Paxil, Prozac and SSRI Induced Suicide by Jeffrey Dach MD
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Jeffrey Dach MD
Mar 12, 2008, 8:58:14 AM3/12/08
to Unsafe Drugs in Litigation
SSRI Antidepressants, a Closer Look at the Data
Original Article can be found here:
http://jeffreydach.com/2007/05/14/paxil-prozac-and-ssri-induced-suicide-by-jeffrey-dach-md.aspx
In 1977, a first year intern at Rush Hospital in Chicago earned an
annual salary of $10,000, a minuscule amount, even in those days. By
1978, having survived the internship experience, I was a cocky young
MD who could handle anything. Needing the money, I eagerly took a job
moonlighting as the Emergency Room doctor in a small hospital in
Kankakee, Illinois. This was before the days of Board Certification
in Emergency Room Medicine, and my internship made me imminently
qualified. The fact that my dad was a doctor on the hospital staff
also helped.
One of my vivid memories of the experience was a weekend in which the
young doc from the previous shift rushed past me on the way out the
door in a hurry. Upon entering, I was supplied with a clipboard and
stethoscope, and directed to the examining room. The first patient was
an 11 year old boy lying dead on the examining table with his head
tilted to the side. Apparently his parents came home to discover he
had hung himself in the closet, and they rushed the boy into the ER
clinging to the hope that it wasn't too late for resuscitation. The
ER staff had been unable to revive him. It was at this point I
realized that the previous doctor had left me with the unpalatable
task of informing the parents that their son was dead, a task which
clearly was one of the worst experiences of my medical career and of
my life.
Sharing this unspeakable grief are the parents of 19 year old Traci
Johnson, a normally healthy, 19-year-old with no history of
depression. She needed money for college, and signed on as a
participant for $150 a day in a Lilly drug trial for "urinary stress
incontinence" which involved the SSRI drug, Cymbalta. Four weeks
after starting on the drug, she hung herself with a scarf in the
shower room. David Shaffer, an Eli Lilly spokesman in Indianapolis,
admitted that Traci was only one of five test subjects (none of whom
where depressed) with SSRI induced suicide. (1)(2)(3)(4)(5)
This story is not an isolated event. There are 1,400 similar stories
of SSRI induced suicide and violence including 18 school shootings, 41
road rage tragedies, and 110 murder-suicides. (6) In response to
this, the FDA issued an SSRI-Suicide advisory on March 22, 2004, and
a "black box" suicide warning label on all SSRI drugs January 2005. In
2002, 11 million prescriptions for SSRI drugs were given to children,
2.7 million of them to children under 12. (7)(8)(9)(10)
SSRI drug use is so prevalent in the population that many patients
come through my office with the obvious signs of exhaustion, insomnia
and agitation. They may have purple rings under the eyes, and they
usually have hyper-active reflexes. The involuntary facial movements,
tics, and mouth and tongue movements are common and can also be
observed in the general population at large. For example, when
observing nationally televised political speeches, the figures in the
background may demonstrate involuntary facial movements indicating
long term SSRI drug usage. (11) These movements are also called
"Tardive Dyskinesia" and includes rhythmic involuntary movements of
the tongue, face, mouth, or jaw (e.g. frequent poking out of the
tongue, chewing, puckering, or blowing out of the cheeks).
Tardive dyskinesia is a dreaded complication of anti-psychotic
medications like prolixin and haldol, in the past associated with
institutionalized patients. It is actually an iatrogenic form of
Parkinson's disease with a tremor upon initiation of voluntary motion
and the classic pill rolling hand tremor. In its early stages, the
SSRI induced dyskinesia effect can be subtle. For example, one day my
tennis partner exhibited signs of SSRI drug use. I noticed he could
easily hit a winning angled shot into the corner, but completely lost
his coordination from the intentional effort of the serve which went
wild. He later disclosed he had been taking an SSRI drug for many
years. Anyone concerned about maintaining fine motor coordination
should be aware of this side effect. (11)
In the early 90's, Peter Kramer's book, Listening to Prozac, suggested
that Prozac and other SSRI drugs were safe, non-habit forming and even
suitable for only mild social phobias. (12) Kramer also speculated
that this SSRI drug invites a future possibility of "cosmetic
psychopharmacology", in which the patient becomes more confident,
articulate and less bashful and shy while on the drug. Prozac would
produce a "more socially confident" personality. In those days, my
doctor colleagues would laud the SSRI drugs they were taking, and
those who couldn't take them made excuses. The surgeons couldn't take
the SSRI drugs because it caused a tremor which interfered with eye
hand coordination and impaired their ability to operate.
Of course, we know now the hidden dangers of the SSRI antidepressants
that experts like David Healy (Let them Eat Prozac), Joseph Glenmullen
(Prozac Backlash) and Peter R. Breggin (Talking Back to Prozac) have
been writing about for years. (13)(14)(15)(16) Not only do the SSRI
drugs cause akathesia, a form of agitation which drives people to
commit suicide, they also cause sexual dysfunction (impotence),
tremor, involuntary body and facial movements, tardive dyskinesia, and
hyperactive reflexes indicating a hyperactive nervous system. The
SSRI induced loss of sexual function may be irreversible even after
discontinuation of the drug.(17)(18)(19)(20)
As pointed out by David Healy, the SSRI drugs (selective serotonin
reuptake inhibitors) are by no means selective in their actions on
brain neurotransmitter systems. Imagine a pinball let loose in the
pinball machine. Most of the time the pinball hits the correct
bumpers and lights up the scoreboard. However, in a small percentage
of patients the pinball bounces around affecting the wrong
neurotransmitter systems in the brain, causing the machine to go
"tilt". These are the "akasthesia", agitation cases estimated by the
FDA to affect 1 in 50 patients, some of these inflicting self harm or
commiting suicide. (7) The drug companies who finance the research
have simply avoided the question of why this happens. For example,
what are the preliminary lab tests to identify the subpopulation at
risk for these adverse effects? We don't know. Currently the only
test is a trial of the SSRI medication to find out. As pointed out by
Healy during FDA testimony, we track postal parcels 100 times better
than we track adverse side effects from SSRI drugs.
I started medical school at the University of Illinois in Chicago in
1972. Robert Mendelsohn was my adviser and I spent a few evenings at
his dinner table learning things about the institution of medicine not
safely repeated to anyone if I wished to continue medical school (1)
(2).
After a full year listening to basic science lectures and taking
exams, our class was released into the hospital wards to start
clerkships. This involved making rounds with the intern and resident
team examining patients and doing the "scut work" which maintained the
University teaching hospital (3). Doing rounds was a daily ritual, and
we methodically worked our way up and down the long corridors which
had the distinctive smell of alcohol and pseudomonas.
My first rotation was internal medicine, and we saw the usual litany
of diseases: diabetes, rheumatoid arthritis, GI bleeding, congestive
heart failure, cancer, and various bacterial and viral infections.
After examining each patient, we convened in the hallway wearing our
long white coats and stethoscopes as in a football huddle to discuss
the diagnosis and treatment. Actually, the discussion was between the
intern and resident, while the rest of us listened in. The two of
them routinely had a running debate punctuated by brief forays into
the rooms to examine patients. Both of them were armed with a pocket
notebook inscribed with references to the medical literature which was
brandished to support their decisions regarding testing or treatment.
On a good day, I endeared myself to the intern by starting a difficult
I.V., or by making a diagnostic coup like homonymous hemianopsia or
acute intermittent porphyria.
In those days, the medical literature was rock solid truth and
trustworthy beyond question. It was inconceivable to us that any
doctor would ever falsify or distort the results of a medical study or
research. After all, people's lives were hanging in the balance.
This gradually changed over time. I am not sure when awareness of
problems with the medical literature emerged and it became sadly
obvious that much of medical science is up for sale. After this
revelation, I became skeptical and I now tend to believe the data more
than the written conclusions of any medical study. A recent example
of this fraudulent conduct in medical research is given in the BBC
documentary on the SSRI drug Seroxat (Paxil) and pediatric
prescriptions (4)(5).
We have previously discussed the adverse risks of SSRI drugs including
agitation, suicidal or violent behavior, movement disorders, and
chemical dependency (6) in adults. We might imagine their "side
effects" in children are no less, but what about their efficacy?
Surely they must be magic pills against a debilitating "illness" to
risk such terrible consequences. However, Jon Jureidini in a
comprehensive review of the available data found only minimal benefit
from the SSRI drugs in children. He writes, " The magnitude of benefit
is unlikely to be sufficient to justify risking those harms, so
confidently recommending these drugs as a treatment option, let alone
as first line treatment, would be inappropriate." (7)
According to Irving Kirsch in Prevention & Treatment , "there is now
unanimous agreement that the mean difference between response to
antidepressant drugs and response to inert placebo is very small. It
is so small that, despite sample sizes involving hundreds of
participants, 57% of the trials funded by the pharmaceutical industry
failed to show a significant difference between drug and placebo. Most
of these negative data were not published and were accessible only by
gaining access to US Food and Drug Administration (FDA) documents. The
small difference between the drug response and the placebo response
has been a "dirty little secret". It was not known to the general
public, depressed patients, or even their physicians".(8)
(19)(20)
Various methods were used to manipulate the results of SSRI drug
studies to insure a favorable outcome:
1) Responders to the placebo are eliminated at the beginning of the
study. (Placebo washout)
2) Benzodiazepine sedatives were given to mask the SSRI induced
agitation.
3) Unfavorable drug studies are buried in the file cabinet and not
disclosed to the public.
4) Miscoding suicidal events as "emotional lability", and homicidal
events as "aggression" to hide suicidal events from regulators.
5) False attribution of suicide to the placebo arm.
6) Hiring ghost writers to make the medical articles more favorable.
7) Cash settlements for SSRI drug litigants which seals records and
withholds unfavorable drug studies from the public.
Using these and other gimmicks, the drug industry managed to gain FDA
approval for the SSRI class of drugs. Since the FDA approval is the
foundation of our medical system, the first step in restoring
integrity is to halt the "waiver system" which gives doctors immunity
from prosecution for conflicts of interest. The system allows doctors
to deliberate on FDA advisory committees while receiving money from
the drug industry, a conflict of interest that is also a federal crime
(9)(10).
The harm caused by consumer drug advertising was discussed in a
previous report (11). Direct to consumer advertising of SSRI drugs
presents the message that depression is a disease caused by a chemical
imbalance in the brain, namely a deficiency of serotonin, which is
cured by the SSRI drug (12). The precursor to the neurotransmitter
serotonin is tryptophan (5-HTP), a naturally occurring amino acid.
Unfortunately, the serotonin deficiency concept as presented by the
DTC advertising is poorly supported by medical science (13). In
addition, it is well known that brain serotonin can be increased
safely with ingestion of a food supplement, 5HTP, available at the
health food store. Why risk the adverse side effects of SSRI drugs
when a safer alternative is available? (14)
The unfortunate soul who loses his job, gets divorced or experiences
the grief of a death in the family now has a "disease" caused by a
chemical imbalance which requires him to be prescribed an SSRI drug.
This is not a description of a disease state. This is a description
of a life event which makes anyone depressed, and the treatment is the
support of friends and family through a difficult time. Perhaps the
depressed individual bears inner turmoil of unresolved conflicts with
work or family, and the SSRI drug "numbs" the individual to this
unbearable inner conflict, allowing continuation of the job or unhappy
home. Perhaps this is the true utility of SSRI drugs in our
society.
We have known about SSRI drug induced suicide since Teicher's landmark
article in 1990 (15). Where is the overpowering sense of public
outrage that should have banned these drugs in children years ago?
The drug industry, the FDA and the medical profession continue the
widespread drugging of our children with addictive toxic placebos in
an uncanny similarity to the classic Lucas film THX 1138, a science
fictional remake of Orwell's 1984 which paints a totalitarian world of
enslaved citizens controlled by drugs (16)(17).
Child sacrifice is an important theme of the three major, monotheistic
religions (18). Abraham's intended sacrifice of Isaac took place at
the "Dome of the Rock" on the temple mount, near the "Wailing Wall" in
the old city of Jerusalem. Isaac's life was spared at the last minute
by an angel who ordered Abraham to sacrifice a ram instead. We know
today's Abrahams and Issacs well enough, but the horizon seems
frighteningly devoid of any signs of angels.
References
(1) http://www.antidepressantsfacts.com/Traci-Johnson-19-duloxetine2.htmPosted
on Tue, Feb. 10, 2004 Woman testing depression drug kills herself
BY GLORIA CAMPISI Knight Ridder Newspapers
(2) http://www.antidepressantsfacts.com/Traci-Johnson-19-duloxetine3.htm
Suicide brings changes to Lilly drug trials By J.K. Wall and John
Tuohy
February 11, 2004
(3) http://www.antidepressantsfacts.com/Traci-Johnson-19-duloxetine4.htmWed,
Feb. 11, 2004 Bucks woman found dead in Ind. laboratory Traci R.
Johnson was found at clinic where she was part of testing for a new
drug.
By Walter F. Naedele Inquirer Staff Writer
(4) http://www.antidepressantsfacts.com/2004-02-12-Philad-Traci-Johnson.htm
Thu, Feb. 12, 2004 Drug test altered in wake of suicide By Walter F.
Naedele Inquirer Staff Writer
(5) http://query.nytimes.com/gst/fullpage.html?sec=health&res=9C03E5D8133AF931A25751C0A9629C8B63
Student, 19, in Trial of New Antidepressant Commits Suicide By
GARDINER HARRIS Published: February 12, 2004
(6) http://www.ssristories.com/
SSRI Stories Antidepressant Nightmares WARNING! Withdrawal can often
be more dangerous than continuing on a medication. It is important to
withdraw extremely slowly from these drugs, usually over a period of a
year or more, under the supervision of a qualified specialist.
(7) http://www.fda.gov/cder/drug/antidepressants/default.htm
FDA - Antidepressant Use in Children, Adolescents, and Adults, The
U.S. Food and Drug Administration (FDA) today proposed that makers of
all antidepressant medications update the existing black box warning
on their products' labeling to include warnings about increased risks
of suicidal thinking and behavior, known as suicidality, in young
adults ages 18 to 24 during initial treatment (generally the first one
to two months).
(8) http://content.apa.org/psycarticles/browse/?UseCanonicalURLs=1&pg=33&iss=1&vol=5&jrn=pre&Printable=1
Antidepressants and placebos: Secrets, revelations, and unanswered
questions. July 15, 2002. Responds to numerous comments on the
authors' original article (see record 2002-14079-003) on drug and
placebo responses in studies on antidepressants. Unlike some of the
responses to a previous meta-analysis of antidepressant drug effects
(I. Kirsch and G. Sapirstein, 1998),
there is now unanimous agreement among commentators that the mean
difference between response to antidepressant drugs and response to
inert placebo is very small. It is so small that, despite sample sizes
involving hundreds of participants, 57% of the trials funded by the
pharmaceutical industry failed to show a significant difference
between drug and placebo. Most of these negative data were not
published and were accessible only by gaining access to US Food and
Drug Administration (FDA) documents. The small difference between the
drug response and the placebo response has been a "dirty little
secret," known to researchers who conduct clinical trials, FDA
reviewers, and a small group of critics who analyzed the published
data and reached conclusions similar to that of the authors. It was
not known to the general public, depressed patients, or even their
physicians. The authors are pleased that their effort facilitates
dissemination of this information. Kirsch, Irving; Scoboria, Alan;
Moore, Thomas J. , Prevention & Treatment. 2002 Jul Vol 5(1)
(9)http://www.commondreams.org/headlines/092500-01.htm
Published on Monday, September 25, 2000 in USA Today, FDA Advisers
Tied To Industry,by Dennis Cauchon, More than half of the experts
hired to advise the government on the safety and effectiveness of
medicine have financial relationships with the pharmaceutical
companies that will be helped or hurt by their decisions, a USA TODAY
study found.
(10)http://www.senate.gov/~finance/hearings/testimony/2004test/
111804dgtest.pdf
Testimony of David J. Graham, MD, MPH, November 18, 2004, Mr. Chairman
and members of the Committee...The big picture. The problem you are
confronting today is immense in scope. Vioxx is a terrible tragedy and
a profound regulatory failure. I would argue that the FDA, as
currently configured, is incapable of protecting America against
another Vioxx. We are virtually defenseless. It is important that this
Committee and the American people understand that what has happened
with Vioxx is really a symptom of something far more dangerous to the
safety of the American people. Simply put, FDA and its Center for Drug
Evaluation and Research are broken.
(11) http://barnesworld.blogs.com/barnes_world/2007/01/jeffrey_dach_on.html
Jeffrey Dach on Lipitor and "The Dracula of Modern Technology" Jan 3
2007
(12) http://www.zoloft.com/zoloft/zoloft.portal?_nfpb=true&_pageLabel=depr_causes
Zoloft web site, "Scientists believe that it could be linked with an
imbalance of a chemical in the brain called serotonin. If this
imbalance happens, it can affect the way people feel. "
(13) http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0020392
Serotonin and Depression: A Disconnect between the Advertisements and
the Scientific Literature Jeffrey R. Lacasse, Jonathan Leo*
(14) http://www.thorne.com/altmedrev/.fulltext/5/1/64.pdf
Use of Neurotransmitter Precursors for Treatment of Depressionby
Stephen Meyers, MS, Thorne Research
(15) http://www.ncbi.nlm.nih.gov/pubmed/2301661?dopt=AbstractPlus
Emergence of intense suicidal preoccupation during fluoxetine
treatment.
Teicher MH, Glod C, Cole JO. Department of Psychiatry, Harvard Medical
School, MA.
Six depressed patients free of recent serious suicidal ideation
developed intense, violent suicidal preoccupation after 2-7 weeks of
fluoxetine treatment. This state persisted for as little as 3 days to
as long as 3 months after discontinuation of fluoxetine. None of these
patients had ever experienced a similar state during treatment with
any other psychotropic drug.
(16) http://www.lucasfilm.com/films/other/thx1138.html
THX-1138 Population controlled by a government controlled sedating
drug program
(17) http://www.thx1138movie.com/ THX-1138 Movie trailer
(18) http://198.62.75.1/www1/ofm/sbf/dialogue/symp95.html
March 16-17, 1995 - Symposium on The Sacrifice of Isaac in the Three
Monotheistic Religions
(19) http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050045
Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data
Submitted to the Food and Drug Administration
Irving Kirsch, Brett J. Deacon, Tania B. Huedo-Medina, Alan Scoboria,
Thomas J. Moore5, Blair T. Johnson
Irving Kirsch, summarising the paper, says: "Although patients get
better when they take antidepressants, they also get better when they
take a placebo, and the difference in improvement is not very great.
This means that depressed people can improve without chemical
treatments."
What Do These Findings Mean? These findings suggest that, compared
with placebo, the new-generation antidepressants do not produce
clinically significant improvements in depression in patients who
initially have moderate or even very severe depression, but show
significant effects only in the most severely depressed patients. The
findings also show that the effect for these patients seems to be due
to decreased responsiveness to placebo, rather than increased
responsiveness to medication. Given these results, the researchers
conclude that there is little reason to prescribe new-generation
antidepressant medications to any but the most severely depressed
patients unless alternative treatments have been ineffective. In
addition, the finding that extremely depressed patients are less
responsive to placebo than less severely depressed patients but have
similar responses to antidepressants is a potentially important
insight into how patients with depression respond to antidepressants
and placebos that should be investigated further.
(20) http://www.bmj.com/cgi/content/full/336/7643/516
BMJ 2008;336:516-517 (8 March) Editorials, Efficacy of
antidepressants Is not an absolute measure, and it depends on how
clinical significance is defined
In February 2008, Kirsch and colleagues reported a meta-analysis of
the efficacy of antidepressants using data from clinical trials
submitted to the Food and Drug Administration. They provocatively
concluded, "there seems little evidence to support the prescription of
antidepressant medication to any but the most severely depressed
patients."
Original Article can be found here:
http://jeffreydach.com/2007/05/14/paxil-prozac-and-ssri-induced-suicide-by-jeffrey-dach-md.aspx
Jeffrey Dach MD
4700 Sheridan Suite T
Hollywood Florida 33021
954-983-1443
www.drdach.com
www.jeffreydach.com
disclaimer http://www.drdach.com/wst_page20.html
(c) 2008 all rights reserved Jeffrey Dach MD
http://www.drdach.com disclaimer http://www.drdach.com/wst_page20.html
Disclaimer: This article is for educational purposes only. Always
consult with a knowledgable physician before starting or altering any
treatment programs, medications or supplements.
Original Article can be found here:
http://jeffreydach.com/2007/05/14/paxil-prozac-and-ssri-induced-suicide-by-jeffrey-dach-md.aspx
In 1977, a first year intern at Rush Hospital in Chicago earned an
annual salary of $10,000, a minuscule amount, even in those days. By
1978, having survived the internship experience, I was a cocky young
MD who could handle anything. Needing the money, I eagerly took a job
moonlighting as the Emergency Room doctor in a small hospital in
Kankakee, Illinois. This was before the days of Board Certification
in Emergency Room Medicine, and my internship made me imminently
qualified. The fact that my dad was a doctor on the hospital staff
also helped.
One of my vivid memories of the experience was a weekend in which the
young doc from the previous shift rushed past me on the way out the
door in a hurry. Upon entering, I was supplied with a clipboard and
stethoscope, and directed to the examining room. The first patient was
an 11 year old boy lying dead on the examining table with his head
tilted to the side. Apparently his parents came home to discover he
had hung himself in the closet, and they rushed the boy into the ER
clinging to the hope that it wasn't too late for resuscitation. The
ER staff had been unable to revive him. It was at this point I
realized that the previous doctor had left me with the unpalatable
task of informing the parents that their son was dead, a task which
clearly was one of the worst experiences of my medical career and of
my life.
Sharing this unspeakable grief are the parents of 19 year old Traci
Johnson, a normally healthy, 19-year-old with no history of
depression. She needed money for college, and signed on as a
participant for $150 a day in a Lilly drug trial for "urinary stress
incontinence" which involved the SSRI drug, Cymbalta. Four weeks
after starting on the drug, she hung herself with a scarf in the
shower room. David Shaffer, an Eli Lilly spokesman in Indianapolis,
admitted that Traci was only one of five test subjects (none of whom
where depressed) with SSRI induced suicide. (1)(2)(3)(4)(5)
This story is not an isolated event. There are 1,400 similar stories
of SSRI induced suicide and violence including 18 school shootings, 41
road rage tragedies, and 110 murder-suicides. (6) In response to
this, the FDA issued an SSRI-Suicide advisory on March 22, 2004, and
a "black box" suicide warning label on all SSRI drugs January 2005. In
2002, 11 million prescriptions for SSRI drugs were given to children,
2.7 million of them to children under 12. (7)(8)(9)(10)
SSRI drug use is so prevalent in the population that many patients
come through my office with the obvious signs of exhaustion, insomnia
and agitation. They may have purple rings under the eyes, and they
usually have hyper-active reflexes. The involuntary facial movements,
tics, and mouth and tongue movements are common and can also be
observed in the general population at large. For example, when
observing nationally televised political speeches, the figures in the
background may demonstrate involuntary facial movements indicating
long term SSRI drug usage. (11) These movements are also called
"Tardive Dyskinesia" and includes rhythmic involuntary movements of
the tongue, face, mouth, or jaw (e.g. frequent poking out of the
tongue, chewing, puckering, or blowing out of the cheeks).
Tardive dyskinesia is a dreaded complication of anti-psychotic
medications like prolixin and haldol, in the past associated with
institutionalized patients. It is actually an iatrogenic form of
Parkinson's disease with a tremor upon initiation of voluntary motion
and the classic pill rolling hand tremor. In its early stages, the
SSRI induced dyskinesia effect can be subtle. For example, one day my
tennis partner exhibited signs of SSRI drug use. I noticed he could
easily hit a winning angled shot into the corner, but completely lost
his coordination from the intentional effort of the serve which went
wild. He later disclosed he had been taking an SSRI drug for many
years. Anyone concerned about maintaining fine motor coordination
should be aware of this side effect. (11)
In the early 90's, Peter Kramer's book, Listening to Prozac, suggested
that Prozac and other SSRI drugs were safe, non-habit forming and even
suitable for only mild social phobias. (12) Kramer also speculated
that this SSRI drug invites a future possibility of "cosmetic
psychopharmacology", in which the patient becomes more confident,
articulate and less bashful and shy while on the drug. Prozac would
produce a "more socially confident" personality. In those days, my
doctor colleagues would laud the SSRI drugs they were taking, and
those who couldn't take them made excuses. The surgeons couldn't take
the SSRI drugs because it caused a tremor which interfered with eye
hand coordination and impaired their ability to operate.
Of course, we know now the hidden dangers of the SSRI antidepressants
that experts like David Healy (Let them Eat Prozac), Joseph Glenmullen
(Prozac Backlash) and Peter R. Breggin (Talking Back to Prozac) have
been writing about for years. (13)(14)(15)(16) Not only do the SSRI
drugs cause akathesia, a form of agitation which drives people to
commit suicide, they also cause sexual dysfunction (impotence),
tremor, involuntary body and facial movements, tardive dyskinesia, and
hyperactive reflexes indicating a hyperactive nervous system. The
SSRI induced loss of sexual function may be irreversible even after
discontinuation of the drug.(17)(18)(19)(20)
As pointed out by David Healy, the SSRI drugs (selective serotonin
reuptake inhibitors) are by no means selective in their actions on
brain neurotransmitter systems. Imagine a pinball let loose in the
pinball machine. Most of the time the pinball hits the correct
bumpers and lights up the scoreboard. However, in a small percentage
of patients the pinball bounces around affecting the wrong
neurotransmitter systems in the brain, causing the machine to go
"tilt". These are the "akasthesia", agitation cases estimated by the
FDA to affect 1 in 50 patients, some of these inflicting self harm or
commiting suicide. (7) The drug companies who finance the research
have simply avoided the question of why this happens. For example,
what are the preliminary lab tests to identify the subpopulation at
risk for these adverse effects? We don't know. Currently the only
test is a trial of the SSRI medication to find out. As pointed out by
Healy during FDA testimony, we track postal parcels 100 times better
than we track adverse side effects from SSRI drugs.
I started medical school at the University of Illinois in Chicago in
1972. Robert Mendelsohn was my adviser and I spent a few evenings at
his dinner table learning things about the institution of medicine not
safely repeated to anyone if I wished to continue medical school (1)
(2).
After a full year listening to basic science lectures and taking
exams, our class was released into the hospital wards to start
clerkships. This involved making rounds with the intern and resident
team examining patients and doing the "scut work" which maintained the
University teaching hospital (3). Doing rounds was a daily ritual, and
we methodically worked our way up and down the long corridors which
had the distinctive smell of alcohol and pseudomonas.
My first rotation was internal medicine, and we saw the usual litany
of diseases: diabetes, rheumatoid arthritis, GI bleeding, congestive
heart failure, cancer, and various bacterial and viral infections.
After examining each patient, we convened in the hallway wearing our
long white coats and stethoscopes as in a football huddle to discuss
the diagnosis and treatment. Actually, the discussion was between the
intern and resident, while the rest of us listened in. The two of
them routinely had a running debate punctuated by brief forays into
the rooms to examine patients. Both of them were armed with a pocket
notebook inscribed with references to the medical literature which was
brandished to support their decisions regarding testing or treatment.
On a good day, I endeared myself to the intern by starting a difficult
I.V., or by making a diagnostic coup like homonymous hemianopsia or
acute intermittent porphyria.
In those days, the medical literature was rock solid truth and
trustworthy beyond question. It was inconceivable to us that any
doctor would ever falsify or distort the results of a medical study or
research. After all, people's lives were hanging in the balance.
This gradually changed over time. I am not sure when awareness of
problems with the medical literature emerged and it became sadly
obvious that much of medical science is up for sale. After this
revelation, I became skeptical and I now tend to believe the data more
than the written conclusions of any medical study. A recent example
of this fraudulent conduct in medical research is given in the BBC
documentary on the SSRI drug Seroxat (Paxil) and pediatric
prescriptions (4)(5).
We have previously discussed the adverse risks of SSRI drugs including
agitation, suicidal or violent behavior, movement disorders, and
chemical dependency (6) in adults. We might imagine their "side
effects" in children are no less, but what about their efficacy?
Surely they must be magic pills against a debilitating "illness" to
risk such terrible consequences. However, Jon Jureidini in a
comprehensive review of the available data found only minimal benefit
from the SSRI drugs in children. He writes, " The magnitude of benefit
is unlikely to be sufficient to justify risking those harms, so
confidently recommending these drugs as a treatment option, let alone
as first line treatment, would be inappropriate." (7)
According to Irving Kirsch in Prevention & Treatment , "there is now
unanimous agreement that the mean difference between response to
antidepressant drugs and response to inert placebo is very small. It
is so small that, despite sample sizes involving hundreds of
participants, 57% of the trials funded by the pharmaceutical industry
failed to show a significant difference between drug and placebo. Most
of these negative data were not published and were accessible only by
gaining access to US Food and Drug Administration (FDA) documents. The
small difference between the drug response and the placebo response
has been a "dirty little secret". It was not known to the general
public, depressed patients, or even their physicians".(8)
(19)(20)
Various methods were used to manipulate the results of SSRI drug
studies to insure a favorable outcome:
1) Responders to the placebo are eliminated at the beginning of the
study. (Placebo washout)
2) Benzodiazepine sedatives were given to mask the SSRI induced
agitation.
3) Unfavorable drug studies are buried in the file cabinet and not
disclosed to the public.
4) Miscoding suicidal events as "emotional lability", and homicidal
events as "aggression" to hide suicidal events from regulators.
5) False attribution of suicide to the placebo arm.
6) Hiring ghost writers to make the medical articles more favorable.
7) Cash settlements for SSRI drug litigants which seals records and
withholds unfavorable drug studies from the public.
Using these and other gimmicks, the drug industry managed to gain FDA
approval for the SSRI class of drugs. Since the FDA approval is the
foundation of our medical system, the first step in restoring
integrity is to halt the "waiver system" which gives doctors immunity
from prosecution for conflicts of interest. The system allows doctors
to deliberate on FDA advisory committees while receiving money from
the drug industry, a conflict of interest that is also a federal crime
(9)(10).
The harm caused by consumer drug advertising was discussed in a
previous report (11). Direct to consumer advertising of SSRI drugs
presents the message that depression is a disease caused by a chemical
imbalance in the brain, namely a deficiency of serotonin, which is
cured by the SSRI drug (12). The precursor to the neurotransmitter
serotonin is tryptophan (5-HTP), a naturally occurring amino acid.
Unfortunately, the serotonin deficiency concept as presented by the
DTC advertising is poorly supported by medical science (13). In
addition, it is well known that brain serotonin can be increased
safely with ingestion of a food supplement, 5HTP, available at the
health food store. Why risk the adverse side effects of SSRI drugs
when a safer alternative is available? (14)
The unfortunate soul who loses his job, gets divorced or experiences
the grief of a death in the family now has a "disease" caused by a
chemical imbalance which requires him to be prescribed an SSRI drug.
This is not a description of a disease state. This is a description
of a life event which makes anyone depressed, and the treatment is the
support of friends and family through a difficult time. Perhaps the
depressed individual bears inner turmoil of unresolved conflicts with
work or family, and the SSRI drug "numbs" the individual to this
unbearable inner conflict, allowing continuation of the job or unhappy
home. Perhaps this is the true utility of SSRI drugs in our
society.
We have known about SSRI drug induced suicide since Teicher's landmark
article in 1990 (15). Where is the overpowering sense of public
outrage that should have banned these drugs in children years ago?
The drug industry, the FDA and the medical profession continue the
widespread drugging of our children with addictive toxic placebos in
an uncanny similarity to the classic Lucas film THX 1138, a science
fictional remake of Orwell's 1984 which paints a totalitarian world of
enslaved citizens controlled by drugs (16)(17).
Child sacrifice is an important theme of the three major, monotheistic
religions (18). Abraham's intended sacrifice of Isaac took place at
the "Dome of the Rock" on the temple mount, near the "Wailing Wall" in
the old city of Jerusalem. Isaac's life was spared at the last minute
by an angel who ordered Abraham to sacrifice a ram instead. We know
today's Abrahams and Issacs well enough, but the horizon seems
frighteningly devoid of any signs of angels.
References
(1) http://www.antidepressantsfacts.com/Traci-Johnson-19-duloxetine2.htmPosted
on Tue, Feb. 10, 2004 Woman testing depression drug kills herself
BY GLORIA CAMPISI Knight Ridder Newspapers
(2) http://www.antidepressantsfacts.com/Traci-Johnson-19-duloxetine3.htm
Suicide brings changes to Lilly drug trials By J.K. Wall and John
Tuohy
February 11, 2004
(3) http://www.antidepressantsfacts.com/Traci-Johnson-19-duloxetine4.htmWed,
Feb. 11, 2004 Bucks woman found dead in Ind. laboratory Traci R.
Johnson was found at clinic where she was part of testing for a new
drug.
By Walter F. Naedele Inquirer Staff Writer
(4) http://www.antidepressantsfacts.com/2004-02-12-Philad-Traci-Johnson.htm
Thu, Feb. 12, 2004 Drug test altered in wake of suicide By Walter F.
Naedele Inquirer Staff Writer
(5) http://query.nytimes.com/gst/fullpage.html?sec=health&res=9C03E5D8133AF931A25751C0A9629C8B63
Student, 19, in Trial of New Antidepressant Commits Suicide By
GARDINER HARRIS Published: February 12, 2004
(6) http://www.ssristories.com/
SSRI Stories Antidepressant Nightmares WARNING! Withdrawal can often
be more dangerous than continuing on a medication. It is important to
withdraw extremely slowly from these drugs, usually over a period of a
year or more, under the supervision of a qualified specialist.
(7) http://www.fda.gov/cder/drug/antidepressants/default.htm
FDA - Antidepressant Use in Children, Adolescents, and Adults, The
U.S. Food and Drug Administration (FDA) today proposed that makers of
all antidepressant medications update the existing black box warning
on their products' labeling to include warnings about increased risks
of suicidal thinking and behavior, known as suicidality, in young
adults ages 18 to 24 during initial treatment (generally the first one
to two months).
(8) http://content.apa.org/psycarticles/browse/?UseCanonicalURLs=1&pg=33&iss=1&vol=5&jrn=pre&Printable=1
Antidepressants and placebos: Secrets, revelations, and unanswered
questions. July 15, 2002. Responds to numerous comments on the
authors' original article (see record 2002-14079-003) on drug and
placebo responses in studies on antidepressants. Unlike some of the
responses to a previous meta-analysis of antidepressant drug effects
(I. Kirsch and G. Sapirstein, 1998),
there is now unanimous agreement among commentators that the mean
difference between response to antidepressant drugs and response to
inert placebo is very small. It is so small that, despite sample sizes
involving hundreds of participants, 57% of the trials funded by the
pharmaceutical industry failed to show a significant difference
between drug and placebo. Most of these negative data were not
published and were accessible only by gaining access to US Food and
Drug Administration (FDA) documents. The small difference between the
drug response and the placebo response has been a "dirty little
secret," known to researchers who conduct clinical trials, FDA
reviewers, and a small group of critics who analyzed the published
data and reached conclusions similar to that of the authors. It was
not known to the general public, depressed patients, or even their
physicians. The authors are pleased that their effort facilitates
dissemination of this information. Kirsch, Irving; Scoboria, Alan;
Moore, Thomas J. , Prevention & Treatment. 2002 Jul Vol 5(1)
(9)http://www.commondreams.org/headlines/092500-01.htm
Published on Monday, September 25, 2000 in USA Today, FDA Advisers
Tied To Industry,by Dennis Cauchon, More than half of the experts
hired to advise the government on the safety and effectiveness of
medicine have financial relationships with the pharmaceutical
companies that will be helped or hurt by their decisions, a USA TODAY
study found.
(10)http://www.senate.gov/~finance/hearings/testimony/2004test/
111804dgtest.pdf
Testimony of David J. Graham, MD, MPH, November 18, 2004, Mr. Chairman
and members of the Committee...The big picture. The problem you are
confronting today is immense in scope. Vioxx is a terrible tragedy and
a profound regulatory failure. I would argue that the FDA, as
currently configured, is incapable of protecting America against
another Vioxx. We are virtually defenseless. It is important that this
Committee and the American people understand that what has happened
with Vioxx is really a symptom of something far more dangerous to the
safety of the American people. Simply put, FDA and its Center for Drug
Evaluation and Research are broken.
(11) http://barnesworld.blogs.com/barnes_world/2007/01/jeffrey_dach_on.html
Jeffrey Dach on Lipitor and "The Dracula of Modern Technology" Jan 3
2007
(12) http://www.zoloft.com/zoloft/zoloft.portal?_nfpb=true&_pageLabel=depr_causes
Zoloft web site, "Scientists believe that it could be linked with an
imbalance of a chemical in the brain called serotonin. If this
imbalance happens, it can affect the way people feel. "
(13) http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0020392
Serotonin and Depression: A Disconnect between the Advertisements and
the Scientific Literature Jeffrey R. Lacasse, Jonathan Leo*
(14) http://www.thorne.com/altmedrev/.fulltext/5/1/64.pdf
Use of Neurotransmitter Precursors for Treatment of Depressionby
Stephen Meyers, MS, Thorne Research
(15) http://www.ncbi.nlm.nih.gov/pubmed/2301661?dopt=AbstractPlus
Emergence of intense suicidal preoccupation during fluoxetine
treatment.
Teicher MH, Glod C, Cole JO. Department of Psychiatry, Harvard Medical
School, MA.
Six depressed patients free of recent serious suicidal ideation
developed intense, violent suicidal preoccupation after 2-7 weeks of
fluoxetine treatment. This state persisted for as little as 3 days to
as long as 3 months after discontinuation of fluoxetine. None of these
patients had ever experienced a similar state during treatment with
any other psychotropic drug.
(16) http://www.lucasfilm.com/films/other/thx1138.html
THX-1138 Population controlled by a government controlled sedating
drug program
(17) http://www.thx1138movie.com/ THX-1138 Movie trailer
(18) http://198.62.75.1/www1/ofm/sbf/dialogue/symp95.html
March 16-17, 1995 - Symposium on The Sacrifice of Isaac in the Three
Monotheistic Religions
(19) http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050045
Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data
Submitted to the Food and Drug Administration
Irving Kirsch, Brett J. Deacon, Tania B. Huedo-Medina, Alan Scoboria,
Thomas J. Moore5, Blair T. Johnson
Irving Kirsch, summarising the paper, says: "Although patients get
better when they take antidepressants, they also get better when they
take a placebo, and the difference in improvement is not very great.
This means that depressed people can improve without chemical
treatments."
What Do These Findings Mean? These findings suggest that, compared
with placebo, the new-generation antidepressants do not produce
clinically significant improvements in depression in patients who
initially have moderate or even very severe depression, but show
significant effects only in the most severely depressed patients. The
findings also show that the effect for these patients seems to be due
to decreased responsiveness to placebo, rather than increased
responsiveness to medication. Given these results, the researchers
conclude that there is little reason to prescribe new-generation
antidepressant medications to any but the most severely depressed
patients unless alternative treatments have been ineffective. In
addition, the finding that extremely depressed patients are less
responsive to placebo than less severely depressed patients but have
similar responses to antidepressants is a potentially important
insight into how patients with depression respond to antidepressants
and placebos that should be investigated further.
(20) http://www.bmj.com/cgi/content/full/336/7643/516
BMJ 2008;336:516-517 (8 March) Editorials, Efficacy of
antidepressants Is not an absolute measure, and it depends on how
clinical significance is defined
In February 2008, Kirsch and colleagues reported a meta-analysis of
the efficacy of antidepressants using data from clinical trials
submitted to the Food and Drug Administration. They provocatively
concluded, "there seems little evidence to support the prescription of
antidepressant medication to any but the most severely depressed
patients."
Original Article can be found here:
http://jeffreydach.com/2007/05/14/paxil-prozac-and-ssri-induced-suicide-by-jeffrey-dach-md.aspx
Jeffrey Dach MD
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Hollywood Florida 33021
954-983-1443
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(c) 2008 all rights reserved Jeffrey Dach MD
http://www.drdach.com disclaimer http://www.drdach.com/wst_page20.html
Disclaimer: This article is for educational purposes only. Always
consult with a knowledgable physician before starting or altering any
treatment programs, medications or supplements.
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