Statements on conflict of interest of PACE trial TSC

Interested in where the protocols covering definition of Conflict of Interest in medical research are. I may be very dense, but haven’t seen this in all the info on this thread and elsewhere.

Is there an ‘industry’ definition, laid down by professional, ethical or regulatory body?

Are there different definitions applicable to different types of research eg drugs vs procedures vs therapies?

Or does each journal set their own definition?

Or just a convention that can be narrowly or broadly defined as felt appropriate - and who decides whether views or narrow criteria apply?

Ie to what objective standard(s) is/are the PACE Trial authors, investigators and therapists accountable?
 
RuthT said:
Interested in where the protocols covering definition of Conflict of Interest in medical research are. I may be very dense, but haven’t seen this in all the info on this thread and elsewhere.

Is there an ‘industry’ definition, laid down by professional, ethical or regulatory body?

Are there different definitions applicable to different types of research eg drugs vs procedures vs therapies?

Or does each journal set their own definition?

Or just a convention that can be narrowly or broadly defined as felt appropriate - and who decides whether views or narrow criteria apply?

Ie to what objective standard(s) is/are the PACE Trial authors, investigators and therapists accountable?
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There is none as such. They did have to follow MRC best practice (which I would argue they did not). They also agreed to abide by the Helsinki Declaration (which they didn't, as they didn't tell the patients about their COIs). Each journal where they published (check out the thread on the TMG COI statements for what they told The Lancet) will have its own.
 
COI is a very, very grey area. When I worked at The Lancet, CoI was considered if you'd received any payment by Big Pharma. But I realised how problematic this is when I worked in research, because often drugs companies will pay for you to attend conferences, will pay for you to eat while at the conference, and will sponsor the talks you want to attend. And they all pile in, so there is no perceived favouritism. And the work I did had nothing to do with the medications anyway, so what did it matter.

And I guess for these guys it's the same. They don't see that they are being influenced as such by taking money or working "for free" for insurance companies and the like. They already hold the views they hold. They are simply advising others. And all of this is already in the public domain anyway, etc, etc. There is no conflict; those companies interests are their interests; so why declare it?
 
RuthT said:
Interested in where the protocols covering definition of Conflict of Interest in medical research are. I may be very dense, but haven’t seen this in all the info on this thread and elsewhere.

Is there an ‘industry’ definition, laid down by professional, ethical or regulatory body?

Are there different definitions applicable to different types of research eg drugs vs procedures vs therapies?

Or does each journal set their own definition?

Or just a convention that can be narrowly or broadly defined as felt appropriate - and who decides whether views or narrow criteria apply?

Ie to what objective standard(s) is/are the PACE Trial authors, investigators and therapists accountable?
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As far as doctors conducting research, the GMC Good Practice in Research guidance:

https://www.gmc-uk.org/guidance/ethical_guidance/6006.asp

'Avoiding conflicts of interest

26. You must be open and honest in all financial and commercial matters relating to your research and its funding.

27. You must not allow your judgement about a research project to be influenced, or be seen to be influenced, at any stage, by financial, personal, political or other external interests. You must identify any actual or potential conflicts of interest that arise, and declare them as soon as possible to the research ethics committee, other appropriate bodies, and the participants, in line with the policy of your employing or contracting body.'

'Doctors must follow all our guidance: serious or persistent failure to do so will put their registration at risk.'

At time of publication in 2011, Professors Sharpe and White were honorary consultants in liaison psychiatry within different NHS trusts.

Edited for accuracy: Professor White remains on GMC register: Registered with a licence to practise; this doctor is on the Specialist Register. His surname is listed as Denton White.
 
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Lucibee said:
COI is a very, very grey area. When I worked at The Lancet, CoI was considered if you'd received any payment by Big Pharma. But I realised how problematic this is when I worked in research, because often drugs companies will pay for you to attend conferences, will pay for you to eat while at the conference, and will sponsor the talks you want to attend. And they all pile in, so there is no perceived favouritism. And the work I did had nothing to do with the medications anyway, so what did it matter.

And I guess for these guys it's the same. They don't see that they are being influenced as such by taking money or working "for free" for insurance companies and the like. They already hold the views they hold. They are simply advising others. And all of this is already in the public domain anyway, etc, etc. There is no conflict; those companies interests are their interests; so why declare it?
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That's very interesting. And I think you're right that they weren't doing it for the money and couldn't (can't?) see the genuine conflict.

I also think that the biggest COI for them was not financial but reputational. They are closely associated with this approach and their narrative of their careers is dependent upon it. It's already looking pretty bad for them, but if say NICE drop CBT-GET then in 5 years' time the biology of ME is understood and, eventually, 3 years after that The Lancet, under a new editor, retracts the 2011 paper, followed by retraction of all their other post-trial papers, then they know they'll be an academic laughing stock, viewed as acupuncturists. Their careers will be in shreds.
 
I remember that round about the time of the PACE trial starting people were complaining that PW (and maybe others) listed COIs in US medical journals which had strict rules but was happy to say no conflicts in UK ones. Can't remember details though, maybe someone else can. It implies that he knew what he was doing just getting away with as much as possible.
 
Mithriel said:
I remember that round about the time of the PACE trial starting people were complaining that PW (and maybe others) listed COIs in US medical journals which had strict rules but was happy to say no conflicts in UK ones. Can't remember details though, maybe someone else can. It implies that he knew what he was doing just getting away with as much as possible.
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Interesting.
 
White said this in an email from Co-Cure (will try and find the date but circa May 2004)

"
3. It is wrong that the psychiatrists carrying out this research are
themselves employed to provide the therapies being studied at the newly
operational ME/CFS centres. It is unethical for people with proven
commercial interests in these studies to be designing and running this
£2.5m trial, given the proven evidence of their commercial interest in the
desired outcome.

The actual position: None of the psychiatrists are employed to provide any
of these therapies. No researcher will make any personal financial gain
from these trials.

....

Dr Peter White
Professor Michael Sharpe
Professor Trudie Chalder
Dr Alison Wearden

"
 
ukxmrv said:
White said this in an email from Co-Cure (will try and find the date but circa May 2004)

"
3. It is wrong that the psychiatrists carrying out this research are
themselves employed to provide the therapies being studied at the newly
operational ME/CFS centres. It is unethical for people with proven
commercial interests in these studies to be designing and running this
£2.5m trial, given the proven evidence of their commercial interest in the
desired outcome.

The actual position: None of the psychiatrists are employed to provide any
of these therapies. No researcher will make any personal financial gain
from these trials.

....

Dr Peter White
Professor Michael Sharpe
Professor Trudie Chalder
Dr Alison Wearden

"
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I think both White and Wearden got their chairs after PACE and FINE and I assume they formed a big part of the case. But career progression doesn't seem to be a CoI. I wonder if the pressure to run a big trial and show positive results is a CoI for academics looking for promotions. Has anyone ever got a chair for running a trial with null results?
 
Sly Saint said:
Again it would be interesting to see what levels of funding the authors received for subsequent trials which might not have happened had it not been for PACEs 'success'.........TC certainly seems to have done very nicely in terms of her CBT treatments.
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Trudie Chalder has built her career around CBT for CFS, now expanded to researching CBT for other 'MUS' and CFS in children. I would think her role as a PI on PACE was instrumental in her getting that professorship, and PACE being debunked would and should lead to all her other research coming into question and her losing that status and position. She has a lot riding on it.

I note that her entire career in CBT/CFS has been at Kings, which is Wessely's fiefdom. I can't help seeing her as his mouthpiece. Especially as he is a psychiatrist, and she is a nurse turned therapist.

https://www.national.slam.nhs.uk/about-us/our-experts/trudiechalder/

Director, Chronic Fatigue Service |Professor
Professor Chalder is the director of the Chronic Fatigue Service as well as a professor of cognitive behavioural psychotherapy with the Department of Psychological Medicine, at the Institute of Psychiatry, King’s College London.

Other roles
Professor Chalder gives national and international lectures on CFS. She has been closely involved in developing and evaluating treatments for adolescents and adults with CFS. These studies have contributed to recommendations made in the NICE guidelines.
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Sly Saint said:
Again it would be interesting to see what levels of funding the authors received for subsequent trials which might not have happened had it not been for PACEs 'success'.........TC certainly seems to have done very nicely in terms of her CBT treatments.
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So none of them actually get research funding in that it goes to the institutions they work for. But they get career advancement, pay rises and possible pay (or someone to do their lecturing duties) from the research funding.

I do wonder if the institutions backing these trials should also declare conflict of interests as they are responsible for governance but have an interest in reporting success in terms of the REF (research excellence framework) as we saw from REF2014 in terms of PACE. They also have an income stream for running treatments through associated hospitals. And they are legal entities.

If for example QMUL were not to investigate issued raised about PACE (and fund a legal defense to block others looking) because Barts offers such treatments and because they used PACE to get a good REF assessment leading to better funding then this is a real conflict of interest.
 
A minor point but I imagine sales of Chalders book “are pretty much exclusively driven by the fact the “CFS/ME” clinics have it at the top of a very short list of suggested further reading at the end of their patient manual for group programmes. It’s called “Overcoming Chronic Fatigue” which sums up the problem right there......... read the reviews on Amazon and a lot of people giving it positive reviews are doing so because of these clinics
 
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