Information Commissioner's Office orders release of PACE trial data

[sarah darwins]

The more I see of this stuff, the more I'm reminded of some monstrous hybrid of Kafka and Joseph Heller. But this stuff goes way beyond parody.

The reasons cited for Queen Mary’s denial of the request relate to sections of the Act that allow researchers to withhold data prior to publication of the papers on which they are based. In this case, the researchers claimed that since they were continuing to publish papers, they were exempt from releasing the data

What friggin' planet are they on? The PACE trial report was published 4 years ago, wasn't it? On this basis, any researcher could withhold data indefinitely. "I'm thinking about publishing another paper next year."

St Mary's argument is pretty much a flat out recognition that they're just rehashing the same old stuff and managing to find new "meaning" in it. Impressive, given what bunk the data was in the first place.

side note: I think MEAction's report has that first sentence I quoted slightly back to front (but we know what they meant). I think it should read: "relate to sections of the Act that allow researchers to withhold data prior to publication of papers based on that data."

 

[Sidereal]

Real scientists share raw data, it happens frequently. There is zero justification for their claims that it will lead to identification of participants. How can you identify someone from their test scores especially given that demographic data have not been requested, this is total bullshit. An embarrassing desperate flailing attempt to withhold access to data to spare themselves from further embarrassment when per-protocol re-analysis shows almost no one recovered.

 

[mfairma]

The irony is that the more they resist release, the more strongly and clearly they demonstrate, to the outside world, not just bad science, but bad faith.

 

[Yogi]

As part of the argument to not release they even tried to use the following argument:

"It related to an illness to which a certain amount of social stigma was attached."

Again any such stigma has arisen from these small number of psychs and media reporting of that trial spun by themselves.

 

[Ecoclimber]

One of the reasons for the retraction of the xmrv research paper in Science was the exclusion of certain critical material that was omitted in the original paper. How else can other scientists replicate the original authors findings if the data is hidden? This is a strigent requirement in biomedicial research.

 

[Denise]

One of the reasons for the retraction of the xmrv research paper in Science was the exclusion of certain material that was obmitted in the original paper. How else can other scientists replicate the origianl authors findings if the data is hidden? This is a strigent requirement in biomedicial research.

(I am not dissing what @Ecoclimber says)

Let's not forget that PACE isn't strictly biomedical - but is more like lots of biopsychosocial hoohah.

 

[cornwall13]

I dont know much about law, but if you look at the 1st tribunal decisions, alot of the appeals are dismissed.

http://www.informationtribunal.gov.uk/Public/search.aspx?Page=1

I think bcause the ICO rules in favour of releasing the data, i think they may struggle overturning thedecision. .... I think

 

[Dolphin]

Just to remind people that the personal data isn't very personal (and doesn't even include people's ages, gender, location, etc.):

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).

If I was in a trial, I would want this data to be released so that a true record of the findings was available rather than spin from a particular research team that were known to be biased.

 

[Sasha]

BTW, guys, anyone who wants to ensure that that data get published should be signing this currently 8,000-strong petition because one of the points is that we:

– call upon the study authors to publish the recovery outcomes according to the analyses specified in the trial’s protocol [4] and to give independent researchers full access to the raw data (anonymised by removing trial identifiers and all other data superfluous to the calculation, such as age, sex or location). #MEAction undertakes to meet any reasonable cost of analysis or data preparation;
http://www.meaction.net/why-the-pace-trial-authors-should-publish-the-planned-recovery-analyses/

So sign it now and send it to everyone you know. The target is 10,000 and we're nearly there!

 

[sarah darwins]

I think bcause the ICO rules in favour of releasing the data, i think they may struggle overturning thedecision. .... I think

I do hope you're right. Though I have to think that people who come up with some of the plainly ridiculous arguments mentioned in that piece will surely fight the decision.

 

[snowathlete]

Queen Mary’s reasons for denying the request

“This isn’t a purely scientific debate; this is going to the heart of the integrity of the scientists who conducted this study.”

Those are their own choice of words. Is the data worse than we've ever imagined, to the point where it would bring those who conducted it into question? If the data requested is so unimportant as to justify its exclusion in the first place then, then why make such a statement? Seems very strange thing to say. Then again, if the data is so innocuous then why such determination to keep it secret in the first place?

Regardless, both patients and the wider scientific community want to see the findings for themselves, not be fed only a biased viewpoint based on part of the study data.

This should have been released years ago. It's very anti-science that it wasn't.

 

[Dolphin]

I wonder could pressure be put on Queen Mary, University of London not to appeal so that the data can be released and also so that a lot of money isn't spent on legal fees.

 

[Sidereal]

Is the data worse than we've ever imagined

This is what I'm wondering.

 

[worldbackwards]

"...this is going to the heart of the integrity of the scientists who conducted this study.”

If they're prepared to lie about the outcomes of their follow up study in such a barefaced manner, haven't they already completely thrown away the integrity argument ?

 

[Sean]

Ah, shit, likes for everybody.

 

[Esther12]

I wonder could

Is there a danger that even that would be seen as some sort of terrorist activity?

I don't know, but it seems that patients are expected to act in an amazingly docile way while trying to gain access to information that is so important to them. Wanting to encourage a public body to do the right thing could be totally beyond the pale.

 

[Ecoclimber]

(I am not dissing what @Ecoclimber says)

Let's not forget that PACE isn't strictly biomedical - but is more like lots of biopsychosocial hoohah.

I know but they like to spin it as though it's on the same level as biomedical research. I rememer the UK researchers hammering about the need for replication. I don'tt know what raw data or datasets that have been hidden or obfuscated but they should not be identifiable patient info.

There was a similar uproar here in the States concerning the failure to release hidden datasets on MMR vaccines and autism caused a claim of bias in the results. The research paper was retracted. So this is not first go-around on such an issue.

How a Now-Retracted Autism Study Went Viral -- Again

An autism study that was slammed by experts and retracted this week by its publisher is still alive and well on the Internet, thanks to what critics are calling a perfect storm of lax publishing standards.

Experts say the lone study author played fast and loose with statistics to show a link between autism and the MMR vaccine for measles, mumps and rubella, some experts going as far as saying that the author deliberately did this, but the dubious results took off online anyway, quickly going viral.

 

[SOC]

Queen Mary’s reasons for denying the request

“This isn’t a purely scientific debate; this is going to the heart of the integrity of the scientists who conducted this study.”

Uh... yeah... and...?

 

[Sean]

rememer the UK researchers hammering about the need for replication.

Replication alone is not enough. Replicating bad results with the same bad methodology is not acceptable.

 

[Dolphin]

Just to remind people that the personal data isn't very personal (and doesn't even include people's ages, gender, location, etc.):

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).

If I was in a trial, I would want this data to be released so that a true record of the findings was available rather than spin from a particular research team that were known to be biased.

@Graham said:

It's astounding that the PACE team tried to claim that this data could threaten patients' anonymity. I can just imagine getting the data 60, 65, 28, 25, 10, 10, yes, yes, 4, 3, 321, 332, CBT and announcing to the world, "Yes, that's Annie Gsampel! I'd recognise her anywhere!"