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Ketek Safety Data Questioned

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The Wall Street Journal recently investigated a clinical study involving 24,000 patients, referred to as 3014, which analyzed the safety of Ketek, a popular antibiotic sold by Sanofi-Aventis SA. Reports of severe liver damage, including death, have surfaced among patients taking Ketek, and the WSJ’s investigation reveals serious flaws in the study, principally due to questionable practices by doctors who served as study investigators.

One of those doctors, Maria “Anne” Kirkman Campbell, is in federal prison after pleading guilty to defrauding Aventis and others. Another doctor, who treated the third-most patients in the study, was on probation during the study and later lost his license after police responding to a domestic violence call at his home found him holding a loaded semi-automatic handgun, and hiding cocaine in his underwear.

The Senate Finance Committee is examining issues raised by Ketek, and Sen. Charles Grassley, Chairman, was quoted by the WSJ as saying, “The Ketek allegations appear to be as serious as anything I’ve seen so far.”

Sanofi-Aventis defends the data in the Ketek study, concluding that “these events do not alter the overall benefit/risk profile of Ketek.”

See the full Wall Street Journal article here: