How Puerto Rican women were used to test the birth control pill

‘Guinea pigs or pioneers?’

Adapted from a story by The Washington Post’s Theresa Vargas.

On May 9, 1960, the birth control pill was first approved by the FDA as a contraceptive method in the U.S. The demand was immediate. Within four years, more than four million women had used what was then marketed under the name Enovid.

More than a half century later, the pill is the most common birth control method used.

But before the circular dials and rectangular packs gained a regular spot on bathroom sinks and at the bottom of purses, the people behind them first had to prove they were effective — and to do that, they needed to test them on humans.

Where they chose to conduct those tests marks one of the most controversial — and rarely discussed — chapters in the history of a drug that symbolizes women’s liberation. In the mid­ 1950s, the first large ­scale human trial of the pill was launched in a public housing project in Puerto Rico — and the distrust was immediate.

The truth was that little was known about the drug’s effects when human trials were launched. The drug had been tested on rats and rabbits, and on a small sampling of women in Rock’s medical practice in Massachusetts. But its largest test would be in Puerto Rico, where as many as 1,500 women took the drug over several years.

Three women in the trials died. But no autopsies were conducted, and so it remains unclear if their deaths were linked to the drug, which was given in much higher doses than it is today.

“In some ways, it was exploitative — you’re giving this drug that you don’t really know for sure what its effects are going to be,” said Margaret Marsh, who co-wrote a biography of one of the pill’s creators, John Rock.

“On the other hand the people involved in developing it really believed it was safe,” she said. They also believed it would give women choices.

Descriptions of the women in the study show that even if they were poor, and, in some cases illiterate, they were eager to have control over their family planning.

One woman, described in Marsh’s book as Senora J. G. was 30 years old and had 10 children, ages 10 months to 16 years old. She also had a husband who “drank heavily and insisted on daily intercourse but claimed to be too ill to work.”

Before the pill, the main option women in Puerto Rico had for preventing pregnancy was sterilization, called simply “la operacion.”

The theories as to why Puerto Rico was chosen as a testing ground, despite its heavily Catholic population, are multiple: It was an easy flight from the U.S. mainland. There were no laws there against birth control. And the location’s overcrowding and poverty made it especially attractive to biologist Gregory Pincus, who was concerned about global population control.

Years later, following congressional hearings in 1970 about the pill’s safety, some women would still question the process behind the drug’s approval.

The Washington­-based Women’s Liberation group, issued a statement at the time, saying:

“In spite of the fact that it is women who are taking the pill and taking the risks, it was legislators, the doctors, and the drug company’s representatives, all men of course, who were testifying and dissecting women as if they were no more important that the laboratory animals they work with every day.”

The women in Puerto Rico meanwhile were left grappling with what happened to them for decades. An Orlando Sentinel article about them in 2004, did not depict the women freed from chains. It showed women who were not fully informed about what they had participated in and could be called either “pioneers” or “guinea pigs.”

They remained part of the trial until 1964, receiving the drug even as women across the U.S. complained about the side effects and lawsuits were launched against its manufacturer.

“The experiments were both good and bad,” Delia Maestre told the Orlando Sentinel, crying. “Why didn’t they let us make some decisions for ourselves? I have difficulty explaining that time to my own grown children. I have very mixed feelings about the entire thing.”