The NEJM can't get over the fact that the FDA Adcomm ignored their wizened advice and Steven Nissen/their best efforts to get Avandia canned, so on the heels of the incredibly inaccurate and whiny article by Jerry Avorn, it publishes yet another screed by Sheila Smith about how the FDA has failed to respond to the IOM recommendations -- which of course were made by Bruce Psaty, David Blumenthal and Sheila Burke.
Let's remember at the Avandia meeting David Graham used meta-analysis and unpublished data from an observational study that did not have safety as a primary endpoint to remove a drug. I guess that's what Sheila Smith means in her article about giving safety staff a strong voice.
http://content.nejm.org/cgi/content/full/357/10/960?query=TOC
Let's remember at the Avandia meeting David Graham used meta-analysis and unpublished data from an observational study that did not have safety as a primary endpoint to remove a drug. I guess that's what Sheila Smith means in her article about giving safety staff a strong voice.
http://content.nejm.org/cgi/content/full/357/10/960?query=TOC
