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Home > Archive > Depression Medications > September 2004 > DA Statement on Recommendations of the Psychopharmacologic Drugs and Pediatric Advisor
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DA Statement on Recommendations of the Psychopharmacologic Drugs and Pediatric Advisor
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| nomdeplume1000@yah00.com 2004-09-21, 3:08 am |
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FDA Statement on Recommendations of the Psychopharmacologic Drugs and Pediatric
Advisory Committees
The Food and Drug Administration (FDA) generally supports the recommendations
that were recently made to the agency by the Psychopharmacologic Drugs and
Pediatric Advisory Committees regarding reports of an increased risk of
suicidality (suicidal thoughts and actions) associated with the use of certain
antidepressants in pediatric patients. FDA has begun working expeditiously to
adopt new labeling to enhance the warnings associated with the use of
antidepressants and to bolster the information provided to patients when these
drugs are dispensed.
In summary, the members of the advisory committees:
endorsed FDA's approach to classifying and analyzing the suicidal events and
behaviors observed in controlled clinical trials and expressed their view that
the new analyses increased their confidence in the results;
concluded that the finding of an increased risk of suicidality in pediatric
patients applied to all the drugs studied (Prozac, Zoloft, Remeron, Paxil,
Effexor, Celexa Wellbutrin, Luvox and Serzone) in controlled clinical trials;
recommended that any warning related to an increased risk of suicidality in
pediatric patients should be applied to all antidepressant drugs, including
those that have not been studied in controlled clinical trials in pediatric
patients, since the available data are not adequate to exclude any single
medication from an increased risk;
reached a split decision (15-yes, 8-no) regarding recommending a "black-box"
warning related to an increased risk for suicidality in pediatric patients for
all antidepressant drugs;
endorsed a patient information sheet ("Medication Guide") for this class of
drugs to be provided to the patient or their caregiver with every prescription;
recommended that the products not be contraindicated in this country because the
Committees thought access to these therapies was important for those who could
benefit; and
recommended that the results of controlled pediatric trials of depression be
included in the labeling for antidepressant drugs.
--
Nom dePlume, Ph.D
Why, yes, in fact, I am a rocket scientist.
Guide to Medications for Mental Illness:
http://www.geocities.com/nomdeplume1001
=====
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--
<nomdeplume1000@yah00.com> wrote in message
news:1095536386.f5frzmi/qE3T48hDIW4jjg@teranews...
>
> FDA Statement on Recommendations of the Psychopharmacologic Drugs and
Pediatric
> Advisory Committees
"the finding of an increased risk of suicidality in pediatric
patients applied to all the drugs studied (Prozac, Zoloft, Remeron, Paxil,
Effexor, Celexa Wellbutrin, Luvox and Serzone) in controlled clinical
trials"
now thats not too hard to understand ..now is it?
> --
> Nom dePlume, Ph.D
>
> Why, yes, in fact, I am a rocket scientist.
>
> Guide to Medications for Mental Illness:
> http://www.geocities.com/nomdeplume1001
--
'All policymakers must be vigilant to the possibility of research data being
manipulated
by corporate bodies and of scientific colleagues being seduced by the
material charms of
industry.
Trust is no defence against an aggressively deceptive corporate sector.'
Editorial (2000). Resisting smoke and spin. Lancet 355, 1197.
> =====
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| --
'All policymakers must be vigilant to the possibility of research data being
manipulated
by corporate bodies and of scientific colleagues being seduced by the
material charms of
industry.
Trust is no defence against an aggressively deceptive corporate sector.'
Editorial (2000). Resisting smoke and spin. Lancet 355, 1197.
<nomdeplume1000@yah00.com> wrote in message
news:1095538018.lScDAo5EOuNydSg7M2jQcw@teranews...
> On Sat, 18 Sep 2004 12:51:38 -0700, in alt.support.depression.medication
"jake"
> <invalid@invalid.com> wrote:
>
Paxil,[vbcol=seagreen]
>
>
>
> STFU you stupid lame XXX clam!
>
oh that REALLY upsets the FDAs findings now doesnt it?
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| nomdeplume1000@yah00.com 2004-09-21, 3:08 am |
| On Sat, 18 Sep 2004 13:29:43 -0700, in alt.support.depression.medication "jake"
<invalid@invalid.com> wrote:
>
>oh that REALLY upsets the FDAs findings now doesnt it?
>
Suck my cock you faggot!
--
Nom dePlume, Ph.D
Why, yes, in fact, I am a rocket scientist.
Guide to Medications for Mental Illness:
http://www.geocities.com/nomdeplume1001
=====
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| nomdeplume1000@yah00.com 2004-09-21, 3:08 am |
| On Sat, 18 Sep 2004 13:29:43 -0700, in alt.support.depression.medication "jake"
<invalid@invalid.com> wrote:
>
>oh that REALLY upsets the FDAs findings now doesnt it?
>
You're a big fat motherXXXXing jackass! You should lick your frikking XXX you
XXX clucker! You should put your head up your XXX and then put a rotten fish up
your nose. XXXX you Jake!
--
Nom dePlume, Ph.D
Why, yes, in fact, I am a rocket scientist.
Guide to Medications for Mental Illness:
http://www.geocities.com/nomdeplume1001
=====
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| nomdeplume1000@yah00.com 2004-09-21, 3:08 am |
| On Sat, 18 Sep 2004 12:51:38 -0700, in alt.support.depression.medication "jake"
<invalid@invalid.com> wrote:
>now thats not too hard to understand ..now is it?
Well it's a really stupid thing to say Jake! You don't have good Chinese.
--
Nom dePlume, Ph.D
Why, yes, in fact, I am a rocket scientist.
Guide to Medications for Mental Illness:
http://www.geocities.com/nomdeplume1001
=====
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| ..
<nomdeplume1000@yah00.com> wrote in message
news:1095539491.jAKP7ERn9VUsC8XLLMugdw@teranews...
> On Sat, 18 Sep 2004 13:29:43 -0700, in alt.support.depression.medication
"jake"
> <invalid@invalid.com> wrote:
>
>
>
> You're a big fat motherXXXXing jackass! You should lick your frikking XXX
you
> XXX clucker! You should put your head up your XXX and then put a rotten
fish up
> your nose. XXXX you Jake!
>
> --
> Nom dePlume, Ph.D
You swine. You vulgar little maggot. Don't you know that you are pathetic?
You worthless bag of filth. As we say in Texas, I'll bet you couldn't pour
piss out of a boot with instructions on the heel. You are a canker. A sore
that won't go away. I would rather kiss a lawyer than be seen with you.
You are a fiend and a coward, and you have bad breath. You are degenerate,
noxious and depraved. I feel debased just for knowing you exist. I despise
everything about you. You are a bloody nardless newbie twit protohominid
chromosomally aberrant caricature of a coprophagic cloacal parasitic pond
scum and I wish you would go away.
You're a putrescence mass, a walking vomit. You are a spineless little worm
deserving nothing but the profoundest contempt. You are a jerk, a cad, a
weasel. Your life is a monument to stupidity. You are a stench, a revulsion,
a big suck on a sour lemon.
You are a bleating fool, a curdled staggering mutant dwarf smeared richly
with the effluvia and offal accompanying your alleged birth into this world.
An insensate, blinking calf, meaningful to nobody, abandoned by the
puke-drooling, giggling beasts who sired you and then killed themselves in
recognition of what they had done.
I will never get over the embarrassment of belonging to the same species as
you. You are a monster, an ogre, a malformity. I barf at the very thought of
you. You have all the appeal of a paper cut. Lepers avoid you. You are vile,
worthless, less than nothing. You are a weed, a fungus, the dregs of this
earth. And did I mention you smell?
If you aren't an idiot, you made a world-class effort at simulating one. Try
to edit your writing of unnecessary material before attempting to impress us
with your insight. The evidence that you are a nincompoop will still be
available to readers, but they will be able to access it more rapidly.
You snail-skulled little rabbit. Would that a hawk pick you up, drive its
beak into your brain, and upon finding it rancid set you loose to fly
briefly before spattering the ocean rocks with the frothy pink shame of your
ignoble blood. May you choke on the queasy, convulsing nausea of your own
trite, foolish beliefs.
You are weary, stale, flat and unprofitable. You are grimy, squalid, nasty
and profane. You are foul and disgusting. You're a fool, an ignoramus.
Monkeys look down on you. Even sheep won't have sex with you. You are
unreservedly pathetic, starved for attention, and lost in a land that
reality forgot.
And what meaning do you expect your delusionally self-important statements
of unknowing, inexperienced opinion to have with us? What fantasy do you
hold that you would believe that your tiny-fisted tantrums would have more
weight than that of a leprous desert rat, spinning rabidly in a circle,
waiting for the bite of the snake?
You are a waste of flesh. You have no rhythm. You are ridiculous and
obnoxious. You are the moral equivalent of a leech. You are a living
emptiness, a meaningless void. You are sour and senile. You are a disease,
you puerile one-handed slack-jawed drooling meatslapper.
On a good day you're a half-wit. You remind me of drool. You are deficient
in all that lends character. You have the personality of wallpaper. You are
dank and filthy. You are asinine and benighted. You are the source of all
unpleasantness. You spread misery and sorrow wherever you go.
I cannot believe how incredibly stupid you are. I mean rock-hard stupid.
Dehydrated-rock-hard stupid. Stupid so stupid that it goes way beyond the
stupid we know into a whole different dimension of stupid. You are
trans-stupid stupid. Meta-stupid. Stupid collapsed on itself so far that
even the neutrons have collapsed. Stupid gotten so dense that no intellect
can escape. Singularity stupid. Blazing hot mid-day sun on Mercury stupid.
You emit more stupid in one second than our entire galaxy emits in a year.
Quasar stupid. Your writing has to be a troll. Nothing in our universe can
really be this stupid. Perhaps this is some primordial fragment from the
original big bang of stupid. Some pure essence of a stupid so uncontaminated
by anything else as to be beyond the laws of physics that we know. I'm
sorry. I can't go on. This is an epiphany of stupid for me. After this, you
may not hear from me again for a while. I don't have enough strength left to
deride your ignorant questions and half baked comments about unimportant
trivia, or any of the rest of this drivel. Duh.
The only thing worse than your logic is your manners. I have snipped away
most of what you wrote, because, well... it didn't really say anything. Your
attempt at constructing a creative flame was pitiful. I mean, really,
stringing together a bunch of insults among a load of babbling was hardly
effective... Maybe later in life, after you have learned to read, write,
spell, and count, you will have more success. True, these are rudimentary
skills that many of us "normal" people take for granted that everyone has an
easy time of mastering. But we sometimes forget that there are "challenged"
persons in this world who find these things more difficult. If I had known,
that this was your case then I would have never read your post. It just
wouldn't have been "right". Sort of like parking in a handicap space. I wish
you the best of luck in the emotional, and social struggles that seem to be
placing such a demand on you.
P.S.: You are hypocritical, greedy, violent, malevolent, vengeful, cowardly,
deadly, mendacious, meretricious, loathsome, despicable, belligerent,
opportunistic, barratrous, contemptible, criminal, fascistic, bigoted,
racist, sexist, avaricious, tasteless, idiotic, brain-damaged, imbecilic,
insane, arrogant, deceitful, demented, lame, self-righteous, Byzantine,
conspiratorial, satanic, fraudulent, libelous, bilious, splenetic, spastic,
ignorant, clueless, illegitimate, harmful, destructive, dumb, evasive,
double-talking, devious, revisionist, narrow, manipulative, paternalistic,
fundamentalist, dogmatic, idolatrous, unethical, cultic, diseased,
suppressive, controlling, restrictive, malignant, deceptive, dim, crazy,
weird, dystopic, stifling, uncaring, plantigrade, grim, unsympathetic,
jargon-spouting, censorious, secretive, aggressive, mind-numbing, abrasive,
poisonous, flagrant, self-destructive, abusive, socially-retarded, puerile,
clueless, and generally Not Good.
I Hope This Helps...
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| nomdeplume1000@yah00.com 2004-09-21, 3:08 am |
| On Sat, 18 Sep 2004 13:45:55 -0700, in alt.support.depression.medication "jake"
<invalid@invalid.com> wrote:
>
>You swine. You vulgar little maggot. Don't you know that you are pathetic?
>You worthless bag of filth. As we say in Texas, I'll bet you couldn't pour
Well if you say that then you're and even bigger maggot than I am and a faggot.
--
Nom dePlume, Ph.D
Why, yes, in fact, I am a rocket scientist.
Guide to Medications for Mental Illness:
http://www.geocities.com/nomdeplume1001
=====
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<nomdeplume1000@yah00.com> wrote in message
news:1095540239.h/IfdEjiMPJrJTrmr4KESw@teranews...
> On Sat, 18 Sep 2004 13:45:55 -0700, in alt.support.depression.medication
"jake"
> <invalid@invalid.com> wrote:
>
pathetic?[vbcol=seagreen]
pour[vbcol=seagreen]
>
>
> Well if you say that then you're and even bigger maggot than I am and a
faggot.
>
oh no..I think I am going to cry now
>
> --
> Nom dePlume, Ph.D
>
> Why, yes, in fact, I am a rocket scientist.
>
> Guide to Medications for Mental Illness:
> http://www.geocities.com/nomdeplume1001
> =====
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| Larry Hoover 2004-09-21, 3:08 am |
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"jake" <invalid@invalid.com> wrote in message
news:cii3dd$sg4$0@pita.alt.net...
>
> "the finding of an increased risk of suicidality in pediatric
> patients applied to all the drugs studied (Prozac, Zoloft, Remeron, Paxil,
> Effexor, Celexa Wellbutrin, Luvox and Serzone) in controlled clinical
> trials"
>
> now thats not too hard to understand ..now is it?
No, simplistic statements like that are necessary, sometimes. But the FDA is
also making known the entire set of data upon which their political
statement, above, is based. The science does not support such a broad and
sweeping statement.
If you go to
http://www.fda.gov/ohrms/dockets/ac...004-4065b1.htm, you'll see
the complete list of submissions and information for review by the committee
members. Of particular interest to this subject are:
http://www.fda.gov/ohrms/dockets/ac...lder-review.pdf
http://www.fda.gov/ohrms/dockets/ac...mads-Review.pdf
and
http://www.fda.gov/ohrms/dockets/ac...AB-9b-Final.pdf
If you give more than a cursory glance at the data contained therein, you'll
see some rather interesting findings. For example, in no case did a relative
risk for fluoxetine (Prozac) exceed the risk of placebo, with respect to
suicidality. All estimates were less than unity, yet Prozac is included in
the warning. Why, you might ask? That's because the only way they could get
a risk estimate that was significant is to include Effexor, which isn't even
an SSRI, in the analysis. Only when they collapsed all SSRI trials *with*
the results for the atypicals were they able to achieve significance.
Wellbutrin should not be included, period. There were no buproprion related
incidents. Not one. Remeron had the lowest risk estimate of all drugs, and
there was only one incident in the entire trial. You cannot derive
statistics when the denominator in one arm is a zero. Why is it included in
the warning? Because the risk estimate, in absolutely its literal sense,
only applies to all those drugs, when lumped together. "...increased risk of
suicidality in pediatric patients applied to all the drugs studied." That's
a bit like lumping BMWs and Volvos in with Yugos and Ladas when you're
assessing automotive safety. Together, there may be a significant risk, but
individually, that risk is not the same.
The statement is made, "the available data are not adequate to exclude any
single medication from an increased risk". That should also be front and
centre, jake. That's the Precautionary Principle, which can be states as:
"When an activity raises threats of harm to human health or the environment,
precautionary measures should be taken even if some cause and effect
relationships are not fully established scientifically." That isn't evidence
of risk.
So, what do we find if we look deeper into the FDA reports under review? A
few snippets from the Hammad paper:
"No individual trial showed a statistically significant signal for
suicidality."
"The majority of the primary outcome (outcome 3) events in the MDD trials
(39/66=59%) were in the four trials that had the highest rate of patients
with history of
suicide attempt or ideation at baseline, namely trials # 94404 [Celexa],
HCCJ [Prozac], and 329 & 377 [Paxil]."
Just a little background for that one. Out of 21 trials, 59% of all suicidal
events arose in only 4 of those trials. And those four trials had the
highest number of subjects with a history of suicide attempt or ideation at
baseline. How high? For the two Paxil trials, no less than 81% of subjects
in any arm of the study. Other studies had about 20%. How can you compare
outcomes when your trial subjects are so very very different from one
another?
More snippets:
"Given the size of the individual trials and the background rates of suicide
behavior/ideation, the conducted trials were capable of detecting an
increase in the risk of suicidality of 4-12 fold. Therefore, none of the
individual trials showed statistically significant results. Clearly, these
trials were designed for efficacy andwere not powered for safety purposes."
There were no SSRI trials that showed such an increase in suicidality. Not
even close to the level required. No "almosts", or "nearlies". Not even
close.
Another significant issue was the failure to have balanced and equal
treatment and placebo arms in the drug trials. Where there are significant
differences in baseline variables in the study subjects, you do not have
comparable groups. Your results are confounded by uncontrolled variables.
From the detailed analyses of the study protocols and enrollments, the
following uncontrolled variables were found. I just collected a few,
willy-nilly.
Variables showing potential randomization failure or imbalances (p-values)
(summary from all trials, significant values or those approaching
signficance):
"exposure (0.03), Hx irritability (0.08), exposure (0.03), race (0.03),
discontinuation (0.005), exposure (0.02), gender (0.02), Hx insomnia (0.03),
suicidality item score at baseline (0.06), suicidality item score at
baseline (0.07), exposure (0.09) gender (0.01), Hx insomnia (0.08), age
(0.07), gender (0.01), Hx irritability (0.04), Hx suicidal ideation (0.04),
Hx irritability (0.09), discontinuation (0.06), exposure (0.06), baseline
severity (0.007), Hx substance abuse (0.03), Hx psychiatric hospitalization
(0.05)"
From this summary, it can be seen that numerous studies showed different
time periods of exposure to drug and placebo. Gender, age, race,
irritability, insomnia, suicidal ideation/suicidality, substance abuse and
history of psychiatric hospitalization were baseline differences between the
drug and placebo arms. One trial even had a highly significant difference in
baseline severity of symptoms (baseline severity (0.007)), before the trial
even got underway. Differences in discontinuation rate were not significant,
but were substantial in more than one trial.
With these sorts of flaws, the FDA tried to make a silk purse out of a sow's
ear. I'm sorry, but it's still a sow's ear. It's all they had to work with,
though.
Hammad concluded, "It is worth noting that what is reported in this review
represents a post-hoc analysis with multiple outcomes involved. This is
complicated by the lack of statistical significance for many of the
sub-analyses, which increase the level of uncertainty. Therefore, caution is
warranted in the interpretation of the findings."
Lar
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