Poor Sanofi Aventis.
Anna Wilde Mathews at the WSJ is on their case with agreat piece of investigative reporting about their antibiotic Ketek.
Documents (including internal Aventis emails reviewed by The Wall Street Journal) are raising questions about a key clinical trial -- called study 3014 -- of more than 24,000 people that the company submitted to the FDA seeking approval for the drug.
The doctor who treated the most patients in the study, Maria "Anne" Kirkman Campbell, is now in federal prison after pleading guilty to defrauding Aventis and others.
An indictment says Dr. Campbell fabricated data she sent to the company.
The documents show that Aventis was worried about Dr. Campbell early in study 3014 but didn't tell the FDA until the agency's own inspectors discovered the problem independently.
The Senate Finance Committee is now examining issues raised by Ketek. "The Ketek allegations appear to be as serious as anything I've seen so far," said Sen. Charles Grassley, an Iowa Republican who is chairman of the Finance Committee, in a statement.
Read much much more here.
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