Watt from MRC defends PACE in letter to Times

[Anthony Carney]

THE MRC WROTE
Activities have included a dedicated funding call – Understanding the mechanisms of CFS/ME – in 2011. We want to encourage a broad range of scientists, some of whom are wary of this controversial area, to apply to us for funding. At present, response-mode applications are encouraged through a cross-board highlight notice to undertake innovative research into the mechanisms underlying the chronic changes associated with CFS/ME, particularly in relation to immune regulation, pain, different symptom profiles, childhood CFS/ME and neurological inflammation.


Well that is fascinatiing- per their data.

I. 2010-11 the MRC spent £nil on CFS research ditto £nil in the following year.
2. In 2012-3 £504k, in 2013-4 £602k, in £2014-5 £652k.
3. In 2015-6 £287k and £286 in 2016-7.

if as the MRC estimates 0.2 to 0.4 percent of the population suffers from CFS then why is only 0.045% of their budget allocated to it in 2016-7?

it's most definitely a unloved cinderella.

Watt should be challenged on that ground alone. Disengenuous drivel.

 

[Jonathan Edwards]

Could someone clarify Brian Hughes' point 'b' for me please in the context of PACE. I presume he means how treatments the authors favoured were selectively hyped, but not sure if I'm missing something beyond that.

As I understood it the problem with the 'controls' in PACE is that they are not equivalent in the sense that they should match/mimic all reasonable contextual influences not specific to the test. In other words a placebo control for a strawberry flavoured pink pill should not be a tasteless brown capsule. Standard medical care was pretty tasteless and brown.

 

[Barry]

Weren't there more than 600 participants in PACE though?

data from over 600 participants

I think that is just a lazy way of saying 641, or maybe they think it's catchier?!

 

[Barry]

But then wasn't the PACE data lost?

Wasn't it more akin to inaccessible rather than lost?

 

[Wonko]

I think that is just a lazy way of saying 641, or maybe they think it's catchier?!

or...it might mean that the trial data was stored in a box, on a shelf, above the trial participants. It's difficult to know what they mean when such precise language is used.

 

[Stewart]

Could someone clarify Brian Hughes' point 'b' for me please in the context of PACE. I presume he means how treatments the authors favoured were selectively hyped, but not sure if I'm missing something beyond that.

This is explained in a bit more detail a couple of pages later (in the third paragraph of page 137). The CBT and GET groups were offered many more appointments with their respective therapists than the people in the control groups were. This greater regularity of contact would have biased the trial results in favour of CBT and GET. In a well-designed trial patients in all the treatment arms would have had identical amounts of contact with their specialists.

 

[Lucibee]

I think that is just a lazy way of saying 641, or maybe they think it's catchier?!

They can't say 641 because one person withdrew consent and insisted their data was destroyed.

 

[Barry]

They can't say 641 because one person withdrew consent and insisted their data was destroyed.

I picked up on this a good while back, but I think that may have been in the context of recruitment. Yes, I agree you are right, they do only have data for 640.

 

[Daisymay]

Feels like it could be worth a whip round to send Michael Sharpe a complimentary copy!

And Fiona Watts?

And Wessely, it might give him some food for thought for the next edition of his book "Clinical Trials in Psychiatry".

 

[Adrian]

Forgive me - I'm not entirely following the story as my attention is elsewhere somewhat - but is the suggestion that the 'extended version' is, in reality, a revised version?

Rhetorical questions and points but, firstly, they're not being entirely accurate if they're saying 'extended version' as there is some excision (which they appear to have not alerted readers to), also, what was the reason for the removal of that inflammatory paragraph? Was there some concern that - as was pointed out to them - the 'harassment' issue had more or less been rubbished in a legal setting?

The original inclusion of the 'harassment' stuff was, I'm suggesting, knowingly done as I simply cannot believe that Ms. Watt was unaware of the judgment two years ago. It was untrue propaganda the inclusion of which was highly unprofessional.

Again, sorry if I'm being a bit dim/repeating the obvious again etc!

I wonder if she actually read the statement and removed it but didn't bother reading the letter to the times and just signed it. The whole thing reads like the normal propaganda put out by the PACE team and the SMC - including the appeal to its ok because others found the same and Cochrane say its ok.

 

[CFS_for_19_years]

[...]At the launch of The Psychological Medicine Network [...] on 10th December 2004 at Regent’s Park College, Sensky’s presentation was entitled “Somatisation and Primary Care”, in which he made some disturbing statements (backed by his PowerPoint slides, some of which have now been removed from the internet) about patients with medically unexplained symptoms (MUS) in which he includes CFS patients.

In addition to numerous cartoons that denigrate sick people (one of which shows a woman sobbing in front of a doctor, with the caption “Madam, this is a consultation, not an audition”), Sensky’s slides state, for example, that:
· “People who present with somatisation disorders are often difficult to manage (and) may arose (sic) strong feelings in clinicians”

· patients with a “rating as ‘difficult’ (are) strongly associated with functional disorders”

· “Difficulties in Doctor – Patient Relationship: Correlations with Number of Somatoform Symptoms (extent of frustration with patient’s symptoms; perception that patient is manipulative)”

· “Correlations with GP Clinical Grading of Somatisation (helpless behaviour of patient; tiresome patient; difficult patient)”

· “Attitudes of GPs toward patients with medically unexplained symptoms (they are difficult to manage; they have personality problems; they have a psychiatric illness)”.

In his slide “GPs’ Views: irritable bowel and CFS compared”, Sensky states that IBS patients have an anatomical or physiological basis for their symptoms but there is no such basis in CFS; that IBS patients do not have a low threshold for symptoms but that CFS patients do have a low threshold for symptoms; that IBS patients do not lack stoicism but that CFS patients do lack stoicism, and that IBS patients do not transgress the obligations of the sick role but CFS patients do transgress it.

Sensky maintains that GPs make “inappropriate referrals” for patients with medically unexplained symptoms (MUS) and teaches that GPs should make “persuasive statements” to patients with MUS in the form of “Provision of a ‘non-disease’ explanation of the patient’s symptoms”.

His slides state that: “medical tests are logically ambiguous”; that interventions for somatoform disorders should include “reattribution” of the patient’s presenting symptoms and he gives as an example: “I feel my heart pounding in my chest”, which he dismisses as somatic (he makes no mention of the possibility of autoimmune thyroiditis or of dysautonomia, both of which could cause a pounding heart and both of which are documented in the literature as occurring in ME/CFS).

Why is someone holding such views about ME/CFS as Professor Sensky a member of the PACE Trial Steering Committee? Who approved his membership of the TSC?

Starting at slide 25, Sensky's entire slide presentation from 2004 is here:

There are 24 slides that precede his presentation - not sure I understand their context.

 

[dave30th]

And there's no sign of any TSC approval for the recovery criteria they eventually used, or any evidence that this criteria was devised before they analysed data for the 2011 Lancet paper.

I used to say that the recovery paper did not report any approval by any oversight committees. More recently I've simply stated it as a declarative. If they had approval, they would have cited it. Absent mention of oversight committee approval, as far as I'm concerned it means they didn't get it. They have never contradicted that point. They have been careful to point out that the new primary outcome was approved but have never made that claim about the new recovery definition, as far as I've seen.

 

[dave30th]

They can't say 641 because one person withdrew consent and insisted their data was destroyed.

In fact she withdrew consent after finishing the study when she found out the PACE authors had links with disability insurance companies. she was very angry not to have been told about these conflicts of interests. they tried to convince her to let them use her data but she refused. I don't know if her information was destroyed, but it was not used in the analysis.

 

[Adrian]

I used to say that the recovery paper did not report any approval by any oversight committees. More recently I've simply stated it as a declarative. If they had approval, they would have cited it. Absent mention of oversight committee approval, as far as I'm concerned it means they didn't get it. They have never contradicted that point. They have been careful to point out that the new primary outcome was approved but have never made that claim about the new recovery definition, as far as I've seen.

I think there is a slightly different question which is whether they got approval to drop recovery as a secondary outcome (along with the step test). I believe the consort guidelines require them to publish all secondary outcomes.

 

[Sly Saint]

We are currently supporting the PACE trial investigators to anonymise the study data

Who is over-seeing this?(ie monitoring that there is no tampering).
And, as others have pointed out, given that QMUL said not so long ago that no-one could access the data because Peter White had left, who is in overall 'control', or have they pulled him out of retirement?

 

[Adrian]

Who is over-seeing this?(ie monitoring that there is no tampering).
And, as others have pointed out, given that QMUL said not so long ago that no-one could access the data because Peter White had left, who is in overall 'control', or have they pulled him out of retirement?

Also I would argue that the MRC are not independent. They have shown themselves incapable of doing a proper assessment and instead repeat QMULs weak statements. Its not like they have investigated and come to a different conclusion they have simply not looked and hence cannot summarise and deal with the criticisms.

So I would have no faith in any review body they set up to mediate data access.

 

[WillowJ]

Sir, Further to your report “Call for review of ‘flawed’ ME research”(Aug 21), as funders of the Pace trial we reject the view that the scientific evidence provided by the trial for using cognitive behavioural theory and managed exercise in the treatment of chronic fatigue syndrome (also known as ME) was unsound.

Unsupported assertion (thesis or topic sentence)

The Pace trial was funded following expert peer review,

Arguing from authority/process /tradition

was overseen by an independent steering committee, and its published findings have also been independently peer-reviewed.

Argument from process/authority/tradition

Other research groups have drawn similar conclusions.

Bandwagon/tradition/process/authority

Chronic fatigue syndrome/ME remains a priority for the Medical Research Council (MRC)

Irrelevant. (Also undemonstrated assertion.)

and it is important that researchers are not discouraged from working on the disease because of concerns that they could be subject to the level of hostility that Pace researchers have experienced. Medical research can only flourish when there is mutual respect between all parties.

Ad hominem

It’s all just assuming that processes/traditions work without bothering to check into what’s being said, then slamming critics for pointing out that the process/traditions can’t be assumed to be going right.

 

[Lucibee]

Action for ME have now issued a statement: https://www.actionforme.org.uk/news/pace-trial-and-behavioural-treatments-for-me/

[Thread: https://www.s4me.info/threads/actio...l-treatments-for-m-e-position-statement.5532/]https://www.actionforme.org.uk/news/pace-trial-and-behavioural-treatments-for-me/

 

[Peter T]

While most of the criticism focuses on the PACE trial, there is a large amount of evidence from other studies that also shows CBT and graded exercise therapy (GET) can be helpful to some CFS/ME patients. Other research groups, using different study designs, have drawn similar conclusions about the benefit of these treatments.

Is this a downright falsehood? I have read many though not all the the GET/CBT studies, but my understanding is that they all use the same flawed methodology of subjective outcomes in unblinded trials. If any objective measures were used, they are either quietly dropped from the reporting or show null results. Most also use the problematic Oxford criteria and a surprising number engage in unethical practises such as outcome switching.

Presumably we need Prof Watt to cite the studies she is referring to over and above Cochrane, or do we just assume that she is uncritically accepting the Cochrane review and overgeneralising from there?

 

[Trish]

Action for ME have now issued a statement: https://www.actionforme.org.uk/news/pace-trial-and-behavioural-treatments-for-me/

That looks like it should have a thread of its own to discuss it. (I haven't read it yet). Andy has started one here.