1990: FDA issued a waiver from informed consent for military use of experimental drugs The FDA waiver from informed consent was to permit the DOD to use unapproved, experimental drugs and vaccines on enlisted soldiers—in violation of the foremost “absolutely essential” mandatory ethical principle defined by the Nuremberg Code. 1990:…
1993 Kathryn Hamilton died 44 days after being enrolled in Protocol 681 at the Hutchinson Cancer Center in Seattle Siix days later, Hamilton’s doctors submitted the journal article documenting what they had known for more than a year: The primary rescue drug didn’t work. Read “Unnformed Consent,” a monumental five-part investigative…
The Declaration of Helsinki defines ethical research: “In any medical study, every patient – including those of a control group, if any – should be assured of the best proven diagnostic and therapeutic method.” (1964; 1996) That standard for ethical research was reaffirmed by the World Medical Association in 2000:…
1998: Doing Harm: Research on the Mentally Ill, a prize winning research expose by The Boston Globe In November, 1998, the first of a four-part series by Robert Whitaker and Dolores Kong shed light on the abusive research parameters of non-therapeutic experiments conducted on mentally incapacitated individuals. They focused on several…
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…
According to the U.S. Environmental Protection Agency’s own scientific assessment reports (2004, 2009), Ultrafine particles (UFP) are considered more dangerous than PM2.5. EPA has determined that UFP can cause sudden death. “there is strong epidemiological evidence linking short-term (hours, days) exposure to PM2.5 with cardiovascular and respiratory mortality and morbidity.” Yet,…
Several major government-sponsored experiments conducted at major academic institutions highlight increasingly inappropriate clinical trial designs that disregard the individual survival needs of critically ill patients who cannot give or refuse consent to research. Their incapacity is exploited in experiments that increase the risk of death. 1996 – 1999: The National…
2000: Office of Protection from Research Risks (OPRR) was shifted from NIH jurisdiction to the Department of Health and Human Services (DHHS), and was renamed Office of Human Research Protection (OHRP). OHRP posts letters of determination following investigations into ethical violations. See Government Investigations adapted from OPRR Compliance Oversight Investigations…
National Bioethics Advisory Committee Report: Ethical & Policy Issues in Research Involving Human Participants. The shift from “human subject” as defined by the Nuremberg Code to “participant” obscures the role & function of human subjects in medical experiments.
In 2003, the Veterans Affairs ordered a 90-day national “stand down” for all human subject research activities “in response to the death of subjects”; as well as use of “unqualified researchers.” In January 2004, the Director of Defense Research and Engineering (DDR&E) initiated a review of all Defense Department human subjects…
2004: Traci Johnson, a 19-year-old student volunteer commits suicide in Eli Lilly’s laboratory Traci Johnson, a healthy 19-year-old Bible student who was a volunteer in Eli Lilly’s antidepressant trial of Cymbalta committed suicide at Eli Lilly’s laboratory. Ms. Johnson was found hanging from a shower rod in the laboratories of…
Alliance for Human Research Protection Fri, 18 Jul 2003 Dear Dr. Campbell and others concerned about ethical research: This is in response to your July 11 comments objecting to AHRP’s criticism of the ethics of two controversial ARDS experiments sponsored by the National Heart Lung and Blood Institute conducted at…
