Virology blog: Open letter to Queen Mary University London about PACE, 6 September 2016
Professor Simon Gaskell
President and Principal
Queen Mary University of London
Mile End Road
London E1 4NS
Dear Professor Gaskell:
Last month, the First-Tier Tribunal ordered Queen Mary University of London to release critical data from the PACE trial of treatments for chronic fatigue syndrome, also known as myalgic encephalomyelitis, or ME/CFS. In its decision, which rejected the university’s appeal of last fall’s ruling from the Information Commissioner’s Office, the tribunal dismantled all of QMUL’s rationalizations for keeping the data secret.
In particular, the tribunal dismissed the fears of QMUL’s security expert that hostile patients would be able to de-anonymize the data in order to identify and harass trial participants. Such concerns, noted the tribunal, were “grossly exaggerated” and based on “a considerable amount of supposition and speculation with no actual evidence.” The tribunal also noted pointedly that the “seeming reluctance” of the PACE investigators “to engage with other academics they thought were seeking to challenge their findings” had strengthened the case for releasing the data publicly.
Significantly, the tribunal emphasized that criticism of the PACE trial was not limited to a small group of patients, citing the “impressive” roster of 42 scientists and clinicians who supported Virology Blog’s open letter of concern to The Lancet last February.
The open letter was based on an investigative report about PACE by David Tuller, a lecturer in public health and journalism at the University of California, Berkeley; Virology Blog posted Dr. Tuller’s investigation last October. The letter outlined some of the study’s major deficiencies, declared that “such flaws have no place in published research,” and requested that The Lancet seek a fully independent analysis of the trial data. All of us signed or later endorsed that open letter.
The current case involves a freedom-of-information request filed by an Australian patient, Alem Matthees. The data he requested would allow for an independent analysis based on the primary outcome thresholds and the definition of “recovery” outlined in the published trial protocol. These promised results remain unknown, because the investigators dramatically changed their protocol methods of assessing the two primary measures of fatigue and physical function. They also relaxed all four criteria for determining “recovery”—so much so that participants could already be “recovered” at baseline on the two primary measures, before any treatment at all.
The investigators have refused to provide the results per the original methods established in the protocol. They have also not provided any sensitivity analyses to assess the impact of the mid-trial changes on the reported findings. This is unacceptable. It is also antithetical to good science and honest debate, as are the other flaws cited in the Virology Blog open letter and in Dr. Tuller’s investigation. (In fact, patients and advocates began pointing out the study’s problems years ago, but their legitimate concerns were consistently ignored, ridiculed or misrepresented.)
The PACE trial has greatly impacted policies and attitudes toward ME/CFS, popularizing the notion that psychotherapy and exercise are effective treatments. Yet patients routinely experience serious relapses after even minimal activity. A report last year from the Institute of Medicine called this phenomenon “exertion intolerance”and identified it as the defining symptom of the disease. This key IOM finding strongly suggests that to increase activity levels, as the PACE interventions recommend, is contraindicated and potentially harmful.
The PACE trial remains under an enormous cloud, and the requested data will provide answers to some of the questions. Given the tribunal’s powerful and persuasive rejection of QMUL’s arguments, prolonging the legal process will only further tarnish the university’s reputation, waste more public funds, and discourage others from participating in future QMUL-sponsored research—all for an indefensible and ultimately losing cause.
We strongly urge QMUL not to appeal the decision of the First-Tier Tribunal and to release the PACE trial data as soon as possible.
Ronald W. Davis, PhD, Professor of Biochemistry and Genetics, Stanford University, Stanford, California
Jonathan C.W. Edwards, MD, Emeritus Professor of Medicine, University College London, London, England
Rebecca Goldin, PhD, Professor of Mathematics, George Mason University, Fairfax, Virginia
Bruce Levin, PhD, Professor of Biostatistics, Columbia University, New York, New York
Zaher Nahle, PhD, MPA, Vice President for Research and Scientific Programs Solve ME/CFS Initiative Los Angeles, California
Vincent R. Racaniello, PhD, Professor of Microbiology and Immunology Columbia University New York, New York
Charles Shepherd, MB BS, Honorary Medical Adviser, ME Association, London, England
John Swartzberg, MD, Clinical Professor Emeritus, School of Public Health, University of California, Berkeley, Berkeley, California