE trial with other researchers only when there is a confidentiality agreement in place and an agreed pre-specified statistical plan for data analysis.”
Tom Kindlon, a patient whose critical analyses of PACE have been published in the medical literature, said, “QMUL’s statement that they have only shared data with researchers who have an agreed, prespecified statistical analysis plan in place is spectacularly ironic. If they had stuck to their own protocol-specified analysis plan in the first place, Alem Matthees would never have been forced to ask for the anonymised data.”
Alem Matthees, who made the data request, said, “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.” He added, “This case ended up costing me greatly in time, energy, and health” and said that he was “currently bedridden”.
“Claims of clinically significant improvement may be open to interpretation, but false or misleading claims of full recovery from debilitating illness simply have no place in the scientific literature.”
— Alem Matthees
He said, “I utilised the Freedom of Information Act 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.” He described the PACE authors’ changes to the analysis protocol as “questionable and poorly or erroneously justified”. He said, “Claims of clinically significant improvement may be open to interpretation, but false or misleading claims of full recovery from debilitating illness simply have no place in the scientific literature.”
Reaction to the tribunal’s decision from academic critics of the PACE trial has been positive, although there are concerns that QMUL might attempt to appeal the decision. Such an appeal, however, can now only be made on the basis that the law has been incorrectly applied, rather than on the basis of fact or new argument.
Dr. David Tuller, whose 14,000-word critique of the PACE trial in October drew wide scientific attention to the problems with the trial, described the ruling as “fantastic news” and “a huge win for science and for patients”. He tweeted: “PACE team ordered to release the trial’s actual data rather than the false, manipulated data they have presented”, and “They’ll appeal but will lose”.
He said, “It’s Alem Matthees who deserves the congratulations for this First-Tier Tribunal decision. He pulled together an incredible brief in arguing his case, and that comes through in the way the decision is written. An amazing piece of work.”
Trevor Butterworth, the director of Sense About Science USA, called the tribunal decision a “major development in transparency” and said that the tribunal had exonerated the ME/CFS community from “harassment” of researchers over the controversial trial. Journalist and ME/CFS patient Julie Rehmeyer tweeted, “Journos who reported PACE researchers got death threats from CFS pts have a moral obligation to report their error.”
Tom Kindlon said, “I hope QMUL won’t make another appeal and waste more taxpayers’ money on a new court case. But whatever they do, they should immediately release the results for the primary outcomes and recovery outcomes as defined in their own protocol that was published before the trial began. Otherwise, people will think that they’ve spent all this time and money on trying to hide inconvenient results. It would have been so much easier for them to have published those requested results when they were asked for them — they could so easily have avoided all this.”