2014

FDA grants patent to Vanda for Hetlios (tasimeltonin), a new molecule functionally equivalent to melatonin (i.e., it bonds with melatonin receptors), for treatment of Non-24, an obscure sleep disorder among the totally blind, whose inability to perceive light throws off circadian rhythm. A boutique drug company, Vanda based its application on “fungible surrogate endpoints,” such as shrinking the study population to 62 patients, and then focusing only on the 25% of nights when subjects’ sleep time was lowest. In this manner, it relied on “surrogate measurements” to prove efficacy and get “expedited approval” from the FDA. The result: Hetlios proved less effective than melatonin and cost over $200 a day, whereas melatonin was an OTC drug that cost $6 for a bottle of 100 pills (Rosenthal, 101-105).