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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
Studies of Thalidomide's Effects on Rodent Embryos from 1962-2008
Thalidomide is a sedative drug introduced to European markets on 1 October 1957 after extensive testing on rodent embryos to ensure its safety. Early laboratory tests in rodent populations showed that pregnant rodents could safely use it, so doctors prescribed Thalidomide to treat morning sickness in pregnant women. However, in humans Thalidomide interfered with embryonic and fetal development in ways not observed in rodent tests.
Subject: Organisms, Reproduction, Disorders
"Predictors of Postpartum Depression: An Update” (2001), by Cheryl Tatano Beck
In her 2001 paper “Predictors of Postpartum Depression: An Update,” researcher Cheryl Tatano Beck presents the most common risk factors associated with postpartum depression in women. Postpartum depression occurs when women experience symptoms such as tearfulness, extreme mood changes, and loss of appetite for a lengthened period after giving birth. At the University of Connecticut in Storrs, Connecticut, nursing professor Beck updated a previous study of hers by analyzing literature about postpartum depression published in the 1990s.
"Effects of Social Support During Parturition on Maternal and Infant Morbidity” (1986), by Marshall Klaus, John Kennell, Steven Robertson, and Roberto Sosa
Robert Geoffrey Edwards and Patrick Christopher Steptoe's Clinical Research in Human in vitro Fertilization and Embryo Transfer, 1969-1980
The biomedical accomplishment of human in vitro fertilization and embryo transfer (IVF-ET) took years to become the successful technique that presently enables infertile couples to have their own children. In 1969, more than ten years after the first attempts to treat infertilities with IVF technologies, the British developmental biologist Robert Geoffrey Edwards fertilized human oocytes in a Petri dish for the first time.
Subject: Experiments, Reproduction
"Mitochondrial DNA and Human Evolution" (1987), by Rebecca Louise Cann, Mark Stoneking, and Allan Charles Wilson
In 1987 Rebecca Louise Cann, Mark Stoneking, and Allan Charles Wilson published Mitochondrial DNA and Human Evolution in the journal Nature. The authors compared mitochondrial DNA from different human populations worldwide, and from those comparisons they argued that all human populations had a common ancestor in Africa around 200,000 years ago. Mitochondria DNA (mtDNA) is a small circular genome found in the subcellular organelles, called mitochondria.
Subject: Publications, Theories
“The Standardization of Terminology of Female Pelvic Organ Prolapse and Pelvic Floor Dysfunction” (1996), Richard C. Bump, Anders Mattiasson, Kari Bø, Linda P. Brubaker, John O.L. DeLancey, Peter Klarskov, Bob L. Shull, Anthony R.B. Smith
In 1996, a team of researchers associated with the International Continence Society published “The Standardization of Terminology of Female Pelvic Organ Prolapse and Pelvic Floor Dysfunction” in American Journal of Obstetrics and Gynecology. Pelvic organ prolapse is characterized by the descent of the pelvic organs into the lower portion of the pelvis and is often caused by a weakening of the muscles and ligaments that normally hold the organs in place.
Subject: Publications, Disorders
Enovid: The First Hormonal Birth Control Pill
Enovid was the first hormonal birth control pill. G. D. Searle and Company began marketing Enovid as a contraceptive in 1960. The technology was created by the joint efforts of many individuals and organizations, including Margaret Sanger, Katharine McCormick, Gregory Pincus, John Rock, Syntex, S.A. Laboratories, and G.D. Searle and Company Laboratories.
Subject: Technologies, Reproduction
José Pedro Balmaceda (1948- )
José Pedro Balmaceda was born 22 August 1948 in Santiago, Chile. His mother Juanita owned a women's boutique in the city and his father José was a successful owner of several timber mills. He grew up with five sisters who remained in Santiago all their lives. Balmaceda attended the college preparatory school San Ignatius where he met Sergio Stone, his future partner at the Center for Reproductive Health fertility clinic in the University of California Irvine Medical Center.
Subject: People, Reproduction
J.B. v. M.B. [Brief] (2001)
In a dispute over frozen embryos during a divorce case, the court decided the wife's fundamental right to not procreate mandated destruction of the pre-embryos in light of the husband's continuing ability to procreate with a different partner. The court also said embryo disposition agreements used by in vitro fertilization clinics were generally enforceable subject to either spouse's right to change his or her mind prior to use of the pre-embryos.
Subject: Legal, Reproduction
"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.
Breast Augmentation Techniques
Breast augmentation involves the use of implants or fat tissue to increase patient breast size. As of 2019, breast augmentation is the most popular surgical cosmetic procedure in the United States, with annual patient numbers increasing by 41 percent since the year 2000. Since the first documented breast augmentation by surgeon Vincenz Czerny in 1895, and later the invention of the silicone breast implant in 1963, surgeons have developed the procedure into its own specialized field of surgery, creating various operating techniques for different results.
Subject: Technologies, Processes, Reproduction, Ethics
Shoukhrat Mitalipov and Masahito Tachibana's Mitochondrial Gene Replacement Therapy Technique
In 2009, Shoukhrat Mitalipov, Masahito Tachibana, and their team of researchers developed the technology of mitochondrial gene replacement therapy to prevent the transmission of a mitochondrial disease from mother to offspring in primates. Mitochondria contain some of the body's genetic material, called mitochondrial DNA. Occasionally, the mitochondrial DNA possesses mutations.
Adolescent Family Life Act (1981)
The 1981 Adolescent Family Life Act, or AFLA, is a US federal law that provides federal funding to public and nonprofit private organizations to counsel adolescents to abstain from sex until marriage. AFLA was included under the Omnibus Reconciliation Act of 1981, which the US Congress signed into law that same year. Through the AFLA, the US Department of Health and Human Services, or HHS, funded a variety of sex education programs for adolescents to address the social and economic ramifications associated with pregnancy and childbirth among unmarried adolescents.
Subject: Legal, Outreach, Ethics, Reproduction
Robert Geoffrey Edwards's Study of Fertilization of Human Oocytes Matured in vitro, 1965 to 1969
Robert Geoffrey Edwards, a British developmental biologist at University of Cambridge, began exploring human in vitro fertilization (IVF) as a way to treat infertility in 1960. After successfully overcoming the problem of making mammalian oocytes mature in vitro in 1965, Edwards began to experiment with fertilizing matured eggs in vitro. Collaborating with other researchers, Edwards eventually fertilized a human egg in vitro in 1969. This was a huge step towards establishing human IVF as a viable fertility treatment.
Subject: Experiments, Reproduction
Biological Lectures Delivered at the Marine Biological Laboratory in Woods Hole
The Marine Biological Laboratory in Woods Hole, Massachusetts, began in 1888 with one building housing researchers upstairs and students in a shared lab and lecture space downstairs. For the first two years, instruction took the form of general lectures covering a range of topics in zoology. In addition, the trustees offered some public lectures in Boston to raise funds for the lab.
Subject: Organizations, Outreach
The Food and Drug Administration’s Pregnancy and Lactation Labeling Rule (2014)
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.
"RNA-Guided Human Genome Engineering via Cas 9" (2013), by Prashant Mali, Luhan Yang, Kevin M. Esvelt, John Aach, Marc Guell, James E. DiCarlo, Julie E. Norville, and George M. Church
In 2013, George Church and his colleagues at Harvard University in Cambridge, Massachusetts published RNA-Guided Human Genome Engineering via Cas 9, in which they detailed their use of RNA-guided Cas 9 to genetically modify genes in human cells. Researchers use RNA-guided Cas 9 technology to modify the genetic information of organisms, DNA, by targeting specific sequences of DNA and subsequently replacing those targeted sequences with different DNA sequences. Church and his team used RNA-guided Cas 9 technology to edit the genetic information in human cells.
US Regulatory Response to Thalidomide (1950-2000)
Thalidomide, a drug capable of causing fetal abnormalities (teratogen), has caused greater than ten thousand birth defects worldwide since its introduction to the market as a pharmaceutical agent. Prior to discovering thalidomide's teratogenic effects in the early 1960s, the US Food and Drug Administration (FDA) did not place regulations on drug approval or monitoring as it later did. By 1962, approximately 20,000 patients in the US had taken thalidomide as part of an unregulated clinical trial before any actions were taken to stop thalidomide's distribution.
Subject: Legal, Reproduction
Inducing Fertilization and Development in Sand Dollars
Sand dollars are common marine invertebrates in the phylum Echinodermata and share the same class (Echinoidea) as sea urchins. They have served as model laboratory organisms for such embryologists as Frank Rattray Lillie and Ernest Everett Just. Both Lillie and Just used Echinarachnius parma for their studies of egg cell membranes and embryo development at the Marine Biological Laboratory (MBL) at Woods Hole, Massachusetts, in the early 1900s.
Advanced Cell Technology, Inc.
Advanced Cell Technology, Inc. (ACT) is a biotechnology company that uses stem cell technology to develop novel therapies in the field of regenerative medicine. Formed in 1994, ACT grew from a small agricultural cloning research facility located in Worcester, Massachusetts, into a multi-locational corporation involved in using both human embryonic stem cells (hESC) and human adult stem cells as well as animal cells for therapeutic innovations.
Subject: Organizations, Reproduction
45 CFR 46: Protection of Human Subjects under United States Law (1974)
In the United States, the Code of Federal Regulations Title 45: Public Welfare, part 46 (45 CFR 46) provides protection for human subjects in research carried out or supported by most federal departments and agencies. 45 CFR 46 created a common federal policy for the protection of such human subjects that was accepted by the Office of Science and Technology Policy and issued by each of the departments and agencies listed in the document.
Andrew Francis Dixon (1868-1936)
Andrew Francis Dixon studied human anatomy and egg cells at the turn of the twentieth century in Ireland and Great Britain. Dixon studied the sensory and motor nervous system of the face, the cancellous bone tissue of the femur, supernumerary kidneys, and the urogenital system. In 1927 Dixon described a mature human ovarian follicle. This follicle, Dixon noted, contained an immature human egg cell (oocyte) with a visible first polar body and the beginnings of the second polar body.
US Food and Drug Administration’s Requirements on Content and Format for Labeling for Human Prescription Drugs Rule (1979)
“Female Ejaculation: A Case Study” (1981), by Frank Addiego, Edwin G. Belzer Jr., Jill Comolli, William Moger, John D. Perry, and Beverly Whipple
In 1981, Frank Addiego and colleagues published “Female Ejaculation: A Case Study” in The Journal of Sex Research. In the article, the authors find that female ejaculation, or the expulsion of fluid from a female’s urethra during or before orgasm, is a legitimate phenomenon that can occur when one stimulates an area in the vaginal wall that the team names the Gräfenberg-spot. According to the authors, at the time of publication, many individuals believed that if a female expelled fluid during orgasm, the fluid was urine and, thus, improper bladder control caused the expulsions.
Subject: Publications, Processes, Reproduction