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A cultural revolution – Andromeda freed from her chains
The Syntex team of George Rosenkranz, Carl Djerassi, and Luis Miramontes produce and patent norethindrone, a synthetic version of the hormone progesterone in 1951. The substance becomes the key active ingredient in the first safe and effective birth control pill. It was generally known since the 1920s that progesterone inhibited ovulation, but it was not the intent of the Syntex team in the early 1950s to develop an oral contraceptive. Djerassi has said, “Not in our wildest dreams did we imagine it.”
Others with social reform in mind are doggedly pursing this end, however. In 1952, birth control advocate Margaret Sanger, philanthropist Katherine McCormick, biologist Robert Pincus, and gynecologist John Rock join forces in Massachusetts to investigate the use of natural progesterone as a contraceptive. They soon learn of work performed by Frank Colton, the chief chemist of G.D. Searle & Co.
Colton has formulated norethnodrel, a progesterone prodrug. It is converted to the active hormone when ingested and metabolized, and so does not infringe on the Syntex patent. Rock, Pincus, and Sanger organize and McCormick funds clinical trials of the compound delivered in pill form by Searle & Co. The FDA approves norethnodrel in 1957 under the trade name Enovid®, as a treatment for menstrual irregularities. In 1960, the compound is approved as a contraceptive (after an estimated 500,000 women are already using the product off-label for birth control purposes).
Regulatory scuffling over formulations, dosing, and side effects (e.g., thrombosis, diabetes, cancer) continues for some time, but by 1967, more than 12 million women are on the pill. Searle’s market dominance is being challenged, however, by several safer and more effective products containing synthetic versions of progesterone, including Syntex’s Ortho Novum® (norethindrone).
The profits for the drug companies are enormous. The social and cultural impacts are even more profound. Searle’s advertising campaign for Enovid® anticipates the significance of the hormone for women, in terms of transforming roles and lifestyles:
“From the beginning, woman has been a vassal to the temporal demands of the cyclic mechanism of her reproductive system. Now, to a degree heretofore unknown, she is permitted… suspension of cyclic function and procreative potential. This new method of control is symbolized in an illustration from ancient Greek mythology: Andromeda freed from her chains.”