By Peter R. Breggin, M.D.
Getting the FDA to move forward by
presenting it with scientific data is like using a peacock feather to tickle a
sleeping giant tortoise on its shell.
Many people die before the agency opens its eyes and then it barely
reacts at all.
The FDA Confirms Antidepressant-Induced
Suicidality in Adults
So, after years of prodding by me and more lately by a handful
of other professionals, what new point in its journey has the FDA tortoise
reached? In a May 2006 release in collaboration with the manufacturer
GlaxoSmithKline (GSK), the FDA has acknowledged the antidepressant Paxil
causes a statistically significant increased rate of suicidality in
depressed adults as measured in controlled clinical trials.  The
results are based on a re-analysis of all adult controlled clinical
trials that compared Paxil with placebo.
other antidepressants were mentioned in the FDA’s warning but all
SSRI antidepressants share a common profile of adverse mental and
behavioral effects, including Paxil, Prozac, Zoloft, Celexa, Luvox,
and Lexapro. Several other relatively new antidepressants
have also been implicated in producing similar psychiatric abnormalities,
including Wellbutrin, Effexor, Serzone, and Cymbalta. All of the newer antidepressants can produce stimulation or activation
with the potential for increased agitation, anxiety, mood instability,
disinhibition, irritability, aggression, hostility, mania, and crashing
into depression and suicide. They
can also cause a flattening of emotional responses, including a loss
of caring, that can unleash dangerous actions.
http://www.breggin.com/). I based my observations on suppressed company
data that I had discovered during a three-day investigation inside
the drug company’s secret files, working as a medical expert in a
murder-suicide product liability case against the company.
The Struggle to Enlighten
the Public, the Profession and the FDA
The FDA allowed
the Paxil manufacturer to soft pedal the results by claiming, for example, that
the results could be compounded by the fact that suicide is an aspect of
“psychiatric illnesses.” This is
nonsense—and every scientist knows it. Since both groups were depressed, and since they differed only in the
substances they were given to take, Paxil and not depression was the cause of
this astronomical increase in suicidality.
The Real-Life Risk
Is Much Greater than Described
short of a miracle that GSK-sponsored clinical trials have demonstrated
the increased risk of suicidality from antidepressants. If not a miracle, it’s a confirmation that
the risk is enormous—far more so than indicated by the studies. Keep in mind that controlled clinical trials
are planned by the drug companies, supervised by the drug companies,
and carried out by paid lackeys of the drug companies. Keep in mind that all the data analysis is done at drug company
headquarters by drug company execs.
Keep in mind that the trials are constructed in order to prove
the usefulness of the drug and to minimize its adverse effects such
as suicidality. Keep in mind
that the controlled clinical trials are very short, usually 4-6 weeks
long, and that prescreening excludes suicidal and psychotic patients
from participating in the studies.
If Paxil increased
the rate of suicidality by more than six times in the drug company’s
controlled clinical trials, it may be doing so by sixty times in actual
practice. We can’t determine
exactly how much greater the risk will be in clinical practice but
it will be astronomically greater.
And the Antidepressants
Don’t Even Work
a comprehensive review of all studies of antidepressant drugs submitted
for approval to the FDA showed that when the studies are taken as
a whole, antidepressants don’t work.  A drug company may perform twenty studies in
an attempt to show efficacy Exemplified
by the case of Prozac, as I described in Talking Back to Prozac
(1994), as long as two studies show a positive effective, the FDA
will approve the drug. If
a drug company cannot massage their self-generated data sufficiently
to obtain a positive result in two out of twenty clinical trials,
the company’s paid consultants and employees don’t deserve to stay
employed. And of course, they won’t stay employed if
they fail to meet the company’s needs to promote new products.
many people feel helped by antidepressants, as well as by many other
psychiatric and even psychoactive drugs.
The placebo effect is enormous.
In addition, the artificial euphoria or emotional flattening produced at
times by antidepressants may provide temporary relief at the cost of
rationality or effective dealing with life.
to say again what I’ve been saying for too many years on end. The antidepressants aren’t
antidepressants. They are more likely
to make a person worse than better.
More tragically, these toxic agents push may people over the brink into
suicide and violence.
the antidepressants are very difficult to stop taking. Withdrawal from antidepressants can lead to
“crashing,” with agitation, violence and suicide. Withdrawal from these noxious drugs should be done slowly with
experienced clinical supervision. These
drugs are not only unsafe to start—they are dangerous to stop. The best approach to antidepressants: Don’t start taking them.