Dr. David Graham of the tort lawer funded Goverment Accountability Project told the FDA that Avandia, along with "one meelion" other drugs should be yanked from the market.
Graham ostensibly "works" for the FDA but splits his time between GAP, having lunch with Senator Charles Grassley and talking to reporters. In his presentation to the FDA Graham never quite explained how a the RECORD study on Avandia, a prospective, observational study with defined endpoints that was reviewed and approved by the European Medicines Evaluation Agency could be considered inferior data to the retrospective Kaiser database he used to deem Vioxx dangerous.
http://news.yahoo.com/s/ap/20070730/ap_on_he_me/diabetes_drug
PS...Karen Mahoney of the FDA dumped all over Graham and Del Pan's rationale for rejecting RECORD namely that it was designed to capture how diabetes is actually treated. Of course the media will not capture this important difference.
Graham ostensibly "works" for the FDA but splits his time between GAP, having lunch with Senator Charles Grassley and talking to reporters. In his presentation to the FDA Graham never quite explained how a the RECORD study on Avandia, a prospective, observational study with defined endpoints that was reviewed and approved by the European Medicines Evaluation Agency could be considered inferior data to the retrospective Kaiser database he used to deem Vioxx dangerous.
http://news.yahoo.com/s/ap/20070730/ap_on_he_me/diabetes_drug
PS...Karen Mahoney of the FDA dumped all over Graham and Del Pan's rationale for rejecting RECORD namely that it was designed to capture how diabetes is actually treated. Of course the media will not capture this important difference.
