13, 2006 the FDAs Psychopharmaceutical Drugs Advisory Committee
(PDAC) is meeting in Silver Spring, Maryland to discuss antidepressant-induced
suicidal behavior in adults. In 2004 the FDA held similar hearings
on children and concluded that antidepressants do in fact cause
suicide in humans under age eighteen. A warning has been placed
in all antidepressant labels or package inserts.
Now the agency
has given advanced notice of its new findings antidepressants,
all of them, according to the FDA, cause increased suicidality in
young adults. Suicide occurs more than twice as much on antidepressants
than on sugar pills in individuals under age 25.
First the agency
admits that antidepressants cause suicidality in children. Now the
agency admits the drugs cause the same disasters in young adults.
Meanwhile, an independent review of all antidepressant trials submitted
to the FDA has shown that the drugs are no better than placebo.
Americas drug watchdog needs to come clean. Its been
approving depressants as antidepressants.
But it gets
worse. The primary data on suicidality has been generated in short-term
controlled clinical trials planned by drug companies, carried out
by drug company hacks, and evaluated by drug company employees at
corporate headquarters. If that kind of carefully cultivated evaluation
bears such bad fruit, imagine what the real data must show.
Since I first
began working as a medical expert in product liability cases way
back in the early 1990s, Ive spent innumerable hours culling
the sealed data contained within the files of companies like GlaxoSmithKline
and Eli Lilly. Among other things, I long ago found evidence that
Paxil and Prozac cause suicidality in adults. These discoveries
then led to settlements in product liability suits brought against
the two companies brought by surviving family members. Ive
also communicated my conclusions in books like Talking
Back to Prozac and the Antidepressant
Fact Book and in scientific articles but the primary data
until recently remained sealed.
data creates the biggest loophole in the FDAs evaluations
of drug safety. In May 2006 GSK published a 'Dear Healthcare Provider'
letter admitting that Paxil causes suicidality in depressed adults,
but even that data was diluted before it was processed. The real
picture is even worse.
Data Sealed in Company Files
published analyses of previously sealed GSK data on Paxil suicide
in the journal Ethical Human Psychology and Psychiatry. I combed
the data out of GSK files during a several-day investigation of
the companys Paxil records. My original medical/legal report
recently became unsealed and provided the basis for the published