Embargo broken: Bristol University Professor to discuss trial of quack cfs tx

[AndyPR]

This site look to be of interest as well - http://www.sayer.abel.co.uk/MESNORFOLK/LP.html

This web page has been created as a place for people to record, in the public interest, their misgivings about LP and/or its failure to 'cure' them.

 

[lilpink]

This site look to be of interest as well - http://www.sayer.abel.co.uk/MESNORFOLK/LP.html

Sayer's site is very informative.

 

[Jenny TipsforME]

Intrigued about the bullet point in the press release re researchers' scepticism. Is there going to be a narrative of conversion?

Or is it a retrospective narrative that they were always sceptical which is confirmed by null results (so no egg on face)? I'm not sure that will stand up because it makes it even more unethical to do this to children. It beggars belief that this was passed for ethical approval on children without similar research on adults first.

 

[Cheshire]

Deleted

Tweet reposted suppresed.

 

[lilpink]

https://twitter.com/i/web/status/909700292731645953

Is there a cache for this? Seems to have disappeared...

 

[Demepivo]

Details of the SMC/Crawley Press Briefing Wed 20th Sept 10.30am Wellcome Collection

 

[Demepivo]

Intrigued about the bullet point in the press release re researchers' scepticism. Is there going to be a narrative of conversion?

Or is it a retrospective narrative that they were always sceptical which is confirmed by null results (so no egg on face)? I'm not sure that will stand up because it makes it even more unethical to do this to children. It beggars belief that this was passed for ethical approval on children without similar research on adults first.

I was thinking something similar, the handout for the briefing implies brave Esther conducted a trial to uphold the honour of science...

I expect an endorsement for CBT/GET & FITNET...The woman has no shame!!!

 

[Cheshire]

https://twitter.com/i/web/status/909668816631758848

 

[Jo Best]

Extracts from: https://frownatsmile.wordpress.com/2016/02/14/smile-trial-summary-of-concerns/

A small online focus group formed in October 2010 to share various concerns after the SMILE trial passed approval by the South-West 2 Research Ethics Committee in September 2010.

The group included psychologists, educators, former clients of the Lightning Process, patients and parents of children with ME/CFS. Correspondence with the South-West 2 Research Ethics Committee, National Research Ethics Service, General Medical Council, and Clinical Medical Officer was posted here for reference, and the site is now in the process of being updated (February 2016).

One of the main concerns was that SMILE was processed as a feasibility study, rather than as a clinical trial of a previously untested intervention, when in fact, the trial participants were required to undergo the intervention as an integral part of the feasibility study.

The feasibility study went ahead, and results were published on 5th December 2013. Meanwhile, two further favourable opinions were provided by the South West 2 Local Research Ethics Committee on on 31 May 2011 and 6 September 2012 for amendments to study documents and protocol, seemingly to convert the study to a full clinical trial. This trial was completed and publication of the paper was expected by the end of 2015.

Main Issues of Concern

1. There was no sound justification for conducting this research on
children before its safety and effectiveness had been assessed in adults.

2. The Lightning Process is advertised as a non-medical tool and the
LP practitioners are not medically qualified, yet the PI claimed that
this was a study of treatment for ME/CFS.

3. In Q2 of the study application form, the lead researcher (Dr. Esther Crawley)
did not declare this to be a clinical trial, yet the children were to undergo the
Lightning Process as part of the feasibility study.

4. Dr. Esther Crawley claimed that it was necessary to assess
the safety and effectiveness of the Lightning Process, yet in QA22, she replied,
“We do not believe there are any risks of being part of this study.”
Minutes of the SW ethics committee meeting (10) show that Dr. Esther Crawley was
aware there are risks to patients from doing the Lightning Process.

5. The trial participants were denied their right to give informed consent
to take part in the research, in breach of the Declaration of Helsinki.

6. Child Protection concerns regarding risk to the trial participants mental and physical health; and the Lightning Process research collaborators were trading in breach of Advertising & Trading regulations.

SUMMARY OF CONCERNS RAISED BY ‘frown at SMILE’ in 2010

Failure to –
• process SMILE as a clinical trial
• meet official guidelines for research in children
• take account of existing (and new) research on children with ME/CFS
• justify why the research should be done
• disclose risks (psychological and physical) of the LP intervention
• protect the safety of trial participants
• informed consent in breach of the Declaration of Helsinki
• declare financial incentive for trial participants
• declare conflicts of interest of key investigators/collaborators in the study
• ensure impartiality of ‘Independent Advisory Group’

 

[AndyPR]

Looking at the language in that press release thingy, it looks like they are going to claim some positive results, especially given the phrase "Should this treatment be rolled out more widely" - can't see our patron saint Esther getting to that bit and saying "no, it's not worth while, I wasted everybodys time, sorry".

 

[Dx Revision Watch]

https://www.coyneoftherealm.com/blo...l-of-quack-chronic-fatigue-syndrome-treatment

"...It’s not just patients and patient family members activists who object to the trial. As professionals have gotten more informed, there’s been increasing international concern about the ethics and safety of this trial.

"The Science Media Centre has consistently portrayed critics of Esther Crawley’s work as being a disturbed minority of patients and patients’ family members. Smearing and vilification of patients and parents who object to the trial is unprecedented.

"Particularly with the international controversy over the PACE trial of cognitive behavior therapy and graded exercise therapy for chronic fatigue syndrome, the patients have been joined by non-patient scientists and clinicians in their concerns."


Let us not forget the work that has been done by selected of the UK patient organisations and parliamentarians on Lightning Process in general, and NRES and ASA complaints in particular:

Posts archiving background to the SMILE Trial are archived on my old site, ME agenda, under Category "Lightning Process, SMILE study" (2011 and earlier):

https://meagenda.wordpress.com/category/lightning-process-smile-study/

Posts:

Complaints to NRES and NRES responses (2011),
ME Association Board of Trustees discussions (2010),
Forward-ME discussions (2010),
Bath/Bristol Lightning Process pilot study: Minutes of meeting of External Advisory Group (02.11.10), Transcript: BBC Radio Berkshire, Anne Diamond, ME/CFS: Shepherd, Findley, Parker (2010),
Response from Joan Kirkbride, NRES (SMILE pilot study in children) (2010),
Lightning Process pilot study in children (SMILE): request for the funding application documents (2010),
AYME welcomes ethical approval of Bath/Bristol Lightning Process pilot study in children (SMILE) (2010),
Countess of Mar Written Question on ethical approval of Lightning Process study: Response from Earl Howe (2010),
Which patient organisations were involved in the development of the SMILE pilot study? (2010)
Response from NRES following complaints about Lightning Process trial (2010),
Countess of Mar: Questions for Written Answer: Lightning Process pilot study ethical approval (2010),
Children should not be used as guinea pigs: Prof Robin Gill, Church Times (LP pilot study) (2010),
House of Commons: Written answers and statements: Phil Parker Lightning Process (2010),
Chutzpah – he’s got it in spades! (Lightning Process and scientific research), (2010).
SMILE – Specialist Medical Intervention and Lightning Evaluation Key published documents (2010),
“Unethical” Lightning Process pilot study in children receives ethics approval (2010),
An open AGM and some questions for Action for M.E. (Lightning Process) (2010),
Landmark agreement extends ASA’s digital remit (Lightning Process pilot study in children) (2010),
Lightning Process: further statement from ME Association and Young ME Sufferers Trust (2010),
Update on ethics approval: Dr Esther Crawley Bath/Bristol Lightning Process pilot study for children 8 to 18 (2010),
Questions for Action for M.E. (Lightning Process pilot study in children) 2010,
Action for M.E. and Lightning Process research on children – An opinion: Peter Kemp (2010),
Action for M.E. issues second position statement on Lightning Process pilot in children 8 to 18 (2010),
25% ME Group position statement on Lightning Process pilot study in children 8 to 18 (2010),
Response to request for Internal Review FOI: Lightning Process pilot study in children (2010),
Lightning Process pilot: Update and response from Research Governance Manager, DoH (2010),
House of Commons Debate: Health: Lightning Process (2010),
FOI requests: South West SHA and National Research Ethics Service (2010),
Teen ‘trained’ to overcome illness: This is Cornwall (2010),
Scientific trial involving children and the Lightning Process is unethical, says joint statement issued by two national ME charities (2010),
BRAME Statement about the Lightning Process (2010),
Request for internal review: FOI responses Lightning Process pilot using ME and CFS children (2010),
Lightning Process pilot for ME and CFS children: Funding letters (2010),
A question of ethics; Juvenile Treatment – Testing and LP – CBT/GET ethics (2010),
Unethical Bristol/Bath Lightning Process ME/CFS children pilot study (2010),
ME Association: Advertising Standards Authority upholds a complaint against a Lightning Process practitioner (2010),
Advertising Standards Authority upholds complaint against Withinspiration (Lightning Process) (2010),
GOSH gives platform to Lightning Process (2009),
Letter to AYME: Your articles on CBT and the lightning process, Lawrence Alexander, (2008),
Radio 4: Leo, Rusty and ME: You and Yours follow-up, (July 2007)

 

[Daisymay]

Looking at the language in that press release thingy, it looks like they are going to claim some positive results, especially given the phrase "Should this treatment be rolled out more widely" - can't see our patron saint Esther getting to that bit and saying "no, it's not worth while, I wasted everybodys time, sorry".

I agree that's the most likely scenario but.....the wording made me wonder, perhaps they will make a big scene of showing LP didn't work and spuriously claim they did the trial to protect children from it?

The wording made me wonder if they were going to try and cover their backs as it hadn't worked but they felt pressure to publish?

OK, I'm probably completely wrong in even wondering about the wording.

 

[Cheshire]

I agree that's the most likely scenario but.....the wording made me wonder, perhaps they will make a big scene of showing LP didn't work and spuriously claim they did the trial to protect children from it?

The wording made me wonder if they were going to try and cover their backs as it hadn't worked but they felt pressure to publish?

OK, I'm probably completely wrong in even wondering about the wording.

Whatever the results, as Crawley has no direct hand in the LP, it will be sold as Esther did a wonderfull job of:
- showing the LP is a safe and effective treatment for children with ME/CFS
- proving the LP is unsafe and ineffective.

And all will be thanking her for making such an incredible work in the name of Science.

 

[Demepivo]

Looking at the language in that press release thingy, it looks like they are going to claim some positive results, especially given the phrase "Should this treatment be rolled out more widely" - can't see our patron saint Esther getting to that bit and saying "no, it's not worth while, I wasted everybodys time, sorry".

I think the spin will be

1 more research is needed...
2 CBT/GET are brilliant. Kids can't get enough
3 Patient are b#st#rds
4 do you like my hair?
5 "Mary-Jane Willow (& Sonya C), can you get me a latte"

 

[Sean]

And all will be thanking her for making such an incredible work in the name of Science.

Yeah, colour me cynical too.

 

[Jo Best]

I agree that's the most likely scenario but.....the wording made me wonder, perhaps they will make a big scene of showing LP didn't work and spuriously claim they did the trial to protect children from it?

The wording made me wonder if they were going to try and cover their backs as it hadn't worked but they felt pressure to publish?

OK, I'm probably completely wrong in even wondering about the wording.

I suspect that Esther Crawley would have known from the feasibility study that LP doesn't work so the fact that she ploughed on with the full trial and now will hold a press conference suggests it was a 'success'.

 

[Seven7]

If it is so easy for plp to put a medical
License investigation on those that treat ME as a physical condition ( Myhill said she is the most investigated doctor in history), how come nobody had denounce EC to the medical board? At least the disclosure of conflict of interest should get he license.

Is funny how dirty they fight but somehow they are untouchable. I think the ME organizations on U.K. Should persue medical licenses suppensions.

 

[Jo Best]

If it is so easy for plp to put a medical
License investigation on those that treat ME as a physical condition ( Myhill said she is the most investigated doctor in history), how come nobody had denounce EC to the medical board? At least the disclosure of conflict of interest should get he license.

Is funny how dirty they fight but somehow they are untouchable. I think the ME organizations on U.K. Should persue medical licenses suppensions.

Complaints were made to the UK General Medical Council of suspected research misconduct relating to the SMILE trial but the GMC decided to take no action against her (even though they conceded they could find no evidence of similarities or differences between adult and paediatric ME or CFS, which was a key point in the SMILE trial).

The GMC has been criticised generally for being unfit for purpose.

Esther Crawley was medical advisor to a UK patient charity at the time of the SMILE trial (AYME recently merged with Action for ME) and both AYME and Action for ME supported the SMILE trial so unless Action for ME decides to change its opinion on these matters then it is just viewed by the GMC as differences of opinion between patient organisations. It really needs patients/parents of patients of Esther Crawley to complain but this is very difficult in the current climate of referrals to Child Protection services so they may be fears of repercussions.

 

[Cinders66]

I can't see a press conference on a negative result. Horror regarding the question what does this tell is re CFS/ME etc. And horror for implication as to further research. The bizarre FITNET coverage last year was harmful , now this. Best case scenario was the research was scrupulous enough to analyse data according to criteria met or symptom type so it will only be declared suitable for certain fatigue types in a subgroup and not generalised for all kids with "CFS/ME" label. I honestly thought this had died a quiet death.

 

[Robert 1973]

@Jonathan Edwards and @charles shepherd, Is there any way that you could attend the SMC press conference and/or put out a counter press-release from like-minded scientists and charities opposed to quackery?