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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.
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).
An Experimental Medical Atrocity Approved by Officials of the Indian Government
“Human beings are being treated like animals” R.M. Lodha, former Chief Justice of the Supreme Court of India An opinion article in The Sunday Guardian by Jacob Puliyel, MD, focuses on the plan to conduct unethical medical experiments in which human beings are deliberately infected with infectious diseases in order…
“An Ethical Breakdown”
Disclosure of the egregious ethical, methodological and legal violations outlined in the letter of determination by the Federal Office of Human Research Protections (OHRP) regarding the so-called SUPPORT oxygen experiment. . . .
- Informed Consent | Informed Consent Waivers | Investigations | Medical Research Ethics | Unethical Experiments
OHRP Letter to ARDSNetwork re: Investigation of Acute Respiratory DistressSyndrome
OHRP Investigation of experimental treatment for Acute Respiratory Distress Syndrome. ARDSNet studies: ARMA, FACCT, and ALVEOLI Table of Contents to Fax from OHRP page 1 Oct. 7, 2002 OHRP letter to: Ronald S. Newvbower, Ph.D(Mass. General Hospital), Lee E. Limbird, Ph.D. (Vanderbilt University), and Robert Kay, MD) (Cleveland Clinic Foundation)…
Antibiotic Ketek Trial in Children
One day following a rport in The New York Times, Sanifo-Aventis, manufacturer of Ketek, suspended the trial in children. The FDA has not announced any action.
