Comments on: The FDA in Transition: Diabetes Treatment at Risk http://www.diabetesmine.com/2008/12/the-fda-in-transition-diabetes-treatment-at-risk.html A gold mine of straight talk and encouragement for people living with diabetes Thu, 18 Mar 2010 02:09:44 +0000 http://wordpress.org/?v=2.9.1 hourly 1 By: affiliate http://www.diabetesmine.com/2008/12/the-fda-in-transition-diabetes-treatment-at-risk.html/comment-page-1#comment-496593 affiliate Thu, 25 Feb 2010 08:32:37 +0000 http://www.diabetesmine.com/?p=5264#comment-496593 i want the best therapies available to them. i want the best therapies available to them.

]]> By: Truman Burbank http://www.diabetesmine.com/2008/12/the-fda-in-transition-diabetes-treatment-at-risk.html/comment-page-1#comment-247428 Truman Burbank Thu, 15 Jan 2009 00:16:36 +0000 http://www.diabetesmine.com/?p=5264#comment-247428 Great dialogue. Any thoughts on the diabetes drug being developed by AtheroGenics, a Georgia company that is in bankruptcy proceedings (due primarily to the credit crunch) that has an anti-oxidant drug (AGI-1067) in phase 3 trials for type-2 diabetes? The drug was initially being developed as a cardiovascular treatment. As such, it had a large phase 3 trial that ended in March of 2007. AGI-1067 "failed" on the primary endpoint in that trial, but still showed interesting outcomes including reduced strokes, heart attacks and cardiovascular deaths, plus there was significant lowing of blood sugar as measured by HbA1c among the 2,000 or so diabetics in the study group (who where already on state-of-the-art care for diabetes), and a significantly lower number of patients with metabolic syndrome that became diabetic during the trial. And due to the HbA1c reduction, about 30% more diabetics getting AGI-1067 than placebo achieved their treatment goal on this measure. With these interesting results the company retooled and began to pursue a diabetes indication for AGI=1067 (probably as an add-on to existing therapy). Notably, due to the large cardio-related trial, the drug already has an established cardio safety profile that probably meets the FDA's new threshold for cardio safety. I suspect that the AGI-1067 experience informed the FDA's deliberations. Here's a drug that showed actual improvements in hard endpoint outcomes (not just reduction in HbA1c, but reduced strokes, etc.), and reduction of new-onset diabetes when compared with a placebo. Perhaps this is what FDA is looking for in new diabetes drugs, not just a secondary measure such as lowered HbA1c. Thoughts? Great dialogue. Any thoughts on the diabetes drug being developed by AtheroGenics, a Georgia company that is in bankruptcy proceedings (due primarily to the credit crunch) that has an anti-oxidant drug (AGI-1067) in phase 3 trials for type-2 diabetes? The drug was initially being developed as a cardiovascular treatment. As such, it had a large phase 3 trial that ended in March of 2007. AGI-1067 “failed” on the primary endpoint in that trial, but still showed interesting outcomes including reduced strokes, heart attacks and cardiovascular deaths, plus there was significant lowing of blood sugar as measured by HbA1c among the 2,000 or so diabetics in the study group (who where already on state-of-the-art care for diabetes), and a significantly lower number of patients with metabolic syndrome that became diabetic during the trial. And due to the HbA1c reduction, about 30% more diabetics getting AGI-1067 than placebo achieved their treatment goal on this measure.

With these interesting results the company retooled and began to pursue a diabetes indication for AGI=1067 (probably as an add-on to existing therapy). Notably, due to the large cardio-related trial, the drug already has an established cardio safety profile that probably meets the FDA’s new threshold for cardio safety.

I suspect that the AGI-1067 experience informed the FDA’s deliberations. Here’s a drug that showed actual improvements in hard endpoint outcomes (not just reduction in HbA1c, but reduced strokes, etc.), and reduction of new-onset diabetes when compared with a placebo. Perhaps this is what FDA is looking for in new diabetes drugs, not just a secondary measure such as lowered HbA1c. Thoughts?

]]> By: AmyT http://www.diabetesmine.com/2008/12/the-fda-in-transition-diabetes-treatment-at-risk.html/comment-page-1#comment-180308 AmyT Mon, 15 Dec 2008 15:08:30 +0000 http://www.diabetesmine.com/?p=5264#comment-180308 Hi Aubrey, That's a strange comment coming from someone who is surely aware that fraud and misconduct often come from within the system itself. To understand our concerns, please read this post carefully: http://closeconcerns.typepad.com/close_concerns_weblog/2008/12/problems-at-fda-prompting-slowdowns-in-development-should-patients-accept-this-.html Thanks! Hi Aubrey,
That’s a strange comment coming from someone who is surely aware that fraud and misconduct often come from within the system itself.

To understand our concerns, please read this post carefully:
http://closeconcerns.typepad.com/close_concerns_weblog/2008/12/problems-at-fda-prompting-slowdowns-in-development-should-patients-accept-this-.html

Thanks!

]]> By: Aubrey http://www.diabetesmine.com/2008/12/the-fda-in-transition-diabetes-treatment-at-risk.html/comment-page-1#comment-180094 Aubrey Mon, 15 Dec 2008 11:57:51 +0000 http://www.diabetesmine.com/?p=5264#comment-180094 This is a strange post. I would have thought diabetic people would want more drugs based on proper science, with transparent information and based on honest research. Who benefits from scientific fraud and science/data which cannot be scrutinized? To criticize Nissen is to fail to understand anything of rthe problem facing medicine. Aubrey This is a strange post. I would have thought diabetic people would want more drugs based on proper science, with transparent information and based on honest research.

Who benefits from scientific fraud and science/data which cannot be scrutinized? To criticize Nissen is to fail to understand anything of rthe problem facing medicine.

Aubrey

]]> By: AmyT http://www.diabetesmine.com/2008/12/the-fda-in-transition-diabetes-treatment-at-risk.html/comment-page-1#comment-177131 AmyT Sat, 13 Dec 2008 20:01:02 +0000 http://www.diabetesmine.com/?p=5264#comment-177131 Hey Scott, This is far from over. We'd definitely like your assistance making some noise here. Hey Scott,
This is far from over. We’d definitely like your assistance making some noise here.

]]> By: Scott http://www.diabetesmine.com/2008/12/the-fda-in-transition-diabetes-treatment-at-risk.html/comment-page-1#comment-174701 Scott Fri, 12 Dec 2008 13:52:14 +0000 http://www.diabetesmine.com/?p=5264#comment-174701 Amy, thanks for your response, but I think you mistake my response to be bitter, and that wasn't what I was trying to imply, rather we lost a terrific opportunity by our failure to respond when the issue was first raised. Back in March, we had the opportunity to comment on the FDA's proposed guidance documents (which I did personally), but today, we're trying to approach this retrospectively. There is power in numbers, but its a lot harder to stop a wheel in motion than it is to prevent the wheel from moving in the first place!! Amy, thanks for your response, but I think you mistake my response to be bitter, and that wasn’t what I was trying to imply, rather we lost a terrific opportunity by our failure to respond when the issue was first raised. Back in March, we had the opportunity to comment on the FDA’s proposed guidance documents (which I did personally), but today, we’re trying to approach this retrospectively. There is power in numbers, but its a lot harder to stop a wheel in motion than it is to prevent the wheel from moving in the first place!!

]]> By: Lauren http://www.diabetesmine.com/2008/12/the-fda-in-transition-diabetes-treatment-at-risk.html/comment-page-1#comment-174118 Lauren Fri, 12 Dec 2008 07:33:24 +0000 http://www.diabetesmine.com/?p=5264#comment-174118 Plenty of doctors regard type 2 as a disease that results from unhealthy lifestyle choices. One of my clinic preceptors remarked to me that a half hour of exercise a day would do type 2 diabetics more good than all the drugs on the market. So I'm not surprised by Dr. Nissen's comment. I will have type 2 diabetic patients in the future, so of course I want the best therapies available to them. Being type 1, I am very tired of hearing the blanket term "diabetes epidemic." These days I don't volunteer that I have diabetes, or call myself diabetic, precisely because I am tired of all the rampant misconceptions. I want someone appointed who #1) recognizes the difference between the two types of diabetes and #2) will specifically address the needs of each type separately, in terms of drug approval, stem cells research, etc. Plenty of doctors regard type 2 as a disease that results from unhealthy lifestyle choices. One of my clinic preceptors remarked to me that a half hour of exercise a day would do type 2 diabetics more good than all the drugs on the market. So I’m not surprised by Dr. Nissen’s comment.

I will have type 2 diabetic patients in the future, so of course I want the best therapies available to them.

Being type 1, I am very tired of hearing the blanket term “diabetes epidemic.” These days I don’t volunteer that I have diabetes, or call myself diabetic, precisely because I am tired of all the rampant misconceptions.

I want someone appointed who #1) recognizes the difference between the two types of diabetes and #2) will specifically address the needs of each type separately, in terms of drug approval, stem cells research, etc.

]]> By: Kelly Close http://www.diabetesmine.com/2008/12/the-fda-in-transition-diabetes-treatment-at-risk.html/comment-page-1#comment-173950 Kelly Close Fri, 12 Dec 2008 04:59:09 +0000 http://www.diabetesmine.com/?p=5264#comment-173950 hey there...wow great dialogue. A couple thoughts to build on the above. A number of drugs might lower A1c but not all reduce variability -it would be nice to have both. And, since side effects can make taking drugs hard, I do think the same A1c drop and fewer side effects is a positive - it makes it easier to keep moving ahead! If some drugs lower A1c impressively but are hard for patients to take, then we need to either improve education or create alternatives. To Amy's point, we just don't want alternatives removed. A balance is needed where safety is paramount and where innovation is valued. Clearly things can be improved if over 8 million people (type 1 and type 2) are struggling with A1cs that are above the recommended level in the US alone. Some type 1s and type 2s could benefit from better products and if a federal agency is limiting the development unnecessarily behind the scenes, that doesn't make me feel great about the next decades. We want great safety testing done in a smart, balanced, way. Risk can be assessed in a sensible way, by doing the right trials, but not by driving away development of tools that could help us. The FDA patient rep has emphasized this herself and I think it would be great to rally around her and the idea of improved tools to manage our diabetes. Scott we super appreciate that you were the one out there early!!!!!! This is the case yet again and big time thanks from me : >. I have to admit I didn't think it would get as dire as it has. Companies are moving AWAY from investing in diabetes - again, a call for balance would be great by my view. And about Dr. Nissen - he has done a lot of impressive work in his career. But, he doesn't seemlike the best person to lead the agency at a time when someone truly visionary about diabetes could really move our diabetes cause forward, someone who really understands the disease from a patient perspective and has had lots of experience with the challenges.This could be an incredible opportunity to help usher in someone who really understands diabetes and to communicate with them regularly about our thoughts and needs. hey there…wow great dialogue. A couple thoughts to build on the above. A number of drugs might lower A1c but not all reduce variability -it would be nice to have both. And, since side effects can make taking drugs hard, I do think the same A1c drop and fewer side effects is a positive – it makes it easier to keep moving ahead! If some drugs lower A1c impressively but are hard for patients to take, then we need to either improve education or create alternatives. To Amy’s point, we just don’t want alternatives removed. A balance is needed where safety is paramount and where innovation is valued.

Clearly things can be improved if over 8 million people (type 1 and type 2) are struggling with A1cs that are above the recommended level in the US alone. Some type 1s and type 2s could benefit from better products and if a federal agency is limiting the development unnecessarily behind the scenes, that doesn’t make me feel great about the next decades. We want great safety testing done in a smart, balanced, way. Risk can be assessed in a sensible way, by doing the right trials, but not by driving away development of tools that could help us. The FDA patient rep has emphasized this herself and I think it would be great to rally around her and the idea of improved tools to manage our diabetes.

Scott we super appreciate that you were the one out there early!!!!!! This is the case yet again and big time thanks from me : >. I have to admit I didn’t think it would get as dire as it has. Companies are moving AWAY from investing in diabetes – again, a call for balance would be great by my view.

And about Dr. Nissen – he has done a lot of impressive work in his career. But, he doesn’t seemlike the best person to lead the agency at a time when someone truly visionary about diabetes could really move our diabetes cause forward, someone who really understands the disease from a patient perspective and has had lots of experience with the challenges.This could be an incredible opportunity to help usher in someone who really understands diabetes and to communicate with them regularly about our thoughts and needs.

]]> By: AmyT http://www.diabetesmine.com/2008/12/the-fda-in-transition-diabetes-treatment-at-risk.html/comment-page-1#comment-173531 AmyT Thu, 11 Dec 2008 22:13:40 +0000 http://www.diabetesmine.com/?p=5264#comment-173531 To Scott: please don't be bitter. If I've learned anything, it's that one blog post does not a campaign make. You really need to contact folks directly and shake their tree a little. So we've woken up to this issue now - that's good news, right? To Stephen: that was rather snarky, and I think you're wrong there. Everybody else: please keep the input coming :) To Scott: please don’t be bitter. If I’ve learned anything, it’s that one blog post does not a campaign make. You really need to contact folks directly and shake their tree a little. So we’ve woken up to this issue now – that’s good news, right?

To Stephen: that was rather snarky, and I think you’re wrong there.

Everybody else: please keep the input coming :)

]]> By: help4mac http://www.diabetesmine.com/2008/12/the-fda-in-transition-diabetes-treatment-at-risk.html/comment-page-1#comment-173421 help4mac Thu, 11 Dec 2008 20:33:31 +0000 http://www.diabetesmine.com/?p=5264#comment-173421 There is a lot wrong with the current diabetic treatment methodologies. On one hand A1C is important. On the other hand post prandial is more important but not necessarily reflected in the A1C. Meanwhile diet can accomplish as much or even more than these so-called modern drugs. I'm reminded of the chimps who know to eat a certain plant leaf when they feel indigestion. They can't go to the clinic but seem to do just fine in the wild on their own. There is a lot wrong with the current diabetic treatment methodologies. On one hand A1C is important. On the other hand post prandial is more important but not necessarily reflected in the A1C.

Meanwhile diet can accomplish as much or even more than these so-called modern drugs. I’m reminded of the chimps who know to eat a certain plant leaf when they feel indigestion. They can’t go to the clinic but seem to do just fine in the wild on their own.

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