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.
[fright]
[/fright]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.
Next
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.
[fright]
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.
Next
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.
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