Puerto Rico clinical trials

Las Borinqueñas: The Science and History Behind the Play

The EST/Sloan Project is committed to “challenge and broaden the public’s understanding of science and technology and their impact on our lives.” In that spirit, we offer this essay on the science and history behind Las Borinqueñas, the 2023/2024 Mainstage Production of the Ensemble Studio Theatre/Alfred P. Sloan Foundation in collaboration with the Latinx Playwrights Circle & Boundless Theatre Company.  Las Borinqueñas began previews at the Ensemble Studio Theatre on April 3 and ran through May 5.

An essay by Rich Kelley

The United States in the 1950s was an unlikely place to develop the first oral contraceptive. The U.S. Federal Government and 30 states banned birth control. The NIH, the National Science Foundation, and the WHO refused to support reproductive research. Pharmaceutical companies considered testing an oral contraceptive too risky: They would need healthy women of childbearing age as test subjects. Why would those women want to take part?

Birth control activists wanted to fund the development of a “simple, foolproof birth control method,” preferably a pill. They approached Dr. Gregory Pincus, whose work studying fertility had earned him a reputation as something of a “mad scientist.” As a researcher at Harvard, Pincus garnered national attention when he developed the first test tube rabbit embryo. Scare headlines about “fatherless babies” followed and Pincus was denied tenure.

Pincus accepted the challenge to develop a birth control pill. He focused his research on progesterone, “nature’s contraceptive.” When an egg is fertilized, progesterone prepares the uterus for implantation and shuts down the ovaries, so no more eggs are produced. Could progesterone be put into a pill, effectively tricking a woman’s body into thinking it was pregnant?

From left: Celson-Ramon Garcia, John Rock, Gregory Pincus (seated) in 1957. Source: Worcester Foundation for Biomedical Research

Pincus began doing animal studies using synthetic progesterone with promising results. For the first human tests, he partnered with Dr. John Rock. Rock had been working on curing infertility by injecting women with progesterone and estrogen to pause ovulation and allow the reproductive system to reset. In one study, after stopping the hormones, 13 of 80 patients became pregnant within four months, an effect gynecologists called the "Rock rebound." At Pincus's suggestion, Rock tried the same experiment with the new oral contraceptive, with similar success.

For their first large-scale clinical trial, Pincus and Rock chose Puerto Rico, where the population had surged by 18% in a decade, a growth which caused concern among American politicians and activists (often, but not always, motivated by xenophobia and racism) as well as some of the Puerto Rican upper classes. Unlike the mainland U.S., birth control was legal in Puerto Rico. Sixty-seven family planning clinics promoted the rhythm method, provided diaphragms, spermicides, or condoms, and also referred patients to hospitals for sterilization. Many physicians and reformers believed sterilization was the solution to population control. Hospitals had policies urging maternal patients to have la operación after delivery; some required it after the third child. One survey in 1953-54 found that 40% of all women who had practiced some form of contraception had had la operación. But Puerto Rican women were often not informed by their doctors that sterilization is permanent. 

Dr. Edris Rice-Wray consulting with low-income women in the 1950s Source: Henrylee Marlo CC4.0

Oral contraceptive trials began in Rio Piedras in 1956, directed by American Dr. Edris Rice-Wray and Puerto Rican social worker Iris Rodriguez. They selected a group of 100 women and a control group of another 125. Participants had to be under 40 and must have already had two children to ensure fertility. The trial targeted economically disadvantaged women in Puerto Rico, who were often marginalized and lacked access to adequate healthcare. Many of these women were not adequately informed about the potential risks and benefits of the pill. Some were not aware that they were participating in a clinical trial and taking an experimental drug. 

Rice-Wray gave each woman a 20-day supply of the pills, known as Enovid. "When the bottle is over and you start menstruating," she told her participants, "you count one, two, three, on your fingers, and when you have counted all your fingers, that is the time to start again" on a new bottle. If birth rates went down among participants taking Enovid compared with those in the control group, the pill could be deemed effective.

Enovid, the first birth control pill from G. D. Searle Source: G.D. Searle & Co.

The pills used in the first trials contained an extremely high dose of hormones: more than 10 times the average dose of the pill today. Many participants experienced extreme, sometimes debilitating, side effects. Rice-Wray recorded her findings: among the first 221 women in the study, about 17% had negative reactions and 25 withdrew because of those reactions. There were complaints of dizziness, nausea, headaches, vomiting, and abdominal pain. Pincus considered most of these psychosomatic. Some women reported severe complications, such as blood clots and strokes. The high incidence of adverse reactions raised concerns about the safety of the pill and the adequacy of monitoring and oversight during the trial. Even more troubling, three women died during the trials, but because there were no autopsies, it was never learned if the pill was a factor in their deaths. After the trial concluded, there was limited follow-up and long-term monitoring of the participants to assess the lasting effects of the contraceptive pill. 

By the end of 1958, more than 800 women had enrolled in tests of the pill, but only 130 had taken it for a year or more. To disguise this shortfall, Pincus presented his data in terms of the number of menstrual cycles instead of the number of women. "In the 1,279 menstrual cycles during which the regime of treatment was meticulously followed,” Pincus wrote, “there was not a single pregnancy.” 1,279 menstrual cycles sounded more impressive than 130 women. 

In 1957, the FDA approved pharmaceutical giant Searle’s application for Enovid as a treatment for menstrual disorders and infertility. The FDA finally approved Enovid as a contraceptive in May 1960. By 1965, more than 6.5 million married women and an untold number of unmarried women in the U.S. were using the pill.

The introduction of the birth control pill marked a revolutionary turning point in women's reproductive rights, societal roles, and economic empowerment. With the ability to control when and if they became pregnant, women gained unprecedented freedom to make decisions about their bodies and futures. This autonomy extended beyond family planning to encompass educational pursuits, career advancement, and personal fulfillment and to challenge traditional gender roles and patriarchal structures. According to data from the U.S. Bureau of Labor Statistics, the labor force participation rate of women aged 25 to 54 in the United States increased from 34.9% in 1950 to 60% in 1999. Data from the U.S. Census Bureau shows that the gender wage gap narrowed from 60% in 1960 to 75% in 2020.

Labor Force Participation of Women in the USA, 1955–2005 Source: Our World in Data

By enabling women to control their fertility and delay childbirth, the pill has reduced maternal and infant mortality in countries with high fertility rates and has empowered women to pursue higher education and increased women’s labor force participation worldwide. Yet, according to the World Health Organization (WHO), an estimated 214 million women of reproductive age in developing regions have an unmet need for modern contraception, highlighting the persistent barriers to access.

Today, about 10 million women in the U.S. use the pill, and 13 million have undergone sterilization. However, in 2016, 40% of Puerto Rican women of childbearing age who used birth control had been sterilized, while less than 10% surveyed used an oral contraceptive. During the Zika outbreak of that year, a temporary CDC assistance program made many forms of birth control available for free and included a broad education campaign to inform women of the opportunity. During that program, there was a surge in women accessing birth control, suggesting that price and information access are both factors that continue to make birth control less accessible to Puerto Rican women today.

Resources:

Briggs, Laura. Reproducing Empire: Race, Sex, Science, and U.S. Imperialism in Puerto Rico. University of California Press, 2002.

Eng, Jonathan. The Birth of the Pill: How Four Crusaders Reinvented Sex and Launched a Revolution. W. W. Norton & Company, 2014.

Garcia, Ana Maria, La Operación documentary, 40 minutes. Latin American Film Project, 1982.

Lankford, Kathryn. More than a Way Station: Ground-Level Experiences in the Field Trials of Oral Contraceptives and IUDs in Puerto Rico, 1956-1966 (Ph.d dissertation, 2021)

Ramirez de Arellano, Annette, and Conrad Seipp. Colonialism, Catholicism, and Contraception: A History of Birth Control in Puerto Rico. The University of North Carolina Press, 1983.

Speroff, Leon. A Good Man, Gregory Goodwin Pincus: The Man, His Story, the Birth Control Pill.  Arnica Publishing Inc., 2009.

Tone, Andrea. Devices and Desires: A History of Contraceptives in America. Hill & Wang, 2001.

World Health Organization, “Contraception

Historians Donna J. Drucker and Kathryn Lankford join Bioethicist Inmaculada de Melo-Martín and Activist Alia Tejeda to discuss contraceptives, clinical trials, consent, and LAS BORINQUEÑAS

From left, Donna J. Drucker, Kathryn Lankford, Inmaculada de Melo-Martín, Alia Tejeda

On Saturday, April 27, following the 2:00 PM matinee performance of LAS BORINQUEÑAS, the powerful new drama by Nelson Diaz-Marcano,  everyone is encouraged to stay for a talkback discussion about the cultural, historical, and scientific context of the play.

Set in the 1950s in Puerto Rico, LAS BORINQUEÑAS tells the stories of María, Fernanda, Yolanda, Rosa, and Chavela, all fighting to live full lives in a changing country with crushing societal rules for women. Into their lives comes the American scientist Dr. Gregory Pincus, trying to find test subjects for a clinical trial to test the safety and effectiveness of the first birth control pill, an invention that could give women everywhere freedom. This is a story about medical innovation and the women who risked everything for the chance to live. The audience will have the opportunity to ask questions and join the discussion.

Reproductive Justice advocate Alia Tejeda will moderate the discussion with historians Donna J. Drucker and Kathryn Lankford and bioethicist Inmaculada de Melo-Martín,

LAS BORINQUEÑAS is the 2024 mainstage production of the EST/Sloan Project, EST’s partnership with the Alfred P. Sloan Foundation to develop new plays “exploring the world of science and technology,” an initiative now in its twenty-fifth year. 

About the Panelists

Donna J. Drucker

Donna J. Drucker is a historian who focuses on the history of gender and sexuality as it intersects with science and technology. She received a PhD in history from Indiana University in 2008 and has published four books: The Classification of Sex: Alfred Kinsey and the Organization of Knowledge (Pittsburgh, 2014), The Machines of Sex Research: Technology and the Politics of Identity (Springer, 2014), Contraception: A Concise History (MIT, 2020), and Fertility Technology (MIT, 2023). Her next book on the recent history of abortion worldwide is under contract with Reaktion Books. She works in research development at the Columbia University School of Nursing and tweets from @histofsex. 

Kathryn Lankford

Kathryn Lankford is an Assistant Teaching Professor in the School of Applied Sciences and Arts at Arizona State University where she teaches history and interdisciplinary courses related to medicine, science, technology, gender, and sexuality across a variety of times and places. She previously taught at Michigan State University and served as an advisor at the University of Michigan. Kathryn earned her Ph.D. in History from Michigan State University in 2021. Her dissertation, “More than a Way Station: Ground-Level Experiences in the Field Trials of Oral Contraceptives and IUDs in Puerto Rico, 1956-1966,” examined the field trials of the first birth control pills and new intrauterine devices in Puerto Rico from the perspective of ground-level actors and the agencies affiliated with the tests. She is currently expanding and revising this research.

Inmaculada de Melo-Martín

Inmaculada de Melo-Martín, PhD, MS is Professor of Medical Ethics in the Division of Medical Ethics, and in the Graduate School of Medical Sciences at Weill Cornell Medical College. She is also the Co-Director of the Regulatory and Ethics Knowledge and Support Core for the Clinical & Translational Science Center (CTSC) at Weill Cornell. She holds a Ph.D. in Philosophy and a M.S. in Molecular Biology. Her research interests include bioethics and philosophy of science and she has published extensively in both areas.  Her work explores epistemic aspects and ethical challenges confronting the biomedical sciences. In her research, informed by feminist values, she has called attention to the importance of science when making ethical judgments, the importance of ethics when evaluating new scientific and technological developments, and the importance of attending to the social and political context when assessing science and technology. She has served on the Empire State Stem Cell Board Ethics Committee and is a Fellow of the Hastings Center. Her most recent books are Rethinking Reprogenetics (OUP, 2017), and with Kristen Intemann, The Fight Against Doubt (OUP, 2018).

About the Moderator

Alia Tejeda

Alia Tejeda, a native New Yorker, serves as New York Field Organizer at the National Latina Institute for Reproductive Justice (Latina Institute), where they are building the New York activist base to raise the voices of Latina/xs in the state for reproductive justice. Alia comes to Latina Institute with years of activism experience in abortion access. Since 2015, Alia has been a lead clinic escort for multiple clinics in New York City. They have also been a dedicated case manager for New York Abortion Access Fund (NYAAF), assisting its board in training new case managers.

Alia has worked in education and youth development for over five years at Exploring the Arts (ETA). During their time at ETA, Alia partnered with over 60 different art and cultural institutions throughout New York City and created a bicoastal training series in leadership and development with social-emotional learning components. They have also received certifications from the National Council for Mental Wellbeing. Alia received their BA in Theatre and Performance with a concentration in Directing and Arts Management from the State University of New York at Purchase College.

 LAS BORINQUEÑAS began previews on April 3 and runs through May 5 at EST. You can purchase tickets here.

Bioethicist Tia Powell, New York State Assemblymember Jessica González-Rojas, Playwright Nelson Diaz-Marcano join Activist Elizabeth Estrada to discuss clinical trials, consent, and LAS BORINQUEÑAS

From left: Tia Powell, Jessica González-Rojas, Nelson Diaz-Marcano, Elizabeth Estrada

On Saturday, April 20, following the 2:00 PM matinee performance of LAS BORINQUEÑAS, the powerful new drama by Nelson Diaz-Marcano, everyone is encouraged to stay for a talkback discussion about the many charged issues the play addresses.

Set in the 1950s in Puerto Rico, LAS BORINQUEÑAS tells the stories of María, Fernanda, Yolanda, Rosa, and Chavela, all fighting to live full lives in a changing country with crushing societal rules for women. Into their lives comes the American scientist Dr. Gregory Pincus, trying to find test subjects for a clinical trial to test the safety and effectiveness of the first birth control pill, an invention that could give women everywhere freedom. This is a story about medical innovation and the women who risked everything for the chance to live. The audience will have the opportunity to ask questions and join the discussion.

Reproductive Justice advocate Elizabeth Estrada will moderate the discussion with bioethicist Dr. Tia Powell; activist, academic, and New York State Assemblymember Jessica González-Rojas; and the author of LAS BORINQUEÑAS, Nelson Diaz-Marcano.

LAS BORINQUEÑAS is the 2024 mainstage production of the EST/Sloan Project, EST’s partnership with the Alfred P. Sloan Foundation to develop new plays “exploring the world of science and technology,” an initiative now in its twenty-fifth year. 

About the Panelists

Dr. Tia Powell

Tia Powell, MD is a Professor of Epidemiology and Psychiatry at Albert Einstein College of Medicine and Montefiore Medical Center and former director of the Montefiore Einstein Center for Bioethics. Dr. Powell focuses on bioethics issues related to public policy, aging, dementia, end-of-life care, and public health disasters. She served as Executive Director of the New York State Task Force on Life and the Law, which was New York State’s bioethics commission. She founded Einstein’s MS program in Bioethics and directed it for 13 years. Dr. Powell has worked with the National Academies of Science, Engineering and Medicine on many projects, and currently chairs their report Committee for Research Priorities for Preventing and Treating Alzheimer’s Disease and Related Dementias. She has worked with the CDC, NY State and City, and various professional organizations on issues related to public health ethics and disasters. She served as a special advisor to AHRQ on ethics, dementia and multiple chronic conditions. She is on the American Psychiatric Association ethics committee and is a Fellow of the New York Academy of Medicine and the Hastings Center. She wrote Dementia Reimagined: Building a Life of Joy and Dignity from Beginning to End, published by Penguin Random House. Dr. Powell received a BA from Harvard College and an MD from Yale Medical School. She is currently collaboratively developing a film project on living well at the end of life.

New York State Assemblymember Jessica González-Rojas

New York State Assemblymember Jessica González-Rojas (Democrat/Working Families Party) represents the 34th Assembly District, which includes the diverse communities of Astoria, Corona, East Elmhurst, Jackson Heights, and Woodside in Queens County. She has dedicated her life to fighting for immigrant rights, racial justice, LGBTQ liberation, health care access, labor power, and gender equity while forging connections between various progressive movements. Jessica is a progressive champion and brings her advocacy and organizing expertise to her work as an Assemblymember.

Before running for office, Jessica served in leadership for 13 years at the National Latina Institute for Reproductive Justice (formerly the National Latina Institute for Reproductive Health), including as Executive Director. The nonprofit is the only national reproductive justice organization dedicated to building power among Latinas to advance the health, dignity, and justice of over 30 million Latinas across the country. Jessica is currently an adjunct faculty at New York University (NYU) School of Law and has served as adjunct faculty at NYU’s Robert F. Wagner Graduate School of Public Service and the City University of New York’s (CUNY) City College. She has taught courses on Latinidad, reproductive rights, and gender and sexuality. She recently co-instructed a course at the New York University School of Law. She has authored essays in multiple publications on those topics as well.

Nelson Diaz-Marcano

Nelson Diaz-Marcano is a Puerto Rican NYC-based theater maker, advocate, and community leader whose mission is to create work that challenges and builds community. His play, LAS BORINQUEÑAS, is the 2024 EST/Sloan Mainstage Production in April 2024. He currently serves as the Literary Director for the Latinx Playwright Circle where he has helped develop over 100 plays in the past three years. His plays have been developed by the Ensemble Studio Theatre, The Road Theatre Company, Pipeline Theatre Company, Clubbed Thumb, The Lark, Vision Latino Theater Company, The Orchard Project, The William Inge Theatre Festival, Classical Theatre of Harlem, and The Parsnip Ship, among others. Recent credits include: World Classic (Bishop Theatre Arts Center), Y Tu Abuela, Where is She? Part 1 (CLATA), When the Earth Moves, We Dance (Clubbed Thumb, Teatro Vivo), The Diplomats (Random Acts Chicago), Paper Towels (INTAR), Misfit, America (Hunter Theatre Company), I Saw Jesus in Toa Baja (Conch Shell Productions), and Revolt! (Vision Latino Theatre Company).

About the Moderator

Elizabeth Estrada

Elizabeth Estrada serves as the New York Field and Advocacy Manager at the National Latina Institute for Reproductive Justice (Latina Institute) where she engages in movement-building for reproductive justice, develops community leadership, builds relationships with key stakeholders, and develops campaigns throughout New York State.

Previously, she served as the Civic Engagement Manager where she organized voter engagement campaigns to raise the voices of Latinxs in Florida, Texas, and Virginia for policy change at all levels of government on issues that impact people's reproductive freedom and self-determination. Elizabeth immigrated to the U.S. from Mexico with her parents at the age of 4, where she remained undocumented until age 13.  She learned grassroots organizing and policy advocacy in The Southeast while partnering with immigrant justice organizations throughout the region. Elizabeth then went on to become a state certified Sexual and Reproductive Health Worker or “Promotora” for the Lifting Latina Voices Initiative (LLVI) at the Feminist Women’s Health Center in Atlanta. Elizabeth has had the honor of supporting the growth and leadership of hundreds of women, girls, and femmes in the reproductive justice movement. She continues to translate her 10+ years’ experience to the work she is currently building in New York. Additionally, Elizabeth serves as the Board Secretary for SisterSong Women of Color Reproductive Justice Collective and is a Case Manager with the New York Abortion Access Fund (NYAAF).

 LAS BORINQUEÑAS began previews on April 3 and runs through May 5 at EST. You can purchase tickets here.