AvandiaGate, as it is now being called, heated up again last week. There has been considerable discussion of Dr. Steve Nissen’s recent meta-analysis of GlaxoSmithKline’s Avandia.
Several gentlemen who run a pharma blog have been attacked for criticizing Dr. Nissen’s “study.” However, they haven’t been attacked for what they have said, only who they are and what they do professionally.
Here’s how I see it—
Dr. Nissen, by his own admission under examination by Patrick McHenry (R-NC), has indicated that he provided “very preliminary results” of his study to Democratic congressional staff in February, prior to peer review or submitting for publication. Why? Dr. Nissen, again by his own admission, felt that a publicity campaign via Congress was more his style. When asked directly why he didn’t report this to the regulatory agency in charge of patient safety, he replied, “That is not how it’s done.” Interesting…
Even backers of Dr. Nissen have acknowledged the fact this meta-analysis study has more holes than the U.S. border with Mexico. Which leads me to ask a question—had Dr. Nissen’s study gone the other way and actually supported Avandia, would the methodology have been sufficient to get the study published? I suspect not.
I can’t say for certain that Dr. Nissen aspires to the job of FDA Commissioner, as the gentlemen have claimed. However, it would appear that Nissen has been promoting himself for a long time now. You can draw your own conclusions.
As for the gentlemen bloggers, it is interesting that their critics have been unable to assail anything they’ve actually said. They have been criticized for working at a PR firm or a non-profit think tank. The inability of their detractors (and Dr. Nissen’s supporters) to shoot holes in their ideas lends credibility to what they are saying—this appears to be a shrewd move and was about political gain.
Personally, I will wait for July’s FDA meeting before making a decision on the drug itself.
Several gentlemen who run a pharma blog have been attacked for criticizing Dr. Nissen’s “study.” However, they haven’t been attacked for what they have said, only who they are and what they do professionally.
Here’s how I see it—
Dr. Nissen, by his own admission under examination by Patrick McHenry (R-NC), has indicated that he provided “very preliminary results” of his study to Democratic congressional staff in February, prior to peer review or submitting for publication. Why? Dr. Nissen, again by his own admission, felt that a publicity campaign via Congress was more his style. When asked directly why he didn’t report this to the regulatory agency in charge of patient safety, he replied, “That is not how it’s done.” Interesting…
Even backers of Dr. Nissen have acknowledged the fact this meta-analysis study has more holes than the U.S. border with Mexico. Which leads me to ask a question—had Dr. Nissen’s study gone the other way and actually supported Avandia, would the methodology have been sufficient to get the study published? I suspect not.
I can’t say for certain that Dr. Nissen aspires to the job of FDA Commissioner, as the gentlemen have claimed. However, it would appear that Nissen has been promoting himself for a long time now. You can draw your own conclusions.
As for the gentlemen bloggers, it is interesting that their critics have been unable to assail anything they’ve actually said. They have been criticized for working at a PR firm or a non-profit think tank. The inability of their detractors (and Dr. Nissen’s supporters) to shoot holes in their ideas lends credibility to what they are saying—this appears to be a shrewd move and was about political gain.
Personally, I will wait for July’s FDA meeting before making a decision on the drug itself.