Saturday, December 20, 2008

Rough Times for New Diabetes Drugs: The Diabetes Conspiracy Part III

It seems as if there are some individuals or groups of folks that just don't want new diabetes medicines. If diabetes was not a major problem in our country and/or if most patients with Type 2 diabetes were well controlled, then maybe this would not be so much of a problem. However, increasing rates of diabetes in the US have reached epidemic proportions, and most patients with Type 2 diabetes are not under good control (as defined by an A1c under 7%).

In the latest blow to Type 2 diabetics, the FDA recently announced that it will have stricter criteria before approving any new diabetes medications. Specifically, they are looking at cardiovascular risks:

We need to better understand the safety of new antidiabetic drugs. Therefore, companies should conduct a more thorough examination of their drugs' cardiovascular risks during the product's development stage," said Mary Parks, M.D., director, Division of Metabolism and Endocrinology Products, Center for
Drug Evaluation and Research (CDER), FDA

Though this may sound like a good thing, it means that it will take a lot more effort (time, money, patients needing to be enrolled in trials), for new diabetes pills to be approved. As the Wall Street Journal points out, this affects pending approval applications for one new diabetes drug called saxagliptin (made by Bristol-Myers Squibb Co. and AstraZeneca ) as well as a once weekly version of Byetta (made by Eli Lilly & Co. and Amylin Pharmaceuticals )

There is no question that there ought to be a balance between safety and efficacy when it comes to new drugs. Drugs that have substantial risks should be studied more carefully, even if that means delaying needed treatment for patients. The problem here is that the delayed approval for newer diabetes medicines which are currently needed is due to one highly publicized and poorly done meta-analysis, which has not be substantiated and in fact has been pretty much been disproven based on recent studies.

In the The Diabetes Conspiracy (Part I), I mentioned how the newer diabetes pills, specifically Advanida and Januvia, were being blamed for the increased cost of diabetes care, when in fact newer insulins were not only contributing equally but also being prescribed at a much faster pace. In Avandia Vindicated (Again): The Diabetes Conspiracy Part II , as well as other posts, I go over study after study which shows that there is no real heart attack risk seen with Avandia, since we now have randomized studies where over 26,000 patients have been studied for over 3.5 years, of which more than 15,000 patients took Avandia and showed absolutely no difference in heart attacks or myocardial ischemia.

The FDA's decision to make it harder for newer diabetes drugs to be approved based on one poorly done, highly publicized and likely politically motivated study is the first action to likely have a real impact on patients. If older (and cheaper) drugs worked so well, then this wouldn't be a problem. However, the reality is that we need new drugs to get a handle on this very difficult to control disease. However, there are some that would like to turn back the clock, and only use older medications which we know aren't working. These folks are waving the banner of safety to defend their position. The next step, which will go beyond headlines and also have real patient impact will be the new diabetes guidelines, which will be published in just a few weeks. When these come out, I will comment on what I anticipate to be ridiculous and impractical recommendations in The Diabetes Conspiracy Part IV.

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