The findings contained in the 11-page
warning letter, which the agency posted on its web site late today, have mostly been aired previously. For those who don't recall, though, the Ketek antibiotic was at the center of a scandal in which Aventis - which was later bought by Sanofi - was tagged for failing to properly conduct its clinical trials. And the FDA was similarly chastened for a sloppy review process.
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 FDA’s Office of Criminal Investigation began looking into it, but the FDA’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: “This 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 it’s time to hold the FDA accountable for its own failures to be a check on this process."
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And some here question why we have no faith in the pharmceutical industry and the FDA. Here is a prime example of just how bad it can be.
Ed,
Dr. Carmen Palazzo was Indicted by a Federal Grand Jury for Healthcare Fraud and false documentation associated w/clinical trial of Paxil in Children and Teens
Max. Prison Term 445 years 10,150,000 Fine
http://www.usdoj.gov/usao/lae/press/2007/2007_06_14_palazzo_ind.htm
OMG -- GET A JOB, HOBBY, FAMILY. The world does not revolve around your daughter and parenting skills. Let the posts that don't involve psych meds alone. Go repost your same crazy thoughts on those articles. There is a reason I intentionally skip all the psych posts. Don't make me avoid the site altogether!!!!
Well, I didn't want to be the one to point out the non sequitur, but...
It does raise a question I've been wondering for a while:
Lisa, given your advocacy and tenacity with the psychotropic drug issue, I'm surprised you don't have your own blog. Any reason?
Reality, Good Morning, "non sequitur" hmmm....Attorney Language,maybe.... "advocacy and tenacity", I will take that as a compliment, Thank You.
Not interested in having my own blog,why.....
Because Pharmalot is owned by the Newark Starledger which is my local newspaper and I am one of its loyal readers.
TODD What does KeteK and Paxil have in common.. 1)Physicians who broke the Law 2)False documentation associated w/clinical trial data 3)Whistleblower and Senator Grassley 4)And of course the wonderful and reliable FDA!!!..
"The world does not revolve around you daughter or parenting skills"
I never said it did....Those are your "DELUSIONS" not mine..
TODD, What, no come back, or does the cat have your tongue?
I love to pick fights as well. A lot of fun, I hope you treat your family differently.
I will stay on topic. But if you want to post a link on how the pharma industry is now killing our cats with Prozac, I would appreciate it.
But really, keep acting like my 5 year old - yes the world revolves around you. You almost let the cold medicine post go by - but my question to you. If any children died from cold medicine do you not care about them? Or only psychologically impaired adolescents who are on psychotropic medications? Why? I actually consider my 3 month old to be a little more helpless than teenagers. But I am glad to see you cleared that up - I was afraid you cared about all kids, now it does make sense it is only the ones on GSK meds.
TODD, Wow,... That was a pretty freaky rant..
Yeah, I am pretty out of it and out of control when I am not on my Paxil. But my doc took me off of it because he had heard bad things about it. Thank goodness I am doing better.