FDA denial of anticancer drug spurs lawsuit.[ILLUSTRATION OMITTED] A group of disappointed patients and disgruntled dis·grun·tle tr.v. dis·grun·tled, dis·grun·tling, dis·grun·tles To make discontented. [dis- + gruntle, to grumble (from Middle English gruntelen; see investors is suing Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) officials over the agency's decision to nix a proposed vaccine Provenge [R] for advanced prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. . * 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 in·fight·ing n. 1. Contentious rivalry or disagreement among members of a group or organization: infighting on the President's staff. 2. Fighting or boxing at close range. . It also accuses the agency of ignoring conflict-of-interest issues, naming Dr. Howard Scher, a leading investigator of a competitor anticancer drug anticancer drug see antineoplastic. anticancer drug Chemotherapeutic, see there 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. Reference * Available at: http://seattletimes.nwsource.com/html/ businesstechnology/2003813806_dendreon31.html. Accessed August 13, 2007. |
|
||||||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion