Unreasonable Standards by the FDA for New Diabetes Drug Approval?

This post is the third in a series under the title: 2009. Another Troubled Year for Endocrinologists.

This year the FDA has instituted new standards for diabetes drugs coming up for approval. These new standards require that each new drug prior to approval must demonstrate the lack of any negative impact on cardiovascular (heart and blood vessel) health. While this may seem a legitimate requirement, in reality it requires thousands of patients be treated for many more years in research settings to acquire this information. So far three new diabetes medications from Takeda Pharmaceuticals, Novo Nordisk and Bristol Myers have all been put in limbo due to delays on their approval based on the new requirements.

I would point to the case of Avandia as an example of how difficult it is to prove that a drug has negative cardiovascular effects. In 2007 an alarm was sounded by several outspoken critics, whose analysis pointed to increased cardiovascular risk from Avandia. At that time Avandia was a key diabetes medication on the market for over 5 years with millions of individuals treated. Although the diabetes community remained split on the truth of these assertions major medical organizations such as the American Diabetes Association placed a virtual ban on the use of this medication and the FDA placed its highest “black box” level warning on Avandia use. At that time the FDA was criticized widely for allowing this supposed public danger to go unrecognized for so long. Many think that it is in response to this criticism that the FDA was forced to add the new much more stringent requirements on new drug approval.

Since 2007 however, a large V.A. study (the VADT study) and the 2009 RECORD study both found no evidence of cardiovascular risk with Avandia use. The belief is growing that the FDA was initially correct in allowing Avandia to come to market, although so much negative publicity has hurt the use of Avandia and led the FDA to take a highly defensive approach to new drug approval.

Some pharmaceutical executives believe the new FDA requirements will double the cost of bringing a new drug to market. Approval of several promising new diabetes treatments has already been stalled and the companies developing new medical therapies are beginning to move diabetes treatment to the back-burner. It is likely that it will takes years to reverse this trend, if a reversal is possible at all.

Gary Pepper, M.D. Editor-in-Chief, Metabolism.com

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  • 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

    • Dr. G. Pepper

      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.

  • Al Lazzara

    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.