Contraceptive trials in Puerto Rico

The first large-scale human trial of the birth control pill was carried out in Puerto Rico in the 1950s. Between conceptualization and legalization of the first birth control drug in the United States in 1960, there were many developments and trials of test drugs. One such trial happened in Puerto Rico in the 1950s. Before the drug was approved as safe in the U.S., many Puerto Rican women were tested on.[1] The trials were conducted by Gregory Pincus and John Rock in 1955. These trials are a major component in the history of the development of female oral contraceptives, in between initial small trial testing on the east coast and the release of the drug for public consumption.

American testing surrounding the Puerto Rico trials

In the 1873, the United States Government passed a series of legislation commonly known as the Comstock Laws. The Comstock Laws prohibited not only the usage of contraceptives by the general public, but also criminalized the use of the postal service as a means of obtaining or sending anything considered obscene or salacious (including books, pamphlets, abortifacients, anything used to “facilitate sex”, or containing sexual language, etc.).[2] Legislation, however, did not prevent women, nor businesses, from continuing to explore and attempt different methods of birth control. Unfortunately, these unregulated contraceptive and abortive methods often lead to the death and unintentional sterilization of many women.

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 more importantly, rights to govern their own bodies. The movement for public access to birth control started in the early 20th century, propelled by figures like Margret Sanger. Sanger believed that a woman would never truly be free until she had the right to determine whether or not 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 having left New York for five years to escape persecution for violating the Comstock Laws, Margaret 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, which offered women information and resources regarding birth control.[3] The clinic quickly gained popularity and women were soon lining up to get in. 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. Unfortunately, the clinic was closed only 9 days after it opened, and Sanger was put into jail for 30 days.[4]

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 done 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. These sentiments regarding family planning and fertility opened up the door for the United States’ leading expert in fertility and hormone disorders, Dr. John Rock, and biologist Gregory Pincus to join forces in 1953, in order to develop an oral contraceptive. Pincus had already established himself as an extremely accomplished scientist after achieving in-vitro fertilization in rabbits in 1934, and established the Worcester Foundation for Experimental Biology in 1944.[5] Around the same time, Chemist Dr. Carl Djerassi demonstrated that he was able to synthesize progesterone from a wild yam root found in Mexico.[6] The artificial production of progesterone became a key discovery for future fertility research since it was demonstrated that high doses of progesterone could halt ovulation.[7]

However, even though Pincus and Rock’s research plans had been laid out, they still lacked proper funding. This is where Margaret Sanger and Katherine Dexter McCormick (an heiress who would ultimately fund a large part of the research project) came in to play.[8] Sanger and McCormick approached Pincus in 1953 about focusing his research on a hormonal contraceptive that would ultimately enable women to control their reproduction. [9]

Once Rock and Pincus had adequate funding, they were able to begin their research. However, laws in Massachusetts still prohibited any research on contraceptives, and as a result, the researchers were forced to conceal the true purpose of their research. The two biologists had already been able to prove that the contraceptive hormone treatment they had been working on had prevented pregnancies in both rats and rabbits, and wanted to take the trial to human test subjects. Consequently, the two made the decision to test their treatment on patients in the Worcester State Psychiatric Hospital. Once the research team was ready to take the trial further in the form of a wider clinical trial, they had to choose a location which would not only offer them a guise from the U.S. government, but also an opportunity to closely monitor and control their test subjects. In the words of Katherine Dexter McCormick, the scientists needed “… a cage of ovulating females to experiment with”.[10]

Dr. Edris Rice-Wray, M.D.

Medical researcher Dr. Edris Rice-Wray was also heavily involved with this research and raised early concerns about heavy dosage causing health problems for women.[11] The pharmaceutical company G. D. Searle & Company created the pills for the trial.[12] 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.[13] 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.[14]

Drug

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 female oral contraceptive pills.[15]

Dosage

The drug used in this trial was a much higher dosage than oral contraceptive pills prescribed today. The original dose was 10 milligrams, but this dose was dropped to 5 milligrams after severe side effects were emerging.[16]

The trials

The research team decided that Puerto Rico would be the perfect place to test out the pill. More specifically, a small village called Rio Piédras, where the first trial would take place in 1956. [17]Puerto Rico offered the perfect location for the trials for three key reasons. The first reason was that contraceptives had been legal in Puerto Rico since 1937, so long as they were being used for medical reasons, rather than “social or economic ones. [18]  The second reason was that Puerto Rico was facing a tremendous population boom, along with high rates of poverty and unemployment. [19] And lastly, the third major reason why Puerto Rico was the perfect spot for the trials was because Sanger and Pincus’ team had an ally with a strong foothold on the island. Puerto Rico already contained multiple birth control clinics which were originally funded by the U.S. government under the New Deal programs. However, many of these clinics were turned over to the heir of Procter & Gamble and eugenicist Clarence Gamble, who had already been involved in plans lead by the government to control the population by pushing women towards sterilization as a method of birth control.[20]

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”[21], and were poorly educated, nonetheless they were willing to do whatever it took to avoid sterilization. The women who were given the pills only understood that they would prevent pregnancy, they knew nothing of the potential health and safety risks of taking the pills. As one woman who participated in the trials described it, “[p]hysicians dispatched their assistants to rap on doors throughout the town's slums, telling women they didn't have to have another child if they took the pills regularly. That's how many of the test recruits were found, said Conchita Santos, 80, a lifelong resident…Santos, a homemaker, accepted her first package of pills in 1955, shortly after the birth of her first and only child. ‘You have to do what's best for you and your family,’ she said. ‘It's not easy making a choice like that."’[22]

The women were administered 10 milligrams of the experimental combination of estrogen and progesterone, more commonly known as Envoid, the first contraceptive pill.[23] Envoid contained up to ten times the now acceptable dose of hormones found in modern-day birth control. Even though the health risks were originally hidden from the women testing the contraceptive, they nonetheless began to show themselves. The women participating in the trial began to experience “ side effects of nausea, dizziness, headaches, and blood clots…”[24], however, these complaints were dismissed since the women were deemed unreliable. A small group of female medical students were also recruited to participate in the study, but dropped out due to similar symptoms despite being told that they would receive worse grades if they quit.[25] Furthermore, three women are said to have died while taking part in the trial, yet their deaths cannot be linked to the pill directly since autopsies were never done on their bodies.[26] In the minds of the researchers behind the pill, these side-effects were insignificant in comparison to what they had discovered; a hormonal oral contraceptive that did in fact stop women from becoming pregnant. Envoid was approved by the FDA in the year 1960, and became an instant success in the United States.

Deaths

Three deaths occurred among patients who were taking the birth control drug during these trials.[12] Despite strong circumstantial evidence that the pill was causing these unexpected deaths, they were not reported, as those conducting the trial considered the deaths to be coincidental.

Ethics and Controversy

 Although the contents of the original birth control pill had to be adjusted, due to their dangerously high hormone levels, the discovery and approval of the pill was revolutionary for women’s reproduction rights in the United States. The legalization of the pill, as well as the studies done to produce it, meant that women now had control over their own fertility. This new found control meant that women could postpone having children so they might have time to attend college or get a job, rather than being trapped by an accidental or unwanted pregnancy. According to statistics, the pill was listed as “…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”.[27]Furthermore, studies have shown 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”.[28] It is undeniable that oral contraceptives have forever changed women’s reproductive rights, as well as what they are capable of in today's society.

However, it is important to note that the birth control pill has also left behind a trail of negative impacts. Delia Mestre is one of the Puerto Rican women who unknowingly participated in the trial that made the pill possible. For Mestre, it is difficult to think of the experiments under which she and hundreds of other women acted as human guinea pigs to test a pill that would ultimately benefit mainly rich white women on the mainland of the United States. When asked about how she felt about her participation in the experiments, Delia Mestre explained that “"the experiments were both good and bad. Why didn't anyone let us make some decisions for ourselves?" she asked, her eyes welling with tears. ‘I have difficulty explaining that time to my own grown children. I have very mixed feelings about the entire thing"’.[29] Unfortunately, Mestre and the other women involved in the trials did not have a choice as to whether or not they wanted to be participants in the sexual revolution that was occurring within the continental United States. Instead, the bodies and wellbeing of impoverished and uneducated women were sacrificed for those of white women and male scientists who deemed the pill a victory in the fields of science and society.

A Gendered Perspective

Alice Wolfson is among the many advocates that critiqued and condemned the contraceptive trials conducted on Puerto Rican women. Not only were advocates challenging the bigoted and hateful outlooks of both liberal and conservatives within the United States, but also the systematic inferiorization of women through colonial, racial and gendered structures.

Feminist scholar and activist, Antonia Darder analyzed the various degrading policies that were enforced following World War II. As explained, women were seen as the means towards the advancement of imperialistic interests held by philanthropists and foreign policy makers. Notoriously, it was the exploitation of poor and working-class women’s sexuality and reproduction in which forged the crude occupation of the United States in Puerto Rico. Furthermore, feminist Catherine MacKinnon scrutinized the hierarchy of power between men and women as a key component in their encroached subjection. Such disparities within Puerto Rico constrained their advancement and rendered them as inferior citizens.[30]

In addition, native Puerto Rican women were constantly targeted and discriminated based on derogatory stereotypes. Considered incapable of socio-economic achievement, they were often deemed as prostitutes, welfare abusers and incompetent mothers.

This stigma enforced the idea that low socio-economic communities had the moral obligation to limit and restrict the growth of families with inadequate capability to sustain themselves. This ideology was cultivated by the fears and biases of white pro-birth control groups in the United States who wanted to prevent abusive dependency on social welfare services by poor familial units.

Among those culpable in supporting this race-suicide discourse as explained by political activist, Angela Yvonne Davis, were white pro-birth control women like Margaret Sanger. Her public statement in support for the implementation of forced contraceptive trials in Puerto Rico is a direct example of the negative rhetoric that harmed minority women. As she argued, “morons, mental defectives, epileptics, illiterates, paupers, unemployables, criminals and prostitutes” should be forcibly sterilized or given contraception to limit their reproductive capabilities.[31]

As Kimberlé Williams Crenshaw would argue through the theory of intersectionality, Sanger exclusively includes women in her hateful remarks since women are also victims of multiple conditions and societal strains at the same time. Due to this hateful discourse, minority women from Puerto Rico were coerced to undergo clinical treatments. In her film, La Operación, Ana Maria Garcia provides these women a platform to denounce the practices. Some women as seen in the film, were inadequately advised on procedures, and others argued that they did not have other choices due to the constant coercion.[32]

Through a gendered perspective, it is evident that women are exclusively targeted due to their innate attributes such as their ability to reproduce. By forcibly restricting and removing their capabilities, women are actively being denied their fundamental right to parenthood. Not only is this hindering the progression of minority women, but also an attempt in annihilating “inferior” and “other” groups.

References

  1. http://jhmas.oxfordjournals.org/content/57/2/117.full.pdf/
  2. Burnette, Brandon R. “Comstock Act of 1873.” Comstock Act of 1873. Middle Tennessee State University. Accessed April 10, 2020. https://www.mtsu.edu/first-amendment/article/1038/comstock-act-of-1873.
  3. Parenthood, Planned. “The History & Impact of Planned Parenthood.” Planned Parenthood. Accessed February 20, 2020. https://www.plannedparenthood.org/about-us/who-we-are/our-history.
  4. Biography.com Editors. “Margaret Sanger Biography.” Biography.com. A&E Networks Television, March 2, 2020. https://www.biography.com/activist/margaret-sanger.
  5. Marsh, Margaret S., and Ronner, Wanda. The Fertility Doctor : John Rock and the Reproductive Revolution. Baltimore: Johns Hopkins University Press, 2008.
  6. Soto Laveaga, Gabriela. "Uncommon Trajectories: Steroid Hormones, Mexican Peasants, and the Search for a Wild Yam." Studies in History and Philosophy of Biol & Biomed Sci 36, no. 4 (2005): 743-60.
  7. Liao, Pamela Verma, and Janet Dollin. “Half a century of the oral contraceptive pill: historical review and view to the future.” Canadian family physician Medecin de famille canadien vol. 58,12 (2012): e757-60.
  8. Planned Parenthood. “Fact Sheets and Reports: Margaret Sanger - Our Founder.” Planned Parenthood Fact Sheets & Reports. Planned Parenthood, June 2016. https://www.plannedparenthood.org/about-us/facts-figures/fact-sheets-reports.
  9. Marsh, Margaret S., and Ronner, Wanda. The Fertility Doctor : John Rock and the Reproductive Revolution. Baltimore: Johns Hopkins University Press, 2008.
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  12. "American Experience | The Pill | People & Events". Pbs.org. Retrieved 2012-12-06.
  13. Bakalar, Nicholas (2010-10-25). "'Birth Control Pill' Made Its Times Debut in 1957 — First Mention". NYTimes.com. Retrieved 2012-12-06.
  14. https://www.pbs.org/wgbh//amex/pill/filmmore/ps_pincus.html
  15. https://www.pbs.org/wgbh//amex/pill/sfeature/sf_stories.html
  16. "Enovid Oral Contraceptive | National Museum of American History". Americanhistory.si.edu. Retrieved 2012-12-06.
  17. Liao, Pamela Verma, and Janet Dollin. “Half a century of the oral contraceptive pill: historical review and view to the future.” Canadian family physician Medecin de famille canadien vol. 58,12 (2012): e757-60.
  18. Marsh, Margaret S., and Ronner, Wanda. The Fertility Doctor : John Rock and the Reproductive Revolution. Baltimore: Johns Hopkins University Press, 2008.
  19. Andrews, Katherine. “The Dark History of Forced Sterilization of Latina Women.” Panoramas, October 31, 2017. https://www.panoramas.pitt.edu/health-and-society/dark history- forced-sterilization-latina-women.
  20. Blakemore, Erin. “The First Birth Control Pill Used Puerto Rican Women as Guinea Pigs.”  History.com. A&E Television Networks, May 9, 2018.  https://www.history.com/news/birth-control-pill-history-puerto-rico-enovid.
  21. Seaman B. The Greatest Experiment Ever Performed on Women. Exploding The Estrogen Myth. 2nd ed. New York, NY: Hyperion Books; 2003. [Google Scholar]
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  23. Ordover, Nancy. American Eugenics : Race, Queer Anatomy, and the Science of Nationalism.   Minneapolis: University of Minnesota Press, 2003.
  24. Liao, Pamela Verma, and Janet Dollin. “Half a century of the oral contraceptive pill: historical review and view to the future.” Canadian family physician Medecin de famille canadien vol. 58,12 (2012): e757-60.
  25. Seaman B. The Greatest Experiment Ever Performed on Women. Exploding The Estrogen Myth. 2nd ed. New York, NY: Hyperion Books; 2003. [Google Scholar]
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  27. Planned Parenthood. “Fact Sheets and Reports: Margaret Sanger - Our Founder.” Planned Parenthood Fact Sheets & Reports. Planned Parenthood, June 2016.  https://www.plannedparenthood.org/about-us/facts-figures/fact-sheets-reports.
  28. Ibid
  29. Quintanilla, Ray. “Puerto Ricans Recall Being Guinea Pigs for `Magic Pill'.” chicagotribune.com. Chicago Tribune, August 27, 2018. https://www.chicagotribune.com/news/ct-xpm-2004-04-11-0404110509-story.html.
  30. "Colonized Wombs? Reproduction Rights and Puerto Rican Women |". publici.ucimc.org. Retrieved 2018-05-07.
  31. Davis, Angela Y. (1983). Women, Race & Class. New York: Vintage Books. pp. 359–361. ISBN 0394713516.
  32. "Film & History". www.filmandhistory.org. Retrieved 2018-05-07.


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