Watt from MRC defends PACE in letter to Times

dave30th said:
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.
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I seem to remember Peter White talking about it as being a huge hassle - but I can't remember where - was it early during the FOIA tribunal? (I've checked the final docs, but it isn't mentioned there.)
 
If your MP spoke in the recent Westminster Hall debate on ME, it could well be worth drawing their attention to the letter from Prof Watt and asking if they'd be prepared to write to her to convey:

a) disappointment that she has publicly repeated unsubstantiated allegations against ME patients that were shown to be baseless at the Information Tribunal hearing in 2016.

b) surprise that the MRC continues to stand fully behind this trial considering the numerous methodological flaws and the growing concern in the scientific community - especially given the fact that millions of pounds of public funds were spent on this study. The MRC's failure to engage with these issues in any meaningful way raises legitimate concerns about whether it is fit for purpose.​

Professor Watt obviously isn't prepared to listen to privately well-reasoned concerns from people like Jonathan Edwards, but perhaps a bit of criticism from politicians will give her pause to reconsider.
 
from the MRC's website:
Cinders66 said:
[...] 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.
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from Merriam-Webster's website: https://www.merriam-webster.com/dictionary/some :
Definition of some

1 : being an unknown, undetermined, or unspecified unit or thing
  • some person knocked

2 a : being one, a part, or an unspecified number of something (such as a class or group) named or implied
  • some gems are hard
b : being of an unspecified amount or number
  • give me some water
  • have some apples
3 : remarkable, striking
  • that was some party

4 : being at least one —used to indicate that a logical proposition is asserted only of a subclass or certain members of the class denoted by the term which it modifies
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ETA: Is there yet a more unspecific wording than saying "some" patients?
 
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dave30th said:
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.
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Very interesting that that was the reason. Brings that issue into sharp (Sharpe?) focus.
 
Reading the excerpt from @Brian Hughes' book made me think (it happens occasionally :)) that the bad-science psychiatrist' running trials, seem to fall into a trap of their own short-sightedness.
  1. They are trialing psychological treatments.
  2. There are psychological factors that can influence their trial design and methodology.
They seem incapable of distinguishing between the two. As if they see the whole thing as a continuum, and the methodological psychological factors can just be bundled in with the treatment aspects. If it 'works' (i.e. gives the results they want) then they must have got it right ... :rolleyes:.

They seem so wedded to their trials' greatness, and so blind to others' justifiable criticisms, I really do begin to wonder if this is what it is with them. Scientists who really do not understand how to run trials, psychological or otherwise. As if "If it's psychology, then we can do what we want with it's, because it all about psychology anyway isn't it?"
 
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Stewart said:
b) surprise that the MRC continues to stand fully behind this trial considering the numerous methodological flaws and the growing concern in the scientific community - especially given the fact that millions of pounds of public funds were spent on this study. The MRC's failure to engage with these issues in any meaningful way raises legitimate concerns about whether it is fit for purpose.
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I think one of the most worrying things is that the MRC isn't even trying to understand what the criticisms are let alone address them. This shows that they have no intent of applying any form of governance to the research they fund and as long as there are reviews an a committee then no questions will be asked and support given. It would be different if the MRC were to address in detail the issues raised and explain why they think they are not issues (although I think they would struggle to do so). The statement really suggests they have not bothered to find out.
 
Lucibee said:
I seem to remember Peter White talking about it as being a huge hassle - but I can't remember where - was it early during the FOIA tribunal? (I've checked the final docs, but it isn't mentioned there.)
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There are a few examples of this, but I can only remember the details of this one now.

It looks like the page is now inaccessible, but here's a copy of White submission to a FOIA review that I copied previously. In the second to last paragraph he mentions the trouble of destroying these patients' data, although rather misrepresents the reason this was done (implying it was out of concern data would be released via FOIA):


Maxwhd turns up so much interesting stuff. I slightly reformatted to make it easier to see what has being said.

He's arguing for Universities to be exempted from the FOIA.

From: https://www.gov.uk/government/uploa...file/487271/Online_Responses_CitizenSpace.xls

Peter White's submission:

Q: What protection should there be for information relating to the internal deliberations of public bodies? For how long after a decision does such information remain sensitive? Should different protections apply to different kinds of information that are currently protected by sections 35 and 36? - What protection should there be for information relating to the internal deliberations of public bodies? For how long after a decision does such information remain sensitive? Should different protections apply to different kinds of information that are currently protected by sections 35 and 36?

A: It is an important principle of science that internal deliberations should be undertaken in a "safe space", allowing for freely expressed arguments for and against decisions made in planning and implementing a scientific study. It is equally important that such decisions, and the reasons for making them, are recorded formally and accurately, so that these documents can be used as source references used at the time of writing up and publishing research. This would not be possible, or would be very limited, if such minutes of such meetings were known to be liable to public release. This would have a "chilling" effect on open discussion This is particularly the case in Medicine where the principle of patient involvement in research is so valuable - individual patients and patient organisations are vulnerable to abuse and harassment if their names were to be made public as part of such minutes. Making such data exempt from the Act would protect scientific work in controversial subjects within and outside of medicine. Please refer to Information Tribunal decision notice Appeal No: EA/2013/0019, where Judge Hughes outlines these arguments in more detail, in an appeal regarding a medical research trial that I led (see answers to question 6).

Q: Is the burden imposed on public authorities under the Act justified by the public interest in the public’s right to know? Or are controls needed to reduce the burden of FoI on public authorities? If controls are justified, should these be targeted at the kinds of requests which impose a disproportionate burden on public authorities? Which kinds of requests do impose a disproportionate burden? - Is the burden imposed on public authorities under the Act justified by the public interest in the public’s right to know? Or are controls needed to reduce the burden of FoI on public authorities? If controls are justified, should these be targeted at the kinds of requests which impose a disproportionate burden on public authorities? Which kinds of requests do impose a disproportionate burden?

A:
I am the principal investigator (PI) of the PACE trial, the main findings of which were published in the Lancet medical journal in 2011 (White PD et al. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. The Lancet 2011;377:823-36. doi:10.1016/S0140-6736(11)60096-2). I write here in my personal capacity.

The PACE trial is a trial of four treatments for patients suffering from chronic fatigue syndrome (CFS), which is sometimes called myalgic encephalomyelitis (ME). CFS is a controversial condition, and attracts a strong patient activist voice. This group has used the FoI Act many times since this main paper was published, asking for all sorts of data, from the minutes of all meetings overseeing the trial to all of the patient data collected. See the following for a description of activism (http://www.bmj.com/content/342/bmj.d3780)

The administration of these requests has caused a very significant burden on the University's FOIA manager, the University's academic department of law, and myself as PI. I have had to spend a considerable amount of time addressing the requests, advising colleagues, collating the views of my research colleagues at other universities, and writing witness statements for the various appeals (internal, ICO and IT). This means that my further research into the causes and treatments of this debilitating and misunderstood illness has been delayed. Paradoxically, the time taken up in this has delayed publication of the papers that contain some of the very data that have been requested.

Perhaps most damaging of all have been requests by two trial ex-participants to "destroy" all their data collected on them during the trial because of their concern that the data will not be held securely and confidentially, something we promised them to do as part of their giving informed consent. The first such request was received after we had finished all trial data collection and had started the main analysis. After some months of trying to obtain advice on what to do, we were advised to destroy this ex-participant's data, which we did (and which took some time to do due to the complexity of the data), but this meant that we had to restart the analysis, which caused several month's delay in publishing the main results paper in 2011. This paper was important since it showed that there were two treatments for this condition which were safe and moderately effective. It is estimated that some 250,000 people suffer from CFS in the UK.

Section 22a of the Act is insufficient protection for science into controversial subjects, and requires that the research is on-going, so is irrelevant to completed research. We need science in the UK to be protected or it will continue to be damaged as this trial has been (other examples include climate change science, and research into the health effects of tobacco). Exempting Universities from the FOIA would achieve that. Exempting scientific research data produced by Universities and other higher educational institutes might be a workable alternative.
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Adrian said:
I think one of the most worrying things is that the MRC isn't even trying to understand what the criticisms are let alone address them.
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I think the MRC understands the criticisms perfectly well, but has decided that they don't want to acknowledge any responsibility for the failures of oversight that allowed the situation to occur and public funds to be squandered. If they admit that they messed up with PACE, people might start to wonder whether this was indicative of a wider problem and begin looking into how other trials were run or other aspects of the MRC's operation - and who knows what they'll find then.

Like the Lancet and the BMJ, they seem to have decided the best approach is to vigorously deny that there's a problem while refusing to engage with the detail of the complaints, in the hope that the story will blow over.
 
Stewart said:
I think the MRC understands the criticisms perfectly well, but has decided that they don't want to acknowledge any responsibility for the failures of oversight that allowed the situation to occur and public funds to be squandered. If they admit that they messed up with PACE, people might start to wonder whether this was indicative of a wider problem and begin looking into how other trials were run or other aspects of the MRC's operation - and who knows what they'll find then.

Like the Lancet and the BMJ, they seem to have decided the best approach is to vigorously deny that there's a problem while refusing to engage with the detail of the complaints, in the hope that the story will blow over.
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They show no sign of understanding the criticisms because they are not addressed in any public statement and their statement would suggest that they are unaware of the methodological criticisms as they point to other trial results. It may be that they do understand and are just covering up but they show no evidence of having taken the trouble to understand. I think its more of a simplistic defense action to just bluster rather than spending time to understand.
 
Thanks, @Esther12 , that's the one I remembered.

Perhaps most damaging of all have been requests by two trial ex-participants to "destroy" all their data collected on them during the trial because of their concern that the data will not be held securely and confidentially, something we promised them to do as part of their giving informed consent. The first such request was received after we had finished all trial data collection and had started the main analysis. After some months of trying to obtain advice on what to do, we were advised to destroy this ex-participant's data, which we did (and which took some time to do due to the complexity of the data), but this meant that we had to restart the analysis, which caused several month's delay in publishing the main results paper in 2011. This paper was important since it showed that there were two treatments for this condition which were safe and moderately effective. It is estimated that some 250,000 people suffer from CFS in the UK.
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Seems a little different from the account given to @dave30th though.
 
Adrian said:
I suspect few academics in the UK who look towards the MRC for funding will want to get involved.
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And, that in itself, should be raising red flags all over the place. It seems to have become a political entity, where it's best to keep your mouth shut to keep in with them, rather than an council dedicated to good, rigorous research carried out in the interests of public health.
 
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