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Evidence, Regulation and Clinical Practice of Avandia
- 1. Tales of Avandia: Evidence, Regulation, and Clinical Practice Harry M Marks Institute of the History of Medicine Johns Hopkins University Center for Clinical Trials, JHSPH September 1, 2010
- 6. The Spectrum of Diabetes, c 1967 Camerini-Davalos Excerpta Medica (1967)
- 7. “ What may be regarded as prediabetic today will later be shown to be a clear manifestation that the disease is present.” -JW Conn, The Banting Memorial Lecture 1958 Diabetes 7 (1958), 355
- 8. The Spectrum of Diabetes, c 1967 Camerini-Davalos Excerpta Medica (1967)
- 10. Orinase Ad: Annual Increases in Rx
- 13. 1962 Drug Amendments "No person shall introduce into interstate commerce any drug, unless they have demonstrated whether or not the drug is safe and effective for use under the conditions prescribed, recommended or suggested in the proposed labeling thereof."
- 15. “ He said, she said”
- 19. “ These sponsored [web] links make representations and/or suggestions about the efficacy of avandia … but fail to communicate any risk information. This omission of risk information is particularly concerning as… Avandia [has a] boxed warning.” -Michael Sauers [FDA] to GSK, March 26, 2009
- 20. GSK’s Proposed Labeling 7/09
- 22. “ He said, she said”
- 23. Questions and Answers