The FDA has been quite a controversial government agency, particulary regarding the process for new-drugs approval. Once again, a new drug has been developed; this time, Merck is trying to fight insomnia with an effective slepping pill without the common side effects of the existing sleep disorder medication. Ian Parker wrote an article regarding this matter in The New Yorker called "Big Sleep". In this article, Parker reviews the "sleeping pill" industry and provides an insight of the troubled, bureaucratic F.D.A drug approval process. What are the economic consequences of such approval processes? What should really be the role of the F.D.A, specially concerning the approval of medications that could benefit millions of people?
A few weeks later, the F.D.A. wrote to Merck. The letter encouraged the company to revise its application, making ten milligrams the drug’s starting dose. Merck could also include doses of fifteen and twenty milligrams, for people who tried the starting dose and found it unhelpful. This summer, Rick Derrickson designed a ten-milligram tablet: small, round, and green. Several hundred of these tablets now sit on shelves, in rooms set at various temperatures and humidity levels; the tablets are regularly inspected for signs of disintegration.
The F.D.A.’s decision left Merck facing an unusual challenge. In the Phase II trial, this dose of suvorexant had helped to turn off the orexin system in the brains of insomniacs, and it had extended sleep, but its impact didn’t register with users. It worked, but who would notice? Still, suvorexant had a good story—the brain was being targeted in a genuinely innovative way—and pharmaceutical companies are very skilled at selling stories.
Merck has told investors that it intends to seek approval for the new doses next year. I recently asked John Renger how everyday insomniacs would respond to ten milligrams of suvorexant. He responded, “This is a great question.” After the approval process is finished, the marketing division of Merck—a company whose worldwide sales last year totalled forty-seven billion dollars—will conduct a different kind of public trial. The study will address this question: How successfully can a pharmaceutical giant—through advertising and sales visits to doctors’ offices—sell a drug at a dose that has been repeatedly described as ineffective by the scientists who developed it? (Ian Parker, "Big Sleep").
Insomnia, far from being just a sleep disorder, has negative biological and cognitive consequences and, unfortunately, is terribly common.
• About 30 percent of adults have symptoms of insomnia• About 10 percent of adults have insomnia that is severe enough to cause daytimeconsequences• Less than 10 percent of adults are likely to have chronic insomnia (according to the American Academy of Sleep Medicine.)