The 50th anniversary of the first trials of the contraceptive pill this year is shining a new light on the low ethical standards of their informed consent procedures. Critics have compared these early experiments with the notorious syphilis trials on poor black men in Tuskegee, Alabama, that were going on at about the same time.
In 1954, scientists Gregory Pincus and John Rock began the first human trials in the American state of Massachusetts. However, because they were carried out surreptitiously under the guise of fertility treatments, and not as birth control experiments, and because the pill had serious side effects, large-scale trials there were impossible. So they targeted Puerto Rico. Hundreds of women were enrolled in tests of a pill which had three times more hormones than today's version. It was later marketed as Enovid.
According to a feature in the Orlando Sentinel, Puerto Rican women in slums and poor farming villages were often not informed that they were participating in an experiment which could not be carried out on the US mainland. Suzanne White Junod, an historian for the US Food and Drug Administration, says that Puerto Rican women "were more willing to put up with the noxious side effects than women in similar trials in the United States". Amongst other problems, two healthy women died and no autopsies were done to determine what had caused their deaths. The pill was approved by the FDA in 1960, but the Puerto Rican trials continued until 1964 because women on the Mainland US were experiencing side effects such as depression, acne and painful periods.
Many Puerto Rican women are still angry that they were exploited as unwitting guinea pigs for Mainland doctors. They were not told that the drug was experimental or that it could have dangerous side effects. Their bitter comment nowadays is that Americans have lost interest in what used to be the island's three main products: sugar, coffee and ovaries.
FDA officials now admit that early trials of the pill were conducted without the kind of informed consent that is now mandatory for new drugs in the US. However, they maintain that the experience led to stronger rules and became the basis for a law requiring every participant to be fully informed of the scope of tests before agreeing to participate.
MORE ON THESE TOPICS |