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 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.

In 2017, Julie Carré, Nicolas Gatimel, Jessika Moreau, Jean Parinaud, and Roger Léandri published “Does Air Pollution Play a Role in Infertility?: a Systematic Review,” hereafter “Does Air Pollution Play a Role,” in the journal Environmental Health. The authors completed a systematic literature review to investigate the effects of air pollutants on fertility in exposed populations. Since air quality has an impact on overall health as well as on reproductive function, the authors sought to increase the awareness of the importance of environmental protection issues among the general public and the authorities. The article “Does Air Pollution Play a Role” provided the foundation for further research on how air pollution can contribute to low reproductive capacity in areas with high exposure.

In September 2003, Robert L. Goldenberg and Cortney Thompson published the article “The Infectious Origins of Stillbirth” in the American Journal of Obstetrics and Gynecology. In the article, the authors conducted a literature review of articles from the US National Library of Medicine database to review the relationship between perinatal infections, which are infections around the time of birth, and the occurrence of stillbirth. Stillbirth is the death of a fetus in the uterus after at least twenty weeks of pregnancy. Infectious disease can cause or increase the risk of stillbirth in several ways, by causing illness in the pregnant person, damaging the placenta, or directly infecting the fetus. Infectious agents can be viruses, bacteria, or protozoa. Rates of infectious disease and stillbirth are both higher in developing than in developed countries, and the authors state that stillbirth due to infectious disease is also higher. “The Infectious Origins of Stillbirth” provides a comprehensive review of the information available on how infections can lead to stillbirth, providing a foundation for further research.

In 2014, the United States Food and Drug Administration published the Pregnancy and Lactation Labeling Rule to amend previous guidelines for the prescription of drugs for pregnant and lactating women. The 2014 Pregnancy and Lactation Labeling Rule was intended to increase the safety and efficacy of prescription drugs by making drug labels easier for physicians to understand and utilize. The Pregnancy and Lactation Labeling Rule restructured drug labels and required that they include narratives describing drug-associated risks to women and fetuses, rather than using complicated letter categories. The Pregnancy and Lactation Labeling Rule changed the framework for drug labeling, making it easier for doctors to prescribe safe and effective drugs to pregnant women, lactating women, and people of reproductive capacity.