The 13% Difference
Yesterday GlaxoSmithKline (NYSE:GSK) Chief Executive Jean-Pierre Garnier said it is “very possible” that sales of its diabetes drug Avandia could regain lost ground once safety data the company expects to vindicate the treatment becomes available.
Today we learned that nearly six years ago Dr. John Buse, then and now the director of UNC-Chapel Hill’s Diabetes Care Center, cautioned U.S. officials about Avandia, according to documents from the U.S. Food and Drug Administration (FDA).
What Diabetic Investor finds most interesting is that GSK’s own studies found that Avandia increased the risk of heart attack by 30 percent, and said it told the FDA this last year. The New England Journal of Medicine on Monday that said people taking the drug have a 43 percent greater risk of heart attack than patients using other diabetes drugs, or no medication. Does it really matter if Avandia increased the risk of heart attack by 4 out of 10 patients rather than 3 out of 10? Is the 13% difference between GSK’s own data and the data presented Monday enough to vindicate the drug?
Think for a moment if you’re a physician advising a patient who is currently taking Avandia. Assume for a moment that you believe the meta-analysis by Dr. Nissen has too many flaws and you have greater faith in GSK’s analysis. Does the fact that the company’s own data says that 3 out of 10 patients have increased risk of heart attack make you more comfortable? Do these numbers give relieve your concerns in light of the fact there are other drugs available that you could put your patient on? Are you willing to risk a malpractice lawsuit on these numbers? And what happens should the drug be pulled from the market, how will you explain that to the patients you told to stay on Avandia?
Let’s get real here folks. It’s understandable that GSK will do anything they can to prevent Avandia from becoming the next Vioxx or Rezulin. However the company’s own data indicates there is a problem with the drug and it’s not the only adverse event associated with Avandia. Edema, weight gain and an increase in bone fractures are also associated with Avandia usage. Will it take patient’s dropping dead before physicians start to see the light here?
Metformin, Januvia, Byetta and insulin are all alternatives that can be used, alternatives which are both safe and effective. Why would any physician or patient want to take the chance on having a heart attack with continued Avandia usage when they could easily switch to another option with a lower risk profile? This is like someone believing its ok to drive intoxicated because they only have short drive and their really not that drunk. Let’s get real here.