- Step right up, little lady, and get your serotonin selective
reuptake inhibitors (SSRIs) to treat anything and everything that ails
the mind and body " social phobias, eating disorders, insomnia, headaches
and depression, to name but a few. This "medication," guar-an-teed
safe and efficacious by the phantasmagoria of federal science, is prescribed
to reduce the symptoms of whatever ails you and to assure healthy and happier
lives.
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- Ah, but caveat emptor, my friend! A recent study conducted
by Arif Khan, medical director of the Northwest Clinical Research Center
in Bellevue, Wash., and adjunct professor of psychiatry at Duke University
School of Medicine, has revealed startling numbers of suicides committed
and suicides attempted in the clinical trials for the new SSRI antidepressants
" numbers that for years had been hidden from both prescribing physicians
and the public.
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- Kahn has examined the official clinical drug-trial data
for all SSRIs approved by the Food and Drug Administration (FDA) between
1985 and 2000, in which 71,604 participants in the clinical trials were
treated with antipsychotics, all SSRIs and anticonvulsants. The rate of
suicides in the general public is 11 in 100,000, which means an incidence
rate for those participating in the SSRI clinical trials of nearly 68 percent
" that's 718 suicides for every 100,000. Kahn's research further revealed
that nearly 4 percent of SSRI drug-trial participants attempted suicide
within the following year.
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- Because people with a history of suicide are excluded
from drug trials, the dramatically elevated drug-trial numbers revealed
by Kahn raise important questions. Given the large number of attempted
and completed suicides among drug-trial participants, why were these drugs
approved by the FDA? Furthermore, since the new SSRIs are approved to reduce
risk among depressed patients, does this data require a re-evaluation of
the efficacy and safety of SSRIs?
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- Asked what the FDA considers an acceptable number of
deaths in clinical trials, Thomas Laughren, team leader for the neuropharmachological
drug-products division of the FDA, tells Insight, "Your question is
not particularly pertinent because these trials are not designed to influence
suicide. If you look at any one individual trial it is very unlikely you
will find a suicide in the trial, and generally we don't."
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- You see, says Laughren, "It's only if you accumulate
data across a large number of trials that you even have enough data to
look at. What you do see in individual trials is that patients who get
drugs improve more than patients who get placebo. That's what we see. When
you do a meta-analysis across a large number of trials and you look at
the other outcomes of suicide and attempted suicide, you don't see any
particular benefit from being assigned the drug compared to placebo."
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- Which, of course, is the point. And Laughren further
announced that "the drug is not approved for the treatment of suicide.
They are approved for the treatment of depression. Dr. Khan's findings
and our findings suggest that these drugs that we're studying and approving
for depression don't appear to have a benefit on the outcome of suicide.
That is not to say that they don't have a benefit in treating depression."
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- The drugs don't have a "benefit" on the outcome
of suicide, which they in fact increase dramatically, but they do have
a "benefit" for depression. How is this possible when in fact
the clinical trials for SSRIs show the suicide rate increased by 68 percent?
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- "What this [increased suicide rate] would tell us,"
says Laughren, "is that this is a serious condition, not a trivial
condition. Depression is a serious condition. If you look at individual
trials there are so few suicides that you wouldn't be able to make sense
of it all. It's only after you look across multiple development programs
over a very long period of time that you have enough events that you can
get this kind of analysis."
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- So, does this mean that FDA should wait longer periods
of time before approving such drugs? "No," says Laughren, "because
the data are very clearly showing that these drugs benefit patients. What
this tells us is that it is very difficult to exclude patients that are
suicidal. As hard as you try you really are not able to predict who is
suicidal and who is not. It [the trial data] does not tell us that being
in clinical trials puts you at risk of suicide. It is not surprising to
see a few suicides when you look at a fairly large number of patients,
many of whom are followed for months or years."
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- But the data show the suicide rate is elevated 68 percent
when comparing SSRI participants to those given placebo and to the general
population. So the question isn't whether being in a clinical trial puts
a person at risk, but whether a particular drug puts a participant in a
clinical trial at risk. Besides, what good does it do to be declared officially
less depressed if it means you are 68 percent more likely to kill yourself?
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- And Robert Whitaker, author of Mad in America: Bad Science,
Bad Medicine and the Enduring Mistreatment of the Mentally Ill, tells Insight
that, "Clinical trials are skewed against the placebo." Basically,
explains Whitaker, "What happens in these drug trials is that people
who respond well are put into an extension of the trial. The point is that
the longer people are kept on whatever arm they're in " either placebo
or drug " you expect suicide rates to drop over time. It's only the
good responders through the six-week trials that are put into the extension
trials, and so it's biased against the placebo because after six weeks
no one is kept on to do extensions on placebo."
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- Whitaker says, "You shouldn't be seeing four to
five times the suicide rate in drug-treatment groups, especially when these
drugs are supposed to prevent this. It's terrible that the FDA approved
drugs with these high suicide rates. Naturally they do expect some suicides,
but the question is whether there is something the drug is doing that is
increasing that rate, and here it looks like it may be. A further question
that has to be asked is why it has taken 15 years to find out about this
data. Why are we learning about these increased suicides in clinical trials
15 years after the drugs were approved?"
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- Reviewing the Kahn report on the clinical data, Whitaker
says, "There are two questions that need to be raised about the FDA
review. First, is there an elevated suicide risk beyond the background
rates [number of depressed people in the population] such that the drug
should be seen as unsafe? And, second, is there enough of a hint of suicide
risk that it needs labeling? Is a public warning needed with the SSRIs?"
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- He sees the Kahn revelations as "confirmation of
what a lot of people have been complaining about for many years. An analogy
would be that you have some disease, like cancer or heart disease, and
you're going to see death in those trials. The question with the new treatment
is, 'Are you getting a lower, higher or no difference in the number of
deaths?' There is a key piece of information missing from Dr. Khan's research
and that is the background rate for depression. Even so, we should be seeing
in these trials a lower rate than the background rate because people who
are suicidal are excluded from participating in the clinical trials "
they are supposed to be testing these drugs among safe populations. This
data tells me something is very wrong."
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- Kahn did not respond to Insight's requests for an interview,
but according to Clinical Psychiatry News he reported to a meeting of the
New Clinical Drug Evaluation Unit of the National Institutes of Health
that, "In the case of trials for depression and anxiety disorders,
suicide rates were in fact higher among those who received the investigational
drugs than the placebo." In fact, according to shocked experts, when
projected the increase in both attempted and completed suicides for those
on the SSRIs is stunning. And the FDA knew this when it approved these
drugs.
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- Kelly Patricia O'Meara is an investigative reporter for
Insight magazine.
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