The PACE data have been released (9 Sept 2016)

[Tom Kindlon]

@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?

The 6-minute walking test data.

 

[Forbin]

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.

There's an older metaphor for being assigned the blame.
​

"You're taking the fall!"

 

[BruceInOz]

The 6-minute walking test data.

Thanks Tom. Sorry, I forgot the 6MWT was included in Alem's list.

Took me a while to find the list of what he did ask for so I thought I'd bring a copy to here in case anyone else can't remember. (I eventually thought to look for the earliest reference to Annie Gsampel - thanks Annie)

In this post: http://forums.phoenixrising.me/inde...e-of-pace-trial-data.41046/page-2#post-661179
Dolphin quotes from Alem Matthees FOI request:

In order to help ease the burden of staff having to perform the required calculations themselves once the relevant data is located and retrieved, I would like to request the following selection of baseline and 52-week followup data on all 640 individual PACE Trial participants for which the data exists, in a spreadsheet or equivalent file with separate columns for each variable:
• SF-36 physical function scores (range 0-100 points) [baseline and 52-week followup];
• CFQ fatigue Likert scores (range 0-33 points) [baseline and 52-week followup];
• CFQ fatigue bimodal scores (range 0-11 points) [baseline and 52-week followup];
• Oxford criteria CFS caseness (does participant meet criteria, yes or no) [52-week followup only];
• Participant-rated CGI scores (range 1-7) [52-week followup only];
• Doctor-rated CGI scores (range 1-7) [52-week followup only];
• 6MWT walking distances (in meters) [baseline and 52-week followup];
• The group which each participant was allocated to after randomisation (i.e. either to APT, CBT, GET, or SMC).

I notice that data for meeting the CDC and London CFS case definitions is not included. Does this cause much of a problem for examining recovery? I presume it will mean we can only place an upper bound on the recovery figures per protocol since having to also not meet CDC and London should reduce the number that recovered (although their recovery paper indicated this was only a small effect).

 

[Sean]

Thank you, Alem Matthees.

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

Except that before the trial results were known the PACE authors themselves described PACE as the "definitive" test of these treatments.

If it was definitive then they have to accept that it was a null result, and that the treatments don't work. ("There was little evidence of differences in outcomes between the randomised treatment groups at long-term follow-up." Their words, not mine.)

If it wasn't definitive then what the hell did they just spend several million pounds on, not to mention more than a decade of our lives, and lost research opportunities elsewhere?

They placed themselves in this position. Nobody else did it to them. Indeed, they were given endless warnings about the mistakes they were making. But they just kept on digging.

Of sympathy I have none.

 

[simeyss]

For anyone wanting to thank Alem Matthees, the deadline for signing the e-card has been extended for a few weeks. Sign and share:

http://www.groupcard.com/c/8l2DPogN98e

 

[adreno]

Does anyone know what Matthees plans to do with the data? Is anyone in contact with him?

 

[trishrhymes]

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.

I agree, but the main task, as I see it is to re-analyse the data according to their own original published protocol.

They've now done this for us for 'improvement', showing 20% in treatment groups, not the 60% they had claimed.

For me, the most interesting omission on their part is the results for their original definition of 'recovery'. All we need to do is count how many patients in each group fulfilled that protocol defined outcome. The fact that they haven't published it so far suggests the results were dire.

Putting these two together should be sufficient to demolish the trial and declare it a null result. The fact that the 2 year follow up has already been published and shows no between group differences simply confirms this.

I think our main problem now is to find ways of publicising this, and getting NICE guidelines, Cochrane review, textbooks, medical training, ME/CFS clinics, doctors, the Medical research council, the Lancet, employers, government benefits agencies, insurance companies, the media including the Science Media Centre etc. to accept the null finding as definitive proof that GET and CBT don't work, and act accordingly.

And all PACE papers retracted and addenda added to any other research papers that have quoted it. And the MAGENTA trial stopped...

And as a bonus, to get the researchers involved to admit publicly and contritely that they have been spinning and pushing a false story about the causes and treatment of ME and CFS!

And pigs might fly!

This is, sadly, only the beginning of the next phase of a very long fight.

But I'm so grateful for those who have taken the fight this far, especially Alem Mathees.

 

[A.B.]

Putting these two together should be sufficient to demolish the trial and declare it a null result. The fact that the 2 year follow up has already been published and shows no between group differences simply confirms this.

What I would like to see is an infographic that simply reports all the outcomes in graph form, with a small note. Then a paragraph on what PACE authors claimed.

Presented like that, everyone can see at a glance that the treatment doesn't work and that the PACe authors are liars and psychopaths that don't mind misleading patients and doctors to advance their agenda.

 

[Cheesus]

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.

Maybe you just need to do some graded exercise and you would be hurling him like a Scottish caber.

Or maybe not...

 

[Snow Leopard]

Does anyone know what Matthees plans to do with the data? Is anyone in contact with him?

I heard Matthees is planning an air-drop with leaflets of the data! Data for all!

https://en.wikipedia.org/wiki/Airborne_leaflet_propaganda

 

[AndyPR]

I asked the question about Alem Mathees distributing the data that he's receives from QMUL of a relative who is a practicing barrister, albeit one not specialising in FOI issues. His answer is

I think it might depend on whether there were any conditions attached to the release. But given the nature of the application and the fact that it was (I understand) being made by one named person on behalf of many others, I would be very surprised if the data was limited in any way. I don't imagine anyone involved in the case thought that it was only the applicant who was interested in it.

So I would think that it can be shared around. And part of the argument as set out in the judgment was that QMUL wanted to restrict any publication because individuals could be identified - and the Court rejected that argument.

So use that as you will

 

[Sean]

Does anyone know what Matthees plans to do with the data?

I heard Matthees is planning an air-drop with leaflets of the data! Data for all!

Somehow I doubt he went to all this trouble just for the lols.

 

[Gijs]

I don't think it is good to release the data to everybody at this time. It is better that Alem contact 2 or 3 independent scienetists to reanalyse the data and produce a publication in a journal.

 

[Cheesus]

I don't think it is good to release the data to everybody at this time. It is better that Alem contact 2 or 3 independent scienetists to reanalyse the data and produce a publication in a journal.

That could be a good idea as it would likely create the biggest media splash, but only if the raw data is released alongside any publication so it can be subject to public scrutiny.

 

[Sidereal]

I don't think it is good to release the data to everybody at this time. It is better that Alem contact 2 or 3 independent scienetists to reanalyse the data and produce a publication in a journal.

I agree.

 

[A.B.]

A publication in a journal, accompanied by press releases by patient organization, as well as a premade infographic suitable for sharing on social media would surely make headlines.

But Alem Matthees can't do it alone. He's going to need help.

 

[slysaint]

@charles shepherd
Is the All Party Parliamentary Group on M.E. aware of this development?

 

[Amused]

I find the statement but haven't yet found a link to the data. (Perhaps I am too excited to be able to see the link...)

We won't get to see the data. The FOI request is for the data to be released to Alem himself. I'm not sure what rules there are about how the data is disseminated from Alem onwards. I'm pretty sure it's not a 'free for all' with anybody being able to access it. But I would expect there to be rules about what happens to the data and how it's used going forwards.

 

[Amused]

A Tribunal has concluded by a 2:1 majority that certain PACE trial data should be disclosed to a member of the public

What does "certain data" mean - only some of the data and not all of it ? And as others are wondering, what pressure will be put on the individual as to what they can do with the information ? Not celebrating until the results from a proper analysis of the full data set are available and the lies everyone has been fed by the bps brigade are made public headline news.

The Tribunal only has jurisdiction to order the release of the data that was requested. No more and no less. So Alem should be getting the data he asked for. Not all the data if he didn't ask for it.

Also, it DOES NOT MEAN that QMUL are obliged to release any other data or even that particular data under this Tribunal judgement to anyone else ie to publish it publicly in paper or online form UNLESS individuals ask for it.

I'm not sure if it creates a precedent whcih means QMUL then have to release similar data to similar individuals who have made or will make future FOI requests. the 28 day period post Tribunal exists for the person taht lost to take legal advice on the implications of either complying or reasons for appeal. ie so that options can be properly considered.

If Alem doesn't get what he asked for, ie QMUL don't release what he asked for by the date set by the Tribunal, then it depends what is contained in the Tribunal's order as to what Alem can himself do next. Only QMUL and Alem were parties to this particular case, so only they can enforce or appeal it.

{Edit: Actually I'm wrong there, apparently there are provisions that once a data set is released under an FOI that dataset must be publically available - I saw Trisha post some extracts from it on another thread about this }

 

[Tom Kindlon]

https://twitter.com/i/web/status/774667307163455488