Aventis allowed a clinical trial of Ketek to proceed uncorrected despite its own audits that revealed "serious protocol violations and regulatory noncompliance by multiple clinical investigators." In a letter to Sanofi-Aventis, regulators severely criticized Aventis for not throwing doctors out of the study or informing the FDA. The FDA approved Ketek back in 2004. Ketek has since been linked to an increased risk of liver damage [1], and the questionable study was designed to investigate the drug's potential side effects, including liver damage. One doctor responsible for one site involved in the study was subsequently convicted of fraud. Sanofi-Aventis says the company acted in good faith and plans a detailed response, but that's hardly likely to mollify the company's critics.
- see the FDA release [2]
- here's the article [3] from The Wall Street Journal
Related Articles:
Sanofi underscores pipeline advances, setbacks. Report [4]
FDA panel votes to restrict Ketek. Report [5]
Senator makes dramatic demand in Ketek probe. Report [6]
Sanofi's Ketek could cause liver problems. Report [1]
Links:
[1] http://www.fiercebiotech.com/story/sanofi-s-ketek-could-cause-liver-problems/2006-01-20
[2] http://www.fiercebiotech.com/press-releases/press-release-fda-sends-sanofi-warning-letter-ketek-study
[3] http://online.wsj.com/article/SB119328145497070973.html?mod=googlenews_wsj
[4] http://www.fiercebiotech.com/story/sanofi-underscores-pipeline-advances-setbacks/2007-09-17
[5] http://www.fiercebiotech.com/story/spotlight-fda-panel-votes-to-restrict-ketek/2006-12-18
[6] http://www.fiercebiotech.com/story/senator-makes-dramatic-demand-in-ketek-probe/2006-06-15