The PACE data have been released (9 Sept 2016)

[osisposis]

Yes, I didn't even notice "pulled out on FUNDING" language here. @osisposis I believe you're thinking of the recent Canadian kerfuffle.

-J

ok, sorry, to much to keep up with

 

[medfeb]

I doubt that they've given up, however. I think they can feel pretty confident that the Lancet will support them no matter how poor their data, so they can continue other, very similar trials with impunity. Even if PACE were totally discredited (er.... moreso), imply that it was only this one trial, not the thinking behind their actions that is to blame.

That's my concern - they will just point to all the other trials and say that even if PACE is discredited, their theory and treatment approach are still valid, at least for some subset of "CFS" patients

But their theory that the debility of the disease is the result of deconditioning which is the result of activity avoidance and false cognitions has nothing to do with the disease described by the CCC and the IOM. The IOM report and IOM chair Clayton and panel member Rowe were very clear that this disease is not deconditioning and not a psychogenic problem

Beyond disease theory, these studies use patient selection methods in research that do not require hallmark features required by the CCC but the methods do allow patients with mental illness - producing cohorts who do not have ME but who could respond to their treatment approach.

Its fantastic to have the QMUL ruling and I can't wait to see what the data says.

But if we have to fight this battle one data request and one study at a time, we will be here for decades. I think we need to amp up our demands that the disease described by CCC, the ME-ICC and the IOM has nothing whatsoever to do with this disease theory and these patient cohorts. (Lots of statements from recent reports to support that view.) It is medically unethical and against the standards of "evidence-based" medicine to base statements about the nature of the disease and its appropriate treatment on studies in patients who do not have the disease. That would never be accepted in any other disease and we need to demand no less for this disease.

 

[osisposis]

ok, I remember now, lols

 

[JayS]

I wonder about the ramifications for the Cochrane Reviews. Medicine is still going to refer heavily to them, and they certainly carry more weight than the IOM report. It would be terrific if they were inclined to shift gears in how they choose their approach to analysis, but how likely is it to happen, with or without PACE, and how soon? PACE could still linger for some time even after many consider it discredited, given Lancet's history, after all.

 

[Denise]

I think we need to amp up our demands that the disease described by CCC, the ME-ICC and the IOM has nothing whatsoever to do with this disease theory and these patient cohorts.

Totally agree!

 

[Kati]

I wonder about the ramifications for the Cochrane Reviews. Medicine is still going to refer heavily to them, and they certainly carry more weight than the IOM report. It would be terrific if they were inclined to shift gears in how they choose their approach to analysis, but how likely is it to happen, with or without PACE, and how soon? PACE could still linger for some time even after many consider it discredited, given Lancet's history, after all.

What about all the papers referring to PACE, what about the PACE follow up papers including the one in PLOS One which allowed authors to not give out the data for? These should be retracted.

 

[Denise]

What about all the papers referring to PACE, what about the PACE follow up papers including the one in PLOS One which allowed authors to not give out the data for? These should be retracted.

And the textbooks that need to be rewritten....
And handouts given to patients and continuing medical education and on and on.....

Also - how certain can we be that these authors will now completely STOP publishing based on PACE data?

 

[TiredSam]

Also - how certain can we be that these authors will now completely STOP publishing based on PACE data?

I think until they are clearly sacked, disgraced or thrown under a bus they are likely to keep spouting self-justificatory bollocks at every opportunity.

 

[JaimeS]

OMG @TiredSam , the blurb below your name!

 

[John Mac]

or thrown under a bus

Careful @TiredSam you know how they like to twist what we say on PR

 

[Mark]

They've had a month to strategise and consult legal experts (of the kind who likely don't mind playing dirty).

I think the ME community need to also take a breath after celebrating and think about how to proceed moving forward with the release of data. I know that the info is in the hands of Alem Matthees who I understand is not well.

Perhaps some legal advice of our own would be good.

I would not put it past the QMUL group to have some strategy in play pending what we do next.

FWIW, I think the more all people know and have the facts the better our situation is. We need to ensure that PDW does not try to hijack the narrative again.

I don't personally believe there is any legal risk whatsoever to releasing the data into the public domain now, but that is a matter for Alem to decide. It's normal practice for the data to be released publicly, I think, but I don't think there's any obligation on Alem to release it. The only strategic consideration I can think of is that it might be wise for anybody considering publishing research analysing this data to publish their protocol before the data is released. Otherwise they are open to the allegation that they decided on their protocol after they had seen the data. That applies also to non-academic analyses of the data, i.e. any analyses that the patient community might wish to undertake.

 

[TiredSam]

Careful @TiredSam you know how they like to twist what we say on PR

I would like to thank my learned friend for urging caution. For the avoidance of doubt that was a metaphor for being disowned by QMUL. Furthermore, I would like to make it clear that I don't have a bus drivers licence.

EDIT: And further and in the alternative, I would ask the court to take judicial notice of the saying "I wouldn't trust him as far as I could throw him", which if accepted proves that I couldn't throw Peter White anywhere.

 

[BruceInOz]

Live now: : http://www.meaction.net/2016/09/09/qmul-releases-pace-data/

@JaimeS, in this blog you quote @Tom Kindlon as saying

Looking at how the objective data relate to the subjective outcomes will also be very interesting.

But Alem's request did not include data for the objective measures, so I'm not sure how this will be possible. What did you have in mind Tom?

 

[Wolfiness]

That's my concern - they will just point to all the other trials and say that even if PACE is discredited, their theory and treatment approach are still valid, at least for some subset of "CFS" patients

I understand why people are pessimistic when they've been fighting this fight for so long and kept thinking the tide was turning only to get more obstacles and defeats and slaps in the face. But PACE was supposed to produce the decisive evidence in this long-running dispute. Without it the whole edifice of crap has nothing to stand on, especially if we end up not merely with PACE's absence but its disgrace.

And especially if now with the OMF's work we can come up with a more seductive narrative for the public, replacing 'whiny hypochondriacs need to exercise' with, say, 'downtrodden patients in David v Goliath revolution and vindication'. What the ME massive is doing here is something a LOT of people, not just those neglected and scorned by the establishment but anyone who cares about enlightenment values, egalitarianism, rationality - can empathise with and be inspired by. I don't want to jinx anything but everyone who has contributed even to this as yet partial victory, you should be very proud of yourselves. You've done something amazing. And we need to capitalise on it by getting the story across somehow.

 

[Wolfiness]

I think until they are clearly sacked, disgraced or thrown under a bus they are likely to keep spouting self-justificatory bollocks at every opportunity.

I'd settle for discredited. The dustbin of history is the dustbin of history.

 

[Kati]

Also - how certain can we be that these authors will now completely STOP publishing based on PACE data?

They won't. They have plenty of support around for them to continue their antics. This is only one example.
http://www.sciencemediacentre.org/cbt-does-it-really-work/

Also, stopping Nigel Speight from getting involved in ME practice and even speaking in public. The Magenta trial. Speaking engagement. Knighthoods. O'Sullivan's book. Societies awarding bravery prizes. Lancet and Plos remaining very silent (deafening)... It doesn't end here. It's not over.

 

[Denise]

.... It doesn't end here. It's not over.

True.

Does anyone know if there is a plan in place for the analysis of the data that Alem is due to receive?
Who will do it? When? How long will it take? Who will corroborate it?

 

[Dolphin]

http://retractionwatch.com/2016/09/...-loses-phd-controversial-data-to-be-released/

Retraction Watch
Tracking retractions as a window into the scientific process

Posts you may have missed: Student loses PhD, controversial data to be released

We’ve got some late-breaking news to report — plus, it’s been a busy news week overall, and some of our email alerts didn’t go out, due to a programming glitch. Below, here are some recent stories you may have missed.


A tribunal at Queen Mary University of London has decided to disclose the data from the controversial PACE trial, which tested various therapies for chronic fatigue syndrome. For critics of this study, this has been a long-awaited decision.

 

[Kati]

Blogpost by @Dr Speedy :
http://niceguidelines.blogspot.ca/2016/09/the-statement-which-we-should-have.html

The statement which we should have issued

We sincerely apologize for not releasing the data earlier. We now realise this was a big mistake; even more so as the trial was funded with more than 5 million pounds of public money and therefore the public has a right to see the raw data.
We also sincerely regret ignoring our own NULL effect and making it make it look as if our two favorite treatments ie CBT and GET are moderately effective; it was a major oversight on our side to suggest that 22% of people recovered courtesy of CBT and GET;
We now realise that we have been exposing people with this disease for at least 25 years to ineffective and harmful treatments and that hundreds of thousands of patients have been severely harmed by especially GET;
We also regret decades of ridiculing patients with a debilitating neuro immune disease and pretending it to be a functional disorder, MUS, PPS or words to that effect

Continue reading at the link above... All worth it.

 

[alex3619]

Functional disorder = fictional label, the disorder/s and disease/s are real, but putting an empty label on them does not give us better understanding and hence pave the way to a cure. Functional disorders, or any of the alternative labels, are not even science fiction, they don't rate that well.