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A Case Study in Unethical Transgressive Bioethics: “Letter of Concern from Bioethicists” About the Prenatal Administration of Dexamethasone.
- Source :
- American Journal of Bioethics; Sep2010, Vol. 10 Issue 9, p35-45, 11p
- Publication Year :
- 2010
-
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. [ABSTRACT FROM AUTHOR]
- Subjects :
- GYNECOLOGIC surgery
STEROID drugs
FEMALE reproductive organs abnormalities
SEX differentiation disorders
ADRENAL diseases
ANTI-inflammatory agents
BRAIN
CHILD development deviations
CHILDREN
CLINICAL trials
FETAL diseases
FEMALE reproductive organs
INFORMED consent (Medical law)
MEDICAL ethics
PHYSICIANS
PRENATAL diagnosis
PRENATAL influences
STEROIDS
PLASTIC surgery
OFF-label use (Drugs)
DRUG administration
DRUG dosage
PHARMACODYNAMICS
DRUG side effects
ETHICS
PATHOLOGY
PATHOLOGICAL physiology
STANDARDS
DRUG therapy
PREVENTION
DIAGNOSIS
Subjects
Details
- Language :
- English
- ISSN :
- 15265161
- Volume :
- 10
- Issue :
- 9
- Database :
- Complementary Index
- Journal :
- American Journal of Bioethics
- Publication Type :
- Academic Journal
- Accession number :
- 53466484
- Full Text :
- https://doi.org/10.1080/15265161.2010.499745