title: A case study in unethical transgressive bioethics: "Letter of concern from bioethicists" about the prenatal administration of dexamethasone.
abstract: 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 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 fetaldex.org to withdraw the letter and for co-signatories to withdraw their approval of it.
authors.affiliation: Center for Medical Ethics and Health Policy, Baylor College of Medicine, One Baylor Plaza, Houston, TX 77030-3411, USA. mccullou@bcm.edu
authors.forename: Laurence B
authors.initials: LB
authors.lastname: McCullough
authors.forename: Frank A
authors.initials: FA
authors.lastname: Chervenak
authors.forename: Robert L
authors.initials: RL
authors.lastname: Brent
authors.forename: Benjamin
authors.initials: B
authors.lastname: Hippen
mesh_terms: D000312:Adrenal Hyperplasia, Congenital / Q000150:complications / Q000175:diagnosis* / Q000188:drug therapy* / Q000201:enzymology; D002986:Clinical Trials as Topic; D015709:Correspondence as Topic; D003907:Dexamethasone / Q000008:administration & dosage*; D012734:Disorders of Sex Development / Q000209:etiology / Q000517:prevention & control*; D004334:Drug Administration Schedule; D026822:Ethicists / Q000592:standards*; D028744:Ethics Committees, Research; D005260:Female; D005315:Fetal Diseases / Q000175:diagnosis / Q000188:drug therapy* / Q000201:enzymology; D005836:Genitalia, Female / Q000002:abnormalities* / Q000601:surgery; D005938:Glucocorticoids / Q000008:administration & dosage; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D008297:Male; D056687:Off-Label Use / Q000941:ethics; D011247:Pregnancy; D011296:Prenatal Diagnosis; D019651:Plastic Surgery Procedures; D012017:Referral and Consultation; D013255:Steroid 21-Hydroxylase / Q000378:metabolism; D036302:Therapeutic Human Experimentation / Q000941:ethics*; D014481:United States; D014486:United States Food and Drug Administration; D014770:Virilism / Q000517:prevention & control
chemical_list: D005938:Glucocorticoids; D003907:Dexamethasone; D013255:Steroid 21-Hydroxylase