2001 Uninformed Consent; Healthy Volunteers Die

2001: National Bioethics Advisory Committee issues Report Ethical & Policy Issues in Research Involving Human Participants.  Thereafter the ambiguous term”participant” — rather than informative term, “human subject” as defined by the Nuremberg Code — becomes the preferred  term used within the bioethics community. The shift is clearly aimed at obscuring the role and function of human subjects in medical experiments.

2001: An internal FDA Document titled: “Use of Placebo in Life Threatening Diseases: Is the Developing World the Answer?  FDA officials acknowledged that such tests would be illegal in U.S. nevertheless, they proceeded to address a request by Discovery Laboratories, a biotech company that sought FDA permission to conduct placebo trials in Latin America to test Surfaxin (its version of surfactant which is used to treat Respiratory Distress Syndrome (RDS) in premature infants). Read more AHRP  and here

2001: Ellen Roche, a healthy 24-year old volunteer at Johns Hopkins
A month after inhaling hexamethonium, an unapproved blood pressure drug in an experimental asthma provocation study, Ellen Roche, a healthy volunteer at Johns Hopkins University where she was a technician, died.  Her death was due to negligence; failure to read the literature for clues of hazards. OHRP shut down all human research at Hopkins for four days. Read more AHRP

 2001: Healthy nurse dies in Tobacco Industry-funded Alzheimer’s experiment at Case Western
Elaine Holdern-Able was a healthy retired nurse was given a glass of orange juice that had been mixed with a dietary supplement in a Case Western University Alzheimer’s experiment, financed by the tobacco industry. Her death was called a ”tragic human error.” Federal Office of Human Research Protections did not interview hospital staff, mostly accepted the hospital’s internal report, imposed no penalty, and closed the case without mentioning the death in its letter of determination.

In 2001, the Seattle Times  published “Uninformed Consent,” a monumental five-part investigative series by Duff Wilson and David Heath. Uninformed Consent provides detailed facts about the experiment, demonstrating how financial conflicts of interest undermine the safety of human subjects in clinical trials.

2001: Maryland Court of Appeals renders a landmark decision affirming “best interest of the child” The case, Higgins and Grimes v. Kennedy Krieger Institute involved exposing African American toddlers to lead paint. The Maryland Court of Appeals (Maryland’s highest court) affirmed “the best interest of the individual child” as a standard for medical research involving children. The Court unequivocally prohibited nontherapeutic experimentation on children such as in this case which involved exposing small children to lead poisoning in EPA funded experiment. The Alliance for Human Research Protection was the only entity to file an Amicus Curiae brief in support of the Court decision. Read more…Maryland Court Decision and AHRP Amicus Brief

2002: Best Pharmaceuticals for Children Act (BPCA) extends FDAMA (1997)
BPCA is anything but a “best pharmaceuticals for children act.” It provides pharmaceutical companies an additional six months patent exclusivity for testing their drugs in children—with no foreseeable benefit for the children. That financial incentive can amount to a billion dollar bonanza: not surprisingly, the number of children in commercially driven drug trials has increased.

2002: U.S. public health officials propose testing smallpox vaccine in young children
US Office of Public Health and FDA Proposed smallpox vaccine trial to test the safety of Dryvax in children 2 to 5 years of age. The proposal was announced in the Federal Register (Oct. 31). Such an experiment would be a gross ethical and legal violation. Federal regulations prohibit the inclusion of children in medical research that poses greater than minimal risk without a potential benefit for the children involved.  Read more here; Read public comments here