UK Health Research Authority defends PACE. Answer to MP's question, February 2019.

NelliePledge said:
Agreed and I guess if we say the AFME and MEA surveys are evdence of harm it’s difficult to then say there isn’t evidence that some people consider GET/CBT helped them.
Click to expand...

I think there is a difference: people say they feel better for all sorts of reasons. It doesn't mean that the treatment has been effective.

On the other hand, even if these interventions only make people feel worse without any change in the underlying condition, then that is enough for them to be considered as harmful.

Something which is often not considered with these trials is that for someone who is ill even a small harm can have a massive impact on quality of life.
 
NelliePledge said:
Agreed and I guess if we say the AFME and MEA surveys are evdence of harm it’s difficult to then say there isn’t evidence that some people consider GET/CBT helped them.
Click to expand...

No one is claiming the surveys are scientific proofs of moderate harm for some people etc unlike in the case wherby AfME are claiming that PACE is a scientific claim of moderate benefit for some.
 
Esther12 said:
BMJ coverage (from Nigel Hawkes and predictably terrible): https://www.bmj.com/content/364/bmj.l639

http://sci-hub.tw/https://www.bmj.com/content/364/bmj.l639

"Whenever the arguments raised are answered, they spring upanew elsewhere. In recent years US activists have discoveredPACE and have repeated all the same arguments originally putin the UK, while ignoring or discounting the answers provided."

David Tuller is now "A US activist".
Click to expand...
A good thing about the BMJ is that they post most if not nearly all e-letters.
 
Lucibee said:
Part of the problem is the lack of evidence about the potential risks - but that's because the researchers know that once they go down that road, that will be the end of their research. It's a case of, if we don't record it, no-one will know. And of course, if you are aware of the risks, you wouldn't be able to do such a study without it being unethical.

But another problem was the lack of any kind of piloting of the measures and interventions they were going to use. Had they done so properly, they wouldn't have run into the issues they did with actigraphy and the step test. None of the intervention arms were properly piloted or tested - they seemed to be fire-fighting as they went along. But of course, this is after they had received ethics approval.
Click to expand...

My point was not one about harm but that the protocol wasn't good enough to give any solid results because the relied too heavily on subjective measures. If the results from an experiment aren't able to judge the hypothesis then there is no point in doing the experiment. In this case where human subjects are involved it is not just a case of money and time spent doing the experiment but that the experiment is on human subjects (with potential associated risk).

Thus it seems to me the HRA should consider the validity of the protocol and its ability to produce meaningful results in assessing the ethical situation. But I think they just ask has a protocol been written.
 
I agree, @JohnTheJack, @Jonathan Edwards, and @Strategist, people will say they've gotten better from all sorts of treatments.

Some time ago I met a person who very enthusiastically claimed super blue green algae cured their ME. I didn't buy this product. Many months later I saw this pwME and they were still very ill, and not touting this "miracle" supplement.

About subjective evidence - either it's reliable, or it's not. It's both ways right now - whatever suits the researchers, authorities, powers that be.

A man died in an ER waiting room after more than a 24 hour wait - others' reports
he was very ill were ignored partly because "the public is not a reliable source of information".

Some possible pwME, and some with who knows what, go through a muddled psych trial. Some say they got better, and these subjects' word is gold-plated.

Odd, how those who say they got better are believed by the BPSites, and those who say they got worse are disbelieved.

One is only believed and praised if one confirms the argument. A natural course of events in human interaction. However, in science there is supposed to be a bit more objectivity. How naive of me to say!

I understand from this thread AfME did a patient survey. What case definition did the respondents meet? If they qualified for the PACE trial which used broad criteria, doing a post study survey interviewing these same people is going to give inappropriate results on which to base treatments for pwME. If someone said they got better participating in GET, it is extremely doubtful they have ME.
 
Last edited:
In the trial, the GET arm were assured that the treatment was completely safe and that there would be no underlying harm done even if they felt worse. What was the evidence that this was the case? If that evidence was not robust then people were brought into the trial under false pretences. Before they could ethically make such a statement there would have to be trials which looked seriously for any harms but found no bad effects whatsoever.

Did the ethics committees see such research? Did they not feel that there was a conflict with the stated aim of the PACE trial to investigate whether there were harms from any of the treatments being considered?

This looks like the opposite of the stated aims of ethical approval, but then I am just a patient not a highly paid academic.
 
There is this study, which IMO is not cited enough.

I know it's only one study, but it showed GET and CBT were "not superior to usual treatment [exercise counselling and pharmacological treatment] at 12 months in terms of HRQL", and indicated "worse SF-36 physical function and bodily pain scores in the intervention [GET/CBT/pharmacological] group."



Clin Rheumatol. 2011 Mar;30(3):381-9. doi: 10.1007/s10067-010-1677-y. Epub 2011 Jan 15.
Health-related quality of life in patients with chronic fatigue syndrome: group cognitive behavioural therapy and graded exercise versus usual treatment. A randomised controlled trial with 1 year of follow-up.
Núñez M1, Fernández-Solà J, Nuñez E, Fernández-Huerta JM, Godás-Sieso T, Gomez-Gil E.
Author information

Abstract
Chronic fatigue syndrome (CFS) produces physical and neurocognitive disability that significantly affects health-related quality of life (HRQL). Multidisciplinary treatment combining graded exercise therapy (GET) cognitive behavioural therapy (CBT) and pharmacological treatment has shown only short-term improvements. To compare the effects on HRQL of (1) multidisciplinary treatment combining CBT, GET, and pharmacological treatment, and (2) usual treatment (exercise counselling and pharmacological treatment) at 12 months of follow-up. Prospective, randomized controlled trial with a follow-up of 12 months after the end of treatment. Patients consecutively diagnosed with CFS (Fukuda criteria) were randomly assigned to intervention (n = 60) or usual treatment (n = 60) groups. HRQL was assessed at baseline and 12 months by the Medical Outcomes Study Short-Form questionnaire (SF-36). Secondary outcomes included functional capacity for activities of daily living measured by the Stanford Health Assessment Questionnaire (HAQ) and comorbidities. At baseline, the two groups were similar, except for lower SF-36 emotional role scores in the intervention group. At 12 months, the intervention did not improve HRQL scores, with worse SF-36 physical function and bodily pain scores in the intervention group. Multidisciplinary treatment was not superior to usual treatment at 12 months in terms of HRQL. The possible benefits of GET as part of multidisciplinary treatment for CFS should be assessed on an individual patient basis.

https://www.ncbi.nlm.nih.gov/pubmed/21234629
 
Jonathan Edwards said:
But there is an important asymmetry. It is not difficult to say there isn't evidence that GET/CBT helped them.

The issue of harm is subtle. It is that there are only two consistent views to hold.

1. What patients say in terms of considering they are better or worse is unreliable.
In which case there is no evidence CBT and GET are effective.
2. What patients say in terms of considering they are better or worse should be taken seriously.
In which case we have to assume GET is unsafe.

Which view are the proponents of these treatments advising we take?
Click to expand...

That the harms do exist but these are due to patients being not being given the "appropriate advice and therapeutic support”.

So it's fine and beneficial if done in the "right" way and in the "right place".

This was alluded to in a BMJ paper by White, Moss, Armstrong (AFME) Spencer (another AFME CEO not Clarke who collaborated with PACE!) and it could be this one but I can't find the whole paper to double check

https://www.bmj.com/content/335/7617/411
 
NHS Health Research Authority:
"It is not clear what ‘personal gain’ the investigators stood to make from the trial and, in particular, it is not clear how any remuneration they received from advisory roles would have been different depending on the outcome of the trial."
Click to expand...
Click to expand...
I decided to respond to this. As the piece is not short, I gave it a separate thread here:

How payments from insurance companies might potentially bias proponents of CBT and/or GET for ME/CFS (such as the PACE Trial investigators)
https://www.s4me.info/threads/how-p...fs-such-as-the-pace-trial-investigators.8066/
 
Mithriel said:
In the trial, the GET arm were assured that the treatment was completely safe and that there would be no underlying harm done even if they felt worse. What was the evidence that this was the case?
Click to expand...
Quite so.
Lancet 2011 PACE paper said:
Graded exercise therapy (GET)
GET was done on the basis of deconditioning and exercise intolerance theories of chronic fatigue syndrome. These theories assume that the syndrome is perpetuated by reversible physiological changes of deconditioning and avoidance of activity.
Click to expand...
[My bold]
  • This clearly shows that the treatment was applied on the presumption of a disease mechanism that the paper itself concedes to be unproven.
  • It should be fundamental to good science that if the disease mechanism is unproven, that the treatments are being applied on the basis of, then the trial safety methodology should incorporate the possibility that the presumption is invalid.
  • If the disease mechanism is unproven, then surely there have to be special safeguards against the possibility of a treatment causing harm, especially the possibility that some more serious harms may be delayed until some time after the treatment session.
  • Given the unknowns, and the need to err on the safe side (literally), any symptoms that might be indications of harm must not be ignored, because the knowledge does not exist to safely presume otherwise.
  • The body's own warning signals would seem to be prime candidates as safety indicators in such a situation, because they may be all the warning you are going to get; hopefully in sufficient time, though by no means guaranteed. Ignore this at the patient's peril!
  • To not only ignore these symptoms, but to actively coerce dismissal of them, seems the height of irresponsibility.
  • But if you have complete faith that your presumptions are valid, and there is no need for you (or anyone else - how dare they!) to question that, then ... who needs science :rolleyes:.
 
Last edited:
Not read full thread, so forgive if repetition, but... now we know the reason for the eerie silence from the BPS brigade after their mauling in the House of Commons ME/CFS debate: they already knew the outcome of the HRA review, weeks before it was even published. Nothing sinister about that, old chap.
 
How pension & insurance companies use GET & CBT trial data to reduce payments a

From a Patient: To Invest in ME
http://investinme.org/Documents/Fac...ception of Myalgic Encephalomyelitis 2018.pdf

“I have had M.E. for almost four years and am quite severely affected. I am housebound most of the time and often bedbound.
I was previously a 'high flyer' (my neurologists' words) and a civil servant with a social work background.
Due to my illness I am no longer able to work, and have just been through the very painful process of applying for ill health retirement.My pension provider (through the (name provided) pension scheme) has a two tier system for pension awards in the circumstance of ill health retirement. I have undergone five medical assessments during the process and have been assessed as permanently incapacitated in terms of employment. However, as I have not completed the treatment, as recommended in the NICE guidelines, I cannot obtain the higher rate pension. The treatment namely being CBT and GET. I have engaged with the specialist M.E. service in (location provided) but was unable to continue as attending sessions made me more unwell. I tried CBT through my local mental health service, attending three out of six sessions, this made me more unwell and put me back into bed for weeks. I am in receipt of the highest rate of both ESA and PIPS. These were both awarded following the first medical assessment, which I understand is not the position for far too many M.E. sufferers. I have taken my ill health retirement case to appeal within my pension service. The position of the original decision not to award me the higher rate pension has been upheld on the grounds that I have not completed CBT and GET. My pension provider will now escalate my appeal to stage two of the process. However, the decision makes it clear that, in order to succeed, I need to prove that I have completed CBT and GET.
I am faced with a position that is unfair and takes away any right I have not to undergo treatment that exacerbates my illness.
I have had support from my union (name provided), however they aren't familiar with the fight that M.E. suffers like myself face.
I have previously had a life where i travelled up and down the country for my career, helping to make a difference in the lives of vulnerable children.
I had authority and was very much a professional.
I have always worked within the public sector, both local and central government. I had a lively social life, always on the go with my partner and family.
Now my life revolves around my bedroom. I rely on pillows, blackout curtains and strong medication to try and control my pain. If I journey out, it is to visit my G.P. which takes around three hours to get me ready for, with lots and lots of assistance from my wife, who is also my carer and carer to our 18 year old disabled son.
I often find it difficult to construct challenges around my illness as I simply can't find the words due to my diminished cognitive functioning.
This is one of the hardest symptoms to deal with. The loss of intellect.
It's in there somewhere, I'm in there somewhere, but I just can't get the words to make sense.
It is imperative that someone listens to our voices and I am so thankful for your determination in challenging the medical profession around our treatment options.
It will probably be too late to make any difference to my case.
I hope that in the future no one will be penalised for not undergoing treatment that is harmful to their health as a result of your campaigning; that CBT and GET will be removed from the guidelines with immediate effect, rather than waiting for years while the guidelines are revised.
Please please continue the fight for those of us struggling to do it for ourselves."
daftasabrush said:
It should be simple for Action for ME confirm or deny involvement with the ongoing FITNET-NHS - they need to be put on the spot about that since without the involvement of any ME charity the steering group is affected.
Click to expand...
 
Just 6 months between the main PACE publication and Bavinton her Vitality 360 GET company.

Maybe the HRA would claim it's not a conflict since she we don't know how much she earns? JB of course was on the NICE guidelines committee recommending GET before the PACE trial was published. And possibly during the early PACE trial recruitment

Info from MEpedia

Jessica Bavinton has one total current appointment. She is a director of and the sole shareholder of Vitality 360 Ltd . It was incorporated as a company on 9 November 2011 after the publication of the PACE trial on 5 March 2011.
 
You must log in or register to reply here.
Back
Top Bottom