¿ESTOY EMBARAZADA? BIRTH CONTROL OR PLACEBO
During the early 1970s, concern about the potential health harming side effects of oral contraceptives spread across the United States. As a response, many women discontinued their birth control pills and pharmaceutical companies immediately began to fund oral contraceptive research. In 1971, the San Antonio Pill Study was conducted to examine the side effects of oral contraceptives in comparison to women who received a placebo or “dummy pills”. The study worked in collaboration with the Planned Parenthood Center in San Antonio and the Southwest Foundation for Research and Education (SFRE) clinical unit.
Since its establishment in 1958, the SFRE or Southwest Foundation’s Clinic Unit in San Antonio, Texas led several birth control research programs and administered birth control pills to about 500 women a month in exchange for research participation. The majority of the women who attended the clinic were mainly indigent Hispanic women. These women may have obtained these services privately due to social, cultural, or religious sensitivities and grew to trust the providers at the clinic. According to a female patient at the Southwest Foundation’s Clinic Unit for nearly nine years:
I feel by going to the clinic I have everything to gain…and certainly nothing to lose.
Dr. Joseph W. Goldzieher, a researcher at San Antonio’s SFRE, organized and led the San Antonio Pill Study with a nearly one million dollar grant. The study consisted of testing five drugs, one being the placebo or “dummy pills”, to compare the side effects such as nausea and vomiting, abdominal discomfort, depression, and weight gain. The San Antonio Pill Study was designed as a double-blind crossover clinical trial and his test subjects一 the indigent Hispanic women of San Antonio seeking free birth control pills.
It was reported that the 398 women who enrolled in the study had done so voluntarily and signed a consent form to participate. The consent form did not include that inactive oral contraceptives would be given in order to preserve the design of the study. It was also noted that the women who were allowed to participate in the study were women who had never taken oral contraceptives before. The notion that the women may have not properly understood the scope of the study and their medications is emphasized by the removal of several women from the study because they were reported as being “grossly unreliable” in the use of their medications. Some of the participants may have found it difficult to read or comprehend the information, either due to level of education and/or a language barrier. About 18 women were removed from the study, and a reported seven women became pregnant over the course of the study with the majority from the placebo group. Moreover, two years after the study was conducted, the Texas Monthly reported an estimated 10 pregnancies resulted from the study. Furthermore, the newspaper article included Dr. Goldzieher’s response to the resulting pregnancies from the study:
We could have aborted them if the abortion statute here in Texas weren’t in limbo right now. A court order
overturned the law and the case is awaiting Supreme Court review. If we had a liberalized law, we’d abort them.
The study concluded that the frequency of side effects from the treatment groups was similar to that of the placebo group. The San Antonio Pill Study ended prematurely due to one of the drugs being removed by the federal government due to reports of its carcinogenic properties in animals. Dr. Goldzieher received some backlash for conducting the study, but no lawsuit was filed and he continued to organize contraceptive studies.
Sources:
Curtis, Gregory, et al. “Maybe Baby.” Texas Monthly, 1 Oct. 1973, www.texasmonthly.com/articles/briar-patch-6/.
Goldzieher, Joseph W., et al. "A Placebo-Controlled Double-Blind Crossover Investigation of the Side Effects Attributed to Oral Contraceptives." Fertility and Sterility 22.9 (1971): 609-623.
“Most ‘Pill’ Side Effects Coincidental.” Progress, Jun. 1971. pp. 7-10. Texas Biomedical Research Institute Publications Collection, UTSA Special Collections.
“Opinion.” Progress, Sep. 1970. pp. 4. Texas Biomedical Research Institute Publications Collection, UTSA Special Collections.
“Pill’s Effect on Women… Only Concern of SFRE.” Progress, Sep. 1970. pp. 7-9. Texas Biomedical Research Institute Publications Collection, UTSA Special Collections.
Shute, D. (1971) “Mexican-Americans 'Outraged’ by Pill Study”, Express and News, Page 7, 19 June, [Online]. Available at: https://www.newspapers.com/newspage/29704362/ (Accessed: 17 April 2020).
“Southwest Foundation Receives Near Million Dollar Contract.” Progress, Sep. 1970. pp. 6,18. Texas Biomedical Research Institute Publications Collection, UTSA Special Collections.