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Niccolò Tempini

Research Findings

The danger of pharmaceutical populism

March 3, 2020

Most readers of this blog probably live in countries where a pharmaceutical regulatory agency decides what medical treatments are made available. Following the paradigm of the US Food and Drug Administration, for the last fifty years these agencies have been testing new treatments for safety and efficacy with a standardized experimental design called randomized clinical trials (RCTs). Historians of medical experimentation (like the late Harry Marks) claim that RCTs were adopted because they implemented controls that warranted the impartiality of the experiment. 

There is an open debate over how the experiments bear relevance to the world in which regulatory decisions play out. But regulatory agencies have trusted evidence from well-designed RCTs as the most impartial ground to decide on the safety and efficacy of a new treatment. 

A clinical trial often generates major conflicts of interest because the sponsoring pharmaceutical company wants its treatment to succeed in the trial and patients often have preferences on treatments even before enrolling in the trial. Blinding all participating stakeholders is a device to control the experiment and prevent interferences. If neither physicians nor patients know whether they are receiving the experimental treatment or a placebo, their preferences will not influence the outcome of the trial. 

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