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FDA Internal Document: Use of Placebo-Controls in Life Threatening Diseases
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.
Premature Babies, Targets of Unethical Experimentation
Newly obtained documents from the SUPPORT oxygen experiment on tiny premature babies reveal far more extensive medical ethics violations. . . .
Infomail Archive 2004
Infomail 2004 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Dec 31: FDA to review “missing” drug company documents Dec 30: Family of Woman Killed by AIDS Drug Test Sues Doctors, Manufacturer Dec 30: Doctors, Too, Ask: Is This Drug Right? Dec 29: Bill would shield…
Chief Respiratory Care Mass General Hospital-Harvard-Rejects ARDS Recommendation
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).
Does the FDA have the authority to trump the Declaration of Helsinki?
The FDA is sliding rapidly down the slippery slope, abandoning widely accepted, international ethical research standards articulated in the internationally accepted, Declaration of Helsinki–to facilitate commercial medical experiments.
UK Patients Used as Drug ‘Guinea Pigs" Guardian
UK Patients Used as Drug ‘Guinea Pigs”_Guardian Feb 9 2003 Medical fraud experts in the U.K. estimate that one per cent of all drug trials involve fraud, including failure to get proper consent from patients. An investigation by The Guardian / Observer (UK) found widespread abuse by doctors who use…