In 2000, Ketek initially sought FDA approval but was denied due to potential side effects such as liver damage, blurred vision, and more discovered in Aventis clinical trials.The FDA requested more information so the drug maker hired Pharmaceutical Product Development to conduct a study known as 3014. The FDA approved Ketek knowing that some of the clinical trials involved in study 3014 were fraudulent.
What influences the FDA more? Public health safety? Pharmaceutical lobbyist pressure? Big pharmaceutical money?
The clinical trial with the largest number of subject was conducted at a weight loss clinic in Alabama. The doctor involved is now sitting in a federal prison serving a sentence for falsifying data. She enrolled relatives and friends who did not have respiratory illnesses and subjects who never even took Ketek. An employee who was forced to falsify documents turned the doctor in.
Ketek was finally approved in April 2004 for the adult treatment of acute bacteria infections from chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia. Ketek has been linked to extremely serious adverse reactions.
Doctors from the FDA say they were overruled about releasing Ketek into the marketplace and the Ketek debacle rages on. (Best Syndication)
