Dr James Coyne tackles the PACE follow-up paper

[Scarecrow]

Thanks @esther. My edit crossed with your post. Think we're in agreement about the feasibility study being rolled into the full trial.

D'oh!! Tagged the wrong Esther.

 

[eafw]

Some blogging platforms stick your comment in the spam filter if you post too many links

My first attempt was split in two, I started with only para 1) (no links) I added the rest later and tried to send again through his contact page, so I'll leave it for now.

 

[Riley]

What's up with these people and the creepy acronyms? SMILE, FINE, PACE. It's very Orwellian.

 

[Roy S]

https://mobile.twitter.com/CoyneoftheRealm/status/661349744283906049?p=v

 

[Countrygirl]

This is a statement from Dr Enlander on the recent developments that was launched on his FB page

Dr. Enlander statement on recent controversy over the PACE trial:

We have followed with great interest the events of the past 2 weeks involving the PACE studies which have been published over the years in the Lancet, Lancet Psychiatry, Psychological Medicine, and others. The publication of New York Times journalist David Tuller’s through investigation on Virology Blog, the release this past week of a PACE followup paper, the resultant media coverage, and the interest of Psychology Professor and blogger James C. Coyne has all added up to probably the most eventful week for ME and CFS patients, physicians, and researchers, for some time.

In clinical practice, it is hard to say we have ever found the conclusions of PACE to be particularly helpful. We view ME as primarily a condition of immunological dysfunction with often-severe neurological symptoms, and have had best success treating it in accordance with that viewpoint. Without ever desiring to quarrel with the PACE investigators, their approach has encouraged exertion in a condition that we see to produce post-exertional relapse. In fairness, they have always maintained that their approach of Cognitive Behavioral Therapy, often combined with Graded Exercise Therapy, is not an indication that they view ME or CFS as a primarily psychological condition. However, it is not hard to see why others may draw that exact conclusion regarding their views. As such, for many, PACE provides a de facto overview of the condition itself, whether intended or not. And it can be difficult to extrapolate the conclusions of PACE into a view that ME and CFS should be viewed as primarily physical condition (s). This is, in my opinion, to the detriment of all involved, regardless of any relevance to discussion of Cartesian Dualism.

The issue of design issues and methodological flaws, questionable entry criteria and investigator bias, in PACE is another matter. The Lancet saw fit to publish the initial paper; individuals such as Malcolm Hooper and Tom Kindlon, among others, have spent years analyzing it, and its followups; and it is helpful to remember that this was a publicly-financed study. And an expensive one, at that, in a realm where funding for ME and CFS research (with, perhaps, the exception of research that might suggest primary psychological and/or psychiatric etiology) is and has always been scant, on a global scale. This, also, has been to the detriment of all involved.

My position has always been consistent: this is a physical disease. Yet I have never denied that there is a secondary depression that mirrors those found in other serious physical diseases. As such, I've never felt it proper to suggest that there should be no role for psychological and/or psychiatric involvement--provided that involvement is proportional. The existing paradigm seems to place psychiatric involvement at the forefront, to the exclusion of all else. We don't have to deny any role to our esteemed colleagues; we can work together. At present, though, their role is clearly overstated, and their theories perhaps less than helpful, especially if they serve to put roadblocks in the way of medical research and investigation into treatments.

So it is hard not to see the vigorous discussion of the past week as a firmly positive, and professional, development. There have been pertinent questions, most of which remain unanswered, for years. Perhaps we shall be provided with some much-needed answers soon.

Derek Enlander, MD

"

 

[worldbackwards]

A welcome development:

 

[Cheshire]

Why the scientific community needs the PACE trial data to be released

A university and clinical trial investigators must release data to a citizen-scientist patient, according to a landmark decision in the UK. But the decision could still be overturned if the University and investigators appeal. The scientific community needs the decision to be upheld. I’ll argue that it’s unwise for any appeal to be made. The reasons for withholding the data in the first place were archaic. Overturning of the decision would set a bad precedent and would remove another tooth from almost toothless requirements for data sharing.

http://blogs.plos.org/mindthebrain/...ity-needs-the-pace-trial-data-to-be-released/

 

[Sidereal]

Why the PACE investigators should not appeal

In the past, PACE investigators have been quite dismissive of criticism, appearing to have assumed that being afflicted with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis precludes a critic being taken seriously, even when the criticism is otherwise valid. However, with publication of the long term follow-up data In Lancet Psychiatry, they are now contending with accomplished academics whose criticisms cannot be so easily brushed aside. Yes, the credibility of the investigators’ interpretations of their data are being challenged. And even if they do not believe they need to be responsive to patients, they need to be responsive to colleagues. Releasing the data is the only acceptable response and not doing so risks damage to their reputations.

QMUL, Professors White and Sharpe, let the People’s data go.

 

[Sidereal]

Let’s think about this novel argument. I checked with University of Pennsylvania bioethicist Jon Merz, an expert from who has worked internationally to train researchers and establish committees for the protection of human subjects. His opinion was clear:

The litany of excuses – not reasons – offered by the researchers and Queen Mary University is a bald attempt to avoid transparency and accountability, hiding behind legal walls instead of meeting their critics on a level playing field. They should be willing to provide the data for independent analyses in pursuit of the truth. They of course could do this willingly, in a way that would let them contractually ensure that data would be protected and that no attempts to identify individual subjects would be made (and it is completely unclear why anyone would care to undertake such an effort), or they can lose this case and essentially lose any hope for controlling distribution.

 

[Sidereal]

Twitter action:

James C.Coyne ‏@CoyneoftheRealm
QMUL, Professors White and Sharpe, let the People’s data go.@WesselyS http://blogs.plos.org/mindthebrain/...ty-needs-the-pace-trial-data-to-be-released/…

 

[SOC]

And even if they do not believe they need to be responsive to patients, they need to be responsive to colleagues.

Ouch. Talk about feeling like a nobody.

 

[Esther12]

Ouch. Talk about feeling like a nobody.

The last five years have shown how important status is in academic arguments. Not ideal.

 

[Kyla]

Ouch. Talk about feeling like a nobody.

"And even if they do not believe they need to be responsive to patients, they need to be responsive to colleagues."

Note the use of the word 'believe'.
I don't think he is saying patient criticism doesn't matter. Just that even if they get away with ad hominem attacks or ignoring complaints from patients (which they have so far) the same tactics aren't likely to work when the criticism comes from colleagues.

 

[SOC]

"And even if they do not believe they need to be responsive to patients, they need to be responsive to colleagues."

Note the use of the word 'believe'.
I don't think he is saying patient criticism doesn't matter. Just that even if they get away with ad hominem attacks or ignoring complaints from patients (which they have so far) the same tactics aren't likely to work when the criticism comes from colleagues.

Oh, I understand that. I'm not quibbling with Coyne at all. His statement reflects reality -- the PACE authors, and other medical researchers, do not believe they need to be responsive to patients, but feel their colleagues actually are important. Coyne is right that objections, critiques, and commentary have more weight coming from other medical professionals than from us, no matter how intelligent and correct we are in our evaluations. To say nothing of being the ones most impacted by medical research.

It's still an 'ouch' moment to see your total relevance pointed out so clearly, even when you know it's the absolute truth.

 

[halcyon]

let the People’s data go.

Free Annie Gsampel.

 

[Graham]

I must make a confession and grovel. I thought halcyon's suggested slogan of "Free Annie Gsampel" was really good, so I used it in a reply to the MEAction article about the need to release data. I didn't give halcyon credit though, because I thought that would be just too puzzling for the average reader. But if you hear it used, please spread the word as to who the real author was!

 

[SOC]

Free Annie Gsampel.

Brilliant! C'mon my mighty ME activists, all together now...
Free Annie Gsampel! Free Annie Gsampel! Free Annie Gsampel!
(This really needs some flag or banner graphics. )

 

[worldbackwards]

I must make a confession and grovel. I thought halcyon's suggested slogan of "Free Annie Gsampel" was really good, so I used it in a reply to the MEAction article about the need to release data. I didn't give halcyon credit though, because I thought that would be just too puzzling for the average reader. But if you hear it used, please spread the word as to who the real author was!

Just as well it was that one. If you'd used #JeSuisAnnieGsample, I'd have sued your ass off.

 

[ahimsa]

@Graham @SOC

Freeing Annie Gsampel is all very well, as far as it goes.
But don't we actually need to free Oleg Sampels?

(all examples)

 

[SOC]

@Graham @SOC

Freeing Annie Gsampel is all very well, as far as it goes.
But don't we actually need to free Oleg Sampels?

(all examples)

Free Annie Gsampel! Free Oleg Sampels! Free ME!