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Publications:

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(5/5/09) Petition to the FDA Requesting Enhanced Warnings for Amitiza (lubiprostone) (HRG Publication #1871)

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(5/5/04) Testimony before FDA advisory committee concerning alosetron (Lotronex) (HRG Publication #1697)

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(6/7/02) Allowing Lotronex Back on the Market Will Endanger Patients (HRG Publication #1622)

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(4/23/02) Testimony Before FDA Advisory Committee Concerning Alosetron (LOTRONEX) (HRG Publication #1617)

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(7/21/01) Letter to the FDA concerning tegaserod (Zelnorm), for constipation-predominant irritable bowel syndrome, and Novartis' reluctance to use ultrasound monitoring for their clinical trial subjects. (HRG Publication #1582)

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(6/7/01) Letter to the Food and Drug Administration on a study stating a possible mechanism for the induction of ovarian cysts with the use of tegaserod (Zelmac) (HRG Publication #1577)

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(4/18/01) Letter to the FDA concerning a memo from their Office of Post-marketing Drug Risk Assessment (OPDRA) that confirms and extends the dangers of the drug Lotronex (alosetron) for irritable bowel syndrome (HRG Publication #1566)

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(3/22/01) Letter to the Food and Drug Administration urging that it not approve tegaserod (Zelmac) because of its highly questionable efficacy and its potential to cause ovarian cysts (HRG Publication #1561)

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(12/9/00) Letter in Lancet on Alosetron for irritable bowel syndrome showing data manipulation in a company-sponsored clinical trial. (HRG Publication #1551)

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(10/30/00) Letter to the Food and Drug Administration updating the number of cases of ischemic coliitis reported in our 8/31/00 petition. (HRG Publication #1544)

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(8/31/00) Petition to the Food and Drug Administration to remove Lotronex from the market. (HRG Publication #1533)

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(4/11/00) Letter to the Food and Drug Administration/FDA asking for the immediate withdrawal of Propulsid (cisapride) from the market. (HRG Publication #1519)


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