PACE trial TSC and TMG minutes ordered released

Yes, I think that I found the uncritical presentation of some of QMUL's misleading arguments frustrating, but it could be that they know to just try to avoid disputable section within a ruling. It's the overall judgement what really matters.

Thanks for all your work on that. Maybe it helped affect the overall judgement, even if there were parts that still seemed strangely respectful of the processes around academia.

Oh... I didn't take it like that, but I guess that is an alternative reading.

 

In case anyone is interested, this judgement is now on the ICO website: https://ico.org.uk/media/action-weve-taken/decision-notices/2018/2258289/fs50687719.pdf

20 February 2018... I wonder when we're going to get those minutes, or hear that QMUL appealed?

Also, when Carol Monaghan asked Mark Walport about concerns over PACE, he used supposed TSC approval for protocol deviations occuring before data was available as a key part of his response (I've not seen the PACE trial researchers claim that they had approval from the TSC for their changes to their recovery criteria): http://parliamentlive.tv/event/index/6a03dbf8-ff09-4dca-b681-477d184c44c0?in=09:50:55

Maybe further highlighting the legitimate public interest in seeing exactly what was discussed? I think that it's getting harder and harder for QMUL to appeal.

 

I think this is an important video snippet.

I know Mark Walport well from days in rheumatology and he is a highly intelligent individual. The implication of that is that he will absolutely see that the design of PACE makes it valueless. However, in this video he appears not to be aware of the problem. He says he has had some briefing. He then refers to some criticism of methodology but appears to think that this has been answered by the authors saying that they changed outcome measures before analysing the data. This implies that he thinks that this is the only substantive problem, when of course the overriding problem is built into the design from the outset.

One has to conclude that Mark Walport simply has no idea of the real problems with PACE. Presumably he has not read the trial publications. It would be immediately clear to an academic rheumatologist from the abstract of the main PACE paper that it was seriously flawed. Mark is an astute politician but the hallmark of a really astute politician is that they do not knowingly make themselves look stupid. I assume he simply does not know.

Having been head of medicine at the Hammersmith and moved on to posts in Wellcome and government admin Walport is perhaps the single most relevant person if one were to ask who represented the British establishment Medical Science viewpoint. And I do not mean establishment in a pejorative sense. Mark has a deep understanding of the complexities of medical research. He cannot possibly not see that PACE is absurd if he puts his mind to it.

I will email Carol Monaghan. Waldport says he will write about PACE. I think if he can be engaged seriously he will not be able to sit on any fences, as he seemed to do here.

 

This gets repeated a lot. Have the authors ever said exactly what then prompted them to make the changes?

eta: it is baffling that all these great men of science, and academia don't require a definitive and congruous answer to this.

 

Not in any way that makes sense.

 

Being able to analyse FINE trial data and appreciate how to turn a null result into a positive one?

 

I'd forgotten that. Would that have been to check for evidence of harms? It would certainly have also indicated that none of the treatments were dramatically more effective than SMC alone in the way thy had expected CBT/GET to be.

 

I was just looking through reference 12 they referred to, and it had some stuff on blinding: http://www.ich.org/fileadmin/Public...Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf

I wonder if 'blind review' of data is possible in an open label trial?

In the document the do still talk of blind review of data for an open-label trial though.

As everyone always thought, the statistical analysis plan is meant to provide more detail on analysis laid out in the protocol, rather than a dramatic change of every outcome, making it easier for the researchers to claim success.

 

This came to my mind. I think it is reasonable to assume that 'before the data were analysed' means nothing in the context of an open trial like this. Those involved will be constantly discussing with each other how people are getting on and if it is open label it will be obvious to everyone what the 'data' are going to show.

I wonder at what stage that newsletter saying how well people were doing was sent out? Was that by chance before the switch in criteria?

 

Wouldn't that same representative of the patient representative body, acknowledge at the time, that they would need to consult with colleagues to confirm views expressed were indeed representative of their colleagues/members/the wider needs of PwME? If not, would it not be more likely, that they believed that their views represented the best interest of their colleagues/members/the wider needs of PwME?

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Why would this not also apply to the patient representative body?

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Other than the dismissal of the COI issue raised, this aspect of the ruling is what I find most troubling, and find "chilling". Essentially, representatives of a patient representative body would be allowed to express views privately, views which may significantly be removed from those they present publicly. As such, both patients and carers - be they members, supporters, or otherwise - and to a lesser degree perhaps, colleagues - would be unaware of which views have been expressed on their behalf.

This aspect of the ruling could well set a precedent, with far-reaching and 'unintended' consequences, particularly across the charitable sector?

Wishing everyone improved health and every happiness, John

 

Maybe there's a view that private bodies should be able to present different views in private than they do in public? The UK's FOIA doesn't seem founded on that radical a commitment to transparency, and parts of it seem intended to allow quite some management of the public's understanding of important matters.

At this point, it is Action for ME that should be doing what it can to inform their members of exactly what they had been doing behind closed doors.