Days before the advisory committee hearing on Ketek's risk/benefit profile guess who sends a letter to the NEJM claiming that the FDA's use of post market safety data in approving the drug was inappropriate?
David Graham.
But I thought that using observational databases were the key to identifying safety signals like those he found with Vioxx.
I guess they are only good if you find what you are looking for. Or if your sponsor Senator Grassley wants to put pressure on the FDA commissioner to politicize the review of Ketek by conducting a political show trial instead of a scientific inquiry.
I said I would criticize Graham and I will. He is nothing but a hack who will twist science to curry favor with his political patrons.
He also twists the truth. Ketek use is just not limited to sinus infections. Or maybe Graham and Grassley failed to read the medical literature about the use of ketek in treating COPD as well as community acquired pneumonia and the role the drug plays in reducing the risk of developing drug resistant bacterial strains...
If Andy doesn't get confirmed because he doesn't cave into Grassley's bullying and Graham's zealotry, good for him. It will make the FDA a stronger and saner place. Someone should drawn the line.
David Graham.
But I thought that using observational databases were the key to identifying safety signals like those he found with Vioxx.
I guess they are only good if you find what you are looking for. Or if your sponsor Senator Grassley wants to put pressure on the FDA commissioner to politicize the review of Ketek by conducting a political show trial instead of a scientific inquiry.
I said I would criticize Graham and I will. He is nothing but a hack who will twist science to curry favor with his political patrons.
He also twists the truth. Ketek use is just not limited to sinus infections. Or maybe Graham and Grassley failed to read the medical literature about the use of ketek in treating COPD as well as community acquired pneumonia and the role the drug plays in reducing the risk of developing drug resistant bacterial strains...
If Andy doesn't get confirmed because he doesn't cave into Grassley's bullying and Graham's zealotry, good for him. It will make the FDA a stronger and saner place. Someone should drawn the line.
