Trial By Error: Claims Built on Fraudulent Trials Should Be Ignored

By David Tuller, DrPH

When researchers cite fraudulent studies in support of their claims, it is best not to take anything they write at face value. That is certainly the case with a recent paper titled “Persistent physical symptoms not explained by structural abnormalities or disease processes: a primary care approach to promote recovery,” published earlier this month in the Scandinavian Journal of Primary Health Care. (I use “fraudulent” here not in the legal sense but in the sense of “deceptive” or “deceitful.”)

As evidence of something or other, the paper’s references include both the fraudulent PACE trial, whose reported findings have been discredited and rejected by leading medical authorities, and a fraudulent pediatric trial of the Lightning Process, in which the investigators violated core methodological principles of scientific research. (The Lightning Process, a woo-woo “brain retraining” program, was created by osteopath and former spiritual healer Phil Parker, who once claimed to be able to diagnose people’s ailments by stepping into their bodies for a look-see.)

The Scandinavian Journal of Primary Health Care has emerged as something of a house organ for members of the biopsychosocial ideological brigades, including prominent non-Nordic fellow travelers like Professor Paul Garner and Professor Trudie Chalder. (The former is the corresponding author of this paper; the latter is one of multiple co-authors.) Both were also co-authors of a similarly misguided document published by the same journal In 2023–a manifesto from the self-styled Oslo Chronic Fatigue Consortium called “Chronic fatigue syndromes: real illnesses that people can recover from.”

The new paper’s goal is to offer primary care physicians a short summary of “contemporary theories of PPS” along with purported “evidence-informed pathways” for treating patients. The research involved a “narrative literature review and consensus development with experienced practitioners.” In other words, the paper presents the beliefs, opinions and biases of a self-interested and insular group of professionals—or cultists, if you will—as if they were actionable facts. 

In the abstract, the authors assert the following regarding PPS: “When diagnosis, advice and care are based solely on a biomedical interpretation of symptoms, patients may not improve. This can result in repeated and often frustrating consultations and investigations.”

This statement is undoubtedly true in some circumstances, but it is also pretty meaningless. The statement is also true if “biomedical” is replaced with “biopsychosocial,” to wit: “When advice and care are based solely on a biopsychosocial interpretation of symptoms, patients may not improve. This can result in repeated and often frustrating consultations and investigations.” The question is, which scenario is more representative of reality?

Per the authors’ theories, “symptoms may arise from brain-based responses to perceived threat, influenced by expectations and learned associations,” and these responses “can become unhelpful when benign sensations are interpreted as dangerous.” And the essence of the advice is “validating patients’ symptoms and emotional experiences, providing clear explanations of symptom persistence, and developing personalised management plans that combine biological, psychological, and social approaches.” These approaches “can reduce or resolve symptoms, foster hope and a sense of agency, and often lead to recovery.”

We have heard these sorts of claims from members of the biopsychosocial cabal over and over again. If the authors presented legitimate and robust evidence that their “evidence-informed pathways” produced substantive benefits, that would be one thing. But where is the data showing that their prescriptions “often lead to recovery”? As is, this assertion is pure propaganda. Beyond PACE and the Lighting Process study, the evidence that has “informed” their approach is similarly flawed and untrustworthy, as first-year epidemiology graduate students at Berkeley would quickly understand. 

One reference is an infamous Cochrane review called “Exercise therapy for chronic fatigue syndrome.” This review has been widely contested and is no more reliable than the largest included study, which is the fraudulent PACE trial. Another cited study, called “Brief outpatient rehabilitation program for post–COVID-19 condition: a randomized clinical trial,” claimed success even though the benefits reported for self-reported physical function did not reach the predesignated threshold for clinical significance, as I reported in this post

The paper proposes that clinicians adopt a “stages-of-change” framework from the field of smoking cessation, with recovery presented as within the individual’s power to achieve. The authors do not explain why an addiction template would be appropriate for chronic illness. They also repeat the frequent but unproven argument that having a “strictly biomedical understanding shaped by prior healthcare experiences” is an obstacle to getting better. This argument is generally based on observational studies documenting associations, not causal relationships. It is just as likely, if not more so, that patients who fail to get better are more likely to decide that their problems are biomedical.

Not surprisingly, the paper does not mention the 2021 ME/CFS guideline from the UK’s National Institute for Health and Care Excellence (NICE), which rescinded its own previous recommendations for graded exercise therapy and a curative form of cognitive behavior therapy based on the “unhelpful beliefs” model. Multiple authors of this PPS paper have flatly rejected that document, but pretending it doesn’t exist is to present a distorted version of reality. These folks have clearly lost the plot.

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