Comments on: Unreasonable Standards by the FDA for New Diabetes Drug Approval?

By: Al Lazzara

Al Lazzara — Thu, 25 Jun 2009 18:55:08 +0000

I am a male 47 years of age. 2 years ago my A1C was at 9.9 i was eating horribly and not exercising. Now my diet consists of South beach diet phase 2 my A1C is now 6.5 and my sugars are between 80 to 130 . My exercise routine is every other day due to my weight I am 5′ 7 1/2 lbs and at 282lbs my back is killing me.

I understand that there needs to be a lot of testing for these things and rightly so. Ive noticed that there is some hazards with Byetta and am glad im not on that and on avandia. I must point out that with the problems diabetics already have we do not need to compound it with more even though I do wish the testings would some how be able to go faster and that more and more research is done with stem cell testing.

My next option is to go for bariatric surgery..but my insurance wont cover it.

So here i am at a catch 22 . I hope they come up with something soon.

By: Dr. G. Pepper

Dr. G. Pepper — Wed, 17 Jun 2009 02:24:03 +0000

Hi Brian

The purpose of my post was not to comment on the ability of the new diabetes drugs to control blood sugar, but to show how fragile the medical community is when it comes to setting policy. In the case of the FDA a few vocal critics were able to undermine the whole process by which new diabetes drugs are evaluated. I agree with you that the new drugs now being stalled in the approval process are likely to be no better than available choices. I also agree that if type 2 diabetics would follow vigorous diet and exercise programs that much of the medicine they take would not be necessary. If you come up with a reliable way to get diabetics to change their life styles sufficiently to achieve that goal, you will accomplish what no one else has in the last century.

By: Brian Dean

Brian Dean — Tue, 16 Jun 2009 22:27:21 +0000

Hi Dr. Pepper,

Thanks for providing that information. However, I have to disagree with certain points in the post.

Firstly, as much as advancing diabetes treatments through new pharmacological methods sounds great in theory, it ignores the fact that there is already a safe and efficacious treatment for diabetes: diet and exercise. This should be our primary option when treating patients with DMII. The more medications come out, the more marketing dollars get put behind drugs for diabetes, the more diet gets ignored.

Also, there is no paucity of antihyperglycemic agents available now. They are generally well tolerated and combined with lifestyle change, can have a significant influence on A1C levels.

In summary, I’m absolutely fine with forcing Big Pharm to collect more data on safety before releasing medications that may overshadow the amazingly effective treatment of diet and exercise.

-Brian Dean MS, RD