Evidence-based medicine (EBM) has been a very useful paradigm for assessing evidence in medicine. However, like any other framework, it can be misused, particularly when
fundamentalist EBM methodolatry leads to its inappropriate application to questions for which it is ill-suited, a misuse that has been weaponized against public health during the pandemic.
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Randomized controlled clinical trials are just that: clinical trials in which subjects are randomized to receive either the intervention or a control (such as a saline placebo) and then followed to determine which group has better outcomes, which are prespecified in the clinical trial protocol. The reason for randomization is to ensure that the two groups being compared resemble each other as closely as possible in characteristics relevant to the outcomes being tested. For example, if you’re testing a drug to treat hypertension, you would want the groups to be matched as closely as possible for, among other characteristics, age, race, sex, severity of hypertension, and relevant risk factors for poor outcomes. Ideally, these RCTs are then double-blinded, so that neither the subjects nor the doctors or medical personnel administering the drugs and assessing outcomes know which group any given subject is in. Double blinding is especially important in clinical trials with more subjective outcomes such as pain, for which placebo effects can be strong, but it’s also important even in trials with “hard” outcomes like tumor progression because it could affect how clinicians interpret tests and radiology studies if they know which group a given patient is in. Moreover, such clinical trials have strict inclusion and exclusion criteria, which ensure that those being treated actually have the disease, do not belong to a group that might be harmed by the drug, and are subjects who are likely to benefit if the drug does have efficacy; i.e., does work.
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Worse, as Dr. Jonathan Howard has pointed out, there is now a whole cadre of
physicians demanding RCTs for every COVID-19 intervention, regardless of whether such RCTs are practical or even ethical to carry out.
2023: The year that the evidence-based medicine (EBM) paradigm was weaponized against vaccines and public health (Science-Based Medicine, Jan 1, 2024)