Posted by Michael Wonder on 17 Aug 2016
The FDA, Juno Therapeutics, and the ethical imperative of transparency
15 August 2016 - Despite deaths, investigational new drugs are still protected trade secrets of the manufacturer.
On July 7, Juno Therapeutics announced that the US FDA had placed a clinical hold on the company’s phase 2 trial of its investigational immunotherapy, JCAR015, as a treatment for patients with relapsed or refractory B cell acute lymphoblastic leukaemia (ALL). The trial planned to enrol 90 ALL patients. However, at the time of the hold, only 20 patients had been enrolled, three of whom had died unexpectedly from cerebral oedema.
