An American Sickness: How Healthcare Became Big Business and How You Can Take It Back

by Elisabeth Rosenthal

The FDA granted Vanda’s Hetlioz the green light in January 2014. To his consternation, Dr. Sack was an expert on the panel that had unanimously recommended the approval a few months before. “I came out thinking our system of drug approval doesn’t make any sense,” he told me two years later. “Because of the FDA’s criterion we were following to determine efficacy, I was forced to vote yes, but it made me deeply uncomfortable.” It was not demonstrably better than melatonin itself. FDA panels don’t consider the cost of the products they review. When Hetlioz received approval, Dr. Sack assumed it would be maybe $10 or $15 a pill. In fact, Hetlioz was later priced at $96,000 a year, $8,000 a month, or $267 per dose. “So now we have a prescription medicine for over two hundred dollars a day that is not as effective as melatonin used properly—which you can buy for six dollars over the counter for a bottle of one hundred,” Dr. Sack said. “It is eye-popping that we could get in this situation. And that it would be advertised on TV.”