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Medicine is not science
ABSTRACT: Abstract Most modern knowledge is not science. The physical sciences have successfully validated theories to infer they can be used universally to predict in previously unexperienced circumstances. According to the conventional conception of science such inferences are falsified by a single irregular outcome. And verification is by the scientific method which requires strict regularity of outcome and establishes cause and effect.
Medicine, medical research and many âsoftâ sciences are concerned with individual people in complex heterogeneous populations. These populations cannot be tested to demonstrate strict regularity of outcome in every individual. Neither randomised controlled trials nor observational studies in medicine are science in the conventional conception. Establishing and using medical and other âsoft scienceâ theories cannot be scientific. It requires conceptually different means: requiring expert judgement applying all available evidence in the relevant available factual matrix.
The practice of medicine is observational. Prediction of outcomes for the individual requires professional expertise applying available medical knowledge and evidence. Expertise in any profession can only be acquired through experience. Prior cases are the fundament of knowledge and expertise in medicine. Case histories, studies and series can provide knowledge of extremely high reliability applicable to establishing reliable general theories and falsifying others. Their collation, study and analysis should be a priority in medicine. Their devaluation as evidence, the failure to apply their lessons, the devaluation of expert professional judgement and the attempt to emulate the scientific method are all historic errors in the theory and practice of modern medicine
An unattractive hypothesis â RCTs' descent to non-science
Eyal Shaharâs essay review [1] of James Penstonâs remarkable book [2] seems more inspired playful academic provocation than review or essay, expressing dramatic views of impossible validity. The account given of modern biostatistical causation reveals the slide from science into the intellectual confusion and non-science RCTs have created:
ââŠ. the purpose of medical research is to estimate the magnitude of the effect of a causal contrast, for example the probability ratio of a binary outcome âŠâ
But Shaharâs world is simultaneously not probabilistic, but of absolute uncertainty: âWe should have no confidence in any type of evidence âŠ.. We should have no confidence at allâ. Shaharâs "Causal contrast" is attractive. It seems to make sense, but bypasses in two words the means of establishing causation by the scientific method. This phrase assumes a numeric statistically significant âcontrastâ is causal rather than a potential correlation requiring further investigation.
The concept of âcausal contrastâ is a slippery slope from sense into biostatistical non-science. This can be illustrated with an hypothetical RCT where 100% of interventions exhibit a posited treatment effect and 0% of placebo controls. Internal validity is seemingly quite reasonably assumed satisfied (common-sense dictating the likelihood of an awesome magnificent fraud, bias or plain error of the magnitude required is infinitesimal). Scientific method appears satisfied. The RCT demonstrates: (1) strict regularity of outcome in the presence of posited cause; (2) the absence of outcome in its absence and (3) an intervention (experiment) showing the direction of causation is from posited cause to posited effect.
Now travel further down the slope from science. Assume 50% of interventions and 0% of controls are positive. We compromise scientific method, but justify this by assuming a large subgroup which we say surely
must on these figures be exhibiting the posited treatment effect. But what of 10% of interventions and 9% of placebo controls exhibiting the posited treatment effect? Our biostatistician says the 1% âcausal contrastâ is statistically significant. But we have: (1) minimal evidence of regularity; (2) the posited outcome irrespective of presence of posited cause and (3) our intervention is at the highest equivocal in demonstrating any form of causation. This is not science. It is, however, where biostatistics has unthinkingly taken us, as Penston has shown comprehensively [2].
We, the audience of published medical research, are now for the 10% / 9% example well down the slope from science.
An unattractive hypothesis results requiring numerous assumptions similar to these:-
"There is a 'contrast' which is âcausalâ, albeit the method employed is not scientific. An effect of the intervention has been observed in a very small subgroup. This subgroup is susceptible to treatment. The similar number of placebo controls exhibiting the outcome sought is irrelevant, because the 1% difference between intervention and controls is statistically significant. The statistical analysis is valid and reliable. The RCTâs internal validity is sufficiently satisfied. No funding or bias or fraud has affected the results or their analysis.â
As Penston notes:
âConfirming and refuting the results of research is crucial to science âŠ. But ⊠thereâs no way of testing the results of any particular large-scale RCT or epidemiological study. Each study ⊠is left hanging in the air, unsupported.â
It gets worse. To identify a rare serious adverse reaction of a frequency of 1:10,000 can require a trial of 200,000 or larger split between controls and interventions. This is not done. But for every 100 who prospectively
benefit from the intervention, 9,900 also receive it. And for every 100 benefiting one person (who likely gains no benefit) will suffer a serious unidentified adverse reaction. This is also without taking account of more common adverse reactions whether serious or otherwise.
References
[1] Shahar, E. (2011) Research and medicine: human conjectures at every turn. International Journal of Person Centered Medicine 1 (2), 250-253.
[2] Penston, J. (2010). stats.con: How weâve been fooled by statistics-based research in medicine. London: The London Press, UK
On Evidence, Medical and Legal
Medicine, like law, is a pragmatic, probabilistic activity. Both require that decisions be made on the basis of available evidence, within a limited time. In contrast to law, medicine, particularly evidence-based medicine as it is currently practiced, aspires to a scientific standard of proof, one that is more certain than the standards of proof courts apply in civil and criminal proceedings. But medicine, as Dr. William Osler put it, is an "art of probabilities," or at best, a "science of uncertainty." One can better practice medicine by using other evidentiary standards in addition to the "scientific." To employ only the scientific standard of proof is inappropriate, if not impossible; furthermore, as this review will show, its application in medicine is fraught with bias. Evidence is information. It supports or undermines a proposition, whether a hypothesis in science, a diagnosis in medicine, or a fact or point in question in a legal investigation. In medicine, physicians marshal evidence to make decisions on how to best prevent, diagnose, and treat disease, and improve health. In law, courts decide the facts and render justice. Judges and juries assess evidence to establish liability, to settle custody and medical issues, and to determine a defendant's guilt or innocence
The Real World Failure of Evidence-Based Medicine
As a way to make medical decisions, Evidence-Based Medicine (EBM) has failed. EBM's failure arises from not being founded on real-world decision-making. EBM aspires to a scientific standard for the best way to treat a disease and determine its cause, but it fails to recognise that the scientific method is inapplicable to medical and other real-world decision-making. EBM also wrongly assumes that evidence can be marshaled and applied according to an hierarchy that is determined in an argument by authority to the method by which it has been obtained. If EBM had valid theoretical, practical or empirical foundations, there would be no hierarchy of evidence. In all real-world decision-making, evidence stands or falls on its inherent reliability. This has to be and can only be assessed on a case-by-case basis applying understanding and wisdom against the background of all available factsâthe "factual matrix." EBM's failure is structural and was inevitable from its inception. EBM confuses the inherent reliability and probative value of evidence with the means by which it is obtained. -/- EBM is therefore an ad hoc construct and is not a valid basis for medical decision-making. This is further demonstrated by its exclusion of relevant scientific and probative real-world decision-making evidence and processes. It draws upon a narrow evidence base that is itself inherently unreliable. It fails to take adequate account of the nature of causation, the full range of evidence relevant to its determination, and differing approaches to determining cause and effect in real-world decision-making. EBM also makes a muddled attempt to emulate the scientific method and it does not acknowledge the role of experience, understanding and wisdom in making medical decisions
Social Conditions of Territorial Kansas
Who were the people making up Kansas Territory, or simply âK.T.â, as correspondence was addressed from everywhere? Coming to Kansas from New England and the Middle Atlantic states through the agency of the Emigrant Aid Company, from the Middle and Western states, from the Southern states, and from foreign countries, they had a variety of folk lore and pioneer technique they could put to work. It seems that they would constitute an extremely chaotic society when viewed from this standpoint; yet, they were all sired by progressive peoples, and, if we consider them from the viewpoint of culture and social manifestations we find factors to contribute to their cosmopolitanism instead
Alien Registration- Miller, Clifford A. (Easton, Aroostook County)
https://digitalmaine.com/alien_docs/26468/thumbnail.jp
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