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Your search keyword '"Off-Label Use ethics"' showing total 7 results
Start Over Descriptor "Off-Label Use ethics" Topic dexamethasone
7 results on '"Off-Label Use ethics"'

1. Politics and persuasion in medical controversies.

Author

Kamenova K

Subjects
Adrenal Hyperplasia, Congenital complications, Adrenal Hyperplasia, Congenital diagnosis, Correspondence as Topic, Disorders of Sex Development etiology, Female, Fetal Diseases diagnosis, Glucocorticoids administration & dosage, Humans, Off-Label Use ethics, Virilism prevention & control, Adrenal Hyperplasia, Congenital drug therapy, Dexamethasone administration & dosage, Disorders of Sex Development prevention & control, Fetal Diseases drug therapy, Persuasive Communication, Politics
Published
2010
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2. Speaking of accuracy.

Author

Frader J

Subjects
Adrenal Hyperplasia, Congenital complications, Dexamethasone adverse effects, Disorders of Sex Development etiology, Drug Administration Schedule, Female, Fetal Diseases diagnosis, Glucocorticoids administration & dosage, Glucocorticoids adverse effects, Humans, Informed Consent ethics, Informed Consent standards, Off-Label Use ethics, Prenatal Diagnosis, Virilism prevention & control, Adrenal Hyperplasia, Congenital diagnosis, Adrenal Hyperplasia, Congenital drug therapy, Dexamethasone administration & dosage, Disorders of Sex Development prevention & control, Fetal Diseases drug therapy, Therapeutic Human Experimentation ethics
Published
2010
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3. A case study in unethical transgressive bioethics: "Letter of concern from bioethicists" about the prenatal administration of dexamethasone.

Author

McCullough LB, Chervenak FA, Brent RL, and Hippen B

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

Published
2010
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4. Attracting attention: right or wrong.

Author

Robichaud A

Subjects
Adrenal Hyperplasia, Congenital complications, Adrenal Hyperplasia, Congenital drug therapy, Clinical Trials as Topic ethics, Disorders of Sex Development etiology, Ethics Committees, Research, Female, Fetal Diseases diagnosis, Fetal Diseases drug therapy, Glucocorticoids administration & dosage, Humans, Informed Consent ethics, Off-Label Use ethics, United States, Virilism prevention & control, Adrenal Hyperplasia, Congenital diagnosis, Correspondence as Topic, Dexamethasone administration & dosage, Disorders of Sex Development prevention & control, Therapeutic Human Experimentation ethics
Published
2010
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5. Why I signed, and why I would do it again.

Author

Kraft RE Jr

Subjects
Bioethics education, Disorders of Sex Development etiology, Ethical Analysis, Ethics Committees, Research, Female, Glucocorticoids administration & dosage, Humans, Off-Label Use ethics, Virilism prevention & control, Adrenal Hyperplasia, Congenital complications, Adrenal Hyperplasia, Congenital diagnosis, Adrenal Hyperplasia, Congenital drug therapy, Correspondence as Topic, Dexamethasone administration & dosage, Disorders of Sex Development prevention & control, Fetal Diseases diagnosis, Fetal Diseases drug therapy, Therapeutic Human Experimentation ethics
Published
2010
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6. The intellectual and moral integrity of bioethics: response to commentaries on "A case study in unethical transgressive bioethics: 'Letter of concern from bioethicists' about the prenatal administration of dexamethasone".

Author

McCullough LB, Chervenak FA, Brent RL, and Hippen B

Subjects
Adrenal Hyperplasia, Congenital complications, Adrenal Hyperplasia, Congenital diagnosis, Bioethics trends, Disorders of Sex Development etiology, Ethical Analysis, Ethicists standards, Female, Fetal Diseases diagnosis, Glucocorticoids administration & dosage, Glucocorticoids adverse effects, Humans, Informed Consent ethics, Off-Label Use ethics, Prenatal Diagnosis, Virilism prevention & control, Adrenal Hyperplasia, Congenital drug therapy, Correspondence as Topic, Dexamethasone administration & dosage, Dexamethasone adverse effects, Disorders of Sex Development prevention & control, Fetal Diseases drug therapy
Published
2010
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7. Still concerned.

Author

Dreger A, Feder EK, and Lindemann H

Subjects
Adrenal Hyperplasia, Congenital complications, Clinical Trials as Topic, Disorders of Sex Development etiology, Female, Humans, Informed Consent ethics, Male, Pregnancy, Prenatal Diagnosis, Virilism prevention & control, Adrenal Hyperplasia, Congenital diagnosis, Dexamethasone administration & dosage, Disorders of Sex Development prevention & control, Glucocorticoids administration & dosage, Off-Label Use ethics, Therapeutic Human Experimentation ethics
Published
2010
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