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This article has been peer reviewed. It is the authors' final version prior to publication in American Journal of Bioethics Volume 10, Issue 9, 2010, Pages 35-45. The published version is available at DOI: 10.1080/15265161.2010.499745. Copyright © Taylor & Francis Group


On February 3, 2010, a "Letter of Concern from Bioethicists," organized by, 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 standards of evidence-based reasoning, makes undocumented claims, treats as settled matters what are, instead, ongoing controversies, offers "mere opinion" as a substitute for argument, and makes contradictory claims. The Letter of Concern is a case study in unethical transgressive bioethics. We call on to withdraw the letter and for co-signatories to withdraw their approval of it.

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