Diabetes Drug Safety: Has Another Red Flag Been Raised?
Reaction to part of a big government-sponsored diabetes drug study being halted over fatalitiesis pouring in from several corners.
The American Diabetes Association put out a press releasesaying it "strongly encourages people with diabetes not to alter their course of treatment without first consulting with their health care team. The ADA continues to encourage good control of blood glucose for the management of diabetes and its complications."
But David Kliff, an insulin-dependent Type-2 diabetic who writes "The Diabetic Investor" newsletter is a little more blunt in a note to subscribers. "This announcement today will compound patient fears and likely create more confusion in the diabetes community." He goes on to say, "...it is possible, even likely, type 2 patients could use this announcement as another excuse to be non-compliant with their daily therapy regimen."
Meantime, I interviewed Dr. Michael Cuffe, a cardiologist at the Duke University Medical Center, who acknowledges that patients who hear about the halted study might be tempted to go off their meds.
On the one hand, he believes the results challenge the conventional wisdom that lower blood sugar is always better. But on the other hand he points out that most diabetics are not even getting their blood sugar level down to the currently recommended level. The higher number of deaths in the study occurred among patients who were being treated to a level below the guidelines.
Nonetheless Dr. Cuffe, who consults for diabetes drugmaker GlaxoSmithKline , says a letter is being sent out this afternoon to all Duke doctors telling them about the study news and advising them to check their patients who are being intensively treated.
The researchers were not able to conclude that any one diabetes drug or combination of diabetes drugs caused the higher number of deaths. GSK, which is dealing with a separate cardiovascular safety controversy over its diabetes pill Avandia,put out a statement taking heart in the fact that there's no evidence of a cause and effect.
No doubt, I will ask GSK CEO JP Garnier about it during his post-earnings announcement interview tomorrow morning on CNBC's "The Call" at about 11:10 ET.
Questions? Comments? Pharma@cnbc.com