Watt from MRC defends PACE in letter to Times

From the MRC website: https://mrc.ukri.org/news/browse/cr...rial/?utm_medium=email&utm_source=govdelivery

Text of full response from Fiona Watt
‘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 Requestopens in new window (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.

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“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.”

If I can list those that I know:

1) issuing some kind of ineffective highlight notice
2) the 2011 ring fenced grant and then some minor stuff funded since
3) the CMRC, attending, initiating maybe and some funding for it
4) stating that we are a priority whilst doing little and the field advances at a snails pace

 

It appears they may have a menu, to make constructing non responses from previously constructed drivel less taxing.

It was hogwash then, it's still hogwash, even when put next to hogwash from previous other non responses.

 

The insurance companies and BPS cult had MS in their sights before there was a means to 'prove' diagnosis :
"
Two factors
threatened future profits however. The first was falling interest rates, and the
second was the growth in new kinds of ‘subjective illnesses’, for which diagnostic
tests were disputable. The old industrial injuries were giving way to illnesses with
no clear biological markers - Myalgic Encephalomyelitis (ME) or Chronic Fatigue
Syndrome (CFS), Fibromyalgia, Chronic Pain, Multiple Sclerosis, Lyme Disease."

https://www.s4me.info/threads/government-and-insurance-companies-establishing-the-bps-model.2319/

I would have thought the MS community would have been aware of this; maybe the resurgence of the BPS cult for MS is that they think most sufferers will not know about the history. The MS Society in their support of these therapies appear to be adopting the AfME approach....

(I don't know anything about the MS charities or any details of the history apart from the 'Unrest' 'hysterical paralysis' quote from Nancy Klimas)

had a quick look and the Dutch BPS gang appear to be taking the lead.....the usual suspects;
Knoop, Bleijenburg, Twisk etc
their conclusions as per all their other research (substitute 'MS' with name of chosen illness)
"Severe MS-related fatigue can be reduced effectively with CBT in the short term. More research is needed on how to maintain this effect over the long term."

 

I had to look that up, not always being in touch with UK goings on. Got it now - he said "You can't polish a Trudie". I think. Brainfog.

 

Spin, in other words.

The only upshot here might be that they now feel shamed into accepting some biomedical studies. We shall see.

 

From the full statement:

"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."

This is more positive, is it not?

 

Weren't there more than 600 participants in PACE though? Are they cherry-picking the best data? I'm always highly sceptical.

 

I would like to think so, but experience has made me suspicious.

Depends on who is on the CSDR Independent Review Panel and how they interpret the word "Independent" .

 

"over 600 participants"

 

You're right. It was only 641. I thought it was a larger trial. Seems very expensive for £5m.

 

But interesting that Watt's final paragraph in The Times does not appear in the "extended" version:

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

 

Pity they don't respect us.

 

Researchers should be discouraged from continuing to do poor research. Mutual respect is impossible when the researchers in question continue to inflict harm on patients, including but not limited to deterioration due to GET, promotion of stigmatizing views, fabricating false positive results through biased methods and spin that then lead to waste of resources in a variety of ways.

 

From their sign-up page, https://www.clinicalstudydatarequest.com/Profile.aspx, it looks like access will be restricted to those researchers who are affiliated to an institution, so keeping any pesky unaffliated patient-researchers away from the data still.

 

But they can no longer claim that the data is inaccessible.

 

Brian seems a v good guy, he follows me on Twitter and retweeted my post on Suzanne O'Sullivan a couple years ago, he himself referred to ‘pseudoscience of ME’:

https://twitter.com/user/status/728933028173590528


Academic books always cost a fortune.

 

Limiting their audience thereby!

I don't blame @Brian Hughes (welcome to the forum!) in the slightest - this is his publishers' decision.