Last Updated Feb 25, 2010 2:24 PM EST
In a 30-page response, GSK angrily blasts the report as "misleading" and says "the Staff Report mischaracterizes and distorts the efforts that GlaxoSmithKline LLC ("GSK") took to continue to monitor the safety and efficacy of its diabetes medication."
The company cites nine studies that included Avandia and makes the case that none of them showed significant risks of various types of heart problems. At first glance it seems convincing. But, as always, the devil is in the details. If you read the studies themselves -- rather than GSK's summary of them -- you find that there are indeed some findings for Avandia that aren't altogether rosy.
The nine studies, all funded by GSK, had cutesy acronym-based names, as is the habit in the drug business: RECORD, APPROACH, VICTORY, VADT, ACCORD, BARI-2D, ADOPT, DREAM and STARR. Seven of them showed either that there were some increased side effects in patients taking Avandia, including heart attacks, or that Avandia wasn't as effective as other treatments. Here's a sampling (in which, by the way, Avandia is often referred to by its generic name rosiglitazone):
RECORD: "Heart failure causing admission to hospital or death occurred in 61 people in the rosiglitazone group and 29 in the active control group."
"Addition of rosiglitazone to glucose-lowering therapy in people with type 2 diabetes is confirmed to increase the risk of heart failure and of some fractures, mainly in women."
APPROACH: This study showed no difference in side effects between Avandia and other drugs, but also that Avandia was no better at reducing atherosclerosis.
ACCORD: GSK notes that 91.2% of patients were taking Avandia in the "intensive strategy" arm of this study. The study says, " The intensive strategy group had a 22 percent higher risk of death â€" or 54 more deaths -- compared to the standard group."
VADT: "The rates of adverse events, predominantly hypoglycemia, were 17.6% in the standard-therapy group and 24.1% in the intensive-therapy group."
ADOPT: This study showed higher rates of fluid retention and weight gain with Avandia than other drugs.
DREAM: "14 (0.5%) participants in the rosiglitazone group and two (0.1%) in the placebo group developed heart failure."
Those aren't all the studies done on this drug, of course. And you can fault me for cherry-picking data. So here's a meta-analysis performed by the University of British Columbia that was not funded by GSK. In the first six months of use, it found a 50 percent increase in heart attacks in Avandia users.