According to internal emails among FDA scientists and researchers, the antibiotic Ketek should not have been approved for the pharmaceutical marketplace. The Ketek emails further stated that there was no real proof if the drug actually worked, if it worked better than other drugs of this genre, or if it was safer. The data actually suggested that Ketek was more toxic than antibiotics.
Dr. Graham, a FDA physician shared emails with the New York Times about the internal debate over Ketek's safety and appropriateness. Four other FDA physicians also expressed their concerned. Yet, the FDA only chose to announce changes to Ketek's label emphasizing that the drug could in rare circumstances cause serious liver injury, liver failure, and death. In addition to liver problems, Ketek may cause blurred vision and loss of consciousness. For patients who suffer from myasthenia gravis, a rare neurological disorder, Ketek may cause death.
This action undermined the seriousness of these FDA's physicians' concerns.
In May, Dr. Johann-Liang, a FDA physician requested that Sanofi-Aventis stop testing Ketek for children with ear infections. Johann-Liang argued that cutting the duration of ear pain by one day was hardly worth risking death. Shortly after these concerns were reported in the New York Times, Sanofi-Aventis announced a pause in its pediatric clinical trials.
One has to wonder whose side is the FDA on anyway? Is it public safety or in the deep pockets of the hardball pharmaceutical companies? (Corp Watch)
