Analyzing the Scientific Debate of Coxibs and The Ethics Impact of Vioxx's Withdrawal on Drug Regulation and an Ongoing Phase III Clinical Trial with a New Cox-2 Inhibitor

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dc.contributor.advisorGwirtz, Patricia A.
dc.contributor.committeeMemberRubin, Bernard R.
dc.contributor.committeeMemberJiminez-Williams, Cynthia
dc.creatorFu, Jingwei
dc.date.accessioned2019-08-22T19:59:09Z
dc.date.available2019-08-22T19:59:09Z
dc.date.issued2005-11-01
dc.date.submitted2014-01-14T06:24:04-08:00
dc.description.abstractOn September 30, 2004, Merck & Co. Inc announced voluntary withdrawal of its $25 billion blockbuster drug Vioxx from the market, five and a half years after Voixx received FDA approval. This is the largest prescription drug withdrawal in history. Merck made the decision based on the results of APPROVe (Adenomaous Polyp Prevention on Vioxx) clinical trial, which showed that Voixx had an increased risk of myocardial infarction and cerebral vascular stoke compared with placebo. The repercussions of Merck’s action were tremendous from both a financial aspect and an ethical aspect. The recalling of Vioxx has become an important public health issue and has placed drug regulation agencies in controversy. In April, 2005, Pfizer agreed to voluntarily suspend sales and marketing of its COX-2 inhibitor, Bextra in the United States as requested by the FDA. Vioxx and Bextra withdrawal has left a huge impact on the pharmaceutical industry. Debates are ongoing in the scientific community regarding the use of Cox-2 inhibitors and have caused much confusion in the medical community and in those who use these drugs for pain control for osteo- and rheumatoid arthritis disease. The goal of this report is to analyze the impact of Vioxx withdrawal and comment on how to apply this incident in guiding the industry with regards to drug development, drug regulation, and clinical practice in order to ensure the effectiveness in the drug development and safe usage of new pharmaceutical agents.
dc.format.mimetypeapplication/pdf
dc.identifier.urihttps://hdl.handle.net/20.500.12503/27480
dc.language.isoen
dc.provenance.legacyDownloads0
dc.subjectChemical Actions and Uses
dc.subjectChemicals and Drugs
dc.subjectMedicinal and Pharmaceutical Chemistry
dc.subjectMedicine and Health Sciences
dc.subjectOther Chemicals and Drugs
dc.subjectOther Pharmacy and Pharmaceutical Sciences
dc.subjectPharmaceutical Preparations
dc.subjectPharmaceutics and Drug Design
dc.subjectPharmacy and Pharmaceutical Sciences
dc.subjectAPPROVe
dc.subjectAdenomaous Polyp Prevention on Vioxx
dc.subjectrecall
dc.subjectmyocardial infection
dc.subjectcerebral vascular stroke
dc.subjectpharmaceutical industry
dc.subjectVoixx withdrawal
dc.subjectdrug development
dc.subjectdrug regulation
dc.subjectclinical practice
dc.subjectsafety
dc.subjectpharmaceutical agents
dc.titleAnalyzing the Scientific Debate of Coxibs and The Ethics Impact of Vioxx's Withdrawal on Drug Regulation and an Ongoing Phase III Clinical Trial with a New Cox-2 Inhibitor
dc.typeThesis
dc.type.materialtext
thesis.degree.departmentGraduate School of Biomedical Sciences
thesis.degree.disciplineClinical Research Management
thesis.degree.grantorUniversity of North Texas Health Science Center at Fort Worth
thesis.degree.nameMaster of Science

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