Wednesday, October 2, 2013

Diabetes, Drugs, and Cardiovascular Risk

The October 3 New England Journal features a “Perspectives” written by Drs. William R. Hiatt, Sanjay Kaul, and Robert J. Smith, all members of the FDA Endocrine and Metabolic Drugs Advisory Committee:

The basic thrust of their piece is to defend the drug rosiglitazone (Avandia) from the accusations we’ve reviewed widely in this blog, that it causes excess cardiovascular risk. These authors appear to believe that when all the data are in, the risk has been overblown. (According to the on-line disclosure forms, two of the three have some financial ties to the drug industry, but this group does not appear to be overloaded with conflicts of interest so far as I can tell.)

They then proceed to discuss two newer diabetes drugs that have been subjected to extra scrutiny by the FDA, which is now gun-shy over diabetes drugs since the Avandia affair.  These newer drugs also appear to be reasonably safe in terms of not causing excess cardiovascular risks. But the flip side of that was that neither drug decreased cardiovascular risks, either, as one would hope for from a drug that treated a condition that is a major cause of cardiovascular disease.

In previous posts I have hammered on about one of the major consequences of drug industry marketing on diabetes:
--which is the promulgation of a flawed disease model among both practicing docs and the general public. We now have a lot of evidence that Type 2 (adult) diabetes should not be viewed primarily as “high blood sugar,” that drugs that lower blood sugar very well may be useless for preventing the downstream complications of diabetes. Yet drug industry and device marketing still finds the big bucks in pushing tight sugar control and close sugar monitoring.

So I find it worthwhile noting these passages in the “Perspective” by Drs. Hiatt, Kaul and Smith, and if they have financial ties to companies that make diabetes drugs, these passages are all the more impressive:

“From a cardiovascular perspective, rosiglitazone, saxagliptin, and alogliptin appear to be relatively safe. It is disappointing, however, that neither intensive glycemic control nor the use of specific diabetes medications is associated with any suggestion of cardiovascular benefit. Thus the evidence does not support the use of glycated hemoglobin as a valid surrogate for assessing either the cardiovascular risks or the cardiovascular benefits of diabetes therapy….New therapies targeting glycemic control may have cardiovascular benefit, but this has yet to be shown. The optimal approach to the reduction of cardiovascular risk in diabetes should focus on aggressive management of the standard cardiovascular risk factors rather than on intensive glycemic control.”

Let me translate a bit: Drugs that lower blood sugar have not yet been shown to prevent heart and blood vessel disease in adult-type diabetes. Treating Type 2 diabetes today should focus on proven methods for preventing such diseases, which is to lower cardiovascular risk factors. Simply showing that a drug lowers blood sugar says nothing about its value for preventing the serious complications of diabetes and should not be accepted by the FDA as a reason to market a new drug. And there you have it, from the (supposed) experts.

No comments: