[Spambayes] GRAHAM: I think that PDUFA funding for the FDA is a mistake.
Booker M. Elinor
tkwlos at idnovo.com
Sat Dec 23 12:50:45 CET 2006
They don't have an argument that's substantial. A grant to develop a drug delivery implant so you could implant this in the brains of people with schizophrenia and then they wouldn't even have a chance not to take the drugs! " But next thing you know, they don't introduce this; and in fact, all of a sudden, the plaintiffs no longer are presenting very damaging evidence to make their case. Direct-to-consumer advertising is part of what made Vioxx a blockbuster drug.
All this shows how the American public was betrayed and didn't know about all the problems with these drugs and why it was kept from them.
Clearly Vioxx was the problem. You set up stringent standards of evidence that might lead to the approval of safe drugs that actually have benefits to the population. And once they have a drug-induced manic episode, what happens?
They go to an emergency room, and at that point they're newly diagnosed. So someone who is on an antidepressant, after a time ends up with an abnormally low level of serotonin receptors in the brain.
" But next thing you know, they don't introduce this; and in fact, all of a sudden, the plaintiffs no longer are presenting very damaging evidence to make their case. He just went directly to the Lancet.
That's very difficult and it is a little bit discouraging.
If it were restructured properly, I think that it could actually provide a great benefit to the public health.
For every member of the House of Representatives somebody in their district died because of Vioxx.
And they were successful.
But he goes on to make the startling claim that these new psychiatric drugs have directly contributed to an alarming new epidemic of drug-induced mental illness.
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