Open letter to Queen Mary University of London about PACE

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.

Sincerely–

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

Comments on this entry are closed.

  • Sasha

    Many thanks to all of the signatories for writing to QMUL. Patients simply cannot understand how a university could support its employees in such utter madness.

  • clark ellis

    thank you, important

  • Priscilla

    And thank you on behalf of the parents of children with ME, two of whom were mine. All they were offered as ‘treatment’ was CBT and/or GET. We declined and let them handle it at their own pace, and am thankful to say that after several years they seem to be recovered, quite possibly because they didn’t push thru and harm themselves, but we’ll never know — just grateful as there are no guarantees. Thanks to all pursuing solid, well-planned biomedical research, and for all who have persevered in the fight for releasing the PACE trial data.

  • Simone

    Thank you for your persistence in holding the PACE trial authors to account. As you say, patients have pointed out the flaws within this trial for years, but our voices have been disparaged and dismissed. Having had esteemed scientists join this chorus of voices calling for the trial to undergo an independent reanalysis has validated our concerns. I hope that QMUL follows your advice and releases the data. After all, if the findings are as robust as the authors claim, then there would be nothing to fear, right?

  • Ian Barnes

    Thanks to David and all 42 signatories to the Virology Blog’s open letter of concern on the PACE trial. Doubtful and dodgy looking research should be openly scrutinised, not protected from criticism. Patients, scientists and clinicians raising serious concerns should not be ignored, slandered or shouted down. The PACE trial data must be released.

  • Brenda Vreeswijk

    Why don’t you provide the raw data QMUL ? If the results are so promising.. why not show the world?
    Research need to be transparent so all can learn and benefit.
    Thank you all 42 signatories and David Tuller and all who participated in trying to get the data open to study.

  • Rhid

    Thanks so much for the continued support. The disregard for the lives of patients and scientific integrity in this case is astonishing. As the tribunal concluded, it is definitely in the best interests of patients for QMUL to release this data.

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  • This isn’t normally an argument I agree with, but it works well here: If you have nothing to hide, you have nothing to fear.

  • Valentijn

    It’s not surprising that the principal investigators (Trudie Chalder, Peter White, and Michael Sharpe) and other psychosomatic philosophizers would defend the PACE trial, since they have largely hinged their careers upon CBT and GET. But it is incomprehensible that The Lancet and Queen Mary’s University of London would similarly stake their reputations on it.

    The only apparent explanation for their behavior is that they have been persuaded by those investigators’ campaign to paint pretty much the entire ME/CFS patient community as mentally-unbalanced militants. What sort of doctor does that to their own patients? What sort of university allows their staff to do that to patients?

    I think there is one helluva story here – not just about PACE, or the Lancet, or QMUL, but about the lengths that these researchers have gone to protect their low-quality research from any scrutiny. Can it get any more shocking than slandering millions of disabled people – not for our own good, but for the good of their careers? When that slander itself is used to help stonewall appropriate research and medical treatments?

    The real scandal isn’t PACE: it’s the denigration and abuse of patients in the process of covering up the flaws of their research careers.

  • Rosa

    Thank you to everyone who signed this open letter, it means so much that there are people fighting for me and others like me. I have suffered greatly at the hands of GET in the UK, and the PACE trial and related research has contributed hugely to the attitudes of all the medical professionals I’ve come into contact with at hospitals in the UK. If medical research is robust, as the authors claim it is, it should be transparent. QMUL should uphold the tribunal’s decision and release the data immediately.

  • uab9876

    Great letter.

    I think it is important that those making the decisions within the university have more information. It is easy for them just to accept the word of White. But a letter from will known and respected scientists may make them look more carefully at the trial.

    Up till now there is no evidence that QMUL as an institution have tried to understand the issues with the PACE trial or why patients are so unhappy. As far as I’m aware they have not tried to reach out to patients or patient organizations to understand why people have so many issues with the trial. So hopefully this letter will make them ask the question that they should be asking particularly when patient safety and autonomy are at the heart of the issues.

    For Gaskell the question is does he want to be remembered as the person who backed a trial where people could recover and still reenter the trial.

    I wonder if it is worth copying the letter to others in the management of QMUL and members of their governing council.

  • sarahdarwin

    And thank you, Virology, for helping to throw light into a dark corner where science is being alarmingly twisted and misused, and for giving this platform to principled scientists who want to see something better.

    Enough, now, QMUL. The instinct to stand up for your staff is honourable, but their attempts to prevent scrutiny of their work by smearing patients is indefensible, and the case for independent analysis of data unanswerable.

    Time to stop digging.

  • Simon

    The poor science behind the PACE trial must be exposed so that inappropriate treatments are not foisted on extremely ill people.

  • A.B.

    The PACE authors have lost touch with reality and their bizarre and misleading claims continue to harm patients and waste resources.

    QMUL must protect patients instead of defending the indefensibly bad PACE trial. This is also the only way QMUL can save its reputation.

  • Antithesis

    Many thanks for your continuing support of ME patients and for investigating the scandal that is the PACE trial. I am most grateful for the support of the signatories of this open letter and hope that QMUL will release the data so that the results of the trial can be independently assessed.

  • Ned

    Thank you for keeping this story alive. It has to be told.

  • JustinReilly

    Agreed, Valentijn!

  • JustinReilly

    Yes, I think it’s a great idea to distribute as widely as possible to all of QMUL’s top brass!

    “For Gaskell the question is does he want to be remembered as the person who backed a trial where people could recover and still reenter the trial.”

    Agree, this is really what it comes down to! Thank you!

  • JustinReilly

    Another as another commentor wrote:

    “For Gaskell the question is does he want to be remembered as the person who backed a trial where people could recover and still reenter the trial.”

    Please QMUL, stop spending hundreds of thousands of pounds defending pseudo-science. Free the data, so the damage to the science of ME can be addressed! Millions of patients have been damaged by this study. Please stop defending it!

  • JustinReilly

    President Gaskell, the eyes of science and the world are on you for defending junk science and spending hundreds of millions of pounds to hide data in a study paid for with tax dollars and published in an open-access journal which requires all data be released!

  • Claire Prideaux

    Thanks for this letter.

    Shame on QMUL for spending money in an effort to hide data.

  • jA

    i appreciate the diligence of those fighting to show the truth about the PACE trial.

    this info should be open to be evaluated, just like any research, to ensure that it holds up to solid scientific standards, or show that it does not. bad science should be retracted, and measures should be taken to prevent further harm to patients.

  • Thank you for writing this letter.

    When I was first ill, my well meaning doctor told me to get out and take 3 short brisk walks every day. My health declined dramatically as a result. Sadly the “exercise” message put out in the media coverage of the PACE trial has had far reaching effects, and that combined with the Graded Exercise Therapy advice given in NICE guidelines for doctors, means patients are frequently encouraged push themselves to exercise in the conventional manner.

    The PACE trial data needs to be re-evaluated using the original criteria. Patients have no faith that the data could possibly show that regimes of increasing exercise could possibly help with an illness where intolerance to exercise is the primary problem.

    The continued determination to hid the data does QMUL no favours, and this lack of transparency certainly doesn’t help patients either. It’s time to release the data.

  • Thane Asylum

    They say this isn’t a cover-up. I say let them prove it. Release the data.

  • Nita Dozer Thatcher

    Thank you! All or you are HEROES! The data has been released! As one who was harmed by GET I would like to give each one of you a great big hug! Thank You, David Tuller, for your remarkable dedication!

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  • Carole Gardner

    Many thanks to you all – at last we feel the truth will be told – eventually

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