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Uncertain Compassion in Using a Drug Before the Risks and Benefits Are Known

Uncertain Compassion in Using a Drug Before the Risks and Benefits Are Known CONTROVERSIES Uncertain Compassion in Using a Drug Before the Risks and Benefits Are Known Raja Narayanan, MD; Baruch D. Kuppermann, MD, PhD IRST, DO NO HARM,” IS the objective of all new drug and pro- compassionate care, depending on a critical dictum in cedure investigation activities. Al- whether the clinician is proposing medical practice. though there is no FDA regulation the off-label use of an approved drug, Medical practitioners or policy to define “compassionate a new surgical procedure, or a new F from ancient times to use” of drugs, it is commonly un- drug. The last option can only be the present have used individual and derstood as the use of drugs to treat performed under the watchful eyes shared scientific observations to de- diseases, usually serious life- of the FDA, and significant benefit termine the risks and benefits of in- threatening conditions such as AIDS and safety of the drug have to be dividual therapies. However, the and cancer, without first going shown in the early phases before the yield in this somewhat random pro- through the full process of random- drug can be subjected to a phase 3 cess is certainly low. Since the de- ized, controlled http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Ophthalmology American Medical Association

Uncertain Compassion in Using a Drug Before the Risks and Benefits Are Known

Narayanan, Raja; Kuppermann, Baruch D.
JAMA Ophthalmology , Volume 124 (7) – Jul 1, 2006
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References (11)

Publisher
American Medical Association
Copyright
Copyright 2006 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
2168-6165
eISSN
2168-6173
DOI
10.1001/archopht.124.7.1032
pmid
16832028
Publisher site
See Article on Publisher Site

Abstract

CONTROVERSIES Uncertain Compassion in Using a Drug Before the Risks and Benefits Are Known Raja Narayanan, MD; Baruch D. Kuppermann, MD, PhD IRST, DO NO HARM,” IS the objective of all new drug and pro- compassionate care, depending on a critical dictum in cedure investigation activities. Al- whether the clinician is proposing medical practice. though there is no FDA regulation the off-label use of an approved drug, Medical practitioners or policy to define “compassionate a new surgical procedure, or a new F from ancient times to use” of drugs, it is commonly un- drug. The last option can only be the present have used individual and derstood as the use of drugs to treat performed under the watchful eyes shared scientific observations to de- diseases, usually serious life- of the FDA, and significant benefit termine the risks and benefits of in- threatening conditions such as AIDS and safety of the drug have to be dividual therapies. However, the and cancer, without first going shown in the early phases before the yield in this somewhat random pro- through the full process of random- drug can be subjected to a phase 3 cess is certainly low. Since the de- ized, controlled

Journal

JAMA Ophthalmology – American Medical Association

Published: Jul 1, 2006

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