Coyne - What it takes for Queen Mary to declare a request for scientific data “vexatious”

[worldbackwards]

In real life, however, if such a method (e.g. the published protocols) supported the authors' conclusions, they probably wouldn't have gone to so much trouble changing their method. Bit of a smoking gun there.

Apart from any of the statistical chicanery, the inclusion of the objective measures would have damaged their conclusions pretty badly anyway. That was just a blatant omission that they unilaterally decided was irrelevant.

 

[elliepeabody]

Cort Johnson's thoughts on the Editors note from PLoS

"As part of our follow up we are seeking further expert advice on the analyses reported in the article" Plos One

In a win for advocates pressing for a retraction of several studies associated with the PACE trial, Retraction Watch recently reported that one of them, PLOS One has begun its own internal investigation.

They stated that the editors of PLOS One have flagged the article with an "editor's note" . The note states that they are aware of the controversy, that they expect the authors of the study make their data available, and that they have begun their own investigation into it.

If you click on the article you can see that Editor's is plastered over the front of the page - there's no missing it.

This is the first official action by a publication that I know of to address the controversy swirling around the study. If the PLOS ONE article falls then it's hard to imagine that Lancet - one of the most esteemed medical journals in the world - would not be obliged to examine the original study.

Given the huge cost of that study, and the numerous publications that have come and are still coming out of the it, a retraction of the original Lancet study would have enormous implications for the researchers involved, and perhaps even for the CBT/GET field.

http://www.cortjohnson.org/forums/t...al-to-re-examine-pace-me-cfs-study-data.3467/

 

[JayS]

Small note: Cort's link is to the comments tab. If you click on the article, there isn't actually any mention of the note.

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0040808

Not a big deal. Bigger deal: James Coyne has written on Facebook that he's been fact-checking Yesterday there was a post discussing the story of a patient who'd brought a knife to a Simon Wessely talk who, according to Wessely (somewhere in the 'death threats' coverage from years ago, I assume), was threatening. Coyne says that this patient did have a knife, and did speak up loudly. But the knife was apparently a dull-bladed instrument that she used for apples, and was never removed from her purse, nor could it be reasonably construed as a threat (which would presumably be why she was not charged by the police who were called in to investigate). This may be common knowledge, and it rings a bell, but I don't recall specifically off the top of my head.

A new post is specific to the Smith blog, and explains that the story of his wife receiving a threatening message over the telephone was little more than a miscommunication/misunderstanding. There was a phone call that involved some consternation over a paper in the Lancet, and PACE may have been part of the conversation; but the most consternation stemmed from a paper that should not have been published, led to a suicide, and was damaging to psychological intervention in oncology in the UK for years. Whether Smith will offer an update clarifying remains to be seen. But so far that's two refutations of the 'death threats' story in less than 24 hours.

 

[Yogi]

@JayS that is a very interesting post. It would be good to dig more into these allegations of knife wielding death threat militants narrative that has taken a life of its own. Is that on a public Facebook post that we can read?

This militant narrative gives the impression we are like Al Qaeda or the IRA.

Anyway I saw this on maxwhd twitter account. He seems to have aloft of interesting info. Even the independent member of PACE trial had COI with the "outlaw insurer" UNUM as well as all the PIs.

https://pbs.twimg.com/media/CWbxKE-WwAACAWM.jpg:large

https://twitter.com/i/web/status/677493950312226816

 

[Cheshire]

Answer from King's College

We are currently seeking further ethical and scientific advice, as well as the advice of patients, on how best to provide independent decisions about appropriate access to relevant data in a way that balances the rights of trial participants, and future progress of the trial analysis and follow up, with the public interest in releasing trial data."

http://www.kcl.ac.uk/ioppn/news/records/2015/december/release-of-data-from-the-PACE-trial.aspx

 

[JayS]

@Cheshire I put this on Twitter, but gave you a h/t. Then I saw that Simon Wessely put it up as well. Bearer of good news.

@Yogi let me get back to yon on that. Not sure how public it was as far as security settings. A request to share it publicly wasn't answered, and there was a bit of a squabble around some of this. I may have misspoken characterizing it as 'little more than' when it's a very serious subject; it did lead to a suicide, and it actually requires more explanation than was my initial impression. There's a thread in General Discussion based on the Smith blog where Ellen Goudsmit goes into more detail, and she has far more knowledge on this than I do--actually she may very well have been the source for what I read. In any case I think we'll be seeing a blog on this before long. It remains to be seen how much credibility will be assigned to the refutations, but it looks like some progress may be made in challenging the 'death threats'/harassment meme.

 

[Cheshire]

Thanks @JayS but I'm only the messenger!

 

[jimells]

We have supplied requested, anonymised data to independent scientists, as part of normal research collaboration. Among others, these include a Cochrane review group who have independently validated the trial findings on the primary outcomes, and who are now undertaking an individual patient data meta-analysis using these data.

The Cochrane people have reviewed the PACE primary outcomes? Has this review been released? I recall a discussion of a Cochrane review of treatment, but not the PACE primary outcomes...

 

[chipmunk1]

Small note: Cort's link is to the comments tab. If you click on the article, there isn't actually any mention of the note.

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0040808

Not a big deal. Bigger deal: James Coyne has written on Facebook that he's been fact-checking Yesterday there was a post discussing the story of a patient who'd brought a knife to a Simon Wessely talk who, according to Wessely (somewhere in the 'death threats' coverage from years ago, I assume), was threatening. Coyne says that this patient did have a knife, and did speak up loudly. But the knife was apparently a dull-bladed instrument that she used for apples, and was never removed from her purse, nor could it be reasonably construed as a threat (which would presumably be why she was not charged by the police who were called in to investigate). This may be common knowledge, and it rings a bell, but I don't recall specifically off the top of my head.

A new post is specific to the Smith blog, and explains that the story of his wife receiving a threatening message over the telephone was little more than a miscommunication/misunderstanding. There was a phone call that involved some consternation over a paper in the Lancet, and PACE may have been part of the conversation; but the most consternation stemmed from a paper that should not have been published, led to a suicide, and was damaging to psychological intervention in oncology in the UK for years. Whether Smith will offer an update clarifying remains to be seen. But so far that's two refutations of the 'death threats' story in less than 24 hours.

Fiction vs Facts:

What they claimed to see:

What really happened:

 

[Daisymay]

The Cochrane people have reviewed the PACE primary outcomes? Has this review been released? I recall a discussion of a Cochrane review of treatment, but not the PACE primary outcomes...

I guess it would be PACE trial primary outcome not the protocol primary outcomes therefore if Cochrane got similar results it's not surprising and of course completely misses the point.

I find it rather rich PACE authors being concerned about ethics.

 

[jimells]

I guess it would be PACE trial primary outcome not the protocol primary outcomes therefore if Cochrane got similar results it's not surprising and of course completely misses the point.

I find it rather rich PACE authors being concerned about ethics.

Yes, I was mixing up "protocol" primary outcome with the "reported" primary outcome. In any event I'm still looking for a "independently validated" Cochrane review of just the PACE trial - I couldn't find it on Pubmed. I may very well be misunderstanding something, but my impression of Cochrane reviews is that "independently validating" trial results is not the same as judging trial quality for inclusion in a summary of trials data.

 

[Gijs]

It is clear that the authors are looking for excuses not to release the data. They can still give the data to the medical profession who have asked for it like professor Coyne. Problem solved.

 

[elliepeabody]

Yes, I was mixing up "protocol" primary outcome with the "reported" primary outcome. In any event I'm still looking for a "independently validated" Cochrane review of just the PACE trial - I couldn't find it on Pubmed. I may very well be misunderstanding something, but my impression of Cochrane reviews is that "independently validating" trial results is not the same as judging trial quality for inclusion in a summary of trials data.

I'm not sure if this is relevant but I found this 'Intervention Review of Exercise Therapy for CFS' (published 10/2/15) on Cochrane website which uses PACE as one of the studies the review is based on
http://onlinelibrary.wiley.com/doi/...ionid=60E3F53046591F022EBCD073E48DD8D7.f03t02

The review helpfully concludes that

Patients with CFS may generally benefit and feel less fatigued following exercise therapy, and no evidence suggests that exercise therapy may worsen outcomes. A positive effect with respect to sleep, physical function and self-perceived general health has been observed, but no conclusions for the outcomes of pain, quality of life, anxiety, depression, drop-out rate and health service resources were possible. The effectiveness of exercise therapy seems greater than that of pacing but similar to that of CBT. Randomised trials with low risk of bias are needed to investigate the type, duration and intensity of the most beneficial exercise intervention.

The review is included under a 'Common Mental Disorders' Group.

CBT is included in the same group but is dated 2008 and so doesn't include PACE
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD001027.pub2/references

 

[leela]

@chipmunk1 that Rambo/AppleLady thing is hilarious! I hope it goes viral!

 

[alex3619]

The Cochrane people have reviewed the PACE primary outcomes? Has this review been released? I recall a discussion of a Cochrane review of treatment, but not the PACE primary outcomes...

More to the point, what data? If this is any data refused under FOI for cost grounds, that refusal is invalid because the anonymized data already exists, unless they deleted it ... but what valid reason would they have to delete it?

 

[jimells]

I'm not sure if this is relevant but I found this 'Intervention Review of Exercise Therapy for CFS' (published 10/2/15) on Cochrane website which uses PACE as one of the studies the review is based on
http://onlinelibrary.wiley.com/doi/...ionid=60E3F53046591F022EBCD073E48DD8D7.f03t02

Yes, this study was discussed and heavily criticized on the forum. I suspect that the PACE investigators consider that including PACE in this review constitutes "independent validation". Do researchers in other areas of medical research claim that inclusion in a review equals "independent validation"? (not a rhetorical question)

 

[Countrygirl]

http://andrewgelman.com/2015/12/18/28362/#.VnQ4-gn_GCR.twitter


Tug of War: Epic battle over data in controversial paper on chronic fatigue syndrome
Posted by Andrew on 18 December 2015,

He sent me a copy of the paper (Rehabilitative therapies for chronic fatigue syndrome: a secondary mediation analysis of the PACE trial, by Trudie Chalder, Kimberley Goldsmith, Peter White, Michael Sharpe, and Andrew Pickles) that he’d criticized. I glanced at the paper and his comments and wrote back to him:

Maybe it’s worth just ignoring this stuff. There’s so much bad research out there! Or is the topic itself important, and you’re concerned that the bad research will have a malign effect on policy?

Before going on, that you should not consider my above statement as a diss of the Chalder et al. paper, nor, for that matter, should you consider this disclaimer as a statement of support. I looked at the paper only very quickly, and I have a skepticism of pretty much any of these mediation models (as illustrated, for example, by figure 7 from Chalder et al.), so I responded to Coyne with a generic statement that sometimes it’s better just to ignore bad research.

Coyne replied:

I agree it’s an absolute disaster of a paper. It otherwise should not be the object of my attention but there is some nastiness associated with its dissemination. Peter White, one of the authors is paid for working with a group trying to get social welfare payments denied to people with chronic physical illness. He promotes the idea that chronic fatigue syndrome, whatever its origins, is perpetuated by fears of exertion. The deconditioning model that is the basis for these claims has been discredited. So he is forced to rely on dodgy research like this to promote the view that chronic fatigue syndrome is largely “cognitive” and psychosomatic. I’ve seen horrible testimony from him that patients who “appear” to be disabled should be denied handicap parking passes because that will force them to walk more. He has personally testified in a number of hearings where patients with chronic fatigue syndrome have had the benefits revoked.

The Institute of Medicine has recently released an extensive report that takes issue with conceptualization of chronic fatigue syndrome as psychosomatic. It explores a number of physiological bases for what is a very heterogeneous group of conditions. Most importantly, while the report indicates that fatigue is a common symptom, the disabilities are much more extensive and subjective fatigue is not a suitable primary outcome for evaluating interventions.

So, this is emerging as a major, maybe historic confrontation between the forces pushing for sharing of data and the British establishment. I think I am going to get the data, but the task remains of degrading this ridiculous mediational analysis paper which is used to deny benefits to patients with chronic fatigue syndrome. One of the authors, Peter White, was testifying before a British government toward to get the handicap parking passes of persons with chronic fatigue, before the data were even analyze. Furthermore, primary outcomes were changed after patients started new crew. It’s an incredible mess.

 

[worldbackwards]

This militant narrative gives the impression we are like Al Qaeda or the IRA.

I think it's more like a cross between climate change deniers and animal rights activists. Just pitched right to push all the scientists' buttons.

 

[Sasha]

http://andrewgelman.com/2015/12/18/28362/#.VnQ4-gn_GCR.twitter


Tug of War: Epic battle over data in controversial paper on chronic fatigue syndrome
Posted by Andrew on 18 December 2015,

Andrew Gelman is a professor of statistics and political science and director of the Applied Statistics Center at Columbia University.

He has received the Outstanding Statistical Application award from the American Statistical Association, the award for best article published in the American Political Science Review, and the Council of Presidents of Statistical Societies award for outstanding contributions by a person under the age of 40.

His books include Bayesian Data Analysis (with John Carlin, Hal Stern, David Dunson, Aki Vehtari, and Don Rubin), Teaching Statistics: A Bag of Tricks (with Deb Nolan), Data Analysis Using Regression and Multilevel/Hierarchical Models (with Jennifer Hill), Red State, Blue State, Rich State, Poor State: Why Americans Vote the Way They Do (with David Park, Boris Shor, and Jeronimo Cortina), and A Quantitative Tour of the Social Sciences (co-edited with Jeronimo Cortina).

Andrew has done research on a wide range of topics, including: why it is rational to vote; why campaign polls are so variable when elections are so predictable; why redistricting is good for democracy; reversals of death sentences; police stops in New York City, the statistical challenges of estimating small effects; the probability that your vote will be decisive; seats and votes in Congress; social network structure; arsenic in Bangladesh; radon in your basement; toxicology; medical imaging; and methods in surveys, experimental design, statistical inference, computation, and graphics.

 

[elliepeabody]

Yes, this study was discussed and heavily criticized on the forum. I suspect that the PACE investigators consider that including PACE in this review constitutes "independent validation". Do researchers in other areas of medical research claim that inclusion in a review equals "independent validation"? (not a rhetorical question)

I'd say it's possible as the Intervention Review also cites the research it did not include in the review.

There is also a Intervention Protocol - Exercise therapy for chronic fatigue syndrome (individual patient data) which they might also be referring to
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD011040/abstract