Contraceptive trials in Puerto Rico

In 1873, the United States federal government passed a series of laws commonly known as the Comstock Laws. The Comstock Laws criminalized the use of the postal service as a means of sending, obtaining, or possessing items considered obscene or salacious (including books, pamphlets, abortifacients, anything used to "facilitate sex", or containing sexual language, etc.). The Comstock Laws thus basically criminalized contraceptive devices and instruments used in abortion procedures. The legislation, however, did not prevent women or businesses from continuing to explore and attempt different methods of birth control. Forced underground, abortion procedures often led to unintentional sterilization or death. Over three-quarters of self-induced abortions resulted in complications. Infuriated with the lengths that many were forced to go to in order to regulate their own fertility, women began to push for legal rights to contraceptive methods and to govern their own bodies. The movement for public access to birth control started in the early 20th century, propelled by figures like Margaret Sanger. Physicians also lobbied against Comstock Laws, asserting their right to prescribe contraceptives. By the 1930s, U.S. courts were limiting Comstock restrictions on birth control and other purportedly obscene materials. == Important figures ==

Margaret Sanger Margaret Sanger (1879–1966) was a nurse and life-long advocate of women's reproductive rights. Sanger believed that a woman would never truly be free until she had the right to determine whether she wanted to be a mother, and acted on these beliefs by starting a campaign to educate women about sex. She did this while also working as a nurse treating those who had resorted to illegal and unsafe methods of abortion. After fleeing to England for five years to escape persecution for violating the Comstock Laws, Sanger returned to the United States and opened up a clinic (now widely known across the United States as Planned Parenthood) in Brooklyn, New York. The clinic offered women information and resources regarding birth control. The clinic quickly gained popularity and women were soon lining up to be educated. Prior to the birth control movement, there was no uniform sexual education for women, and many found it difficult to find information regarding fertility and contraception. The clinic was only open for ten days before being shut down by authorities for violating the Comstock Act. Sanger was put into jail for 30 days. Although Sanger's clinic was not a success, the movement for public access to birth control was. By the 1950s there had been a significant amount of research conducted regarding the effects of hormonal drugs. These substances were not explicitly labeled as contraceptive methods, but rather hormonal treatments for infertility, since the laws against contraceptives applied to scientific research as well. John Rock and Gregory Pincus Dr. John Rock and biologist Gregory Pincus, leading experts in fertility and hormone disorders in the United States at the time, collaborated in 1953 to develop an oral contraceptive. Pincus had already established himself as an accomplished scientist after achieving in vitro fertilization in rabbits in 1934, and had established the Worcester Foundation for Experimental Biology in 1944. Around the same time, chemist Carl Djerassi demonstrated the synthesis of progesterone from a wild yam root found in Mexico. The artificial production of progesterone became a key discovery for future fertility research since it was found that high doses of progesterone could halt ovulation. While Pincus and Rock's research plans had been laid out, they still lacked proper funding. Margaret Sanger and Katharine Dexter McCormick, an heiress who would ultimately fund a large part of the research project, approached Pincus in 1953 about focusing his research on a hormonal contraceptive that would ultimately enable women to control their reproduction. Katharine Dexter McCormick Katharine Dexter McCormick was an heiress and philanthropist who ended up funding a large part of the research surrounding the first oral contraceptive pill. The pharmaceutical company G. D. Searle & Company produced the pills for the trial. == The trials ==

Location The research team decided that Puerto Rico would be the most suitable place to test the pill. More specifically, the former municipality of Río Piedras, Puerto Rico, where the first trial would take place in 1956. The second reason was that Puerto Rico was facing a tremendous population boom, along with high rates of poverty and unemployment. The birth control pill was offered as a solution to overpopulation, and was seen as a way for the United States government to test population control as a global policy. Participants When Pincus and Rock began their experiment, over 200 women were registered to take part in the program. The women that were recruited for these trials were " …the poorest of the poor, had no place else to go, and, short of sterilization, no birth control options," The women were also not provided any help or care. Margaret Marsh described in her work how many of these women were exploited for their use. During the trial, these women still had the responsibility of caring for and providing for their families. Marsh describes how one woman was 30 years old with ten children, and a husband that "drank heavily and insisted on daily intercourse, but claimed to be too sick to work." Marsh also described a woman who had five children and a husband who was frequently hospitalized for mental illnesses. At times, this treatment left them unable to work or even care for their family and children. Drug administration and side effects The women were administered 10 milligrams of the experimental combination of estrogen and progesterone, more commonly known as Enovid, the first contraceptive pill. The women participating in the trial began to experience side effects, but their complaints were deemed unreliable and outright dismissed by researchers. Some symptoms reported among patients included dizziness, vomiting, nausea, headache, and menstrual irregularities; some of which were so severe that they required hospitalizations. After the trials in Puerto Rico, the drug was approved in the U.S. in 1957 for consumer use as a medication to treat severe menstrual side effects. The drug was approved as a female oral contraceptive, the first in the U.S., in May 1960. G.D. Searle and company profited greatly from widespread sales of the product, although the company was initially extremely hesitant to be associated with the trials in any way. Deaths Three deaths occurred among patients who were taking the birth control drug during the trials. Despite strong circumstantial evidence that the pill was causing these unexpected deaths, they were not reported for two reasons. Firstly, those conducting the trial considered the deaths to be coincidental. Secondly, autopsies were never conducted on the bodies of the three women. == Enovid ==

The drug used in this trial was known as Enovid. The drug was a combination of estrogen and progesterone, the same hormones used in modern combined oral contraceptive pills. Enovid was submitted for regulatory approval in 1957. Dosage The drug Enovid used in this trial was a much higher dosage than oral contraceptive pills prescribed today. Modern health practices facilitate prescriptions for birth control, averaging about 0.75 milligrams per dose. The original dosing of 10 milligrams is more than 100 times the acceptable concentration of hormones in contraceptive pills today. The original dosage from the trials was eventually dropped to 5 milligrams after severe side effects were observed, including nausea, dizziness, headaches, and blood clots, along with the death of three women in Puerto Rico. == Ethics and controversy ==

Even though the composition of the original birth control pill was modified after trials due to the dangerous levels of hormones, the discovery and the authorization of the pill made a profound impact on women's reproductive rights in the United States. Women were now able to directly control their own fertility because of the legalization of the pill and the studies that aided in the authorization of the pill. Instead of having to deal with an accidental pregnancy, women were provided with the opportunity to delay having children, allowing them to pursue higher educational goals or seek employment. Based on statistics, the pill was considered "…one of the most transformational developments in the business sector in the last 85 years. Fully one-third of the wage gains women have made since the 1960s are the result of access to oral contraceptives." Additionally, studies have shown evidence that "between 1969 and 1980, the dropout rate among women with access to the pill was 35 percent lower than women without access to the pill," and that "birth control has been estimated to account for more than 30 percent of the increase in the proportion of women in skilled careers from 1970 to 1990." The ethics of the trial in Puerto Rico are still debated. A Puerto Rican woman named Delia Mestre, who participated in the trial unknowingly, was questioned about her participation in the experiments. She explained that "the experiments were both good and bad. Why didn't anyone let us make some decisions for ourselves?" She also stated, "I have difficulty explaining that time to my own grown children. I have very mixed feelings about the entire thing." Mestre and the other women who participated in the trials were not allowed to make an informed decision on whether they wanted to serve in the trials. == Feminist response to trials ==

In a 2006 review of Ana María García's 1982 film La Operación, Tamara Falicov noted that "Puerto Rico became an important testing ground for U.S. pharmaceutical companies working on the effectiveness of the birth control pill." == References ==