Here's what happens when President Bush appoints people with rich pharmaceutical ties to high ranking positions in the FDA. Drugs like Ketek, an antibiotic taken for bacterial infections, are released into the drug marketplace without even uttering potentially lethal side effects.
One of the current investigations of the FDA involves allegations that the FDA approved the antibiotic, Ketek, despite serious questions about Ketek's safety and with full knowledge that the clinical study submitted to support Ketek's approval was fraudulent.
Critics say Ketek's side effects of liver damage were known to its maker, Sanofi-Aventis, early in clinical trials but was covered up. The drug has been blamed for the death of four patients and the liver damage or liver failure in 37 other patients since 2004. The FDA's actions in regard to Ketek are being investigated by Senator Charles Grassley's (R-Iowa), Senate Finance Committee, and by Representatives, Edward Markey (D-Massachusetts), and Henry Waxman (D-California).
Lawmakers released a statement that said although the FDA has consistently assured the public of Ketek's safety, public documents obtained and examined indicate that the approval process for this drug was seriously flawed. (FDA)
