The Ketek saga has opened a new chapter, with subpoenas and accusations and even threats. For instance, here's what an FDA investigator told the House Energy and Commerce Committee yesterday: Sanofi-Aventis had plenty of evidence that a safety study of the antibiotic contained fake data. Study documents bore all the hallmarks of fraud, including forged signatures and crossed-out results, he said.
He stopped short of accusing Aventis of deliberately passing off the fakery as genuine, but did call the company's handling of that trial a "catastrophic failure." Another FDA agent said he tried to get permission to investigate whether Aventis knew about the fake data when it submitted the study, but agency higher-ups quashed it.
It's a variation on the song-and-dance we've heard before on Ketek: Obviously faked data, but proof only that the trial was very badly mishandled. Sanofi says Aventis submitted the data to FDA in good faith, and that whatever mistakes were made then have been corrected with new data-handling procedures. (The trial took place pre-merger.)
The committee, though, thinks there's more evidence in government files--and that the Bush administration is protecting it. It's threatening to hold Health and Human Services Secretary Michael Leavitt in contempt for refusing to comply with a document subpoena. The committee wants a briefing used to prep FDA chief Andrew von Eschenbach for his hearing testimony on Ketek. "What is in those briefing books that he does not want [us] to see? Is there evidence of perjury?" asked Rep. John Dingell, the committee chair.
Schering, Sanofi execs face questions. Report
FDA criticizes Aventis for Ketek study failures. Report
Senator makes dramatic demand in Ketek probe. Report
FDA panel votes to restrict Ketek. Report
Sanofi halts Ketek trial amid blistering warnings. Report