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. "The Pill" had been conceptualized as early as 1912 by Margaret Sanger.[1] Before female combined oral contraceptives. 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.[2] 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

The first human trial of the female oral contraceptive was conducted by Gregory Pincus and John Rock in Massachusetts on a test group of 50 women.[3] The trial was described as a fertility study to avoid state legal interruption of the trial. Massachusetts at the time had strong legislation against birth control. In the 1950s in Massachusetts it was a felony to "exhibit, sell, prescribe, provide, or give out information" on birth control.[3][4][5] Rather than distributing birth control, women were receiving hysterectomies to avoid continuing to get pregnant and have birth.[6] Pincus and Rock felt confident that the combined oral contraceptive pill they had developed was ready for consumers in the United States. Once the Food and Drug Administration approved, the drug could potentially be released in the U.S., but they could not get the approval of the FDA without a larger clinical trial. In 1955 they developed a larger clinical trial of the drug, and tested it on women in Puerto Rico. The pharmaceutical company G. D. Searle & Company created the pills for the trial.[7] 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.[8] 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.[9]

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.[10]

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.[11]

Subjects

The women who volunteered as subjects for the trial were Puerto Rican women searching for an effective method of birth control. Many were not fluent in English, and many were illiterate. The researchers believed that this would be beneficial to their study, as it would reveal whether or not these pills could be used by anyone around the world.[7] For people to participate, they had to be under forty years old, have two children minimum, fertile, and be in good health. Also, the women had to agree to give birth should they get pregnant during the trial.[12]

The Puerto Rican women did not know they were experimental subjects. Contraceptives were illegal in the United States but not in the occupied territory so experiments were not regulated in the Island as it was in the mainland. The experimental dosages were many times higher than the legal dose today. Puerto Rican women were poor and many illiterate. This made it easier for researchers to conduct the experiment without the subjects understanding the risks. This avoided fear and reluctancy from the subjects. The effects of high doses of estrogen birth-control are understood today but the effects on Puerto Rican women have not been studied nor accounted for.

Side Effects

Side effects of this high dose pill were similar to that of modern-day oral contraceptives, only more severe; these included nausea, bloating, weight gain, depression, loss of libido, severe mood changes, etc. Doctors did include patients in details of the study.

Blood clotting also became a major problem with women participating in the trial, and is the currently suspect cause of death for the three deaths that occurred in the subjects while the trials were being conducted. However, it took over a decade for official recognition that there was a link between blood clotting and the use of the drug, leading to multiple deaths within the trial itself.[13][14]

Deaths

Three deaths occurred among patients who were taking the birth control drug during these trials. However, at the time of occurrence these deaths were not reported in the U.S. to be linked to the trials. Despite strong circumstantial evidence that the pill was causing these unexpected deaths, it was not reported, and those conducting the trial considered the deaths to be merely coincidental. The estrogen in the Pill was making the women susceptible to blood clotting.

Controversy

After the drug came into the American public, controversy over the ethical standards of the trial in Puerto Rico arose. Language barriers inhibited the Puerto Rican women from gaining access to answers about side effects and potential risks. The women were informed that they were being given a pill, free of charge, to prevent potential pregnancy. They were not fully informed that this was a clinical trial, or of the risks involved. Autopsies were never conducted on the bodies of the women that died during the trial, causing worry that drugs manufacturers were overlooking serious issues in order to quickly gain access to sales in the U.S.

There are many people who believe that "The Pill" at its current dosage is still a drug which poses a health threat to women.[15] Alice Wolfson, a young activist who spoke at the Nelson Pill Hearings in the 1970s said "It must be admitted that women make superb guinea pigs. They don't cost anything, they feed themselves, they clean their own cages, pay for their own pills, and remunerate the clinical observer." [6]

References

  1. ↑ http://www.pbs.org/wgbh/amex/pill/sfeature/sf_history_pill.htm
  2. ↑ http://jhmas.oxfordjournals.org/content/57/2/117.full.pdf/
  3. 1 2 iPad iPhone Android TIME TV Populist The Page (2010-05-03). "A Brief History of Birth Control". TIME. Retrieved 2012-12-06.
  4. ↑ http://www.pbs.org/wgbh/amex/pill/timeline/index.html
  5. ↑ "American Experience | The Pill | Timeline". Pbs.org. Retrieved 2012-12-06.
  6. 1 2 http://www.pbs.org/wgbh/amex/pill/filmmore/pt.html
  7. 1 2 "American Experience | The Pill | People & Events". Pbs.org. Retrieved 2012-12-06.
  8. ↑ Bakalar, Nicholas (2010-10-25). "'Birth Control Pill' Made Its Times Debut in 1957 — First Mention". NYTimes.com. Retrieved 2012-12-06.
  9. ↑ http://www.pbs.org/wgbh/amex/pill/filmmore/ps_pincus.html
  10. ↑ http://www.pbs.org/wgbh/amex/pill/sfeature/sf_stories.html
  11. ↑ "Enovid Oral Contraceptive | National Museum of American History". Americanhistory.si.edu. Retrieved 2012-12-06.
  12. ↑ http://www.plannedparenthood.org/files/PPFA/PPFA_IB_Pill_Ann_051010.pdf
  13. ↑ "FDA's Approval of the First Oral Contraceptive, Enovid". Fda.gov. 2009-04-15. Retrieved 2012-12-06.
  14. ↑ http://www.pbs.org/wgbh/amex/pill/filmmore/ps_declaration.html
  15. ↑ B, Seaman, The Doctor's Case Against the Pill: 25th Anniversary (Alameda, CA.: Hunter House, 1995).
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