Equipoise and the ethics of clinical research

It is widely maintained that a clinical trial is ethical only if some form of equipoise between the treatments being compared obtains. To be in equipoise between two treatments, A and B, is to be cognitively indifferent between the statement 'A is strictly more effective than B' and its negation. It is natural to claim that equipoise regarding A and B is necessary for randomized assignment to treatments A and B to be beneficent and non-maleficent and is sufficient for such an assignment to be fair. Cashing this out precisely is difficult, and various forms of equipoise have been discussed which consider whose equipoise is relevant to the decision. This is to make judgement of equipoise something to be managed socially, while its prima facie significance is supposedly cognitive. Recent reconstructions of equipoise-like concepts in epistemology give clues about how to understand equipoise cognitively. In this paper, I examine some of this work and discuss how successful it has been. I suggest that while this work is promising, it still has far to go, and that while equipoise remains the best theory we have of the cognitive justification for clinical trials, it is nonetheless incoherent.

1) You give 1 anecdotal example, and in turn suggest that somehow that means the British have always been conservative? I remind you that it is almost a FULL CENTURY since the incident you mentioned and both medicine and medical sciences have made signficiant strides across all countries. Please provide some more recent examples
2) The whole point here is that this “medicine” offered in the US is not even in experimental stages… It has been tested in a different group of people but to date has not been experimented in the population with Charlie Gard’s mutation — hence there’s no evidence that it would actually work, unlike the insulin case you brought up.

The concept of non-maleficence is embodied by the phrase, "first, do no harm," or the Latin, primum non nocere . Many consider that should be the main or primary consideration (hence primum ): that it is more important not to harm your patient, than to do them good. This is partly because enthusiastic practitioners are prone to using treatments that they believe will do good, without first having evaluated them adequately to ensure they do no (or only acceptable levels of) harm. Much harm has been done to patients as a result, as in the saying, "The treatment was a success, but the patient died." It is not only more important to do no harm than to do good; it is also important to know how likely it is that your treatment will harm a patient. So a physician should go further than not prescribing medications they know to be harmful—he or she should not prescribe medications (or otherwise treat the patient) unless s/he knows that the treatment is unlikely to be harmful; or at the very least, that patient understands the risks and benefits, and that the likely benefits outweigh the likely risks.

Equipoise and the ethics of clinical research

equipoise and the ethics of clinical research


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