For months now, we have been talking about the dangers of Avandia, the controversial type 2 diabetes drug made by GlaxoSmithKline. Now, it seems that the main alternative to the drug, Actos, may be an equally dangerous drug. In the August 2010 issue of Circulation: Cardiovascular Quality and Outcomes, the official journal of the American Heart Association, a large comparison of the two drugs showed essentially equal risk of cardiovascular problems and all-cause mortality, in contrast to a number of important studies showing Avandia resulted in a higher risk of heart attacks and other negative effects. The newest study was conducted by HealthCore, Inc, a division of Blue Cross and Blue Shield that mines the insurer’s clients for data in the service of pharmaceutical companies, government agencies, and other insurers. It took data from a population of about 36,000 people who began treatment with Actos (pioglitazone) or Avandia (rosiglitazone) from 2001 to 2005. Patients were matched with two similar controls to check for confounding variables. The study found that patients taking Actos were just as likely as those taking Avandia to suffer heart attack, heart failure, or death. Patients taking the drugs for less than a year were excluded, and the average time of following patients was 1.6 years. So does this study mean that Actos has the same risk as Avandia? Maybe, but there are several reasons why I doubt it:
- This study’s results are far from clear. The 95% confidence interval (the interval within which the actual number should be 95% likely to fall) is really large (0.24, almost a quarter of the reported 1.03 relative risk). It is so large that it significantly overlaps the large FDA study linked to above that shows a very clear risk.
- This is another study showing “no conclusive relative risk.” This is suspiciously like the same old story GSK has been telling us for years. We’ve already talked about ways in which the RECORD study may have been manipulated to conceal Avandia’s risk with confusion. With a few tantalizing hints that Avandia’s risks are greater, and none saying they are less, it seems unlikely that the risks are the same.
- GSK researched this question already. In 1999 GSK wanted to find out if its drug was safer for the heart than Actos. The results of that study were ordered concealed by GSK management. If this data showed that Avandia and Actos had the same level of risk, it would have been brought out this study in 2007 when it was losing market share, instead of complaining that the main reason Avandia seemed more dangerous was that no-one was researching Actos. Instead, it seems that GSK officials, at least, were convinced that Avandia had a higher risk and worked systematically to conceal that risk.
It is also worth noting that this class of drugs (thiazolidinediones, or TZDs) is potentially dangerous for relatively little gain. In fact, the first drug in the class was withdrawn after only three years on the market because it led to sometimes fatal liver damage. Whether Actos actually has the same level of risk as Avandia is still up in the air, but what is certain is that GSK has worked hard to conceal the level of risk posed by Avandia. If you or a loved one has suffered a serious injury related to Actos, Avandia, or another dangerous drug, the pharmaceutical injury lawyers of Robert W. Kerpsack, CO, LPA may be able to help you. Please call or email us today for a free initial consultation.