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

First, I think SW hinted at this in a tweet that essentially suggested that PACE would not be declared poor science at any inquiry I know the letter isn't an inquiry but I think it's indicative of the tenor of continued support (and pressure) that would come from on high. He is well aware of the people who are invested in protecting the integrity of the trial.

The letter seems to have a lot of caveats and is cautiously worded.

The best strategy I can think of is to isolate this London group from the rest of the world as much as possible.
In other words, they will never capitulate. There is no sense trying. But if most of everyone else can see that the trial is nonsense then they will start to look so ridiculous that they will at least need to quietly withdraw.

Will now go back to reading others posts.
 
Andy said:
Do you think they really mean this?
However, the full picture shows that the general approach was to release data responsibility
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Surely they intended to say.....
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What they are trying to say was the only reason they didn't release data was to protect patient confidentiality, and because of "vexatious requests" and all the other usual crap that White and co tried to pull.

The whole thing reads like they just went and asked White about all of this and then just said to him can you write the response for us you know more about it than us.

They seem to think that's a reasonable way to carry out an inquiry.
 
Wondering if, having been a response to a single question during the hearing before the Select Committee last year where J Montgomery said he was unsighted on the topic, this letter is weak enough for the Select Committee to consider calling him back to discuss?
 
So basically they say it was a high quality trial because the MRC funded it, the journals published it, Cochrane said it was high quality, it was co-designed with a patient group, and the protocol and stats plan were public and data available to other researchers. Eminence based science.

And on conflicts of interest - it was supposedly in line with what was normally done at the time, so therefore OK. And on FOI's and release of data they say QMUL was right on the grounds that it won more cases than it lost.

As for this:

''We have not seen evidence that outcome measures were changed in order to achieve a specific outcome.''
Words fail me. How could there be any other reason for changing them? Even SW with his daft ship's course being changed in order to reach the right port metaphor admitted as much.

It's one of the biggest buck passing exercises I've seen. They didn't investigate anything, just trusted everyone else to have done the right thing.
 
Trish said:
''We have not seen evidence that outcome measures were changed in order to achieve a specific outcome.''
Words fail me. How could there be any other reason for changing them?
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Even the authors asserted they did it because the original criteria were too strict, which is another way of saying the original criteria would have produced outcomes unacceptable to them.
 
It would be as inappropriate for the regulator to disregard these indications that the trial was of high quality as to ignore the criticisms that have been expressed. The range of views suggests that the debate needs to be continued, not constricted by regulatory action.
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[My bold]
Fair enough ... so can we finally have a debate on PACE? Because so far the authors and their supporters have refused to engage in one. Their only "engagement" is to cast aspersions at those who strive to debate the science with them. The above comment acknowledges the quality of PACE is not nearly so cut and dried as they might otherwise suggest. Deliberate ambiguity?
Critics of the trial raise concerns that there was a failure to comply with the standards contained in the Declaration of Helsinki over the disclosure of conflicts of interest. One issue concerns the involvement of the Department of Work and Pensions (DWP) as one of the funders. The information that all participants received included this fact and we therefore conclude that this was transparent and must be taken as acceptable to those who chose to take part. Concern has also been raised about potential conflicts of interest on the part of investigators. The trial protocol notes more extensive ‘competing interests’ than were included in the Patient Information Sheet (PIS). The differences concerned the advisory roles of the researchers. These were noted in the protocol but the PIS records only the sources of funding.
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[My bold]
Any one undisclosed CoI would presumably constitute failure to comply with the Declaration of Helsinki. They cite one they deem to not be a failure, yet tail off identifying clear omissions in the PIS ... is that not a failure then? Even though they don't say it's a failure, they don't dispute it.
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.
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They were advising insurance companies to not pay out to patients unless those patients underwent treatments that the authors had trialled and recommended. Seeing as they no doubt saved the insurance companies pots of money by reducing their payouts, they would therefore have assured long term continuance of their advisory roles, so their remunerations assured long term. And the professional kudos that went with that is also a form of personal gain.
However, looking forward, there is a need for further clarification of transparency requirements, particularly as a result of the second tribunal decision, in which a number of arguments raised by QMUL were rejected. The HRA will take this forward as part of its work on transparency. It is entirely proper that trials are debated in the scientific community. One of the objectives of transparency regulation is to ensure that this is possible.
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That debating thing again.
We have not seen evidence that outcome measures were changed in order to achieve a specific outcome. The decisions were made prior to analysis being carried out, as reported in the published statistical analysis plan and corroborated by the minutes of the joint meeting of the Trial Steering Committee and Data Monitoring and Ethics Committee on 10 September 2010. As both the protocol and the statistical analysis plan were placed in the public domain, any differences between initial plans and published results can be identified and their significance debated. The changes were also openly reported in the main Lancet paper of 2011. This seems to us to be an example of the benefits of transparency.
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And again. Oh for some real debate.
 
Great example of sunk cost and escalation of commitment, trying evermore people to the failure of this fake research, giving them motivation to help defend it.

Now any trial criticized for changing their success criteria in order to achieve a more positive outcome can cite this judgment. Overlapping entry and "success" criteria? Same. Conflicts of interest, self-reviews and mutual admiration networks, fast-tracking, broad selection criteria, biasing and cherry-picking patients, monetary gain from paid advisory work, all of this can now be brushed off in any trial done in the UK by simply pointing at this as validation that it's all fine. Telling your participants that the treatment they're testing works during the trial, basically promising a cure? All good and proper. Registering and then arbitrarily changing protocol? No problem, just hide it well enough and nobody cares.

The judgment also makes a point that it's probably all good since Lancet hasn't retracted it (and Cochrane too but it's kind of linked). It's likely that another high profile retraction could sink the Lancet for good, showing it has learned absolutely nothing from the Wakefield paper and cannot be counted as a reliable arbiter of science, as if the recent EAT-Lancet debacle wasn't bad enough. Every institution has been ensnared, the rope firmly around everyone's neck. If this falls, they all feel the pain.

Destroying the credibility of all UK medical institutions, all for the stupid ideological IAPT project. I guess we have our first confirmed case of actual mass hysteria driven by unhelpful illness beliefs. It's usually one possible explanation but here, clearly, madness is the driving force.
 
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