All 13 organisations in the European ME Alliance (EMEA) have answered ME/CFS patient Clark Ellis’s call to request Queen Mary University of London (QMUL) to release data from the PACE trial.
QMUL are due to appeal the UK Information Commissioner’s decision that they should release the data to a patient who requested it, at a tribunal to be held in late April. The data would allow calculation of the trial’s main clinical effectiveness and recovery outcomes as they were originally specified in the study protocol.
The EMEA’s action brings the total number of organisations who have written to QMUL to 24, from 14 countries: the UK, the US, Belgium, Denmark, Finland, Germany, Iceland, Ireland, the Netherlands, Norway, Spain, Sweden, and Switzerland. Together, the groups represent tens of thousands of patients.
The letter from the EMEA says, “The evidence from the PACE Trial… directly affects patients across Europe and therefore the data must be freely available… It is totally unacceptable for QMUL to ignore the many reasonable requests for data to be released for truly independent review. QMUL now have an opportunity to save, or even restore their reputation before it is too late.”
Clark Ellis said, “It’s simply incredible. The support from patients and the organizations that represent them has far exceeded my expectations. It’s unprecedented and I think it highlights how absurd QMUL’s position has been.”
He added, “It’s clearly untenable for them to avoid transparency and deny patients access to the data that impacts their lives. It’s a very peculiar stance they’ve chosen and I hope this organic movement that just keeps growing will cause them to realize that and reverse their position.”
The online ME/CFS forum, Phoenix Rising, which is a US-based non-profit with 14,000 members, have now also written to QMUL. In their letter, they said, “flaws [in the study], and the PACE authors’ failure to adequately address them, have caused a catastrophic loss of confidence in the trial among patients worldwide…. We do not believe that patients risked their health in the PACE trial so that its authors could evade scrutiny of their questionable analyses by preventing other researchers from reanalysing the data.”
The organisations who have written to QMUL include six UK charities invited by Clark Ellis and 18 others who have joined the campaign, which he began on 1 February.
They are the ME Association, the 25% ME Group, Action for ME, Invest in ME, the Tymes Trust, ME Research UK, the Irish ME Trust, Hope 4 ME & Fibro NI, the Welsh Association of ME & CFS Support, the Dutch Citizen’s Initiative for ME, Het Alternatief (Netherlands), the Belgium ME/CFS Association, ME-Gids.net (Belgium), WUCB (Belgium), Foreningen for Myalgisk Encefalomyelitis (Denmark), Suomen CFS-Yhdistys/Finlands CFS-förbund (Finland), Fatigatio e.V. (Germany), the Icelandic ME Association, Norges ME-forening (Norway), Liga SFC (Spain), Riksföreningen för ME-patienter (Sweden), Verein ME/CFS Schweiz (Switzerland), ME Foreningen (Denmark), and Phoenix Rising (US).
The only organisation to reject Clark Ellis’s call to join the campaign is the UK charity AYME (the Association of Young People with ME), whose chief medical adviser is Dr. Esther Crawley, who is herself planning a trial of graded exercise therapy for children with ME/CFS. AYME now stands isolated among the international community of ME/CFS organisations in its refusal to act in support of data release.
Clark Ellis encourages patients to continue to contact organisations in their own countries to ask them to write to QMUL to urge them to release the PACE data.