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Thomas Jefferson University

Department of Pediatrics Faculty Papers

2010

Clinical Trials as Topic

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A Case Study In Unethical Transgressive Bioethics: "Letter Of Concern From Bioethicists" About The Prenatal Administration Of Dexamethasone., Laurence B Mccullough, Frank A Chervenak, Robert L Brent, Benjamin Hippen Sep 2010

A Case Study In Unethical Transgressive Bioethics: "Letter Of Concern From Bioethicists" About The Prenatal Administration Of Dexamethasone., Laurence B Mccullough, Frank A Chervenak, Robert L Brent, Benjamin Hippen

Department of Pediatrics Faculty Papers

On February 3, 2010, a "Letter of Concern from Bioethicists," organized by fetaldex.org, was sent to report suspected violations of the ethics of human subjects research in the off-label use of dexamethasone during pregnancy by Dr. Maria New. Copies of this letter were submitted to the FDA Office of Pediatric Therapeutics, the Department of Health and Human Services (DHHS) Office for Human Research Protections, and three universities where Dr. New has held or holds appointments. We provide a critical appraisal of the Letter of Concern and show that it makes false claims, misrepresents scientific publications and websites, fails to meet …