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

The argument is similar for GET but may not be quite so watertight. For GET the therapist can simply say that they think the patient may improve if they give exercise a try. CBT is different in that it explicitly takes the position that the patient has incorrect beliefs that need to be changed by education, and that education may involve 'cognitive strategies' which effectively means using persuasion techniques as in brainwashing.

 

I guess that's why the clinics tend to use CBT and GET in combination. I still don't really understand why they didn't do that in PACE. Was it a professional face-off between White's GET and Sharpe's CBT?

 

I think FINE did? It was more of a hodge-podge that didn't explicitly mention CBT or GET but basically seems to amount to some combination of the two.

Anyway, part of GET is convincing the patient to push through and ignore their symptoms so conversion therapy / CBT is pretty much implicitly used. It's not as if there's a precise protocol about what they are anyway, the treatments were made-up to maximize some placebo response, not provide any actual therapeutic effect.

 

Comparing GET with CBT was actually a good scientific idea. Although they drew on the same theory and were both 'active test' treatments they were methodologically separable and so could act as plausible controls for each other. The problem is that they gave the same result so neither had power to provide evidence of efficacy of the other.

I suspect that as much as anything, with pacing and standard care as necessary comparator arms it would have seemed nice to have at least two arms involving treatments that would corroborate the pet theory. But I suspect that it at least crossed their minds that the two would look good as plausible 'sham' comparators.

 

Thanks to @Michiel Tack for making me look at the Protocol again.

From this section (in tweet below), I can only presume that no-one has ever been harmed or made worse if they received treatment from one of the PACE authors, manual authors, or anyone properly trained by them...

https://twitter.com/user/status/1093875035159302144


There are also some factual inaccuracies here. Patient surveys cannot possibly say that "APT helps many patients and does not cause harm" because APT does not exist as a therapy.

 

Yes, I'm almost positive it was obtained using a Freedom of Information request, but not one I made:
https://www.mediafire.com/file/7a4uenbw241cdnc/PACE_Trial_Protocol_searchable.pdf/file

 

That one is a doozy. How is it OK to just make stuff up like that? When such obviously false claims are brushed off, how can any part of the judgment be considered credible? Using the same word but making up a whole new definition is not something serious people do.

 

Someone thinks they are defending good research from excessive criticism.

https://www.bmj.com/content/364/bmj.l639/rr

 

It makes you wonder though, in principle, if they treat different things, the effect should stack. We know it doesn't as the crossover shows no effect (crossover was uncontrolled in PACE trial, but still no effect).

 

MRC Guidelines for Good Clinical Practice in Clinical Trials (1998)
5.4.1 The principles of informed consent in the current revision of the Helsinki Declaration and those laid out in the 13 principles at the beginning of this document should be implemented in all RCTs.

That's very interesting--hadn't seen that. I guess one would have to check the 1998 version of Helsinki. It got updated in early 2000s I think.

 

Unfortunately, Guidelines for Good Clinical Practice ≠ Legal Requirement

 

You can find the different versions here. https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/

A quick search indicated that it was the 2000 revision that brought in the passage about informing participants about conflicts of interest

 

Could the MRC really provide funding for a trial without making it a condition for funding that it followed their own Guidelines for Good Clinical Practice?

 

I wonder how a company that exists "to carry on business associated with the establishment and promotion of a system of health based on a BPS model" would rate as far as institutional affiliation? Or being a chief medical officer for an insurer advising on mental health exemptions for this disease.

I'm sure this would be fine with regulators if some researchers for a drug trial were directors in a company that aimed "to carry on business associated with the establishment and promotion of" said drug. Totally clears the researchers, thank you!

As for potential risks, assurances that it cannot be harmful are absolutely not based in evidence and are wildly contradicted by patient reports and surveys. But I guess as long as no one publishes peer-reviewed research showing that, which would never get ethical approval, thousands of people all over the world are just... confused?

It's never really ever been explained why there are so many testimonies of harm, in contradiction with the work of researchers who assure harm cannot occur and who won't release their data for independent analysis. Total coincidence, I'm sure.