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

JohnTheJack said:
The MRC Guide refers to the Helsinki Declaration, not to a specific version.
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I would interpret it like that as well. But the actual wording is:
in the current revision of the Helsinki Declaration
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It refers to an appendix, where the old version of the Helsinki Declaration is given. So without mentioning the part about conflicts of interest.

EDIT: it's a shame because IMO they obviously stressed the word 'current', to refer to the most recent version of the Helsinki Declaration, not the 1996 version per se.
 
Michiel Tack said:
I would interpret it like that as well. But the actual wording is:

It refers to an appendix, where the old version of the Helsinki Declaration is given. So without mentioning the part about conflicts of interest.
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I would interpret 'current' to mean that which is current, not 'the one that was current at the time the guidelines were written'.
 
JohnTheJack said:
I would interpret 'current' to mean that which is current, not 'the one that was current at the time the guidelines were written'.
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I would interpret it to mean the opposite--the one current in 1998. But the phrase is certainly ambiguous. Anyway, it should be a moot point because the protocol promised to adhere to Helsinki, and when the consent forms were signed the version clearly called for the disclosures. Unfortunately, the HRA did not address or acknowledge this violation of their protocol promises but gave them a complete pass on this issue, for reasons that I don't get.

I included the Helsinki violation in my original Trial By Error series. In their non-responsive rebuttal, the PACE folks ignored the point about Helsinki and wrote this piece of nonsense:

"There was a bias caused by many investigators’ involvement with insurance companies and a failure not to declare links with insurance companies in information regarding consent

No insurance company was involved in any aspect of the trial. There were some 19 investigators, three of whom have done consultancy work at various times for insurance companies. This was not related to the research and was listed as a potential conflict of interest in the relevant papers. The patient information sheet informed all potential participants as to which organizations had funded the research, which is consistent with ethical guidelines."

And I responded in my rebuttal of their stupid answers like this:

"The PACE authors here seriously misstate the concerns I raised in my piece. I did not assert that bias was caused by their involvement with insurance companies. I asserted that they violated an international research ethics document and broke a commitment they made in their protocol to inform participants of “any possible conflicts of interest.” Whether bias actually occurred is not the point.

In their approved protocol, the authors promised to adhere to the Declaration of Helsinki, a foundational human rights document that is explicit on what constitutes legitimate informed consent: Prospective participants must be “adequately informed” of “any possible conflicts of interest.” The PACE authors now suggest this disclosure was unnecessary because 1) the conflicts weren’t really conflicts after all; 2) they disclosed these “non-conflicts” as potential conflicts of interest in the Lancet and other publications, 3) they had a lot of investigators but only three had links with insurers, and 4) they informed participants about who funded the research.

These responses are not serious. They do nothing to explain why the PACE authors broke their own commitment to inform participants about “any possible conflicts of interest.” It is not acceptable to promise to follow a human rights declaration, receive approvals for a study, and then ignore inconvenient provisions. No one is much concerned about PACE investigator #19; people are concerned because the three main PACE investigators have advised disability insurers that cognitive behavior therapy and graded exercise therapy can get claimants off benefits and back to work.

That the PACE authors made the appropriate disclosures to journal editors is irrelevant; it is unclear why they are raising this as a defense. The Declaration of Helsinki is about protecting human research subjects, not about protecting journal editors and journal readers. And providing information to participants about funding sources, however ethical that might be, is not the same as disclosing information about “any possible conflicts of interest.” The PACE authors know this.

Moreover, the PACE authors appear to define “conflict of interest” quite narrowly. Just because the insurers were not involved in the study itself does not mean there is no conflict of interest and does not alleviate the PACE authors of the promise they made to inform trial participants of these affiliations. No one required them to cite the Declaration of Helsinki in their protocol as part of the process of gaining approvals for their trial.

As it stands, the PACE study appears to have no legitimate informed consent for anyof the 641 participants, per the commitments the investigators themselves made in their protocol. This is a serious ethical breach."
 
No insurance company was involved in any aspect of the trial.
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What do they think the DWP is?

National Insurance (NI) is a tax system in the United Kingdom paid by workers and employers for funding state benefits. Initially, it was a contributory form ofinsurance against illness and unemployment, and eventually provided retirement pensions and other benefits.
National Insurance - Wikipedia
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https://en.wikipedia.org/wiki/National_Insurance


The PACE study was publised on 27th Feb 2011.

On the subject of conflicts interest here is the DWP response to a 2nd March 2011 FOI on why they part funded the PACE trial.....

https://www.whatdotheyknow.com/request/part_funding_of_the_pace_trial_b


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The funding was agreed by a previous Departmental Chief Medical Adviser,
who supported PACE due to his combined expertise and academic interest
in this area of work. In his role as Chief Medical Adviser he felt it
reasonable to support this trial, particularly as when the trial was
initially being developed, consideration was given to exploring the use
of a five point measure of work and social adjustment, which would look
at employment and social outcomes for people taking part in the trial.
Additionally, one of the secondary measures considered as part of the
trial, was the impact that the trial would have on ability for
employment and study


We believe that the findings of the trial will contribute to the
continuingly growing evidence base, which informs the development of
health and work related policy, policy based on the large body of
evidence showing that work is good for physical and mental wellbeing and
that being out of work can lead to poor health and other negative
outcomes.
*****************************************

Yet they went on to drop all of those measures in the reporting didn't they claiming that they were not a reliable measure of how successful the treatments were.
 
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Esther12 said:
Yeah, but you can't say the DWP is an insurance company. Even if their policies and personnel seem overly influence by the insurance industry.
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You "cant say it" because you believe it is not a "company". You give your consent to the claim. That's how the illusion works.

I understand the claim of the difference between a private company and a state interest but its fictional. Its a much bigger discussion not worth having on an ME forum.
 
Graded exercise therapy (GET)
GET was done on the basis of deconditioning and exercise intolerance theories of chronic fatigue syndrome. These theories assume that the syndrome is perpetuated by reversible physiological changes of deconditioning and avoidance of activity.
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So the first thing they should have done was establish the existence and nature of deconditioning, and measure activity.

The assumptions are always the first thing to test. Progress is usually made in science by abandoning an unjustified assumption or preconception.

But they have never tested the deconditioning claim, and when objective activity measurement didn't support their model, they dropped it rather than modify or abandon the model.

This whole show has been a farce from the very start.
 
I've submitted a rapid response to the BMJ article yesterday afternoon at 15.45 PM (Brussels time).

I've got a confirmation of it on email, but it still hasn't been posted by BMJ.

I think that's weird because the equally long response by Simon E Kolstoe was published the day the original article was published, on 07/02. So that obviously went faster.

Does that mean my response has been rejected? Don't you normally get confirmation of that or something?

EDIT: does anyone knows how long it usually takes for a rapid response is visible online at the BMJ?
 
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With regard to the Declaration of Helsinki, there is also this bit:
Physicians should abstain from engaging in research projects involving human subjects unless they are satisfied that the hazards involved are believed to be predictable.
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Given that one of the explicit aims was to determine the safety of the therapies concerned and to make predictions about who was most likely to well or badly, this seems like an enormous oversight on their part in such a large study. It's very clear from the data that those who scored lowest on the PF scale were also those most likely to deteriorate or drop out in the GET group, yet no analysis of this has been made.

And whether it is the 1996 or the 2000 or the 2004 version that is being referred to, it doesn't matter. Any changes to the Declaration that materially affected the ongoing consent of the participants should have been addressed at the time. They easily could have said, "We need to inform you that we under obligation to let you know of this additional bit of information (conflicts of interest) about the researchers. We don't think it's a problem, but we have to let you know. Do you still provide your consent?"
It's not hard to do!

ETA: The thing is, this change happened in 2000, well before the trial started. Knowing the scrutiny they were likely to be under from the charities etc, it seems poor to leave it out. They don't even seem to have stated who the lead investigators were, let alone what their affiliations or conflicts were. (Only the names of the immediate centre leader and the institution names of the other centres are given.)
 
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dave30th said:
Moreover, the PACE authors appear to define “conflict of interest” quite narrowly. Just because the insurers were not involved in the study itself does not mean there is no conflict of interest and does not alleviate the PACE authors of the promise they made to inform trial participants of these affiliations. No one required them to cite the Declaration of Helsinki in their protocol as part of the process of gaining approvals for their trial.
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This comment ""just because the insurers were not involved in the study...". needs further questioning. Is there not evidence that in 2003 PDW was Chief Medical Officer of Swiss Re? This is not someone who writes occasional case reports for the company. This is presumably a salaried post for someone having a key role in strategy of medical matters for them. Presumably he reports direct to the board or to a director. What measures were taken to ensure that he was not pursuing the policy of the company? How was the company not involved if its Chief Medical Officer was?
 
Michiel Tack said:
I've submitted a rapid response to the BMJ article yesterday afternoon at 15.45 PM (Brussels time).

I've got a confirmation of it on email, but it still hasn't been posted by BMJ.

I think that's weird because the equally long response by Simon E Kolstoe was published the day the original article was published, on 07/02. So that obviously went faster.

Does that mean my response has been rejected? Don't you normally get confirmation of that or something?

EDIT: does anyone knows how long it usually takes for a rapid response is visible online at the BMJ?
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I think timing can be quite random. I can only think of one rapid response what was not published which was when Alem Matthees wrote to correct a claim that Nigel Hawkes made in a story on the information tribunal - that he had tried to contact Alem. He did put it up on pubmed commons but that has now gone.

Nigel Hawkes has a history of bad reporting around ME this time he surprisingly hasn't condemned ME patients so perhaps the BMJ are learning that it is unacceptable.
 
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