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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.

Evidence-Based Validation of the AHRP Mission for Disclosure & Voluntary, Informed,Consent
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Evidence-Based Validation of the AHRP Mission for Disclosure & Voluntary, Informed,Consent

 “Nothing is more fundamental to the ethical conduct of clinical trials than the informed consent of research participants. The Nuremberg Code and every subsequent major international statement about ethics and medical research enshrine this role.” In his recent article in Science and Engineering Ethics, Dr. Mark Yarborough, Dean’s Professor of…

1999-2006: EPA Human Pollutant Experiments on Elderly Diabetics

According to the U.S. Environmental Protection Agency’s own scientific assessment reports (2004, 2009), Ultrafine particles (UFP) are considered more dangerous than PM2.5. EPA has determined that UFP can cause sudden death. “there is strong epidemiological evidence linking short-term (hours, days) exposure to PM2.5 with cardiovascular and respiratory mortality and morbidity.” Yet,…

1998: Doing Harm: Research on the Mentally Ill

1998: Doing Harm: Research on the Mentally Ill

1998: Doing Harm: Research on the Mentally Ill, a prize winning research expose by The Boston Globe In November, 1998, the first of a four-part series by Robert Whitaker and Dolores Kong shed light on the abusive research parameters of non-therapeutic experiments conducted on mentally incapacitated individuals. They focused on several…