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.

"Casti Connubii," a papal encyclical given by Pope Pius XI on 31 December 1930, served primarily as a reaffirmation and expansion of the issues discussed in Arcanum, an encyclical written by Pope Leo XIII. It was released to address new threats to marriage and conjugal unity, and indeed is translated "On Christian Marriage" or "On Chastity in Marriage." The document explores the meaning of Christian marriage and emphasizes its threefold purpose as borrowed from St. Augustine: to produce offspring, to grow in conjugal faith, and to show benefit from the sacrament. It begins by exploring the nature of marriage, followed by a discussion of its advantages for individuals and societies, erroneous but common beliefs about marriage, threats to pure marriage, and finally how to address them. Included in the threats to pure marriage is that of the growing popularity of contraception and abortive procedures, at which point Pope Pius XI elaborates on the Church' s statement that life begins at conception.

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.

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.

The principal work of St. Thomas Aquinas, the Summa Theologica is divided into three parts and is designed to instruct both beginners and experts in all matters of Christian Truth. It discusses topics central to Christian morality, ethics, law, and the life of Christ, providing philosophical and theological solutions to common arguments and questions surrounding the Christian faith. The views presented in this body of writing are currently upheld in large part by the modern doctrines of the Roman Catholic Church. Interesting references to and insights on ensoulment and embryology, as well as other topics discussed in Summa Theologica, indicate a strong Aristotelian and Augustinian influence.

Karl Wilhelm Theodor Richard von Hertwig is an important figure in the history of embryology for his contributions of artificial hybridization of sea urchin eggs and the formulation of his coelom theory. He was born 23 September 1850 in Friedelberg, Germany, to Elise Trapp and Carl Hertwig. Richard and his older brother Oscar began their studies at Jena under the direction of Ernst Haeckel from 1868 to 1871. In 1872 Hertwig became a lecturer in zoology at Jena while Oscar lectured in anatomy and embryology. As both brothers advanced in their respective fields, Hertwig left Jena to become a professor at Königsberg. In 1883 he was professor at Bonn and in 1885 in Munich, where he stayed until his retirement in 1925. Hertwig married Julia Braun in 1887 and had two sons and one daughter. He remained very active his entire life, outliving his brother Oscar by fifteen years.

Chorionic villus sampling (CVS) is a test used for prenatal diagnosis. Safe to perform at an earlier stage in pregnancy than amniocentesis, CVS is another invasive prenatal diagnostic test that can be performed as early as ten weeks after the woman's last menstrual cycle. While this test does carry some risks, it is generally very effective at predicting heritable diseases during or soon after the embryonic stage of development.