Embryo Project Encyclopedia

In 2006, the United States Food and Drug Administration, or FDA, published the “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products,” also called the Physician Labeling Rule, to improve the safety and efficacy of prescription drugs and drug products. Within the Physician Labeling Rule, the FDA includes a section titled “Use in Specific Populations” or Section 8, which refers to drugs used by pregnant women, lactating women, and people of reproductive capacity. The FDA stated that the purpose of the Physician Labeling Rule was to make drug labels easier for physicians to understand and use when prescribing drugs to pregnant women. With the Physician Labeling Rule, the FDA improved patient-physician communication and the safety of drug use during pregnancy.

The problem of whether women should be involved in drug research is a question of who can assume risk and who is responsible for disseminating what specific kinds of information. The problem tends to be framed as one that juxtaposes the health of women and fetuses and sets their health as in opposition. That opposition, coupled with the inherent uncertainty in testing drugs, provides for a complex set of issues surrounding consent and access to information.

In the early twentieth century, Paul Kammerer conducted a series of experiments to demonstrate that organisms could transmit characteristics acquired in their lifetimes to their offspring. In his 1809 publication, zoologist Jean-Baptiste Lamarck had hypothesized that living beings can inherit features their parents or ancestors acquired throughout life. By breeding salamanders, as well as frogs and other organisms, Kammerer tested Lamarck's hypothesis in an attempt to provide evidence for Lamarck's theory of the inheritance of acquired characteristics. In particular, Kammerer argued that the inheritance of acquired characteristics caused species to evolve, and he claimed that his results provided an explanation for evolutionary processes through developmental phenomena.

In the first decade of the twentieth century, Paul Kammerer, a zoologist working at the Vivarium in Vienna, Austria, conducted research on developmental mechanisms, including a series of breeding experiments on toads (Alytes obstetricans). Kammerer claimed that his results demonstrated that organisms could transmit acquired characteristics to their offspring. To explain how evolution occurred, biologist Jean-Baptiste Lamarck in France suggested in his 1809 book that offspring inherited the features their ancestors acquired throughout the lives of those ancestors, a process termed the inheritance of acquired characteristics. Kammerer conducted breeding experiments to test the theory of inheritance of acquired characteristics, which he said described the mechanics of evolution. Additionally, Kammerer's experiments aimed at explaining how development shaped evolutionary processes.

In the early twentieth century, Paul Kammerer, a zoologist working at the Vivarium in Vienna, Austria, experimented on sea-squirts (Ciona intestinalis). Kammerer claimed that results from his experiments demonstrated that organisms could transmit characteristics that they had acquired in their lifetimes to their offspring. Kammerer conducted breeding experiments on sea-squirts and other organisms at a time when Charles Darwin's 1859 theory of evolution lacked evidence to explain how offspring inherited traits from their parents. In 1809, zoologist Jean-Baptiste Lamarck in France theorized that living beings can inherit the features their parents or ancestors acquired during those ancestor's lifetime, a theory called the inheritance of acquired characteristics. Kammerer attempted to provide evidence for the theory of inheritance of acquired characteristics, which constituted, he argued, the mechanics of evolution. Kammerer claimed that his results could explain evolutionary processes through developmental phenomena.

Hamlin Fistula Ethiopia is a nonprofit organization that began in 1974 as a joint endeavor by Reginald and Catherine Hamlin and the Addis Ababa Fistula Hospital in Addis Ababa, Ethiopia. Hamlin Fistula Ethiopia promotes reproductive health in Ethiopia by raising awareness and implementing treatment and preventive services for women affected by obstetric fistulas. It also aims to restore the lives of women afflicted with obstetric fistulas in Ethiopia and eventually to eradicate the condition. Obstetric fistulas occur in pregnant women during labor when pressure placed on the pelvis by the fetus causes a hole, or fistula, to form between the pregnant woman's vagina and bladder (vesicovaginal fistula) or between the vagina and the rectum (rectovaginal fistula). Hamlin Fistula Ethiopia is governed by a board of trustees which includes founding member Catherine Hamlin. By 2014, Hamlin Fistula Ethiopia supported the Addis Ababa Fistula Hospital, five treatment centers across Ethiopia, a midwife school, and a long-term rehabilitation center for women impacted by obstetric fistula.

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.

The Stazione Zoologica Anton Dohrn (Anton Dohrn Zoological Station) is a public research institute focusing on biology and biodiversity. Hereafter called the Station, it was founded in Naples, Italy, in 1872 by Anton Dohrn. The type of research conducted at the Station has varied since it was created, though initial research focused on embryology. At the turn of the twentieth century, researchers at the Station established the sea urchin (Echinoidea) as a model organism for embryological research. A number of scientists conducted experiments on embryos and embryonic development at the Station from the 1890s to the 1930s, including Hans Driesch, Jacques Loeb, Theodor Boveri, Otto Warburg, Hans Spemann and Thomas Morgan. Research completed during this time at the Station contributed to the study of experimental embryology and developmental biology and helped shape the history of embryology.

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.