Debiasing Methods and the Acceptability of Experimental Outcomes

The trade-off between impartiality and freedom in the 21st Century Cures Act

“…Their own preferences therefore become dispensable in trials. For instance, most patients are not indifferent about which treatment they want to receive in a test (Mills et al 2006) but they are unable to choose one (allocation is randomized) and, if possible, they will not be informed which treatment they are receiving (blinding), so that their preferences do not contaminate the outcome (Teira 2013). The standard argument to justify this form of paternalism in bioethics is based on the superiority of RCT evidence (Levine 1988): the treatments under study are, in principle, equivalent (equipoise) until the trial outcome eventually breaks the equivalence.…”

“…Over the last three decades, terminally ill patients have been advocating for quicker access to experimental treatments, lately rallying behind the "right to try" movement (Carrieri, Peccatori and Boniolo 2018). Their opposition to pharmaceutical paternalism goes hand in hand with a general critique of regulatory experiments, arguing that new sources of evidence would serve their interests better (Teira 2017). Our claim is that, more and more frequently, trial participants have become not only more vocal in expressing their preferences but also more capable of acting upon those preferences and breaking the trial protocol.…”

“…The success of randomization owes much to its appearance as a fair lottery for the allocation of scarce treatments. For more complex accounts of these two debiasing methods, see Teira (2013Teira ( , 2016. 2 From now on, we assume the standard definition of paternalism (Dworkin 2020): a third party interferes with the freedom of physicians/patients to prescribe/consume drugs for the sake of the patients' welfare.…”

Placebo trials without mechanisms: How far can they go?

“…The first step in my argument will be to explain in what sense the placebo effect has been, at most, an experimental phenomenonone in which the causal structure did not arise from any theory but rather from the very design of the experiment. Historians of the placebo effect usually refer to the tests conducted by the Franklin commission in 1784 as the first experimental study of the placebo effect (Teira, 2016). At the request of the French monarchy, the commission had to assess the efficacy of J.B. Mesmer's magnetic therapy.…”