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Columbia University Blood Experiment Revisited_TRUTHOUT |
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Tuesday, 23 February 2010 |
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Why Has Columbia Expended So Much Effort to Avoid the Conclusion of Patient Harm?
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Schism Between Ethical Principles and the US Regulatory System |
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Thursday, 13 August 2009 |
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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.
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Sen. Grassley Letter to Harvard: Biederman Research Protocol Breaches |
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Saturday, 21 March 2009 |
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The most shocking disclosure is that Dr. Biederman's study testing powerful antipsychotics in PRESCHOOL CHILDREN "was beset by breaches of research protocol,"
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NYS Bar Non-Consensual Research |
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Friday, 19 October 2007 |
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FDA Internal Document: Use of Placebo-Controls in Life Threatening Diseases |
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Thursday, 04 October 2007 |
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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.
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