By David Tuller, DrPH
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No human being should ever have to read as many papers as I have from Professor Esther Crawley, Bristol University’s methodologically and ethically challenged pediatrician, and Professor Trudie Chalder, King’s College London’s statistically and factually challenged cognitive behavior therapy specialist. Most recently, I had to ask the UK’s Health Research Authority to track down why most of the papers that Professor Crawley was ordered to correct a few years ago, per the results of an investigation into her work, had not been corrected. And Professor Chalder makes one egregious error after another–as when she declared at a PACE press conference that people in the trial got “back to normal,” a serious misstatement of the findings.
Really, I’ve had it up to here with the crap that they publish. Perhaps that’s why I have so far avoided paying attention to a major study in which they both play a role. But the time has come to discuss the project called Children & young people (CYP) with Long Covid—which the authors shorthand as the CLoCk study. (Enough with these stupid pseudo-acronyms! What the @#$ does “clock” have to do with anything???)
Professors Chalder and Crawley are not the main investigators but are members of a larger consortium of researchers across multiple universities. Nonetheless, their participation is certainly a red flag. The prospective study is sponsored by University College London’s Great Ormond Street Institute of Child Health and has been awarded £1.35 million from UK funding agencies. Here is a description of the project from UCL’s site:
“This project has identified test positive and test negative 11–17-year-olds through Public Health England’s database. We will be contacting families 3, 6, 12 and 24 months after the young person’s COVID-19 test asking them to complete a questionnaire about the young person’s physical and mental health. We will compare the symptoms between those who have tested positive and those who do not, and also track symptoms over time.”
In a problematic sign, the study is housed under the umbrella of UCL’s “psychological medicine research.” That suggests that this project is not likely to demonstrate a sense of urgency about the need to uncover any pathophysiological mechanisms related to long Covid. It seems designed in a way likely to maximize the chances of generating data that would allow the authors to attribute reported symptoms to the effects of lockdown and related challenging circumstances.
It is undeniable that some children identified as having long Covid are likely suffering from anxiety, depression and other pandemic-related mental health issues, and that such mood states can manifest as physical symptoms. But that truism does not mean that emotional distress is the major cause of the current wave of pediatric medical complaints. And it certainly does not explain why so many formerly healthy kids are experiencing disabling conditions—just like these hypothesized psychological mechanisms cannot explain why so many adults now find themselves unable to engage in their regular daily activities, including work.
Unfortunately, it is always easy to use broad criteria and inappropriate or otherwise problematic comparison groups to generate results suggesting that prolonged symptoms are related to “psychosocial” factors. That happened most recently with the recent Norwegian study published in JAMA Network Open, which I analyzed here and here. The study was conducted in conjunction with Recovery Norway, an organization with strong links to the mind-body “retraining” program known as the Lightning Process. The study’s conclusion—that reports of prolonged symptoms are mainly related to factors other than coronavirus infection—is not credible. But it aligns with the bias of leaders of the research team.
With the CLoCK study. I’m coming late to the party. Luckily, others have already weighed in on this one, so I’m highlighting the steps they’ve already taken to address the situation. In particular, Claire Higham, who writes a newsletter called Long Covid Advocacy and lives in England, sent a letter to UCL last July expressing a number of cogent concerns. The letter was co-signed by several physicians, researchers and other experts who have become known for speaking out about long Covid. Higham has a long history of post-acute viral illness, and her daughter has long Covid. According to a statement on the newsletter, “The purpose of Long Covid Advocacy is to highlight systemic injustice in the fields of Long Covid and ME/CFS.”
Long Covid Advocacy’s letter highlighted the following issues (read the full letter for details):
*Ethical breaches in recruitment and data collection: Informed consent; Deception; Fishing and Data Protection.
*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.
*Psychosocial aspects such as ‘Lockdown Anxiety’ and ‘abnormal thoughts’ are being inappropriately researched in CLoCK.
*Insufficient public patient involvement: issues raised are being inadequately addressed from a PPIE perspective resulting in major flaws in the proposed trial.
*Harmful exercise programmes may be used with CYP on the CLoCK study.
*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.
The UCL response, needless to say, was disappointing. Some of the explanations also demonstrated a level of bureaucratic bungling and incompetence that is especially concerning when the people involved are dealing with vulnerable pediatric patients. For example, Higham’s complaint was apparently passed around among multiple offices and agencies because no one seemed to know who was responsible for responding to it. That’s why it took almost a year for UCL to respond. And some of the forms used by the investigators created confusion about whether pediatric patients at clinics were or were not being enrolled in the study. Etc.
Beyond the specifics of the CLoCk study, a major problem–at least from my observation–is that people seem to fail upwards in this domain of UK academia, which appears to operate under Trumpian approaches to logic and intregity. Professors Crawley and Chalder should by now be considered major embarrassments to their respective institutions, given their documented methodological errors, ethical missteps and false public statements. Both of these prolific and high-profile investigators have committed what I consider to be serious research misconduct, and arguably worse—Professor Chalder with the discredited PACE trial in The Lancet and Professor Crawley with the disastrous pediatric trial of the Lightning Process in Archives of Disease in Childhood, a BMJ journal. The latter now carries a 3,000-word correction and a 1,000-word editor’s note explaining with tortured logic why the paper wasn’t retracted. But it still gets cited authoritatively.
The CLoCK study is only the latest example of questionable work connected to this bunch. It seems largely based on long-held but unproven assumptions that unexplained symptoms are mainly caused by psychosocial factors. Professors Crawley and Chalder and their colleagues are one-trick ponies. Despite the obvious flaws in their research, they retain undeserved levels of professional applause and continue to pull in grant money from leading UK funders. It is hard to fathom.