The drug Ketek, made by the drug company Aventis (now Sanofi-Aventis SA) was approved by the U.S. Food and Drug Administration (FDA) in early 2004. But recent reports of severe liver damage to those taking the drug have come to light.

The drug was approved after completion of study 3014, which included [tag]clinical trials[/tag] of over 24,000 people. The doctor who treated the most patients in the study, Maria “Anne” Kirkman Campbell is currently in federal prison after pleading guilty to [tag]defrauding drug companies[/tag] with fabricated data. Another doctor who participated with a significant number of patients in the clinical trials has since had his license revoked.

Study 3014 was commenced by Aventis in 2001 at the request of the FDA. The FDA was concerned about liver damage and other side effects of Ketek, and would not approve the drug without further testing. The FDA has since decided that the data from the study cannot be relied upon.

Aventis discovered [tag]irregularities[/tag] with more than one doctor in the clinical trials, but did not alert the FDA to any problems with study 3014. It is the FDA’s policy that if a drug company suspects [tag]fraud[/tag] during a study, the company should inform the FDA right away.

Ketek was formally approved by the FDA on April 1, 2004 as a treatment for sinusitis, bronchitis, and pneumonia. The FDA approved its use despite the problems with study 3014, citing other smaller studies that the FDA believes provided accurate data.

Read the whole story in the Wall Street Journal.

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