Mr. Paul Smallcombe
Records & Information Compliance Manager
Queen Mary University of London
Mile End Road
London E1 4NS
Dear Mr Smallcombe:
The PACE study of treatments for ME/CFS has been the source of much controversy since the first results were published inÂ The LancetÂ in 2011. Patients have repeatedly raised objections to the studyâ€™s methodology and results. (Full title:Â â€œComparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome: a randomized trial.â€)
Recently, journalist and public health expert David TullerÂ documented that the trial suffered from many serious flawsÂ that raise concerns about the validity and accuracy of the reported results. We cited some of these flaws inÂ an open letter toÂ The LancetÂ that urged the journal to conduct a fully independent review of the trial. (Dr. Tuller did not sign the open letter, but he is joining us in requesting the trial data.)
These flaws include, but are not limited to: major mid-trial changes in the primary outcomes that were not accompanied by the necessary sensitivity analyses; thresholds for â€œrecoveryâ€ on the primary outcomes that indicated worse health than the studyâ€™s own entry criteria; publication of positive testimonials about trial outcomes and promotion of the therapies being investigated in a newsletter for participants; rejection of the studyâ€™s objective outcomes as irrelevant after they failed to support the claims of recovery; and the failure to inform participants about investigatorsâ€™ significant conflicts of interest, and in particular financial ties to the insurance industry, contrary to the trial protocolâ€™s promise to adhere to the Declaration of Helsinki, which mandates such disclosures.
Although the open letter was sent toÂ The LancetÂ in mid-November, editor Richard Horton has not yet responded to our request for an independent review. We are therefore requesting that Queen Mary University of London to provide some of the raw trial data, fully anonymized, under the provisions of the U.K.â€™s Freedom of Information law.
In particular, we would like the raw data for all four arms of the trial for the following measures: the two primary outcomes of physical function and fatigue (both bimodal and Likert-style scoring), and the multiple criteria for “recovery” as defined in the protocol published in 2007 inÂ BMC Neurology, not as defined in the 2013 paper published inÂ Psychological Medicine.Â The anonymized, individual-level data for â€œrecoveryâ€ should be linked across the four criteria so it is possible to determine how many people achieved â€œrecoveryâ€ according to the protocol definition.
We are aware that previous requests for PACE-related data have been rejected as â€œvexatious.â€ This includes a recent request from psychologist James Coyne, a well-regarded researcher, for data related to a subsequent study about economic aspects of the illness published inÂ PLoS Oneâ€”a decision that represents a violation of the PLoS policies on data-sharing.
Our request clearly serves the public interest, given the methodological issues outlined above, and we do not believe any exemptions apply. We can assure Queen Mary University of London that the request is not â€œvexatious,â€ as defined in the Freedom of Information law, nor is it meant to harass. Our motive is easy to explain: We are extremely concerned that the PACE studies have made claims of success and â€œrecoveryâ€ that appear to go beyond the evidence produced in the trial. We are seeking the trial data based solely on our desire to get at the truth of the matter.
We appreciate your prompt attention to this request.
Ronald W. Davis, PhD
Professor of Biochemistry and Genetics
Bruce Levin, PhD
Professor of Biostatistics
Vincent R. Racaniello, PhD
Professor of Microbiology and Immunology
David Tuller, DrPH
Lecturer in Public Health and Journalism
University of California, Berkeley