She hasn't even got this right. The steering committee included independent members but also the PIs so it was not an independent committee.
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Watt from MRC defends PACE in letter to Times
- Thread starter JohnTheJack
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She hasn't even got this right. The steering committee included independent members but also the PIs so it was not an independent committee.
From the MRC perspective the accusation is that the process was followed but failed to ensure sufficient quality in the result. That should be seen as a serious issue and as a minimum lead to a review of their process.
Esther12
Senior Member (Voting Rights)
Thanks John - I added some notes in case they're of any use.
I liked the final point focussing on the problems at the MRC. I think that it could be useful for us to focus more on these sorts of institutional problems, but I don't know how - who watches the watchmen? If we could get more political involvement that could be useful. I don't know how many MPs would feel comfortable challenging the UK medical Establishment.
It could be worth responding to, but think it would be best to do so with specifics, and it's difficult to do that in a concise letter. Could try to quote from the tribunal ruling "activist behaviour was, in our view, grossly exaggerated and the only actual evidence was that an individual at a seminar had heckled Professor Chalder." Could cite the SMC meeting where they list very weak examples of 'harassment'? Could quote some of the prejudice claims that have been made about the motivations of those criticising PACE. There are things that could be done, but it's difficult to address this precisely and concisely. I'd worry that we cannot know something like 'no examples of hostility to the researchers could be given', and it provides justification for researchers to provide hearsay testimony about hostility that will distract from the problems with PACE as a piece of research.
I liked the final point focussing on the problems at the MRC. I think that it could be useful for us to focus more on these sorts of institutional problems, but I don't know how - who watches the watchmen? If we could get more political involvement that could be useful. I don't know how many MPs would feel comfortable challenging the UK medical Establishment.
It could be worth responding to, but think it would be best to do so with specifics, and it's difficult to do that in a concise letter. Could try to quote from the tribunal ruling "activist behaviour was, in our view, grossly exaggerated and the only actual evidence was that an individual at a seminar had heckled Professor Chalder." Could cite the SMC meeting where they list very weak examples of 'harassment'? Could quote some of the prejudice claims that have been made about the motivations of those criticising PACE. There are things that could be done, but it's difficult to address this precisely and concisely. I'd worry that we cannot know something like 'no examples of hostility to the researchers could be given', and it provides justification for researchers to provide hearsay testimony about hostility that will distract from the problems with PACE as a piece of research.
Robert 1973
Senior Member (Voting Rights)
Need to be careful here. The FTT found the allegation of threats from activists to be unsubstantiated. However, I think it may be accurate to suggest that PACE researchers have been subject to “hostility” (ie opposition).
From the OED:
Letters to the Editor of the Times should be sent to letters@thetimes.co.uk
Best to keep them under 250 words.
Must include full postal address and tel no.
@dave30th Again I wonder if this provides an opportunity for you to get a short multi-signatory letter published in response. I realise that you decided against this beofre but I wonder if Prof Watt’s letter may prompt you to reconsider.
@Jonathan Edwards I’ve attached the actual final letter you sent to Watt. I don’t know if an admin can swap it with the earlier draft you posted before. (Pleased to see I’m not the only one who labels files as “final” before they are finalised!)
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Jonathan Edwards
Senior Member (Voting Rights)
But the reason why she is in the position she is is that she is expected to understand good experimental design and on that basis to be able to recognise and reject lobbying on behalf of the unbackable. She can only reject such lobbying if she herself understands the problem. Otherwise she is just relying on someone else's opinion.
I think it may be a mistake to regard Watt as a civil servant or a mouthpiece. She is a scientist, amongst a group of scientists, who, as a group called the MRC, are given free rein to self-police. She is expressing her opinion as a scientist representing a group. Which is all the more worrying because this is not just a bureaucrat trying to stop the boat rocking.
Jonathan Edwards
Senior Member (Voting Rights)
Yes but the version sent off is always the finalfinalfinal version.
TiredSam
Committee Member
Fortunately for us part of the BPS cult ideology involves believing that it's better to do something, even if it's harmful, than do nothing, so from Fiona Watt's viewpoint jumping onto the good ship PACE to drill a few more holes in the side as it goes down probably looks like a winning strategy.
Another one flushed out of the woodwork to lay their cards on the table and make a complete fool of themselves. It's progress. The only strategy they know is to close ranks, repeat the lies, and hope that there's safety in numbers and their position. Like the PACE authors on twitter before her, every time she opens her mouth from now on it's likely to be to our advantage. I reckon if they ran a "shooting yourself in the foot" trial they could probably get a positive result and a write-up in the Lancet, but it doesn't mean it's an effective strategy. Not that they'll listen to anyone who tries to tell them otherwise, of course.
Another one flushed out of the woodwork to lay their cards on the table and make a complete fool of themselves. It's progress. The only strategy they know is to close ranks, repeat the lies, and hope that there's safety in numbers and their position. Like the PACE authors on twitter before her, every time she opens her mouth from now on it's likely to be to our advantage. I reckon if they ran a "shooting yourself in the foot" trial they could probably get a positive result and a write-up in the Lancet, but it doesn't mean it's an effective strategy. Not that they'll listen to anyone who tries to tell them otherwise, of course.
I take it as she is not interested in trying. For example, you wrote to her and it seems like she just dismissed your letter without thought and certainly not looking or trying to understand the issues. This says to me that she has an eye on the politics and lobbying rather than understanding the scientific arguments. For her to be in a position to understand the scientific arguments she would have to do the work to look the work, read it and make an assessment of it but it doesn't appear that she has done this rather she has come out with the same line as before (I suspect having passed it back to Francis Rawle who previously dismissed complaints).
By a civil servant I don't mean a mouthpiece or a non-scientist (I've come across many good scientists in the civil service). But I mean she has a responsibility to ensure good governance, good practice and ethics for the group she runs. She should not have free reign but needs to uphold certain standards. When she expresses this opinion she is doing so on behalf of the government and saying something about government research policy and governance (that follows from her role).
I think if she were working for a company serious questions would be asked.
If you edit a message then you should be able to change the file that was uploaded,
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Sly Saint
Senior Member (Voting Rights)
I have been trying to find MRCs guidelines for RCTs involving treatments other than drugs; all it appears to say is that "these guidelines may be helpful " to those conducting non drug trials.
(NB these appear to have been 'updated' in 2004 to align with EU regulations).
But one publication I found from the same time highlights some of the pitfalls:
"In a recent observational study, Schulz et al showed that in trials in which allocation was not concealed, estimates of treatment effect were exaggerated by about 41% compared with those that reported adequate allocation concealment.13"
"Although an RCT should, in theory, eliminate selection bias, there are instances where bias can occur.15 You should not assume that a trial methodology is valid merely because it is stated to be an RCT. Any selection bias in an RCT invalidates the study design and makes the results no more reliable than an observational study. As Torgesson and Roberts have suggested, the results of a supposed RCT which has had its randomisation compromised by, say, poor allocation concealment may be more damaging than an explicitly unrandomised study, as bias in the latter is acknowledged and the statistical analysis and subsequent interpretation might have taken this into account.14"
"
Blinding
There is always a risk in clinical trials that perceptions about the advantages of one treatment over another might influence outcomes, leading to biased results. This is particularly important when subjective outcome measures are being used. Patients who are aware that they are receiving what they believe to be an expensive new treatment may report being better than they really are. The judgement of a doctor who expects a particular treatment to be more effective than another may be clouded in favour of what he perceives to be the more effective treatment. When people analysing data know which treatment group was which, there can be the tendency to “overanalyse” the data for any minor differences that would support one treatment."
"
CONCLUSIONS
An RCT is the most rigorous scientific method for evaluating the effectiveness of health care interventions. However, bias could arise when there are flaws in the design and management of a trial. It is important for people reading medical reports to develop the skills for critically appraising RCTs, including the ability to assess the validity of trial methodology, the magnitude and precision of the treatment effect, and the applicability of results."
https://adc.bmj.com/content/90/8/840#ref-6
this was all known at the time; clearly some people didn't 'get the memo'.
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I agree we shouldn't overstate, but I don't think we should be overcautious either. The reanalysis didn't find any evidence. The CDC and FDA say there are no treatments. The NIH and American healthcare guidelines both reject all research based on Oxford and PACE played no role in the IOM report.
How about then:
Sir,
We are surprised by Professor Watt's wholehearted and inaccurate defence of the PACE trial.
Questions have been raised about the independence of both the trial steering committee and the peer-review, and the speed with which the main paper was fast-tracked by The Lancet. The small trials that have found similar results to PACE repeated its major flaws.
When data from the trial have been reanalysed, no evidence has been found for the claims the interventions are effective. The trial findings have been rejected by every major institution in the USA, scientists and statisticians from around the world and in debate in Parliament. A number of universities now use it as an example of how not to conduct research.
Justified criticism of a flawed and poorly conducted trial should not be confused with hostility to the researchers.
There are many questions raised by this massive failure, not least about the MRC's own role in the trial and the competence of its system of peer-review.
Edits:
Added 'and poorly conducted' so 'flawed and poorly conducted trial'.
Deleted 'a' in 'conduct a research'.
Sir,
We are surprised by Professor Watt's wholehearted and inaccurate defence of the PACE trial.
Questions have been raised about the independence of both the trial steering committee and the peer-review, and the speed with which the main paper was fast-tracked by The Lancet. The small trials that have found similar results to PACE repeated its major flaws.
When data from the trial have been reanalysed, no evidence has been found for the claims the interventions are effective. The trial findings have been rejected by every major institution in the USA, scientists and statisticians from around the world and in debate in Parliament. A number of universities now use it as an example of how not to conduct research.
Justified criticism of a flawed and poorly conducted trial should not be confused with hostility to the researchers.
There are many questions raised by this massive failure, not least about the MRC's own role in the trial and the competence of its system of peer-review.
Edits:
Added 'and poorly conducted' so 'flawed and poorly conducted trial'.
Deleted 'a' in 'conduct a research'.
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MeSci
Senior Member (Voting Rights)
Is it quite right to say this?
I addressed this above:
The CDC and FDA say there are no treatments. The NIH and American healthcare guidelines both reject all research based on Oxford and PACE played no role in the IOM report.
Maybe clarify by saying ever major national institution
Daisymay
Senior Member (Voting Rights)
Yes and it's not just the PI's, see this from Magical Medicine, pp 294/295
http://www.margaretwilliams.me/2010/magical-medicine_hooper_feb2010.pdf
Professor Tom Sensky - Member of PACE Trial Steering Committee
Professor Sensky from the Division of Neurosciences and Mental Health, Imperial College, London is, like Simon Wessely, a liaison psychiatrist and he practices cognitive behavioural therapy.
At the launch of The Psychological Medicine Network (established to “facilitate knowledge and information sharing among staff providing psychiatric and psychological care for medical patients in London”, whose aim is “to identify and unify those working in psychological medicine in London in order to create better networking opportunities between individuals and services” and to “disseminate examples of good practice”) 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?
Esther12
Senior Member (Voting Rights)
"Justified criticism of a flawed trial should not be confused with hostility to the researchers." - I think that's a really good response to the 'hostility' line.
I tend to be rather cautious - if we get understated criticisms acknowledged, that will be enough to bring PACE down, so there's no need to risk any over-stating imo.
The reanalysis did find that CBT and GET led to significant improvements for the trial's primary outcomes, but that these differences were not significant after accounting for multiple comparisons using the Bonferroni method. To me, along with problems of relying on subjective self-report outcomes, etc, this means that there's no good evidence to support claims of efficacy, but 'no evidence has been found for the claims the interventions are effective' seems too strong, especially when Cochrane have still got their flawed reviews out.
To claim that major US institutions had rejected that PACE trial's findings, I think that I'd want to be able to point to quotes from them saying something like "we reject the PACE trial's findings". How about "The Centre for Disease control has now removed reference to the PACE researchers' work"?
QMUL had previously touted this:
http://impact.ref.ac.uk/CaseStudies/CaseStudy.aspx?Id=18135
I tend to be rather cautious - if we get understated criticisms acknowledged, that will be enough to bring PACE down, so there's no need to risk any over-stating imo.
The reanalysis did find that CBT and GET led to significant improvements for the trial's primary outcomes, but that these differences were not significant after accounting for multiple comparisons using the Bonferroni method. To me, along with problems of relying on subjective self-report outcomes, etc, this means that there's no good evidence to support claims of efficacy, but 'no evidence has been found for the claims the interventions are effective' seems too strong, especially when Cochrane have still got their flawed reviews out.
To claim that major US institutions had rejected that PACE trial's findings, I think that I'd want to be able to point to quotes from them saying something like "we reject the PACE trial's findings". How about "The Centre for Disease control has now removed reference to the PACE researchers' work"?
QMUL had previously touted this:
http://impact.ref.ac.uk/CaseStudies/CaseStudy.aspx?Id=18135
Peter T
Senior Member (Voting Rights)
Typo, should read 'how not to conduct a research trial' or 'how not to conduct research'.
Daisymay
Senior Member (Voting Rights)
Or that they feel so secure in their ability to maintain the status quo from their positions of power and influence they think they can still just ride it all out.
But they won't succeed, ultimately research is progressing, eyes are being opened, and all the MRC has done with this response is dig themselves into an ever deeper pit.