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Compliance

Knowledge-gap risk and audit trails (examples plus research-market inefficiencies)

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Liability-generation from elevated probability of unlawful clinical and administrative judgement does not only stem from practitioners’ incorrect beliefs regarding disease aetiology (causes) and pathology (symptoms). Practitioners also generate further excess risk from their knowledge gap versus formal ME/CFS and related diagnostic criteria, which offer 1) rigour and ease of diagnosis and 2) risky diagnostic audit trails of the progression of liability-generating harm.

This specific knowledge gap is versus appropriately rigorous ME/CFS diagnostic criteria (ICC, CCC and IoM), which account for the serious symptomatology that 1) has been repeatedly found across neurological, immune, endocrine, metabolic and other biophysical abnormalities and 2) that persist or risk exacerbation from malconstrued psychogenic interventions. It is therefore commonly underappreciated that ME/CFS has been found not to be medically unexplained idiopathic fatigue (see unlawful false equivalence with FND, etc.). Neither is ME/CFS mere “chronic fatigue,” which can be symptomatic of a wide range of diseases, including cancer, depression, multiple sclerosis, stroke or other maladies not diagnostically consistent with ME/CFS being the cause of fatigue (misdiagnosis has thus been empirically found to be a disproportionate risk, not just chronic underdiagnosis). Post-viral fatigue syndrome is a pre-cursive diagnosis with looser criteria, often incorrectly used as a synonym for ME/CFS. Moreover, fatigue often manifests as a mere secondary symptom in ME/CFS.

These differential diagnoses mean that litigation, or other complaints contributed to by the elevated probability of in this field, can be additionally confronted with a diagnostic audit trail that documents 1) accelerated progression through these differential diagnoses and 2) generation of PTSD resultant from unlawful medical encounters (a phenomenon in this field documented as being caused by frontline belief systems and knowledge gaps).

ME/CFS “fatigue” alone (idiopathic, unexplained)

ME/CFS “chronic fatigue” alone (idiopathic, unexplained, FND, MUS, PPS)

ME/CFS post-viral fatigue syndrome alone

ME/CFS has distinct diagnostic criteria, multi-system symptomatology, scientific consensus and legal status

Normalised mismanagement can accelerate progression through these diagnoses, with a diagnostic audit trail documenting liability-generating harm

Illustration: normalised lack of knowledge and regulatory response

The above lack of knowledge extends to ignorance of the scientific consensus and its repeated findings of biophysical abnormalities, which either cause or result from a quantified, negative and non-psychogenic response to in ME/CFS. As an illustration, medics are rarely introduced to the consensus paradigm that in ME/CFS results in range of non-psychologic anomalies. The overall pictues includes findings and research avenues regarding 1) a breach of the anaerobic threshold that occurs with exertion that actually reduces that threshold (reversing the normal process of getting fitter), 2) resulting in the release of pathogens in the blood, accumulation of lactate, including in the brain, and then followed by 3) delayed experience of neurological, metabolic and cognitive symptoms. This includes lack of awareness that different pilot studies repeatedly find that plasma exchange affects both cell health and energy transmission in ME/CFS, impacting the mitochondria’s ability to function properly, further contradicting incorrectly normalised beliefs systems thus with serious risk management implications.

The science is incomplete and suffers from prejudicial research-market and funding conditions generated by institutionalised lack of knowledge and prejudice. Nonetheless the addressable consensus repeatedly and independently cross-corroborates phenomena amongst a globally spread community of scientists. This paradigm of open medicine also results in consensus regarding limitations of current findings and agreement around the broad avenues for future research. It is also explicitly clear regarding the unfounded irrelevance of predominant underlying medical assumptions regarding the disease. All without the dispute or concern regarding quality of scientific methodology, discipline, probity or basic methodological literacy identified by regulators versus medical norms (see links regarding expertise-risk, jurisdictions, and elevated risks of unlawful judgement).

In response, the UK medical regulatory guideline review is openly documenting and accounting for consistently deep failings in normalised somatic assumptions that are not borne out by science (reflective of the expertise-risk identified above). The US Institute of Medicine (now National Academy of Medicine) proposed renaming the illness to Systemic Intolerance Disease, based on its assessment over nine thousand scientific research articles. The US CDC has also removed dangerously irrelevant biopsychosocial guidance and is now expressly clear that the disease is biophysical, serious, multisystemic and not malingering:

‘ME/CFS is a biological illness, not a psychologic disorder. with ME/CFS are neither malingering nor seeking secondary gain” (US CDC)

Illustration: contra-scientific belief systems and normalised clinical fallacies that perpetuate the knowledge gap

In contrast and despite facing increasing legal vulnerability, the aforementioned liability generating knowledge gap still leads to unlawful decision-making in a number of fields. This reinforces contra-scientific belief systems deployed by practitioners, without being aware that these theories are legally demonstrable as illiterate in applied medical and research terms, risk harm that regulators are addressing and thus is of consequence to organisations and contracting third parties.

These hazardous belief systems are partially explained by the expertise-risk factors outlined above, which continue to undermine procurement networks and legacy thinking. This is due to:

  • fears that balance -risk versus employment progression/security (particularly among less senior personnel or where funding is/has been directed at work of the less literate variety)
  • the inherently undermined receptiveness of many risk-generating practitioners (which can extend to arbitrary and discriminatory mistruths in writing)
  • their unfamiliarity with the scientific consensus

This overall risk profile of unlawful decision-making is punctuated by clinical fallacies that are widely normalised and self-perpetuating. These risky fallacies include:

Liability Generating Fallacious Belief Systems
– vs –
Legally Demonstrable Reality
“ME/CFS does not exist / is merely fatigue / is not a distinct disease cohort / is a ‘functional neurological disorder’ / is psychogenic”worse than ironically, the scientific consensus repeatedly quantifies the very medical ignorance that self-documents such egregiously contra-scientific refutations for ease of litigious or other use. The scientific consensus, regulatory review and circa ten thousand peer-reviewed articles that contradict such refutations also document the diagnostic specificity of ME/CFS as a biophysical disease and the hazardous irrelevance of pyschogenic-treatment belief systems (which have been sold and productised into frontline risk profiles). This document offers compliance measures and considerations focused on this unusually weak and circular risk profile (see above regarding 1) Medico-legal status, requirements and enforcement, 2) Legal obligations on service providers vs current risk generation contextualised by 3) medical and legal expertise-risk).
“clinical judgement provides self-justifying carte blanche, whether habitual or not,” or “eminent or lay assertions can rebut obligations with tenable legality”decision-making operates within the limits of the law, determination of lawfulness is by law and not medicine and the basis of elevated risk of unlawful judgement has been quantified and widely reported (see above regarding medical education failings and regarding management of expertise-risk)
“there is disagreement/split in the science”there is no disagreement. such a claim requires fallacious redefinition of science to include illiterate standards. scientific consensus and international regulatory reviews clearly define what is known about the biophysical nature of ME/CFS, effective future research avenues, limitations on findings so far, the explicit lack of psychogenic disease or curative treatments, and that medicine suffers from an acute lack of knowledge and contra-scientific belief systems versus ME/CFS (see above regarding medical education failings and regarding management of expertise-risk).
“our organisation does not require education, is compliant and behaves lawfully”the scientific consensus repeatedly documents lack of medical and the dominance of contra-scientific and incorrect belief systems in medicine and third party procurement (see above regarding medical education failings and regarding management of expertise-risk
“official guidance does not require me to do/supply/reply/detail a specific issue”unlawful decision-making is never lawful and flawed assumptions are endemic. Policy, categorisation and implications regarding ME/CFS as a neurological condition lead to clear legal requirements. Official pronouncements from US federal authorities document ME/CFS as explicitly non-psychogenic. UK regulators document that habitually medicalised assumptions are based on “very low” and “low standard” foundations – sufficiently low to result in employment dismissal, regulatory discipline or ridicule in more advanced fields.
“there is a “mind-body link” that provides a curative opportunity for believers”
the scientific consensus finds this to be as irrelevant/relevant as in other chronic or critical diseases e.g. cancer or multiple sclerosis i.e. beliefs or maladaptive thinking are curatively irrelevant, beyond management of mental health consequences of disease, with regulators documenting 1) the harms from assuming otherwise and 2) the current ostracisation by such malpractice of those ME/CFS who may need mental health care. The repeated consensus also finds little difference in emotional or mental health versus other chronic diseases, despite confirmation of ME/CFS as having a greater physical disability. Citable tenured authority also describes the medical-encounter PTSD caused by frontline belief systems and knowledge gaps
“deconditioning of the body is the cause of ME/CFS and exercise is the answer”there is no evidence for this – there is instead repeated evidence of the opposite and sufficient evidence of harm. Scientific consensus, independent and open reanalysis, and regulatory review contradict these abortive theories expressly, documenting “very low” and “low” quality assumptions regarding cause or prolongation. The wider biophysical research consensus considered by these reviews is worse than incompatible with normalised practitioner beliefs.
“crowdfunding is pejorative and biases research outcomes”as in other biophysical research contexts, funding source is irrelevant to the probity or quality of peer-reviewers, verifiable observations or quantifications. It is the role of peer-reviewers, practitioners and researchers to honestly and competently assess with rigour and probity, without bias or appealing to habitually low standards. These obligations can be of legal impact