Yesterday four scientists, led by world-famous geneticist Professor Ronald Davis, added to the pressure for scientific transparency on the PACE trial by making a request for raw data under the Freedom of Information Act.
Davis was accompanied in his request by biostatistician Professor Bruce Levin and immunologist Professor Vincent Racaniello, both of Columbia University, and Dr. David Tuller, Lecturer in Public Health and Journalism at the University of California, Berkeley.
The letter appears on Racaniello’s popular Virology blog. The scientists write: “Recently, journalist and public health expert David Tuller documented that the [PACE] trial suffered from many serious flaws that raise concerns about the validity and accuracy of the reported results. We cited some of these flaws in an open letter to The Lancet that urged the journal to conduct a fully independent review of the trial… Although the open letter was sent to The Lancet in mid-November, editor Richard Horton has not yet responded to our request for an independent review. We are therefore requesting… Queen Mary University of London to provide some of the raw trial data, fully anonymized, under the provisions of the U.K.’s Freedom of Information law.”
The letter comes after the rejection last week of the request by well-known psychologist Professor James Coyne for PACE data relating to a study published in PLoS One, which mandates data-sharing for all papers published in the journal. King’s College London, acting for the PACE authors, treated the request under the Freedom of Information Act and dismissed it as “vexatious”.
In their letter, Davis and his colleagues describe the rejection decision as “a violation of the PLoS policies on data-sharing” and they “assure Queen Mary University of London that the request is not “vexatious,” 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 “recovery” 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.”
The PACE investigators have issued a statement in which they reveal that they already shared anonymised data outside their group, even though Professor Peter White, the lead author of PACE, told Retraction Watch in September, “We have yet to release any raw data. It’s part of our patient’s consent form.” Their statement concludes, “We are currently seeking further ethical and scientific advice, as well as the advice of patients, on how best to provide independent decisions about appropriate access to relevant data in a way that balances the rights of trial participants, and future progress of the trial analysis and follow up, with the public interest in releasing trial data.”
Professor James Coyne yesterday blogged about the apparent contradiction in the PACE team’s approach to data-sharing.
The PACE trial was a £5 million randomised trial whose authors claim that it showed benefits of cognitive behavioural therapy and graded exercise therapy for patients with chronic fatigue syndrome. The results are highly contested and so far, all attempts to obtain raw data to conduct the protocol-specified analyses have been denied.
It has come to light that a letter from NHS England and NHS Improvement to all vaccination centres and GPs in the UK has omitted advice that health professionals can and should apply their clinical judgement when placing people in group 6. Vaccination of people with underlying health conditions that put them at risk of