Pharmaceutical Holiday

Pharmaceutical Holiday by • July 21, 2010 • Printer-friendly

Can you imagine the FDA approving a drug that, say, increased the risk of blood clots, hypertension, stroke, heart attacks, breast cancer, and migraines for women? And fathom, if you will, the absurd notion that such a drug could be approved for the treatment of something that isn’t even a disease, a genetic abnormality, or a mental disorder but the very way that God designed women’s bodies to work.

Well, fasten your Malthusian belts, because they did. Now here’s where you’d expect a very special Dateline NBC exposé or an investigative report from Katie Couric to unmask this conspiratorial threat to women’s health. Instead, she called it “a tiny tablet that revolutionized women’s health,” before blasting the government for not giving it to every single woman for free.

And then the New York Times, the Washington Post, the Boston Globe, Time, and all of the TV networks threw a party to celebrate its birthday.

In the mid-1950’s, when many American women were using Lysol to keep from having babies, Gideon Daniel (“G.D.”) Searle (formerly of Metamucil fame) struck gold. Frank Colton, a researcher at his pharmaceutical company in Sko­kie, Illinois, had created a synthetic progesterone compound (norethynodrel), with a mind to curing “female problems.” Dr. Gregory Pincus heard about it and asked for some of it to test his theories about the relationship between progesterone and the prevention of ovulation. (Lucky for him, he had money to burn, thanks to his friend Margaret Sanger and her rich pal, Cyrus McCormick’s daughter Katharine.)

Pincus assembled a team led by Dr. John Rock, a Roman Catholic fertility expert who publicly rejected Church teaching on contraception, and they began experimenting on women, inducing “false pregnancies.” Meanwhile, back in Skokie, Searle researchers developed their drug, reducing the amount of mestranol (estrogen) in their compound to prevent bleeding. They called it Enovid and shipped it off to Team Pincus for testing on women in Puerto Rico and Haiti.

According to Planned Parenthood, Puerto Rico was chosen because, unlike Dr. Rock’s native Massachusetts, the island “had no laws against contraception.” Bonus!

Many of the women were semi-literate or illiterate, which allowed the researchers to test whether or not the pill could also be used by women around the world, regardless of their educational accomplishments.

G.D. Searle & Co. applied for FDA approval of Enovid for the treatment of menstrual problems at the same time it was organizing a symposium with Team Pincus on marketing the drug as a combined oral contraceptive. The FDA approved it for the former use in 1957, and two years later, Searle applied for the government’s approval of the latter use. Enovid officially became The Pill on June 23, 1960. One year later, a million women had already used it. Four years later, Searle was up to $24 million in annual profits.

The Pill has had a side effect or two on American culture, not the least being the Sexual Revolution. In addition, writes Gardiner Harris in the New York Times, “in regulatory terms, the pill brought about a kind of reformation.”

Because Team Pincus’s tests on the Puerto Ricans had been “relatively brief,” the FDA had no good reason (other than social pressure) to approve the drug for long-term use. So they slapped an arbitrary two-year limit on prescription durations. But women were so wild for The Pill that they simply asked for it under a different brand, consequences be damned.

It turned out that Pincus had ignored the evidence presented by his team which indicated that 17 percent of the illiterate women had experienced a host of side effects from chemically altering their otherwise healthy bodies—vomiting, headaches, nausea. (Pincus dismissed the women as hypochondriacs.) Added to that in the early 60’s were increasing reports of pulmonary embolism, congestive heart failure, and pulmonary tuberculosis.

What to do? If the FDA pulled The Pill, women would be forced to return to sexual servitude. The answer was to order doctors to distribute literature to their prescribees containing long lists of fine print that they are free to ignore. In the name of sexual freedom, the U.S. government stood between a woman and her doctor.

To commemorate the liberation of women, Planned Parenthood sent out a press release declaring May 9 the 50th Anniversary of The Pill, and the American media joined the celebration in lockstep. Now technically, the FDA only announced that it had plans to approve The Pill on May 9, 1960. But shucks, this year, May 9 fell on a Sunday, and it was Mothers’ Day.

This article first appeared in the July 2010 issue of Chronicles: A Magazine of American Culture.

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