"The Embryo Project Encyclopedia is a digital and Open Access publication of the Embryo Project. Begun in 2007, the Encyclopedia and the Embryo Project are funded by the US National Science Foundation in Washington D.C., and by Arizona State University in Tempe, Arizona. The Embryo Project is a collection of researchers who study the historical and social contexts of developmental and reproductive biology." --The Embryo Project Encyclopedia
Topics include: the Cutter Incident, Simian virus 40, Swine flu vaccine and Guillain-Barre Syndrome, Hepatitis B vaccine and Multiple Sclerosis, Rotavirus vaccine and intussusception, GBS and Meningococcal vaccine, Hib vaccine recall, H1N1 Influenza vaccine and narcolepsy, Porcine circovirus in rotavirus vaccines, and the HPV vaccine recall.
1962 August 1. Dr. Frances Oldham Kelsey was a pharmacologist who worked for the Food & Drug Administration; in her work she was instrumental in preventing the distribution in the United States of the sedative Thalidomide, which was responsible for severe birth defects in babies born in Europe. - United Press International telephoto. cph 3c31535 //hdl.loc.gov/loc.pnp/cph.3c31535
"That Dr. Frances Oldham Kelsey saved countless lives and prevented numerous physical deformities of infants and children is a remarkable accomplishment in any career. More remarkable still is the fact that she accomplished this feat not through the discovery of a cure, the development of an innovative surgical procedure, or the invention of a life-saving device. Rather, it was Dr. Kelsey's professional behavior—her unwillingness to compromise the priorities of patient health and safety—that single-handedly averted an appalling tragedy nearly thrust upon an unsuspecting American public." -- AMA Journal of Ethics, Karen Geraghty, Virtual Mentor. 2001;3(7): doi: 10.1001/virtualmentor.2001.3.7.prol1-0107.
"Landmark legislation was signed into law by President John F. Kennedy that established the scientific safeguards used today by the Food and Drug Administration (FDA) to ensure that consumers will not be the victims of unsafe and ineffective medications." -- FDA
Rehman, Waqas et al. “The rise, fall and subsequent triumph of thalidomide: lessons learned in drug development.” Therapeutic advances in hematology vol. 2,5 (2011): 291-308. doi:10.1177/2040620711413165
Thalomid (Thalidomide) Capsules, Company: Celgene Corp., Application No.: 020785, Approval Date: 07/16/1998. This drug comes with a warning that it can cause severe, life-threatening human birth defects
U.S. Department of Health, Education, and Welfare. Public Health Service. Final Report of the Tuskegee Syphilis Study Ad Hoc Advisory Panel. [Washington, D.C.: Government Printing Office]. 1972. HE 20.2:T 87. Indiana University Bloomington, Digital Archive
In early 1961 a young Yale University psychologist conducted a series of experiments that revealed a shocking truth to the world: ordinary people would do extraordinary acts of harm if ordered to do them by someone in authority. And for the following 40 years the standard interpretation of Stanley Milgram's research was that it clearly demonstrated unquestioning "obedience to authority". More-recently, however, researchers such as Haslam and Reicher have questioned this idea. In this film, using a range of data from the original study, they take us "beyond Milgram" to explore a very different interpretation of his research - one that focuses as much on disobedience as obedience.
Streaming media title. 2013, distributed by Infobase, 2016. " This program discusses the importance of ethics in research and presents an overview of research studies that have raised ethical issues, including Milgram's obedience study, the Tuskegee studies, and Zimbardo's prison study. The program looks at such elements of ethical research as informed consent, right to privacy, right to withdraw, and debriefing."--library catalog record
Summary: "Describes an experiment in prison psychology. In the summer of 1971, Philip Zimbardo, Craig Haney, and Curtis Banks carried out an experiment to test a simple question: What happens when you put good people in an evil place? Does humanity win over evil, or does evil triumph? College student volunteers were pretested and randomly assigned to play the role of prisoner or guard in a simulated prison at Stanford University." -- library catalog record.
Wax, P. M. (1995). Elixirs, diluents, and the passage of the 1938 Federal Food, Drug and Cosmetic Act. Annals of Internal Medicine, 122(6), 456–461. https://doi.org/10.7326/0003-4819-122-6-199503150-00009
"GSK agreed to plead guilty to a three-count criminal information, including two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce and one count of failing to report safety data about the drug Avandia to the Food and Drug Administration (FDA)." -- United States Department of Justice, Office of Public Affairs, 7/2/2012
Le Noury J, Nardo J M, Healy D, Jureidini J, Raven M, Tufanaru C et al. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence BMJ 2015; 351 :h4320 doi:10.1136/bmj.h4320
"Study 329 was a clinical trial which was conducted in North America from 1994 to 1998 to study the efficacy of paroxetine, an SSRI anti-depressant, in treating 12- to 18-year-olds diagnosed with major depressive disorder ... study 329 became controversial when it was discovered that the article had been ghostwritten by a PR firm hired by SmithKline Beecham; had made inappropriate claims about the drug's efficacy; and had downplayed safety concerns." -- Wikipedia
Abstract only. Klitzman, R. L., & Kelmenson, A. M. (2020). Experiment on identical siblings separated at birth: ethical implications for researchers, universities, and archives today. Journal of Medical Ethics. https://doi.org/10.1136/medethics-2019-105983
offman, L., & Oppenheim, L. (2019). Three Identical Strangers and The Twinning Reaction-Clarifying History and Lessons for Today From Peter Neubauer’s Twins Study. JAMA, 322(1), 10–12. https://doi.org/10.1001/jama.2019.8152
Anthony J. Pelosi, Journal of Health Psychology, Volume: 24 issue: 4, page(s): 421-439 Article first published online: February 22, 2019; Issue published: March 1, 2019 This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/)
Craig, Russell, et al. “Research Misconduct Complaints and Institutional Logics: The Case of Hans Eysenck and the British Psychological Society.” Journal of Health Psychology, Oct. 2020, doi:10.1177/1359105320963542.
"The accusations relate to investigations for the study, based on 12 youngsters with bowel disorders, carried out between 1996 and 1998....
The GMC heard that vulnerable children were subjected to "inappropriate and invasive" tests by the doctors, who breached of "some of the most fundamental rules in medicine".Wakefield did not have paediatric qualifications and had not worked as a clinical doctor for several years when he ordered the tests, the panel was told. One of the key claims was that Wakefield accepted more than £50,000 from the Legal Aid Board for research to support a group of parents' attempts to fight for compensation....Wakefield was accused of paying children £5 for blood samples at his son's birthday party, then joking about it afterwards." -- theguardian.com, 1/28/2010
Suelzer EM, Deal J, Hanus KL, Ruggeri B, Sieracki R, Witkowski E. Assessment of Citations of the Retracted Article by Wakefield et al With Fraudulent Claims of an Association Between Vaccination and Autism. JAMA Netw Open. 2019;2(11):e1915552. doi:10.1001/jamanetworkopen.2019.15552
Information about the following cases: Wafefield MMR-Autism, PAXIL, Univ. of Wisconsin Goodwin case, the Hwang stem cell case, the Translational omics case, The Riken-Stap case. National Academies of Sciences, Engineering, and Medicine. 2017. Fostering Integrity in Research. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/21896.
"A link between autism and the Measles-Mumps-Rubella shot has been largely refuted by the medical establishment. But some doctors, along with many parents of autistic children, remain convinced of a connection. This program sifts through both sides of the issue, fully explaining both the link theory and the epidemiological research that vindicates the MMR. Interviews with Dr. Andrew Wakefield-the gastroenterologist who first asserted that the vaccine can cause intestinal infections and lead to brain damage-accompany moving testimony from families affected by autism, as well as extensive commentary from skeptical physicians." -- video description
Khan H, Gasparyan AY, Gupta L. Lessons Learned from Publicizing and Retracting an Erroneous Hypothesis on the Mumps, Measles, Rubella (MMR) Vaccination with Unethical Implications. J Korean Med Sci. 2021;36(19):e126. https://doi.org/10.3346/jkms.2021.36.e126