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http://blogs.wsj.com/health/2008/06/27/fda-ponders-requiring-heart-studies-for-diabetes-drugs

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FDA Ponders Requiring Heart Studies for Diabetes Drugs

June 27, 2008
by Jacob Goldstein

The FDA is summoning a panel of experts to consider whether drug makers should be forced to study the cardiovascular effects of diabetes drugs. It’s a complicated question that raises some thorny (and interesting) issues.

Diabetes dramatically raises the risk of serious cardiovascular problems such as heart attacks and strokes. So it stands to reason that a drug that controls the blood-sugar swings that are the defining feature of diabetes should also lower cardiovascular risk.

But that doesn’t always seem to be the case. In fact, as this FDA briefing notes, no diabetes drugs have ever been clearly proven to lower the risk of heart attacks and strokes. And GlaxoSmithKline’s Avandia definitely helps with blood sugar issues, but it may actually raise cardiovascular risks (though the evidence is inconclusive).

So should diabetes drugs — which are tested primarily for their ability to control blood sugar — also be tested for cardiovascular effects?

It sounds easy enough. But heart attacks and strokes are pretty rare events, even among diabetics. That means you need really big studies, and they need to last for a while, if you’re going to get any clear answers about whether drugs increase (or decrease) the risk of heart attacks or strokes. That’s very expensive, and could slow the development of new drugs.

The FDA briefing makes this clear:

“Establishing a hurdle of long-term, costly trials to exclude cardiovascular harm may also affect drug development for type 2 diabetes, particularly if this mandate applies to every product, even those that have no suggestion of cardiotoxicity.” [The above use of the word “may” is a heck of an understatement!]

Still, this draft of questions to be considered at next week’s panel meeting suggests that the discussion could be pretty wide-ranging. The first question on the list gets to heart of the matter: “What specific cardiovascular assessments should be required as part of the approval process for drugs and biologics developed for the treatment of type 2 diabetes, and why?”
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