Tell our charities: QMUL must release PACE data

[ukxmrv]

Ah...sorry! All too plausible...how would AfME know if the people who contacted them were trial participants or not?

Unless they were AFME trustees or local group leaders or BARTS patient representatives who know people in AFME and contacted them direct. People who have been working together on PACE for years and know participants.

When AFME had Chris Clark (their CEO) sitting in on PACE trial meetings and a Trustee who was a Barts Patient representative then they could have met with trial participants and know who they are.

When the PACE trial researchers met with local groups (who support AFME and have links to) to explain the trial and recruit participants some of these people will know who was on the trial. The local groups who were approached and had their members feed into PACE will know.

AFME has not stood separate from the PACE trial . They were actively involved in more than one way

 

[Scarecrow]

continued from this thread:
http://forums.phoenixrising.me/inde...-scientists-join-request-for-pace-data.42957/

But the consent form didn't have a data sharing clause. So the PACE participants who have already contacted AfME may have misunderstood what they were consenting to, unless there was another form that we haven't yet seen.

Are we absolutely sure of that now? If so that's good news, means that can be argued in next appeal when patient confidentiality is raised as an excuse.
But if that really is the case why has the issue of patients not wanting their anonymised data released been such a sticking point?
Something isn't adding up...

I don't think the sticking point is of patients not wanting their anonymised data released so much as it is QMUL trying to use the Data Protection Act (DPA) as one of their reasons not to release the trial data under Freedom of Information requests and scaring participants.

The DPA

Here is an extract from QMUL's reponse to Alem Matthees on 22 April 2014 (but remember that the Information Commission Officer has subsequently ruled that the anonymised data should be released and that there is no risk of individuals being identified):

https://www.whatdotheyknow.com/request/selected_data_on_pace_trial_part#incoming-508208
For the purposes of determining release of personal data under FOIA,
Principle 1 is the most relevant (1). Principle 1 states that personal
data must be fairly and lawfully processed by a data controller (in this
case QMUL). Given that assurances of this sensitive data’s confidentiality
were given as a condition precedent to trial participation, it would not
be within the reasonable expectations of these individuals that the data
would be released in to the public domain. In addition, it is very likely
that the disclosure to members of the public without these data subjects’
further explicit consent would cause great distress, evidently to their
detriment. It is not fair to process personal data in a manner which leads
to adverse consequences, such as revealing that an individual suffers from
a certain health condition.

When these participants consented to taking part in the PACE trial, they
consented that the collection, use and analysis of their sensitive
personal data would be for a specific limited purpose only i.e. for
disclosure only to individuals associated directly with the PACE trial,
for its research analysis in this trial. Not only did the PACE trial
participants not consent explicitly to the further release of their
sensitive medical data beyond the scope of this limited purpose, they were
given assurances of its confidentiality, often as an essential condition
of their voluntary participation in the PACE trial. All participants
signed informed consent to participate based on the understanding that
"information collected about me for the trial, including my personal
details, a copy of this consent form and all of the questionnaires I
complete for the trial, will be held securely by the local trial staff and
at the PACE trial coordinating centre at Queen Mary, University of
London." Furthermore, they signed the consent form on the basis of a
patient information sheet, which included the following: "Will you keep my
details confidential? Yes. All your details and all recordings will be
kept strictly confidential and held in a locked filing cabinet or on a
secure computer. People on our research team will only see your records if
they need to for the research." The patient information sheet also stated:
"The data and recordings we collect will be securely stored for 20 years
after the end of the trial, for your protection and to follow good
clinical practice (GCP). The same applies to other records gathered for
our study, including your medical notes and the database holding the
collected data for this trial."

Here's a link to the consent forms:
https://www.whatdotheyknow.com/request/203455/response/508208/attach/3/Consent forms.pdf

There are several clauses that concern access to information, data collection, data storage and data security, i.e. 3, 4, 5, 6 and 13. None relate to data sharing, so the trial participants cannot have provided any kind of consent or refusal about this.

If QMUL are trying to argue that anonymised data should not be released, then they also shouldn't have allowed the data to be aggregated and published, as somebody else on the forum pointed out recently.

 

[Cheshire]

If QMUL are trying to argue that anonymised data should not be released, then they also shouldn't have allowed the data to be aggregated and published, as somebody else on the forum pointed out recently.

And they shouldn't have allowed a publication in Plos.

 

[ClarkEllis]

It's possible that AfME know for sure that these individuals are patient participants from the trial, or they may not know for sure. But it probably would not be entirely reasonable to expect AfME to know either way, and not knowing doesn't mean they can discount those opinions.

But the thing is, assuming these are indeed patient participants, and assuming that they understand that the data being discussed will not allow them to be identified (which AfME have explained to them) do they realise that they were not ever legally required to provide consent for the de-identified data to be released? The consent they signed was for personal data, which is still protected and is something different from the de-identified anonymous data that patients want released. With QMUL's muddying of the waters I wouldn't be surprised if some people did not fully understand the important distinction still, and that wouldn't be their fault, but QMUL's.

But despite all that, I think we must always remember that there is no risk to these patient participants being identified, regardless of how well they might understand that, and we must remember the context, which is that at least 12,000 patients want the data released, and there were only 640 odd patients in the trial. I dare say the vast majority of those patient participants do actaully want the data released as well, though perhaps they are less likely to have voiced that to AfME. The point is that AfME's position must be made in that context (no risk and the vast majority want the data released).

We must judge AfME on their decision after their trustee meeting; it's good that they acknowledge it is an important topic that needs discussion. Until then, I hope those who believe the data must be released and have not yet contacted them will do so.

 

[Sasha]

Do when know when AfME's trustee meeting is yet?

 

[worldbackwards]

Isn't it curious that The ME Association, who were always far more likely to endorse data sharing, have had nobody contacting them to query their endorsement, whilst Action for ME, who were always far more likely to do nothing to upset the PACE authors, have had a bunch of patients suddenly emerge from nowhere, pushing exactly the same line that the PACE authors themselves suddenly concocted when they realised that calling people vexatious wasn't really cutting it anymore.

No really, I'm astonished.

 

[BurnA]

Isn't it curious that The ME Association, who were always far more likely to endorse data sharing, have had nobody contacting them to query their endorsement, whilst Action for ME, who were always far more likely to do nothing to upset the PACE authors, have had a bunch of patients suddenly emerge from nowhere, pushing exactly the same line that the PACE authors themselves suddenly concocted when they realised that calling people vexatious wasn't really cutting it anymore.

No really, I'm astonished.

Me too. Statistically what are the chances of this happening I wonder ?

 

[BurnA]

So here is what would have to happen.

A patient who was part of the PACE trial has been following events. One would assume that anyone following events probably does have ME/CFS.
We know the PACE trial didn't make this person any better ( at least in the long term ). They would have read newspaper articles proclaiming the exact opposite of this.

They probably feel frustrated that they partook in such a trial which at best turned out to be a complete waste of time and effort. At worst they may have got worse.

Now there is the opportunity for the data to be analysed which might explain why they didn't recover the same way the newspapers were proclaiming.

What does this patient do ?

Phone AfME and tell them not to release their data, of course.
Yeah, I believe that alright.

 

[Stewart]

So here is what would have to happen.

A patient who was part of the PACE trial has been following events. One would assume that anyone following events probably does have ME/CFS.
We know the PACE trial didn't make this person any better ( at least in the long term ). They would have read newspaper articles proclaiming the exact opposite of this.

They probably feel frustrated that they partook in such a trial which at best turned out to be a complete waste of time and effort. At worst they may have got worse.

Now there is the opportunity for the data to be analysed which might explain why they didn't recover the same way the newspapers were proclaiming.

What does this patient do ?

Phone AfME and tell them not to release their data, of course.
Yeah, I believe that alright.

I think it's quite possible that the people contacting AfME genuinely are trial patients and that they genuinely don't want the data released. I have a theory that would explain why. It's only a theory you understand - I have absolutely no evidence to support it.

Perhaps QMUL really has been 'seeking advice' from patients. And by 'seeking advice' I mean contacting some of the trial participants and putting the fear of God in them that all their personal medical data is about to be made public.

"QMUL is going to do everything they can to stop this from happening of course, but frankly it's not looking good for you. What's that? Is there anything that you, a trial participant, can do to stop your personal medical data being viewed and abused by everyone and their aunt? Well, you could always contact Action for ME - you know, that friendly patient group that was so supportive of our work on the PACE trial - and ask them to oppose the data being made public as well. People might be more likely to pay attention if they also say that trial participants don't want the data released..."

As I say, this is just a wild conspiracy theory, and I'm not normally big on conspiracy theories. But the one aspect of this I am completely sure of is that if QMUL really was serious about contacting patients, you can bet that they won't be presenting the potential release of the trial data in anything but the most negative light possible.

 

[BurnA]

I think it's quite possible that the people contacting AfME genuinely are trial patients and that they genuinely don't want the data released. I have a theory that would explain why. It's only a theory you understand - I have absolutely no evidence to support it.

Perhaps QMUL really has been 'seeking advice' from patients. And by 'seeking advice' I mean contacting some of the trial participants and putting the fear of God in them that all their personal medical data is about to be made public.

"QMUL is going to do everything they can to stop this from happening of course, but frankly it's not looking good for you. What's that? Is there anything that you, a trial participant, can do to stop your personal medical data being viewed and abused by everyone and their aunt? Well, you could always contact Action for ME - you know, that friendly patient group that was so supportive of our work on the PACE trial - and ask them to oppose the data being made public as well. People might be more likely to pay attention if they also say that trial participants don't want the data released..."

As I say, this is just a wild conspiracy theory, and I'm not normally big on conspiracy theories. But the one aspect of this I am completely sure of is that if QMUL really was serious about contacting patients, you can bet that they won't be presenting the potential release of the trial data in anything but the most negative light possible.

The reason I doubt this is because QMUL would run a high risk of being exposed by an angry trial participant.

 

[Snowdrop]

Isn't it curious that The ME Association, who were always far more likely to endorse data sharing, have had nobody contacting them to query their endorsement, whilst Action for ME, who were always far more likely to do nothing to upset the PACE authors, have had a bunch of patients suddenly emerge from nowhere, pushing exactly the same line that the PACE authors themselves suddenly concocted when they realised that calling people vexatious wasn't really cutting it anymore.

No really, I'm astonished.

Yes, me too totally astounded.
How convenient AfME.

 

[Stewart]

The reason I doubt this is because QMUL would run a high risk of being exposed by an angry trial participant.

I've done a bit of telephone canvassing in the past, and I'm sure an experienced canvasser could quickly and subtly work out which patients could be persuaded to have concerns about the release of the trial data, and then nudge those people (and only those people) towards registering their opposition. If someone indicated they were in favour of the data being released (or were largely ambivalent) the canvasser would simply switch to a completely different script, leaving the patient none the wiser as to where the conversation might have gone. I reckon the risk of exposure would be much lower than you think...

But like I said, it's only a wild (and probably highly implausible) theory.

 

[Esther12]

The reason I doubt this is because QMUL would run a high risk of being exposed by an angry trial participant.

It could be that they've stayed in close contact with a few. I think that there was one who they used for media interviews when they were first reporting results.

 

[Art Vandelay]

Isn't it curious that The ME Association, who were always far more likely to endorse data sharing, have had nobody contacting them to query their endorsement, whilst Action for ME, who were always far more likely to do nothing to upset the PACE authors, have had a bunch of patients suddenly emerge from nowhere, pushing exactly the same line that the PACE authors themselves suddenly concocted when they realised that calling people vexatious wasn't really cutting it anymore.

No really, I'm astonished.

I dare say that these 'concerned' patients are as real as the death threats made against the Wessley cabal.

 

[ukxmrv]

I dare say that these 'concerned' patients are as real as the death threats made against the Wessley cabal.

I wouldn't call them phantom concerned patients. There is at least 1 local UK support group leader who is a vocal and committed BARTS and PACE supporter.

They would have acted as a conduit shuffling patients from their group onto Barts and PACE.

In recent weeks they would have most likely contacted their members and raised a lot of "concern". This would have been fed back to AFME because of their still close ties to the organisation.

We can't ignore that PACE was supported by AFME and they played a strong role in it.

The creation of "concerned" patients would have occurred downstream in my opinion and then eagerly fed back to the mothership

 

[Keela Too]

The concern could now either be fanned to a greater level, or patients could be re-assured that there is nothing to be concerned about. Perhaps their concern is linked to breaches that have already happened?

 

[Mrs Sowester]

In light of this, Action for M.E. strongly supports the release of anonymised data from the PACE trial
https://www.facebook.com/actionforme/?fref=photo
Whoop!

 

[Scarecrow]

....and a further statement about AfME's position on "PACE and related issues" to follow.

 

[Mrs Sowester]

Here it is, better than I expected:
Yesterday our Board of Trustees met to discuss in detail Action for M.E.’s position on a range of issues relating to the charity’s work and its future strategy.

As part of this, the Board considered the charity’s stance in relation to the sharing of data from research. They considered the wide range of views shared with the charity by people affected by M.E., and the expert scrutiny of the Information Commissioner, who identified principles in relation to the sharing of data ...collated as part of the PACE Trial (http://bit.ly/1WhxMvQ).

In the interests of transparency, Action for M.E. supports the sharing of research data to enable replication and validation. As a point of principle, it is important that research data is used to its full potential and that as much benefit as possible is derived from it. This means that the investment in collecting and producing data should be maximised by enabling other researchers to analyse the data and generate more research findings.

In light of this, Action for M.E. strongly supports the release of anonymised data from the PACE trial.

We understand that Queen Mary University London (QMUL) has stated its interest in hearing the views of people with M.E. (http://bit.ly/20seFAz) and so we will be writing to them to outline the charity’s position. We would encourage any individual with concerns regarding the release of PACE trial data to please contact QMUL for information. Individuals who require support with this can contact us should they wish to. The Board is continuing to consider Action for M.E.’s position on the PACE trial and related issues more widely, and will make a further statement in due course.

In addition, the Board has agreed that any future research will only be funded by Action for M.E. if the researchers agree to share, appropriately in an anonymised form, their raw data, in line with the protocol set by their academic institution.

All future research contracts will now include this as a specific condition of funding. Being clear contractually from the outset about the sharing of appropriately anonymised data offers an umbrella under which researchers can work with integrity. While we only have the remit to enforce this within the context of our own funded research, we feel this is a positive move towards transparency, clarity and collaboration.

 

[worldbackwards]

And we all eat our words! Good for them.

Although details to follow of course..