I don't think we should try to diagnose the state of health of others, and especially with ME, where many of us have serious problems with people saying you can't be that ill, you look well.
-
New Forum Software Installed (Still a few issues but reopening the forum) More details.
Trial By Error: An Open Letter to Dr Godlee about BMJ’s Ethically Bankrupt Actions
- Thread starter Andy
- Start date
Yes Trish - insensitive of me.
Looking and being are the problem with LP. Working as per previously may have been more of a gauge re LP effectiveness.
I think it entirely legitimate to ask how well people are if they allow themselves to be used to endorse the sale of spurious procedures to the desperate and gullible. One is also entitled to ask whether they are rewarded for their contributions on the subject.
That is what is strange about the whole thing. You would think someone would have said "wait a second, what actually is this treatment?"
And then you quickly get into Parker's background in hypnosis, children standing in a circle pointing and all that which is not hard to find and Tuller has even pointed out.
Either they haven't looked into the LP or they regard a retraction as more damaging than leaving it because the public at large doesn't care enough and their morals are in the dirt. I think it's the latter and that disturbs me.
Sly Saint
Senior Member (Voting Rights)
http://fionafinchcoaching.com/lightning-process/
the Get Change team (Bristol based)
https://www.getchange.co.uk/the-team/
https://lightningprocess.com/find-a-practitioner/
so to maintain their 'status' they have targets for number of victims/patients and seminars to meet.
I wonder if this also affects how much they can charge?
what is this 'pre-course coaching'? was it included in SMILE?
the Get Change team (Bristol based)
https://www.getchange.co.uk/the-team/
https://lightningprocess.com/find-a-practitioner/
so to maintain their 'status' they have targets for number of victims/patients and seminars to meet.
I wonder if this also affects how much they can charge?
Argh. Literally, yes. The methods don't make it clear if anyone dropped out like in the material you quoted. That would be pretty damning, but it seems this happened after they were participaing in the study. It's also not clear (probably delibrately left out) if they got pre-course coaching AKA grooming before participating. Just "discussed' the course.
Last edited:
Kalliope
Senior Member (Voting Rights)
Another letter to Fiona Godlee, this time from Alan Gurwitt:
Here's the most recent message sent to Dr Fiona Godlee about the transparently face-saving "correction" on the Lightning Process study. This message is from retired Yale psychiatrist Alan Gurwitt. Dr Gurwitt also cc'd the 25+ other co-signatories that I had included on the initial e-mail to Dr Godlee.
*****
Fiona Godlee
British Medical Journal
September 4, 2019
Dear Dr. Godlee:
This message is to add to the others you have already received regarding the correction and republication of the Lightning Process study, originally published by Archives of Disease in Childhood in September 2017. That article was entitled “Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical for paediatric chronic fatigue syndrome: randomized controlled trial.”
I fully agree with the points outlined in Dr Tuller’s letter, which many other clinicians and scientists also signed. This study must be retracted in order to protect the interests of children. The decision to republish the study with the original findings was grossly inappropriate.
I am a retired psychiatrist and one of several co-authors of "Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Diagnosis and Management in Young People: A Primer," published in Frontiers in Pediatrics (June 2017). In the process of reviewing the literature for that primer, I reviewed what was available on the Lightning Process. I came to the conclusion that this treatment was utter nonsense. Its proposed use for ME/CFS emanates from the misguided belief in the UK that the illness has psychological rather than pathophysiological underpinnings.
Sincerely,
Alan Gurwitt, MD
Psychiatrist in Private Practice (retired)
Associate Clinical Professor (retired)
Yale Child Study Center
Yale School of Medicine
New Haven, Connecticut, USA
Here's the most recent message sent to Dr Fiona Godlee about the transparently face-saving "correction" on the Lightning Process study. This message is from retired Yale psychiatrist Alan Gurwitt. Dr Gurwitt also cc'd the 25+ other co-signatories that I had included on the initial e-mail to Dr Godlee.
*****
Fiona Godlee
British Medical Journal
September 4, 2019
Dear Dr. Godlee:
This message is to add to the others you have already received regarding the correction and republication of the Lightning Process study, originally published by Archives of Disease in Childhood in September 2017. That article was entitled “Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical for paediatric chronic fatigue syndrome: randomized controlled trial.”
I fully agree with the points outlined in Dr Tuller’s letter, which many other clinicians and scientists also signed. This study must be retracted in order to protect the interests of children. The decision to republish the study with the original findings was grossly inappropriate.
I am a retired psychiatrist and one of several co-authors of "Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Diagnosis and Management in Young People: A Primer," published in Frontiers in Pediatrics (June 2017). In the process of reviewing the literature for that primer, I reviewed what was available on the Lightning Process. I came to the conclusion that this treatment was utter nonsense. Its proposed use for ME/CFS emanates from the misguided belief in the UK that the illness has psychological rather than pathophysiological underpinnings.
Sincerely,
Alan Gurwitt, MD
Psychiatrist in Private Practice (retired)
Associate Clinical Professor (retired)
Yale Child Study Center
Yale School of Medicine
New Haven, Connecticut, USA
Mithriel
Senior Member (Voting Rights)
I hadn't thought about the cost effectiveness part of this study. Is that cost effectiveness to the NHS or does it take into account the large sums parents will have to pay considering that other treatments are available on the NHS for conditions taken more seriously?
Sly Saint
Senior Member (Voting Rights)
Only speculation, but I imagine that certainly in Bristol anyway they would come up with a mutually beneficial deal between the fatigue clinic and the numerous LP practitioners. I don't know how much the weeks/months of CBT and GET cost, but if it can 'all be sorted out' in 3 days of jumping on circles then I imagine they would argue that it is cost effective.
Mithriel
Senior Member (Voting Rights)
Yes, it was probably cost effective for the trial but there is no suggestion it will be available on the NHS though maybe they were hoping it would be, give it time.
I don't suppose the cost to parents who are influenced by reading a fake positive trial matters to them. They don't care if their treatments leave children in wheelchairs for the rest of their lives.
I don't suppose the cost to parents who are influenced by reading a fake positive trial matters to them. They don't care if their treatments leave children in wheelchairs for the rest of their lives.
rvallee
Senior Member (Voting Rights)
Something like LP would never get covered by a public, or even a private one, health insurance system so definitely this is 100% about NHS savings and does not care that it depends on sufferers spending thousands on an obvious scam.
There's nothing more cost-effective than not spending anything. Even better if it makes the participants worse, they won't even be able to get to the clinics anymore and so this lowers health care costs by simply making people too sick to use them at all. In the psychosocial framing, sicker simply means "retreating to bed" or whatever, there is no disease, so it makes no difference at all, nevermind the recorded deaths and overwhelming evidence of immense lifelong suffering, denial takes care of that.
Arnie Pye
Senior Member (Voting Rights)
Just for interest ...
@dave30th
Dr Fiona Godlee has signed a letter along with lots of other signatories on the subject of statins. And one of the people replying to the blog post where the letter is published has referred to lots of Trial by Error posts on the Virology Blog.
The blog post mentioning all this is published on Dr Malcolm Kendrick's blog.
Review of Statins Needed by Dr Malcolm Kendrick
addressed to Sir Norman Lamb MP, Chairman, Science and Technology Select Committee. [Actually it is addressed to Sir Normal Lamb, but we can pretend we didn't notice.
]
The letter mentioning Dr David Tuller's virology blog posts is written by someone called Pauline Sykes, and at time of me writing this it is the third reply to Dr Kendrick's blog.
@dave30th
Dr Fiona Godlee has signed a letter along with lots of other signatories on the subject of statins. And one of the people replying to the blog post where the letter is published has referred to lots of Trial by Error posts on the Virology Blog.
The blog post mentioning all this is published on Dr Malcolm Kendrick's blog.
Review of Statins Needed by Dr Malcolm Kendrick
addressed to Sir Norman Lamb MP, Chairman, Science and Technology Select Committee. [Actually it is addressed to Sir Normal Lamb, but we can pretend we didn't notice.
]The letter mentioning Dr David Tuller's virology blog posts is written by someone called Pauline Sykes, and at time of me writing this it is the third reply to Dr Kendrick's blog.
Jonathan Edwards
Senior Member (Voting Rights)
Don't be so sure. I am certain that LP will have been evaluated along with everything else for evidence and cost effectiveness by NICE. If it scores high enough it will be funded by NHS.
Jonathan Edwards
Senior Member (Voting Rights)
Moderator note:
This post is copied from this thread.
https://www.s4me.info/threads/news-from-scandinavia.647/page-37#post-200059
I have today sent a letter to Dr Godlee of BMJ about the Lightning Process. The content is given below.
Dear Fiona,
I note the recent publication in BMJ of an account of the finalised Risk of Bias 2 tool (RoB2) used in the context of the GRADE system used by Cochrane and NICE for assessing quality of clinical trial evidence. The document focuses on reducing the stringency of RoB assessment principally in unblinded trials.
My immediate reaction to this was that it is a retrograde step, since, increasingly, unblinded trials appear to be given more credence than they deserve. My immediate reaction was then followed by a more serious concern when it was brought to my notice that the corresponding author, Jonathan Sterne from Bristol, is also an author on the paper reporting on the SMILE trial of the Lightning Process that has been the topic of previous correspondence and is now again.
Amongst the proposals for increasing leniency when considering bias in trials, the RoB2 document re-assesses the impact of changing outcome measures after trial initiation but before data analysis and also makes reference to problems with bias due to beliefs held by the patient or treatment delivery team when outcome measures are subjective. It will have not have escaped your notice that amongst the many flaws in the SMILE trial are the issues of outcome switching midstream and the problem of severe risk of expectation bias relating to subjective outcome measures.
So I find myself writing to you again to support the request from David Tuller, and now fifty or more other colleagues, to take the problems with the SMILE trial seriously. I think I had previously suggested that a retraction or clear indication of the flaws of the trial was needed. Looking at the revised manuscript I cannot see that anyone would consider the problem adequately addressed since the inappropriate conclusion remains the same.
Things are beginning to look surreal. It is almost as if the SMILE trial was an exercise in demonstrating that scrutiny by GRADE and RoB systems can be circumvented with impunity.
The GRADE system starts from the premise that a randomised trial provides high quality evidence unless it suffers from one or more defects including bias. The weakness of this can be illustrated by proposing a trial in which patients are randomised to being taught that they will only get better if they think and say they feel better, whether they do or not, or to being told to say how they really feel, and then using how the patient says they feel as outcome. One might think such a trial would be absurd, and never proposed. Yet this appears to be more or less what the SMILE trial is. It is pretty much how patients describe their experience. On the other hand, as Dr Oltra points out, we are not told what really went on, and it looks as if according to RoB2 the risk of bias is not scored high if we do not know what went on!
RoB2 does mention the possibility that bias might arise from patient or therapist beliefs but gives as examples the rather extreme cases of a physiotherapist assessing the benefit of her own treatment or a patient having a belief in homeopathy. There appears to be no recognition of the fact that expectation bias due to beliefs about the value of any sort of treatment are ubiquitous in trials (and in any scientific experiment, including work in the lab) and are the basic reason why we blind ourselves to test and control. In ME/CFS we have seen dramatic responses due to expectation bias with conventional drugs with no therapeutic effect, including rituximab and anti-virals. The RoB2 analysis appears either very naïve or disingenuous.
As we are all aware, the SMILE trial had a highly unsatisfactory structure, being initiated as a ‘feasibility study’, with a large number of patients recruited, and then being registered as a ‘formal study’ after switching of outcomes in the knowledge of the progress of the first 50 or so patients. This might fall under Dr Sterne’s allowed situation of before data analysis but it is a classic cherry picking scenario.
‘Feasibility trials’ and ‘pragmatic trials’ appear to be increasingly popular. As far as I can see these techniques are designed to make trials look as if they have a valid structure for gathering reliable evidence when they almost certainly do not. I have a strong impression that ‘methodological experts’ associated with clinical trials units and other related departments may have a conflict of interest in terms of co-authorship on publications of poor quality trials.
I had for some time thought that the problems of poor quality trials in ME/CFS were at the periphery of academic medicine. Now I get the strong feeling that they may be typical of a general process of degrading the quality of clinical science in the UK. We appear to be moving towards acceptance of methodology that for decades we have known yields meaningless results. I get the impression that bodies like Cochrane and the BMJ are sleepwalking into a situation where they rubber stamp commercial ventures of no merit. In this wider context I can only emphasise the view of all those copied above, that the SMILE trial paper should be retracted and that a fully independent investigation should be completed as soon as possible.
Yours sincerely,
Jo Edwards
This post is copied from this thread.
https://www.s4me.info/threads/news-from-scandinavia.647/page-37#post-200059
I have today sent a letter to Dr Godlee of BMJ about the Lightning Process. The content is given below.
Dear Fiona,
I note the recent publication in BMJ of an account of the finalised Risk of Bias 2 tool (RoB2) used in the context of the GRADE system used by Cochrane and NICE for assessing quality of clinical trial evidence. The document focuses on reducing the stringency of RoB assessment principally in unblinded trials.
My immediate reaction to this was that it is a retrograde step, since, increasingly, unblinded trials appear to be given more credence than they deserve. My immediate reaction was then followed by a more serious concern when it was brought to my notice that the corresponding author, Jonathan Sterne from Bristol, is also an author on the paper reporting on the SMILE trial of the Lightning Process that has been the topic of previous correspondence and is now again.
Amongst the proposals for increasing leniency when considering bias in trials, the RoB2 document re-assesses the impact of changing outcome measures after trial initiation but before data analysis and also makes reference to problems with bias due to beliefs held by the patient or treatment delivery team when outcome measures are subjective. It will have not have escaped your notice that amongst the many flaws in the SMILE trial are the issues of outcome switching midstream and the problem of severe risk of expectation bias relating to subjective outcome measures.
So I find myself writing to you again to support the request from David Tuller, and now fifty or more other colleagues, to take the problems with the SMILE trial seriously. I think I had previously suggested that a retraction or clear indication of the flaws of the trial was needed. Looking at the revised manuscript I cannot see that anyone would consider the problem adequately addressed since the inappropriate conclusion remains the same.
Things are beginning to look surreal. It is almost as if the SMILE trial was an exercise in demonstrating that scrutiny by GRADE and RoB systems can be circumvented with impunity.
The GRADE system starts from the premise that a randomised trial provides high quality evidence unless it suffers from one or more defects including bias. The weakness of this can be illustrated by proposing a trial in which patients are randomised to being taught that they will only get better if they think and say they feel better, whether they do or not, or to being told to say how they really feel, and then using how the patient says they feel as outcome. One might think such a trial would be absurd, and never proposed. Yet this appears to be more or less what the SMILE trial is. It is pretty much how patients describe their experience. On the other hand, as Dr Oltra points out, we are not told what really went on, and it looks as if according to RoB2 the risk of bias is not scored high if we do not know what went on!
RoB2 does mention the possibility that bias might arise from patient or therapist beliefs but gives as examples the rather extreme cases of a physiotherapist assessing the benefit of her own treatment or a patient having a belief in homeopathy. There appears to be no recognition of the fact that expectation bias due to beliefs about the value of any sort of treatment are ubiquitous in trials (and in any scientific experiment, including work in the lab) and are the basic reason why we blind ourselves to test and control. In ME/CFS we have seen dramatic responses due to expectation bias with conventional drugs with no therapeutic effect, including rituximab and anti-virals. The RoB2 analysis appears either very naïve or disingenuous.
As we are all aware, the SMILE trial had a highly unsatisfactory structure, being initiated as a ‘feasibility study’, with a large number of patients recruited, and then being registered as a ‘formal study’ after switching of outcomes in the knowledge of the progress of the first 50 or so patients. This might fall under Dr Sterne’s allowed situation of before data analysis but it is a classic cherry picking scenario.
‘Feasibility trials’ and ‘pragmatic trials’ appear to be increasingly popular. As far as I can see these techniques are designed to make trials look as if they have a valid structure for gathering reliable evidence when they almost certainly do not. I have a strong impression that ‘methodological experts’ associated with clinical trials units and other related departments may have a conflict of interest in terms of co-authorship on publications of poor quality trials.
I had for some time thought that the problems of poor quality trials in ME/CFS were at the periphery of academic medicine. Now I get the strong feeling that they may be typical of a general process of degrading the quality of clinical science in the UK. We appear to be moving towards acceptance of methodology that for decades we have known yields meaningless results. I get the impression that bodies like Cochrane and the BMJ are sleepwalking into a situation where they rubber stamp commercial ventures of no merit. In this wider context I can only emphasise the view of all those copied above, that the SMILE trial paper should be retracted and that a fully independent investigation should be completed as soon as possible.
Yours sincerely,
Jo Edwards
Last edited by a moderator:
It appears you could drop out after the phone call but still be considered a participant in the original proticol.
It is techincally part of the intervention LP + SMC intervention. It is said the child/his family decide together before treatment but after radomization if they want to particpate in the study. Edit: this may mean they were shifted to SMC cohort.
From the quote you provided and the vagueness it seems very possible the the practitioner has enough leeway to suggest to certain patients not to continue.
The final paper method section does not say children had a choice to continue or not after this phone call, but before participating in the LP.
It's very confusing. The flow chart does not list it as a seperate step from the intervention.
Last edited:
Simbindi
Senior Member (Voting Rights)
I remember reading in relation to IAPT CBT that the NHS estimates the overall costs to be £100 per individual session to the CCGs, which is actually much higher than the cost would have been when the CBT therapist (or person centred counsellor) was employed directly by the GP surgery.
However, overall the IAPT model saves [sic] the NHS money because most patients are assigned to the much cheaper to employ 'Wellbeing Practitioners' - and unofficially because only a small proportion of referrals actually complete a full (clinically meaningful) course (i.e.8 weeks or more) of high intensity CBT treatment or indeed, see anyone at all.
Of course, in IAPT the patient is officially deemed to have 'completed treatment' if they attend/complete a minimum of 2 sessions, that is, if they have filled in the anxiety and depression questionnaires at two different points in time (so a comparison of scores can be made and 'recovery' calculated). This makes everything look nice and rosey for the stats, which is the most important outcome of the therapy.
A little addition to my previous comment:
Of 51 patients, 9 were moved to SMC from SMC + LP, 2 of 49 were moved from SMC to SMC+LP post randomization. I have no idea why they were moved. Maybe I missed something.
It seems possible this was because of the phone call consulation or "pre-coach groaming" as @Sly Saint pointed out. It occured before the LP sessions took place. I have no idea where this falls in ethical research. It seems conceivable that a shift of 10% of the patients based on LP practitioner innuendo would subvert the purpose of randomization and give a more favorable SMC + LP cohort. We don't really know what happened on those calls.
Sorry, if this is old news, there are so many things wrong with this study it's genuinely hard to keep track.
Of 51 patients, 9 were moved to SMC from SMC + LP, 2 of 49 were moved from SMC to SMC+LP post randomization. I have no idea why they were moved. Maybe I missed something.
It seems possible this was because of the phone call consulation or "pre-coach groaming" as @Sly Saint pointed out. It occured before the LP sessions took place. I have no idea where this falls in ethical research. It seems conceivable that a shift of 10% of the patients based on LP practitioner innuendo would subvert the purpose of randomization and give a more favorable SMC + LP cohort. We don't really know what happened on those calls.
Sorry, if this is old news, there are so many things wrong with this study it's genuinely hard to keep track.
Last edited:
