Validity of Key Clinical Trial Questioned

A key clinical trial for the antibiotic Ketek is being questioned after reports of patients suffering severe liver damage.

An internal U.S. Food and Drug Administration analysis has cited 10 reports of people suffering liver failure after taking Ketek, though it wasn’t clear how many cases were caused by the drug, The Wall Street Journal reported.

Ketek was approved by the FDA in April 2004. Its maker at the time was Aventis, now called Sanofi-Aventis SA, the newspaper said.

Internal Aventis e-mails reviewed by The Wall Street Journal are raising questions about a clinical trial of more than 24,000 people that the company submitted to the FDA seeking approval for the drug.

The newspaper said the doctor who treated the most patients in the study is in federal prison after pleading guilty to defrauding Aventis and others. Another doctor involved in the study lost his medical license after allegedly being caught with cocaine and a handgun, the newspaper said.

The Journal says Sanofi-Aventis denies withholding any information that it was supposed to disclose to the FDA. The company says that infrequent liver events do not alter the overall benefit/risk profile of Ketek.