Here's Steve Nissen's take on the 20-12 recommendation of the FDA advisory committee to keep Avandia on the market:
“Effectively, this drug is gone.”
U.S. sales of the drug have plunged from $2.2 billion in 2006 to $520 million last year because of fears generated largely by Nissen. Meanwhile Actos, made by Takeda, the company Nissen has consulted for, has seen sales of it's product soar from $1. 9 billion in 2006 to $3.4 billion last year.
I think they got their money's worth.
Whether patients did is another matter. During the same time, the combined number of scrips for TZDs declined overall by 40 percent and scrips for oral diabetes agents fell by 20 percent. (I am going to double check this figure..) Did cardiovascular events among diabetics decline by 25 to 43 percent as might be predicted? No.
While there was an effort to depict Avandia's problems as a matter of deadly risks purposely hidden by GSK the issue was really two-fold. First, the fact that the FDA had to react to the risks of Avanda as framed by Nissen rather than the overall risk and benefits of each drug in the class in the context of treating diabetes and all it's complications. It had to focus on heart risks and whether surrogate endpoints were reliable, etc. all of which were issues framed to undermine confidence in the FDA and shift power to Nissen and outside or rogue forces. Second, and only after wading through this thicket, was the FDA able even to carry out it's public health responsibility and provide the advisory committee with that task. To that end, Commissioner Hamburg's leadership on this issue, along with the stewardship of Drs. Woodcock, Temple, Jenkins and DelPan should be applauded. And once again David Graham demonstrated why he is best suited for getting coffee in the FDA's division of psychopharmacology..
The big question is whether the treatment and management of diabetes is better off after the fearmongering.
More people have diabetes and fewer people are taking drugs. Is that a good thing?
Maybe Nissen should worry more about patients instead of his publicity and his bank account.
“Effectively, this drug is gone.”
U.S. sales of the drug have plunged from $2.2 billion in 2006 to $520 million last year because of fears generated largely by Nissen. Meanwhile Actos, made by Takeda, the company Nissen has consulted for, has seen sales of it's product soar from $1. 9 billion in 2006 to $3.4 billion last year.
I think they got their money's worth.
Whether patients did is another matter. During the same time, the combined number of scrips for TZDs declined overall by 40 percent and scrips for oral diabetes agents fell by 20 percent. (I am going to double check this figure..) Did cardiovascular events among diabetics decline by 25 to 43 percent as might be predicted? No.
While there was an effort to depict Avandia's problems as a matter of deadly risks purposely hidden by GSK the issue was really two-fold. First, the fact that the FDA had to react to the risks of Avanda as framed by Nissen rather than the overall risk and benefits of each drug in the class in the context of treating diabetes and all it's complications. It had to focus on heart risks and whether surrogate endpoints were reliable, etc. all of which were issues framed to undermine confidence in the FDA and shift power to Nissen and outside or rogue forces. Second, and only after wading through this thicket, was the FDA able even to carry out it's public health responsibility and provide the advisory committee with that task. To that end, Commissioner Hamburg's leadership on this issue, along with the stewardship of Drs. Woodcock, Temple, Jenkins and DelPan should be applauded. And once again David Graham demonstrated why he is best suited for getting coffee in the FDA's division of psychopharmacology..
The big question is whether the treatment and management of diabetes is better off after the fearmongering.
More people have diabetes and fewer people are taking drugs. Is that a good thing?
Maybe Nissen should worry more about patients instead of his publicity and his bank account.
