A Case Study in Unethical Transgressive Bioethics: "Letter of Concern from Bioethicists" About the Prenatal Administration of Dexamethasone

作者：McCullough Laurence B^*; Chervenak Frank A; Brent Robert L; Hippen Benjamin

来源：The American Journal of Bioethics, 2010, 10(9): 35-45.

DOI：10.1080/15265161.2010.499745

• bioethics
• fetal treatment
• human subjects research
• methodological integrity
• off
• label use of medications
• public advocacy
• transgressive bioethics

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.

• 出版日期2010