Not surprisingly, the Avandia news was the big buzz at the meeting of the European Association for the Study of Diabetes (EASD) in Stockholm. Attendees I spoke with expressed surprise that although the U.S. Food and Drug Administration and the European Medicines Agency had made announcements on same day, their decisions were different: The EMA had suspended Avandia entirely from the European market while the FDA decided to keep it on the U.S. market with tight restrictions.
How could the European and American agencies have reviewed the same data yet come to different conclusions regarding risk/benefit? And which decision was right? There was much speculation and debate in the hallways at EASD.
Simultaneously, another transatlantic debate was taking place at the meeting. This one, though less likely to make headlines, also has major implications for clinical practice worldwide.
Back in January 2010, the American Diabetes Association recommended the use of hemoglobin A1c for diagnosing diabetes, listing convenience and stability of the test among the advantages. The move was controversial, with many scientists citing data suggesting that sizable proportions of people with diabetes will be missed by using that test rather than either fasting glucose or an oral glucose tolerance test (OGTT), considered the gold standard.
At the EASD meeting, investigators from the U.K., Spain, Norway, France, Portugal, and the Republic of Korea presented data showing a lack of correlation between the tests, and either advised against or at least recommended caution in the use of A1c as a diagnostic.
Prof. George Alberti summarized an expert committee’s recommendation to the World Health Organization that glucose testing should remain the preferred diagnostic method, with A1c as an alternative provided that certain conditions are met. Both the WHO and the EASD are expected to issue positions soon.
I asked Dr. M. Sue Kirkman, clinical affairs vice president at ADA, to comment. She said that the ADA had been aware of data showing that the A1c may be less sensitive and therefore would identify fewer people with diabetes than does the fasting glucose, which in turn detects fewer cases than does the OGTT.
She noted that the ADA didn’t advise against glucose tests. “If people want to use glucose tests, they certainly can. But the reality is that a quarter of people with type 2 diabetes in the U.S. are undiagnosed. If you have a test that doesn’t require fasting, that you do when the patient’s in your office—especially in populations with less access to medical care—we think in the real world you can actually diagnose more people.”
While there’s disagreement over diagnostics, at least there’s one point of agreement: Few if any of those patients will be treated with Avandia.
—Miriam E. Tucker (@MiriamETucker on Twitter)