Document Detail


Side effects and pharmaceutical company bias: adverse event reporting in cancer supportive and palliative care trials.
MedLine Citation:
PMID:  19012496     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Over 10 years after their approval as cancer supportive and palliative care agents, erythropoietin and the bisphosphonates began to show unexpected, serious adverse events, which resulted in dramatic changes in how they were subsequently prescribed to cancer patients. OBJECTIVE: The purpose of this opinion piece is to reexamine what happened. METHODS: We relied on the published literature as well as the investigators' own experience and preliminary data. CONCLUSION: The importance of adverse event reporting in cancer supportive and palliative agents should go beyond that which is mandated by the Food and Drug Administration (FDA). Funding agencies and practicing oncologists should remain vigilant for such adverse events during the testing of new agents and after their approval. They should be willing to report such events without delay.
Authors:
Aminah Jatoi; Phuong L Nguyen
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Expert opinion on investigational drugs     Volume:  17     ISSN:  1744-7658     ISO Abbreviation:  Expert Opin Investig Drugs     Publication Date:  2008 Dec 
Date Detail:
Created Date:  2008-11-17     Completed Date:  2009-01-07     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9434197     Medline TA:  Expert Opin Investig Drugs     Country:  England    
Other Details:
Languages:  eng     Pagination:  1787-90     Citation Subset:  IM    
Affiliation:
Mayo Clinic, Departments of Oncology, 200 First Street SW, Rochester, Minnesota 55905, USA. jatoi.aminah@mayo.edu
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MeSH Terms
Descriptor/Qualifier:
Antineoplastic Agents / adverse effects*,  therapeutic use*
Diphosphonates / therapeutic use
Erythropoietin / therapeutic use
Humans
Neoplasms / drug therapy*
Palliative Care*
Chemical
Reg. No./Substance:
0/Antineoplastic Agents; 0/Diphosphonates; 11096-26-7/Erythropoietin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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