Long Covid Advocacy: Is the “greatest medical scandal of the last century" being repeated for a generation of children? (about the CLoCK study)

Trish

Trish

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https://longcovidadvocacy.substack.com/p/is-the-greatest-medical-scandal-of

Is the “greatest medical scandal of the last century" being repeated for a generation of children?

Part One - The CLoCK Files, the Crisis in Paediatric Long Covid

In July 2022 Long Covid Advocacy wrote a formal complaint to UCL Research Ethics Committee regarding serious concerns about the paediatric Long Covid research study CLoCK. We had received concerns from parents about the study and decided to investigate in detail. Yet it is not just parents and advocacy groups that have concerns, it is leading doctors and researchers in Long Covid. We were fortunate that Dr Binita Kane, Dr Asad Khan, Dr Brian Holloway, Dr Clare Rayner, Dr Kelly Fearnley, Dr Ben Marsh, Dr Ian Barros D'Sa, Dr Claire Taylor, Dr Deepti Gurdasani, Ms Claire Hastie all agreed to co-sign the letter.

Why was this letter deemed necessary? Because a crisis is emerging in paediatric Long Covid. There is only one study for CYP in the UK, CLoCK, for £1.4 million. Yet it makes no attempt to biologically investigate Long Covid or find an effective treatment - where is the urgency? Yet what is at the crux of the crisis is the attempt to incorporate a behavioural model into Long Covid.

[...]

Now that we have received a response, 8 months later, on the 27th March. We have decided that it would be in the interest of the Long Covid community that the letter and response should be opened and made public. Without scrutiny and critical thinking, we risk a generation of children being lost to a model that won’t produce effective care or treatment and at worst puts them at risk of harm. That isn’t acceptable.

The response to the complaint and our critique is covered in ‘Part Two – The CLoCK Files, The Crisis in Paediatric Long Covid.’

[...]

More at link.
 
Long COVID in Children and Young People

To determine the symptoms of Long COVID-19, define Long COVID-19 and determine how many young people suffer from Long COVID-19. Please note, CLoCK is a research project that is entirely separate from the provision of clinical services.

CLoCk Team
Professor Bianca de Stavola
Professor of Medical Statistics

Jake Dudley
Honorary Research Assistant

Leonard Jones
Admin Assistant

Fiona Newlands
PhD Student

Dr Manjula Nugawela
Research Fellow in Quantitative Methods

Dr Snehal Pinto Pereira
Lecturer in Population Health and Applied Statistics

Natalia Rojas
PhD Student

Professor Roz Shafran
Chair in Translational Psychology

Professor Sir Terence Stephenson
Nuffield Professor of Child Health

Laila Xu
Research Assistant

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CLoCk Consortium Members
Marta Buszewicz
University College London

Trudie Chalder
King’s College London

Esther Crawley
University of Bristol

Emma Dalrymple
PPI Lead

Professor Tamsin Ford
University of Cambridge

Shruti Garg
University of Manchester

Dougal Hargreaves
Imperial College London

Anthony Harnden
University of Oxford

Professor Isobel Heyman
Consultant Child and Adolescent Psychiatrist at Addenbrooke’s Hospital

Michael Levin
Imperial College London

Vanessa Poustie
University of Liverpool

Terry Segal
University College London Hospitals NHS Foundation Trust

Malcolm Semple
University of Liverpool

Kishan Sharma
Manchester University NHS Foundation Trust

Olivia Swann
University of Edinburgh

Elizabeth Whittaker
Imperial College London
 
Beyond that, the whole set of studies funded by this round has turned out to be a terrible waste of resources. Unless I'm mistaken, they're all completed. And absolutely nothing to show for it.

Not that research is guaranteed to produce results, but the selection of proposals was very weak and not at all aligned with the needs. Clock was especially bad, for sure, but this was a terrible allocation of priorities. I think only one study even had merit, and barely at that. Zero coherent overarching strategy or effort.
 
I sure love a good naming and shaming when it is deserved. More of this. People are failing us. Not nature. Not fate. People. Even systems are made of people. Name them. Shame them. Send them packing, they have a great career in alternative medicine if they really want to keep doing the same crap.

This indeed important. Regardless of the overall sabotage of the guidelines, they offer the only written protection from a lot of this:
The absence of an attempt to link a subset of Long Covid with MECFS means that we had concerns that the protections given in the NICE guidelines would not be applicable to CYP with Long Covid
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Of course the guidelines are blatantly ignored and violated on purpose. But it is written that they're not supposed to be doing most of what they do. Which also shows blatant disregard for proper process, and especially for evidence. The deep irony of evidence-based medicine is that evidence is truly irrelevant to the paradigm.

Whenever research is this poor, when experts are failing miserably, it sadly falls on the public to hold them accountable and criticize them where the system is failing at it. This is their own failing, however. It does not reflect a public that doesn't understand science, so much as a profession that doesn't understand what their job is even about.
 
From the text, very interesting:

We had been made aware of a CYP who had been assigned the control group even though she had a Long Covid diagnosis and that this had been raised in the CLoCK questionnaire with no action. This raises the question that if one child has been put in the control group due to a negative test but has self-reported Long Covid and/or a Long Covid diagnosis other incidents are inevitable. This means an invalid study as the control group is contaminated.

The control group needs to be contacted to see if there are other cases of self-reported symptoms and/or Long Covid diagnosis’. This flaw will give false results and will not be in the favour of CYP. It has the ability to discredit Long Covid as connected to a Covid infection as symptoms will be seen in the control group. Relying on the unreliable, tests for Covid for a diagnosis of Long Covid, is fraught with difficulties.

This is especially important as the study;

“will assess if there are any differences between CYP who initially tested negative or positive test for covid”.​
 
Sean said:
It's déjà vu again, folks.
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Precisely

"For the study, published on the preprint site Research Square and funded by the NIHR and UK Research and Innovation (UKRI), researchers surveyed---!

Have no lessons been learned from PACE ---- have the APPGs been lobbied --- public money being wasted on flawed research --- post NICE review ---

Jonathan predicted all of this ---
[https://www.s4me.info/threads/post-covid-19-syndrome-and-the-potential-benefits-of-exercise-2021-jimeno-almazán-et-al.20964/#post-350680]

Maybe we should have some grudging respect for these scam merchants --- after all, if they keep getting paid [public money] [EDIT - for] the same flawed result, then why change ----
 
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Peter Trewhitt said:
Part 2 is now online

Not Reassuring – the response to the formal complaint about the Long Covid paediatric study, CLoCK.
Part Two - The CLoCK Files, the crisis in paediatric Long Covid
See https://longcovidadvocacy.substack....id=114996733&isFreemail=true&utm_medium=email
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We can definitely see that it's not a clinical study. No confusion here.
We would like to reassure you that the CLoCk research project is not a clinical study, nor does it draw in any way on psychosocial research into ME/CFS
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But the second part is a blatant lie. I don't know how these people think they're right when they have to lie so much about everything they do, but it's even more absurd that no one in the system cares, how this practice is encouraged and nurtured. Models, already a flimsy construct when they lack evidence, built on lies have no place in healthcare. And yet here they clearly are, drawing on the exact same formulaic process drawn from psychosocial research into, well, anything, really.

Especially the "in any way" is just excessive. It's in all the ways, but they can't bother putting out a half lie, they simply go all the way and tell the most excessive possible lie. Absurd. None of this happens in other professions. People with poor ethics work in every profession, but the lack of ethics has to be checked out during work hours. Not here, work hours are the time for lying, it seems. In medicine. Of all things.

The only scenario where this is not a blatant lie is the sad fact that, truly, most of this type of research, and especially BPS research, is just universally as poor as this. So in a way they feel that it's true, since it's not just ME research that is as awful as this, they can draw plentifully from equally awful "research". But we know better, the formula is identical, and the involvement of both Chalder and Crawley makes this lie especially insulting.

But given the high % of LC that is ME, this only scenario would mean they didn't bother addressing the overlap, while doing everything identical to psychosocial garbage done on ME, which as an excuse is about right where "uh, I don't even know what room I'm in right now" level of ineptitude.

Just deeply unserious. There is no leadership anywhere to be found, no quality control, no ethical protection and a deeply disturbing obsession with pseudoscience.
 
the reply said:
Your original letter was submitted to the UCL Research Ethics Committee (UCL REC) for consideration. However, as the UCL REC did not originally review and ethically approve the research, it was not able to consider the issues raised in your letter. As the study had been approved by the Yorkshire & The Humber - South Yorkshire Research Ethics committee of the Health Research Authority (HRA), your concerns were raised directly with them, as is the normal process. This matter was subsequently referred back to UCL by the HRA for consideration as UCL is the Sponsor for the CLoCk study.
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What a mess of buck-passing. I don't understand why the research ethics committee that approved the research (Yorkshire/Humber/South Yorkshire REC) isn't answering the letter of complaint. I'm not sure what 'sponsor' means, but it sounds a lot like someone marking their own homework. How can this be ok?

Edit - maybe the letter writing team need to make a submission direct to the Yorkshire etc REC?
 
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the response to the reply said:
It is clear that a repeat of the mistakes made in ME/CFS research and the Cognitive Behavioural Model and Biopsychosocial model is happening. The cultural and political influence of CLoCK is profound. The not reassuring WHO clinical definition of paediatric Long Covid was led by CLoCK researchers Stephenson and Shafran. The consequences of this looks likely to restrict access to care and will not improve or benefit paediatric outcomes. This definition needs a positive covid test (argghhhh - because testing is so widespread, accepted and equitable now, not) and only defines as ‘reliable’ 3 symptoms fatigue (not PEM), loss of smell and yes our old friend anxiety. All other symptoms are minimised & misrepresented:

“Symptoms described thus far in children and adolescents are non-specific and can occur with other childhood infections and illnesses. Due to the lack of empirical evidence, a broad list of potential post COVID-19 condition symptoms affecting different organ systems should be considered until more data are available.”

Regardless of the reassurance and all the words, we have to look at the cold outcome - and that is children with Long Covid have been labelled as anxious. Anxiety in the modern age is the rebranded hysteria and the stage is now set for psychosomatic medicine.
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One of the biggest problems is that the CLoCK study is going to say 'oh, these symptoms are very common. Look, the children who weren't infected with Covid (as evidenced by a negative test) have just the same sort of symptoms. So, Long Covid isn't a thing.'

So, again, there's trouble with a vague WHO definition of Long Covid, this time a paediatric one. I think Long Covid as a term needs to be abandoned now. Instead, refer to post-Covid ME/CFS (requiring PEM) and post-Covid fatigue syndromes (not requiring PEM).

And trouble with assuming that a negative Covid test equates to not having had Covid.

I guess we can't stop the CLoCK study, but perhaps, like the fairy godmother in Sleeping Beauty, we can limit the damage. We could demand some additions to the protocol that make it less harmful. e.g.
* require periodic testing of the young people in the Covid negative group for Covid antibodies (not the ones given in vaccinations)? If they test positive to the antibodies, remove them from the Covid negative group.

* if people in the Covid negative group report having Long Covid symptoms (eg debilitating fatigue), take a family history of Covid infections around the time of the Long Covid onset in the young person. If close family members did have a Covid infection around the time of onset, then it can be assumed that the young person did in fact have a Covid infection, but, for some reason tests haven't found the antibodies, and so they should be removed from the Covid negative group.

* require the assessment of all young people in the study to be assessed for PEM, and for ME/CFS using a criteria that requires PEM (e.g. the NICE one, or the IOM/NAM one)


Regarding the UCL reply that it is standard practice when assessing the mental health of young people to use a questionnaire that asks about things like stealing, I think it is right to push back about this. Just because it's a standard questionnaire and has been used in assessing mental well-being in cancer, that doesn't make it right. It just compounds the harm. I can recall filling out a questionnaire for my 13 year old son, for an ME/CFS study, on whether he smoked or chewed tobacco, and if he was afraid of spiders. Enough with these stupid surveys. If it's a standard questionnaire, then update it, amend it, chuck it out and create a new one.

I think we could ask that the data from the questions of very limited relevance to Long Covid are deleted and not analysed. At the very least, we could ask that parents and the young people in the study are asked whether they would like to withdraw their data on these questions.

Edit - I note that the letter writers are calling for any reference to lockdown to be removed from the study. That seems like a good idea.
 
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