A case study in unethical transgressive bioethics: "Letter of concern from bioethicists" about the prenatal administration of dexamethasone

Am J Bioeth. 2010 Sep;10(9):35-45. doi: 10.1080/15265161.2010.499745.

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.

MeSH terms

  • Adrenal Hyperplasia, Congenital / complications
  • Adrenal Hyperplasia, Congenital / diagnosis*
  • Adrenal Hyperplasia, Congenital / drug therapy*
  • Adrenal Hyperplasia, Congenital / enzymology
  • Clinical Trials as Topic
  • Correspondence as Topic*
  • Dexamethasone / administration & dosage*
  • Disorders of Sex Development / etiology
  • Disorders of Sex Development / prevention & control*
  • Drug Administration Schedule
  • Ethicists / standards*
  • Ethics Committees, Research
  • Female
  • Fetal Diseases / diagnosis
  • Fetal Diseases / drug therapy*
  • Fetal Diseases / enzymology
  • Genitalia, Female / abnormalities*
  • Genitalia, Female / surgery
  • Glucocorticoids / administration & dosage
  • Humans
  • Informed Consent / ethics
  • Male
  • Off-Label Use* / ethics
  • Plastic Surgery Procedures
  • Pregnancy
  • Prenatal Diagnosis*
  • Referral and Consultation
  • Steroid 21-Hydroxylase / metabolism
  • Therapeutic Human Experimentation / ethics*
  • United States
  • United States Food and Drug Administration
  • Virilism / prevention & control

Substances

  • Glucocorticoids
  • Dexamethasone
  • Steroid 21-Hydroxylase