Re: [Biofuel] FDA Minimized Issue of Lotronex's Safety
Marty Phee wrote: They chose a paid consultant to Glaxo to serve with an advisory committee that recommended approval of the drug. Who do you think advises the govt on many critical issues? Many govt organizations who make decisions for us have corporations on the boards. You don't say, well I never, whatever next. :-/ Keith Keith Addison wrote: http://www.latimes.com/news/nation/updates2/lat_lotronex001102.htm Thursday, November 2, 2000 FDA Minimized Issue of Lotronex's Safety Health: Times study finds officials sided with drug maker on regulatory concerns. Agency reevaluation is underway. By DAVID WILLMAN, Times Staff Writer WASHINGTON--In the drug's first eight months on the market, five people who took it died. Several others underwent bowel surgeries--one had a colon removed. A total of 49 patients developed ischemic colitis, a potentially life-threatening complication. As a result, the Food and Drug Administration is now reevaluating the safety of Lotronex, a drug intended to treat women with a nonfatal disorder, irritable bowel syndrome. But a Los Angeles Times investigation of the FDA's handling of Lotronex found that over the last year agency officials repeatedly played down questions about the drug's safety while siding with the manufacturer, Glaxo Wellcome Inc., in important regulatory decisions. ___ Biofuel mailing list Biofuel@sustainablelists.org http://sustainablelists.org/mailman/listinfo/biofuel_sustainablelists.org Biofuel at Journey to Forever: http://journeytoforever.org/biofuel.html Search the combined Biofuel and Biofuels-biz list archives (50,000 messages): http://www.mail-archive.com/biofuel@sustainablelists.org/
Re: [Biofuel] FDA Minimized Issue of Lotronex's Safety
They chose a paid consultant to Glaxo to serve with an advisory committee that recommended approval of the drug. Who do you think advises the govt on many critical issues? Many govt organizations who make decisions for us have corporations on the boards. Keith Addison wrote: http://www.latimes.com/news/nation/updates2/lat_lotronex001102.htm Thursday, November 2, 2000 FDA Minimized Issue of Lotronex's Safety Health: Times study finds officials sided with drug maker on regulatory concerns. Agency reevaluation is underway. By DAVID WILLMAN, Times Staff Writer WASHINGTON--In the drug's first eight months on the market, five people who took it died. Several others underwent bowel surgeries--one had a colon removed. A total of 49 patients developed ischemic colitis, a potentially life-threatening complication. As a result, the Food and Drug Administration is now reevaluating the safety of Lotronex, a drug intended to treat women with a nonfatal disorder, irritable bowel syndrome. But a Los Angeles Times investigation of the FDA's handling of Lotronex found that over the last year agency officials repeatedly played down questions about the drug's safety while siding with the manufacturer, Glaxo Wellcome Inc., in important regulatory decisions. ___ Biofuel mailing list Biofuel@sustainablelists.org http://sustainablelists.org/mailman/listinfo/biofuel_sustainablelists.org Biofuel at Journey to Forever: http://journeytoforever.org/biofuel.html Search the combined Biofuel and Biofuels-biz list archives (50,000 messages): http://www.mail-archive.com/biofuel@sustainablelists.org/
