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The History of the Birth Control Pill, Part 5: Clinical Trials

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Gregory Pincus, Min-Chueh Chang, and John Rock, three scientists employed by Margaret Sanger and Katharine McCormick to develop the birth control pill.

Gregory Pincus, Min-Chueh Chang, and John Rock were hired by Margaret Sanger and Katharine McCormick to develop the birth control pill.

Welcome to the fifth installment of our series chronicling the history of the birth control pill. In the previous installment, Margaret Sanger and Katharine McCormick envisioned and bankrolled the development of the birth control pill. Now it had to be tested in large-scale trials.

John Rock, Gregory Pincus, and Min-Chueh Chang had collaborated in the Pill’s development; now it was time to conduct clinical trials. The first study observed 60 women, some of whom were infertility patients while others were nurses. These small trials involved daily temperature readings, vaginal smears, and urine samples, as well as monthly endometrial biopsies. Although the initial results seemed promising, the sample size was small and few of the subjects complied with the protocol.

The approval of the Pill in 1960 marked a turning point in our history.

More test subjects were needed. At this point, historians’ accounts differ. Elaine Tyler May claims that, unable to locate an acceptable pool of volunteers, the researchers tested the Pill on subjects who could not give their consent, such as psychiatric patients. According to Bernard Asbell, however, Rock was scrupulous when it came to informed consent, despite it not being a legal requirement — or even much of a concept at all at this time in history.

Willing participants notwithstanding, conducting such trials in the United States posed a challenge, due to laws against contraception. So the first large-scale clinical trials were conducted in Puerto Rico in 1956. Puerto Rico was densely populated and there was a high demand for alternatives to permanent sterilization, which was widespread on the island due to funding from a wealthy eugenicist named Clarence Gamble, who advocated sterilization for the world’s poor. The clinical trials in Puerto Rico were conducted by Drs. Edris Rice-Wray and Adaline Sattherthwaite; the brand of birth control pill tested was named Enovid. Volunteers were so easy to come by that some clinics had waiting lists. Continue reading →

Let’s Talk Contraception: What’s the Difference Between Generic and Brand-Name Birth Control?

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Oral contraceptives (birth control pills) have been around for decades, and many are now available as generics. In general, generics cost less than brand-name medications. Despite saving money, some users question whether generic birth control pills are as “good” as brand-name pills. To confuse the situation, new brand-name birth control pills have been developed that specifically claim other benefits in addition to protection from pregnancy, such as treatment of acne. The cost of these brand-name pills is much higher. To understand the generic vs. brand-name debate, it is first important to understand how drugs are developed.

Clinical evidence doesn’t support the idea that generic birth control pills have different failure rates or side effects than their name-brand counterparts.

When a drug is first discovered and developed it goes through a drug review process. This involves many steps: chemistry experiments to discover the active chemical structure of the drug, manufacturing and testing the chemical drug product, inspections of the manufacturing process, and many other developmental studies. Then there are animal studies to check safety and efficacy — and if the drug works without major side effects. Finally, clinical studies are conducted in people; these studies test to assure bioavailability (the amount of time it takes for the body to absorb the drug). These last tests, in animals and people, show bioequivalence. Bioequivalence means the drug must enter the body, be absorbed in the same time frame, and work in the body the same way consistently.

When a new drug is finally approved by the FDA, it has met strict standards regarding its strength, purity, quality, potency, safety, and clinical effectiveness. New drugs are awarded patents for 20 years, but by the time they come to market, much of that time has run out due to all of the testing requirements. Generics are usually less expensive — manufacturers do not need to repeat discovering the drug, nor must they redo animal and human studies to assure the drug is safe and works as intended. The generic companies also do not need to spend as much money on advertising, marketing, and promotion. Continue reading →