The PACE Trial's Big Stumble: UK Tribunal Orders Release of PACE Data

Discussion in 'ME/CFS and FM News' started by Cort, Aug 17, 2016.

  1. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    MEAction reported today that after reviewing three days of testimony a UK tribunal panel ordered the Queen Mary University of London (QMUL) to release anonymized data to Alem Matthees, an ME/CFS patient. QMUL had appealed an earlier decision by a commision to release the data. A further appeal is possible but is unlikely to succeed. QMUL has already spent about $200,000 trying to keep the PACE trial data out of the public's hands.

    The data will allow researchers to re-analyze the PACE trial data using the original PACE trial protocol.

    The seven year trial ended in 2009 and it's results were published in 2011. Involving over 600 participants and costing over 8 million dollars it's the most expensive chronic fatigue syndrome (ME/CFS) study ever done. The trial concluded that CBT and GET were effective treatments for ME/CFS and prompted some media organizations to publish articles stating CBT/GETcould result in recovery.

    It's results are commonly used by major medical websites to justify using CBT/GET. UpToDate - a popular pay to play website medical professionals use to get the latest information on diseases, for instance, highlights the PACE trial in its assessments that CBT/GET are the only effective treatments for ME/CFS.

    ME/CFS advocates argued that the numerous changes made to the protocol prior to the start of the trial were done to boost the trials results. The PACE trial authors rationalized the changes on other grounds, and asserted they had no meaningful impact n the trials outcome.

    QMUL didn't spend $200,000 pounds battling the release of the data for no reason. A re-analysis of the data which results in greatly down-graded results, however, could suggest the study was manipulated to provide the results the authors wanted. That, of course, is a very big no-no in the medical world which prizes objectivity over all.

    A finding like that certainly wouldn't help the careers of some of the most prominent CBT/GET researchers in the world, or the reputation of QMUL or the UK funders for that matter. It would put a black cloud over the PACE trial that would be difficult to remove.

    QMUL's Arguments and the Tribunal's decision

    The idea that the fix was in with Brits and that they would never turn on one of their proved to be unfounded. The Tribunal's decision appeared to be an easy one.

    Some of the arguments and the decision put forth in the 48 page decision included:

    (1) QMUL argued that even though the data anonymized that some participants could be conceivably identified.

    The Tribunal rejected the idea that any personal information could be gleaned from the anonymized data calling it "realistically impossible". The tribunal cited testimony for QMUL's own experts in its decision.

    (2) QMUL argued that releasing the data could damage the Universities ability to attract further funding in this area.

    The Tribunal disagreed stating the numerous followup studies from the PACE trial had been funded.

    (3) QMUL argued that releasing the data could allow the presence of "borderline sociopathic" individuals to attach themselves to the trial and act in unlawful ways.

    The Tribunal called some of the QMUL's arguments (made by a Professor Anderson) "wild speculation" and accused him of lacking the necessary objectivity his profession demands. It asserted that he was unable to distinguish "legitimate ethical and political disagreement", and that his reports of hostile activist behavior were "grossly exaggerated". It basically accused one of the QMUL's main witnesses of an over-reach unbecoming of his profession.

    It also cited the impressive credentials of those supporting the release of the data, and concluded based partially on that, a strong public interest existed in releasing the data.

    Despite the fact that QMUL spent about $200,000 defending themselves, the Tribunal appeared to easily dismiss their arguments, and took one of their presenters to task for his unprofessional conduct. That suggests QMUL may feel they're sitting on powder keg that could take blow up in their face, taking the PACE trial and its researchers down. Time will tell.


    Until the data is reanalyzed the outcome of the Tribunal's decision is uncertain. A finding that the changes to the protocol substantially altered the trials conclusions, however, would surely rally more academics and others to question the veracity of the PACE trial.

    The scientific community is the key element in all this. The Tribunal gave the researchers request for the release of the data great weight in its decision. Increased calls from the scientific community are likely if the reanalysis finds major changes to the results. Given the controversy regarding the trial considerable media coverage would result as well

    That would substantially increase the pressure on Lancet - the publisher of the original paper - to respond to researchers and statisticians complaints that the trial was fatally flawed.

    Just last month an presentation at an international statisticians conference asserted that the PACE data was so "highly flawed" as to be "uninterpretable." The American Statistical Association urged its delegates to attend the talk to hear how “how bad statistics harm patients and our profession”.

    At some point even Lancet and its hot-tempered editor, Richard Horton, may decide that the damage to its reputation isn't worth continuing to support such a controversial study.
    Last edited: Sep 14, 2016
    Justin, Katie, zzz and 5 others like this.
  2. Gijs

    Gijs Active Member

    This is very good news, Cort! I am stil wondering why Chalder, White e.a. are so scared to release the data anonymously. Their arguments are really unprofessional (Ad ponandum) and outrageous.
  3. tatt

    tatt Well-Known Member

    The tribunal report is very welcome - especially for its comments about Professor Anderson’s “wild speculations”. However we still wait to see if the data is released
  4. GG

    GG Well-Known Member

    I will respond to the Original title of this thread:

    Is PACE Doomed? UK Tribunal Orders Release of PACE Data

    I hope so, so tired of all the BS that comes out of the UK! I am sorry that the USA muddy the waters by naming it CFS, but I definetly prefer my health care system compared to the horror stories I hear coming out of the UK, CFS or just in general!

  5. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    The Tribunal really came down hard on one QMUL's presenters, and I don't think the decision was a close one. That suggests QMUL is quite worried about what will happen.

    Moss likes this.
  6. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    This is a case where the purportedly unresponsible defendants turned out to behave themselves better than the professionals! That analysis will tell all.
    Simon and Moss like this.
  7. sharonklb

    sharonklb Active Member

    They are all bonkers! Another waste of much need funds!
    I have had a nightmare with a company the DWP have decided can help me find work and offered me amongst other things which were totally useless , contact with a physio! The fact that because i have refused i will now have my benefits sanctioned is showing how even a company who the government are employing for vast amounts of money (INGEUS), are not even aware how much damage they can do in the haste to get us all off the benefit system!
  8. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    Check here for an update from MEAction
  9. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

  10. anciendaze

    anciendaze New Member

    Unless my Latin has succumbed to brain fog, I suspect you meant ad pugnandum which would only be professional behavior for gladiators. Having dealt with a number of people with rare diseases, I am really shocked by the extent to which the authors set out to create an adversarial situation. Medical researchers dealing with other rare diseases have consistently found most clues in anecdotal evidence provided by patients, particularly concerning adverse responses. This has to be checked scientifically, but it should not be entirely ignored simply because it originates with patients. Part of the scandal of PACE is that we have no evidence at all, outside the authors' assurances, concerning adverse responses during the trial. From experience we know that ME/CFS patients regularly end up in emergency departments. What is a typical rate for such events? How did the patients in the PACE trial compare in this respect? How many went through a period of hospitalization? All we know is that the authors looked at reported adverse events, changed criteria so these were less likely, and decided none of them amounted to much. The published result is pure opinion.

    BTW: Cort, QMUL spent 204,787 U.K. Pounds on outside legal advice, considerably more than $200,000.
    Last edited: Aug 19, 2016