Source: http://www.sptimes.com/2007/05/31/Opinion/Yet_more_suffer_as_FD.shtml Dozens of people have suffered liver disease and five have died because the Food and Drug Administration (FDA) ignored serious fraud concerns to approve a new antibiotic for sinus infections called Ketek. The agency that is required by law to protect American consumers from dangerous medicines and tainted food has let us down again.
The FDA isn't the only culprit. The drug maker Sanofi-Aventis rushed the drug through the approval process, to the exclusion of serious doubts about the accuracy of its clinical trials.
Both the FDA and Sanofi-Aventis had early warnings that Dr. Anne Campbell of Alabama had faked patient data for the Ketek study. Even after an employee of the third party conducting the study for Sanofi-Aventis reported Campbell's suspicious data, the drug company did nothing. Concerned by similar findings, the FDA drug approval office notified its criminal division, but even then neither the FDA nor Sanofi-Aventis slowed the process.
When the FDA scheduled an audit of Campbell's files, the drug maker sent its experts to coach her in answering questions.
Ketek won FDA approval as a daily-use antibiotic. Soon thereafter, patients using the drug started suffering liver problems. The FDA has linked Ketek to 53 cases of liver failure, including five deaths and two people needing liver transplants. The drug's use is now limited to certain cases of pneumonia.
So far, the criminal investigation has resulted in only one charge, against Campbell, who is serving a prison term. Sanofi-Aventis has fared much better. U.S. sales of Ketek totaled nearly $400-million before the restriction was imposed, cutting revenues in half.
The failure of drug oversight begins with the dubious relationship between drug companies and their regulator. The FDA relies on drug maker fees to account for more than half of its drug approval budget. The entire process is designed for the pharmaceutical industry to get its products to market quickly.
