The FDA has been criticizing the handling of Avandia for the past three weeks now. Avandia was the subject of a meta-analysis which is an overview of the results of many smaller studies. In the study, it was found that those taking Avandia had a 43% greater chance of death or heart attack than those not taking the drug.
The data was being reviewed and the reputations of Glaxo and the FDA was trying to be restored. The FDA asked Glaxo to include a Black Box (highest level) warning on the drug’s packaging at a congressional hearing, to warn people of the heart disease risk.
Some observations were made by insiders, now that some of the craziness has settled down. Avandia should remain a vital part of the treatment for peoples whose blood sugar levels are resistant to control. When compared to the general U.S. population, people with diabetes have twice the risk, (100% greater risk), of death from heart disease and stroke. The American Diabetes Association says that 2 out of 3 people with diabetes (i.e. two-thirds) die from heart disease and stroke. The National Centre for Health Statistics reports that heart disease and stroke are the leading cause of death in the United States, accounting for approximately one-third of all deaths. These statistics are staggering and extremely hard to believe, but they are all 100% true.
The sad part about all of this is that the general public could have been warned about the dangers and effects of Avandia, which could prevent a significant amount of deaths. Another problem is that the FDA spends much more time doing research on new drugs and improvements rather than spending more time doing follow-ups on previously studied drugs in order to better understand them. Not being warned about a drug or anything in life can be detrimental and it’s an extreme cause for concern.
For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.