Yep, looks that way.
PACE Trial and PACE Trial Protocol
- Thread starter Dolphin
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A.B.
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Oops.
SOC
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Wow, they must think their reputation is already incredibly fragile and on the brink of collapse if they think that the release of anonymized data from a single research study (something done by universities worldwide on a daily basis without destroying their reputations) will have such a huge effect on the university as a whole.
Make ya wonder, dunnit?
SOC
Senior Member
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The more I think about it, the weirder it gets....
What did they have to tell the lawyers to get them to write such extreme nonsense -- the equivalent of the insanity or the affluenza defence? As in "We have no defense so we're going to have to punt." I imagine the first reaction of the lawyers when presented with this requirement to produce the data would be, "Why don't you just release the data? Surely that's less expensive, less difficult, and less damaging to the university than refusing to release data generated in a publicly funded study." So, they had to be told the truth in some form which put them into the panic mode that releases the kind of statements we are seeing. "Do you idiots realize what this will do the the university if this gets out? It will ruin our reputation! What possible arguments can we make for not releasing the data?"
It would have been fun to have been in the room when the authors faced the administration and the lawyers.
So... what do we think will do more damage to their reputation -- releasing the data or "accidently" losing the data?
Is it possible that they could credibly falsify the data at this late date? I'm thinking not, since it will be next to impossible to make their data both look good and match up to what they've already published. There's a lot of motivation, though....
What did they have to tell the lawyers to get them to write such extreme nonsense -- the equivalent of the insanity or the affluenza defence? As in "We have no defense so we're going to have to punt." I imagine the first reaction of the lawyers when presented with this requirement to produce the data would be, "Why don't you just release the data? Surely that's less expensive, less difficult, and less damaging to the university than refusing to release data generated in a publicly funded study." So, they had to be told the truth in some form which put them into the panic mode that releases the kind of statements we are seeing. "Do you idiots realize what this will do the the university if this gets out? It will ruin our reputation! What possible arguments can we make for not releasing the data?"
It would have been fun to have been in the room when the authors faced the administration and the lawyers.
So... what do we think will do more damage to their reputation -- releasing the data or "accidently" losing the data?
Is it possible that they could credibly falsify the data at this late date? I'm thinking not, since it will be next to impossible to make their data both look good and match up to what they've already published. There's a lot of motivation, though....
Can't lose the data from such a recent study. Ethics committees demand you keep the paper data in a locked storage in the institution for x number of years afterwards. Also there are multiple copies of electronic databases usually. If you claimed data from a study published 2 weeks ago were lost the university would start disciplinary proceedings against you, trust me. Though it does sound like the university is in on this charade. Who had the audacity to draft this reply?!
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I was wondering if any cognitive test measures (e.g. n-back or similar) were ever considered or used as outcome measures for the trial?
Invisible Woman
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Don't know if this has been posted already - from Dr Enlander's social media:
Start quote:
Dr. Enlander's M.E. and CFS Center at Mt. Sinai
November 5 at 2:04am·
Dr. Enlander statement on recent controversy over the PACE trial:
We have followed with great interest the events of the past 2 weeks involving the PACE studies which have been published over the years in the Lancet, Lancet Psychiatry, Psychological Medicine, and others. The publication of New York Times journalist David Tuller’s through investigation on Virology Blog, the release this past week of a PACE followup paper, the resultant media coverage, and the interest of Psychology Professor and blogger James C. Coyne has all added up to probably the most eventful week for ME and CFS patients, physicians, and researchers, for some time.
In clinical practice, it is hard to say we have ever found the conclusions of PACE to be particularly helpful. We view ME as primarily a condition of immunological dysfunction with often-severe neurological symptoms, and have had best success treating it in accordance with that viewpoint. Without ever desiring to quarrel with the PACE investigators, their approach has encouraged exertion in a condition that we see to produce post-exertional relapse. In fairness, they have always maintained that their approach of Cognitive Behavioral Therapy, often combined with Graded Exercise Therapy, is not an indication that they view ME or CFS as a primarily psychological condition. However, it is not hard to see why others may draw that exact conclusion regarding their views. As such, for many, PACE provides a de facto overview of the condition itself, whether intended or not. And it can be difficult to extrapolate the conclusions of PACE into a view that ME and CFS should be viewed as primarily physical condition (s). This is, in my opinion, to the detriment of all involved, regardless of any relevance to discussion of Cartesian Dualism.
The issue of design issues and methodological flaws, questionable entry criteria and investigator bias, in PACE is another matter. The Lancet saw fit to publish the initial paper; individuals such as Malcolm Hooper and Tom Kindlon, among others, have spent years analyzing it, and its followups; and it is helpful to remember that this was a publicly-financed study. And an expensive one, at that, in a realm where funding for ME and CFS research (with, perhaps, the exception of research that might suggest primary psychological and/or psychiatric etiology) is and has always been scant, on a global scale. This, also, has been to the detriment of all involved.
My position has always been consistent: this is a physical disease. Yet I have never denied that there is a secondary depression that mirrors those found in other serious physical diseases. As such, I've never felt it proper to suggest that there should be no role for psychological and/or psychiatric involvement--provided that involvement is proportional. The existing paradigm seems to place psychiatric involvement at the forefront, to the exclusion of all else. We don't have to deny any role to our esteemed colleagues; we can work together. At present, though, their role is clearly overstated, and their theories perhaps less than helpful, especially if they serve to put roadblocks in the way of medical research and investigation into treatments.
So it is hard not to see the vigorous discussion of the past week as a firmly positive, and professional, development. There have been pertinent questions, most of which remain unanswered, for years. Perhaps we shall be provided with some much-needed answers soon.
Derek Enlander, MD
End quote
Start quote:
Dr. Enlander's M.E. and CFS Center at Mt. Sinai
November 5 at 2:04am·
Dr. Enlander statement on recent controversy over the PACE trial:
We have followed with great interest the events of the past 2 weeks involving the PACE studies which have been published over the years in the Lancet, Lancet Psychiatry, Psychological Medicine, and others. The publication of New York Times journalist David Tuller’s through investigation on Virology Blog, the release this past week of a PACE followup paper, the resultant media coverage, and the interest of Psychology Professor and blogger James C. Coyne has all added up to probably the most eventful week for ME and CFS patients, physicians, and researchers, for some time.
In clinical practice, it is hard to say we have ever found the conclusions of PACE to be particularly helpful. We view ME as primarily a condition of immunological dysfunction with often-severe neurological symptoms, and have had best success treating it in accordance with that viewpoint. Without ever desiring to quarrel with the PACE investigators, their approach has encouraged exertion in a condition that we see to produce post-exertional relapse. In fairness, they have always maintained that their approach of Cognitive Behavioral Therapy, often combined with Graded Exercise Therapy, is not an indication that they view ME or CFS as a primarily psychological condition. However, it is not hard to see why others may draw that exact conclusion regarding their views. As such, for many, PACE provides a de facto overview of the condition itself, whether intended or not. And it can be difficult to extrapolate the conclusions of PACE into a view that ME and CFS should be viewed as primarily physical condition (s). This is, in my opinion, to the detriment of all involved, regardless of any relevance to discussion of Cartesian Dualism.
The issue of design issues and methodological flaws, questionable entry criteria and investigator bias, in PACE is another matter. The Lancet saw fit to publish the initial paper; individuals such as Malcolm Hooper and Tom Kindlon, among others, have spent years analyzing it, and its followups; and it is helpful to remember that this was a publicly-financed study. And an expensive one, at that, in a realm where funding for ME and CFS research (with, perhaps, the exception of research that might suggest primary psychological and/or psychiatric etiology) is and has always been scant, on a global scale. This, also, has been to the detriment of all involved.
My position has always been consistent: this is a physical disease. Yet I have never denied that there is a secondary depression that mirrors those found in other serious physical diseases. As such, I've never felt it proper to suggest that there should be no role for psychological and/or psychiatric involvement--provided that involvement is proportional. The existing paradigm seems to place psychiatric involvement at the forefront, to the exclusion of all else. We don't have to deny any role to our esteemed colleagues; we can work together. At present, though, their role is clearly overstated, and their theories perhaps less than helpful, especially if they serve to put roadblocks in the way of medical research and investigation into treatments.
So it is hard not to see the vigorous discussion of the past week as a firmly positive, and professional, development. There have been pertinent questions, most of which remain unanswered, for years. Perhaps we shall be provided with some much-needed answers soon.
Derek Enlander, MD
End quote
Can't remember whether this was ever highlighted:
Report on Collaborative conference 2014:
35 is a very different figure to 160 (or 168).
https://ico.org.uk/media/action-weve-taken/decision-notices/2015/1043579/fs_50558352.pdf
Report on Collaborative conference 2014:
http://forums.phoenixrising.me/inde...nology-mrc-studies-updates.32873/#post-507746
35 is a very different figure to 160 (or 168).
Um, regarding the requests for data release...it is a publicly funded study, thus the data belongs to the public. Publish the whole darned tkit and kaboodle and forget 35-160-168etc. Just give the data to the people who wish to look at it. They paid for it. Sheesh.
Yes, and not a cheap study: UK£5 million. And they themselves said it was supposed to be the definitive study.
They said a lot of things about PACE on the formal record that I suspect they are now seriously regretting. Like their predictions of response (& 'recovery' ?) rates for CBT and GET.
Last edited:
SOC
Senior Member
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Gosh, these folks sure can't take a hint, can they?
Maybe there's a reason there's an incredible number of requests. There's a huge number of requests because there's a huge need, not because that many people are willing to go to that much trouble simply to be a pain in your... er... neck. I can't decide if it's more paranoid or more narcissistic to think that so many people would go to so much trouble for the sole purpose of annoying you.
Has this been posted before? A FOI request about the PACE Trial that went to the tribunal stage in 2013.
http://www.informationtribunal.gov.uk/DBFiles/Decision/i1069/20130822 Decision EA20130019.pdf
http://www.informationtribunal.gov.uk/DBFiles/Decision/i1069/20130822 Decision EA20130019.pdf
Mainly commenting on comments by an NHS Choice editor on ME/CFS patients and their comments on the PACE Trial.
PR thread on this: http://forums.phoenixrising.me/inde...air-relationship-with-its-readers-coyne.41542
Daisymay
Senior Member
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Dolphin these quotes are not from a book, but in case of help:
http://www.ox.ac.uk/news/2012-08-02-two-effective-treatments-cfsme-are-also-cost-effective
In 2011, the first findings from the PACE trial showed that CBT and GET benefit around 60% of patients with CFS/ME, for whom fatigue was the main symptom.
...................
http://www.independent.co.uk/life-s...rome-treatments-offer-good-value-8000997.html
Early findings from the trial reported last year showed that CBT and GET could benefit 60% of patients for whom fatigue was the main symptom.
....................
Hope someone can point you in the right direction.
http://www.ox.ac.uk/news/2012-08-02-two-effective-treatments-cfsme-are-also-cost-effective
In 2011, the first findings from the PACE trial showed that CBT and GET benefit around 60% of patients with CFS/ME, for whom fatigue was the main symptom.
...................
http://www.independent.co.uk/life-s...rome-treatments-offer-good-value-8000997.html
Early findings from the trial reported last year showed that CBT and GET could benefit 60% of patients for whom fatigue was the main symptom.
....................
Hope someone can point you in the right direction.
Not a medical journal but I found this presentation by Peter White where
the 60% figure mentioned without the 45% figure being mentioned:
http://www.swissre.com/clients/newsletters/Managing_claims_for_chronic_fatigue_the_active_way.html