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Thesis: A History and Analysis of Drug Labeling Policy for Pregnant and Lactating Women and Women's Involvement in Clinical Drug Research from 1970 to 2014
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.
Format: Essays and Theses
Doolan v. IVF America [Brief] (2000)
The implication of the court's decision was that Thomas Doolan's identity or personhood existed at the embryo stage in vitro, thus the fact that he was born with cystic fibrosis was not attributable to the decision of the in vitro fertilization providers to implant one embryo instead of another. The other unused embryo may not have carried the cystic fibrosis genes, but that other embryo was not Thomas Doolan. The decision in Doolan has not been publicly tested in other jurisdictions.
Subject: Legal, Reproduction
Edgar Allen (1892–1943)
Edgar Allen identified and outlined the role of female sex hormones and discovered estrogen in the early 1900s in the US. In 1923, Allen, through his research with mice, isolated the primary ovarian hormone, later renamed estrogen, from ovarian follicles and tested its effect through injections in the uterine tissues of mice. Allen’s work on estrogen, enabled researchers to further study hormones and the endocrine system.
Edward B. Lewis (1918-2004)
Edward B. Lewis studied embryonic development in Drosophila, including the discovery of the cis-trans test for recessive genes, and the identification of the bithorax complex and its role in development in Drosophila. He shared the 1995 Nobel Prize in Physiology or Medicine with Christiane Nüsslein-Volhard and Eric F. Wieschaus for work on genetic control of early embryonic development.
Paretta v. Medical Offices for Human Reproduction [Brief] (2003)
The court decided a child of in vitro fertilization born with cystic fibrosis does not have the right to sue for wrongful life even in the presence of demonstrable acts of medical negligence because to allow such a case would grant the IVF child rights not possessed by naturally born children. The decision in Paretta has not been publicly tested in other jurisdictions.
Subject: Legal, Reproduction
Zhang Lizhu (1921- )
Zhang Lizhu is a Chinese gynecologist and researcher. For most of her career, she worked in the Peking Medical College Third Hospital, renamed in 2000, Peking University Third Hospital. There, she led a team of researchers and physicians in the study of human in vitro fertilization (IVF) and embryo transfer (ET) technology. Zhang and her colleagues contributed to the birth of the first test-tube baby in Mainland China in 1988.
Subject: People, Reproduction
Nettie Maria Stevens (1861-1912)
Multiple theories about what determines sex were tested at the turn of the twentieth century. By experimenting on germ cells, cytologist Nettie Maria Stevens collected evidence to support the connection between heredity and the sex of offspring. Stevens was able to interpret her data to conclude that chromosomes have a role in sex determination during development. For her time, she was an emerging breed: a woman of science making the leap from the world of data collection to that of male-dominated interpretive work.
Subject: People, Reproduction
Human Papillomavirus (HPV) Strains 6 and 11 and Strains 16 and 18
Human Papillomavirus, or HPV, is a viral pathogen that most commonly spreads through sexual contact. HPV strains 6 and 11 normally cause genital warts, while HPV strains 16 and 18 commonly cause cervical cancer, which causes cancerous cells to spread in the cervix. Physicians can detect those HPV strains, using a Pap smear, which is a diagnostic test that collects cells from the female cervix.
US Endocrine Disruptor Screening Program
In 1996, the US Congress mandated that the US Environmental Protection Agency (EPA) create and regulate the Endocrine Disruptor Screening Program. The program tests industrial and agricultural chemicals for hormonal impacts in humans and in wildlife that may disrupt organisms' endocrine systems. The endocrine system regulates the release of small amounts of chemical substances called hormones to keep the body functioning normally.
Genetics and IVF Institute, GIVF
In 1984, human genetics and reproduction researcher and physician Joseph D. Schulman founded the Genetics and IVF Institute, an international organization that provides infertility treatment and genetic services to patients. IVF stands for in vitro fertilization, an infertility treatment in which a female egg is fertilized by male sperm outside of the female body. GIVF is headquartered in Fairfax, Virginia, in association with Inova Health System, formerly called the Fairfax Hospital Association, one of the largest regional hospital systems in the United States.
Subject: Organizations, Reproduction
The Baby Makers (2012)
In 2012, the production company Waddell Media Production released the documentary The Baby Makers. The four-part series, directed and produced by Edel O’Mahony, follows multiple couples in Northern Ireland struggling with infertility problems as they utilize different treatments such as in vitro fertilization, or IVF, egg donation, and egg freezing. IVF is a procedure in which a woman’s egg is fertilized by a sperm outside of her body. Once the sperm fertilizes the egg, a fertility doctor places the fertilized egg back into the woman’s uterus.
William Thomas Astbury (1898–1961)
William Thomas Astbury studied the structures of fibrous materials, including fabrics, proteins, and deoxyribonucleic acid, or DNA, in England during the twentieth century. Astbury employed X-ray crystallography, a technique in which scientists use X-rays to learn about the molecular structures of materials. Astbury worked at a time when scientists had not yet identified DNA’s structure or function in genes, the genetic components responsible for how organisms develop and reproduce. He was one of the first scientists to use X-ray crystallography to study the structure of DNA.
Vegas Baby (2016)
In 2016, Runaway Films released the documentary Vegas Baby. The film, directed by Amanda Micheli, follows three women who struggle with infertility problems as they undergo in vitro fertilization, or IVF treatment, to become pregnant. In IVF treatment, a woman’s egg is fertilized by a sperm outside of the woman’s body. Once the sperm fertilizes the egg, a fertility doctor places the fertilized egg back into the woman’s uterus. The three women in the film enter the I Believe contest hosted by the Sher Institute of Reproductive Medicine in Las Vegas, Nevada.
Carl Richard Moore (1892-1955)
Carl Richard Moore was a professor and researcher at the University of Chicago in Chicago, Illinois who studied sex hormones in animals from 1916 until his death in 1955. Moore focused on the role of hormones on sex differentiation in offspring, the optimal conditions for sperm production, and the effects of vasectomy or testicular implants on male sex hormone production. Moore's experiments to create hermaphrodites in the laboratory contributed to the theory of a feedback loop between the pituitary and fetal gonadal hormones to control sex differentiation.
Alec John Jeffreys (1950–)
Alec John Jeffreys created a process called DNA fingerprinting in the UK during the twentieth century. For DNA fingerprinting, technicians identify a person as the source of a biological sample by comparing the genetic information contained in the person's DNA to the DNA contained in the sample. Jeffreys developed the technique in the 1980s while at the University of Leicester in Leicester, UK. Jeffreys's technique had immediate applications. In forensic science, DNA fingerprinting enabled police to identify suspects of crimes based on their genetic identities.
"Versuche zur Analyse der Induktionsmittel in der Embryonalentwicklung" (1932), by Hermann Bautzmann, Johannes Holtfreter, Otto Mangold, and Hans Spemann
In "Versuche zur Analyse der Induktionsmittel in der Embryonalentwicklung," published in Naturwissenschaften in 1932, Hermann Bautzmann, Johannes Holtfreter, Otto Mangold, and Hans Spemann jointly reported on experiments each had conducted testing the activity of organizers killed by boiling, freezing, alcohol, and drying. Each of the authors had been independently conducting similar experiments, when Holtfreter made a breakthrough allowing him to produce many more successful transplantations.
John Chassar Moir (1900–1977)
John Chassar Moir lived in Scotland during the twentieth century and helped develop techniques to improve the health of pregnant women. Moir helped to discover compounds that doctors could administer to women after childbirth to prevent life-threatening blood loss. Those compounds included the ergot alkaloid called ergometrine, also called ergonovine, and d-lysergic acid beta-propanolamide. Moir tested ergometrine in postpartum patients and documented that it helped prevent or manage postpartum hemorrhage in women.
Subject: People, Reproduction, Disorders
Sheldon Clark Reed (1910-2003)
Sheldon Clark Reed helped establish the profession of genetic counseling in the US during the twentieth century. In 1947 Reed coined the term genetic counseling to describe the interaction of a doctor explaining to a patient the likelihood of passing a certain trait to their offspring. With physicians being able to test for genetic abnormalities like cystic fibrosis, Reed helped trained individuals give patients the tools to make informed decisions. In 1955 Reed published the book Counseling in Medical Genetics.
Paul Kammerer's Experiments on Salamanders (1903-1912)
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.
Neurospora crassa is a red mold that scientists use to study genetics. N. crassa commonly grows on bread as shown in the top left corner of this figure. To culture the mold in lab, researchers grow it in glassware such as test tubes, Erlenmeyer flasks, and petri dishes, as shown in the top right corner of the figure. In the glassware, researchers place a gel, called a medium, of agar, sucrose, salts, and vitamins. The mold grows on the medium, and cotton stoppers prevent anything from contaminating the mold.
Robert Geoffrey Edwards (1925-2013)
Robert Geoffrey Edwards worked with Patrick Christopher Steptoe to develop in-vitro fertilization (IVF) techniques during the 1960s and 1970s in the United Kingdom. Louise Brown, the world' s first "test-tube baby," was born as a result of Edwards and Steptoe's IVF techniques in 1978, and since then more than four million children have been born using IVF techniques. Publicity and controversy accompanied Edwards and Steptoe's work as conservative religious institutions expressed concern over the morality of the IVF procedure.
Subject: People, Reproduction
“Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs” (July 1993), by the United States Food and Drug Administration
The US Food and Drug Administration, or FDA, published the “Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs,” henceforth “Study of Gender Differences,” in July 1993. The document defined acceptable practices for investigators studying new drugs. Prior to 1993, investigators excluded most women from clinical trials because in 1977, the FDA recommended that anyone who could possibly become pregnant be excluded from early phase drug research to minimize risk to a potential fetus.
Edgar Allen and Edward A. Doisy's Extraction of Estrogen from Ovarian Follicles, (1923)
In the early 1920s, researchers Edgar Allen and Edward Adelbert Doisy conducted an experiment that demonstrated that ovarian follicles, which produce eggs in mammals, also contain and produce what they called the primary ovarian hormone, later renamed estrogen. In their experiment, Doisy and Allen extracted estrogen from the ovarian follicles of hogs and proved that they had isolated estrogen by using a measurement later renamed the Allen-Doisy test.
"Maternal Thyroid Deficiency During Pregnancy and Subsequent Neuropsychological Development of the Child" (1999), by James E. Haddow et al.
From 1987 to the late 1990s, James Haddow and his team of researchers at the Foundation for Blood Research in Scarborough, Maine, studied children born to women who had thyroid deficiencies while pregnant with those children. Haddow's team focused the study on newborns who had normal thyroid function at the time of neonatal screening. They tested the intelligence quotient, or IQ, of the children, ages eight to eleven years, and found that all of the children born to thyroid-hormone deficient mothers performed less well than the control group.
"Experiments in Transplanting Limbs and Their Bearing Upon the Problems of the Development of Nerves" (1907), by Ross Granville Harrison
In his 1907 paper, "Experiments in Transplanting Limbs and Their Bearing Upon the Problems of the Development of Nerves," in the Journal of Experimental Zoology that he edited, Ross Granville Harrison tested the development of nerves in transplanted tissue. He studied neural development by examining two competing theories. Victor Hensen proposed a syncytial theory as a way to explain neural development, suggesting that all the nerves of an embryo were connected directly by cytoplasm laid down early in development, and leaving no room for later modification.