http://www.pharmalot.com/2008/06/fda-panel-to-weigh-heart-trials-for-diabetes-meds/ News, Comment and Conversation Fri, 10 Feb 2012 21:39:58 +0000 http://wordpress.org/?v=2.6.2 http://www.pharmalot.com/2008/06/fda-panel-to-weigh-heart-trials-for-diabetes-meds/#comment-363257 Scott Tue, 24 Jun 2008 12:24:28 +0000 http://www.pharmalot.com/?p=14281#comment-363257 In general, these moves are long overdue. However, with regards to insulin, imposing a requirement for demonstrating cardiovascular benefit for type 2 diabetes is very inappropriate since it is an endogenous hormone found in the body rather than a "drug", and furthermore, 75% of the patients who use insulin have autoimmune-mediated type 1 diabetes, and there is scientific evidence that cardiovascular disease in patients with type 1 has an autoimmune basis as well, therefore the imposition of such criteria on insulin to benefit those patients with type 2 diabetes seems particularly inappropriate. There were some comments made to this effect in the FDA's Draft Guidance for Diabetes Drugs and Biologics, but whether this agency considers them remains to be seen. In general, these moves are long overdue. However, with regards to insulin, imposing a requirement for demonstrating cardiovascular benefit for type 2 diabetes is very inappropriate since it is an endogenous hormone found in the body rather than a “drug”, and furthermore, 75% of the patients who use insulin have autoimmune-mediated type 1 diabetes, and there is scientific evidence that cardiovascular disease in patients with type 1 has an autoimmune basis as well, therefore the imposition of such criteria on insulin to benefit those patients with type 2 diabetes seems particularly inappropriate. There were some comments made to this effect in the FDA’s Draft Guidance for Diabetes Drugs and Biologics, but whether this agency considers them remains to be seen.

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