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Tell our charities: QMUL must release PACE data

Messages
55
Thanks Jane, that's helpful to know. At the moment I am in contact with several of the charities and have, I think, made things clear in those communications. When I can manage it I shall catch up with the others I am not already in contact with and try to clear up any ambiguity there might be. Of course, if other people are in contact with any of the charites themselves then it would be helpful if they could have a word as well.
 
Messages
171
Location
London
I want to thank the MEA for making their decision transparent on this matter. I think it is about time that all UK ME/CFS charities release a public statement as to why or why not their members favor the release of trial data. This way patients will be informed of charities' direction with regards to enhancing transparency in this field. This is a critical time for charities, to help progress the state of science in this field. It's of concern that some charities have not been vocal nor representative of their members in the past and there has been no statement giving reason as to why this is the case. We need clear statements from all.
 
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55
Hope 4 ME & Fibro NI will get behind this once the events of tomorrow and Tuesday are sorted!
I hope to be tweeting via the tag #PACEni during both talks

That would be very welcome. The list of charities on my blog is by no means exhaustive and I'd encourage patients to contact whichever charities they feel should be supporting the release of PACE data. Every charity that truly acts in the interest of patients should be formally calling on the data to be released on behalf of patients.

Thanks Keela Too for tweeting those PACE talks, I will be paying attention to that.
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
An "angry mob" shouting from their beds would let the appeals body know that their decision will be scrutinized very closely. That knowledge might encourage them to closely study the case, rather than applying the rubber stamp supplied by establishment VIPs like Sir Simon.
I think anger will harm our case, though I realize the reference to angry mob was tongue in cheek. Careful public scrutiny is what we need. Them knowing we will continue to scrutinize, and continue to protest, indefinitely, might be important.

However FOI hinges in part on benefits and harms. Our opinion on benefit from the release of data, and harm from the non-release, could be crucial. While the large charities are not necessarily representative of the whole ME and CFS population (and this applies to any charity or forum) it might be taken as indicative, especially if all the charities were to sign up to this. However given the political situation I think some charities at least will be very reluctant.

In terms of public benefit and harm, I am not sure this is just UK. This might be a global issue. Research influence does not stop at any border.
 
Messages
171
Location
London
@ClarkEllis Have you had any response from Afme? I have sent an email and await their response. Don't forget that some of these charities may be less forthcoming than they were in the past, as being members of the UK collaborative it may be conceivable that they are encouraged as to not publicly criticize their collaborative peers' work. Even if this comprises profoundly flawed research. I hope this is not the case.
 
Messages
55
@ClarkEllis Have you had any response from Afme? I have sent an email and await their response. Don't forget that some of these charities may be less forthcoming than they were in the past, as being members of the UK collaborative it may be conceivable that they are encouraged as to not publicly criticize their collaborative peers' work. Even if this comprises profoundly flawed research. I hope this is not the case.

I have had some contact from AfME, yes. I replied seeking further clarification on their position and await their response. I think we need to give them a few days because it is an important matter and there will presumably be more than one person involved in their decision making. I intend to post a blog detailing the responses and actions of the charities by Monday the 15th February.

I don't think being part of the collaboration would be a valid excuse. It hasn't stopped some members of the collaborative from being critical of the PACE trial and neither should it. A charity's first obligation must of course be to the patients and if allegiance to other collaborative members trumped patient interests that would be very concerning indeed.

I have yet to hear anything from AYME. So if anyone is in contact with them, or wants to get in contact with them, I would welcome that.
 
Messages
171
Location
London
A charity's first obligation must of course be to the patients and if allegiance to other collaborative members trumped patient interests that would be very concerning indeed.
I couldn't agree more. We will soon see where these charities' obligations lie. If many charities fail to endorse desperately needed transparency a double standard precedent will be set, one in which molecular science, as with Rituximab is obliged to meet, but one in which non-drug interventions such as behavioral therapies are exempt. Despite both having equally disastrous potential implications for patient health. We must demand objective outcomes data from all.
 

charles shepherd

Senior Member
Messages
2,239
MEA letter to QMUL

From: The ME Association
Tuesday 9 February 2016
Attention: Records and Information Compliance Manager, QMUL
Copy to: Professor Simon Gaskell, Principal, QMUL


Dear Sir/Madam

Freedom of Information Act request for release of PACE trial data from QMUL


The Freedom of Information (FOI) request for release of so far unpublished data from the PACE trial, along with the refusal of Queen Mary University of London (QMUL) to comply with this request, is currently causing a great deal of concern and comment from people with ME/CFS.

And we understand that QMUL has now appealed to the First-tier Tribunal to reverse the Information Commissioner's order to release this data.

QMUL statement dated December 18 on release of PACE trial data:http://www.qmul.ac.uk/media/news/items/smd/168729.html

As a national information and support charity for people with ME/CFS, The ME Association (MEA) has a duty to make sure that organisations involved in both clinical care and research are aware of the views of the patient community.

QMUL has confirmed in their 18 December statement that they would like to hear the advice of people with ME/CFS on the issue of providing appropriate access to relevant research data.

We are therefore writing to QMUL to state that all the feedback we are receiving indicates that people with ME/CFS want to see this data released - with, of course, an exemption being made in relation to any information that could identify individual participants in the PACE trial.

The views of people with ME/CFS have also been expressed in a petition signed by over 11,800 people so far. The wording of the petition includes a call for “the study authors… 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)”.

PACE trial petition: http://my.meaction.net/petitions/pace-trial-needs-review-now

The MEA takes exactly the same position.

We also believe that those involved in medical and scientific research have a duty to be transparent in what they do.

Researchers should therefore be willing to share their research data in order to confirm or refute the findings from a study, or to add to the knowledge that might accrue from further independent analysis of the data.

It is clearly of benefit to people with ME/CFS that all relevant research data is open and available and can be exchanged between researchers on international basis.

In addition, open data from research studies and clinical trials is something that will encourage people with ME/CFS to take part in research.

Non disclosure is likely to discourage people from doing so.

It is also worth noting that in addition to this FOI request being supported by the Information Commissioner, a growing number of academics and health professionals are calling for release of the data.

In particular, Dr Richard Smith, former editor of the British Medical Journal, has made a very strong case for release of the PACE trial data in a BMJ commentary dated 15 December 2015.

Dr Smith stated:

QMUL and King’s are making a mistake.

Firstly, the inevitable conclusion is that they have something to hide. This is the age of transparency, and, whether people like it or not, what is not transparent is assumed to be wrong, corrupt, or biased until proved otherwise.

Secondly, QMUL and King’s are going against basic scientific principles. In Popperian science we pose falsifiable hypotheses and then do all we can to tear them down. Hypothesis are never true, they are simply not falsified. This process should include other scientists being able to manipulate the data.

The refusal of two universities to release data relates to the current debate within universities over freedom of speech. In several universities students have stopped the appearance of speakers who have views—on, for example Islam or transgender people—that the students don’t like. This is a dangerous development. Democracies depend on free speech, and universities should be bastions of free speech—and the whole point and value of free speech is that you hear views that may disgust, distress, and anger you.

Finally, the universities may have failed to notice that customs around sharing data in science are changing rapidly. We have recognised that huge value is lost by scientists taking their datasets to the grave with them. More and more funders of research require the release of data they have funded, and journals like F1000Research require authors not just to make their data available on request but actually to submit their data with their study so that anybody can use the data either to confirm or refute the study or do other studies.

I fear that QMUL and King’s are defending the indefensible and like King Canute failing to stop a tide that is coming in fast.

Source: http://blogs.bmj.com/bmj/2015/12/16...lege-should-release-data-from-the-pace-trial/

We have already made our views very clear on what we feel are significant methodological flaws in the way the PACE trail was carried out along with our concerns about the way in which the results have been reported in both the scientific journals and in the lay press.

MEA letter to Lancet Psychiatry covering long term follow up to PACE trial:
http://www.meassociation.org.uk/201...hed-in-the-lancet-psychiatry-18-january-2016/

MEA letter regarding recovery data from PACE trial:
http://www.meassociation.org.uk/201...ournal-of-psychological-medicine-august-2013/


Disclosure of the PACE trial data will help to resolve many of the controversies, disagreements and uncertainties that surround the PACE trial.

The MEA is therefore asking QMUL to reconsider their decision and agree to release of the PACE trial data in line with current scientific opinion on the sharing of research data.



Yours sincerely

Dr Charles Shepherd
Hon Medical Adviser, MEA

7 Apollo Office Court
Radclive Road
Gawcott
Buckingham MK18 4DF

Website: www.meassociation.org.uk

ENDS
 

charles shepherd

Senior Member
Messages
2,239
I wanted to sum up much of what is said on this thread but also added some other stuff. Sorry I sound a bit mumbling at times. Thanks @charles shepherd & MEA for representing patients.

[/USER]

Thank you so much for doing this

It is a superb and thoughtful video presentation of the various key issues from a patient perspective

I hope that some of my medical colleagues, especially those involved in the PACE trial, will get to see it

Can it be reposted?
 
Messages
171
Location
London
Thank you so much for doing this

It is a superb and thoughtful video presentation of the various key issues from a patient perspective

I hope that some of my medical colleagues, especially those involved in the PACE trial, will get to see it

Can it be reposted?
Thanks I feel I've communicated most points as clearly as I'm able at present. Feel free to re-post this.