A general thread on the PACE trial!

alex3619 said:
This option. SD is undefined on this kind of dataset. PDW wrote a paper in 2007 showing he understood it was a biased measure, one which in fact biases toward their hypothesis. Look up his paper on SD for SF36PF data. This is deliberate manipulation of data to obtain a answer biased toward their hypothesis.

As a smell test, to see if it reeks, given that the maximum score is 100, ask yourself what their average PLUS 1 SD results in. Then ask yourself why 65 is serious disability, in their own assessment, but 60 is a basis for recovery. Then ask yourself what SF36PF score applies to other disabling conditions, like heart failure.

The whole thing is a deliberate manipulation of data to deliver a biased outcome to the medical profession. The real tragedy is most doctors fall for it.
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And Peter White's own criteria for CFS are 75 and below on the SF-36. Or at least they were. Maybe they still are, consistency is not really their thing. Regardless this is completely at odds with the concept of 60 being of normal range anything. 60 is a severe level of disability no matter what one thinks, it's what an average 80 year-old rates.
 
If you check the Twitter thread then good suggestions have been made already, but posting in case anybody comes up with a suggestion that has been missed.
 
Andy said:
If you check the Twitter thread then good suggestions have been made already, but posting in case anybody comes up with a suggestion that has been missed.
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Despite spending too much time on Twitter and following some of those who commented, I missed this thread yesterday. So always good to post them here, especially when there are requests for more information. I added two articles.
 
Dr Myhill made a presentation last May on the PACE trial and about her complaint to the GMC. I thought it was an excellent summary of the issues and how they add up to a case of scientific fraud. The violations are so egregious that they are hard to believe, amounting to system-wide failure that should shake the foundations of medical research. And yet, all true and none of the claims have been refuted, simply reworded and whitewashed.

The trial itself, run according to its original methodology and protocol, would have been weak and unreliable but still would have had to admit to the failure of the CBT-GET paradigm. It failed to show any benefits and numerous steps were taken to hide that fact and turn the null results into a fraudulent positive. There is a financial fraud element because of who was involved as well as general misrepresentation of its results. The facts speak for themselves loud and clear.

I doubt it will work, I expect the GMC to find ways to bury it despite the court order. Most likely is what happened with Crawley, where the facts are not disputed but somehow do not amount to anything of concern, a full whitewash whose conclusions are detached from the evidence, just as PACE itself did.

However I still think it will matter in the end, the facts are damning and make the Wakefield MMR fraud look benign by comparison because of who got involved to squash those concerns and the abundance of evidence that the trials represent a cherry-picked outcome-seeking bubble at odds with reality.

I haven't seen the presentation posted here so here it is. The complaint itself is backed by many PACE participants and additionally over 10K signatures from the patient community. A decision to ignore indisputable claims will be a slap in the face to the very idea of patient safety, but then what else is new when it comes to us?

 
Barry said:
Do we know who her audience was?
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Video reference says:
Academy of Nutritional Medicine May 2019 Conference Multi-System Diseases
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It seems like the audience was already familiar with the topic so probably included some supporters who went there to support her. As she explained in the video she gave an ultimatum to the GMC to provide answers to questions she asked about but was ghosted and that she would give this talk to make it more public, in the hope that some press would pick it up. Of course no news media is touching this with the shadowing of the SMC over science reporting and the narrative over poor old aggrieved researchers.
 
Got a PACE-trial question: in the statistical analysis plan (Walwyn et al., 2013) it is said:
Baseline staff expectations regarding the outcome of the trial were recorded
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But has this data ever been reported in a paper? The main PACE trial paper in the Lancet reported only the expectations of trial participants, not of the staff.

Does anyone have an overview of data from the PACE trial that hasn't been reported? if I remember correctly long-term data on employment were also promised?
 
Michiel Tack said:
Got a PACE-trial question: in the statistical analysis plan (Walwyn et al., 2013) it is said:

But has this data ever been reported in a paper? The main PACE trial paper in the Lancet reported only the expectations of trial participants, not of the staff.

Does anyone have an overview of data from the PACE trial that hasn't been reported? if I remember correctly long-term data on employment were also promised?
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I think there is a lot unreported which I suspect will stay that way. I don't think they have reported the step test in actual figures but it did slip out in a graph (and that is a secondary outcome).
 
Michiel Tack said:
Got a PACE-trial question: in the statistical analysis plan (Walwyn et al., 2013) it is said:

But has this data ever been reported in a paper? The main PACE trial paper in the Lancet reported only the expectations of trial participants, not of the staff.
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From: QM FOI Enquiries <foi-enquiries@qmul.ac.uk>
Sent: Tuesday 4 February 2014 14:17
To: 'tomkindlon@oceanfree.net' <tomkindlon@oceanfree.net>
Subject: FOI Request 2014/F6


Dear Mr. Kindlon



Thank you for your email of 7th January, which has been forwarded to be dealt with as a request under the Freedom of Information Act 2000.



We do hold the information that you have requested but I am afraid that I cannot supply it to you. This is because we believe it to be exempt under s.22 as it is information intended for future publication. As you have quoted, there was an indication that this information would be published after the end of the trial. This is indeed the case; there is a planned paper relating to moderators of outcomes in the trial, which is currently in review. Although there is no precise timescale, primarily because this is not within the control of the authors or Queen Mary, it should be in the coming months that this paper is released in to the public domain.



This exemption is subject to the public interest test. On balance we believe that, at this time, the public interest in maintaining the exemption outweighs the public interest in disclosing the information. On the one hand there is always a public interest in the transparency of a public authority. In addition, adding to the understanding of the PACE trial also favours the release of these data.



To date there have been a number of publications and papers arising from the PACE trial. These have all been subjected to a rigorous peer-review process that has ensured that the data and all other commentaries undergo similar scrutiny as to their validity and quality. It is in the public interest that all the publications have the same level of analytical vigour that peer reviewing brings, applied to them – peer-review being a fundamental of academic good practice. Since it has always been the intention to publish this information and it is in the process of being prepared for a future release, the public interest favours the release in that context, rather than at the current time. The First-tier Tribunal (Information Rights) has recognised this approach as reasonable.



If you are dissatisfied with this response, you may ask Queen Mary to conduct a review of this decision. To do this, please contact the College in writing (including by fax, letter or email), describe the original request, explain your grounds for dissatisfaction, and include an address for correspondence. You have 40 working days from receipt of this communication to submit a review request. When the review process has been completed, if you are still dissatisfied, you may ask the Information Commissioner to intervene. Please see www.ico.org.uk for details.

Yours sincerely



Paul Smallcombe

Records & Information Compliance Manager





From: Tom Kindlon [mailto:tomkindlon@oceanfree.net]
Sent: 07 January 2014 23:38
To: PD White
Cc: 'Tom Kindlon'
Subject: Request for data on baseline staff expectations in PACE Trial



Dear Prof. White,

In my reply to comments of mine and others on the PACE Trial protocol, you (and others who were part of the PACE Trial management group) said on behalf of the group[1]:

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Beliefs and expectations of treatment and who is running the trial

The trial has been designed and is being managed by many different healthcare and research professionals, including doctors, therapists, health economists, statisticians and a representative of a patient charity. The Trial Management Group includes five physicians and four psychiatrists. To measure any bias consequent upon individual expectations, all staff involved in the PACE trial recorded their expectations as to which intervention would be most efficacious before their participation, and we will publish these data after the end of the trial.

-------------

The statistical plan for the PACE Trial that was recently published also mentioned that [2]:

-------------

Baseline staff expectations regarding the outcome of the trial were recorded.

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As it is now nearly three years since the main paper on the trial was published in the Lancet[3], I would be like to request such data.

Thanking you in advance,

Tom Kindlon

Irish ME/CFS Association



References:

[1] White PD, Sharpe MC, Chalder T, DeCesare JC, R Walwyn R, for the PACE trial management group: Response to comments on "Protocol for the PACE trial" http://www.biomedcentral.com/1471-2377/7/6/comments#306608



[2]. Walwyn R, Potts L, McCrone P, Johnson AL, Decesare JC, Baber H, Goldsmith K, Sharpe M, Chalder T, White PD. A randomised trial of adaptive pacing therapy, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome (PACE): statistical analysis plan. Trials. 2013 Nov 13;14:386. doi: 10.1186/1745-6215-14-386.

[3]. White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, DeCesare JC, Baber HL, Burgess M, Clark LV, Cox DL, Bavinton J, Angus BJ, Murphy G, Murphy M, O'Dowd H, Wilks D, McCrone P, Chalder T, Sharpe M; PACE trial management group. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet. 2011 Mar 5;377(9768):823-36. doi: 10.1016/S0140-6736(11)60096-2. Epub 2011 Feb 18.
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Sly Saint said:
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Yes, makes you think that maybe the PACE trial could have been based on the Dead Parrot sketch.
http://montypython.50webs.com/scripts/Series_1/53.htm
Monty Python Scripts
Dead Parrot
The cast:
MR. PRALINE
John Cleese
SHOP OWNER
Michael Palin
The sketch:
A customer enters a pet shop.

Mr. Praline: 'Ello, I wish to register a complaint.

(The owner does not respond.)

Mr. Praline: 'Ello, Miss?

Owner: What do you mean "miss"?

Mr. Praline: (pause)I'm sorry, I have a cold. I wish to make a complaint!

Owner: We're closin' for lunch.

Mr. Praline: Never mind that, my lad. I wish to complain about this parrot what I purchased not half an hour ago from this very boutique.

Owner: Oh yes, the, uh, the Norwegian Blue...What's,uh...What's wrong with it?

Mr. Praline: I'll tell you what's wrong with it, my lad. 'E's dead, that's what's wrong with it!

Owner: No, no, 'e's uh,...he's resting.

Mr. Praline: Look, matey, I know a dead parrot when I see one, and I'm looking at one right now.

Owner: No no he's not dead, he's, he's restin'! Remarkable bird, the Norwegian Blue, idn'it, ay? Beautiful plumage!

Mr. Praline: The plumage don't enter into it. It's stone dead.

Owner: Nononono, no, no! 'E's resting!

Mr. Praline: All right then, if he's restin', I'll wake him up! (shouting at the cage) 'Ello, Mister Polly Parrot! I've got a lovely fresh cuttle fish for you if you show...

(owner hits the cage)

Owner: There, he moved!

Mr. Praline: No, he didn't, that was you hitting the cage!

Owner: I never!!

Mr. Praline: Yes, you did!

Owner: I never, never did anything...

Mr. Praline: (yelling and hitting the cage repeatedly) 'ELLO POLLY!!!!! Testing! Testing! Testing! Testing! This is your nine o'clock alarm call!

(Takes parrot out of the cage and thumps its head on the counter. Throws it up in the air and watches it plummet to the floor.)

Mr. Praline: Now that's what I call a dead parrot.

Owner: No, no.....No, 'e's stunned!

Mr. Praline: STUNNED?!?

Owner: Yeah! You stunned him, just as he was wakin' up! Norwegian Blues stun easily, major.

Mr. Praline: Um...now look...now look, mate, I've definitely 'ad enough of this. That parrot is definitely deceased, and when I purchased it not 'alf an hour ago, you assured me that its total lack of movement was due to it bein' tired and shagged out following a prolonged squawk.

Owner: Well, he's...he's, ah...probably pining for the fjords.

Mr. Praline: PININ' for the FJORDS?!?!?!? What kind of talk is that?, look, why did he fall flat on his back the moment I got 'im home?

Owner: The Norwegian Blue prefers keepin' on it's back! Remarkable bird, id'nit, squire? Lovely plumage!

Mr. Praline: Look, I took the liberty of examining that parrot when I got it home, and I discovered the only reason that it had been sitting on its perch in the first place was that it had been NAILED there.

(pause)

Owner: Well, o'course it was nailed there! If I hadn't nailed that bird down, it would have nuzzled up to those bars, bent 'em apart with its beak, and VOOM! Feeweeweewee!

Mr. Praline: "VOOM"?!? Mate, this bird wouldn't "voom" if you put four million volts through it! 'E's bleedin' demised!

Owner: No no! 'E's pining!

Mr. Praline: 'E's not pinin'! 'E's passed on! This parrot is no more! He has ceased to be! 'E's expired and gone to meet 'is maker! 'E's a stiff! Bereft of life, 'e rests in peace! If you hadn't nailed 'im to the perch 'e'd be pushing up the daisies! 'Is metabolic processes are now 'istory! 'E's off the twig! 'E's kicked the bucket, 'e's shuffled off 'is mortal coil, run down the curtain and joined the bleedin' choir invisible!! THIS IS AN EX-PARROT!!

(pause)

Owner: Well, I'd better replace it, then. (he takes a quick peek behind the counter) Sorry squire, I've had a look 'round the back of the shop, and uh, we're right out of parrots.

Mr. Praline: I see. I see, I get the picture.

Owner: (pause) I got a slug.

(pause)

Mr. Praline: Pray, does it talk?

Owner: Nnnnot really.

Mr. Praline: WELL IT'S HARDLY A BLOODY REPLACEMENT, IS IT?!!???!!?

Owner: N-no, I guess not. (gets ashamed, looks at his feet)

Mr. Praline: Well.

(pause)

Owner: (quietly) D'you.... d'you want to come back to my place?

Mr. Praline: (looks around) Yeah, all right, sure.
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