Jonathan Edwards: PACE team response shows a disregard for the principles of science

[user9876]

I have never looked too deeply into the PACE trial controversy, and I'm no expert in medicine, but I decided today to read Jonathan Edward's response, which was excellent.

It took me only a few minutes of reading to grasp the huge methodological flaw in PACE. I have to say I'm absolutely shocked that such a blindingly obvious flaw could possibly be inherent in any modern academic proposal, let alone make its way into any journal, let alone the Lancet.

If the response to a therapy is objectively measured, the therapy doesn't need to be blinded, because you're making objective measurements...
If the response to a therapy is subjectively measured, the therapy needs to be blinded to avoid potential bias introduced by the subjectivity.

You don't need to say anything else, it's a complete non-starter. The people who do not understand this simple concept are in charge of my health?

I'm just...shocked...

You may be shocked but we should remember that this trial was reviewed and accepted by the MRC and subsequently defended by the MRC. Which perhaps just shows that they are not a fit organization to managing government research funds.

 

[Jonathan Edwards]

Quoting Trishrhymes:
"Has anyone got access to a copy of Simon Wessely and Brian Everitt's 'Clinical Trials in Psychiatry'.

I'd be interested to know whether they point out the unscientific nature of unblinded trials with subjective outcome measures. (or any of the other flaws like conflicts of interest, changing recovery criteria etc)

If so, Wessely himself has condemned PACE before it started.

If not, he clearly doesn't understand science. This would help to explain why so many appallingly bad papers are published about ME by psychiatrists and psychologists, and also explain the well known crisis of replicability of psychological research."

Sir Simon was keen to point out to me that he had written the definitive text on psychiatry trials. He also made it clear to me that he did not understand why unblinded trials were no good. So either he clearly does not understand the science or he prefers to give that impression. It probably does explain a lot of what you suggest. The whole business is an elaborate scam.

 

[Esther12]

Sir Simon was keen to point out to me that he had written the definitive text on psychiatry trials. He also made it clear to me that he did not understand why unblinded trials were no good. So either he clearly does not understand the science or he prefers to give that impression. It probably does explain a lot of what you suggest. The whole business is an elaborate scam.

What's worrying is that he may be right about the extent to which he has 'defined' the standards for psychiatry trials in the UK.

I get the impression that PACE was put forth as a model to show psychiatry could be every bit as rigorous and scientific as any other field of medicine, if only funding was a vailable. Hardly surprising for few in psychiatry now want to speak out about the problems with it.

 

[Sean]

Hardly surprising for few in psychiatry now want to speak out about the problems with it.

Yep, this one is ugly all the way to the core of that profession in the UK. (With honourable exceptions, as always.)

Clearly UK psych in its current incarnation is completely incapable of addressing that in any effective manner.

 

[cigana]

The whole business is an elaborate scam.

Smoke and mirrors.

 

[RogerBlack]

Has anyone got access to a copy of Simon Wessely and Brian Everitt's 'Clinical Trials in Psychiatry'.
I refuse to waste £80 on it, and being housebound don't have access to a University library.

I note it's 40p on amazon, and may be quite a useful purpose, though I can't comment on how soft or absorbent the paper is.

 

[A.B.]

Sir Simon was keen to point out to me that he had written the definitive text on psychiatry trials. He also made it clear to me that he did not understand why unblinded trials were no good. So either he clearly does not understand the science or he prefers to give that impression. It probably does explain a lot of what you suggest. The whole business is an elaborate scam.

Please be aware of the UK's draconian libel laws. I hate to discourage you stating the conclusion that makes the most sense but I think the PACE authors could feel very threatened by someone in your position saying this. Do you think that you could win a legal battle in which you'd have to demonstrate that the whole thing is indeed an elaborate scam?

 

[cigana]

Quoting Trishrhymes:
"Has anyone got access to a copy of Simon Wessely and Brian Everitt's 'Clinical Trials in Psychiatry'.

I'd be interested to know whether they point out the unscientific nature of unblinded trials with subjective outcome measures. (or any of the other flaws like conflicts of interest, changing recovery criteria etc)

If so, Wessely himself has condemned PACE before it started.

If not, he clearly doesn't understand science. This would help to explain why so many appallingly bad papers are published about ME by psychiatrists and psychologists, and also explain the well known crisis of replicability of psychological research."

I managed to get hold of a copy, here are a few snippets:

On blinding:

"blindness has been recognized as an important part of valid treatment assessments for over 200 years"

"blinding provides two benefits; first it ensures a high level of objectivity in measurements. Second, blinding removes the possibility of a placebo effect creating an artefactual response in the treatment group."

"blinded treatment administration, however carefully arranged, is rarely 100 per cent effective."

On the need for objective outcome measures:

"Objective measures, however, did not confirm the patient self-reports."

"Such...measurements are the raw material of the trial and they clearly need to be objective, precise and reproducible"

Is PACE therefore a schoolboy error?

Clearly Wessely "wrote the book" on clinical trials in psychiatry but one has to wonder if he "read the book".

 

[lansbergen]

Clearly Wessely "wrote the book" on clinical trials in psychiatry but one has to wonder if he "read the book".

 

[Jonathan Edwards]

Please be aware of the UK's draconian libel laws. I hate to discourage you stating the conclusion that makes the most sense but I think the PACE authors could feel very threatened by someone in your position saying this. Do you think that you could win a legal battle in which you'd have to demonstrate that the whole thing is indeed an elaborate scam?

I spend quite a lot of time advising judges.

 

[Aurator]

I've still got an IBM AT with a 5 1/4 inch floppy disk drives in a cupboard.

I've still got two BBC Micros and a ZX Spectrum in the loft. They were bought in 1982.

 

[Londinium]

I get the impression that PACE was put forth as a model to show psychiatry could be every bit as rigorous and scientific as any other field of medicine, if only funding was a vailable.

It's why I feel there's a parallel between such studies and those seen in alternative medicine. Both want the cachet of scientific rigour. CAM practitioners will author papers that are structured and worded like proper scientific papers and there are a body of alternative medicine 'scientific journals'. All on the face of it looks like real science. It's only when one digs into the literature one finds the papers that 'prove' the efficacy of homeopathy/prayer/whatever rely on short-term subjective outcomes, primary outcome switching, poor selection criteria, unblinded testing, publication bias etc etc. Many of which flaws seem strangely familiar when one looks at PACE and other trials of CBT on various ailments. Indeed, with the recent paper on 'Kineasophobia' (sp?) in patients who failed to respond to GET, it appears it's now entirely possible to still get published when taking on the worst Tinkerbell approach of faith healing: if you don't get better it's because you didn't have faith.

When such flaws are tolerated by senior mainstream figures, it's not surprising that psychology has a replication problem.

 

[Barry53]

I get the impression that PACE was put forth as a model to show psychiatry could be every bit as rigorous and scientific as any other field of medicine, if only funding was a vailable.

Bit of an own goal there then.