[Apr 06, 2004]
The Orlando Sentinel on Monday examined the "bitter feelings" that some Puerto Rican women have about participating in early oral contraception studies in the 1950s and early 1960s. The studies remain controversial in the country because many women were not fully informed that they were involved in testing the world's first oral contraception pill, making them "unwitting pioneers of the modern sexual revolution," according to the Sentinel. The pills, which contained about three times the hormone dosage of modern oral contraceptives, produced side effects ranging from depression to headaches to other pains. After many San Juan participants complained of side effects from the pills, the clinical trials were moved to more rural areas, where there was "great poverty" and a demand for birth control, according to the Sentinel. "Many Puerto Rican women eagerly agreed to participate in the first clinical trials," Suzanne White Junod, an FDA historian, said, adding, "Moreover, they were more willing to put up with the noxious side effects than women in similar trials in the United States." FDA approved the pill for contraceptive use in May 1960, but various versions continued to be tested in Puerto Rico until 1964 because many women in the United States complained of side effects of the pill, according to the Sentinel. Although the clinical trials met FDA standards at the time, officials say that current rules governing trials "hardly resemble" the standards of the 1950s and 1960s, the Sentinel reports. Some critics of the Puerto Rico trials have compared them with the U.S. government's "surreptitious" syphilis tests on black men in Tuskegee, Ala., according to the Sentinel. The Puerto Rican and Tuskegee trials led to stronger rules for future clinical trials that require all participants to be fully informed of the scope of tests before consenting to participate, the Sentinel reports (Quintanilla, Orlando Sentinel, 4/5).
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