Yet more suffer as FDA betrays trust

Published May 31, 2007

Let's start at the end of the Ketek story: Dozens of people have suffered liver disease and five have died because the U.S. Food and Drug Administration 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. When will one more FDA failure be too many?

The FDA isn't the only dishonest player in this story, reported by St. Petersburg Times staff writer Kris Hundley. The drugmaker Aventis Pharmaceuticals (now known as Sanofi-Aventis) rushed the drug through the approval process, to the exclusion of serious doubts the French company should have had about the accuracy of its clinical trials. In fact, according to one doctor who got caught up in the fraud, it was Sanofi-Aventis that helped hide the truth about Ketek.

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.

In fact, when the FDA scheduled an audit of Campbell's files, she said the drugmaker sent its experts to coach her in answering questions. Campbell now blames Sanofi-Aventis for problems with the clinical trials. "They didn't care how you did it, " she told Hundley.

Ketek won FDA approval as a daily-use antibiotic, and not long afterward 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. And 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.

One person not surprised by the outcome is Dr. David Graham, an FDA epidemiologist. "The Ketek story is about the FDA's betrayal of the public trust, " said Graham, who has been with the agency for 23 years. "Unfortunately, Ketek is not an anomaly."

The failure of drug oversight begins with the perverse relationship between drug companies and their regulator. The FDA relies on drugmaker fees - more than $300-million last year - 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.

Congress has yet more proof (remember Vioxx) that the FDA is not worthy of public trust. Lawmakers should investigate the Ketek case and force the FDA to do its job before there are more deaths.