A study funded by GlaxoSmithKline is stirring up the Avandia controversy again, with some critics of the drug questioning  its findings on heart attacks and heart deaths.

The study, called RECORD,  involved 4,447 patients with type 2 diabetes, randomly selected to take Avandia plus metformin and sulfonylurea or just metformin and sulfonylurea.   The study was not blinded, meaning that study investigators and patients knew which treatment they were getting, WebMD said.

According to a report on usnews.com, the study found that Avandia “significantly” raises the risk of heart failure and fractures. But unlike previous research, this study did not find that people taking Avandia were at a higher risk of heart death, and was unable to determine if the Avandia patients in the study had a higher chance of heart attack.

Concerns over Avandia’s heart had prompted the American Diabetes Association to advise against prescribing Avandia in favor of Actos,  another drug in the same class, WebMD said.  But now, the Association may reconsider that stance in light of the RECORD study.

But some critics of the drug are saying “not so fast”. One of them, the renowned cardiologist Dr. Stephen Nissen. According to usnews.com, Nissen called the RECORD study “seriously flawed” because  more patients in the Avandia group were taking cholesterol-lowering statins and that group had what looked to be a high drop-out rate. “Obviously, it is impossible to assess the safety of a drug when patients are not actually taking it,” Nissen said.

In May 2007, Nissen published an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. That summer, GlaxoSmithKline and the Food & Drug Administration (FDA) came under fire for an apparent failure to warn the public about the cardiac risks associated with Avandia. In November 2007, a  warning detailing Avandia’s association with myocardial ischemia was added to the drug’s boxed warning.