2003: University of Iowa seeks dismissal of “Monster Experiment” lawsuit
The lawsuit was brought by surviving victims of the University of Iowa’s induced-stuttering experiment conducted in 1939. Iowa students had dubbed it, the “Monster Experiment.” Read more here
2003: Five patient deaths prompt criminal investigation of Veterans at VA Medical Center in Albany
Veterans at VA Medical Center in Albany were subjected to criminal cancer drug trial sponsored by the National Cancer Institute. A criminal investigation after the death of five patients: “Dr. James Holland, former chief of oncology at the Albany center, and Paul Kornak, former research assistant in the hematology and oncology department, could face involuntary manslaughter charges… the pair are accused of fabricated data, improperly enrolling patients, failing to report adverse events, altering medica charts, and other serious acts of research misconduct in drug company studies involving almost 100 patients. The actions probably caused one death and may have caused at least four more. ” Read more
Update: Paul Kornak was found guilty of fraud, making false statements and criminally negligent homicide in the death of an Air Force veteran, James DiGeorgio. “Research violations were a way of life at Stratton for 10 years,” said Jeffrey Fudin, a pharmacist at the hospital.” Read about criminal investigation
Kornak was sentenced to 6 years in federal prison and fined $688,000, Dr. James Holland pleaded guilty and was fined $20,000. Read Troy Record
2004:10:15 “Women Radium Dial Painters As Experimental Subjects (1920-1990), Or: What Counts as Human Experimentation?” (in Twentieth Century Ethics of Human Subjects Research: Historical Perspectives on Values, Practices and Regulations, Edited by Volker Roelcke and Giovanni Maio, 2004)is an illuminating essay by Maria Rentetzi, a professor of history and sociology of science and technology at the University of Athens, the author of the internationally acclaimed book, Trafficking Materials and Gender Experimental Practices, published by Columbia University Press (2007). Professor Rentetzi examines the hitherto suppressed facts about the experimental exploitation of the already victimized “radium dial painters” by the medical/ technological/ military/ and industrial stakeholders in radium. (Read AHRP Unwitting Experimental Subjects)
This case is especially relevant to the current debate (2013– 2015) about what constitutes as research with human subjects –i.e. experimentation for the pursuit of scientific knowledge – as opposed to standard clinical practice which requires physicians to focus on the best interest of the patient.
Whenever research is involved, the patient’s best interests may suffer; at the very least, the patient’s interest takes a back seat. Therefore, researchers are required to follow a formal set of ethical guidelines before research may begin. (Medical Research Stakeholders Seek to Overturn Informed Consent Protections, 2013)
Rentetzi describes how the women were used as “objects of investment” by the dial painting industry; then they became part of ongoing medical research that were needed for the war industry, the atomic bomb project, and the drug and cosmetic industry. None of the studies were conducted for the purpose of improving their health. But the women were deceived into believing the purpose of the tests they were asked to undergo was to search for a miracle cure for their radium poison disease. Academic and government physicians and scientists gathered data to study the effects of varying doses of radium in the women’s bodies.
The infamous Tuskegee researchers from the U.S. Public Health Service used the Black human subjects in a long-term epidemiological study documenting the debilitating effects of a deadly disease. The researchers from the Radioactivity Center at the Massachusetts Institute of Technology (MIT) and the researchers from the University of Chicago’s Argonne National Laboratory (ANL), exploited the “radium girls” in long-term epidemiological studies to document the horrifying debilitating radium effects on their bodies.
In their published reports, the researchers described their studies as “observation, measurement, tests.” The researchers did not classify the tests as experiments, and did not treat the women as experimental subjects; they turned the women into experimental objects. However, an assistant to the primary investigator described the repetitive, arduous process of measuring the amount of radium in the women’s bodies as “tough not only for the subject, but it’s tough for the reseacher…you have to keep repeating the experiment all over again…”
By suppressing the fact that experiments were being performed on them, enabled the researchers to bypass ethical and legal requirements for research involving human subjects. Rentetzi makes the strong argument that:
“Although women’s medical examinations have been classified as simple, routine measurements of radiation burden on the body, and presented as a great offer to humanity, for more than fifty years those women had been repeatedly used as experimental subjects without proper consent…by passing in silence the fact that a study is an experimental procedure involving human subjects, researchers find the perfect excuse for not posing any ethical issues and not questioning the means and procedures in use.”
Even the Presidential Advisory Committee on Human Radiation Experiments excluded this case from its list of human radiation experiments. (ACHRE Report, 1995) Rentetzi points out that during the time the young women were experimental subjects, they were the subjects of medical controversies, competitive power games between MIT and Argonne. They were treated as “mediums for technological innovations” – not as humans.
“Through this case it becomes obvious that the issue of defining what counts as human experimentation shifts from an epistemological to a serious ethical and political question, concerning the making of scientific knowledge…
To define what an experiment is and classify a study as such opens up a space for discussing the appropriateness of the endeavor considering the potential harms and profits to the subjects involved. Questions about the ways the subjects are selected and their consent is obtained, or the purposes of the research and its ethical aptness become legitimate and unavoidable.
The question of how human experimentation is defined has important implications both for the historical actors, and on the conceptual level of historiography. Once a set of activities is categorized as experimentation, a completely different set of ethical issues are considered relevant and questions of consent and liability have to be taken into account. Complementarily, if the label experimentation is avoided, the associated ethical and related legal issues are avoided as well.”
Books about the “dial painters”: Claudia Clark. Radium Girls, 1997; Ross Mulner Deadly Glow: The Radium Dial Worker Tragedy, 1999)