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

Yes, I also touched on that in post #37. Their words seem a masterly bit of obfuscation.

 

Does anyone have a copy of the patient information sheet?

 

Montgomery quotes from the TSC minutes in the letter, so he has seen the evidence.

 

Royal Society of Medicine conference
www.afme.org.uk

'Action for M.E. Chief Executive, Peter Spencer, will be one of the speakers at a conference of healthcare professionals at the Royal Society of Medicine (RSM) in London, 28 April 2008.

The RSM says the aim of the meeting is to take a broad look at chronic fatigue syndrome, examining its nature and definition, pathophysiology, epidemiology, clinical assessment and diagnosis, the patient perspective, and various approaches to treatment. It says: This is a scientific conference and there will be an emphasis on an evidence-based approach throughout.

The final programme says:

Chronic fatigue syndrome is a common and debilitating illness which can persist for years. Despite extensive research, the nature and pathogenesis of the condition remain enigmatic. There is continuing uncertainty and controversy concerning the physical and psychological components that may contribute to the initiation and perpetuation of the symptoms of chronic fatigue syndrome.

Those attending the meeting will gain understanding of the various aspects of CFS being discussed, and be better able to help people suffering from this disabling condition. The conference is intended for all health professionals who are involved in the assessment and treatment of those with CFS. [End of quote]

The inclusion of a number of psychiatrists in the programme, such as Professor Simon Wessley of King's College London, who is giving a talk on epidemiology, will be controversial amongst some patient groups - but Peter Spencer has no qualms about attending the event to ensure the patient perspective is on the agenda.

It is better to have balanced debate than for different factions to exist in parallel worlds, where they do not engage in dialogue or work together to increase our understanding of this debilitating illness.

On this occasion I will have a great opportunity to set out the serious concerns that we and our members have about the way in which evidence-based principles have produced very dubious outcomes when only a very tiny amount of so-called gold standard data is available from randomised controlled trials.

After a welcome address by Dr John Scadding, Dean, Royal Society of Medicine, who will Chair the first session of talks, questions and answers. Professor Peter White, Barts will lead a session on What is CFS and what is M.E.? Dr Anthony Cleare, Institute of Psychiatry, will discuss Pathophysiology. Action for M.E.'s principal medical adviser, Professor Anthony Pinching, will chair a session opened by Professor Chris Dowrick, University of Liverpool, on Assessment: the GPs approach. Another session, Assessment: the psychiatrist's approach, will be presented by Professor Matthew Hotopf, Institute of Psychiatry.

The first afternoon session, which Peter Spencer will open, will be Chaired by Professor Mansel Aylward, Unum Provident Centre for Psychosocial and Disability Research, Cardiff University. Delegates will hear about Management: the NICE Guidelines, from Professor Richard Baker, Leicester University. The final session of the day, Chaired by Professor Kam Bhui, Department of Psychiatry, Queen Mary School of Medicine and Dentistry, will look at CBT and GET with Professor Rona Moss-Morris, University of Southampton and What drugs can I use?, with Dr Alastair Miller, Royal Liverpool University Hospital.

http://www.rsm.ac.uk/academ/e10-npr.php'

 

Yes. It's in the trial protocol - but I've extracted the relevant pages here:

 

Thanks. Are you sure this is all of it because I don't see any information about funding.

 

Hmm, it appears the HRA are collaborating with a Dr Goldacre on various projects (Ben, presumably). Ben Goldacre is known as an arbiter of bad science yet has steadfastly refused to criticise the PACE trial. I don't think he likes people with ME. Coincidentally, his early career prospered under the tutelage of Simon Wessely at King's.

I imagine he and Prof Montgomery might have had a chat about the PACE trial at some point.

 

Hang on! I'm getting there. There is so much info, I'm doing it a bit at a time...

Next bit, trial information:

 

Ah, yes. Thank you. It's on page 110 of the PACE trial protocol. Final version 5.0. 01.02.2006

 

And Ethical Considerations:

 

I'd imagine that whenever the topic of the quality of the PACE trial comes up, Ben Goldacre mysteriously has to excuse himself to go to the bathroom.

 

You think he's that worried about it?

 

were their industry ties disclosed in the protocol? I don't remember seeing that in it but the HRA report seems to claim that it was.

 

The recovery criteria were also not mentioned. So was that tantamount to allowing them to drop them as secondary outcomes? They have described their recovery paper as a "secondary analysis," as if it were a secondary analysis of an existing data set--not a report of secondary outcomes form a clinical trial. Perhaps they can argue that allows them to make up any post-hoc criteria because they had gotten approval to drop them as secondary outcomes by the publication of the SAP?

 

Does anyone know exactly what Monaghan asked the HRA to do? Is there are record of that?

 

It came out of the science integrity (or lack of) hearing. I'm not sure if there was a specific request and I don't know if it came directly from Monaghan--could have been the committee.

 

Its in the published protocol (2007), under competing interests.

EDIT: can't find it in the 226 pages version that Adrian and Lucibee shared

 

But the point I raised is actually an ethical one. If taken logically it is a very serious ethical one that makes the use of CBT and GET so far unethical and possibly illegal. My reason for not raising it more loudly is that I doubt the HRA people would understand the argument.