Trial By Error, Continued: Why has the PACE Study’s “Sister Trial” been “Disappeared” and Forgotten?

snowathlete

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The nurses were given training in the BPS view of MECFS, and it sounds like they truly believed they had the "truth". They simply couldn't fathom why the patients were so critical of this view. In an article Tuller quotes about the trial process, one or the trial supervisors said “Their frustration has reached the point where they sort of boiled over,"... “There is sort of feeling that the patient should be grateful and follow your advice, and in actual fact, what happens is the patient is quite resistant and there is this thing like you know, ‘The bastards don’t want to get better.’” .
I think it's an interesting facet of the whole CBT/GET approach to ME/CFS that the therapists/nurses/listeners, whatever, are actually more brainwashed than the patients. The reason for this is simply that patients can tell first hand that it's not making them better, nothing to gain from kidding themselves, whereas the practitioners have to either accept the treatment they are responsible for, and that they have vested interests in, doesn't work - which involves believing someone else and accepting the lack of evidence againsy what is being told you. Accepting you are wrong, failing, is hard. Much easier to shift the blame onto the patient.
 

Daisymay

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Posted on behalf of Margaret Williams:

"In addition to its null result, the FINE trial may have been inconvenient to the PACE trial principal investigators for other reasons.

In his letter to the West Midlands Medical Research & Ethics Committee (MREC) dated 9 February 2006 seeking ethical approval to change the eligibility and primary outcome criteria for the PACE trial after recruitment had begun, Professor Peter White wrote about his wish to change the SF-36 threshold:

"We therefore propose an increase of the categorical positive outcome from 70 to 75, reasserting a ten point score gap between entry criterion and positive outcome. The other advantage of changing to 75 is that it would bring the PACE trial into line with the FINE trial, an MRC funded trial for CFS/ME and the sister study to PACE."

As readers of Dr Tuller's articles will know, when the results of the PACE trial were published in The Lancet in 2011, the positive "ten point score gap" promised to the ethics committee had been replaced by a negative five point score gap, allowing participants to deteriorate yet still be described as "recovered".

Consequently the "advantage" of bringing the sibling FINE and PACE trials "into line" – which would have enabled direct comparison between the results of each trial – was lost.

It is therefore reasonable to ask if this substantial amendment to the trial protocol would have received ethical approval had the MREC known that these commitments, together with every other published primary outcome measure, were to be abandoned before the results were published.

It is also reasonable to ask if the PACE trial itself might also have yielded a null result had the primary outcome measures and statistical analysis not been changed mid-trial."

Margaret Williams, 11th November 2015
 

Dolphin

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Here's a summary (645 words) of the piece by journalist David Tuller on the FINE Trial that came out earlier this week: "Trial By Error, Continued: Why has the PACE Study’s “Sister Trial” been “Disappeared” and Forgotten?"

The FINE Trial involved nurses coming to people's homes to "treat" them.

http://www.meaction.net/2015/11/10/pace-trials-sister-study-overlooked/

Phoenix Rising thread on the summary: http://forums.phoenixrising.me/inde...-david-tullers-piece-on-the-fine-trial.41185/
 

beaker

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What isn't explored here is the consequences for vulnerable patients of having their loved ones and carers being told they could be cured if they tried and believed, only for that not to happen. I have been under immense family pressure after health professionals insisted i could be rehabilitated to the extent that they considered abandoning me if i wouldn't agree to a program.
It's hard enough when all that kind of crap come through the media let alone a medical professional whose care you are under.
It is of course, re-enforced by the fact that you are only seen when well enough and pushing.
This all makes for an ugly mess being dumped on patients.
 

MeSci

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Cheshire

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Trial by error, Continued: PACE Team’s Work for Insurance Companies Is “Not Related” to PACE. Really?

In their Virology Blog response, the PACE team also stated that no insurance companies were involved in the research, that only three of the 19 investigators “have done consultancy work at various times for insurance companies,” and that this work “was not related to the research.” The first statement was true, but direct involvement in a study is of course only one possible form of conflict of interest. The second statement was false. According to the PACE team’s conflict of interest disclosures in The Lancet, the actual number of researchers with insurance industry ties was four—along with the three principle investigators, physiotherapist Jessica Bavington acknowledged such links.

But here, I’ll focus on the third claim–that their consulting work “was not related to the research.” In particular, I’ll examine an online article posted by Swiss Re, a large reinsurance company. The article describes a “web-based discussion group” held with Peter White, the lead PACE investigator, and reveals some of the claims-assessing recommendations arising from that presentation. White included consulting work with Swiss Re in his Lancet disclosure.

http://www.virology.ws/2015/11/17/t...surance-companies-not-related-to-pace-really/
 

Woolie

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Great comment here at the end of the article by someone called uab:

uab said:
One of the things that makes insurance companies uncomfortable is where they cannot easily quantify risks and costs. In pushing the line that CBT/GET can help get patients back to work (one not supported in their papers) they are misleading the actuaries who calculate premiums. This could have the effect that insurance companies such as Swiss Re are taking on far more risk than they otherwise would have been comfortable with if they were told that treatments do not lead to changes in employment status or benefit claims. So they are not really helping the insurance industry apart from helping them deal with previous bad advice by not paying out.
 

Woolie

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from the opennotebook interview with David Tuller, that @Cheshire mentions above:
David Tuller said:
It was very frustrating, because I knew it was a story. But then I thought, “Am I crazy? Maybe it’s not a story.” I had a colleague at the journalism school who said, “No, this is an important story.” He couldn’t quite understand why no one wanted to publish it. I felt like I got a minor secondary echo of what patients must experience when they go to doctors or talk to people about CFS.
 

Cheshire

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Here's a Dr James Bolton's talk about MUS (including CFS). Usual BPS BS. People atribute normal sensations to a pathological process and so on. Nothing new under the sun. (particularly disgusting paternalistic tone BTW)

And guess what? He was (maybe still is) Deputy Chief Medical Adviser at the DWP.
Seems like most of the people pushing very hard for a psychosomatic view of "MUS" are linked to assurance industry or DWP.
 

Sean

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Might pass on the video. Having a good day and don't want to spoil it. :cat:

Seems like most of the people pushing very hard for a psychosomatic view of "MUS" are linked to assurance industry or DWP.
Yeah, funny that.

Wonder who recommended them to those positions?

Just shows how deep all this guff taints the whole of society and governance, and why it is so hard to get it stopped. Too many people's jobs and reputations and empires depend on it not being stopped.

No wonder they are fighting tooth and nail to defend PACE. :rolleyes: :p
 

Woolie

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A new name to me, and as you say, @ Cheshire, pretty much the standard view amongst strong adherents of the psychogenic view. Still, this is maybe even extreme for that crowd. There's something about the concerned face of Dr. Bolton as he insinuates that patients may just have been brought up to be whiners, or be looking for attention, or simply don't understand the difference between real illness and the sensations that normally accompany certain emotions, etc.

Here's a gem:
"… how parents handle illness in families can also be important. I remember as a child if I suggested to my mother that I thought I should have a day off school because I felt unwell, she would simply give me my bag and push me out the door. You can see that that might influence the way I deal with physical symptoms in later life."

The usual pearls about how we musn't make an "artificial distinction between mind and body". Incredible! These guys are the very masters of the mind-body divide, perpetuating the idea that physical symptoms are either in the body, or (if no evidence of that), then must be in the “mind”.

Just listen to the references to “organic disease” as a distinct entity. And whether a symptom has a "physical basis" or not. Talk about mind-body divide, or what?