Issue: July 2008
July 10, 2008
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Reproductive liberty and social reform in the shape of a pill

The approval and acceptance of oral contraceptives was an uphill battle.

Issue: July 2008
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The concept of hormone replacement hit prime time in the medical community in the late 1800s. Although pioneering research in this field focused mainly on male hormones, it did not take long for the research to also include the examination of female hormones.

Prior to oral contraceptives women had little control, abstinence aside, regarding reproduction. Methods to prevent pregnancy did exist, but none were as convenient as the pill would become. Products such as condoms, diaphragms and cervical caps were available, but the Comstock Law — passed by Congress in 1873 — made it illegal to disseminate contraceptives in the United States.

The creation of the birth control pill is thought by some to be one of the most socially influential medical discoveries of the last century. Almost 50 years later it remains a widely-used form of birth control.

Medical battle

Patent sketches for dispensing oral contraceptives submitted by D. Wagner in 1962
Patent sketches for dispensing oral contraceptives submitted by D. Wagner in 1962.

Source: U.S. Patent and Trademark Office

Bringing oral contraceptives to market was possible through the work of several key people. Margaret Sanger, RN, devoted her life to developing a form of birth control for women. Sanger may have been motivated due to her mother, who had 18 pregnancies and 11 children. Sanger worked as a nurse with immigrant families in New York’s Lower East Side, witnessing firsthand the plight of women who were frequently giving birth to children. She is thought to have coined the term “birth control” and was often in trouble with the law for her advocacy of contraceptives, including the opening of the nation’s first birth control clinic in Brooklyn.

Sanger’s cause truly gained momentum through her friendship with Katharine McCormick, a wealthy woman who would regularly make contributions to Sanger’s clinics. In 1951, at age 72, Sanger approached Gregory Pincus, MD, an endocrinologist and researcher at the Worchester Foundation in Massachusetts who was experimenting with in vitro fertilization in rabbits, and asked him to take on her cause.

Pincus agreed to research the idea of a “magic pill” to prevent ovulation in women, but required significant funding to conduct the experiments. A small donation from Planned Parenthood got the research off the ground. By 1952, Pincus was able to prove that progesterone worked to prevent ovulation in rabbits, but he was unable to continue his work due to lack of funding. Sanger turned to McCormick for help, and she gave Pincus $40,000 — a large sum at the time — to continue his work.

Pincus’ next step was to seek out a clinician to test the medication in humans. It was in these trials that the medication regimen was established, one that is still used today: 21 days on the pill with a seven-day break for menstruation. Pincus joined forces with John Rock, MD, a gynecologist and fellow birth control advocate, to test the drug. In 1954, Massachusetts still had strict laws about distributing information about birth control methods, so Pincus and Rock called the trial a fertility study.

Their results, which Rock presented at the Laurentian Conference on Endocrinology, showed that none of the 50 women tested ovulated while assigned the drug. Sanger had her “magic” oral birth control pill. Further successful clinical trials were conducted outside of the United States.

Finally, in 1957, the first oral contraceptive, Enovid (G.D. Searle), was approved for the regulation of menses with a warning label that said that the drug prevented ovulation. This formulation contained 150 mcg mestranol and 10 mg ethydiol diacetote. Three years later, the FDA approved the medication as a method of oral contraceptive.

The pill was designed purposefully so that women would still menstruate every month. The formulation was thought of as more “natural” and possibly more reassuring to women as validation that they were not pregnant.

Social battle

Socially, the impact of oral contraceptives is most likely immeasurable. After its approval, family size and maternal and infant mortality rates began to decrease.

“It was revolutionary in the sense that you could now postpone your family,” said Suzanne White Junod, PhD, an FDA historian. “Young couples could profit from spacing their family or waiting to start a family.”

It also may be possible to credit oral contraceptives with helping to fuel the women’s rights movement. With more choices about the timing of starting a family, women could complete or extend their education and then remain in the work force longer before having children.

However, not everyone was happy about the availability of oral contraceptives. Throughout the 1960s the debate about the dissemination of birth control or even information about birth control involved state governments, presidents and popes. Distributing birth control in low income black neighborhoods even led to an accusation by the NAACP that Planned Parenthood clinics were trying to keep the birth rate in the black community low.

All the controversy did little to deter most women. By the end of the decade there were seven brands of oral contraceptives to choose from and more than 12 million women worldwide were taking the pill. By 1984 this number had increased to between 50 and 80 million women.

Although oral contraceptives were originally supposed to be limited to two years’ use, women quickly and easily found ways around the restriction. Switching brands or switching physicians often resulted in a new prescription. But Sanger’s long-wished-for magic pill did not come without adverse effects.

Researchers slowly discovered that taking oral contraceptives put women at increased risk for venous thromboembolic disease and sometimes metabolic syndrome. Eventually the high doses of estrogen and progestin were pinpointed as the cause of this increased risk. Since 1960 the dose of hormones in birth control pills has steadily decreased as researchers have found that less hormone is needed to suppress ovulation.

Despite it all, today at the age of 58, the pill still stands as one of the most popular forms of birth control. – by Leah Lawrence

For more information:

  • Barrett-Connor E. Hormones and the health of women: past, present, and future. Keynote address. Menopause. 2002;9:23-31.
  • Cates W, Grimes DA, Schultz KF. Abortion surveillance at CDC: creating public health light out of political heat. Am J Prev Med. 2000;19:12-17.
  • Fraser IS. Forty years of combined oral contraception: the evolution of a revolution. Med J Aust. 2000;173:541-544.
  • Junod SW. The pill at 40. FDA Consumer Magazine. 2000.
  • PBS. The pill. www.pbs.org/wgbh/amex/pill/timeline/index.html.
  • Schwartz NB. Perspective: reproductive endocrinology and human health in the 20th century — a personal retrospective. Endocrinology. 2001;142:2163-2166.