Three studies were published this week on GlaxoSmithKline’s blockbuster diabetes drug Avandia (rosiglitazone). Two of the studies show that Avandia (rosiglitazone) is a dangerous drug that increases the risk of cardiovascular events such as myocardial infarction (MI, or heart attack), stroke, heart failure, and death. The third implied that there was no such risk. The first study is a follow-up by cardiologist Steven E. Nissen of the cardiovascular bomb dropped on Avandia in 2007, when the drug was the best-selling diabetes drug in the world. Like the previous study, it is a meta-analysis of all randomized trials of Avandia, this time including every study 24 months or longer. The result showed a statistically significant increase in risk of heart attack (28%), but not in cardiovascular or all-cause mortality. When GSK’s RECORD study was excluded, the risk of MI and cardiovascular death increased significantly to 39% and 46%, respectively.
The second study is an observational study based on the records of 227,571 Medicare patients who were on diabetes control drugs Avandia or Actos (proglitazone). The results of this review showed no statistically-significant difference in MI, but heart failure seemed to be increased by 27% and CV death by 14%. Commenting on the disparity between the results, Nissen noted, “It’s two sides of the same coin. It’s really about how you die and when you die. If you followed the people in our study long enough, the fact that they had heart attacks means they are more likely to die sooner.”
The third study, known as BARI 2-D, showed no increased risk of cardiovascular events. It might be considered another in a series of “denial studies” designed by GSK to promote the narrative that “rosiglitazone does not increase the overall risk of heart attack, stroke[,] or death.” The leading “denial study” is GSK’s RECORD study. RECORD stands for “Rosiglitazone Evaluated for Cardiovascular outcomes in ORal agent combination therapy for type 2 Diabetes”, but as early as 2004, the company knew RECORD was “underpowered” to resolve the question (“Staff Report on GlaxoSmithKline and the Diabetes Drug Avandia”). Instead of designing a new study to replace or augment RECORD, the company pursued it for five years so that it could hold the study up and say, “this study doesn’t show any risk.”
If GSK wanted to resolve the issue of Avandia’s heart-attack risk, it could have designed a study to put the question to rest, but it did not. One suspects that GSK knows what the answer will be and doesn’t want us to know. After all, GSK reviewed Nissen’s original analysis (which showed a 68% increase in the risk of cardiovascular death from Avandia use), and internal documents show it agreed with his findings (“Staff Report on GlaxoSmithKline and the Diabetes Drug Avandia”).
If you have been hurt by Avandia or another dangerous drug whose risks were denied, downplayed, or concealed by its manufacturer, the pharmaceutical injury lawyers of Robert W. Kerpsack Co, LPA can help. To learn how, please contact us today for a free initial consultation.