A case study in unethical transgressive bioethics: "Letter of Concern from Bioethicists" about the prenatal administration of dexamethasone Academic Article uri icon


MeSH Major

  • Adrenal Hyperplasia, Congenital
  • Correspondence as Topic
  • Dexamethasone
  • Disorders of Sex Development
  • Ethicists
  • Fetal Diseases
  • Genitalia, Female
  • Off-Label Use
  • Prenatal Diagnosis
  • Therapeutic Human Experimentation


  • 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.

publication date

  • September 15, 2010



  • Academic Article



  • eng

Digital Object Identifier (DOI)

  • 10.1080/15265161.2010.499745

PubMed ID

  • 20818559

Additional Document Info

start page

  • 35

end page

  • 45


  • 10


  • 9