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. Due to thalidomide's effects on fetuses, both nationally and abroad, the US Congress passed the 1962 Kefauver-Harris Amendments to the 1938 Food, Drug, and Cosmetic Act. These amendments imposed guidelines for the process of drug approval in the US and required that a drug be safe as well as effective before it could be approved and marketed. Thalidomide also influenced the FDA's creation of pregnancy categories; a ranking of drugs based on their effects on reproduction and pregnancy. Thalidomide motivated the laws on regulating and monitoring drugs developed in the US and by the FDA in the twentieth and twenty-first centuries.
In 1999, the Inter-agency Working Group on Reproductive Health in Crises, hereafter the IAWG, wrote the Minimum Initial Services Package, hereafter MISP, which is the second chapter in Reproductive Health in Refugee Situations: An Inter-agency Field Manual. The IAWG wrote MISP for governments and agencies, who respond to humanitarian crises, as a guide for the provision of reproductive health services at the beginning of a humanitarian crises. The goal of MISP was to outline the services that people in humanitarian crises are to receive to minimize injury and death from complications related to reproductive health, prevent and manage the consequences of sexual violence, and reduce the transmission of sexually transmitted infections, or STIs. MISP recognizes that reproductive health is a human right and applies to people in humanitarian crises, providing specific details for governments and agencies to follow and mitigate the adverse effects of reproductive health issues in vulnerable populations.
To address the international Human Immunodeficiency Virus epidemic, the World Health Organization, or WHO, developed three drug treatment regimens between 2010 and 2012 specifically for HIV-positive pregnant women and their infants. WHO developed the regimens, calling them Option A, Option B, and Option B+, to reduce or prevent mother-to-child, abbreviated MTC, transmission of HIV. Each option comprises of different types and schedules of antiretroviral medications. As of 2018, WHO reported that in Africa alone about 1,200,000 pregnant women were living with untreated HIV. Those women have up to a forty-five percent chance of transmitting HIV to their offspring if they do not receive treatment. Option B+ has decreased the overall maternal mortality rates in many low- and middle-income countries, and numerous studies have supported the notion that it is the most effective of the three regimens for preventing MTC transmission of HIV.
In 2018, researchers Elie Nkwabong, Romuald Meboulou Nguel, Nelly Kamgaing, and Anne Sylvie Keddi Jippe published, “Knowledge, Attitudes, and Practices of Health Personnel of Maternities in the Prevention of Mother-To-Child Transmission of HIV in a sub-Saharan African Region with High Transmission Rate: Some Solutions Proposed,” in BMC Pregnancy and Childbirth. In their article, hereafter “Knowledge, Attitudes, and Practices,” the authors state the aim of their study was to establish the knowledge, attitudes, and practices held by health professionals who worked in numerous maternal departments throughout Cameroon. They claimed that effective knowledge, attitudes, and practices would likely reduce mother-to-child, hereafter MTC, transmission of HIV. After finding a deficit in the knowledge, attitudes, and practices among a subset of health professionals, the authors recommended increased training, funding, and supervision to reduce MTC transmission of HIV throughout Cameroon.
In 2018, He Jiankui uploaded a series of videos to a YouTube channel titled “The He Lab” that detailed one of the first instances of a successful human birth after genome editing had been performed on an embryo using CRISPR-cas9. CRISPR-cas9 is a genome editing tool derived from bacteria that can be used to cut out and replace specific sequences of DNA. He genetically modified embryos at his lab in Shenzhen, China, to make them immune to contracting HIV through indirect perinatal transmission from their father, who was infected with the virus. HIV is a virus that attacks the immune cells of its host and weakens their ability to fight off diseases. At the time of He’s experiment, various treatments already existed at that could prevent the fetuses from contracting HIV without the need for gene surgery. Nonetheless, He’s experiment led to one of the first successful births of fetuses resulting from genetically modified embryos. He kept his experiment secret until he uploaded the videos announcing the birth of the fetuses, born as two twin girls. The experiment discussed in the videos was successful, but many scientists criticized the experiment due to ethical concerns with the way He conducted it.
To address the international Human Immunodeficiency Virus epidemic, the World Health Organization, or WHO, developed three drug treatment regimens between 2010 and 2012 specifically for HIV-positive pregnant women and their infants. WHO developed the regimens, calling them Option A, Option B, and Option B+, to reduce or prevent mother-to-child, abbreviated MTC, transmission of HIV. Each option comprises of different types and schedules of antiretroviral medications. As of 2018, WHO reported that in Africa alone about 1,200,000 pregnant women were living with untreated HIV. Those women have up to a forty-five percent chance of transmitting HIV to their offspring if they do not receive treatment. Option B+ has decreased the overall maternal mortality rates in many low- and middle-income countries, and numerous studies have supported the notion that it is the most effective of the three regimens for preventing MTC transmission of HIV.
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. Frazer and virologist Jian Zhou conducted research in the 1990s to assess why women with HPV had higher rates of precancerous and cancerous cervical cells. Frazer’s research led the pharmaceutical company Merck to produce the Gardasil vaccination series, and GlaxoSmithKline to produce the Cervarix vaccination. Frazer’s research contributed to the development of HPV vaccinations that have been successful in reducing up to seventy percent of cervical cancer cases in women.
On 1 October 1995, Steven Epstein published “The Construction of Lay Expertise: AIDS Activism and the Forging of Credibility in the Reform of Clinical Trials,” hereafter “Lay Expertise,” in the journal Science, Technology, & Human Values. In the article, Epstein shows how particular activists in the 1980s helped reform government-run clinical trials for people with acquired immunodeficiency syndrome, or AIDS. Those activists did that work at a time when AIDS was widespread among communities of gay men, and there were no treatments available to combat the disease. Epstein documents how AIDS activists gained credibility in the eyes of the scientific establishment through specific tactics of engagement. “Lay Expertise” laid a foundation for understanding how AIDS movement activism transformed the field of biomedicine, and paved the way for additional research on illness-related social movements, such as those related to infertility and embryonic stem cell research.