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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
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
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
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
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
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
“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
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
Progestin: Synthetic Progesterone
Progestin is a synthetic form of progesterone, a naturally occurring hormone, which plays an important role in the female reproductive cycle. During the 1950s two types of progestin that were later used in birth control pills were created, norethindrone and norethynodrel. In 1951 Carl Djerassi developed norethindrone at Syntex, S.A. laboratories located in Mexico City, receiving a patent on 1 May 1956. In 1953 Frank Colton developed norethynodrel at G.D. Searle and Company laboratories located in Chicago, receiving a patent on 29 November 1955.
Format: Articles
Subject: Technologies, Reproduction
The Effects of Thalidomide on Embryonic Development
Embryogenesis is an intricate process that can easily be disrupted by means of teratogenic agents. Some of these agents target the embryonic period's "window of susceptibility," three to eight weeks after a pregnant woman's last menstruation, when the highest degree of sensitivity to embryonic cell differentiation and organ formation occurs. The embryonic period or critical period is when most organ systems form, whereas the fetal period, week eight to birth, involves the growth and modeling of the organ systems.
Format: Articles
Harald zur Hausen (1936–)
Harald zur Hausen studied viruses and discovered that certain strains of the human papilloma virus (HPV), a sexually transmitted disease, can cause cervical cancer, in Europe during the twentieth and twenty-first centuries. Zur Hausen spent his research career identifying the viruses that cause diseases, particularly cancer-causing viruses (oncoviruses). He primarily focused on HPV and cervical cancer. Zur Hausen hypothesized that HPV was cancerous and discovered that two strains, HPV 16 and 18, caused cervical cancer.
Format: Articles
Subject: People
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.
Format: Articles
Subject: Organisms, Reproduction, Disorders
"Induced Pluripotent Stem Cell Lines Derived from Human Somatic Cells" (2007), by Junying Yu et al.
On 2 December 2007, Science published a report on creating human induced pluripotent stem (iPS) cells from human somatic cells: "Induced Pluripotent Stem Cell Lines Derived from Human Somatic Cells." This report came from a team of Madison, Wisconsin scientists: Junying Yu, Maxim A. Vodyanik, Kim Smuga-Otto, Jessica Antosiewicz-Bourget, Jennifer L. Frane, Shulan Tian, Jeff Nie, Gudrun A. Jonsdottir, Victor Ruotti, Ron Stewart, Igor I. Slukvin, and James A. Thomson.
Format: Articles
Subject: Publications
George McDonald Church (1954- )
George McDonald Church studied DNA from living and from extinct species in the US during the twentieth and twenty-first centuries. Church helped to develop and refine techniques with which to describe the complete sequence of all the DNA nucleotides in an organism's genome, techniques such as multiplex sequencing, polony sequencing, and nanopore sequencing. Church also contributed to the Human Genome Project, and in 2005 he helped start a company, the Personal Genome Project. Church proposed to use DNA from extinct species to clone and breed new organisms from those species.
Format: Articles
Subject: People
Teratogens
Teratogens are substances that may produce physical or functional defects in the human embryo or fetus after the pregnant woman is exposed to the substance. Alcohol and cocaine are examples of such substances. Exposure to the teratogen affects the fetus or embryo in a variety of ways, such as the duration of exposure, the amount of teratogenic substance, and the stage of development the embryo or fetus is in during the exposure.
Format: Articles
Subject: Disorders