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 issues 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.

“We show that mental and physical health symptoms are related. Stress might manifest as somatic symptoms, and persisting physical symptoms might be associated with depression and anxiety.” CLoCK

This was what caused and perpetuated the “greatest medical scandal of the last century” Monbiot. Are we seeing a deja vue of the PACE farago? It is looking like the deck is being stacked to replicate the disaster that happened in MECFS where the illness was “denied and downplayed” Monbiot. We have some of the same researchers, the same cognitive behavioural model (CBM) or Biopsychosocial (BPS) agenda, calls to treat with activity and serious concerns over methodological errors. All of these factors lead to a minimising of Long Covid so the illness is treated with lifestyle or behavioural interventions. To the point that medical attention and care is seen as counterproductive.

Family approaches to managing continuing symptoms are key, as is the negative effect of protracted medical investigations and treatments” CLoCK  

The issues at the heart of the CLoCK study are indicative of the greater flawed cultural and ideological research agenda in the UK which is driving the emergency in paediatric Long Covid.

Now that we have received a response, 8 months later, on the 27^th 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.’

The formal complaint in full HERE

Image credit: ‘Rona Lisa’ by Rosie Pidgeon @art_byrosie

We have summarised the main issues of the open letter for accessibility:

1. Ethical breaches in recruitment and data collection: Informed consent; Deception; Fishing and Data Protection.

We had reports from parents that their children could only access a referral to a Long Covid Paediatric Clinic if they filled in a questionnaire that was from the CLoCK study. It was not clear if the CYP were being signed up to the study and parents reported concern about this ambiguity. There are issues regarding the compulsory nature of this request, especially when the psychosocial narrative of the questionnaire is clear. Safeguarding was raised as an issue as the questionnaire was to be filled in without parental supervision.

2. Long Covid and ME/CFS are clinically linked; CLoCK draws heavily on psychosocial research into ME/CFS that contravenes the current NICE ME/CFS Guidelines, and ignores the report from APPG4ME: Rethinking ME.

We had serious concerns about the agenda of the CLoCK study and that serious mistakes are being made that will hold back a generation of children due to the behavioural approach being followed. This demonstrates that the largest funding allocation, £1.4 million, to study Paediatric Long Covid fails to biologically investigate Long Covid in CYP or to find a medical treatment.

There are two major concerns:

 i) Key CLoCK researchers have been involved in ME/CFS research, where they tried to establish the Cognitive Behavioural Model (CBM) of ME/CFS, that is Prof Esther Crawley and Prof Trudie Chalder.

ii) The CBM, or psychosocial model, is being used in CLoCK as it was in MECFS.

The questionnaire (PDF) is investigating retrospective and current abnormal patterns of thought and behaviour in children, including: stealing, anxiety, depression, self-esteem, anger, inability to share, lying, cheating, perfectionism, disordered eating, and likeability. This raised red flags in that an attempt to establish causation or a sustainment of symptoms on psychological abnormalities as in MECFS is being made.

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. Nor does it follow the development in ME demonstrated by the APPG on ME Rethinking ME report, that was supported by Sajid Javid, MP and leading charities.

3. Psychosocial aspects such as ‘Lockdown Anxiety’ and ‘abnormal thoughts’ are being inappropriately researched in CLoCK.

‘Lockdown Anxiety’, social isolation, anxiety and depression are inappropriately being posited as causing, influencing or sustaining Long Covid symptoms in the CLoCK questionnaire.

Before your Covid-19 test, were you getting any help such as ‘talking therapy’ for your mental health? CLoCK Questionnaire

Please use this space if there is there anything else you would like to tell us about your health or how the pandemic or lockdown have affected you. CLoCK Questionnaire

Yet the UK has not been in lockdown since March 2021 and from this time to November Long Covid cases in CYP rose by 87,000. Logically, then, it is the prevalence of Covid in CYP leading cases of Long Covid, not ‘Lockdown Anxiety’. It is an impossible hypothesis.

4. Insufficient public patient involvement: issues raised are being inadequately addressed from a PPIE perspective resulting in major flaws in the proposed trial.

We have had reports from other Long Covid charities that serious concerns about the methodology of the study are not being addressed. These include:

 i) Denominator issues: unreliability of tests due to statistically significant levels of false negatives. This leads to contamination of control group.

ii) Numerator issues: subjective nature of the questionnaire, no attempt to incorporate emerging objective methods to check for pathophysiology i.e. tests for viral persistence, microclots, immune assays

ii) Control issues: impossibility of finding a control group unaffected by Covid due to high levels of initial and reinfections in CYP, the material proportion of asymptomatic cases of Covid-19, including those leading to Long Covid.

iv) Lack of mechanisms in the research design to factor in emerging evidence and changes during the pandemic: principally, reinfection and the end of lockdown.

v) Taking generalised symptoms out of context: lack of differentiation between symptoms in control and case groups leading to false conclusions of lockdown anxiety being causative.

5. Harmful exercise programmes may be used with CYP on the CLoCK study.

We had concerns that CLoCK documentation indicated that the study proposes collecting data for a future RCT into Graded Activity Intervention (GAI) and the dangerous rehabilitative approach as used in MECFS (which has historically been called GET – Graded Exercise Therapy). Again, the lack of attempt to connect the problems with exertion and PEM in ME and Long Covid would lead to CYP being harmed through a disproven and dangerous treatment. Ultimately, we feel that the CLoCK study and researchers are trying to revive an outdated model to try to re-establish their careers and to not have the grace to move on. We already have reports that CYP are being given graded exercise as a treatment pathway in Paediatric Long Covid Clinics.

6. CYP may face a misdiagnosis of PRS or FII or if parents refuse or pull out of treatment or research; this may further prompt inappropriate involvement from Child Protection Services.

We have already had reports that Child Protection Services are being falsely called in to assess Long Covid families. This is supported by the Social Workers Practice Guide:

“recent reports about responses to children with long Covid-19 show how parents and children are being disbelieved and categorised as FII (Munblit et al, 2021 p. 1): “The issue of not being believed is a common one, and the fear of being considered over-anxious and/ or Munchausen’s by proxy is very difficult. (Long et al., 2022, p. 9)”

Therefore we have deep concerns that if psychological factors are being pushed in research as causative or have the nature of driving or prolonging symptoms, as the CLoCK study is doing, we will see a dangerous paradigm and model established in medical culture. This will and is leading to what happened in MECFS where 1 in 5 families had safeguarding/child protection called in.

Addendum

We received direct testimony from a CYP with Long Covid after the letter had been submitted and sent an addendum. She stated that she was upset that her symptoms were being blamed on Lockdown and that she has been put in the control group because her test had been negative even though she had a Long Covid diagnosis. This points to serious contamination of the control group. The experimental design in CLoCK means that the assignation into the Long Covid or the control group is done through inaccurate or unavailable Covid testing. Yet this plays to the advantage of the agenda of the study as if they can ‘prove’ that Long Covid symptoms are in the control group it means they are not connected to infection.

“It is possible that the symptoms described may be due to a mixture of factors related to the COVID pandemic and ‘lockdown’ rather than viral infection per se, including social isolation, anxiety and depression or educational concerns – with or without evidence of SARS-CoV-2 infection.” CLoCK (Shafran 2021)

Image credit - ‘I Want My Life Back’ by Rosie Pidgeon @art_byrosie

Conclusion

This is a concise summary of the open letter which is a fully referenced and more extensively argued piece. You can view the original formal complaint HERE.

Yet it is the families of the children with Long Covid who are feeling this multiple layered epistemic injustice; that their children are ill through a preventable disease through mitigations; that their is no effective treatment and they are often disbelieved through the cultural machinations of those in power. So, let’s end with their words.

“Long Covid for many children has a devastating impact. The repercussions for their families and friends is profound. This experience is amplified because there are no accessible treatment options. Yet these symptoms are not new, we have seen them before in post-acute viral illness. There is no safety net for children because many of the related conditions such as ME, PANS, MCAS and POTS are under researched and often ignored. We have no reassuring news coming from Long Covid studies and decisive action is needed to ensure a future for these children.”
Dr Binita Kane, parent of CYP affected by Long Covid.

“It is clear that as a parent with a child with Long Covid and an advocate not enough is being done. We find ourselves with no options for medical treatment and no efforts being made to prevent reinfection in schools which is dangerous for children with Long Covid. We need emergency funding aimed at biological investigation and effective treatment. It feels like children are acceptable collateral damage from the pandemic and this isn’t good enough.”
Claire Higham, person with Long Covid, Long Covid Advocacy.

Part Two ‘Not Reassuring – the response to the formal complaint about the Long Covid paediatric study, CLoCK.’