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FDA denial of anticancer drug spurs lawsuit.


A group of disappointed patients and disgruntled investors is suing Food and Drug Administration (FDA) officials over the agency's decision to nix a proposed vaccine Provenge [R] for advanced prostate cancer. *

The July 30 federal lawsuit, filed by the non-profit Care to Live, claims Provenge [R] is safe and effective and that the FDA's decision was the result of political infighting. It also accuses the agency of ignoring conflict-of-interest issues, naming Dr. Howard Scher, a leading investigator of a competitor anticancer drug and one of the advisors who reviewed the Provenge [R] data.

The FDA's denial in May of this year followed a thumbs-up from its own advisory panel two months earlier. Provenge [R] developer Dendreon, Inc. is hoping to win approval after a larger trial.


* Available at: businesstechnology/2003813806_dendreon31.html. Accessed August 13, 2007.
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Title Annotation:In The NEWS; Food and Drug Administration
Author:Burke, Cathy
Publication:Life Extension
Article Type:Brief article
Date:Nov 1, 2007
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