Watt from MRC defends PACE in letter to Times

I'm only just finding time to catch up with all Tuller's recent blogs.

It seems significant that Edwards mentioned the problems with Cochrane's work when e-mailing Watt, before her recent statement on the MRC website.

Edwards:

http://www.virology.ws/2018/08/28/trial-by-error-professor-edwards-letter-to-mrcs-fiona-watt/

Watt:

https://mrc.ukri.org/news/browse/criticism-of-the-pace-trial/

 

Argument by authority. This is the difference between evidence based practice, and evidence based worship. A review from Cochrane is a flag to say something might be good, but it still needs to be evaluated. Slavishly accepting something from an authority is right back to where we were before EBM. I am aware many doctors do this, but its still a huge mistake. I keep wondering if this is connected to Gigerenzer's finding that 90% 80% of doctors (in the US) don't have the basic training to read scientific papers.

PS My bad. Typo/miskey on the 9.

 

Doctors' statistical skills are far from brilliant. Mine are poor and my GPs are worse.

 

Has anyone a link to the Times eletters to send to MPs? Good to keep them up to speed before the new session.

 

It seems highly likely. This is just what happened with the House of Lords debate, in 2013. The Lords comments read very much as if they were merely parroting off the PACE/BPS version of the world, accepting unquestioningly the info they had been given. Subsequently, Professor White admitted briefing all those who spoke in favour of PACE and complained at how those pesky patients and activists caused him all this additional work.

What is so appalling is that, especially in such a contentious issue, intelligent people, often scientists, are prepared to so blindly follow what one side says.

It's quite likely these people already believe the negative stereotypes of ME and ME patients, making it easy for the BPS brigade to manipulate them further and play on their prejudices.

 

The MRC will almost certainly have a position as an institution on the PACE trial, and that's highly likely to be "We funded and oversaw this trial so we're going to defend it, regardless of the merit of the criticisms". Professor Watt is most likely just the mouthpiece for that view. But people have tried to privately make her aware of the issues and she's obviously decided to go along with the party line regardless - and in my opinion that makes her part of the problem.

But I agree that the PACE team will almost certainly have had some input into the drafting of the MRC statement.

 

Not in today’s selection of letters: https://www.thetimes.co.uk/edition/comment/tory-fear-of-infiltration-by-ukip-members-2kcmc6nlq

 

https://twitter.com/user/status/1034454887357145088

 

She shouldn't be in the job then.

 

Sorry but I can't read everything so am not sure if this has been posted:

Source: Medical Research Council

Date: August 28, 2018

URL: https://mrc.ukri.org/news/browse/criticism-of-the-pace-trial/

Criticism of the PACE trial
---------------------------

The Times recently reported on a letter to The Lancet which called for the journal to reanalyse the data from the PACE trial.

Independent scrutiny and analysis are to be welcomed in the quest for robust and reproducible research results. The MRC is keen to encourage more research into different aspects of CFS/ME because scientists still know relatively little about this serious condition.

Executive Chair, Professor Fiona Watt, responded in a letter to the Times (27 August 2018), an extended version of which appears here:

'Call for review of 'flawed' ME research'opens in new window (The Times, 21 August 2018) discusses claims that the scientific evidence provided by the PACE trial for using cognitive behavioural therapy (CBT) and managed exercise in the treatment of chronic fatigue syndrome (CFS, also known as ME) is fundamentally unsound.

As funders of the trial, we reject that view: the PACE trial was funded following expert peer review, was overseen by an independent steering committee, and its published findings were also independently peer reviewed. The process through which PACE was funded, supervised and published therefore meets international standards for clinical trials.

CFS/ME is considered to be a spectrum of disorders and understanding the causes and informing the development of new treatments, or the targeting of existing treatments, will require research across a range of approaches and from a holistic view point. The PACE trial investigated the important issue of which available treatments were most likely to benefit patients, and patient consultation resulted in the addition of a treatment to the trial.

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. This evidence is summarised in three Cochrane reviews. Cochrane reviews are systematic reviews of primary research in human healthcare and health policy, and are internationally recognised as the gold standard in evidence-based healthcare.

Making the data available

One criticism of the PACE trial has been that the data is not widely available to other researchers for use in further research and to confirm the reproducibility of results. The MRC strongly supports the sharing of data from clinical trials but it is critical that sensitive personal information from study participants is not released when study data is shared. We are currently supporting the PACE trial investigators to anonymise the study data from over 600 participants so that it can be made available to other researchers in a way that protects the privacy of those patients who took part.

The MRC has recently started (with other research funders) a pilot of a new facility for academic researchers to share data via the Clinical Study Data Request (CSDR) web portal. We hope to include the PACE trial on the CSDR portal within the next 6-12 months.

This will allow researchers to apply to the CSDR Independent Review Panel to gain access to the dataset for their own analyses.

Apply for CFS/ME research funding

CFS/ME is a serious illness that is estimated to affect around 0.2-0.4% of the UK population and it remains a research priority for the MRC. The MRC has undertaken and is actively engaged in a number of strategic activities to promote and encourage research into the causes of this condition and effective treatments, and to support the research community. 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.

The MRC also supports the UK CFS/ME Research Collaborative (CMRC): a platform for patients, researchers, clinicians and funders to coordinate strategies to increase awareness of the condition within the research community and increase research funding.

 

Yes, if this was in response to my comment she seems to have missed the point that it was Cochrane who had expressed worry that their reviews of ME/CFS might not have been gold standard after all.

When I was asked to referee a review of exercise therapy I was expected to fill in a form from the Mental Health team in an arty-farty font that seemed altogether unprofessional. The request came with an apology that they realised maybe it should not have been under Mental Health anyway. It was clear that I, as someone with no official background in ME, had only been asked because they were worried they had goofed and a lay representative had suggested I might enlighten them a bit.

 

If she responded to PACE criticism by pointing to Cochrane's CFS reviews, and presenting these Cochrane's reviews as 'the gold standard in evidence-based healthcare' after having been informed that there were reasons for concern about their CFS work, and without having investigated those concerns for herself, that seems rather unethical.

 

Was this in private correspondence or do you have anything specific to point to that demonstrates Cochrane may have been worried about the standard ?

(apart from the apology about mental health)

Do you think they may be worried enough to do something

 

There are other things mentioned to me in confidence. I was initially pessimistic that anyone within Cochrane would actually be motivated to make a significant change but I am less so now.

 

Does anyone understand the Watt reference to three Cochrane reviews? Besides the 2008 CBT review, is she referring to both the 2015 and 2017 publication of the same exercise review? Or what?

 

Oh, in answering my own question, I assume the first is the 2004 review of exercise for CFS.

 

On thinking, I don't think Watt's reference to Cochrane can have had anything to do with my comment,other than perhaps as a memory jogging. It would be an extraordinarily risky tactic.