Readers’ Corner: It’s a Drug When Big Pharma Wants It to Be a Drug

A medication at the center of a recent court ruling turns out to be a completely natural substance.

Earlier this month we reported on a court decision about free speech issues surrounding the promotion of off-label uses of an FDA-approved drug called Xyrem.

Jonathan V. Wright, MD, writes:

Re your December 4 article on Xyrem, I thought you would be interested to know that Xyrem is actually not a patent medicine (“drug”). It is entirely identical to the natural substance gamma-hydroxybutyric acid (GHB). In the US, it was once used as a sedative. In Europe, it is still used safely as a sedative during childbirth. In the US, by contrast, it was categorized as a Schedule I controlled substance (like heroin) by act of Congress in 2000, principally on the grounds that it had been used for date rape. Alcohol, also associated with date rape, was not included in the same act.

As a controlled substance, GHB cannot be compounded by a compounding pharmacy. It can, however, be sold as Xyrem. Because it is federally approved, it is able to be manufactured by only one company, is sold retail by only one pharmacy, costs (as of 2011) $1,750 per prescription—and is covered by insurance.

Thank you, Dr. Wright. Clearly a “drug” is anything the pharmaceutical industry wants it to be, and the federal government is their willing accomplice.