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What the FDA is requiring is unconscionable. This may not be Tuskegee or Mengele, but it’s still deeply unethical to refuse proven treatments to control “placebo” groups.
Tell me you know nothing about actual testing without saying so.
Thank you Elisa.
Charles actually makes a fair point. These trials should at least offer crossover opportunities onto the experimental arm. This is common practice in cancer studies, since continuing to give cancer patients placebo when the IP is showing efficacy is high unethical. These early dropout issues could be mitigated by offering crossover, especially as incretins are studied in other indications.
This also highlights the same reason why blinded studies in vaccine trials are so problematic. It simply isn’t ethical to give a patient placebo when they think they may have a vaccine, and adjust their risk tolerance and behavior accordingly.