Diabetes is one of the leading causes of death in the world. Diabetic patients are usually on prescription drug to control the insulin levels. Avandia, a drug made by GlaxoSmithKline is one of the most popular drugs for diabetes and is billion dollar cash cow for GlaxoSmithKline. Two independent studies published in reputed medical journals, using different methods for analysis found that Avandia significantly increases risk of heart attack. Avandia is in controversy since May 2007 when a study published in New England Journal of Medicine revealed that Avandia increased risk of heart attack by 43%. The study was lead by Dr. Steven E. Nissen, chairman of cardiology at the Cleveland Clinic, leading healthcare center for heart disease.
What do the two new studies reveal about Avandia?
The two studies were meta-analyses, which mean that data from multiple trials was analyzed into single data set. The main highlights from two studies are:
- Journal of the American Medical Association study used records for 227,571 patients in the federal Medicare program who were given either Avandia or Actos. The study concluded that patients on Avandia had higher risks of stroke, heart failure and death compared to those given Actos. The study was co-authored by Dr. David Graham, an F.D.A. drug safety expert who has advocated for Avandia’s withdrawal after results published in 2007.
- Dr. Graham’s study suggests that more than 47,000 people taking Avandia suffered a heart attack, stroke, heart failure or death from 1999 to 2009. It is also believed that if these patients had been taking Actos, would have been spared such health issues.
- The second study, published in the Archives of Internal Medicine and co-written by Dr. Nissen, is an updated version of his 2007 study. The study found that Avandia increased the risks of heart attack by 39% and the risks of heart-related death by 46%.
- Dr. Nissen’s study reiterated that Advandia should not be given to since Actos works just as well but appears to involve fewer risks.
What was GlaxoSmithKline response to the studies?
Obviously, Avandia brings significant revenue to GlaxoSmithKline, they quoted in view of other studies published on Avandia that “Taken together, these trials show that Avandia does not increase the overall risk of heart attack, stroke or death.”
- In 2007, FDA advised Avandia to be on market in spite of the higher risk of heart attack and this advised was voted by an oversight board. The fact is now responsibility is on the FDA experts that approved the drug in the first place.
- FDA has a meeting on 13 and 14 July to decide fate of Avandia and Dr. Joshua M. Sharfstein, F.D.A.’s principal deputy commissioner, said in an interview that “these are two important papers that will be part of the discussion that F.D.A. has as we consider the important question of Avandia’s safety.”
- Dr. Sharfstein also said that “We need to split up the people who approve a drug from those who oversee its safety.”
Diabetes affects a large population and so does heart disease. In fact heart disease is known to be number one cause for death in the United States. I can imagine that a drug that shows > 40% increased risk on heart attack can still be prescribed to the patients. I can understand that when Avandia was initially approved, FDA panel did not have enough information about the heart risk. Multiple studies since 2007 indicate that Avandia approval need serious attention and I look forward to outcome of FDA panel meeting in mid July.