Healthy Skepticism Library item: 12810

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Publication type: news

Perrone M.
Dems May Hold Bush Official in Contempt
Yahoo Finance 2008 Feb 12
http://biz.yahoo.com/ap/080212/sanofi_congress_hearing.html?.v=2

Abstract:

Democrats Threaten to Hold Bush Official in Contempt Over Sanofi Drug Probe

Full text:

House Democrats on Tuesday threatened to hold a key administration official in contempt for not turning over documents in a probe of a Sanofi-Aventis antibiotic.
The move by Bart Stupak and John Dingell is the latest turn in a year-old investigation of the Sanofi drug, which was linked to death and liver failure in 2006. The Michigan Democrats allege that the Food and Drug Administration approved Ketek despite knowing a key safety study of the drug was plagued by faulty data.

Dingell, who chairs the Energy and Commerce Committee, said he would support holding Health and Human Services Secretary Michael Leavitt in contempt for refusing to turn over FDA briefing documents subpoenaed by the committee. Leavitt oversees the FDA and other health care agencies.

The documents were used to prepare FDA Commissioner Andrew von Eschenbach for his appearance before lawmakers last year. Von Eschenbach testified that FDA did not use the flawed safety study to approve Ketek. Dingell and other Democrats say that statement may be untrue.

“What is in those briefing books that he does not want either my Republican colleagues or our side to see? Is there evidence of perjury?” asked Dingell.

Lawmakers heard from three government staffers Tuesday who had to be subpoenaed because the administration refused to let them testify.

Robert West, an FDA agent who first investigated Ketek, said he tried to get permission in 2002 to probe whether Aventis was aware of fraudulent data when it submitted the study. However, West said his request was blocked by senior FDA officials, though he said he didn’t know which ones.

FDA eventually issued a warning letter to Sanofi in 2007 over its handling of the trial. The agency found that several physicians hired by Aventis falsified data in the safety study.

“A catastrophic failure” was how another FDA investigator, Douglas Loveland, described the company’s handling of the study.

“The decision making process Aventis used to investigate these problems was illogical and ineffective and it could have led them to come to the wrong conclusion,” Loveland told House lawmakers.

The investigator stopped short of saying Aventis, Sanofi-Aventis’ corporate predecessor, knew the results were false when they submitted them, but said it “should have known.” Loveland said the results contained all the hallmarks of sham data, including forged signatures and crossed out information.

Sanofi President for Research and Development Paul Chew testified that the company submitted the study in “good faith.”

The company wasn’t able to spot the fake patient results, Chew said, but has since put in place extra steps to verify data.

Ketek, approved in 2004, received FDA’s most serious warning last February after reports of liver failure appeared. The drug was originally approved to treat sinus infections, but FDA said it should only be used for pneumonia.