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.
[fright]
[/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:
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".
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.
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.
[fright]
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:
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".
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.
- Check out MEAction's piece on the latest developments here.
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