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Statistical Malpractice
Abstract
Statistical malpractice is an insidious, and indeed prestige-laden and grant-rewarded, activity. Brilliantly clever, but fundamentally wrong-headed, number-crunchers are encouraged to devise inappropriate applications of mathematical methods to health problems. This species of misdirected zealot has so far been immune from criticism.
... Medicine has been deluged with uninterpretable answers generated by heavy statistics operating on big databases of dubious validity". [23] "The medical-political complex tends towards suppression of science to aggrandise and enrich those in power. And, as the powerful become more successful, richer, and further intoxicated with power, the inconvenient truths of science are suppressed. ...
Conflicts among pro-vaxxers and vaccine deniers will remain endless if both these groups fail to view vaccination through an unusual lens agreeable to both. Citizen participation encourages people to get involved in decision-making processes to build a better society or nation. Pro-vaxxers and vaccine deniers might be correct from their health activism and citizen participation standpoint but lack effective basis towards scientific precision. Under such circumstances, it is important to scrutinize if any aspect of the science remains neglected to facilitate resolving persistent conflicts. Lack of immunological tests to objectively measure the natural and adaptive immunity could have been instrumental in vaccination disputes. Epidemiological findings and publications should not be solely trusted to devise public health strategies. Affordable and precise immunological tests to prove the necessity and efficacy of vaccination on an individual level should be discovered to equally benefit pro-vaxxers and vaccine deniers. Perhaps, such immunological tests should be made disease-specific and vaccine-specific, and also enable development of an immunological classification system with gradations for immunocompetent and immunodeficient individuals. If disease-specific immunological tests are unavailable or cannot be discovered, tests based on homeostasis could be the best alternative but the relationship between homeostasis and immunity is surprisingly neither well established nor widely discussed, thus, immunity may be often seen as an ‘isolated’, ‘vaccine-dependent’ department in the human body. Any prophylactic intervention or treatment should upbring measurable changes in homeostasis of an individual to prove its scientific credibility. Ideally, both pro-vaxxers and vaccine deniers should be labeled as ‘defeated’ in their meaningless tug-of-war for being ignorant about “objective immunoassays”. As citizens, the pro-vaxxers and vaccine deniers have important onus to eradicate vaccination disputes by exploring what is equally relevant and beneficial to both of them to evaluate and regulate their immunity to ensure satisfactory personal health and community health, without any obligation to be sacrificial to justify the authenticity of their citizen participation. A scope for pro-vaxxers and vaccine deniers to work together (conjoint citizen participation) to eradicate vaccination conflicts is possible only based on ‘affordable and reliable immunological test’ to clinically examine themselves and clearly interpret if they are genuinely contributing to herd immunity or sabotaging herd immunity through their personal immune status. Even a single individual could contribute to massive scientific transformations through his or her discoveries, or just through critically questioning established scientific practices, and this is how naturally science evolves as a marvelous product of intellectual humility. Pseudoscience evolves as a malevolent product of intellectual arrogance. Keywords: Citizen Participation, Vaccination, Immunology, Pro-vaxxers, Vaccine deniers, Herd immunity, Antibodies, Innate immunity, Adaptive immunity, Immunological memory
... Indeed reflex hostility seems largely confined to those who misunderstand and overestimate the role of statistics in science. 8 While clinical case studies are barred from some medical journals, psychological case studies of patients with unusual brain lesions are frequently published in the most prestigious 'pure' scientific journals such as Science and Nature. 9,10 The nature of formal case studies involves two crucial methodological principles. 1 First, developing and deriving a scientific theory of sufficient precision to have implications for individual cases. ...
The critique of EBM is not meant to discard EBM in general, rather to challenge its shortcomings and to support its positive
intentions by introducing a philosophy of evidence, and providing a constructive critique of the concept, methods, and its
findings. The EBM research studies are based largely on complex mathematical and statistical data and data analysis. Statistics
do not give clinical results, but only statistical results. When we quantify we typically remove all of the qualities from
the individual. Evidence answers the question of how we know something. We need philosophical analysis to determine what evidence
is. This is philosophical evidence-based medicine. The problem of placebo in EBM is not resolved yet. Placebo is defined in
this chapter as the positive assessments and emotions one has, and these do have a bodily effect.
A powerful impetus behind the rise of the ‘megatrial’ (a large, simple, usually multi-centred randomized controlled trial analysed by ‘intention to treat’) has been the desire for ever-increasing precision in the measurement of therapeutic effectiveness. However, the demand for precision has been allowed to override other and more important methodological considerations. Megatrials have progressively abandoned the pursuit of scientifically rigorous experimentation, valid measurement and optimal epidemiological sampling in favour of recruiting and processing large numbers of subjects. This is a mistaken strategy which leads inevitably to error, because investigators are seeking a primarily statistical, rather than clinically or scientifically relevant, notion of exactness. We are now in a position to describe a clinical research strategy which offers many advantages over a megatrial-led approach. Research should be planned with an awareness that the validity and applicability of estimates is more important than their numerical precision, and that this requires both an unselected denominator population database of all incident cases, and maximally controlled randomized trials and other studies. The Population-Adjusted Clinical Epidemiology (PACE) strategy is suggested as exemplifying the twin principles of clinically useful research: rigorous science and representative epidemiology.
There appears to be a broad consensus that estrogen is a cause of breast cancer. Proof of cause and effect in clinical medicine requires a different approach for an epidemiological exposure (a 'mosaic' approach) than for an infectious agent suspected of causing a particular disease (a 'chain of evidence' approach). This paper discusses the differences between these two approaches in determining the relationship between a risk factor and a disease, and assesses the strength of the data linking estrogen with breast cancer. Analysis of existing data, including findings from the Women's Health Initiative, finds that all nine of the criteria necessary for confirming the epidemiological strength of a risk factor are not met in the case of estrogen, raising serious questions about the validity of this widespread assumption.
Despite their prestige, megatrials are founded upon a methodological error. This is the assumption that randomization of very large numbers of subjects can compensate for deliberately reduced levels of experimental control, but there is no trade-off between size and rigour. Randomized trials are not a 'gold standard' because no method is intrinsically valid-there are good and bad trials. Interpretation of megatrials is always difficult and requires considerable clinical and scientific knowledge. Three fundamental parameters should be considered when evaluating the applicability of a trial to clinical practice: rigour of design; representativeness of the trial population; and homogeneity of the recruited subjects.
A recent development of the therapeutic trial has been the mega-trial: a large, simple randomised trial analysed on an 'intention to treat' basis. Mega-trials have advantages in terms of increased statistical power, but also raise several new questions of interpretation. In mega-trials, randomisation serves to achieve identical allocation groups in a situation where there is poor experimental control and a large measure of between-subject variation. The results of mega-trials cannot readily be generalised because their conclusions are observations, not casual hypotheses, and are therefore not testable. In this sense, mega-trials can be repeated but cannot be replicated. Basic science and clinical science both seek understanding at the level of the individual subject; but in a mega-trial, analysis is only meaningful at the group level. The non-scientific nature of mega-trials derives from their methodology, which dispenses with the scientific aim of maximum experimental control to remove or minimise bias, and instead uses randomisation to achieve an equal distribution of bias between groups.