Over $1 Million Spent Fighting PACE Trial Data Release

Cort

Founder of Health Rising and Phoenix Rising
Staff member
University Spends Big Bucks To Lock Down Data

The University behind the PACE trial is fighting hard to ensure that no one gets a look at the raw data of the PACE trial. ME Action revealed that the Queen Mary University of London (QMUL) has spent over $300,000 (250,000 pounds) on responding to the request for the release of the raw data of the PACE trial.

It's no surprise. The imbroglio over the huge trial has already left the University in hot water both with patients and researchers. Earlier this year 42 researchers asked that Lancet do an independent analysis of the data. Several statisticians have publicly blasted the study. Over 12,000 patients have signed a petition blasting the trial.

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[/fright]MEAction reported that Mr. Alem Matthees was willing to reanalyze the data at no cost to QMUL. When QMUL refused, Matthees took the matter to the UK Information Commissioner which granted his request. QMUL has spent over $300,000 appealing that request. A ruling on the appeal is expected soon. Find out more here.

The changes to the published trial protocol are just one of many problems associated with the trial. Determining that changes significantly bolstered the success of the trial would undercut PACE trial authors assertion that they were done for other reasons, and provide a wedge issue that could put more pressure on Lancet to to revisit this issue. Plus, once the data is out it is presumably out and subject to review by other statisticians.

Lancet Skewered By Data Requests

This isn't the first time a lot of money has been spent blocking efforts for an independent re-analysis of the data. Richard Horton, editor of the Lancet, one of the most respected medical journals in the world, was reported saying in 2011 that the requests for the data have cost the British taxpayer over $750,000 or over $1,000,000 US. He called the claims "vexatious".

Ironically this is the same Horton who just the year before stated:
Simply accepting a scientist’s assurance that data are accurate and reliable is no longer enough. Scientists will have to make their data available for independent audit…. It is easy to brand the blogosphere as universally damaging and defamatory. But …while some critics do enjoy abusing scientists, others ask tough and illuminating questions, exposing important errors and elisions. These critics have an important part to play in shaping scientific debate and dialogue…
Lancet asserted in 2011 that no problems with the study are present stating that "Your complaint and (the authors’) response were discussed at the highest management level and this group of executive editors was fully satisfied that there were no grounds whatsoever on which to take further action…From an editorial perspective, the case is now closed."

Lancet, however, promised to respond to the recent request for a re-analysis of the data by 42 scientists earlier this year. Eight months later it has not.

"Vexatious" Requests

Peter White, the lead author of the trial, has called attempts to get at the raw data "vexatious".
“believes that the requests are clearly part of a campaign to discredit the trial” and that “the effect of these requests has been that the team involved in the PACE trial, and in particular the professor involved, now feel harassed and believe that the requests are vexatious in nature.”
Vexatious is a legal term which refers to claims that are without merit and which are done solely to produce damage. The PACE trial authors have also stated that they feel that their reputations have been besmirched by the controversy.

Horton and White, of course, are facing much more that bloggers; they're facing calls for data release and analysis from respected researchers and statisticians.

Cost of PACE Trial Nearing $10,000,000

An independent analysis which backed the findings of the trial would, of course, make their problems go away - and would have saved the British taxpayers a boatload of money.

It appears that attempts to block release of the data may have added almost a 1/5th ($1,300,000) of the cost of the $8,000,000 original trial, which was already easily the largest ever to occur in ME/CFS.

The PLOS journal's request this year that the PACE authors release the raw data from one study has apparently not been complied with, but the UK Information Commission holds to its original ruling regarding the data release the cat may be out of the bag soon enough.
 
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asdfasdf

New Member
Give me a goddamn break, people. What's more likely, that Richard Horton didn't know what the hell he was talking about when he was quoted about the £750,000 figure or that the actual amount is what QMUL stated in their FOI response, which was that the amount spent thus far is a little over £250,000?
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
Conclusion: they have something to hide.
Bingo!

What else could justify this? Ron Davis doesn't want to throw the PACE trial to the wolves; he wants a respected independent reviewer to judge the study on its merits. That's how he operates - but even that is apparently too much.
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
Give me a goddamn break, people. What's more likely, that Richard Horton didn't know what the hell he was talking about when he was quoted about the £750,000 figure or that the actual amount is what QMUL stated in their FOI response, which was that the amount spent thus far is a little over £250,000?
I just can't believe that Horton - speaking in 2011 - not 2016 - 2011 was right about the $750,000 being spent on FOIA requests, etc. but who knows? I doubt that anyone thinks Horton is objective at this point.
 
Give me a goddamn break, people. What's more likely, that Richard Horton didn't know what the hell he was talking about when he was quoted about the £750,000 figure or that the actual amount is what QMUL stated in their FOI response, which was that the amount spent thus far is a little over £250,000?
£250,000 relates to very specific costs that were incurred in 2016 related to one specific tribunal hearing. They don't relate to the other expenditure. See:
https://johnthejack.com/2016/06/29/using-public-money-to-keep-publicly-funded-data-from-the-public/
 
The PACE Trial cost a lot more than expected when they didn't reach their recruitment target: they had to get an extension grant. There is a chance that somewhere along the way, in Richard Horton's head this money became due to complaints by patients (maybe the PACE trial authors told him the delay was due to patients but these delays relate to the period before any of the data was published so are not relevant to most patient requests and all the comments from 2011 on when the main PACE paper was published).
 

LondonPots

Active Member
Hell, but they make me embarrassed to be English. Why is raw data not routinely required to be made available? Any old bollox could be claimed from any experiment, otherwise. Like theirs.

I am feeling more and more contempt for the scientific establishment, with how sloppy their systems of excellence and integrity seem to be.
 

Lidia Thompson

New Member
Sorry but it gets even worse I’m afraid. First, the GMC imposes limits on Dr Nigel Speight’s license, a (much-loved) paediatrician in the UK who has been involved in many cases throughout Europe where children with ME/CFS are being threatened with removal from their families by the social services. Soon after that, we hear that the Bristol group publish a protocol for the study of Graded Exercise Therapy in children and young people with ME/CFS.
This will be a non-blinded study with self-reported outcomes … IN CHILDREN … who are so easily ‘persuaded’.
Dr. Esther Crawley is part of this study. She is involved with AYME which is the only ME/CFS charity in the UK which did not ask for the release of the anonymised PACE trial data.
This is such a tragedy.
http://www.meassociation.org.uk/2016/07/bristol-group-publish-protocol-for-study-of-graded-exercise-therapy-in-children-and-young-people-with-mecfs-6-july-2016/
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
Sorry but it gets even worse I’m afraid. First, the GMC imposes limits on Dr Nigel Speight’s license, a (much-loved) paediatrician in the UK who has been involved in many cases throughout Europe where children with ME/CFS are being threatened with removal from their families by the social services. Soon after that, we hear that the Bristol group publish a protocol for the study of Graded Exercise Therapy in children and young people with ME/CFS.
This will be a non-blinded study with self-reported outcomes … IN CHILDREN … who are so easily ‘persuaded’.
Dr. Esther Crawley is part of this study. She is involved with AYME which is the only ME/CFS charity in the UK which did not ask for the release of the anonymised PACE trial data.
This is such a tragedy.
http://www.meassociation.org.uk/2016/07/bristol-group-publish-protocol-for-study-of-graded-exercise-therapy-in-children-and-young-people-with-mecfs-6-july-2016/
Ouch.....
 

LondonPots

Active Member
I wonder if it's time to send letters to all our UK MPs, asking to know why research raw data used in public policy is not being made available to all. Surely government transparency would automatically require this. There can be no commercial 'secrets' at risk. And/or a No 10 petition.
 

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