Larry Stein’s comment on Barry Blackwell’s reply to Jose de Leon’s comment on Thomas A. Ban’s essay on Neuropsychopharmacology: Conflict of Interest: Marketing vs. education

Barry Blackwell concedes that Mogens Schou was right about lithium as an effective bipolar intervention, but that Schou's methodology was wrong.  I did not know Schou, but it seems obvious that he was an unusually insightful clinician with extraordinary case material. True, it was an N=1 situation, but that N=1 happened to be his brother whom he had been trying to cure, or at least to treat, for many years.  So when the brother responded to lithium, after so many failed attempts with other agents, Schou knew!  Furthermore, were not the other early major psychiatric drug discoveries also serendipitous?  Large double-blind clinical experiments have their place and may be fine for final confirmation, but they probably slow down and even discourage discovery.  For the FDA, responsible for safety and sensitive to politics, this is not the biggest problem. Safety demands caution, but discovery requires boldness –a delicate balance. 

Larry Stein

May 15, 2014