Comments on: Pharmalot…Pharmalittle… http://www.pharmalot.com/2007/06/pharmalotpharmalittle-18/ News, Comment and Conversation Fri, 10 Feb 2012 16:25:46 +0000 http://wordpress.org/?v=2.6.2 By: Dr. Remulac http://www.pharmalot.com/2007/06/pharmalotpharmalittle-18/#comment-3751 Dr. Remulac Thu, 07 Jun 2007 00:19:13 +0000 http://www.pharmalot.com/2007/06/pharmalotpharmalittle-18/#comment-3751 In addition to hopeless understaffing and red tape at the FDA, they are in a nearly unwinnable position. If they move too quickly on something and make an error, there are countless lawyers ready to file suit. If they move too slowly on something (often because the decisions are so weighty that the deliberations/analyses must be so thorough in order to stand up in court later), there's entirely different army of lawyers ready to sue. Bottom line: Avandia and Actos should be reserved for control of blood glucose in patients without any evidence of heart disease, and only in those who have failed other therapy. This would significantly curtail their use, as the vast majority of patients with diabetes already have some detectable form of heart disease, and the fact that diabetes itself is considered a CHD risk equivalent. The FDA shpuld settle this as soon as possible, and GSK and Lilly/Takeda must prove in a completed randomized controlled clinical trial that these drugs are safe from a CV perspective before they can be used again widely. Concomitantly, the FDA needs to also immediately turn its attention to Abbott's Tricor. In addition to hopeless understaffing and red tape at the FDA, they are in a nearly unwinnable position. If they move too quickly on something and make an error, there are countless lawyers ready to file suit. If they move too slowly on something (often because the decisions are so weighty that the deliberations/analyses must be so thorough in order to stand up in court later), there’s entirely different army of lawyers ready to sue. Bottom line: Avandia and Actos should be reserved for control of blood glucose in patients without any evidence of heart disease, and only in those who have failed other therapy. This would significantly curtail their use, as the vast majority of patients with diabetes already have some detectable form of heart disease, and the fact that diabetes itself is considered a CHD risk equivalent. The FDA shpuld settle this as soon as possible, and GSK and Lilly/Takeda must prove in a completed randomized controlled clinical trial that these drugs are safe from a CV perspective before they can be used again widely. Concomitantly, the FDA needs to also immediately turn its attention to Abbott’s Tricor.

]]> By: Laurie http://www.pharmalot.com/2007/06/pharmalotpharmalittle-18/#comment-3748 Laurie Wed, 06 Jun 2007 23:52:42 +0000 http://www.pharmalot.com/2007/06/pharmalotpharmalittle-18/#comment-3748 "Beyond the debate over Nissen’s analysis of Avandia risks, the larger issue is the sorry state of drug safety. If the system worked better, data would be accessible for analysis, the FDA would conduct timely reviews and issue appropriate decisions, and - voila! - hearings wouldn’t be needed" LOL!!! I just posted basically the same thing as a comment on the other story. So while the "powers" fight...the public is still left in the dark.. “Beyond the debate over Nissen’s analysis of Avandia risks, the larger issue is the sorry state of drug safety. If the system worked better, data would be accessible for analysis, the FDA would conduct timely reviews and issue appropriate decisions, and - voila! - hearings wouldn’t be needed”

LOL!!! I just posted basically the same thing as a comment on the other story. So while the “powers” fight…the public is still left in the dark..

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