Contentious Ketek correspondence

Executive Summary

CDER officials reiterate that they did not rely on a fraudulent study to approve Sanofi-Aventis' antibiotic Ketek (telithromycin), in a letter in the April 19 New England Journal of Medicine. In response to a critical perspective article by former FDA reviewer David Ross, the FDAers say they "reviewed the study for safety findings that would have counted 'against the drug,' as is consistent with good review practice," and that data-integrity issues with study 3014 were not provided to an advisory committee so as not to compromise an on-going investigation. Not addressed by the response are Ross' charges that Ketek reviewers were subject to "overt internal pressure ... to alter their conclusions." Ketek's approval is being investigated by the House Energy and Commerce/Oversight and Investigations Subcommittee (1"The Pink Sheet" April 9, 2007, In Brief)...