The efficacy and safety of a new drug that treats a serious and life threatening illness in premature infants will be studied versus sham/placebo in Latin America. The sponsor plans to apply for FDA approval, in addition to local and European registration. There are approved therapies (surfactants) for this illness (Respiratory Distress Syndrome, or RDS) in those countries where this trial is proposed to take place, and surfactants are even used in some of their hospitals. However, surfactants are completely unavailable to infants at many other hospitals, secondary to rationing or economic limitations.
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.”
AHRP Letter to Editor re: ARDS published NEJM Fri, 11 Jul 2003 A truncated version of a Letter to the editor submitted by John H. Noble, Jr., PhD and Vera Sharav appears in the current July 10, 2003, issue of The New England Journal of Medicine. Note: On April 3,…
A congressional hearing was held on October 16, 2019, to examine the allegations by two whistleblowers — Martina Buck, Ph.D., a UCSD and VA research scientist and her husband, Mario Chojkier, M.D., UCSD professor of medicine and a liver specialist at the VA Medical Center — that veterans at the…
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:…
“Do we have to wait for him to kill himself or someone else before anyone does anything?” thinking for sure someone would call me back in the morning and re-hospitalize Dan. Unbelievably, no one responded…" Mary Weiss.
