FINE Trial team remove raw data file: pressure from PACE Trial team?

[alex3619]

What I dont understand is even the need for there to be specifically stated on a consent form permission to release "anonomous" data. If it doesnt point to any person as such, why need that?

This is NOT an issue in consent, patient rights or research participant ethics. Its an issue in creating precedent to avoid being scrutinized. This however creates the very situation in which they will be subject to even more scrutiny.

 

[Valentijn]

Why do they keep using a dodgy consent form that gives them an excuse to withhold data later on?

It's a perfectly normal consent form. The same type is used everywhere, and the anonymized data which results from those trials is happily shared.

They're creating an issue where none exists, as an attempt to hide data which they processed and/or reported in a dodgy manner. As others have said, if there is no consent, that applies to their buddies who the researchers have already shared the data with just as much as it applies to the unwashed masses.

 

[Chrisb]

One might suspect that there will be people within the Tribunal Service mightily unimpressed by this development of the withdrawal of these statistics. It could not have come at a worse time, between the hearing and the judgment in a case where one might expect the anomalous position of the disclosure of date in the FINE trial to have been considered.

I do not suggest anything improper has taken place. One would suspect that the steps necessary to bring about this withdrawal would have been commenced sometime before the recent hearing in the FOI case.

If the appeal is to be allowed one would think that it might have been necessary to "distinguish" the cases. One would expect the decision to have been largely drafted by this stage. Will it include references made redundant by this withdrawal? Or will it pass over in silence matters which would expect to find discussed? The decision will no doubt be closely scrutinised when it arrives.

 

[user9876]

It's a perfectly normal consent form. The same type is used everywhere, and the anonymized data which results from those trials is happily shared.

They're creating an issue where none exists, as an attempt to hide data which they processed and/or reported in a dodgy manner. As others have said, if there is no consent, that applies to their buddies who the researchers have already shared the data with just as much as it applies to the unwashed masses.

Perhaps the thing to do is to look for papers from Manchester and QMUL where they publish data with similar consent forms and ask why they aren't being withdrawn.

 

[Luther Blissett]

They have either released patient data that is a data breach if their reasoning is correct in their PACE trial tribunal arguments, or they have withdrawn data that should be public. Hoisted by their own petard either way.

 

[Sean]

Perhaps the thing to do is to look for papers from Manchester and QMUL where they publish data with similar consent forms and ask why they aren't being withdrawn.

A huge can of worms they have opened with this latest tactic. Not sure they have really thought through the full consequences.

 

[Yogi]

A huge can of worms they have opened with this latest tactic. Not sure they have really thought through the full consequences.

David Tuller has described it as "soap opera". It does feel like that way given the PACE trial team's melodrama, the never ending nature of the story and all the PACE trial plot twists and turns and it is becoming addictive just like a soap. I am looking forward to each day's installment especially with this cliffhanger and bringing the forgotten FINE team from manchester into this weeks episode.

https://twitter.com/i/web/status/734107048871268352

Check out the location of Queen Mary University of London (QMUL) where principal investigator Peter White is based. (Zoom out a bit on the map.)

http://www.qmul.ac.uk/about/howtofindus/mileend/index.html

... And the Barts and The London School of Medicine and Dentistry Queen Mary University of London. (Zoom out a bit on the map.)

http://www.qmul.ac.uk/about/howtofindus/whitechapel/index.html

Then compare it to the opening theme tune of Britain's soap opera EastEnders!!

Hilarious you could not make this up!!



Can't wait for the next installment of #PACEtrial!!!!

 

[Sean]

Can't wait for the next installment of #PACEtrial!!!!

I am hanging out for the episode where they find out it has been retracted.

 

[Jonathan Edwards]

It took them 17 months to notice this ethical breach after submitting?

It took them 5 months to notice this ethical breach after it being in the public domain where "motivated intruders" and "vexatious ME activists" had access to it and risked "de-anonomysing the data" ?

The FINE And PACE PIs really do think we are fools.

I am not sure that they think we are fools. But they may hope that their colleagues and that gatekeepers in the establishment are fools. Judging by the deafening silence from the colleagues, maybe they are on firm ground there.

 

[user9876]

I am not sure that they think we are fools. But they may hope that their colleagues and that gatekeepers in the establishment are fools. Judging by the deafening silence from the colleagues, maybe they are on firm ground there.

I suspect rather than thinking of them as fools they know they are people who don't like to question others - perhaps they worry about being questioned themselves.

It should also be noted that people in positions of power have allowed bad research practice for ME. The MRC supported the PACE authors in performing outcome switching. I assume the head of QMUL has sanctioned legal bills to hide data along with accepting the risk to QMUL's reputation due to their support of outcome switching.
Ethics committees also appear to have supported these things. So I think there are a number of people in the establishment who have serious questions to answer as to how they let this situation emerge. I suspect the FINE and PACE team know this and play on it.

 

[Sean]

I suspect the FINE and PACE team know this and play on it.

They absolutely know. That is how they have survived and prospered for so long. They have actively co-opted and (intellectually and morally) corrupted the British medical, political, and media establishments with their relentless nonsense, and given pseudo-scientific succour to some very nasty ideologies and policies.

If PACE/FINE and their biopsychosocial ideology go down, then so do a whole bunch of other people and institutions. There is no nice way out of this for any of them them now. It will be carnage, with wrecked careers, reputations, and lives all over the place.

But it has to happen if this mess is going to be cleaned up.

 

[Snowdrop]

What gets me is the younger people who's careers haven't solidified to the point of no return--you'd think that they might assess the situation and that at least some of them would bail. Or maybe a few have and we've just not noticed and they're keeping mum.

 

[A.B.]

Where are the whistleblowers? Or the people with a functioning moral compass that decided to just quit clinical psychology and are now in a position to freely express their views?

 

[Yogi]

From Leonid Schneider:

"Update 23.05.2016. I received this statement from Alison Weardon, indicating that the unclear formulation of the FINE trial patient consent form was indeed decisive for the removal of the anonymised dataset from public domain:

"We published the PLOS One paper on therapist effects and therapeutic alliance and provided a de-identified dataset containing the variables used in the analysis.

"On 10th March, I received a freedom of information request for a copy of the patient consent form for the FINE trial. The request referred to the ongoing case relating to the PACE trial, and raised the issue of whether in fact we had been correct to make the data relating to the therapist paper open to the public. We did not request permission to do so in our trial consent form.

The dataset supplied to support the PLOS-One article was supplied in good faith and in the belief (still held) that no patient or therapist would be identifiable from it. The Freedom of Information request made me wonder if we had acted correctly, given our ethical permissions."

Read the rest of it on Leonid Schneider's blog:

https://forbetterscience.wordpress....lable-anonymised-patient-clinical-trial-data/

 

[Snow Leopard]

"On 10th March, I received a freedom of information request for a copy of the patient consent form for the FINE trial. The request referred to the ongoing case relating to the PACE trial, and raised the issue of whether in fact we had been correct to make the data relating to the therapist paper open to the public. We did not request permission to do so in our trial consent form.

The dataset supplied to support the PLOS-One article was supplied in good faith and in the belief (still held) that no patient or therapist would be identifiable from it. The Freedom of Information request made me wonder if we had acted correctly, given our ethical permissions."

Which FOI request?

If the recent PACE trial FOI tribunal finds in favor of releasing the data - then will the FINE data be available once again?

 

[BurnA]

The dataset supplied to support the PLOS-One article was supplied in good faith and in the belief (still held) that no patient or therapist would be identifiable from it. The Freedom of Information request made me wonder if we had acted correctly

So if they still believe that no patient or therapist is identifiable why did they withdraw the data ?

Why wasn't the FOI request turned down as vexatious ?

It's a perfectly normal consent form. The same type is used everywhere, and the anonymized data which results from those trials is happily shared.

Why would a FOI request be needed to get this information - would it not have been public ? Even if it wasn't public, surely a request for it via normal channels would have been sufficient.? I'm wondering if there is a subtle second level to this, namely that FOI requests are ( of course ) responded to in a timely fashion ?

 

[Snowdrop]

@BurnA That's a good question--why would someone request FOI that is public?

Is there some info we're missing?

 

[Dolphin]

https://forbetterscience.wordpress....sed-patient-clinical-trial-data/#comment-1138

David Tuller
May 23, 2016 at 17:45

Thanks, Leonid, for the excellent round-up of data shenanigans with the FINE trial. It is important to note that although FINE did not engage in the egregious data manipulation that PACE did, the authors did in fact revise their primary outcomes to make their results appear better. Let’s be clear: At the protocol-designated primary outcome of 70 weeks, FINE had completely NULL results. However, in publishing the report, the authors engaged in serious “outcome-switching.” The authors falsely claimed in the published paper, that the 20-week assessment point AND the 70-week point were in fact co-primary outcome points. Since they had modest but transient improvements in fatigue at 20 weeks–these had disappeared by 70 weeks–the paper cited this as a co-primary outcome in order not to report completely NULL results. In fact, the FINE protocol, published in the journal BMC Medicine in 2006, declared flatly “short-term assessments of outcome [i.e. at 20 weeks] in a chronic health condition such as CFS/ME can be misleading.” That’s why only the 70-week assessment, not the 20-week assessment, was designated as THE “primary outcome point.”

In an accompanying editorial, BMJ did not call out FINE on this outcome-switching and in fact repeated it by citing this purportedly “positive” result, while only later mentioning the completely NULL results at 70 weeks. The authors subsequently published, in a letter to the editor, a non-peer-reviewed, post-hoc re-scoring of the fatigue scale that demonstrated modest improvements at 70 weeks. Since then, they have claimed this as their main finding, routinely failing to mention that this was a post-hoc re-scoring that was presumably not peer-reviewed. This isn’t quite as bad as what the PACE authors did–but it’s still plenty dishonest and anti-scientific. Alison Wearden, like the PACE authors, has never explained these discrepancies.

Not surprisingly, the PACE authors have never mentioned the NULL findings in any of their published work, despite having for years referred to FINE as its “sister trial.” I covered the whole pathetic story of how FINE was “disappeared” last fall, on Virology Blog: http://www.virology.ws/2015/11/09/trial-by-error-continued-why-has-the-pace-studys-sister-trial-been-disappeared-and-forgotten/

Keep up the good work, Leonid!!

David has highlighted a potentially useful quote from the FINE Trial protocol for the future:

“short-term assessments of outcome [i.e. at 20 weeks] in a chronic health condition such as CFS/ME can be misleading.”

 

[BurnA]

I decided that it would be better to remove the dataset from public access (while still being prepared to supply it to bona-fide researchers)

Why would it be supplied to bona fide researchers if it was in contravention of their consent form ?

 

[Daisymay]

And a very interesting comment on Leonid Schneider's blog from johnthejack:

https://forbetterscience.wordpress....sed-patient-clinical-trial-data/#comment-1138

johnthejack
May 23, 2016 at 18:06

I have been in contact with Manchester University. Today I received an email that stated:

‘There has been no breach of the Data Protection Act. There has been a concern about whether the original patient consents for this project allowed for publication of data (even in anonymised form), but I believe that this is close to being resolved and that it is likely that the dataset will be returned to the PLOS site in the near future.’