Schism Between Ethical Principles and the US Regulatory System

A system that was established to safeguard human subjects by implementing those ethical principles is, instead, geared toward lending the appearance of legitimacy to ethical expediency and corner-cutting at the expense of safety for the subjects of clinical trials and for consumers who are at increased risk of harm from defective drugs and devices.

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.

ARDSNet – AHRP Reply to OHRP Response

THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) 142 West End Ave, Suite 28P New York, NY 10023 212-595-8974 ahrp@researchprotection.org September 4, 2002 Michael Carome, MD Associate Director for Regulatory Affairs Office for Human Research Protections The Tower Building 1101 Wootton Parkway, Suite 200 Rockville, Maryland 20852 Re: Acute Respiratory Distress…