Sanofi-Aventis Gave Fake Ketek Data To The FDA
6 CommentsBy Ed Silverman // February 12th, 2008 // 7:00 pm
An FDA criminal investigator told a Congressional committee that Sanofi-Aventis had evidence that a safety study of its Ketek antibiotic contained fake data, but submitted it to the agency anyway, the Associated Press writes. “Catastrophic failure” was how Doug Loveland described the drugmaker’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 the House Energy & Commerce Committee’s subcommittee on oversight and investigations. Loveland, however, stopped short of saying Aventis, Sanofi-Aventis’ predecessor, knew the results were false when they submitted them, but said it “should have known.” He went on to say the data contained all the hallmarks of illegitimacy, including forged signatures and crossed out results.
Loveland and two other government investigators appeared Tuesday after receiving subpoenas, because administration officials refused to let them to testify, the AP writes. Robert West, the FDA investigator who first handled Ketek, said he tried to get permission 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. The agency eventually issued a warning letter to Sanofi in 2007 over its handling of the trial.
However, House Democrats threatened to hold Health and Human Services Secretary Mike Leavitt in contempt for refusing to turn over FDA briefing related documents subpoeaned by the committee. The documents were used to prepare FDA commish Andy von Eschenbach for his appearance before lawmakers last year. Andy the FDA didn’t use the flawed safety study to approve Ketek. House Democrats say that statement is untrue.
Bart Stupak, who chairs the subcommittee, and other Democrats have alleged for months that FDA approved Ketek despite knowing the key safety study was fraught with problems. And he laced into Sanofi, as well. “Only a company intent on ignoring the obvious could have missed the evidence of fraud in the study,” said Stupak.
Paul Chew, Sanofi’s R&D chief, testified that the drugmaker submitted the study in “good faith.” Sanofi wasn’t able to spot the fake patient results, Chew explained, but has since put in place extra steps to verify data, according to the AP.
Ketek, approved in 2004, received FDA’s most serious warning last February after reports of liver failure appeared. FDA later went back and found that several physicians hired by Aventis falsified data in the 2002 study. One is now serving a four-year sentence after pleading guilty to making up results, the AP notes. This was the fifth hearing into the Ketek fraud, by the way.
Justice in Michigan
Every time you think it can’t get scuzzier, it gets scuzzier.
ol cranky
Submitted in good faith my arse! If there’s any information in the monitoring reports that something was amiss (my guess there is if they have a former PPD CRA as a key witness) or other reports provided to Aventis by the CRO, there should be documentation of how the sponsor handled the issue.
I’ve been underwhelmed by PPDs performance for many years and their study management work has been absolute crap even when a monitor indicated problems on a report but it is the responsibility of the study sponsor to ensure the study is compliant with GCP/CFR/ICH. Way too many people on the sponsor side think that the transfer of obligations to a
CRO is a transfer of responsibility. If the CRO is preventing critical information from bubbling up to the sponsor (and, sometimes, they do), and the sponsor can prove they showed due diligence in the review of all information relayed by the CRO (including monitoring reports) then the sponsor can claim they made a good faith effort. Otherwise, people down to the study management level at a sponsor need to step up.
The problem is that too many people in study management at the sponsor either just want to make things nicer, are inexperienced, or are absolutely afraid of the consequences they will face by relaying or acting on concerns they have. The reason for the latter is they’ve seen what happens to people who do relay or act those concerns and/or don’t drop the issue when it has not been addressed adequately.
Justice in Michigan
As usual, agree with OC. Just want to highlight the FDA side of the story, which is critical. It appears at least two officers in FDA’s Office of Criminal Investigations - created in ‘92 exactly for such circustances - were blocked by unnamed “senior FDA officials” from probing what Aventis knew about the marked-up study.
I very much hope we learn the those names. Just for their own accountability. But, yes, they would also make good posterfolk for FDA preemption.
Lisa Van S
Ol Cranky
A female PPD testified before O and I last year.
Donna
Lisa,
Welcome Back………:)
Simon Passanante - Investigations into fake Ketek data continue
[...] Pharmalot notes, the FDA subsequently reviewed the 2002 safety study and discovered that several doctors had [...]