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DEPO PROVERA: A CONTRACEPTIVE INJECTION THAT DID MORE THEN PREVENT PREGNANCY
Around the 1950s a scientist working in the Upjohn Company, a pharmaceutical manufacturing firm, began experimenting with multiple compounds of a hormone called progesterone. That scientist synthesized depot medroxyprogesterone acetate which would be brand named as Depo Provera. Depo Provera first received FDA approval in 1960 for the treatment of endometriosis and threatened/habitual miscarriage only. After testing the drug in Brazil and discovery long term contraceptive effects, Upjohn began the application for FDA approval for the drug to be used as a contraceptive drug.
In 1963 Depo Provera was granted an Investigative New Drug status. This was after submitting requisite rodent studies and plans for further animal and clinical trials. Two years after receiving its new status, Upjohn initiated field studies in 70 foreign countries. In 1967 Upjohn contracted with Grady Memorial Family Planning Clinic in Atlanta, Georgia in order to conduct a large-scale clinical trial of 1,000 women. During this time, Upjohn also completed a New Drug Application for approval for Depo Provera as a contraceptive drug, and the application passed. The application was considered before results of animal studies were yielded.
Testing on monkeys and beagles began in 1968, a year after the large-scale human study at Grady in Atlanta. Additionally, the testing with the beagles showed an increased rate of breast cancer. The testing with the monkeys showed that 2 out of the 12 monkeys had endometrial cancer. The testing with the beagles showed an increased rate of breast cancer. The testing with the monkeys showed that 2 out of the 12 monkeys had endometrial cancer.
In the Grady Memorial Family Planning Clinic study which lasted from 1967-1978, Depo Provera was administered to 11,400 women. These women were primarily poor African American women. The drug is injected intramuscularly every 90 days in order to suppress ovulation. When the study was audited by the FDA, serious shortcomings were found in its design and conduction. The study included inaccurate screening, defective informed consent protocol, and no follow-up of the women being tested on. Side effects of the drug include weight gain, heavy bleeding, depression, decrease in sex drive, weakened bones or osteoporosis, and even cancer specifically breast cancer.
The clinic’s program was eventually ended after the FDA audit. The study was publicly exposed the FDA’s Public Board of Inquiry headed by Judith Weisz, in held hearings in 1983. The women involved in the study at Grady did not receive any legal compensation.
Sources:
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Monitor, T. (1985). Problems in the U.S. Retrieved April 20, 2020, from https://www.multinationalmonitor.org/hyper/issues/1985/02/problems-us.html
Green, W. (2017). Contraceptive risk: The FDA, Depo-Provera, and the politics of experimental medicine. New York, NY: New York University Press.
Griffin, J. (2018, September 02). BIRTH CONTROL SHOT STIRS HEALTH, ETHICS FEARS. Retrieved April 20, 2020, from https://www.chicagotribune.com/news/ct-xpm-1992-11-18-9204150346-story.html
Kline, W. (n.d.). Bodies of Evidence. Bodies of Evidence. Retrieved April 20, 2020, from http://thetarrytownmeetings.org/sites/default/files/Kline%20Bodies%20of%20Evidence.pdf
Upjohn Company. (n.d.). Retrieved April 26, 2020, from https://www.digitalcommonwealth.org/search/commonwealth:js956t39z
Stacey, D. (2019, November 12). 6 Common Depo-Provera Side Effects. Retrieved April 26, 2020, from https://www.verywellhealth.com/common-depo-provera-side-effects-906709