Blog: The PACE Trial: How a Debate Over Science Empowered a Whole Community [Carolyn Wilshire/ME Association]

[Andy]

One group of science-minded patients – including Tom Kindlon, Robert Courtney and Alem Matthees – carefully examined the trial publications, and came across some striking oddities. For example, midway through the trial, the researchers had altered their definitions of improvement and recovery.

Could these changes have worked to favour the trial’s hypotheses? The only way to know for sure was to examine the data. So, these intrepid patients wrote data requests, first to the researchers themselves, then to their institutions, and then finally as requests under the Freedom of Information (FOI) Act.

At every turn, they were met with refusals – and worse. They were accused of harassment, of vexatious behaviour. They were described by the trial investigators as part of a “highly organised, very vocal and very damaging group of individuals”, who wanted to expose and discredit the patients who participated in the trial. But they did not give up.

https://www.meassociation.org.uk/20...ence-empowered-a-whole-community-09-may-2019/

 

[Sly Saint]

typo?
"There are few in the ME/CFS community who have not heard of the PACE Trial. This £1.5 million clinical trial"

 

[Jonathan Edwards]

Very nicely presented summary from Carolyn.

 

[arewenearlythereyet]

This makes me feel, very proud.

Hang on this ground is a bit high ...I might need to sit down.

 

[Cheshire]

Thanks @Carolyn Wilshire

 

[Robert 1973]

Excellent, thanks @Carolyn Wilshire . A very useful and well-written summary for the lay reader.

I spotted a couple of typos, as well as the £1.5 million one:

“In our reanalysis, we set about to see what the results would have looked like if the protocol had been followed.”

“However, in our response we decided to focus on the trial investigator’s own biases.”

 

[Lucibee]

Another inaccuracy:

They were described by the trial investigators as part of a “highly organised, very vocal and very damaging group of individuals”

This quote came from Richard Horton, not one of the trial investigators.

I'm more than happy to read things through at short notice for no fee. I did used to be an editor once... Please, just ask!

[eta: A copyeditor. Not a journalist.]

 

[Carolyn Wilshire]

Another inaccuracy:



This quote came from Richard Horton, not one of the trial investigators.

I'm more than happy to read things through at short notice for no fee. I did used to be an editor once... Please, just ask!

[eta: A copyeditor. Not a journalist.]

Thanks, @Lucibee.

It actually went past the eyes of three different people, but alas we still did not catch everything!

 

[Carolyn Wilshire]

Sorry, I'm confused. about the £1.5 million. What was the right figure? Thought I pulled that from a reliable source, but did I accidentally change the currency or something?

Be worth getting the MEA folks to fix that.

 

[Esther12]

Sorry, I'm confused. about the £1.5 million. What was the right figure? Thought I pulled that from a reliable source, but did I accidentally change the currency or something?

Be worth getting the MEA folks to fix that.

I'm not sure anyone knows the true figure. 'over 5 million' seems to be the commonly used figure. A possible supporting source:

• 2003: £6.6M; Medical Research Council and Department of Health. RCT of CBT, GET for CFS (PACE trial). PI at KCL: T Chalder

https://impact.ref.ac.uk/casestudies/CaseStudy.aspx?Id=41185

 

[Robert 1973]

Sorry, I'm confused. about the £1.5 million. What was the right figure? Thought I pulled that from a reliable source, but did I accidentally change the currency or something?

Be worth getting the MEA folks to fix that.

£5 million is the figure that is usually quoted, although I suspect the costs have exceeded that now.

http://www.rae.ac.uk/submissions/ra5a.aspx?id=176&type=hei&subid=3181:

2.1.4 Psychological Medicine and Symptoms Research Group ... the PACE trial (7 UK centres) of chronic fatigue syndrome (CFS) treatments (MRC; £5.0M);

[Edit crossed with @Esther12]

 

[Obermann]

Thanks, @Carolyn Wilshire, for a nice blog and for participating in this very important debate. I think that the problem is bigger than just PACE or ME/CFS; it is about widespread bad research practices, in medical studies in general and in psychological studies in particular.

It is always painful to abandon a pet theory, so we should all appreciate what the PACE trial authors are going through. A quote by Max Planck comes to mind, about the reluctance of classical physicists to accept the new quantum theory: "A scientific truth does not triumph by convincing its opponents and making them see the light, but rather because its opponents eventually die and a new generation grows up that is familiar with it."

 

[Amw66]

Thanks, @Carolyn Wilshire, for a nice blog and for participating in this very important debate. I think that the problem is bigger than just PACE or ME/CFS; it is about widespread bad research practices, in medical studies in general and in psychological studies in particular.

It is always painful to abandon a pet theory, so we should all appreciate what the PACE trial authors are going through. A quote by Max Planck comes to mind, about the reluctance of classical physicists to accept the new quantum theory: "A scientific truth does not triumph by convincing its opponents and making them see the light, but rather because its opponents eventually die and a new generation grows up that is familiar with it."

Sadly people are living longer

 

[Obermann]

Sadly people are living longer

I'll settle for retirement.

 

[Sly Saint]

Be worth getting the MEA folks to fix that.

I'm surprised that they didn't spot it. The £5m (or sometimes $8m is used in US publications) is all over the place (a lot of headlines too).
Good reference source is me-pedia
https://me-pedia.org/wiki/PACE_trial

The PACE trial[2] was funded by the UK Medical Research Council, Department of Health and Social Care (UK) for England, Scottish Chief Scientist Office, and - apparently uniquely for a clinical trial - the Department for Work and Pensions - the government department for sickness, disability and pension benefits. The PACE trial cost £5 million[10] and is the most expensive piece of research into ME/CFS ever conducted.

@Russell Fleming

 

[Carolyn Wilshire]

I think Russell's going to correct the cost error shortly. Sorry about that.

 

[Sly Saint]

it's been fixed. no harm done

 

[MEMarge]

Liking your comment on the end of this @Graham

 

[JohnTheJack]

Excellent blog, thanks @Carolyn Wilshire and anyone else who contributed.



Not wanting to pile in on all those who did a great job, but some possible typos here.

1.
Para 7:

For example, midway through the trial, the researchers had altered their definitions of improvement and recovery.

Para 15:

They changed the primary outcome measures midway through the trial.

From the trial minutes, these changes were agreed after the trial had been completed but before the data were analysed.

2.
Para 10:

“Finally, in October 2015, after a protracted court case, Alem Matthees’ request was granted. A portion of the PACE trial data would be released to the public under FOI legislation.”

The request was in 2015, the FTT decision was announced in August 2016 and the data were released in September 2016.

3.
Para 13:

Any high-quality clinical trial begins a written plan (or protocol) which

...trial begins with a written...

 

[rvallee]

Thanks, @Carolyn Wilshire, for a nice blog and for participating in this very important debate. I think that the problem is bigger than just PACE or ME/CFS; it is about widespread bad research practices, in medical studies in general and in psychological studies in particular.

It is always painful to abandon a pet theory, so we should all appreciate what the PACE trial authors are going through. A quote by Max Planck comes to mind, about the reluctance of classical physicists to accept the new quantum theory: "A scientific truth does not triumph by convincing its opponents and making them see the light, but rather because its opponents eventually die and a new generation grows up that is familiar with it."

The problem is psychosomatic medicine making a comeback following a retreat that decades of failure brought on themselves. Psychosomatic medicine has always been this bad.

The problem has always existed and always relied on confident pseudoscience indistinguishable from con artistry. It should not have been rehabilitated, especially since most of the old failed ideas have been recycled nearly as is. The theoretical model for psychosomatic peptic ulcers is nearly identical to the current incarnation of the psychosomatic model of ME.

As long as magical thinking of that nature is allowed, the problem will remain. If peptic ulcers had not been solved by incredible courage, they would still feature prominently in MUS and "treated" with CBT/LP/ACT/Whatever. The whole thing has to be challenged as cheap pseudoscience, taken behind the proverbial shed and shot, lit on fire, buried, then the Earth salted and preferably nuked from orbit.