1999: Experiments on the most vulnerable
The research community has consistently demonstrated its disregard for individual patient-subjects’ safety.
1999: One hundred babies are test subjects of the drug, Propulsid
One hundred infants were enrolled by Dr. Susan Orenstein at Children’s Hospital (Pittsburgh) in a clinical trial testing Propulsid for infant acid reflux—i.e., colic which infants outgrow by age two. The Hospital’s consent document misrepresented the risks; it failed to disclose 80 fatalities, including 19 children. One of the dead children was nine month-old Gage Stevens who died “most probably due to cardiac arrhythmia” according to the coroner’s report. The drug was later withdrawn from the market. (Read more: Sharon Begley. Trials – and Errors)
1999: Jesse Gelsinger, aged 18 dies in gene transfer experiment
Jesse Gelsinger died after being injected with 37 trillion particles of adenovirus in gene therapy experiment at University of Pennsylvania. This case underscored the risk for subjects when physician-researchers and the University have financial conflicts of interest. The researchers, who had financial stake in the experiment, failed to consider seriously the foreseeable harm inasmuch as the animal data indicated possible adenovirus-induced liver failure.
“On at least two occasions, the Penn investigators indicated that they had not followed adverse reporting procedures, a lapse for which they publicly apologized. In one instance, the researchers failed to notify the U.S. Food and Drug Administration about serious, although transient, side effects seen in several patients treated before Gelsinger; in the other, the study protocol was changed, altering the route of the gene’s administration, which was not reported to the RAC.”
“Gene therapy has never cured anyone, but until Gelsinger’s death, its safety, or at least a perception of safety, was presumed. “ The public trust has been violated,” noted one physician in the audience. “ There has been a clear failure in the system.” (Susan Jenks. Gene Therapy Death — “Everyone Has to Share in the Guilt” Journal of the National Cancer Institute,
1999: Twenty-nine clinical trials at the National Institute of Mental Health were halted
Dr. Steven Hyman, Director of NIMH suspended 29 clinical trials that failed to meet either ethical or scientific standards. He indicated that the Boston Globe series had prompted him to order an analysis of NIMH’s clinical trials. (Science Magazine.)
1999: Veterans Administration shut down all research at West Los Angeles Medical Center after allegations of medical research performed on patients who did not consent.
1999: FDA convened a placebo seminar where the researchers presumed they had a right to determine: “What degree of suffering is acceptable for patients?”
Dr. Kenneth Rothman and Karin Michels invoked universal ethical standards challenging FDA officials:
“No investigator or regulatory official has the right to decide how much sacrifice in terms of risks or discomfort a patient should endure in the name of science.” (BMJ 2000)