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

[ME/CFS Skeptic]

This thread has been split from the general thread on the PACE trial.

The Health Research authority has responded to questions of MP Norman Lamb from the Science and Technology Committee, House of Commons, regarding the PACE-trial. https://www.parliament.uk/documents...Research-Authority-to-Chair-re-PACE-trial.pdf

The HRA defends the PACE-trial and does not see anything wrong with it.

Our review suggests that the PACE trial exceeded expectations in its transparency when judged against contemporary expectations. [...] We have therefore concluded that there are no regulatory concerns about the conduct of the investigators in relation to these issues.

The Science media Center is promoting the letter, with expert reactions to the letter. http://www.sciencemediacentre.org/e...iry-on-research-integrity-and-the-pace-trial/

 

[Cheshire]

Michael Sharpe makes it look like PACE has been totally cleared:

Patients with chronic fatigue syndrome, and the healthcare professionals who look after them, can be reassured that the evidence provided by PACE that cognitive behaviour therapy and graded exercise therapy are helpful and safe treatments for Chronic Fatigue Syndrome (CFS) is based on sound science.

When the report says:

We also note that some of the criticisms of the PACE trial which have been brought to our attention are outside our regulatory remit and so we are not in a position to comment on them.

Our concern as a regulator is whether the study was properly approved by the Research Ethics Committee (REC).

 

[Cheshire]

From the HRA document

The continuing debate about the design of the study is not an indication that it should not have been approved, but if there was a general and consistent view that it was of poor scientific quality then it would give us cause for concern.

But they found that:

This is not the case in relation to PACE.

How did they arrive to this conclusion?

A review of the reception of the study shows indications that the science is sound, as well as evidence of concern. The results of the trials were published in high impact journals with peer review processes that would generally be regarded as robust (though not infallible). The robustness of the PACE trial has been considered in a Cochrane review that classified it as high quality.

This was also challenged by critics

And so?

the author of the review responded to those criticisms

WTF

 

[Cheshire]

They nonetheless investigated 3 separate issues.

Conflicts of Interest

Critics of the trial have raised concerns that the researchers were conflicted because they were advocates for the therapies that were being investigated. From the evidence we have identified, this is based primarily on presentations they have given to insurance companies and to government. However, it should be noted that the treatments that were being discussed were the therapies that NICE recommended, so all expert advisors would have been expected to explain them to such bodies. It is not clear what ‘personal gain’ the investigators stood to make from the trial and, in particular, it is not clear how any remuneration they received from advisory roles would have been different depending on the outcome of the trial.

Given that the REC was aware of the competing interests that are regarded by some critics as giving rise to a conflict of interest, and that they approved the trial including the PIS, it is not appropriate to criticise the researchers for non-disclosure. However, this is an area where greater clarification of expectations would be helpful. The Academy of Medical Sciences has recommended that further consideration and guidance is needed in relation to problems of conflicts of interest. The Health Research Authority is currently revisiting its guidance in this area

Availability of data for secondary analysis

There has been criticism of Queen Mary University of London (QMUL) as a result of a successful tribunal challenge to their rejection of a request made under the Freedom of Information Act (FOI). However, the full picture shows that the general approach was to release data responsibility. Any suggestion that the researchers have routinely denied access to prevent proper analysis of the data is not consistent with our enquiries, and to focus solely on the tribunal decision that went against QMUL gives a misleading picture.

Alterations in the outcome measures used

we have been able to confirm that changes to the eligibility criteria and the supplement of thecategorical outcome scores by measures of improvement were approved by the relevant research committees as ‘substantial amendments’

 

[Barry]

"However, the full picture shows that the general approach was to release data responsibility."

What data was that then?

 

[NelliePledge]

The Health Research authority has responded to questions of MP Norman Lamb from the Science and Technology Committee, House of Commons, regarding the PACE-trial. https://www.parliament.uk/documents...Research-Authority-to-Chair-re-PACE-trial.pdf

The HRA defends the PACE-trial and does not see anything wrong with it.


The Science media Center is promoting the letter, with expert reactions to the letter. http://www.sciencemediacentre.org/e...iry-on-research-integrity-and-the-pace-trial/

Anyone else think SMC are trying to be clever by getting quote from a Prof from LSHTM

 

[Esther12]

This report seems to be a mix of confusion about what the criticisms made of PACE were and a presumption that if other supposedly authoritative sources said things were okay, they were okay. They don't provide any new information at all.

 

[NelliePledge]

This report seems to be a mix of confusion about what the criticisms made of PACE were and a presumption that if other supposedly authoritative sources said things were okay, they were okay. They don't provide any new information at all.

Establishment digging their heels in - they are embarrassing

 

[dave30th]

what does "the supplement of the categorical outcome scores by measures of improvement" mean? what is that referring to? The post-hoc "improvement" findings?

 

[Binkie4]

Information on the HRA. It’s a relatively new body, established Jan 2015.

https://www.hra.nhs.uk/about-us/

 

[rvallee]

You just have to laugh at the fact that they cite NICE recommending the "treatments" as independent validation of the promise they held at the time when of course this recommendation came from their own work and Wessely's influence.

Literally pointing at their own recommendation as evidence that it was recommended.

According to me, I should receive the Nobel peace prize. I even have a good and proper recommendation: me. Thank me, that clever rascal. I also approve of me nominating myself and voting myself. And, oh would you look at that I can now confirm independent recommendation of my perfection and you just know it is true and perfect because I approve of it.

Also according to my mirror: I am a thing a beauty. My mirror told me independently and I can vouch for it.

 

[Esther12]

OT and not important: Their first Chief Excutive was Janet Wisely, and there is some info about her in this thread relating to SMILE/PACE:

https://www.s4me.info/threads/janet...f-their-discussions-included.1770/#post-30638

 

[Cheshire]

 

[Adrian]

The HRA defends the PACE-trial and does not see anything wrong with it.

Our review suggests that the PACE trial exceeded expectations in its transparency when judged against contemporary expectations.

Since PACE hasn't published all the secondary outcomes as defined in the protocol (although patients published the recovery one) the HRA don't have high expectations over transparency.

 

[Adrian]

The robustness of the PACE trial has been considered in a Cochrane review that classified it as high quality.

So they basically reflect back to their only defense PACE is ok because Cochrane say its ok.

 

[Hoopoe]

This agency does not appear to have performed an independent analysis and was apparently deceived by the carefully crafted illusion that PACE is OK.

That people who look only superficially into PACE conclude that there aren't major problems has happened before. A forensic analysis is required.

For example, the classification of PACE as having low risk of bias by Cochrane violated Cochrane's own rules for assessing bias in clinical trials. The data sharing with Cochrane is also not what it appears, as the PACE authors themselves were part of the review team. Prof. Chalder even admitted that this was not an independent review. They have never released the data to independent scientists as far as I know (or at least not to scientists that were critical).

 

[large donner]

Its rather confusing, which PACE study do they think carries the real results? The revised protocol study where they claimed modest recovery rates or the original protocol that didn't change the definition of recovery to being ill and recovered at the same time which allowed the revised definition to claim the modest efficacy rates rather than showing the facts that there was zero clinically statistical significance to the treatments?

Or is such like out side of the scope of their investigation in which case what exactly did they look into?

 

[Robert 1973]

That people who look only superficially into PACE conclude that there aren't major problems has happened before. A forensic analysis is required.

HRA only concluded (wrongly IMO) that there are no major concerns within its regulatory remit:

We also note that some of the criticisms of the PACE trial which have been brought to our attention are outside our regulatory remit and so we are not in a position to comment on them.

...

While the quality of the trial design has been challenged, it has not been discredited. Criticisms have been made and responded to by the investigators. The issues remain debated but there has been no retraction of papers. In relation to one paper (not the one containing the main results) an ‘expression of concern’ has been registered by the publisher, along with the authors’ response. It would not be appropriate for the HRA to seek to resolve these debates about the quality of the study. Discussion of the meaning and robustness of results is how science is expected to proceed.

 

[dave30th]

I think in any response the limits of their remit must be emphasized. Although I agree that even within their remit this analysis falls short.

 

[Andy]

Do you think they really mean this?

However, the full picture shows that the general approach was to release data responsibility

Surely they intended to say

However, the full picture shows that the general approach was to release data responsibly