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

This link requires me to do more stuff to my computer than I'm happy doing. And to make an account with mediafire. I'm not happy to use it.

 

It's also here:
https://www.s4me.info/docs/PACEProtocolSearchable.pdf

 

Thanks ever so much Tom!

 

It’s quite easy to say people who’ve left made mistakes. Sonya joined AFME just after the 2011 MRC one off grant and did nothing to build on her predecessors call for the MRC to give continued ring fencing until the field was more established, so she didn’t do enough to get biological research funds either. Her predecessor did similar “collaborate with Holgate & the MRC stuff” on groups & workshops etc she is doing so they haven’t really moved ON, they just stopped supporting GET stuff but She was also happy enough with a CMRC, deputy chaired by behaviour focused Esther Crawley which achieved nothing. Also, despite claiming detachment when needed, there can’t be doubt of the connection between ayme and AFME who I think called each other sister charities and i think held Joint conferences and who had some sort of deal to merge, Ayme have helped the BPs side. Finally Sonya kept Alastair miller as medical advisor on for a while when he was a great GET PACE champion, not particularly biomedical research and promotes rubbish such as there’s been extensive research into ME which is falsehood imo.

 

https://twitter.com/user/status/1093461551426797568


https://twitter.com/user/status/1093470737220935680

 

I'm happy to post this or other responses if it seems they're not getting posted at BMJ. Also the story has been tweaked to add my academic credential and also a sentence about academics also being concerned, with a link to BMJ's own coverage of last summer's open letter to Lancet. However, I am still "a US activist" first. I am a public health advocate for my position just as the CBT/GET ideological brigades are medical or public health advocates for theirs. To continue to use this phrase--which would be unoffensive in other contexts--is offensive here and demonstrate BMJ's biases.

 

The exact same response we get every time someone asks to provide examples of harassment.

 

https://twitter.com/user/status/1095017211448696839

https://twitter.com/user/status/1095017705227325440

 

Is there any reason for the xrays of knives or is that an attempt to suggest violent extremists are a thing in PACE debates?

 

It looks like it spells out "knife crime and hospitals" so I'm guessing refers to another article in the edition.

 

Seems to have picked up the front page image used, I'm guessing, for the latest edition

 

I think they don’t really mind which of the two ‘treatments’ is used, as, in many ways, (when it comes to ME/CFS) they view them as one and the same. What matters to them is that the patient is undertaking one or the other forms of active rehabilitation.

There is a two way relationship between cognitions and behaviour, it works in both directions. So you can manipulate either to get the same outcome. CBT to change cognitions, or GET to change behaviour directly. In the case of GET, the quacks believe if they make the patient exercise more they will realise they’re not all that ill after all and change the way they think.

What both strategies agree upon is that the patient has false illness beliefs and needs to be told what to do.

 

I think this is really important. Is anyone working on it? @dave30th?

If not, I think we need to try to do this.

The other thing I’m wondering is whether we have a right to see the evidence upon which the HRA based its assessment. (Note that it is not described as an inquiry or an investigation. The letter just states that the HRA “has examined the study” and made an “assessment”.) It would be interesting to know whether any evidence was sought from those who have raised concerns. It appears to me as though the PACE authors and/or their defenders may have been consulted but not those who have challenged them. If that were so, it would be a like a judge delivering a verdict without hearing the case for the prosecution.

Does anyone know if anyone critical of PACE was consulted?

 

That would be great thank you.

But I still haven't received confirmation that my submission was rejected.

I find it a bit weird that it hasn't been accepted because the BMJ rapid response section used to publish practically every response as far as i can tell.

Are there others who've submitted a response to this BMJ article without it being published online?

 

That's more or less what I expect to have happened...

 

Do we know what information participants were given before they gave their consent? Were they given details about all the treatments, and the theoretical models they were based on, before giving their consent? If so, presumably it would have been clear that the theories behind CBT and APT were mutually exclusive and that there could therefore be no certainty about the validity of either. Or was consent given after they were assigned to a treatment arm?

Could it ever be ethical to test a medical intervention which required the therapist to mislead participants about the evidence upon which the intervention is based? Notwithstanding the fact that it would invalidate the experiment by priming participants to doubt the validity of what they are being told, could such a trail be deemed ethical if its participants were informed (prior to giving consent) that they may be presented with information about their illness and the treatments which is not supported by reliable evidence and may therefore be untrue?

I presume there is no ethical problem with psychology experiments which involve participants being lied to as part of the experiment, but in those cases I assume that it would be necessary to inform the participants of the deceit in the debriefing at the end of the experiment, which would not be possible in a trial of CBT, as the deceit has to be maintained. And of course, there is a big difference between a psychology experiment involving healthy volunteers and a medical trial.

I’m trying to better understand the point that Jo is making. Is it analogous to a trial in which some participants are: 1) falsely informed that the drug is known to be safe, despite a lack of reliable evidence to support this view; 2) presented with an unsubstantiated theories (falsely presented as scientific knowledge) about the mechanisms of the disease and how the drug will interact with those mechanisms in order to effect recovery; 3) told that in order for the drug to be effective the patient must understand and believe what they have been told? Could such a trial ever get ethical approval?

I’m guessing that lying to patients in this way would be considered unethical, regardless of what apparent consent has been given, and I’m struggling to see how this scenario is any different to what happened in PACE.

It seems to me that, if persuading the patient that the treatment is valid is considered to be a requirement for it to work, then it may be impossible to design an ethical trial to test it (because of the Catch 22). But then, to me, any treatment which requires the patient to believe in its efficacy in order for it to work isn’t a serious medical intervention, so it’s not really problem in need of a solution.

Sorry this is a bit of a ramble. I’m just thinking aloud really.

 

There is another issue which arouses interest and indicates the difficulty of obtaining transparency and objectivity in the modern world where small groups of people circulate through the job field. I do not suggest that there is any impropriety here, but there is something which should be understood.

It appears that, from 2005 to 2014, Jonathan Montgomery was "National Chair of the Advisory Committee on Clinical Excellence Awards. In 2015 Sharpe received a platinum rating under this scheme, and in his tweet on the subject referred to his work on PACE.

It is possible that Montgomery's resignation preceded the submission of Sharp's application but even so two questions would arise.

Criticism now of Pace could imply failures on the part of the organisation of which Montgomery was Chair for the nine years leading up to the award. The duties of this former role would naturally create potential for a bias, which might lead to suggestions that he should, ideally, have recused himself from decision in the regulatory role. Admittedly, if all officials took such a high stance it might be difficult for anyone ever to get anything done.

I don't know how these awards work but would presume that to achieve a platinum award, with the pay increase which it involves, one would previously have had a gold award. Questions might be asked as to if and when Sharpe received that and whether Montgomery chaired the Committee granting such an award. If so was work on PACE mentioned as part of the reason for the award.

It all looks potentially a little too close for comfort, but possibly merely a reflection of the modern way of conducting matters rather major problem.

 

@Robert 1973

I think the drug scenarios may be analogous but maybe the important point is that the tactic is unethical whatever it is linked to.

I think the problem is close to the comment in the RCGP document that ffctivly says that people with ME/CFS ar exceptions to the legal position on informed consent because it may be in their best interests to be lied to. It is a hang over from the paternalism of Freud that actually breaks the law. It is much the same as Wessely's 'psychiatry is for grown-ups'.

 

Where do they say that? Do they have a legal authority for the proposition that some people who have mental capacity do not have the same rights as others?

 

I cannot remember where it was. It was flagged up on a thread last week. Something about 'complex CFS cases ' being an exception. There was discussion on the thread about mental capacity issues.