• Welcome to Phoenix Rising!

    Created in 2008, Phoenix Rising is the largest and oldest forum dedicated to furthering the understanding of and finding treatments for complex chronic illnesses such as chronic fatigue syndrome (ME/CFS), fibromyalgia (FM), long COVID, postural orthostatic tachycardia syndrome (POTS), mast cell activation syndrome (MCAS), and allied diseases.

    To become a member, simply click the Register button at the top right.

"Why ME patients are critical of the PACE trial" (from ME Action network)

Dolphin

Senior Member
Messages
17,567
On Sunday November 30 they posted this on Twitter:

---
Also this on Facebook:
https://www.facebook.com/MEActNet/posts/1671369023145497

The #MEAction Network
November 30 at 8:38pm · Edited ·
Several ME patients from the Science & Treatment Policy and the Media Working Group helped draft this new document which debunks the myth of the "ME militant" and the "vociferous minority" as it relates to our massive, community opposition to the PACE trial.

We hope it provides an easy way to correct journalists and others on social media with facts whenever this myth comes up again.

Let us know what you think of this document (and if you see any typos!) We'd love your feedback.

http://www.meaction.net/wp-content/...atient-view-of-the-PACE-Trial-Controversy.pdf

NOTE: please don't download but feel free to distribute the link – we will likely update the document in response to any feedback.

Come help us work! See all issue groups:http://my.meaction.net/local_chapter_collections/15
 

Dolphin

Senior Member
Messages
17,567
Initially I couldn't think what "the failure to report objective measures included in the original trial design in favor of reporting subjective outcome measures" could refer to but the initial plan involved using actometers to see how much activity were doing but this was dropped.

It seems quite likely that when it was approved for funding by the MRC and other bodies actometers were planned as they seems to have been dropped when an ethics committee said they had a lot of outcome measures which in total might be a burden for participants (I think more questionnaires were added by the investigators at around this stage). As I understand it, the ethics committee didn't tell them to drop actometers specifically. Also I recall somebody in the know telling me at the end of 2003 or early 2004 that it contained actometers. This was after MRC approval.
 

Sean

Senior Member
Messages
7,378
Fitness test results were not reported in the main PACE paper (Feb 2011). No unfavourable objective results were reported in that paper. The only objective result reported was the 6MWD test, which was technically 'positive', but only barely, only for one arm (GET), and only for mild-moderately affected patients, with even those patients still being left scoring around the same level as some of the sickest patients medicine has to deal with. Hardly a roaring real-world success. Not to mention that the PACE authors themselves have downplayed the reliability of their own 6MWD results.

All the other objective results were unfavourable (null), and were buried in subsequent secondary papers, and misrepresented/spun/ignored, etc, when they were reported.

Then there is the 2.5 year follow-up results. Null in every direction. (Which, of course, kills off any claim in all previous PACE papers about any practically useful outcomes. For example, the mediation results are now meaningless.)

It is difficult to convey just how bad this all is to people not familiar with either PACE or science in general. Most can't believe the scale and implications of it, and so default to the explanation that patients must be exaggerating/hysterical/conspiratorial/mentally ill/in denial/vexatious cyber-terrorists/malingering parasites, etc. Which views the PACE crowd do their very best to encourage.

Even this life-long cynic, well past the age when I can plead youthful naivety, still has trouble wrapping my head around just how blatant, sustained, and destructive it is, and how the hell they have got away with it for as long as they have.

o_Oo_Oo_O
 
Last edited:

anciendaze

Senior Member
Messages
1,841
I've puzzled over the structure of the PACE protocol, and revisions to same, from a point early in this controversy. Why were all objective measures secondary to questionnaires seeking subjective data? Why were some, but not all, objective measures simply dropped? Why were those which survived implemented in defective ways, causing the authors themselves to declare that they didn't mean much, as was true of the 6-minute walk? Why were participants allowed to skip objective measures if they didn't feel like making the effort?

I think the idea was merely to get the label of "objective randomized controlled trial". (The "control" group was actually receiving standard NHS therapy, which may not have had any significant value, but it wouldn't do to study anything which brought current practice into question.) The value of that data was reduced to the point of meaninglessness, but the label remained.

Given the way these authors have played with words and numbers to indicate this study might actually have had some therapeutic value, I recommend they add another label to the list of authors: "may contain nuts".
 

Kyla

ᴀɴɴɪᴇ ɢꜱᴀᴍᴩᴇʟ
Messages
721
Location
Canada
Initially I couldn't think what "the failure to report objective measures included in the original trial design in favor of reporting subjective outcome measures" could refer to but the initial plan involved using actometers to see how much activity were doing but this was dropped.

It seems quite likely that when it was approved for funding by the MRC and other bodies actometers were planned as they seems to have been dropped when an ethics committee said they had a lot of outcome measures which in total might be a burden for participants (I think more questionnaires were added by the investigators at around this stage). As I understand it, the ethics committee didn't tell them to drop actometers specifically. Also I recall somebody in the know telling me at the end of 2003 or early 2004 that it contained actometers. This was after MRC approval.

Original protocol also included a "Step test" (https://en.m.wikipedia.org/wiki/Harvard_step_test), which I believe is where the "fitness" data came from (the tiny graph that showed worst outcomes from GET)