Garnier: Avandia Is A “Very Unpleasant Event”
Make a commentBy Ed Silverman // July 8th, 2007 // 11:36 pm
Glaxo’s ceo is struggling with Avandiagate, but is trying to show anxious investors that he is in control. As part of the campaign, he chats with The Wall Street Journal (subscription required) about the crisis. JP makes the now de rigeur comments that data was always accessible and downplays concern that patients are switching to other diabetes meds, but he never addresses the charges that Glaxo played rough with skeptics.
Q: Has Glaxo done everything it could to study Avandia and communicate its risks to the public?
JP: We’re not perfect, I’m sure. With 20-20 hindsight we could have done more. But I have to say in the case of Avandia, you see that we were diligent from the day of the launch to start to study the drug in some depth in (clinical) studies and then we did the meta-analysis a year ahead of Dr. Nissen.
As soon as we found out that there was at least a question raised by the meta-analysis, we immediately did the epidemiology study with 30,000 patients that came out absolutely squeaky clean and supportive of Avandia. So you look at the totality, Avandia is by far the most studied diabetic agent on the market today. So sure, maybe we could do more, but frankly the record is very good. Not only have we studied this drug right, left and center, but also we have been transparent, informed everybody.
Q: What feedback are you getting from doctors about Avandia?
JP: Doctors are worried about being sued for putting patients on Avandia and things like this. But overall, they are staying behind Avandia. Very few patients actually are switching off their medication. But some have.
Q: Are doctors more concerned about liability risk when putting new patients on the drug?
JP: Physicians are naturally gun-shy about putting new patients on. The reality is, and we have the data, they’re putting fewer new patients on it. We’ve just run a big survey of physicians, and they’re playing back again the two key points: “Most of my patients have not switched, and I have no intention of switching them. However, as far as putting new patients on Avandia, I’m putting far fewer than before, and I’m waiting to see what the FDA has to say.”
Q: Does the safety flap take up your entire day?
JP: Pretty much, 24-7. This is a very unpleasant event. But on the other hand this is not my first one. I’ve been there before. My job is to manage the company through the crisis.
Q: How do you do that?
JP: We have crisis-management phone calls every day. These things don’t get done without a lot of coordination.