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Non-24: $45 versus $60,000 per year to HELP BLIND PEOPLE’S CIRCADIAN RHYTHMS

Lawrenceville, NJ (Dr Simone) – All animals and plants have an internal body clock, a near-24-hour ‘circadian’ clock rhythm, that regulates the approximate 24-hour cycle of biological processes, such as sleep or hormone production. The brain is linked to circadian rhythms of night and day. Some people are unaware that their ability to sleep at night and be awake in the day is mostly controlled by their internal body clock where light is the primary cue to help reset the internal body clock. 

Most blind people have some light perception and their circadian rhythms are synchronized to a 24-hour day-night cycle as in those people who can see.  However, the totally blind person with no perception of light does not have the benefit of the circadian rhythms of night and day. This is called non-24-hour sleep-wake disorder in totally blind people.  This causes many days or months of insomnia and daytime sleepiness. Over-the-counter melatonin, when use appropriately at the same time each evening, can synchronize (entrain) the internal circadian clock for the blind person producing better sleep at night and alertness during the day.  Also, melatonin, in complete darkness, stops the growth of established small cancers because of its cancer killing effect (Breast and Prostate Cancer Risk from Circadian Disruption by Electric Light).
Now enter Big Pharma with a prescription drug, tasimelteon (Vanda Pharmaceuticals). It can synchronize the internal circadian clock for the blind person but has many side effects: Headaches (17%), Elevated Liver Enzymes (10%), Nightmares or Abnormal Dreams (10%), Upper Respiratory Tract Infections (7%), and Urinary Tract Infections (7%) [Lancet 2015. 386:1754-64].  Experiments with rodents revealed fertility impairment, an increase in certain cancers, and serious adverse events during pregnancy at dosages in excess of what is considered the “human dose.”  In May 2013 Vanda Pharmaceuticals submitted a New Drug Application to the Food and Drug Administration for tasimelteon for the treatment of non-24-hour sleep–wake disorder in totally blind people.  However, FDA updated its press release on October 2, 2014 to clarify the approved use of Hetlioz, which includes both sighted and blind individuals.
Cost of Tasimelteon: $60,000 or more per year per person
Cost of Melatonin: about $45 or less per year per person
What do you think?  


(c) 2017 Charles B. Simone, M.MS., M.D.