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FDA

Published On September 22, 2013

CLINICAL RESEARCH

Mother's Little Helper at 50

After 50 years, we take a look back at the pharmaceutical industry's first $100 million brand.

In 1941, when chemist Leo Sternbach transferred to the U.S. headquarters of Hoffmann-La Roche laboratories, fleeing his Basel home in advance of the Nazis, he began with innocuous work: synthesizing vitamins. But that research would propel him to become one of the company’s top scientists, and in the mid-1950s he stumbled upon benzodiazepines, an entirely new category of tranquilizers that were capable of calming the mind without compromising mental functioning.

The first of these, Librium, was followed by an even better “benzo” that Sternbach and his team synthesized in 1959. Diazepam—which the company’s advertising team dubbed Valium, after the Latin valere (for “to be healthful”)—was more potent than Librium and lacked its unpleasant aftertaste. Valium went on to become the pharmaceutical industry’s first $100 million brand, and, according to Andrea Tone, author of The Age of Anxiety: A History of America’s Turbulent Affair with Tranquilizers, diazepam “rapidly became a staple in medicine cabinets, as common as toothbrushes and razors.”

Approved by the Food and Drug Administration in 1963, Valium has now been with us for half a century. From the late 1960s to the early 1980s, “Mother’s Little Helper” (as described by the Rolling Stones in a 1966 song) was the Western world’s most widely prescribed drug. At its peak of popularity in 1978, Americans consumed more than 2 billion of the tablets. But not long after Valium’s approval, it began losing some of its luster amid reports of addiction. In 1967, the FDA concluded that enough evidence existed to impose controls on diazepam similar to those on amphetamines and barbiturates. Though Hoffmann-La Roche insisted Valium was safe, lawsuits ensued, and by 1975 the U.S. Justice Department ordered benzodiazepines to be classified as Schedule IV drugs, impeding access by limiting refills.

Prescriptions dropped from 61.3 million in 1975 to 33.6 million in 1980. Increasing restrictions paved the way for a shorter-acting tranquilizer, Xanax, introduced by Upjohn in 1981. But Valium never disappeared. One reason, says Tone, is that “no one’s ever questioned the efficacy of tranquilizers like Valium because there’s such overwhelming evidence that they work. Unlike psychoanalysis and psychotherapy, Valium’s effects are immediate.”

 

Photo credit: CLASSICSTOCK

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