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“General Considerations for the Clinical Evaluation of Drugs” (1977), by the United States Food and Drug Administration
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.
Format: Articles
Subject: Publications
Plan B: Emergency Contraceptive Pill
Plan B is a progestin-only emergency contraceptive pill (ECP) that can be taken within seventy-two hours of unprotected sex in order to prevent an unwanted pregnancy. Plan B was created in response to the United States Food and Drug Administration's (US FDA) 1997 request for new drug applications (NDAs) for a dedicated ECP product, and was approved for sales in the US in 1999. Duramed, a subsidiary of Barr Pharmaceuticals, manufactures Plan B for The Women's Capital Corporation (WCC), which owns the patent for Plan B.
Format: Articles
Subject: Technologies, Reproduction
Daubert v. Merrell Dow Pharmaceuticals, Inc. (1993)
In its 1993 decision Daubert v. Merrell Dow Pharmaceuticals, Inc., the US Supreme Court established the Daubert Standard for evaluating the admissibility of scientific knowledge as evidence in US federal courts. When it began in trial court, the case addressed whether or not Bendectin, an anti-nausea medication taken during pregnancy, caused birth defects. However, after the trial court dismissed the case for lack of admissible evidence, Daubert v. Merrell Dow Pharmaceuticals, Inc.
Format: Articles
Subject: Legal
Zidovudine or azidothymidine
In 1964, Jerome Horwitz synthesized the drug zidovudine, commonly abbreviated ZDV, otherwise known as azidothymidine, or AZT, at Wayne State University School of Medicine in Detroit, Michigan. Horwitz and his colleagues originally developed zidovudine to treat cancers caused by retroviruses. In 1983, Nobel Prize in Physiology or Medicine recipients Françoise Barré-Sinoussi and Luc Montagnier discovered a new retrovirus, the human immunodeficiency virus, or HIV, at the Pasteur Institute in Paris, France.
Format: Articles
Subject: Processes
Gardasil HPV Vaccination Series
In 2006, United States pharmaceutical company Merck released the Gardasil vaccination series, which protected recipients against four strains of Human Papillomaviruses, or HPV. HPV is a sexually transmitted infection which may be asymptomatic or cause symptoms such as genital warts, and is linked to cervical, vaginal, vulvar, anal, penile, head, neck, and face cancers.
Format: Articles
Subject: Technologies
Sex Determination in Humans
In humans, sex determination is the process that determines the biological sex of an offspring and, as a result, the sexual characteristics that they will develop. Humans typically develop as either male or female, depending on the combination of sex chromosomes that they inherit from their parents. The human sex chromosomes, called X and Y, are structures in human cells made up of tightly bound deoxyribonucleic acid, or DNA, and proteins.
In humans, sex determination is the process that determines the biological sex of an offspring and, as a result, the sexual characteristics that they will develop. Humans typically develop as either male or female, depending on the combination of sex chromosomes that they inherit from their parents. The human sex chromosomes, called X and Y, are structures in human cells made up of tightly bound deoxyribonucleic acid, or DNA, and proteins.
Format: Articles
The Dalkon Shield
The Dalkon Shield was an intrauterine contraceptive device (IUD) that women used in the early 1970s and 1980s. Produced by the A.H. Robins Company in the US, the Dalkon Shield was a contraceptive device placed directly into a woman’s uterus that was supposed to prevent the development of a fetus in the uterus. In the 1980s, researchers uncovered an array of severe birth defects and injuries caused by the Dalkon shield, including pelvic infection, infertility, and death of the user. Eventually the A.H.
Format: Articles
Subject: Technologies
Barbara Seaman (1935–2008)
Barbara Seaman was a writer, investigator, and advocate for female healthcare rights during the twentieth century in the United States. Seaman’s work addressed the gendered prejudice she observed in the US healthcare system and argued that women of the 1960s lacked the proper tools to make informed decisions about pregnancy care, breastfeeding, childbirth, and contraception. Seaman wrote the book The Doctor’s Case Against the Pill in 1969 to expose the dangers in prescribing and consuming high doses of estrogen in the form of birth control.
Format: Articles
Subject: People
Ian Hector Frazer (1953– )
Ian Hector Frazer studied the human immune system and vaccines in Brisbane, Australia, and helped invent and patent the scientific process and technology behind what later became the human papillomavirus, or HPV, vaccinations. According to the Centers for Disease Control and Prevention of the US, or CDC, HPV is the most common sexually transmitted infection, and can lead to genital warts, as well as cervical, head, mouth, and neck cancers.
Format: Articles
Subject: People
The Development of Mifepristone for Use in Medication Abortions
In the 1980s, researchers at the pharmaceutical company Roussel-Uclaf in Paris, France, helped develop a biological compound called mifepristone. When a woman takes it, mifepristone interferes with the function of hormones involved in pregnancy and it can therefore be used to terminate pregnancies. In 2000, the US Food and Drug Administration approved mifepristone, also called RU 486, as part of a treatment to induce abortions using drugs instead of surgery, a method called medication abortion.
Format: Articles
Subject: Reproduction
Cervarix HPV Vaccination Series
In 2011, United Kingdom pharmaceutical company GlaxoSmithKline released Cervarix, a vaccination series protecting girls and women from two strains of Human Papillomavirus, or HPV. HPV, a sexually transmitted infection, can present in men and women without symptoms, or may cause symptoms such as genital warts. There is a link between HPV and cervical, vaginal, anal, head, neck, and face cancers, and Cervarix can reduce genital cancers in girls and women, particularly cervical cancer.
Format: Articles
Subject: Technologies
“Association of Birth Outcomes with Fetal Exposure to Parabens, Triclosan and Triclocarban in an Immigrant Population in Brooklyn, New York” (2017), by Laura Geer, Benny Pycke, Joshua Waxenbaum, David Sherer, Ovadia Abulafia, and Rolf U. Halden
In 2017, Laura Geer and colleagues published the results of a study investigating the effects of parabens and antimicrobial compounds on birth outcomes in the article “Association of Birth Outcomes with Fetal Exposure to Parabens, Triclosan and Triclocarban in an Immigrant Population in Brooklyn, New York” in the Journal of Hazardous Materials. Parabens are a class of preservatives found in cosmetic and pharmaceutical products and antimicrobial compounds are compounds that kill microorganisms such as bacteria.
Format: Articles
Subject: Publications
The Measles, Mumps, and Rubella (MMR) Vaccine
The measles, mumps, and rubella (MMR) vaccine was created by Maurice Hilleman in 1971 at the Merck Institute of Therapeutic Research, a pharmaceutical company in West Point, Pennsylvania. It combined three separate vaccines for measles, mumps, and rubella, common and sometimes fatal diseases. Measles causes a red skin rash and severe fevers that can be fatal. Mumps causes fever and swelling of the salivary glands in the mouth and jaw, while rubella causes milder fevers and skin rashes.
Format: Articles
Subject: Technologies
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.
Format: Articles
Subject: People, Reproduction, Disorders
Amniocentesis Prior to 1980
The extraembryonic membranes that surround and originate from the embryos of vertebrates such as birds, reptiles, and mammals are crucial to their development. They are integral to increasing the surface area of the uterus, forming the chorion (which in turn produces the placenta) and the amnion, respectively. The amnion will ultimately surround the embryo in a fluid-filled amniotic cavity. This amniotic fluid, which cushions and protects the fetus and helps prevent the onset of labor, is sampled in amniocentesis to screen for genetic diseases.
Format: Articles
Subject: Processes, Reproduction
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.
Format: Articles
Subject: Legal, Reproduction
Human Papillomavirus (HPV) Strains 16 and 18
The Human Papillomavirus (HPV) strains 16 and 18 are the two most common HPV strains that lead to cases of genital cancer. HPV is the most commonly sexually transmitted disease, resulting in more than fourteen million cases per year in the United States alone. When left untreated, HPV leads to high risks of cervical, vaginal, vulvar, anal, and penile cancers. In 1983 and 1984 in Germany, physician Harald zur Hausen found that two HPV strains, HPV-16 and HPV-18, caused cervical cancer in women. In the early twenty first century, pharmaceutical companies Merck & Co.
Format: Articles
Subject: Theories
Human Papillomavirus (HPV) Strains 16 and 18
The Human Papillomavirus (HPV) strains 16 and 18 are the two most common HPV strains that lead to cases of genital cancer. HPV is the most commonly sexually transmitted disease, resulting in more than fourteen million cases per year in the United States alone. When left untreated, HPV leads to high risks of cervical, vaginal, vulvar, anal, and penile cancers. In 1983 and 1984 in Germany, physician Harald zur Hausen found that two HPV strains, HPV-16 and HPV-18, caused cervical cancer in women. In the early twenty first century, pharmaceutical companies Merck & Co.
Format: Articles
Subject: Theories
“Improving Women’s Health”: Section 3509 of the Affordable Care Act of 2010
In 2010, US Congress enacted section 3509 of the Patient Protection and Affordable Care Act or ACA, to target issues relating to women’s health. The ACA, signed into law by US President Barack Obama, aimed to increase people’s access to high-quality healthcare in the United States.
Format: Articles
Subject: Legal
Wolbachia
Bacteria of the genus Wolbachia are
bacteria that live within the cells of their hosts. They infect a
wide range of arthropods (insects, arachnids, and crustaceans) and
some nematodes (parasitic roundworms). Scientists estimate that
Wolbachia exist in between seventeen percent and seventy-six percent of
arthropods and nematodes. The frequency of the bacteria makes them
one of the most widespread parasites. In general, they are divided
into five groups, from A to E, depending of the species of their
Format: Articles
Subject: Organisms
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
Subject: Ethics
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.
Format: Articles
Subject: People
Apoptosis in Embryonic Development
Apoptosis, or programmed cell death, is a mechanism in embryonic development that occurs naturally in organisms. Apoptosis is a different process from cell necrosis, which is uncontrolled cell death usually after infection or specific trauma. As cells rapidly proliferate during development, some of them undergo apoptosis, which is necessary for many stages in development, including neural development, reduction in egg cells (oocytes) at birth, as well as the shaping of fingers and vestigial organs in humans and other animals. Sydney Brenner, H. Robert Horvitz, and John E.
Format: Articles
Subject: Theories
“Consensus on the Current Management of Endometriosis” (2013), by Neil P. Johnson and Lone Hummelshoj
“Consensus on the Current Management of Endometriosis”, henceforth “Consensus”, was written by the World Endometriosis Society, or WES, president Neil P. Johnson and chief executive Lone Hummelshoj and published in 2013 in Human Reproduction. “Consensus” makes recommendations about managing endometriosis for women and healthcare professionals. Endometriosis is a condition where endometrium, the tissue that usually lines the uterus, grows outside of the uterus and is characterized by painful periods, heavy menstrual bleeding, and infertility.
Format: Articles
Subject: Publications
The Birth Control Pill
The birth control pill, more commonly known as "the pill" is a form of contraception taken daily in pill form and consisting of synthetic hormones formulated to prevent ovulation, fertilization, and implantation of a fertilized egg. The US Food and Drug Administration (FDA) approved the first birth control pill, Enovid, in June 1960. It was the first contraceptive pill marketed worldwide. Since then a number of different pills have been developed, which differ in hormone type and dosage, and whether they contain one hormone (the minipill) or two (the combination pill).
Format: Articles
Subject: Technologies, Reproduction