Of course, hindsight is a wonderful thing. And so the FDA now criticizes the drugmaker for failing to ensure investigators were in compliance and for failing to follow-up problems with data analysis and documentation; failing to monitor clinical trials; failing to select qualified investigators; and failing to ensure protocols were followed according to its IND. A key example cited was Anne Kirkman Campbell, a family practice doctor in Gadsden, Ala., who apparently viewed her Ketek clinical trial as one big piggy bank.
She signed up 400 patients, more than any other doctor in the country and, when one patient backed out, she even forged the consent form and faked the data. She also enrolled her entire staff and several family members. Patient consent forms were signed every few minutes, even when the office was closed. A subsequent audit, which was initiated by PPD, the firm running the trial, uncovered the fraud, and the FDAâ€™s Office of Criminal Investigation began looking into it, but the FDAâ€™s drug review division recommended approval anyway over the objection of an agency reviewer.
In a statement, Chuck Grassley, the Republican Senator from Iowa who investigated the Ketek scandal says: â€œThis warning vindicates the courageous FDA insiders who stuck out their necks to let the public know about the flawed safety study that was submitted to FDA to get Ketek approved. The letter starts to hold the drug maker accountable for failing to conduct its clinical trial in a legal way. Now itâ€™s time to hold the FDA accountable for its own failures to be a check on this process."