Experts seek more study of diabetes drugs

Last year, my colleague Dr. Tom Lee wrote a blog [LINK to: http://www.gather.com/viewArticle.jsp?articleId=281474977027417&grpId=3659174697246155&nav=Groupspace] after the diabetes drug Avandia was found to cause heart problems. Though this information came out more than a year ago, its impact is still being felt. For example, a panel of experts that serve as advisors to the U.S. Food and Drug Administration (FDA) said this month that the FDA should require that diabetes drugs be tested to see if they increase heart problems. Though the FDA does not have to do what its advisers suggest, it usually does. 

Here, my colleague Dr. Howard Lewine reacts to the panel's findings: 

Advisers to the U.S. Food and Drug Administration deserve some applause. The advisers are pushing for better evidence that drugs you might need to take for many years really help improve your health.

During the last decade, there has been a big push to have diabetics maintain close to normal blood sugar levels. For type 1 diabetes, keeping blood sugar well controlled right from the day of diagnosis is the right thing to do.

But for the much more common type of diabetes, type 2 diabetes, the evidence for tight blood sugar control is not so clear. Two recent studies suggest that using lots of drugs just to lower blood sugar levels doesn't necessarily lead to better health. In fact, one study suggested that in some people it may be harmful.

This does not mean that all diabetes drugs are suspect. For example, metformin is a relatively low-cost medicine that does much more than lower blood sugar. Metformin decreases sugar production by the liver and helps insulin work more efficiently. It doesn't cause weight gain, lowers total cholesterol levels and seems to decrease risk of heart attack.

In the future, the FDA may request that drug companies wishing to get approval for new diabetes drugs do longer studies on these drugs. Also, the companies will need to show that they do more than just lower blood sugar levels. The drugs should show other benefits with reasonable assurance about safety.

Julie K. Silver, M.D., is an assistant professor in the Department of Physical Medicine and Rehabilitation at Harvard Medical School. She is also the Chief Editor of Books for Harvard Health Publications.

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