Petition: Opposing MEGA

[TiredSam]

Wow! Impressive stuff here. The Bath clinic are so sure of the trial results before the 'research' has begun that they have made this advertisement:

I wonder if that's a way of recruiting for the trial?

 

[Chrisb]

Could a case be made to trading standards for false advertising as it is using our taxes to fund it?

No, I don't think so. Nowhere does it state that the treatment is efficacious.

 

[Valentijn]

No, I don't think so. Nowhere does it state that the treatment is efficacious.

"Most will recover at 6 months with specialist treatment but less than 10% will recover without it"

They're claiming a 40%+ recovery rate, which sounds pretty damned efficacious

 

[Barry53]

Could a case be made to trading standards for false advertising as it is using our taxes to fund it?

Yes I would say so. In true EC style, the words are all there, but the subliminal messaging is incredibly biased. "Treatment" is the big bold first word, and the word "study" is the diminutive last word. Let alone the phrase "specialist treatment is now available". I do not see how a "study" can be conflated with approved treatment, and the word "treatment" in this context has to imply approved treatment.

 

[trishrhymes]

The bigger they are, the harder they'll fall.

And it'll make a much more attractive story when it involves one of the patient-bashing fraudsters having risen to a very high position in the medical community.

Maybe we could crowdfund David Tuller to write the book...

 

[A.B.]

They're already starting to stack the deck in favor of CBT/GET. This is a message to FITNET-NHS participants (or their parents), and it says CBT/GET is super effective, while other things aren't. Now imagine how a participant will feel when they find out they have been allocated to the control group.

The recovery claim is also a lie.

I can't wait for the day when justice is finally served to these fraudsters.

 

[Jo Best]

Could we get to 3000 signatures on the Opposing MEGA petition by the end of today do you think as that will be the same number of days as the MEGA petition was open so will send a stronger message that we do not trust this alliance with very good reason on the basis of the past and present research conduct of the key players. Need about 130 more signatures to reach 3,000 today - https://www.change.org/p/opposing-mega-a-vote-of-no-confidence-in-mega-research-for-me-cfs

 

[eafw]

"1% of secondary school children miss 20% of school because of CFS/ME"
"Most will recover at 6 months with specialist treatment but less than 10% will recover without it"
"Specialist treatment is now available ... as part of a research study"

So, where are the Bad Science brigade, Quackwatch and assorted other Skeptics ..... anyone ???

 

[Jo Best]

@Countrygirl @Barry53 do you have the link for that advertisement please, I couldn't find the poster on the Bath site. Thanks. Is anyone going to refer it to the ASA? I think it worth it. Having got away with the SMILE trial, it looks as though Esther Crawley becomes increasingly brazen. Here is a revealing comment on David Tuller's article (I usually avoid reposting names in case the person decides to delete their comment on the original source).

I inadvertently joined Esther Crawley's Patient Advisory Group last year, not knowing anything about her or PACE, after my teenage daughter collapsed with ME. I had ME myself twenty years ago, and her father has Ankylosing Spondylitis, a rheumatic auto-immune disease. It has always struck me how very similar many of the symptoms are, including the fatigue, which has kept him off work for several years at a time during his working life, and the up-and-down nature of the illness. Although I'm not a medic, I am an academic, and I was interested to meet Esther; when she claimed that most children and young people got better within 6 months, I asked her if she checked how well they were in the months and years after that. She swept away my question by saying that she clearly didn't have the funding to contact people after the end of the study. I thought this odd. My daughter felt better after 6 months, but much, much worse after 8. She has now been housebound for 18 months, and too ill to continue her education. I also asked Esther about the rituximab trial in Norway which I had read about in the New Scientist with real excitement - as my husband is on a similar immune-suppressant which has made a huge difference to his health, I could completely understand that this might be a breakthrough. In response Esther was completely dismissive of the trial itself, making very strong statements about the dodgy nature of the methodology of the investigators involved, and suggesting that this was the general view of the scientific community. How interesting to discover later, then, that very similar aspersions had been made about her own work. As an academic under increasing pressures to get funding and grow my international reputation and evidence of 'impact', I can understand Esther's hard work to convince society of the effectiveness of her research through the media. I don't, however, forgive her for her ability to suspend her morals by dismissing all evidence which suggests that she is wrong. As Karl Popper pointed out, we should all be trying as hard as we can to disprove our hypotheses, as only then can we hope to prove them.

Source - http://www.virology.ws/2016/11/21/trial-by-error-continued-the-new-fitnet-trial-for-kids/

 

[eafw]

where are the Bad Science brigade

Talking of Mr BPS lapdog .. here's a recent video and brief article he wrote saying how important open data and looking at design flaws is

"We need Clinical Study Reports, and individual patient data, of course. But we also need the consent forms, so we can see what patients were told. We need the analytic code, so we can see exactly how the data were analysed. We need access to post-publication peer review, so we can see what design flaws others have identified. And we don’t just need these things to be publicly available, in some form or another: we ideally need them to be available as open data, freely shareable and re-usable"

http://archive.is/aIQCc

 

[Dx Revision Watch]

One last blast at EC (for today). As others have pointed out, she's stayed very quiet about SMILE...

Anyone know who/how to ask where the results are?

My attention has been drawn to this comment on David Tuller's recent blog:

Trial By Error, Continued: The New FITNET Trial for Kids
21 November 2016
By David Tuller, DrPH

Mike Emmans-Dean • 10 hours ago
Thank you for this analysis and commentary. The absence of objective outcomes in studies of therapies designed to alter cognitions is disturbing. SMILE, Dr Crawley's earlier study which compared the Lightning Process with specialised medical care, used the SF-36 physical function subscale at 6 months post-randomisation as the primary outcome, but also included school attendance as one of several secondary outcomes.

I contacted Dr Crawley recently about SMILE as it finished recruiting 3 years ago, and publication was planned for the end of the 2015. It's still not been published but Dr Crawley replied that she hopes to publish in the next year. It will be interesting to compare questionnaire results with time in school.

http://www.bristol.ac.uk/ccah/...

 

[Dx Revision Watch]

There is also a flyer for paediatricians, here:

http://www.bristol.ac.uk/media-library/sites/ccah/cfsme/study-docs/Flyer for paediatricians_v2.0.pdf

Edited to add: The GP Flyer and Paedriatrician Flyer are at the foot of this page:

http://www.bristol.ac.uk/ccah/research/childdevelopmentdisability/chronic-fatigue/fitnet-nhs/gpinfo/

FITNET-NHS: A5 GP flyer (PDF, 164kB)

FITNET-NHS: A5 paediatrician flyer (PDF, 220kB)


FITNET website here:

http://www.bristol.ac.uk/ccah/research/childdevelopmentdisability/chronic-fatigue/fitnet-nhs/


ISRCTN Study Registry
ISRCTN18020851 DOI 10.1186/ISRCTN18020851
How effective is FITNET-NHS for children and young adults with CFS/ME?

http://www.isrctn.com/ISRCTN18020851

 

[user9876]

There is also a flyer for paediatricians, here:

http://www.bristol.ac.uk/media-library/sites/ccah/cfsme/study-docs/Flyer for paediatricians_v2.0.pdf

FITNET website here:

http://www.bristol.ac.uk/ccah/research/childdevelopmentdisability/chronic-fatigue/fitnet-nhs/

ISRCTN18020851 DOI 10.1186/ISRCTN18020851
How effective is FITNET-NHS for children and young adults with CFS/ME?

http://www.isrctn.com/ISRCTN18020851

Visually the leaflet it looks amateurish partly because some of the text is hard to read over a picture.

More importantly it makes claims for the treatment and seems to downplay the aspects that this is a trial to test a treatment.

 

[Dx Revision Watch]

Visually the leaflet it looks amateurish partly because some of the text is hard to read over a picture.

More importantly it makes claims for the treatment and seems to downplay the aspects that this is a trial to test a treatment.

The statement:

"Most will recover at 6 months with specialist treatment but less than 10% will recover without it"

is not referenced, either, to any earlier study, either in the GP flyer or the paediatrician flyer.


Edited to add: The GP Flyer and Paedriatrician Flyer are at the foot of this page:

http://www.bristol.ac.uk/ccah/research/childdevelopmentdisability/chronic-fatigue/fitnet-nhs/gpinfo/

FITNET-NHS: A5 GP flyer (PDF, 164kB)

FITNET-NHS: A5 paediatrician flyer (PDF, 220kB)

 

[Wildcat]

.
If PACE had trouble recruiting 640 adults for the Trial .... how much more difficult to recruit 700 plus youngsters for FITNET.
Also PACE was nationwide (recruited from certain CFS clinics), whereas FITNET is recruiting from the Bristol/Bath CFS Clinic region. I don't know how wide an area the Bath CFS Paediatric service covers.

This is pure speculation - but I suspect that Crawley will widen the recruitment region. There may or may not be financial and logistical reasons for recruiting only from the Bath clinic area.
.

 

[TiredSam]

If PACE had trouble recruiting 640 adults for the Trial .... how much more difficult to recruit 700 plus youngsters for FITNET.

Easy - just diagnose the first 700 kids who yawn within 10 minutes of walking through the door. Perfect for the trial's purposes - most of them won't have ME, won't refuse to do GET or have problems with it, most will recover from their yawn within 6 months. If they don't, blame the mother or re-diagnose with Pervasive Thinking Syndrome and exclude from the results. I'd say EC has designed this trial perfectly for her purposes.

I wonder where she'll hang up her flyers - at the exit to every Bouncy Castle in the Bristol area would be a good starting point, plenty of tired kids who'll recover nicely after a bit of a sit down sorry CBT.

 

[Dx Revision Watch]

.
If PACE had trouble recruiting 640 adults for the Trial .... how much more difficult to recruit 700 plus youngsters for FITNET.
Also PACE was nationwide (recruited from certain CFS clinics), whereas FITNET is recruiting from the Bristol/Bath CFS Clinic region. I don't know how wide an area the Bath CFS Paediatric service covers.

This is pure speculation - but I suspect that Crawley will widen the recruitment region. There may or may not be financial and logistical reasons for recruiting only from the Bath clinic area.
.

http://www.bristol.ac.uk/ccah/research/childdevelopmentdisability/chronic-fatigue/fitnet-nhs/faq/

"Q. How long will this study take?
A. The project was funded May 2016 and is set to open to recruitment on 1 November 2016. We hope to publish the results in May 2022 but it will depend on how long it takes us to recruit 734 children. We have estimated that this may take 42 months."

So an average of 17 children (age 11-17) would need to be recruited each month. These will need to have been referred to the Bath Specialist Paediatric CFS/ME Service by their GP and to be eligible for this study, they need to have been assessed by a Paediatrician.

"We hope to talk to the commissioners in Scotland, Wales and Northern Ireland to try and sort a similar solution for those wanting to access FITNET-NHS in these areas.

"At the moment, if you live in either Scotland, Wales or Northern Ireland and would like your child to be considered for FITNET-NHS, please talk to your GP and paediatrician about referral to the Bath Specialist CFS/ME service. We recommend you discuss with your GP and paediatrician the process of applying for funding for your child to get treatment. We cannot guarantee that they will fund any treatment that we offer."

 

[user9876]

.
If PACE had trouble recruiting 640 adults for the Trial .... how much more difficult to recruit 700 plus youngsters for FITNET.
Also PACE was nationwide (recruited from certain CFS clinics), whereas FITNET is recruiting from the Bristol/Bath CFS Clinic region. I don't know how wide an area the Bath CFS Paediatric service covers.

This is pure speculation - but I suspect that Crawley will widen the recruitment region. There may or may not be financial and logistical reasons for recruiting only from the Bath clinic area.
.

The hospital in Bath is hard to get to as well. There is no car park and it is a walk from parking (which in Bath can fill up). So just going is hard for anyone with a certain level of illness. If people travel further then this will be worse.

 

[Sean]

So, where are the Bad Science brigade, Quackwatch and assorted other Skeptics ..... anyone ???

Quis custodiet ipsos custodes?

 

[slysaint]

SW

he doesn't decide to pursue a new career in politics

maybe an opening in the new Trump administration?............