QMUL responds to Davis/Tuller/Levin/Racaniello PACE data FOI

[Daisymay]

http://www.virology.ws/2016/01/19/at-least-were-not-vexatious/

At least we’re not vexatious
Dave Tuller
19 JANUARY 2016

On 17 December 2015, Ron Davis, Bruce Levin, David Tuller and I requested trial data from the PACE study of treatments for ME/CFS published in The Lancet in 2011. Below is the response to our request from the Records & Compliance Manager of Queen Mary University of London.

 

[Dolphin]

This exemption is subject to the public interest test. While there is a public interest in public authorities being transparent generally and we acknowledge that there is ongoing debate around PACE and research in to CFS/ME, which might favour disclosure, this is outweighed at this time by the prejudice to the programme of research and the interests of participants. This is because participants may be less willing to participate in a planned feasibility follow up study, since we have promised to keep their data confidential and planned papers from PACE, whether from QMUL or other collaborators, may be affected.

This looks to me like a red herring. The latest follow-up I recall being talked about was at five years. The trial is over now longer than that.

 

[Kati]

Any release of information under FOIA is a release to the world at large without limits

I wonder if we ask astronauts on the International Space Station to make a request, that we could have a successful appeal? The world at large, I mean, is restricted to the atmosphere.

 

[Sasha]

@Daisymay, would it be OK if you didn't quote the full thing here, so that Virology Blog can be rewarded with the traffic?

I also wondered if you might want to amend your title to "QMUL responds to Davis/Tuller/Levin/Racaniello PACE data FOI request" to distinguish it from all the others?

(Don't want much, do I?! )

 

[Kati]

@ballard's cartoon is again quite appropriate here, and as she said it herself in previous posts feel free to use on social media.

 

[TiredSam]

The primary outcomes requested are also exempt under s.22A of FOIA in that these data form part of an ongoing programme of research.

Is this consistent with what the PACE authors wrote in their Lancet reply today:

This is because, as explained in the Article,2 the follow-up study was not, as suggested by Coyne and Laws, a continuation of the trial (with or without crossover), but rather a naturalistic follow-up after trial completion.

 

[sarah darwins]

This looks to me like a red herring. The latest follow-up I recall being talked about was at five years. The trial is over now longer than that.

So are they going to schedule another follow-up for, say, 10 years? Probably. Ad infinitum.

 

[Daisymay]

@Daisymay, would it be OK if you didn't quote the full thing here, so that Virology Blog can be rewarded with the traffic?

I also wondered if you might want to amend your title to "QMUL responds to Davis/Tuller/Levin/Racaniello PACE data FOI request" to distinguish it from all the others?

(Don't want much, do I?! )

No problem, done, I should remember to post only part of articles.

 

[Sean]

While there is a public interest in public authorities being transparent generally and we acknowledge that there is ongoing debate around PACE and research in to CFS/ME, which might favour disclosure, this is outweighed at this time by the prejudice to the programme of research...

Yes, all those pesky facts being brought to light at the wrong time could really cramp the style in which some people have become accustomed to operating.

 

[Forbin]

Is the form by which data was collected from the patients known? I can't see how it could identify a patient unless it was in essay form ("My fatigue has abated to the point where I am once again able to fulfill my obligations as King of Ruritania.")

A patient might be able to pick out their own data (say, if they're the only one who walked 123 paces), but no one else would know this.

I wonder if they are concerned with polluting the patient pool by letting them see the responses of other patients - a concern which apparently wasn't foremost in their minds when they sent out their cheer-leading newsletter.

 

[Woolie]

My fatigue has abated to the point where I am once again able to fulfill my obligations as King of Ruritania."

 

[snowathlete]

How silly is that response? Wow.

For any further follow up (hard to see the point as the last one proved it was a failure already) to be jeopardised in any way the data must be damning. How else could it be a problem? If the data was sound then there would be nothing new to criticize and therefore no participants would be put off responding to follow up for this reason. In fact, logically, if it was sound then much of the current controversy would be resolved, increasing the chance of participants responding. So you're left wondering, more than ever, what do they know about how bad the data is that can make them take this approach of such illogical refusal?

 

[Esther12]

Is this consistent with what the PACE authors wrote in their Lancet reply today:

Yes - they can count pretty much anything.

 

[halcyon]

The primary outcomes requested are also exempt under s.22A of FOIA in that these data form part of an ongoing programme of research.

I guess the PIs are going to keep riding this five million pound hobby horse until they retire. This means we can look forward to more papers from them, hurrah.

For your information, the PACE PIs and their associated organisations are currently reviewing a data sharing policy.

Oh I feel better already.

 

[Esther12]

It's always good to get more of their excuses on the record.

 

[Kati]

From tweetosphere:

Michael VanElzakker (@MBVanElzakker)
2016-01-19, 6:29 PM
"We can't anonymize Likert scale data." Hard to convey in 140 characters just how laughable this is. #opendata twitter.com/profvrr/status…

Then this:

Michael VanElzakker (@MBVanElzakker)
2016-01-19, 6:29 PM
Swap every name for a number. Done.

As he is answering Vincent Racaniello's tweet:

Vincent Racaniello (@profvrr)
2016-01-19, 1:41 PM
At least we’re not vexatious -Queen Mary Uni denies of our FOI request for #PACE trial data #mecfs @davidtuller1 bit.ly/1Pf6cR0



Good times.

 

[Esther12]

Their claims about it being personal data are so absurd to anyone with any familiarity with the data actually being requested. Anyone know if there will be a record of the tribunal session publicly available? Would love to see their arguments on this under cross-examination.

 

[Mrs Sowester]

Hi all, New here and my biggest problem is cognitive function so please forgive me if I'm overly simplistic or missing something, but...having read the QMUL response are they suggesting the request for data release includes recorded patient interviews/therapy sessions? Is this where the sticking point lies?
The ME/CFS community and researchers only want the numerical data for analysis, which is obviously easy to anonymise - but if the PACE team distort this request by suggesting release of data includes highly personal and identifying audio recordings then they have a good excuse to refuse the release of data on the grounds of patient confidentiality.
The data release request published is very precise in what data it is asking for - maybe, to avoid (deliberate?) confusion they need to stress what data they are not requesting.

 

[jimells]

I wonder if they are concerned with polluting the patient pool by letting them see the responses of other patients - a concern which apparently wasn't foremost in their minds when they sent out their cheer-leading newsletter.

having read the QMUL response are they suggesting the request for data release includes recorded patient interviews/therapy sessions? Is this where the sticking point lies?

No, they are only concerned with hiding the data at all costs. I believe their strategy is to delay, delay, delay until they get the law changed. Considering the current government's obsession with "security" and secrecy, this probably won't be a problem.

At this point we don't even need the data to show the trial is junk - the latest followup paper admits a null result. So what is there to hide? I believe it is evidence of harms caused by their worthless and damaging GET "treatment". They are clearly damaging their reputations in academic circles, but deliberately hiding adverse effects could put them in serious legal jeopardy.

@Mrs Sowester welcome to the forum. I hope you find it helpful.

http://www.ncbi.nlm.nih.gov/pubmed/26521770

Rehabilitative treatments for chronic fatigue syndrome: long-term follow-up from the PACE trial.
Sharpe M1, Goldsmith KA2, Johnson AL3, Chalder T4, Walker J5, White PD6.

There was little evidence of differences in outcomes between the randomised treatment groups at long-term follow-up.

 

[JohnCB]

This looks to me like a red herring. The latest follow-up I recall being talked about was at five years. The trial is over now longer than that.

According to the ISRCTN Registry ISRCTN54285094 ( PACE)(sorry I can't post links yet)
Overall trial start date
14/06/2004
Overall trial end date
01/07/2011
(sorry I can't post links yet)

Do those dates mean anything?