Based partly on records in the file boxes, the FDA eventually concluded that the lab’s violations were so “egregious” and of such a “pervasive nature” that studies conducted there between April 2005 and August 2009 might be worthless.
“It is non-trivial to have to redo all this, to withdraw drugs, to alarm the public and the providers for a large range of drugs,” said Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research. “There are consequences. To repeat the studies requires human experimentation, and that is not totally without risk.”
In April 2009, Briscoe blew the whistle in a letter to the company written by his lawyer, reporting that “many of the chemists were manipulating and falsifying data.” Soon thereafter, Briscoe told the company that he had documented the misconduct. According to Stone and documents reviewed by ProPublica, Briscoe had photographic evidence that mass spec operators had switched the quality control samples between different runs; before-and-after copies of documents with the dates and other material changed; and information about a shadow computer filing system, where data from failed runs could be stored out of sight of FDA inspectors.
Originally posted by Sandalphon
I remember an article of a survey of the employees at the FDA, that when asked what their job description was, a big number of them didn't have a clue.
Pity the recipients of the chemo drugs that didn't work as the label said because of corruption with tests.
Without the list, who knows what drugs are under-tested? Now all the drugs are questionable.
How many psych meds were on that list? How much confidence has the medical establishment put into those drugs which may have been faulty? Maybe Adam Lanza's drug was on that list. How many doctors get told about the way the name-brand drug changes people's health, and then they get told that the generic works the same, but the tests' books have been cooked, so they are stuck with negative results?
Hey those are just the drugs. There is a bunch of food being looked at by that same group.
The FDA is a rip off. This is the junk you read about with organized criminals. I want the list.