Science Media Centre expert reaction to Journal of Health Psychology’s Special Issue on The PACE Tri

[Yogi]

http://www.sciencemediacentre.org/e...-psychologys-special-issue-on-the-pace-trial/

The Journal of Healthy Psychology has published a special issue focusing on the PACE trial – originally published in The Lancet (2011).



Prof. Malcolm Macleod, Professor of Neurology and Translational Neuroscience, University of Edinburgh, said:

“The PACE trial, while not perfect, provides far and away the best evidence for the effectiveness of any intervention for chronic fatigue; and certainly is more robust than any of the other research cited. Reading the criticisms, I was struck by how little actual meat there is in them; and wondered where some of the authors came from. In fact, one of them lists as an institution a research centre (Soerabaja Research Center) which only seems to exist as an affiliation on papers he wrote criticising the PACE trial.

“Their main criticisms seem to revolve around the primary outcome was changed halfway through the trial: there are lots of reasons this can happen, some justifiable and others not; the main think is whether it was done without knowledge of the outcomes already accumulated in the trial and before data lock – which is what was done here.

“So I don’t think there is really a story here, apart from a group of authors, some of doubtful provenance, kicking up dust about a study which has a few minor wrinkles (as all do) but still provides information reliable enough to shape practice. If you substitute ‘CFS’ for ‘autism’ and ‘PACE trial’ for ‘vaccination’ you see a familiar pattern…”


Dr Neha Issar-Brown, Programme Manager, Population and Systems Medicine at the Medical Research Council (co-funders, along with the National Institute for Health Research, of the PACE trial), said:

“The Medical Research Council funded and supported the PACE trial after subjecting the research proposal to a robust peer-review process involving experts in the field, as is the case with all our funding decisions. This included ensuring adherence to standardised trials methodology and design principles. The researchers’ findings were then peer-reviewed before publication in journals. All research evolves by continually re-evaluating existing evidence and looking for new knowledge and we would always welcome high-quality research applications to better understand the underlying disease mechanisms, causes, prevention and treatments for this extremely debilitating condition.”



A spokesperson for University of Oxford said:

“The PACE trial of Chronic Fatigue Syndrome treatments was conducted to the highest scientific standards and scrutiny. This included extensive peer review from the Medical Research Council, ethical approval from a Research Ethics Committee, independent oversight by a Trial Steering Committee and further peer review before publication in high-impact journals such as The Lancet.

“The allegation that criteria for patient improvement and recovery were changed to increase the reported benefit of some treatments is completely unfounded. As the study authors have repeatedly made clear, the criteria were changed on expert advice and with oversight committee approvals before any of the outcome data was analysed.

“Oxford University considers Professor Sharpe and his colleagues to be highly reputable scientists whose sole aim has been to improve quality of life for patients with ME/CFS. While scientific research should always be open to challenge and debate, this does not justify the unwarranted attacks on professionalism and personal integrity which the PACE trial team have been subjected to.”


* ‘Special Issue on The PACE Trial’ edited by David Marks published in Journal of Health Psychology on Monday 31st July 2017.


Declared interests

Prof. Macleod: “Prof Sharpe used to have an office next to my wife’s; and I sit on the PLoS Data board that considered what to do about one of their other studies.”

Dr. Issar-Brown: Nothing to declare

 

[Cheshire]

The allegation that criteria for patient improvement and recovery were changed to increase the reported benefit of some treatments is completely unfounded.

I don't see how lowering the recovery threshold mid trial could do anything but improve your recovery outcomes.

If you substitute ‘CFS’ for ‘autism’ and ‘PACE trial’ for ‘vaccination’ you see a familiar pattern…

yes, I can see one too, but not the one you're thinking of...

 

[Sidereal]

The Ministry of Truth has spoken. Nothing to see here, peasants, move along.

 

[Kalliope]

Unbelievable..

“So I don’t think there is really a story here, apart from a group of authors, some of doubtful provenance, kicking up dust about a study which has a few minor wrinkles (as all do) but still provides information reliable enough to shape practice. If you substitute ‘CFS’ for ‘autism’ and ‘PACE trial’ for ‘vaccination’ you see a familiar pattern…”

 

[Wonko]

I don't see how lowering the recovery threshold mid trial could do anything else than improving your recovery outcomes.

They aren't saying that isn't true, they're saying that regardless of that effect, that the threshold was moved for a different reason, possibly it was decided by some bizarre public school ritual? but it definitely wasn't decided to lower the threshold because it would make their non results look like only poor results which by a process of spin, exaggeration and outright lying they could claim were outstanding results.

You have to remember these people are experts at lying via misdirection, that's what they do for a living.

 

[Yogi]

https://twitter.com/i/web/status/892015279856906240

https://twitter.com/i/web/status/892024437440172034

 

[Londinium]

“So I don’t think there is really a story here, apart from a group of authors, some of doubtful provenance, kicking up dust about a study which has a few minor wrinkles (as all do) but still provides information reliable enough to shape practice. If you substitute ‘CFS’ for ‘autism’ and ‘PACE trial’ for ‘vaccination’ you see a familiar pattern…”

The irony here is massive. Many of the flaws in PACE highlighted (changes in primary objective, focus on self-reported outcomes, significant conflicts of interest etc etc) are exactly the kind of flaws one sees in 'scientific' research on alternative medicine / anti-vaccination.

 

[SamanthaJ]

What nasty smears from Prof. Macleod.

 

[Sean]

Where is the objective or properly blinded subjective evidence in PACE of any sustained clinically significant benefit?

Until they can produce it, they got nothing.

 

[Cheshire]

A spokesperson for University of Oxford said:

Weird that this person is not named.

 

[Esther12]

Dr Neha Issar-Brown is part of the CMRC. For some reason the SMC continue to be invited to the CMRC. It's pretty clear that the CMRC is not on the side of good science.

 

[lilpink]

Dr Neha Issar-Brown is part of the CMRC. For some reason the SMC continue to be invited to the CMRC. It's pretty clear that the CMRC is not on the side of good science.

Absolutely. And yet the MEA still collude.

 

[Dolphin]

https://twitter.com/i/web/status/892037808424198145

 

[Yogi]

The so called "expert" says "“The PACE trial, while not perfect, provides far and away the best evidence for the effectiveness of any intervention for chronic fatigue;"

Hmm.....can't even refer to the right illness.

Or maybe they are now claiming PACE is for chronic fatigue!

 

[Londinium]

Dr Neha Issar-Brown is part of the CMRC. For some reason the SMC continue to be invited to the CMRC. It's pretty clear that the CMRC is not on the side of good science.

Interestingly, having re-read Dr Issar-Brown's statement there I'm not sure it's as supportive as it first appears. Reading it again, it seems quite defensive as to 'the MRC did nothing wrong, we followed standard procedure' rather than a full-throated defence of the trial itself.

Absolutely. And yet the MEA still collude.

I'm not sure using verbs like 'collude' is particularly accurate or helpful.

 

[alex3619]

Funny nobody from the list of scientists who cosigned for the letter for urgent reevaluation or retraction were cited.

Notice the preponderance of argument by authority.

I need to read these in full, from the source, but it looks like only one major issue was addressed, and that issue was glossed over with a layer of misdirection.

This is not unexpected. These counter-arguments are primarily political and persuasive. Substance and non-fallacious reasoning are lacking. I wonder if they did their due diligence and read all of the abstracts, both from JHP and involving the original PACE publications (satire)? It will be interesting to see what Coyne and Tuller have to say.

 

[Esther12]

Interestingly, having re-read Dr Issar-Brown's statement there I'm not sure it's as supportive as it first appears. Reading it again, it seems quite defensive as to 'the MRC did nothing wrong, we followed standard procedure' rather than a full-throated defence of the trial itself.

I agree that it was a less than full throated defence of PACE, but it still had : "The Medical Research Council funded and supported the PACE trial after subjecting the research proposal to a robust peer-review process involving experts in the field, as is the case with all our funding decisions."

That looks like a willingness to prioritising protecting the reputation of the MRC over pursuing good science, and standing against the way that patient criticis of PACE have been smeared. At this point, that sort of response isn't anywhere near acceptable.

 

[alex3619]

Or maybe they are now claiming PACE is for chronic fatigue!

That would be a step forward, however only a small step. Their lack of any objective outcome, aside from a tiny and clinically irrelevant improvement in the 6MWT, and including no improvement in fitness are a problem. The recovery threshold set for SF36PF at the age of about eighty is a big problem for any formerly young and fit patients. The failure to produce any good result at long term follow up is a deathstroke for their research, with patients being as well off with no treatment, but that was spun too.

 

[Sidereal]

Their main criticisms seem to revolve around the primary outcome was changed halfway through the trial: there are lots of reasons this can happen, some justifiable and others not

The point, which obviously went over this reviewer's head, is that the reasons for changing outcome measures in this particular instance were justified on the basis of erroneous interpretation of normative data. This point has been well-made by Wilshire and others in the peer-reviewed literature. There is no justification whatsoever for lowering SF-36 recovery range to class II congestive heart failure level of functioning.

 

[alex3619]

The thing about argument by authority is that it cuts both ways. Cited authorities will have their reputations burned when all the evidence is finally seen and accepted. That is in the process of happening.