# Open Letter to the Food and Drug Administration about Zelnorm



## Jeffrey Roberts (Apr 15, 1987)

Open Letter to the Food and Drug AdministrationAugust 25, 2001Bernard Schwetz, DVS, Ph.D.Acting Deputy CommissionerFood and Drug AdministrationThe Irritable Bowel Syndrome Self Help Group and Zelnorm Action Group(ZAG) represent over 8,000 sufferers of Irritable Bowel Syndrome, anillness which presents itself as pain and bowel dysfunction. We wagewar on the misconceptions about Irritable Bowel Syndrome and the drasticaffects on the quality of life for an IBS sufferer. Sufferers struggleto overcome symptoms that challenge or impair their physical, emotional,economic, and social well-being.The IBS Group and ZAG seek immediate permanent access and safe distributionto the medicine Zelnorm (tegaserod), which is currently being appealedby its manufacture Novartis Pharmaceutical at the FDA, for those diagnosedwith IBS predominant constipation. Zelnorm represents the only medicinewhich was designed and investigated for the relief of IBS-Constipationsymptoms. We understand Novartis awaits the FDA's decision on theirappeal, due within the next 2 weeks, following the issuance of a"not-approvable" letter by the FDA on June 18, 2001.The IBS Group and Zelnorm Action Group believe the medicine to be safe,if dispensed properly, and that the benefits of Zelnorm far outweigh thepotential risk for adverse side affects.We realize the burden that the FDA has in making decisions that affect somany lives. We urge the FDA to not lose sight of the patient sufferingcaused by IBS. We urge the FDA to realize that the impact of IBS symptomsare comparable to that of other chronic disorders such as gastroesophagealreflux disease, diabetes mellitus, and even chronic renal failure.[IFFGD August 2001]An estimated 5% of the people in the U.S. suffer symptoms of IBS thatoften do not respond to dietary or lifestyle changes alone. We demandcomplete and full access to a medicine which will give us back our qualityof life.Sincerely,Jeffrey RobertsPresident & Founder IBS Self Help GroupFounder & Coordinator Zelnorm Action GroupCo-Founder & Coordinator Lotronex Action Group-------------------------------------------------------------------------Email: jeffrey-roberts###ibsgroup.orgPh: 416-932-3311Fax: 416-932-8909 http://www.ibsgroup.org http://www.geocities.com/zelnormactiongroup http://www.lotronexactiongroup.org (About us: The IBS Self Help Group and Zelnorm Action Group andLotronex Action Group have no affiliation with nor receives any fundingfrom any pharmaceutical company or other organization.)


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