From the St. Pete Times: A detailed article that sheds light on a system that can best be categorized as a mess.
The paper notes how Dr. Anne Kirkman Campbell, a family practice doctor in Gadsden, Ala., signed up 400 patients at $400 a pop to enrol in a Ketek study. When at least one patient withdrew, the doctor forged a consent form and faked the data. The drug's maker however didn't inform the FDA of the action, according to reports. The drug maker just included the faulty data in the reports on the drug.
The paper notes that as FDA's drug approval division checked out the Ketek data, its inspectors were conducting routine audits of the biggest study sites. Their first stop was Campbell's office, where they found violations and called in the FDA's criminal investigators.
You can read the whole story at the St. Pete Times site, or posted on a blog here.
In my opinion, this is more of the same from the FDA. Created to protect consumers, it instead acts to betray the public's trust. Having read "Dispensing with the Truth" (a book detailing the rise and fall of the drug Fen-Phen) this unfortunately does not come as a surprise.
The web has legions of articles on Ketek and the congressional fallout, as well as the worldwide scandal .
Iowa's Senator Charles Grassley's sub-committee heard the testimony that one of the doctors used in the drug's safety study had falsified results, and that FDA managers hid that fact from the FDA panel that recommended the drug, and that the FDA then used unscientific foreign reports of the drug's side effects to claim it was safe. And when cases of death and injury began to appear, the testimony alleges the FDA did not issue an adequate new warning label for at least a year. (Link)
You'll see more to this, and this scandal will not be the last.
