In Revision of History, Thalidomide Made its Way to US

Preventing the sale of the cure-all drug has long been touted as a triumph of the FDA. New lawsuits suggest the agency return its laurels.

The shrunken limbs of children in Europe caused by the 1960s cure-all thalidomide became somewhat iconic of the horror of birth defects, and for decades, the blockage of the sale of thalidomide in the United States was iconic of FDA vigilance and consumer protection. But according to 10 lawsuits filed in the Eastern District of Pennsylvania, fewer bullets were dodged than we thought, and potentially thousands of babies’ deformities can be attributed to pregnant mothers ingesting the drug—not, like doctors and drug companies told mothers, a capricious God.

It’s difficult to convey the importance of thalidomide in 2013, but decades ago, it made headlines, particularly because its ban in the US “did much to create the modern FDA,” Reuben Kramer writes.  Thalidomide was in many ways emblematic of early- to mid-century pharmacology: Extremely potent, indicated for a wide range of conditions and capable of inducing terrifying side effects.

The drug, which was originally marketed for anxiety and sleep, also began being prescribed to mothers suffering from nausea and morning sickness. In Europe, this gave rise to thousands of deformed babies. The FDA banned its sale in the United States, but the lawsuits claim that thousands of people—19,000, according to an early congressional report—were given the drug in clinical trials that were still technically legal. Mothers were led to believe that their babies’ deformities were the result of a chaotic, absurd universe, and only now is history potentially being revised. [Inquirer]