Another Possible FDA Failure With Ketek
Dr. David Graham of the FDA's drug safety office (who notably first brought the FDA's shortcomings to light late last year while testifying in front of the Senate Finance Committee) is now focusing on the FDA's failure to properly test and warn of the antibiotic Ketek. The drug has been linked with severe and life threatening liver problems. Dr. Graham stated in an internal memo:
"It's as if every principle governing the review and approval of new drugs was abandoned or suspended where [Ketek] is concerned. We don't really know if the drug works; no one is claiming it works better than other, safer drugs; and we're flying blind as far as safety goes, except for our own A.D.R. date that suggests [Ketek] is uniquely more toxic than most other drugs."