OHRP Response to AHRP Complaint & AHRP Reply
Did OHRP conduct an investigation of the PolyHeme blood experiment and did OHRP issue a report of its findings?
Medical Ethics
Did OHRP conduct an investigation of the PolyHeme blood experiment and did OHRP issue a report of its findings?
This controversial, commercial experiment is being conducted without informed consent in trauma patients who require blood to survive. PolyHeme is being tested in patients in ambulances and at hospital emergency facilities where these trauma patients are denied life-saving real blood.
The Wall Street Journal reports: “The FDA is allowing Northfield [Laboratories, Inc] to test its blood substitute without the consent of the trauma patients, who often are unconscious.”
"Mr. Stanley says he has donated nearly $300 million — including about $35 million in 2005 — to Dr. Torrey’s efforts, the bulk of it for research at universities and start-up drug companies."
A critical editorial by Dr. Robert M Kacmarek, Head of Respiratory Care Services at Massachusetts General Hospital and professor at Harvard University—the coordinating center for the ARDS Network, calls into question the validity of the ARDS Network recommendation of treating all patients with ALI-ARDS with a fixed, low air ventilation setting (6 mL/ kg).
Fri, 20 May 2005 ARMA was a government-sponsored, $41 million experiment involving 861 critically ill patients with severe lung injury–i.e., acute respiratory distress syndrome (ARDS). It has been at the center of continuing debate prompted by revelations that researchers at 14 of the nation’s major medical research institutions comprising the…
On June 10, 2003, a panel of experts convened by the federal Office of Human Research Protections (OHRP) heard presentations by critics who had filed complaints about $37 million government sponsored, multi-site experiment conducted by major academic institutions participating in the ARDSNetwork, and by the ARDSNet investigators who defend the trial.
The experiment tested two extreme, rarely used methods of mechanical lung ventilation in 861 critically ill, vulnerable patients suffering from acute lung disease (ALD) or acute respiratory distress syndrome (ARDS).
Acute Respiratory Distress Syndrome – ARDSNet experiment criticized – OHRP Fri, 28 Feb 2003 An Acute Respiratory Distress Syndrome (ARDS) study conducted between 1996 and 1999, on critically ill patients at 20 medical facilities (14 major research centers belonging to the ARDS Network), was published in The New England Journal…
"The voluntary consent of the human subject is absolutely essential," reads the Nuremberg Code of 1947, which was drafted in direct response to the sheer barbarity of Nazi-era medical experiments on Jews and other captive groups.
Is it ethical to expose healthy children to risks of drug- induced pathology on a speculative, unproven theory?
The New York Times May 19, 1998 Psychiatric Researchers Under Fire By PHILIP J. HILTS ANDREW BROWNSTEIN, a severe manic-depressive, was desperate. None of his medicines could keep the anxiety and depression of his illness at bay. So in the fall of 1994, he agreed to become a research subject…