Trial By Error: An Open Letter to Dr Godlee about BMJ’s Ethically Bankrupt Actions

dreampop said:
Something else caught my eye.

1) In their final results, the authors reference a baseline dataset before cohort swapping because their reference numbers are 49 and 51. Whatever the case, those are not the numbers of patients that began LP and SMC sessions. They must have known this to misrepresent the situation when writing the paper.





The weird thing is it looks like they did not use the secondary baseline characteristics, but the ones immediately following randomization.



2) There is a leapfrogging of cohorts between baseline and follow-up point 1 in figure 2. SMC starts out higher, but then quickly SMC+LP is higher. This represents the largest change from the interventions. We know baseline is again a misrepresentation, because the numbers are again 49 and 51. So, the cohort dropout took place before baseline and first follow-up.

So, the authors used the baseline immediately after randomization, not after the patients switched cohorts. It doesn't represent the baseline before the actual trials began.

But they knew this couldn't be accurate



Instead they labelled them as "not followed up on" which implies they were unfilled questionnaires. They also, I think shockingly, left this out of the text. This info can only be found in the supplementary data and the info about the phone call is from the feasability trial.
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Amazing sleuth work. Thank you for succinctly highlighting the slipperyness of it all. Surely retraction is the only option open now?
@dave30th, @Jonathan Edwards,@Carolyn Wilshire
 
Amw66 said:
Amazing sleuth work. Thank you for succinctly highlighting the slipperyness of it all. Surely retraction is the only option open now?
@dave30th, @Jonathan Edwards,@Carolyn Wilshire
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I'm not sure if it's the results or just the graphs. I want to go back and recheck everything because it's possible my brainfog made a mess of everything. It's a very messy paper.
 
Eleven letters now....
The trickle of letters from top experts to Dr Fiona Godlee about BMJ’s decision to republish Professor Esther Crawley’s Lightning Process study continues.The letters excoriate BMJ’s actions in this matter and urge Dr Godlee to retract the dung-heap otherwise known as “Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial.”
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I have previously posted six letters, here and here. Below are five more. They were e-mailed directly to Dr Godlee and cc’d to many of the 55 scientists, clinicians and other experts who signed Virology Blog’s recent open letter about the matter. The writers are:

Dr Steve Olsen of Kaiser Permanente’s Northern California region; Professor Alison Bested of Nova Southeastern University in Florida; Professor Rebecca Goldin of George Mason University in Virginia; Professor Ronald Tompkins of Harvard Medical School; and Professor Brian Hughes of National University of Ireland, Galway.
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http://www.virology.ws/2019/09/11/trial-by-error-experts-send-more-tough-letters-to-dr-godlee/

Again, thank you David and all letter writers.
 
The Science Bit: My letter to the BMJ regarding their lax editorial approach to bogus therapy paper

https://thesciencebit.net/2019/09/1...ax-editorial-approach-to-bogus-therapy-paper/

By Brian Hughes

Here it is. I think it is pretty self-explanatory (nonetheless, I have added some additional context below the fold):

Date: Sep 11, 2019

To: <Fiona Godlee>, Editor in Chief, BMJ

RE: BMJ’s scientifically and ethically indefensible decision about Bristol’s Lightning Process study

Dear Dr Godlee,

First of all, thank you for the work that you do as editor in chief of the BMJ. I do not at all mean this as faint praise. While my colleagues and I have expressed our concerns, I believe it is important to note that editing a journal is not always easy. Editors play a crucial part in the production line of science and your own contributions, and those of your editorial colleagues, need to be acknowledged.

Secondly, I feel obliged to add my voice to those others who have written to you about the paper “Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial” and, particularly, the associated correction that was published…
 
Having used my current mental energy to post a comment on the latest batch of letters to Dr Godlee shared on the Virology Blog, I thought I would make the most of it and share it here too:

I genuinely cried on reading these letters.

Patients have been struggling for a number of years to have the methodological problems of the preferred research approach to ME by a small group of primarily British researchers, operating under the misleading portmanteau heading bio psychosocial, addressed. (Misleading because they only pay cursory regard to the ‘bio’ or ‘social’ components, indeed regularly disregard the some 9,000 peer reviewed studies into the biological anomalies found in this condition.)

This investigation into the Lightning Process ought to have been the reductio ad absurdum of their approach, surely a methodology, that demonstrated the effectiveness of this obviously voodoo pseudo science, would inevitably be laughed out of every respectable University and Medical department. However ethics committees, peer reviewers, respectable journal editors and serious science journalists all failed to bat an eyelid.

Instead it seemed to receive an unquestioning endorsement from the British medical establishment, through the University of Bristol, the BMJ and the SMC (Science Media Centre) and the wider British Press. Indeed the British establishment seemed to effectively circle the wagons to protect this eminence based science even when its indefensible failings had been very clearly and publicly set out by Dr Tuller and others.

The public gaslighting of patient critics as dangerous anti science fanatics and of academics supporting patient concerns as irrational activists went unquestioned in the British media. Prof Crawley, the lead author of this paper, even said in a public lecture that she had to involve the police in relation to Dr Tuller’s attacks on her (by ‘attacks’ understand robust scientific critique) and at at least one conference castigated him as ‘slanderous’ (by ‘slanderous’ understand robust scientific critique). So far she has provided no evidence for these outrageous claims.

So to read these strong clear endorsements of patient concerns, one after the other, represents an enormous step forward.

Thank you to all these eminent scientists who feel compelled to address this scientific and publishing outrage.
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Trish said:
I love this from Steve Olsen:

''Lastly, let me know if you would be willing to publish an article if I replaced Lightning Process with voodoo as the only change in methodology?''
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Would achieve the exact same outcome so why not? I would really love that. All the known quack treatments out there would achieve the same outcome if used with profuse promises that it "works". Astrology, LP, piss-on-a-hated-person's-grave, CBT for "unhelpful illness beliefs", free-candy-or-beer therapy, whatever. A fake outcome affecting only perception on self-rated questionnaires, the same outcome nonetheless.

I really think there is value in adding a deliberate quack control arm to those trials, since the thing that is normally used as the control for nothing is considered big and powerful because reasons. That fact that "nothing as control" performs better than actual "treatments" should be a damn big clue that it's a sham but apparently the opposite conclusion is believed. Again because reasons.

Normal arm, placebo control arm, quack control arm. For almost everyone of the psychosomatic trial of CFS with loose criteria, there would likely not be any statistical difference between the sham "treatment as usual" and the "holding a chicken foot and dream about not being sick anymore treatment" with relying on the usual biased questionnaires.

It would essentially disappear the entire body of evidence for psychosomatic treatments so I doubt that would happen but one would think the professional "skeptics" would be interested, except it's a bit too risky for the massive sunk cost that still goes into this.
 
''Lastly, let me know if you would be willing to publish an article if I replaced Lightning Process with voodoo as the only change in methodology?''
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And talk about "cost effective"... a quick Google search shows that you can get a voodoo practitioner to cast a spell for as little as $300!

[Possibly less if you have a coupon.]
 
Blog by Steven Lubet about this publishes Rebecca Goldin's letter.
Last July, I blogged about an article published in BMJ Archives of Disease in Childhood that seemed to validate the so-called Lightning Process – a mishmash of “neuro-linguistic programming,” life coaching, and “emotional self-regulation” – as a potentially effective treatment for ME/CFS in children. David Tuller, of the University of California, documented glaring flaws in the study design, including recruitment of more than half the participants before registering the trial and swapping primary and secondary outcomes after the study was in progress.
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https://www.thefacultylounge.org/20...od-that-seemed-to-validated-the-so-calle.html
 
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