Embryo Project Encyclopedia

The United States Food and Drug Administration, or FDA, published 'General Considerations for the Clinical Evaluation of Drugs,' in September 1977. The document defined acceptable practices for investigators who studied new drugs. Specifically, the document outlined the common clinical trial methods. Clinical trials are studies to test whether a new drug is safe before doctors can prescribe it to patients. Prior to 1977, the Protection of Human Subjects Rule primarily regulated clinical drug trials, but it did not specify who could and could not be included in clinical trials. In the document, the FDA recommended that anyone who could become pregnant be excluded from early-phase clinical trials to minimize risks to a potential fetus. After the FDA published the document, investigators excluded women from clinical trials. The document ultimately prevented women of reproductive capacity from participating in early phase clinical trials, which affected women’s health research.

Charles Knowlton was a physician and author who advocated for increased access to information about reproduction in the nineteenth century in the US. Throughout his early medical education, Knowlton was particularly interested in anatomy and on several instances robbed graves for bodies to dissect. In 1832, Knowlton authored The Fruits of Philosophy, a pamphlet that contained detailed descriptions of the reproductive organs and information on conception and methods to control reproduction. Knowlton circulated his work among his patients until it was republished in Boston, Massachusetts, in 1832. For publishing a book on sex and methods of birth control, Knowlton was convicted of breaking obscenity laws, which prevented the transmission of obscene materials. After his death, social activists Charles Bradlaugh and Annie Besant republished his work in London, England. Knowlton’s writing about sex and birth control allowed individuals to understand and take control of their reproduction and initiated a public discussion about obscenity laws.

In the 2014 case Burwell v. Hobby Lobby, the US Supreme Court ruled that the contraceptive mandate promulgated under the Patient Protection and Affordable Care Act violated privately held, for-profit corporations’ right to religious freedom. The contraception mandate, issued in 2012 by the US Department of Health and Human Services, required that employer-provided health insurance plans offer their beneficiaries certain contraceptive methods free of charge. In a five to four decision, the US Supreme Court maintained that the mandate, in cases of privately held, for-profit organizations like Hobby Lobby Inc., violated the Religious Freedom Restoration Act of 1993. Although the Court did not decide on the constitutionality of the mandate, their ruling enabled privately held, for-profit corporations that objected to the contraceptive mandate on religious grounds to be exempt from it.

Dorothy Andersen studied cystic fibrosis in the United States during the early 1900s. In 1935, Andersen discovered lesions in the pancreas of an infant during an autopsy, which led her to classify a condition she named cystic fibrosis of the pancreas. In 1938, Andersen became the first to thoroughly describe symptoms of the medical condition cystic fibrosis. Commonly mistaken for celiac disease prior to the 1900s, Andersen defined cystic fibrosis as the build-up of pancreatic fluid in the body caused by the blockage of pancreatic ducts, and she determined that the two conditions were symptomatically different. Andersen developed an early method for
diagnosing cystic fibrosis. By conceptualizing cystic fibrosis and
defining its symptoms, Andersen laid the foundation for treatments that
enabled infants diagnosed with the disease to survive into adulthood.

Better babies contests were competitions held in state fairs throughout the US during the early twentieth century in which babies between the ages of 6 and 48 months were judged for their health. In 1908, social activist Mary de Garmo established and held the first better babies contest at the Louisiana State Fair in Shreveport, Louisiana. The contests, mirroring theories established in the US’s eugenics movement of the twentieth century, aimed to establish standards for judging infant health. Nurses and physicians judged infants participating in the contest on mental health, physical health, and physical appearance. In 1913, the Woman’s Home Companion (WHC) magazine cosponsored de Garmo’s better babies contests and introduced the competition to state fairs throughout the US. Better babies contests helped promote routine health assessments of children by medical professionals.

In 1993, the NIH published the Revitalization Act that established guidelines for minorities’ and women’s participation in clinical research. Before the 1990s, investigators largely excluded women from their research based on the 1979 guidance from the US Food and Drug Administration, or FDA. The FDA urged investigators to exclude any woman who was or could become, pregnant to protect the woman and any developing fetuses from harm. Between 1979 and 1993, several other US governmental agencies urged investigators to increase the number of women in their clinical research to improve the state of women’s healthcare. After Congress passed the National Institutes of Health Revitalization Act, hereafter Revitalization Act of 1993, investigators who used NIH funds for clinical research were required to include both women and minorities in their clinical research. The Revitalization Act established the Office of Research on Women’s Health headquartered in Washington, DC and required investigators to include women in their clinical research, thus improving the quality of women’s health research.

Annie Wood Besant was a social activist who advocated for women’s access to birth control as well as marriage reform, labor reform, and Indian Nationalism in the nineteenth century in England and India. In her early career, Besant was involved in various social and political advocacy organizations including the National Secular Society, the Malthusian League, and the Fabian Society. Besant gave many public lectures and authored various articles in support of secularism, workers’ rights and unionization, and women’s rights. In 1877, Besant and her colleague Charles Bradlaugh republished the pamphlet The Fruits of Philosophy, by Charles Knowlton, on reproduction and contraception. Besant and Bradlaugh were tried for violating the obscenity law that prohibited the publication of obscene material, including sex and contraception. Later in her life, she converted to theosophy and moved to India where she joined the Theosophical Society. In India, Besant campaigned for Indian self-rule and became the president of the Indian National Congress. Besant, through republication of The Fruits of Philosophy and many public lectures and writings on women’s rights, expanded public knowledge of birth control.

Charles Bradlaugh was as a political and social activist in the seventeenth century in England. He held leadership positions in various organizations focused on social and political activism including the Reform League, the London Secular Society, the newspaper National Reformer, and the National Secular Society. Throughout his career, Bradlaugh advocated for better conditions for the working poor, and for the separation of government and religion. The British government prosecuted him numerous times for violating laws prohibiting the publication, sale, and transmission of antireligious, antigovernment, and obscene materials. In 1877, Bradlaugh and another secularist, Annie Besant, republished The Fruits of Philosophy, a pamphlet about contraceptive techniques originally whose author was physician Charles Knowlton. In the nineteenth century, individuals did not have access to information on sex, reproduction, and contraception, as much of society argued such information encouraged immoral behavior. Bradlaugh and Besant were tried for publishing information on sexual anatomy, conception, and methods to control reproduction. Bradlaugh expanded public knowledge of reproduction and contraception, and initiated the process of dismantling the obscenity laws.

Better babies contests were competitions held in state fairs throughout the US during the early twentieth century in which babies between the ages of 6 and 48 months were judged for their health. In 1908, social activist Mary de Garmo established and held the first better babies contest at the Louisiana State Fair in Shreveport, Louisiana. The contests, mirroring theories established in the US’s eugenics movement of the twentieth century, aimed to establish standards for judging infant health. Nurses and physicians judged infants participating in the contest on mental health, physical health, and physical appearance. In 1913, the Woman’s Home Companion (WHC) magazine cosponsored de Garmo’s better babies contests and introduced the competition to state fairs throughout the US. Better babies contests helped promote routine health assessments of children by medical professionals.

On 30 June 1980, in a five to four decision, the US Supreme Court ruled in the Case Harris v. McRae that the Hyde Amendment of 1976 did not violate the US Constitution. The Hyde Amendment banned the use of federal funding to pay for any abortion services. The US Supreme Court's decision in Harris v. McRae overturned the decision of McRae v. Califano (1980), in which the US District Court for the Eastern District of New York had ruled that the funding restrictions established by the Hyde Amendment violated the US Constitution. After the US Supreme Court's ruling in Harris v. McRae, the Hyde Amendment continued to prohibit federal Medicaid funding for abortion services, limiting the funds available for low-income women seeking abortions.