David Tuller: Trial By Error: FITNET-NHS Recruitment Ad Promotes ''Recovery''

Kalliope

Kalliope

Senior Member (Voting Rights)
Trial By Error: FITNET- NHS Recruitment Ad Promotes "Recovery"

A British medical education company has recently disseminated a recruitment ad for a high-profile pediatric study of treatment for what it calls CFS/ME. The recruitment ad’s headline describes the intervention being investigated as “effective,” without caveat or reservation. (Full headline: “Chronic fatigue syndrome (CFS/ME): effective home treatment for teenagers”)
 
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I'm not finding time to keep up with these recent posts @dave30th ! Slow down. I still need to listen to the podcast.

I only read the first couple of paragraphs, but I wasn't sure this was a particularly hard hitting criticism to be starting off with:

To back up this assertion, the recruitment ad claims that a previous Dutch study of the intervention reported “impressive” results, with 65 % in that arm achieving “recovery,” compared to only 8 % among other participants. The ad declares that these results were maintained for years. [In fact, the Dutch study reported this “recovery” rate as 66 %.]
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I'm assuming it gets worse?!

I think it's pretty disturbing that Bristol continues to promote Crawley's misleading TEDx talk to potential participants, even after TEDx have made her talk unlisted on youtube: http://www.bristol.ac.uk/ccah/research/childdevelopmentdisability/chronic-fatigue/fitnet-nhs/faq/
 
For me the truly despicable act is ignoring the long-term follow-up results, which were null for both the Dutch FITNET, and PACE.

That should have been the end of the matter.

I am willing to accept that they started out decades back as well intentioned, if mistaken. But at some point they chose to cross over from that into deliberate manipulation and deceit.

To be as generous as possible, the absolute latest they can even plausibly claim innocence and honourable intention was the publication of the LTFU papers. Any claims of benefit from them after those results were entered into the formal literature are clearly fraudulent and deserving of the strongest condemnation and sanction.
 
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dave30th said:
I'm not sure how much "worse" it gets. I think it's pretty bad to promote not only recovery rates but bogus recovery rates for an intervention that you're supposed to be testing.
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Does it get worse when you realize there was no work showing in the original trial that the patients actually received all of the therapy?*

The patients had to do 'online modules' as part of the CBT. The trial does not show how adherence was monitored. So, you have a lot of kids, with limited energy, some with probably cognitive difficulties given 'homework', which involved some kind of reading information. A great recipe for full adherence I'm sure to anyone who doesn't understand kids, especially ill ones. Maybe they did, but where is the evidence that they did?

Millions of people where surprised about Facebook was actually doing with their information, despite it all being documented in the terms and conditions. They didn't read them, they skipped them and clicked O.K. I know someone who got a gift, because it was mentioned how to receive one in the weekly corporate newsletter on the Intranet (mandatory reading). Nobody else in the company got the gift, because nobody else actually read the newsletter!

The Dutch trial was like a drug trial where you don't actually see the triallists taking the dose, or a therapist not noticing if the patient is actually in the room listening to them. :D

*At least I couldn't find how they did measure adherence, despite their being easy ways for this to have happened.
 
Is there any mileage in complaining to the UK Advertising Standards Authority about the mail shot to GPs promoting the study which includes untrue claims of recovery resulting from CBT/GET? See https://www.asa.org.uk/make-a-complaint.html

Their guidelines explicitly include such direct mailing. Though they exclude "claims, in marketing communications in media addressed only to medical, dental, veterinary or allied practitioners, that relate to those practitioners' expertise", I would argue our concerns relate to the false claims of recovery in the mail shot not practitioners' expertise. See https://www.asa.org.uk/type/non_broadcast/code_folder/scope-of-the-code.html

Is any complaint doomed to fail because currently NICE endorses CBT/GET?

What evidence would we need to make a complaint? Presumably @dave30th will be happy to share the original mail shot, there are various articles and blogs pointing out the problems with the studies making the claims of recovery and there are the surveys of patients indicating harm from GET?

Individuals or organisations can complain. Any thoughts on this?
 
Red Whale are unequivocally prejudging the trial outcome and endorsing FITNET- NHS, under the title "effective home treatment for teenagers" they say "we think this is a good opportunity for teenagers with this difficult diagnosis".

See their GP updates section https://www.gp-update.co.uk/updates?reqUpdate=494#upd_update_nid_494

and also for the specific update on FITNET-NHS https://www.gp-update.co.uk/SM4/Mutable/Uploads/pdf_file/CFS-ME_-treatment-for-teenagers.pdf

[added later - if I was a busy GP that had managed to miss the entire PACE controversy, I would be very tempted to take what Red Whale says in this link at face value, it all sounds so plausible, and when I was feeling very inadequate and uncomfortable faced with an ill teenager and their anguished parents it would be very easy to refer them to FITNET-NHS especially as they have a NICE endorsement for CBT/GET.

Red Whale seem to have no other ME/CFS related information on their website.]
 
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Peter Trewhitt said:
Is any complaint doomed to fail because currently NICE endorses CBT/GET?

What evidence would we need to make a complaint? Presumably @dave30th will be happy to share the original mail shot, there are various articles and blogs pointing out the problems with the studies making the claims of recovery and there are the surveys of patients indicating harm from GET?

Individuals or organisations can complain. Any thoughts on this?
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I don't think the situation at NICE is relevant. I think a complaint to ASA is entirely in order. I do not know the rules but I am pretty sure this is unethical.
 
Jonathan Edwards said:
I think a complaint to ASA is entirely in order.
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maybe someone could find out from MEA how the complaint was made about the LP claims(?)
this is the ASA complaint page
https://www.asa.org.uk/make-a-complaint.html

eta:
You will need:
  • information about the ad, including where and when you saw it
  • if possible, a photo, video or screenshot of the ad
  • if you're complaining online, a few minutes to fill in our form
 
Amw66 said:
Perhaps the use of a third party for recruitment may highlight issues with recruitment...
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They also get the benefit of promotion of the approach to all GPs. Which obviously they need to do to try keep them on board with the status quo now that NICE guidelines are being reviewed and non BPS messages are getting out there. It is a political campaign.

ETA. So we hear snippets about work being done on non-BPS GP education about ME. Whatever is developed will need a lot of promotion to cut through I hope this is being worked on too.
 
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From this 30 page PDF detailing the trial:

page 5
CFS/ME is defined as generalised fatigue, causing disruption of daily life, persisting after routine tests and investigations have failed to identify an obvious underlying ‘cause’
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Page 11
Criteria for trial entry
3 months fatigue and 1 or more of: 
post exertional malaise 
difficulty sleeping 
cognitive dysfunction 
muscle and/or joint pain 
headaches 
painful lymph nodes 
general malaise 
dizziness and/or nausea 
palpitations
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The thing that puzzles me is there is no control group. The comparitor is 'activity management'. Both treatments seem to involve persuading the kids to increase activity.
 
Jonathan Edwards said:
I don't think the situation at NICE is relevant. I think a complaint to ASA is entirely in order. I do not know the rules but I am pretty sure this is unethical.
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If the a case is brought and the ASA judge against them, I hope that part of the judgement would be a requirement that Red Whale would have to contact the same GPs that they contacted in the first place and admit their mistake. Otherwise, we've got a CDC-style situation in which potentially harmful treatment is spread and then withdrawn without notifying practioners, which is not acceptable.
 
Red Whale have on their website a 'GP Update' that presumably was also emailed to all GP practices and is what @dave30th was given and refers to in his virology Blog post. See https://www.gp-update.co.uk/SM4/Mutable/Uploads/pdf_file/CFS-ME_-treatment-for-teenagers.pdf

Not only are they wholeheartedly endorsing this research as successful treatment leading to 'recovery' they recommend to GPs "Consider a proactive search of all your patients aged 11-17 with a coded diagnosis of CFS/ME - could you offer them details of this trial?"
 
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