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The Wyeth Petition The stated purpose of the Wyeth petition is to seek "FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs that Endanger Public Health." It asks for an unwarranted federal intrusion into state regulated pharmacies. The petition asks the FDA to "initiate enforcement actions, in the form of seizures, injunctions and or warning letters" against pharmacies that compound bio-identical hormones. In addition to eliminating treatment options for millions of patients, this requested action would: Impose a severe burden on thousands of mostly small and independent businesses, most of them family-owned pharmacies; Strain the resources of the FDA by having this agency interfere on a daily basis with state regulated pharmacies; Ignore Supreme Court precedent and severely restrict pharmacies' right to advertise their products and services; and Interfere with the right of physicians to determine the best medical treatment in consultation with their female patients and pharmacists. In its petition, Wyeth suggests that the Women's Health Initiative also studied bio-identical hormones. It did not. The WHI study was confined to the drugs Premarin and Prempro, and linked these specific drugs to increased risk of breast cancer and or increased heart and circulatory diseases. While a handful of organizations have filed comments supporting Wyeth, nearly all of them have financial ties to the company. Some of these organizations are receiving hundreds of thousands of dollars from Wyeth, yet these ties are not disclosed by any of the organizations in their filings with the FDA. On the other hand, more than 50, 000 patients, physicians and pharmacists have filed comments with the FDA, calling on the agency to reject Wyeth's petition. This is not the first time Wyeth has tried to use its political muscle to force a competitor from the marketplace. According to a 1997 report from Citizens Against Government Waste, a Washington, D.C.based think tank, Wyeth waged a political campaign to influence FDA's decision to keep a generic version of Premarin off the market. In this campaign, Wyeth asserted that its products could not be copied by generic manufacturers. Wrote CAGW: "Although the FDA and Premarin's manufacturer, WyethAyerst, would like the American public to believe that this decision was in their best interests, the reality is that it was driven by hoards of lobbyists, fraught with conflicts of interest, and characterized by questionable behind-the-scenes political maneuvering." Please help ensure that this attack on individualized healthcare is not allowed to succeed. again.
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GPhA 2003 ; . Generic Drug Value Reaffirmed in 2001. Digital document at gphaonline news facts.phtml as of June 1 ; . Washington, DC: Generic Pharmaceutical Association. Grabowski, Henry G., and John M. Vernon 1996 ; . Prospects for Returns to R&D Under Health Care Reform. In Robert B. Helms ed. ; , Competitive Strategies in the Pharmaceutical Industry Washington, DC: AEI Press ; : 194207. Grabowski, Henry, and John Vernon 2000 ; . The Determinants of Pharmaceutical Research and Development Expenditures. Journal of Evolutionary Economics 10, 1 2: Graham, John R. 2000 ; . Prescription Drug Pricing in Canada and the United States--Part 2: Why the Difference? Public Policy Sources 43. Vancouver, BC: The Fraser Institute. Graham, John R. 2001a ; . The Medicine Piracy and Counterfeit Drug Promotion Act of 2000. Fraser Forum January ; : 16, 30. Graham, John R. 2001b ; . Prescription Drug Pricing in Canada and the United States--Part 3: Retail Price Distribution. Public Policy Sources 50. Vancouver, BC: The Fraser Institute. Graham, John R. 2002a ; . Why the Difference between Canadian and American Prices for Prescription Drugs is Widening. Fraser Forum September ; : 3233. Graham, John R. 2002b ; . The Fantasy of Reference Pricing and the Promise of Choice in BC's Pharmacare. Public Policy Sources 66. Vancouver, BC: The Fraser Institute. Graham, John R., and Beverley A. Robson 2000 ; . Prescription Drug Pricing in Canada and the United States--Part 1: A Comparative Survey. Public Policy Sources 42. Vancouver, BC: The Fraser Institute. Gutknecht, Rep. Gil 2003 ; . Gutknecht Introduces Pharmaceutical Market Access Bill. News Release June 12 ; . Washington, DC: Office of US Congressman Gil Gutknecht. Hansen, Ronald W. 2000 ; . Regulation of the Pharmaceutical Industry. In Roger D. Feldman ed. ; , American Health Care: Government, Market Processes, and the Public Interest Oakland, CA: The Independent Institute ; : 26984. Harris, Gardiner 2003 ; . Canada Fills U.S. Prescriptions under the Counter. New York Times June 4 ; . Hausman, Jerry A., and Jeffrey K. MacKie-Mason 1988 ; . Price Discrimination and Patent Policy. RAND Journal of Economics 19, 2: 25365. Health Products and Food Branch Inspectorate 2003a ; . Guidance Document on the Commercial Importation and Exportation of Drugs in Dosage Forms under the Food and Drugs Act May 1 ; . Ottawa, ON: Health Canada. Health Products and Food Branch Inspectorate 2003b ; . Questions and Answers: Q&A on the Commercial Importation and Exportation of Drugs in Dosage Form May 1 ; . Ottawa, ON: Health Canada. Healy, W. Brian 1996 ; . The International Market for Pharmaceuticals: Commentary. In Robert B. Helms ed. ; , Competitive Strategies in the Pharmaceutical Industry Washington, DC: AEI Press ; : 16164. Huttin, Christina 1999 ; . Drug Price Divergence in Europe: Regulatory Aspects. Health Affairs 18, 3: 24549. Huskamp, Haiden A., Arnold M. Epstein, and David Blumenthal 2003 ; . The Impact of a National Prescription Drug Formulary on Prices, Market Share, And Spending: Lessons for Medicare? Health Affairs 22, 3: 14958. IMS Health 2003 ; . World Pharmaceutical Market Summary. Issue 2 2003. London: IMS Health. IMS Health Canada 2002 ; . Top 50 Prescribed Medications, 2002. Pointe-Claire, QC: IMS Health Canada. Irvine, Carl, and Martin Zelder 2002 ; . Medically Uninsured Americans: Evidence on Magnitude and Implications. Public Policy Sources 58. Vancouver, BC: The Fraser Institute. Jacobzone, S. 2000 ; . Pharmaceutical Policies in OECD Countries: Reconciling Social and Industrial Goals. Labour Market and Social Policy Occasional Paper 40. Paris: Organisation for Economic Co-operation and Development. Kanavos, Panos, and Uwe Reinhart 2003 ; . Reference Pricing for Drugs: Is it Compatible with U.S. Health Care? Health Affairs 22, 3: 1630. Kaufman, Marc 2003a ; . Canada to Guarantee Imported Medicines. Washington Post May 8 ; : A6 and psilocybin and prempro, for example, benefits of prempro.
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1. McAdam LP, O Hanlan MA, Bluestone R, Pearson CM. Relapsing polychondritis: prospective study of 23 patients and a review of the literature. Medicine Baltimore ; 1976; 55 3 ; : 193-215. 2. Michet CJ, Jr., McKenna CH, Luthra HS, O Fallon WM. Relapsing polychondritis. Survival and predictive role of early disease manifestations. Ann Intern Med 1986; 104 1 ; : 74-8. 3. Damiani JM, Levine HL. Relapsing polychondritis -- report of 10 cases. Laryngoscope 1979; 89 6 Pt 1 ; 929-46. 4. Jacksch-Wartenhorst R. Polychondropathia. Wien Arch Inn Med 1923; 6: 93-100. Trentham DE, Le CH. Relapsing polychondritis. Ann Intern Med 1998; 129 2 ; : 114-22. 6. Zeuner M, Straub RH, Rauh G, Albert ED, Scholmerich J, Lang B. Relapsing polychondritis: clinical and immunogenetic analysis of 62 patients. J Rheumatol 1997; 24 1 ; : 96-101. 7. Alsalameh S, Mollenhauer J, Scheuplein F, Stoss H, Kalden JR, Burkhardt H, et al. Preferential cellular and humoral immune reactivities to native and denatured collagen types IX and XI in a patient with fatal relapsing polychondritis. J Rheumatol 1993; 20 8 ; : 1419-24. 8. Yang CL, Brinckmann J, Rui HF, Vehring KH, Lehmann H, Kekow J, et al. Autoantibodies to cartilage collagens in relapsing polychondritis. Arch Dermatol Res 1993; 285 5 ; : 245-9. 9. Rajapakse DA, Bywaters EG. Cell-mediated immunity to cartilage proteoglycan in relapsing polychondritis. Clin Exp Immunol 1974; 16 3 ; : 497-502. 10. McCune WJ, Schiller AL, Dynesius-Trentham RA, Trentham DE. Type II collagen-induced auricular chondritis. Arthritis Rheum 1982; 25 3 ; : 266-73. 11. Cremer MA, Pitcock JA, Stuart JM, Kang AH, Townes AS. Auricular chondritis in rats. An experimental model of relapsing polychondritis induced with type II collagen. J Exp Med 1981; 154 2 ; : 535-40.
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