Tribunal orders QMUL to release anonymised PACE data 16 Aug 2016

[BruceInOz]

A while back in this thread the question was raised about how long QMUL have to appeal and I don't recall seeing a definitive answer (sorry if I'm wrong). On this site
http://hmctsformfinder.justice.gov.uk/HMCTS/GetForm.do?court_forms_id=2799
I found this document
https://formfinder.hmctsformfinder.justice.gov.uk/t095-eng.pdf
Which says:

Guidance notes on applications for permission to appeal to the Upper Tribunal

Section C – Time limit for applying for permission to appeal to
the Upper Tribunal
Your completed application for permission to appeal should reach the tribunal within 28
days of the First-tier Tribunal sending you its notice of the decision.
If it reaches us after 28 days you must ask the tribunal to extend the time limit for making
the application giving the full reasons as to why it is late. There are automatic extensions if
you are applying within 28 days of an unsuccessful set aside application or review.

and

Section D – Reasons for applying and outcome you are seeking
You must explain why you think the First-tier Tribunal decision is wrong in law and state
the outcome you are seeking.
Examples of mistakes that may mean the decision is wrong in law are:
• The tribunal did not apply the correct law or wrongly interpreted the law;
• The tribunal had no evidence, or an important part of the decision, to support
its decision;
• The tribunal did not give adequate reasons for the decision.
This list is not exhaustive.

I guess this document represents the horses mouth which seems to clearly say they have 28 days.

 

[TiredSam]

I guess this document represents the horses mouth which seems to clearly say they have 28 days.

QMUL seem to be representing the other end of the horse. Hopefully the head will prevail.

 

[user9876]

A while back in this thread the question was raised about how long QMUL have to appeal and I don't recall seeing a definitive answer (sorry if I'm wrong). On this site
http://hmctsformfinder.justice.gov.uk/HMCTS/GetForm.do?court_forms_id=2799
I found this document
https://formfinder.hmctsformfinder.justice.gov.uk/t095-eng.pdf
Which says:



and

I guess this document represents the horses mouth which seems to clearly say they have 28 days.

Any idea if that is 28 days or 28 working days. When they say 20 days for FoI responses they mean working days

 

[worldbackwards]

They'll just drag it out and then put some pointless appeal in at the last minute again. The form book says so.

 

[BruceInOz]

Any idea if that is 28 days or 28 working days. When they say 20 days for FoI responses they mean working days

The document I quoted from was the instructions accompanying the form that must be submitted to lodge an appeal with the Upper Tribunal. I posted above everything the document said about the time limit for appealing and it only said 28 days - no mention of business days etc. so I would have thought it's straight calendar days. But what would I know:thumbdown:

 

[trishrhymes]

How to analyse the PACE data without a statistician and at 1% of the cost.

Protocol specified results:

IMPROVEMENT:

“The 11 item Chalder Fatigue Questionnaire measures the severity of symptomatic fatigue [27], and has been the most frequently used measure of fatigue in most previous trials of these interventions. We will use the 0,0,1,1 item scores to allow a possible score of between 0 and 11. A positive outcome will be a 50% reduction in fatigue score, or a score of 3 or less, this threshold having been previously shown to indicate normal fatigue [27].

The SF-36 physical function sub-scale [29] measures physical function, and has often been used as a primary outcome measure in trials of CBT and GET. We will count a score of 75 (out of a maximum of 100) or more, ora 50% increase from baseline in SF-36 sub-scale score as a positive outcome. A score of 70 is about one standard deviation below the mean score (about 85, depending on the study) for the UK adult population [51,52].

Those participants who improve in both primary outcome measures will be regarded as overall improvers.”

RECOVERY

“"Recovery" will be defined by meeting all four of the following criteria: (i) a Chalder Fatigue Questionnaire score of 3 or less [27], (ii) SF-36 physical Function score of 85 or above [47, 48], (iii) a CGI score of 1 [45], and (iv) the participant no longer meets Oxford criteria for CFS [2], CDC criteria for CFS [1] or the London criteria for ME [40].”

This would make a nice little project for a class of 14 year olds learning about spreadsheets and statistics. Give the students a spreadsheet for each of the 4 treatment groups. Each spreadsheet would have 4 columns: Chalder Fatigue score before and after, SF-36 score before and after with one row per patient. The students would be given the above protocol defined criteria and asked to calculate how many patients satisfied the criteria for improvement, and how many the first 2 items on the criteria for recovery. They would be asked to produce a table of results and some nice graphs to illustrate the data. Job done. A box of chocolates for the student who does the best job. Total cost £4.50. No statisticians required. Come to think of it I’d save QMUL the £4.50 and do the job myself.


I bet you a box of chocolates they’ve done these calculations themselves and don’t like the look of them.

 

[Snow Leopard]

They'll just drag it out and then put some pointless appeal in at the last minute again. The form book says so.

What are the penalties for non-compliance?

 

[BruceInOz]

What are the penalties for non-compliance?

One would hope that disobeying a court order would finally start to inflict reputational damage that they would have to take into consideration on top of anything else. One can still hope.

 

[Chrisb]

What are the penalties for non-compliance?

So far as I can tell, and there are caveats here as the online copy of the Act indicates that there are amendments which have not yet been entered, the procedure is for the Information Commissioner to serve an enforcement notice requiring compliance by a date not preceding the last date for lodging an appeal (s52).

In the event of failure to comply with the notice the Commissioner then issues a certificate to the High Court to that effect and the matter is then treated as contempt of court (s54).

But I may be completely wrong.

One would presume that Mr Matthees will by now have written to QMUL politely enquiring when and how they propose to release the information.

 

[Yogi]

Thank you to Alem Mathees for all his hard work and everyone who helped on this case.

Taken some time to read through it all.

It is such a big document I have highlighted some of the good bits. Any other good bits missed?


Page 15

From Mr Mathees
" Rather, their withdrawal is more likely to have been motivated by : a) public criticisms of the PACE trial's data security published by Prof. Malcolm Hooper detailing an inadvertent leak of names and addresses of certain participants, the theft of a digital audio recorder and reports from participants
that they were repeatedly questioned on their welfare/benefits claims and
insurance payments; or
b) a series of articles published by David Tuller on the Virology Biog in which it was claimed that researchers had undeclared links to insurance companies."


P.19

(N.B. This Tribunal is of the view that QMUL cannot rely on the strict wording of the consent forms regarding confidentiality if they are happy to share the anonymised data with independent scientists as research collaboration rather than an auditing situation. In our view, they are tacitly acknowledging that anonymization is effective, or else they would be in breach of the consent
agreement and the DPA principles.)


P.19

Chalder talking nonsense again.

"She attributes the basis of these criticisms as the misconception that CBT as a treatment assumes that CFS/ME is perceived as a mental illness."

It is not a misconception. The criticism was nothing to do about perceiving CFS/ME as a mental illness. However that is what Chalder believes and her career has been all about as a mental health nurse. This is the problem with using BPS as they can never be pinned down on what they believe but then can put words in our mouth about what we apparently believe.


P.19

The previously disclosed PACE trial data was released by the NHS West Midlands Research Ethics Committee, and it is not clear as to whether the forms setting out the severe adverse incidents for participants were disclosed. (This Tribunal notes that this is contrary to QMUL's submissions to the Commissioner in which they stated that these were disclosed.)


P.20
Patients have approached Professor Chalder with their concerns about going public with any improvements after CBT/GET for fear of harassment by activists. She extrapolates this concern to
future trials for other 'stigmatised conditions' and to harassment and hostility
towards researchers.

Nonsense and accepted as such. Where was the evidence for this? It is herself and colleagues that has stigmatised the disease and encouraged the smearing of sick patients via the SMC.


P.23

(This Tribunal notes Professor Anderson's witness statement and evidence strays substantially into comments on the law, the standard of proof and the applicability of ECHR principles of this issue, and the Commissioner's previous decisions regarding the definition of personal data, on one occasion differentiating the Commissioner's definition from that of 'normal people's
understanding).


P.27

(This Tribunal find it difficult to see how this objection of 'incompatible processing' can be maintained given that the information is currently being released to other researchers for the purpose of further analysis, such as is being requested in this instance. Given the anonymised nature of the data there is no other conceivable use for the data than further analysis in this context, and the consent forms at no stage advised participants that their data could be shared with researchers not involved in the PACE trial except in circumstances of audit. This Tribunal will 27 consider all the evidence about identification in its assessment of potential victimhood for the purposes of Art. 8 or otherwise.)
QMUL widens the effect of disclosure on its commercial interests; it now argues that disclosure would undermine the entire ethical and regulatory framework for clinical research and deter future participation in clinical trials. (This Tribunal is of the view that this must be an overstatement, as it seems previous FOIA disclosure of information relating to these trials did not have that
apocalyptic effect. QMUL reiterates the argument that there is no universal rule that statutory amendments cannot have retrospective effect and while we accept this, this Tribunal finds there is a rebuttable presumption that they should not have retrospective effect. We further note that there is little by way of tangible evidence before this Tribunal of damage to the Commercial Interests despite this appeal. On the contrary, the evidence has shown that further funding has been obtained.)

The Commissioner makes a distinction between participation in the trial (which is not a commercial interest) and the ability to attract funding (which is). He raises the following points about the concerns of a mass exodus of participants: a) Participants have already consented to significant disclosure of nonanonymised information to other researchers for audit purposes or regulatory purposes;
b) A digital audio recording was stolen in 2006;
c) 2,000 pages of trial documentation has been released;
d) The Cochrane Review team received all the trial data;
And despite all of this, only one participant left the trial over confidentiality concerns. Prejudice is therefore at the lower end of the scale, and this significant and legitimate scientific debate over the trial would be significantly advanced by the release of the information


P.29
Commisioner said:

"The evidence before us is not clear but if QMUL are cherrypicking who analyses their data from within the recognised scientific research sphere to only sympathetic researchers, there could be legitimate concerns that they wish to suppress criticism and proper scrutiny of their trial”.


P.31

"Professor Chalder states that disclosure to the Cochrane review does not count as disclosure to independent scientists as all three of the PACE principal investigators sat on the review panel.

Thank you Trudy for that!!

P.33

(This Tribunal note that this is all predicated on the inability to sufficiently anonymise the data. We note that QMUL accept that there is no evidence of any threats by activists of physical violence against participants but state that it is reasonable to expect that some campaigners will be strongly motivated to identify participants.)


P.35

Commisioner said

"Professor Anderson's "wild speculations" about the possibility of "young men, borderline sociopathic or psychopathic" attaching themselves to the PACE trial criticism "do him no credit". Nor do his extrapolations from benign Twitter requests for information to an "organised campaign" from an "adversarial group" show that he has maintained the necessary objectivity and accuracy that he is required to maintain. He does not distinguish between legitimate ethical and political disagreement, and the use of positions of access to confidential data. He stated that where there was
legitimate disagreement one should assume that people will act in unlawful ways. This proposition that one should in every case assume the absolute worst about data disclosure is clearly neither sensible nor realistic."


The decision from page 38 is very good and should be read in its entirety.

Let us all sign the groupcard to thank Mr Alem Mathees and what he has done for us all.

http://www.groupcard.com/c/8l2DPogN98e

As someone said here PACE trial has become a bit of a bullshit beacon and will only gather more scientific and legal scrutiny of these psychiatrists.

I very rarely agree with Sir Simon Wessely but on this occasion I wholeheartedly agree that:

“For those who appreciate these things, the trial is a thing of beauty”

 

[natasa778]

It is such a big document I have highlighted some of the good bits. Any other good bits missed?

Yes! You missed this pearl on p35:

"... It is common case that disputed information alone cannot identify individuals, and Professor Anderson's 'rough guesstimate' of the likelihood that other information will be available is "remarkably unsophisticated logic."


Their words not ours Maybe the Tribunal and the Commissioner should be called out for being young and borderline sociopathic for this comment. How dare they!!

 

[Wolfiness]

Sorry guys, can someone point me to that scan of the meeting agenda dealing with how those courageous academics were dealing with all the harrassment?

 

[daisybell]

Sorry guys, can someone point me to that scan of the meeting agenda dealing with how those courageous academics were dealing with all the harrassment?

I think it's at the very end of the references for the article by the Centre for Welfare Reform....

 

[Aurator]

Does anyone know whether the judges in the upper tribunal will be the same as in the first-tier tribunal or different? If they're going to be different, and if QMUL know that, isn't it reasonable to say that QMUL will simply be banking on a second roll of the dice, and quite unfairly?

If the judges are different, presumably they'll have to look at the whole PACE business from scratch, and who is to say they'll be as thorough and impartial as the first tier judges? Or does an upper tribunal generally automatically respect the decision of a first-tier tribunal and only look for technical irregularities in the conduct of the first hearing?

It's been said already that the appeal has to be on a point of law, but the quoted guidance notes BruceinOz has given us in post 321 (especially the bit "This list is not exhaustive") suggest to me there is more scope for appeal than simply on a point of law.

 

[Dolphin]

I just thought I would say again that I don't think we should be giving QMUL any encouragement to appeal, give them ideas on grounds they could use, etc. It is known they read PR.

 

[Wolfiness]

@daisybell I thought I saw it posted directly on here somewhere…

 

[Aurator]

I just thought I would say again that I don't think we should be giving QMUL any encouragement to appeal, give them ideas on grounds they could use, etc.

I'm completely at ease on that score, personally, and so should you be; whatever possible avenues of appeal or wiggle room we air on PR you can be sure they, or they lawyers, will already have thought of.

It is known they read PR.

Of course they do, and I can read their minds.

 

[Dolphin]

I'm completely at ease on that score, personally, and so should you be; whatever possible avenues of appeal or wiggle room we air on PR you can be sure they, or they lawyers, will already have thought of.

I'm not convinced. Different people can think of different ways to approach issues including legal issues. Plenty of intelligent people on PR.

Also PDW might have to persuade QMUL to bring in lawyers: at this stage, they potentially may not have legal advice or not much.

 

[viggster]

Big news here: QMUL scientists discover Earth-sized planet orbiting star next door...VOW TO SEND PACE RESEARCHERS TO INVESTIGATE.

https://www.washingtonpost.com/news...t-orbiting-proxima-centauri-our-closest-star/

 

[Stewart]

It's been said already that the appeal has to be on a point of law, but the quoted guidance notes BruceinOz has given us in post 321 (especially the bit "This list is not exhaustive") suggest to me there is more scope for appeal than simply on a point of law.

I think you're misinterpreting the guidance notes. The phrase 'This list is not exhaustive' is referring to the list of examples which immediately precedes it - all of which are illustrations of how a decision might be wrong in law. An appeal to the Upper Tribunal won't be a second bite of the cherry for QMUL - the Upper Tribunal isn't interested in hearing the arguments that QMUL has already made and had rejected. Their only consideration is whether the first-tier decision interpreted existing legislation correctly. Unless QMUL can make a convincing case that the first-tier Tribunal has misapplied the law, any appeal they submit will be rejected without being heard.

(If QMUL *are* reading this thread and looking for legal advice, I'm happy to give them mine; stop wasting money on legal fees and just hand over the data. It'll be cheaper and result in less damage to your reputation in the long run.)