Comments on: FDA: Glaxo Failed To Report Avandia Studies http://www.pharmalot.com/2008/04/fda-glaxo-failed-to-report-avandia-studies/ News, Comment and Conversation Fri, 04 Jul 2008 22:54:02 +0000 http://wordpress.org/?v=2.5.1 By: FDA Accuses GSK of Suppressing Clinical Research | Womenhealth http://www.pharmalot.com/2008/04/fda-glaxo-failed-to-report-avandia-studies/#comment-315529 FDA Accuses GSK of Suppressing Clinical Research | Womenhealth Sat, 26 Apr 2008 07:41:44 +0000 http://www.pharmalot.com/2008/04/fda-glaxo-failed-to-report-avandia-studies/#comment-315529 [...] as first reported on the PharmaLot and WSJ Health Care blogs, the US Food and Drug Administration (FDA) issued a warning letter to GSK [...] [...] as first reported on the PharmaLot and WSJ Health Care blogs, the US Food and Drug Administration (FDA) issued a warning letter to GSK [...]

]]> By: FDA Accuses GSK of Suppressing Clinical Research | pharmaceutical http://www.pharmalot.com/2008/04/fda-glaxo-failed-to-report-avandia-studies/#comment-308309 FDA Accuses GSK of Suppressing Clinical Research | pharmaceutical Tue, 22 Apr 2008 22:32:46 +0000 http://www.pharmalot.com/2008/04/fda-glaxo-failed-to-report-avandia-studies/#comment-308309 [...] as first reported on the PharmaLot and WSJ Health Care blogs, the US Food and Drug Administration (FDA) issued a warning letter to GSK [...] [...] as first reported on the PharmaLot and WSJ Health Care blogs, the US Food and Drug Administration (FDA) issued a warning letter to GSK [...]

]]> By: Simon Passanante - FDA sends harsh warning letter concerning Avandia studies http://www.pharmalot.com/2008/04/fda-glaxo-failed-to-report-avandia-studies/#comment-269756 Simon Passanante - FDA sends harsh warning letter concerning Avandia studies Wed, 09 Apr 2008 20:44:43 +0000 http://www.pharmalot.com/2008/04/fda-glaxo-failed-to-report-avandia-studies/#comment-269756 [...] a harsh warning letter to GlaxoSmithKline, the maker of the diabetes drug Avandia. According to Pharmalot, Glaxo failed to include nine post-marketing studies in a mandatory report to the FDA. A Glaxo [...] [...] a harsh warning letter to GlaxoSmithKline, the maker of the diabetes drug Avandia. According to Pharmalot, Glaxo failed to include nine post-marketing studies in a mandatory report to the FDA. A Glaxo [...]

]]> By: pg http://www.pharmalot.com/2008/04/fda-glaxo-failed-to-report-avandia-studies/#comment-269715 pg Wed, 09 Apr 2008 20:22:18 +0000 http://www.pharmalot.com/2008/04/fda-glaxo-failed-to-report-avandia-studies/#comment-269715 Theres: GSK being indicted for corruption in Italy: http://mondediplo.com/2003/11/14pharma http://www.bmj.com/cgi/content/full/326/7386/413/a http://www.guardian.co.uk/world/2003/feb/13/research.businessofresearch Honest Science. A wonderful thing (when you can get it. Theres:
GSK being indicted for corruption in Italy:

http://mondediplo.com/2003/11/14pharma

http://www.bmj.com/cgi/content/full/326/7386/413/a

http://www.guardian.co.uk/world/2003/feb/13/research.businessofresearch

Honest Science. A wonderful thing (when you can get it.

]]> By: truthman30 http://www.pharmalot.com/2008/04/fda-glaxo-failed-to-report-avandia-studies/#comment-266923 truthman30 Wed, 09 Apr 2008 00:00:10 +0000 http://www.pharmalot.com/2008/04/fda-glaxo-failed-to-report-avandia-studies/#comment-266923 http://finance.senate.gov/press/Gpress/2008/prg013008a.pdf http://www.nature.com/news/2008/080130/full/451509a.html http://www.fiercepharma.com/story/doc-leaked-avandia-study-to-gsk/2008-01-31?utm_medium=nl&utm_source=link Avandia Scandal http://finance.senate.gov/press/Gpress/2008/prg013008a.pdf

http://www.nature.com/news/2008/080130/full/451509a.html

http://www.fiercepharma.com/story/doc-leaked-avandia-study-to-gsk/2008-01-31?utm_medium=nl&utm_source=link

Avandia Scandal

]]> By: Justice in Michigan http://www.pharmalot.com/2008/04/fda-glaxo-failed-to-report-avandia-studies/#comment-266302 Justice in Michigan Tue, 08 Apr 2008 20:34:12 +0000 http://www.pharmalot.com/2008/04/fda-glaxo-failed-to-report-avandia-studies/#comment-266302 And there will be letters, and more letters, and more warnings, and nothing will change, until knowledgeable and principled people inside of companies do the right thing. This will take enormous guts. But it has happened, is happening, and will continue to happen - more and more often, I hope. And there will be letters, and more letters, and more warnings, and nothing will change, until knowledgeable and principled people inside of companies do the right thing.

This will take enormous guts. But it has happened, is happening, and will continue to happen - more and more often, I hope.

]]> By: truthman30 http://www.pharmalot.com/2008/04/fda-glaxo-failed-to-report-avandia-studies/#comment-264920 truthman30 Tue, 08 Apr 2008 16:46:26 +0000 http://www.pharmalot.com/2008/04/fda-glaxo-failed-to-report-avandia-studies/#comment-264920 http://www.scribd.com/doc/2467566/MHRA-to-GSK Link to MHRA CEO Kent Woods Letter to GSK CEO JP Garnier (criminal investigation concludes) http://www.scribd.com/doc/2467566/MHRA-to-GSK

Link to MHRA CEO Kent Woods Letter to GSK CEO JP Garnier (criminal investigation concludes)

]]> By: truthman30 http://www.pharmalot.com/2008/04/fda-glaxo-failed-to-report-avandia-studies/#comment-264425 truthman30 Tue, 08 Apr 2008 15:21:27 +0000 http://www.pharmalot.com/2008/04/fda-glaxo-failed-to-report-avandia-studies/#comment-264425 GSK at it again.. The letter about Avandia reminds me of the letter MHRA (UK regulator) sent JP a few weeks ago.. (in regards to criminal investigation of suicidal kids from seroxat) http://www.guardian.co.uk/society/2008/mar/07/health.health "Such a course of action should be unnecessary in an industry which relies so heavily on public trust and aspires to high ethical standards," he wrote. " I would have thought it self-evident that such information should be made available promptly to the regulator in order that action can be taken to protect public health. However, that moral responsibility now needs to be to be insisted upon by the unambiguous force of law." And also of the one senator Grassley sent him about Paxil before that... http://seroxatsecrets.wordpress.com/2008/02/17/the-missing-nine-pages-glaxosmithkline-misses-sentator-grassleys-deadline-and-continues-to-hide-evidence/ http://seroxatsecrets.wordpress.com/2008/02/22/grassley-receives-gsks-paxil-documents-but-his-concerns-remain/ GSK at it again..

The letter about Avandia reminds me of the letter MHRA (UK regulator) sent JP a few weeks ago.. (in regards to criminal investigation of suicidal kids from seroxat)

http://www.guardian.co.uk/society/2008/mar/07/health.health

“Such a course of action should be unnecessary in an industry which relies so heavily on public trust and aspires to high ethical standards,” he wrote.

” I would have thought it self-evident that such information should be made available promptly to the regulator in order that action can be taken to protect public health. However, that moral responsibility now needs to be to be insisted upon by the unambiguous force of law.”

And also of the one senator Grassley sent him about Paxil before that…

http://seroxatsecrets.wordpress.com/2008/02/17/the-missing-nine-pages-glaxosmithkline-misses-sentator-grassleys-deadline-and-continues-to-hide-evidence/

http://seroxatsecrets.wordpress.com/2008/02/22/grassley-receives-gsks-paxil-documents-but-his-concerns-remain/

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