FDA Approved Ketek Despite Serious Irregularities in its Clinical Trials; Patients Often Faced Liver Failure, Even Death As a Result Of OversightJun 26, 2007 | Parker Waichman LLP Patients being treated with Sanofi-Aventis’ antibiotic Ketek faced serious liver damage or even death, when all that was being treated was a simple sinus infection The story of the dangerous prescription drug Ketek and how it came to be on the market is a case-study in everything that has gone wrong with the FDA drug-approval process.
Ketek was granted approval by the Food and Drug Administration (FDA) in 2004 despite serious concerns with the clinical trials conducted by its manufacture, Sanofi-Aventis. An expensive antibiotic, Ketek was created to treat sinus infectious. But because other cheaper antibiotics (most notably, the more mundane amoxicillin) were extremely effective in treating this condition, the FDA required Aventis to design a study showing that Ketek would work at least as well as existing treatments. Aventis eventually signed up 1800 private physicians to participate in these clinical trails. These doctors would be given $400 for every patient they convinced to participate in the Ketek study.
That huge financial incentive was too much for some doctors to resist. When the FDA audited study participants, they found one family doctor in a small Alabama town had signed up 407 patients for the study. What else they found during the audit at Dr. Ann Campbell’s was shocking. The doctor’s entire staff was enrolled in the trail. It even appeared that some of the patient signatures on consent forms where forged. So gross were Dr. Campbell’s violations that she was eventually convicted of fraud and sentenced to prison. The FDA also visited several other sites with high numbers of participants, and found serious irregularities at every one. Still, Ketek was approved by the FDA in 2004.
Last December, the FDA began investigating reports that Ketek was linked to liver problems. The FDA eventually confirmed 53 cases of liver failure in patients using the antibiotic, including five deaths. This past February, the FDA finally added black box warnings to the Ketek label and severely restricted its use.
Considering that there were many reliable antibiotics on the market to treat sinusitis, whey did the FDA approve Ketek despite the serious problems with its clinical trails? And Ketek has been far from the only problem drug. FDA safety recalls of medicines are double what they were a decade ago, while adding new warnings to already marketed drugs is also on the rise. What can account for this?
While there is no one factor that can explain away these problems, some FDA critics say the agency has become too cozy with the very pharmaceutical companies it is supposed to regulate. For instance, the FDA collects more than $300 million in user fees from drug companies every year. This amounts to more than half the agency’s drug review budget. As a result, many believe that the culture at the FDA has shifted to the point that the drug manufacturers are now considered the agency’s clients.
Whatever the reason, the ramifications of the problems at the FDA are all too apparent. More Americans are getting sick from the very medicines that should be keeping them well. And the FDA, the one agency that is supposed to protect patients, seems to have forgotten them.