PROZAC/SSRIs: Problematic [DEADLY!] For Bipolars: Dr. David Gratzer

NOTE FROM DR. TRACY (www.drugawareness.org):

Problematic???!!!!!” How about using the term DEADLY? How did
we get to the point that using SSRIs is the standard “treatment” for Bipolar
patients when initially doctors would not prescribe them due to their strong
potential to induce Bipolar?! Time has certainly proven the initial fears to be
true when the number of diagnosis for Bipolar Disorder increased by a whopping
4000% from 1996 to 2004!! No wonder every third person you meet any more has the
Bipolar label!
The simple truth of the matter is (as I discuss at length in
my DVD “Bipolar, Shmypolar! Are You Really Bipolar or Misdiagnosed Due to the
Use of or Abrupt Discontinuation of an Antidepressant?”) that antidepressants –
especially the SSRI antidepressants – are by far the BIGGEST CAUSE on
this planet of Bipolar Disorder! And doctors prescribing these drugs as
“treatment” for Bipolar is not only unethical, it is downright criminal! Why
wouldn’t the placebo outperform the drug?! Placebos don’t CAUSE Bipolar Disorder
– Antidepressants do!
Paragraph 14 reads:  “As a physician myself, I know a
thing or two about going by the book and getting it wrong. When I was in
residency, the standard treatment for bipolar patients suffering
depression was Prozac or its sister drugs
. It turned out that

Prozac intervention was not only highly problematic, but also bested by
placebo.”

http://www.washingtonexaminer.com/opinion/columns/Manhattan-Moment/Medicine-isn_t-perfect_-Obamacare-is-even-less-perfect-8582816-72875022.html

Dr. David Gratzer: Medicine isn’t perfect, Obamacare is even less
perfect

By: Dr. David Gratzer
Op-Ed Contributor
November 25, 2009

Pay for the blue pill that works, not the red one that
doesn’t. That’s the president’s simple prescription for improving American
health care, one that relies on government panels and committees to set
guidelines for doctors and patients alike.

At least, that’s the
theory.

The theory met messy reality last week when the U.S. Preventive
Services Task Force recommended that women in their 40s shouldn’t get
mammograms. But the secretary of health and human services — who, incidentally,
oversees this panel — thinks women probably should. And the American Cancer
Society believes that they definitely should; major private insurance companies,

for the record, will continue to fund the tests.

Confused
yet?

Recommendation from a largely unknown government panel hardly seems
like typical material for national headlines. But when it involves breast cancer
and the announcement is made in the heat of debate over health reform, people
are — understandably — concerned.

The U.S. Preventive Services Task
Force, as it turns out, is not part of a larger Obama White House rationing
conspiracy, as some would have it. Task force members were appointed by
President Bush, and they voted on this recommendation before Obama’s
inauguration.

As for cost considerations, the task force had none:
Members are mandated not to weigh dollars and cents when considering the risk
and benefits of recommendations.

That’s not to suggest that their
conclusion isn’t highly controversial. For starters, it seems counterintuitive:
Early screening for cancer makes sense.

No wonder, then, that a full 87
percent of Americans believed that routine scanning was “almost always a good
idea” in a 2004 poll published in the Journal of the American Medical
Association.

Today, American panels and doctors groups are moving away
from the “scan first, ask questions later” philosophy. We aren’t the only ones
having second thoughts.

In Japan, all newborns were screened for

neuroblastoma starting in 1984, but the program was scrapped a few years ago
when more babies died from unnecessary surgeries than the obscure
cancer.

For many, such reversals are deeply unsettling, a reminder that
medicine is far from an exact science.

“The history of medicine is a
record not only of brilliant success and stunning progress,” Theodore Dalrymple,
a British physician, wrote in 2002. “It is also a litany of mistaken ideas and
discarded treatments, some of which came to appear absurd or downright dangerous
after having once been hailed as unprecedented advances.”

As a physician
myself, I know a thing or two about going by the book and getting it wrong. When
I was in residency, the standard treatment for bipolar patients suffering
depression was Prozac or its sister drugs. It turned out that Prozac
intervention was not only highly problematic, but also bested by
placebo.

For those on the left, the answer to the chaos of medicine is to
establish government panels. With Obamacare, for instance, White House officials
propose a commission to cut hundreds of billions from Medicare by improving the
quality of care.

How? By setting up an Independent Medicare Advisory
Commission that would guide clinical decisions for doctors and patients
alike.

The controversy over breast cancer screening, however, shows the
political and practical limitations of this one-size-fits-all approach: Medical
organizations have difficulty in setting and agreeing upon clinical guidelines,
and patients are apt to resent mandates from bureaucrats.

Leaving health
verdicts in the hands of centralized authorities is a sure way to keep making
mistakes in a field where re-examination and reversal are an unavoidable
reality.

David Gratzer, a physician, is a senior fellow at the
Manhattan Institute and author of “Why Obama’s Government Takeover of Health
Care Will Be a Disaster” (Encounter Books,
2009).

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ANTIDEPRESSANTs: Murder: Youth Kills Friend: Oklahoma

NOTE FROM Ann Blake-Tracy:

Applicable to this case and so many others is the fact that the Physicians Desk Reference states that antidepressants can cause a craving for alcohol and alcohol abuse. The liver cannot metabolize the antidepressant and the alcohol simultaneously, which leads to elevated levels of both alcohol and the antidepressant in the human body resulting in toxic behavioral reactions.
________________________

Paragraph 16 reads: “While incarcerated in the Grady County Jail, physician reports indicate Bush was given additional SSRIs, which he refused, saying, “’I killed my friend when I took these, I’m not going to take them’.”

“Bush had previously been placed on antidepressant drugs known as SSRs, a medication Poyner’s research indicates is a “virtual prescription for violence.” The drugs cause serotonin build-up in the brain, causing “terrible things” to occur, and , when combined with alcohol, can lead to violence.”

http://www.chickashanews.com/local/local_story_302093409.html

Published: October 29, 2009 08:34 am

The Express-Star

Ronson Bush’s mother Tina Black took the stand on Wednesday to ask the court to spare her son’s life.

On day two of his trial, Bush admitted killing his friend Billy Harrington but still refuses to say he meant to do it. Because of his refusal, Grady County District Attorney Bret Burns is asking District Judge Richard Van Dyck to hand down a death sentence.

The jury was excused when Bush changed his plea to guilty, and now the decision whether Bush lives or dies in solely in the hands of Van Dyck, who will render his decisiion at 10 a.m. today.

“We had a life before alcohol and drugs, we had laughs and family time and we went to church,” Black said. “If a family has not experienced alcohol and drugs, they had better thank the Lord because they’re an ugly thing that make your child someone you don’t know.”

In her plea to save her son’s life. Black said she is not angry with Ronson for herself, but she is angry for her grandson Brennan, Ronson’s son.

“Brennan loved going out in the truck with his dad,” Black said. “He asked me, ‘If my dad got life, do you think they’d let him go out in the truck one more time?’”

Black said she thinks a person can love their children even if they do not like their actions.

“There was something that fired up that anger, that wasn’t normal,” Black said.

The next witness to testify was Gail Poyner, Ph. D., a licensed psychologist who deals primarily in forensic psychology.

Poyner performed a psychological evaluation of Bush and researched the effects of the medications Bush was taking.

Poyner said members of Bush’s family described him as “flipped out,” “crazy” and “paranoid,” and that Bush experiences anxiety, sleeplessness, depression, severe drug and alcohol problems and says his brain feels “itchy.”

“Likely he was misdiagnosed or not diagnosed with Bipolar Disorder,” Poyner said. “He is severely mentally ill and his involvement with crime is highly correlated with his mental illness.”

Poyner criticized the lack of treatment Bush received after he was admitted to Griffin Memorial Hospital in Norman.

“I very strongly believe at a professional level had Griffin offered a modicum of treatment, this (the murder) could have been possibly avoided,” Poyner said. “They simply did not give him any treatment, no group therapy, no individual therapy. It was documented he was suicidal, yet they did not treat him for that.”

Bush had previously been placed on antidepressant drugs known as SSRs, a medication Poyner’s research indicates is a “virtual prescription for violence.” The drugs cause serotonin build-up in the brain, causing “terrible things” to occur, and , when combined with alcohol, can lead to violence.

While incarcerated in the Grady County Jail, physician reports indicate Bush was given additional SSRIs, which he refused, saying, “I killed my friend when I took these, I’m not going to take them.”

Dr. David Musick, a full professor of sociology at the University of Northern Colorado, also testified.

Describing Bush’s family as “good folks,” Musick discussed alcoholism as a disease and how the “horrific” drug methamphetamine creates powerful addictions in humans.

“The defendant (Bush) has a serious alcohol problem that is overflowing into violence,” Musick said. “As a child, he was a pawn being pulled back and forth by his family who had different parenting styles which creates unbearable pain so he covers up the pain with alcohol and illicit drugs.”

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Prozac/SSRIs: Woman’s Symptoms Worsen Beyond Original Symptoms From Withdrawal

Page seven reads [in part]:  “My doc and I tried a lot of
other medications along the way, and I had all the classic side effects.  I
went hypomanic on the Prozac, so we added mood stabilizers
to even me out.  I lost interest in sex, so we tried another
antidepressant, Wellbutrin, to bring me back.  We switched,
jiggered, and recombined, looking for that perfect pickle.  But if one
thing didn’t give me a rash or panic attacks, then it made me gobble salty junk
food in the middle of the night.  I tried most of the majors, and burned
through their effects.  I got scrawny, then fat,
petrified, then out of control, sexless, then
sex-obsessed.”

“Eventually the dope just doesn’t work the way it used
to.  Even Klonipin needs a boost to keep hammering you.  And that’s
when they start referring to you in whispered tones as ‘medication-resistant’.”

So I ended up in the bin that
first time, to do some serious recalibration.  I was all used up.

In the space of a few years, I went from being just
another twenty-something have a good old-fashioned life crisis to being a
pscyhotropic junky.”

Page 280 [ 3rd paragraph] reads:  “I
know that when I go off medication I feel far worse than I ever felt
before I took it,
and I have never been able to stand the downside for
more than a few months, so I don’t know how long my brain
might take to recalibrate, if it can.”

http://www.amazon.com/Voluntary-Madness-Year-Found-Loony/dp/0670019712/ref=sr_1_1?ie=UTF8&s=books&qid=1252891043&sr=1-1

Voluntary Madness: My Year Lost and Found in the Loony Bin
(Hardcover)

by Norah
Vincent

Norah Vincent (Author)

Editorial Reviews

From Publishers
Weekly
Vincent’s first trip to a mental institution­to which the
writing of Self-Made Man drove her­convinced her that further
immersion would give her great material for a follow-up. The grand tour consists
of voluntary commitments to a hospital mental ward, a small private facility and
a boutique facility; but Vincent’s efforts to make a big statement about the
state of mental health treatment quickly give way to a more personal journey. An
attempt to wean herself off Prozac, for example, adds a greater sense of urgency
to her second research trip, while the therapists overseeing her final treatment
lead her to a major emotional breakthrough. Meanwhile, her fellow patients are
easily able to peg her as an emotional parasite, though this rarely stops them

from interacting with her­and though their neediness sometimes frustrates
her, she is less judgmental of them than of the doctors and nurses. The
conclusions Vincent draws from her experiences tend toward the obvious (the
better the facilities, the better chance for recovery) and the banal: No one can
heal you except you. Though keenly observed, her account never fully transcends
its central gimmick. (Jan.)
Copyright © Reed Business Information, a
division of Reed Elsevier Inc. All rights reserved.

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ANTIDEPRESSANT: Mother of Columbine killer tells of horror 10 yrs after massacre

Michael Moore obtained a copy of Ann Blake-Tracy’s book at the premiere of his movie Bowling for Columbine. Now listen to his bold statement about what really did cause Columbine.


SEE FULL VIDEO Click here

INFO ON OTHER SCHOOL SHOOTINGS

Mark Taylors Site.
NOTE FROM Ann Blake-Tracy: Michael Moore, after reviewing all
the data on Columbine in making his movie, Bowling for Columbine, made his
message clear in the new movie The Drugging of Our Children about what he NOW
believes caused Columbine. Click on his picture to view his video
statement at www.drugawareness.org

In all of these articles out yesterday in the news covering the story by
Dylan’s mother there is STILL no mention of any medication use on Dylan’s part.
Yet we have a friend of Dylan’s who came forward claiming to have been helping
him withdraw from both Zoloft and Paxil.
But the coroner claims they found nothing in his system (I could go into
why that report is suspect but will save that for another time).
IF there really was nothing in his system, was Dylan in withdrawal from his
SSRIs at that point? We know that withdrawal can produce that same extreme out
of character violence since the REM Sleep Behavior Disorder (RBD) is more
prevalent in the withdrawal from these drugs than while on them. And yet of
those being diagnosed with RBD a staggering 86% were taking an antidepressant!
(To learn more about RBD read my FDA testimony on comedian Phil Hartman and is
wife’s Zoloft-induced murder/suicide – a classic case of RBD also found posted
at www.drugawareness.org.)
And if Dylan had been taking antidepressants were they prescribed to
Dylan? If not, where was he getting them? (Let us point out that anyone can
obtain these drugs easily. They have been sold in the streets since the early
90’s to be used recreationally and samples can be found ANYWHERE. Someone just
let me know that they found a bottle of Effexor in a shoe at a second
hand store!) Was a friend sharing their prescription? It happens regularly
from reports I get from kids. Were either of his parents taking one that he was
using for himself?
Years ago I was called in on a case of a 19 year old who was staying with a
married couple where the wife had been prescribed Zoloft and did not like how it
made her feel. She stopped taking it and placed in on top of the fridge. So when
the young man started feeling a little down he remembered the pills were for
depression and were suppose to help you feel better. So he took a couple, waited
a couple of hours and took more because he still was not feeling any better.
Then again took more a little later expecting to feel better right away. After

about five pills he recalls nothing about stabbing a man over 100 times with a
screwdriver.

Mother
of Columbine killer tells of horror 10 years after massacre

•Susan Klebold says she is haunted by school killings
•’I cannot look at a child without thinking about it’

Columbine High School student Dylan Klebold

Dylan
Klebold pictured in the 1999 Columbine High School yearbook. Photograph:
Reuters/© Ho New

The
mother of one of the two teenagers who murdered a dozen fellow students and a
teacher in the massacre at Columbine high school has broken a decade of

silence to say that she is unable to look at another child without thinking
about the horror and suffering her son caused.

Susan
Klebold, whose son Dylan and another youth, Eric Harris, hunted down pupils at
the Colorado school with shotguns, a semi-automatic pistol and a rifle before
killing themselves, has described her trauma over her son’s actions.

“For
the rest of my life, I will be haunted by the horror and anguish Dylan caused,”
she wrote in O, The Oprah Magazine. “I cannot look at a child in a grocery
store or on the street without thinking about how my son’s schoolmates spent the
last moments of their lives. Dylan changed everything I believed about myself,
about God, about family and about love.”

Neither
the Klebold nor Harris families has spoken about the massacre, in which 21
students were also wounded.

Klebold
recounts how the last word she heard from her son was a gruff goodbye as he
rushed out of the door early on the morning of the killings in April 1999.

“I
was getting dressed for work when I heard Dylan bound down the stairs and open
the front door … I poked my head out of the bedroom. ‘Dyl?’ All he said was
‘Bye.’ … His voice had sounded sharp. I figured he was mad because he’d had
to get up early to give someone a lift to class. I had no idea that I had just
heard his voice for the last time,” she said.

Dylan
Klebold was headed to make a final video with Harris to say goodbye and
apologise to their families before they drove to the school to plant bombs,
which failed to detonate, and to carry through their plan to kill their fellow
students.

After
the killings, the authorities said there were indications that the two youths
were disturbed and hints of the looming catastrophe. Harris’s blog included
instructions on how to make explosives and, later, angry denunciations of
society that attracted the attention of the police after Harris posted a death
threat against another student. Closer to the massacre, Harris listed his
stockpile of weapons and posted a hit list. Klebold was less overt but with
Harris made secret videos of their weapons and wrote in his diary of a desire to
plan an attack that would match the bombing in Oklahoma City by rightwing
militiamen that killed 168 people.

Klebold
writes that she had no idea that Dylan was contemplating killing himself or
anyone else. “From the writings Dylan left behind, criminal psychologists have
concluded that he was depressed and suicidal. I’d had no inkling of the battle
Dylan was waging in his mind,” she wrote.

“Dylan’s
participation in the massacre was impossible for me to accept until I began to
connect it to his own death. Once I saw his journals, it was clear to me that
Dylan entered the school with the intention of dying there. In order to
understand what he might have been thinking, I started to learn all I could
about suicide.”

Five
years after the killings, the FBI said they believe that Harris was a clinical
psychopath who masterminded the plan and Klebold depressive.

The
massacre continues to generate debate about the motives of the two youths and
whether anything could have been done to stop them. The magazine said that Susan
Klebold was not paid for the article and will not be making an appearance on
Oprah Winfrey’s television
show.


837 total views, 1 views today

PROZAC/SSRIs: SYMPTOMS WORSEN WHILE MEDICATED – AUTHOR “VOLUNTARY MADNESS”

Page seven reads [in part]:  “My doc and I tried a lot of
other medications along the way, and I had all the classic side effects.  I
went hypomanic on the Prozac, so we added mood stabilizers
to even me out.  I lost interest in sex, so we tried another
antidepressant, Wellbutrin, to bring me back.  We switched,
jiggered, and recombined, looking for that perfect pickle.  But if one
thing didn’t give me a rash or panic attacks, then it made me gobble salty junk
food in the middle of the night.  I tried most of the majors, and burned
through their effects.
I got scrawny, then fat,
petrified, then out of control, sexless, then
sex-obsessed.”

“Eventually the dope just doesn’t work the way it used
to.  Even Klonipin needs a boost to keep hammering you.  And that’s
when they start referring to you in whispered tones as ‘medication-resistant’.”

So I ended up in the bin that
first time, to do some serious recalibration.  I was all used up.

In the space of a few years, I went from being just
another twenty-something have a good old-fashioned life crisis to being a
pscyhotropic junky.”

Page 280 [ 3rd paragraph] reads:  “I
know that when I go off medication I feel far worse than I ever felt
before I took it,
and I have never been able to stand the downside for
more than a few months, so I don’t know how long my brain
might take to recalibrate, if it can.”

http://www.amazon.com/VoluntaryMadness-Year-Found-Loony/dp/0670019712/ref=sr_1_1?ie=UTF8&s=books&qid=1252891043&sr=1-1

Voluntary Madness: My Year Lost and Found in the Loony Bin
(Hardcover)

by Norah
Vincent

Norah Vincent (Author)

Editorial Reviews

From Publishers
Weekly
Vincent’s first trip to a mental institution­to which the
writing of Self-Made Man drove her­convinced her that further
immersion would give her great material for a follow-up. The grand tour consists
of voluntary commitments to a hospital mental ward, a small private facility and
a boutique facility; but Vincent’s efforts to make a big statement about the
state of mental health treatment quickly give way to a more personal journey. An
attempt to wean herself off Prozac, for example, adds a greater sense of urgency
to her second research trip, while the therapists overseeing her final treatment
lead her to a major emotional breakthrough. Meanwhile, her fellow patients are
easily able to peg her as an emotional parasite, though this rarely stops them
from interacting with her­and though their neediness sometimes frustrates
her, she is less judgmental of them than of the doctors and nurses. The
conclusions Vincent draws from her experiences tend toward the obvious (the
better the facilities, the better chance for recovery) and the banal: No one can
heal you except you. Though keenly observed, her account never fully transcends
its central gimmick. (Jan.)
Copyright © Reed Business Information, a
division of Reed Elsevier Inc. All rights reserved.

438 total views, no views today

LEXAPRO: The Howard Stern’s Show’s Artie Lange Arrested for DUI: New York

NOTE FROM Ann Blake-Tracy (www.drugawareness.org): After specializing in antidepressant adverse reactions for 20

 lexapro

years I would say that Lexapro is one of the worst. Giving it, or any other antidepressant, to someone with previous substance abuse problems is criminal! These drugs produce OVERWHELMING CRAVINGS for alcohol and other drugs. They can take those who have never touched these substances before & turn them into addicts almost overnight. (www.drugawareness.org/book-excerpts/ssris-and-alcohol) Antidepressants are notorious for producing mania/bipolar. One of the forms of mania is described as uncontrollable cravings for alcohol.

Adverse reactions can be worse: the deaths of Brynn & Phil Hartman & Andrea Yates’ 5 children. Then there’s the man in Palm Beach who after years of a happy hetrosexual life ran off to NY for a sex change operation after starting an antidepressant. He returned to his wife extremely remorseful & with no idea why he did what he had done.

Paragraphs 2 & 3 read:  “ Artie Lange was noticeably quieter than usual on Monday morning’s broadcast, only peppering the on-air conversations with an occasional joke or cutting remark.  About two hours into the broadcast,Artie Lange finally broke his silence about Friday’s DUI.  After stating that: “for once I’m actually doing something sensible and listening to my lawyer and not talking about it,”  Artie Lange went on to tease the audience with a few details of the incident that catapulted him to the top of Google Trends on Friday, despite The HowardStern Show having been off air for a full two weeks.”

Artie Lange insists that he blew a 0.0 on the Breathalyzer test that he was given at the scene of the accident. Artie Lange also reported that he was also given a urine test at the police station.  Artie Lange states that there were no illicit drugs in his system, and that all the analysts will find that could possibly explain his erratic driving is the antidepressant Lexapro.”

http://www.examiner.com/x-11279-Howard-Stern-Examiner~y2009m7d13-Is-Lexapro-to-blame-forArtie-Langes-DUI

Is Lexapro to blame for Artie Lange‘s DUI?

July 13, 9:05 AM

At long last, The Howard Stern Show returned to the air live this Monday morning.  With the abundance of celebrity news to catch up on and current box office topper “Bruno” in the studio, Howard Stern Show fans really only wanted to hear about one thing: Artie Lange’s DUI.  After proclaiming that he had been clean and sober for months, ArtieLange was arrested on suspicion of DUI on Friday after a fender bender in Tom’s River, New Jersey.

Artie Lange was noticeably quieter than usual on Monday morning’s broadcast, only peppering the on-air conversations with an occasional joke or cutting remark.  About two hours into the broadcast, Artie Lange finally broke his silence about Friday’s DUI.  After stating that: “for once I’m actually doing something sensible and listening to my lawyer and not talking about it,”  Artie Lange went on to tease the audience with a few details of theincident that catapulted him to the top of Google Trends on Friday, despite The Howard Stern Show having been off air for a full two weeks.

Artie Lange insists that he blew a 0.0 on the Breathalyzer test that he was given at the scene of the accident.  ArtieLange also reported that he was also given a urine test at the police station.  Artie Lange states that there were no illicit drugs in his system, and that all the analysts will find that could possibly explain his erratic driving is theantidepressant Lexapro.

Artie Lange spoke openly about his struggles with depression in his recent bestselling book “ Too Fat to Fish.”  Inthe past, the comedian has rejected the idea of taking antidepressants to treat his mood, despite his willingness to dabble in the spectrum of illegal substances.

But could Lexapro really be to blame for Artie Lange’s DUI?  Fans, friends and family members of Artie Lange are all thinking the same thing: the whole story sounds too fat to fishy.  In Artie Lange’s defense, the official website forLexapro lists among the drug’s safety precautions: “Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Lexapro does not affect their ability to engage in such activities.”  Although Artie Lange did not state how long he has been taking Lexapro, he did report that he started it “recently.”

Artie Lange has stated that he has “a lot to say” about Friday’s DUI arrest, and that he is looking forward to talking openly on the subject once his lawyer approves it.  Artie Lange is scheduled to appear in court on Friday, July 17th.

Author: Liz Brown

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Juvenile Murders & Push for Use of Antidepressants in that Age Group Coincide

NOTE FROM Ann Blake-Tracy (www.drugawareness.org): Note that the spiked increase in murders by juveniles came at the same time of the push for the use of antidepressants in juveniles. The push for use in juveniles came after a 1992 Oprah show where juveniles on these drugs were featured. The jump in use of SSRIs by juveniles from that time skyrocketed.

After murders committed by juveniles spiked in the early 1990s, states toughened laws, making the United States the harshest nation in world in the legal punishment of children, according to a recent study.

http://www.kansascity.com/105/v-print/story/1443770.html

Posted on Sun, Sep. 13, 2009

When children kill, punishment varies
By JOE LAMBE
The Kansas City Star
A Kansas City, Kan., girl charged with murder at age 13 faces adult court and many years in prison.

A boy who was 13 when he killed a man last year will stay in the juvenile system and could be released when he is 22½, a Wyandotte County judge ruled early this month.

Both cases illustrate how children who commit heinous crimes are testing the boundaries of the justice system.

After murders committed by juveniles spiked in the early 1990s, states toughened laws, making the United States the harshest nation in world in the legal punishment of children, according to a recent study. However, the number of children who killed declined in the late ’90s and has largely held steady this decade, leading some to question the practice of tougher sentencing.

“Some states are starting to recognize that kids can be treated as kids,” said Michele Deitch, a professor at the University of Texas at Austin and lead author of a study, “From Time Out to Hard Time.”

In 22 states, children as young as 7 still can be tried as adults. There is no age limit in Missouri, but it is 10 in Kansas. As of June, juveniles could not be sentenced to life without parole in seven states, including Kansas. That makes the United States the only nation in the world where juveniles can be sentenced to life without parole, the study reported.

All children who offend at age 12 or younger should be put into juvenile care, the Texas study contends. And it found that when they are put in adult prisons, juvenile offenders are five times more likely to be sexually assaulted and 36 times more likely to commit suicide.

Laurence Steinberg, author of “Rethinking Juvenile Justice” and a professor at Temple University in Philadelphia, believes that a 13-year-old is too young to be charged as an adult.

“You’re exposing kids to adult sanctions for something they did as a kid,” he said, “but no prosecutor is going to be able to run on the platform of ‘I gave somebody a break.’ ”

Weighing the facts

In the Wyandotte County cases, the similar situations are seemingly headed toward different outcomes.

Early this month, defense attorney Kiann McBratney successfully argued that Antwuan Taylor, the Kansas City, Kan., boy who killed last year at age 13, should not be tried as an adult and instead should stay in the juvenile system.

But McBratney, other prosecutors and some defense attorneys do support adult sentences for some children, saying society needs protection from them.

“There are kids out there who function like adults and can kill people in cold blood,” she said.

Robbin Wasson, the prosecutor in the Taylor case, said, “We don’t want to be prosecuting 13-year-olds willy-nilly as adults,” noting that decisions on juvenile offenders are made on a case-by-case basis.

The other juvenile charged in Wyandotte County last year with killing at age 13 was Keaira Brown, who this year became the youngest person ever sent to adult court there.

She allegedly shot 16-year-old Scott Sappington to death after an apparent botched carjacking attempt.

The victim’s grandmother, Joyce Sappington, said she had mixed emotions about the ruling, but children killing children “has got to stop. If nobody sends a message, it will never stop.”

Nationwide from 1985 to 2004, the study reports, judges transferred 961 children age 13 or younger to adult courts. That does not count children from states that have automatic transfer laws for crimes such as murder or states that allow prosecutors to directly file cases in adult court.

“You can have a teen who kills and goes automatically into the adult system and life without parole,” Deitch said. “That’s incomprehensible to me.”

Science and sentencing

Researchers have discovered that the section of the brain related to impulse control does not fully develop until the mid-20s, but that finding doesn’t necessarily help in the legal debate.

Some say it means children grow and change — what they are is not what they will become. Others say it means they are out of control and deadly.

The Supreme Court mentioned those brain studies in a 2005 Missouri case when it ruled that those younger than 18 when they killed could not be executed. That ruling took 72 people off death rows.

The ruling said children change, are less mature than adults, are more influenced by peers and are less to blame.

“Even a heinous crime committed by a juvenile,” the court said, “is not evidence of irretrievably depraved character.”

In the Taylor case in Wyandotte County, the boy was influenced by a 21-year-old woman who gave him a gun and suggested he kill someone. She drove him and picked out a victim, and Taylor shot Charles McElroy six times.

Barry Feld, a professor at the University of Minnesota Law School, said of the Taylor case and the woman’s influence: “It is the absolute paradigm of what the Supreme Court was talking about.”

Thirteen is too young for adult prosecution, he said, but for older children, he has raised questions about whether juvenile court is appropriate.

A “youth discount” is a sentencing method that Feld advocates. “A 14-year-old gets 25 percent of the going rate for the same crime by an adult, a 16-year-old gets about 50 percent,” he said.

Deitch praised another approach sometimes used by Kansas, Missouri and 25 other states. The laws generally allow a judge to combine a juvenile sentence with a further adult sentence if the offender fails in the juvenile system.

Wyandotte County District Judge Wes Griffin imposed the Kansas version of that approach in the Taylor case. Kansas officials say it has been rarely used — only in seven cases of 348 juveniles sent to the state juvenile system last year.

Missouri also rarely uses its version but has had good success, officials said. From 1999 to 2006, they said, 36 people were released after serving their juvenile time. Only six committed other crimes.

Atharene McElroy, mother of the victim in the Taylor case, is satisfied that her son’s killer is staying in juvenile court.

“He’s just a young, troubled boy,” she said, but he is dangerous and needs to be off the streets while he matures.

To reach Joe Lambe, call 816-234-7714 or send e-mail to jlambe@kcstar.com.

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Kauffman Study – (SSRI) Drugs: More Risks Than Benefits?

Journal of American Physicians and Surgeons Volume 14 Number 1 Spring 2009

SSRI Bombshell by Joel M. Kauffman, Ph.D. Tuesday, March 31st, 2009

Selective Serotonin Reuptake Inhibitor (SSRI) Drugs: More Risks Than Benefits?

Joel M. Kauffman, Ph.D.

ABSTRACT

Anecdotal reports have suggested that selective serotonin reuptake inhibitors (SSRIs) may cause suicidal or violent behavior in some patients. Because of the publicity surrounding certain events, and the numerous lawsuits that have been filed, a review of benefits and risks is needed.

At most 30% of patients receive a benefit from SSRIs beyond the large placebo effect in certain mental conditions, especially depression, according to a recent meta-analysis of published trials. An equally recent meta-analysis of all SSRI trials submitted to the FDA showed a small benefit for the severely depressed patients only. Many early unpublished trials did not show any benefit. Adverse effects are common, occurring in up to 75% of subjects.

Severe adverse effects may be underreported.

Meta- analyses of controlled trials did not include any actual suicides or murders, but only suicidality, some finding, in 1991 and 2007, no evidence even of suicidality.

Other meta-analyses using many of the same trials found that suicidality doubled to 1 in 500 on SSRIs compared with placebo or non-SSRI antidepressants, but did not include any actual suicides or murders. The trial designs were devised by SSRI makers to prevent reports of suicides, by eliminating subjects with the slightest trace of suicidal tendencies. Retrospective studies by others showed actual suicides on SSRIs with a relative risk (RR) of 2–3 compared with non-SSRI antidepressants, with an increased incidence of 123/100,000. Lower doses than the smallest available ones were found to maintain benefits in a majority of patients while reducing risks.

table_03_zoloftbusted1

[PLEASE NOTE THAT THE SSRISTORIES DATABASE REFERRED TO BY DR. KAUFFMAN IN THIS STUDY IS NO LONGER POSTED AT THE URL LISTED ABOVE BUT HAS BEEN MOVED TO THE URL www.ssristories.NET ]

No causal connection between SSRIs and suicide and/or violence has been proved; neither has it been ruled out. Physicians need to be vigilant, and aware of legal precedents that may subject them to enhanced liability when prescribing these drugs. The Genesis of SSRIs Fluoxetine (Prozac in the U.S., see Table 1), introduced in 1988 to combat depression, was the fourth selective serotonin reuptake inhibitor (SSRI) on the U.S. market, after being seriously considered by Eli Lilly as an antihypertensive drug. Unlike the earlier “tricyclics” (amitripyline, clomipramine, dothiepin, imipramine, etc.) and other drug classes, SSRIs acted on the brain to raise levels of the neurotransmitter serotonin without raising the levels of norepinephrine. This was thought to be a benefit in treatment of depression, and later anxiety, panic, social phobia, obsessive- compulsive disorder (OCD) , and many other conditions. The SSRIs listed in Table 1 are among the most frequently prescribed in the U.S., and compete with the five non- SSRIs shown, and others.

ssri-drug-table1

Benefits of SSRIs

A prominent recent meta-analysis of Bridge et al. included 27 trials of SSRIs for three defined mental conditions: major depressive disorder (MDD), OCD, and non-OCD anxiety disorders. Benefits, compared with placebo, were found to be highly statistically significant. For MDD, data from 13 trials showed benefit in 61% vs. 50% on placebo, a gain of 11% absolute (NNT=10), <0.001 for all ages of participants. For OCD, data from six trials showed benefit in 52% vs. 32% on placebo, a gain of 20% absolute (NNT=5), <0.001 for all ages. For non-OCD anxiety, data from 6 trials showed benefit in 69% vs. 39% on placebo, a gain of 30% absolute (NNT=3), <0.001 for all ages. These results represent the maximum expectation of benefit from SSRIs since 22 of the 27 trials were financially supported by SSRI makers, and thus subject to the routinely positive bias of industry-sponsored clinical trials. Jay S. Cohen, M.D., author of the 2001 book , wrote that half his patients did well on fluoxetine, but he noted a high incidence (50%) with side-effects. Cohen also cited a pre-approval study showing that the standard 20 mg per day starting dose helped 65% of patients, while 5 mg helped 54%, so Cohen became one of the pioneers in using lower doses before Lilly made them available. The 1996 entry for paroxetine, at least, confirmed that the 17 most common side-effects were dose-dependent.

In four observational cohort studies of four common SSRIs reported by physicians as part of the prescription-event monitoring program in the UK, with more than 10,000 patients in each drug group, only 36% of the physicians reported fluvoxamine as effective, compared with 60% for fluoxetine, sertraline, and paroxetine. These possible benefit rates, which include the placebo effect, parallel the percentage of patients remaining on the drug for 2 months.

See: Over Dose: the Case Against the Drug Companies

An old trial of placebo for anxious and depressed subjects reduced distress in 43%. Three meta-analyses of the antidepressant literature that appeared in the 1990s independently concluded that two-thirds of the effectiveness attributed to SSRIs is actually placebo effect. In a series of nine controlled studies on hospitalized patients with depression, 57% of those given placebo showed improvement in 2–6 weeks. A 1998 meta-analysis of 47 trials on antidepressant medication including SSRIs indicated that 75% of the response to them was duplicated by placebo. This meta-analysis was criticized on several grounds. Therefore, Irving Kirsch, Ph.D., of the University of Connecticut, with other authors, obtained data submitted to the FDA on every placebo-controlled clinical trial on the six most widely used SSRIs, and published a meta-analysis on 47 trials, finding a small, clinically insignificant effect.

This work was updated in 2008:

Analyses of datasets including unpublished as well as published clinical trials reveal smaller effects that fall well below recommended criteria for clinical effectiveness. Specifically, a meta-analysis of clinical trial data submitted to the U.S. Food and Drug Administration (FDA) revealed a mean drug–placebo difference in improvement scores of 1.80 points on the Hamilton Rating Scale of Depression (HRSD), whereas the National Institute for Clinical Excellence (NICE) used a drug–placebo difference of three points as a criterion for clinical significance when establishing guidelines for the treatment of depression in the United Kingdom. Kirsch et al. concluded that the updated findings from 35 carefully vetted trials suggest that, compared with placebo, the four new- generation antidepressants ( fluoxetine, venlfaxine, nefazodone, and paroxetine) do not produce clinically significant improvements in depression in patients who initially have moderate or even severe depression.

They show statistically significant but clinically minor effects only in the most severely depressed patients. Moreover, the significance of the effect probably is based on a 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, they write that the decreased placebo response in extremely depressed patients, combined with a response to antidepressants comparable to that of less severely depressed patients, is a potentially important insight that should be investigated further.

Even these unimpressive findings exaggerated the benefits of antidepressants. In three fluoxetine trials and in the three sertraline trials for which data were reported, the protocol allowed replacement of patients who, in the investigators’ judgment, were not improving after 2 weeks. The trials also included a 1–2 week washout period, during which patients were given a placebo prior to randomization. Those whose scores improved 20% or more were excluded from the study. In 25 trials, the use of other psychoactive medication was reported. In most trials, a chloral hydrate sedative was permitted in doses ranging from 500 mg to 2,000 mg per day. Other psychoactive medication was usually prohibited but still reported as having been taken in several trials.

Perhaps such considerations led David Healy, M.D., an SSRI expert, to his conclusion that “…these drugs do not convincingly work….” His evidence came from early unpublished clinical trials whose results were revealed to him at FDA hearings. For fluoxetine, Healy noted four trials with a positive result and four without. For sertraline, only one of five early studies showed benefit. Because of the huge placebo effect, 32–75%, most physicians unfamiliar with the studies revealing this effect are likely, in my opinion, to say that one-third to two-thirds of their patients are improved on SSRIs. This would also explain Dr. Jay S. Cohen’s findings on lower doses of fluoxetine.

SSRIs reportedly interact with 40 other drugs to cause “serotonin syndrome.”

This presents as twitching, tremors, rigidity, fever, confusion, or agitation. Serotonin/norepinephrine reuptake inhibitors (SNRIs) also may cause serotonin syndrome by interactions. Most tricyclic depressants do not have these interactions, with the exception of amitriptyline.

In a controlled trial of paroxetine vs. clomipramine sponsored by GlaxoSmithKline, 75% of the subjects had an adverse effect on paroxetine, 21% had a severe adverse effect, and 13% committed a suicidal act (1 in 8). The 1996 entry for paroxetine lists 17 side-effects with an incidence of ≥ 5% for approved doses.

They are: asthenia, sweating, constipation, decreased appetite, diarrhea (up to 15%), dry mouth (up to 21%), nausea (up to 36%), anxiety, dizziness, nervousness, paresthesia, somnolence (up to 22%), tremor (up to 15%), blurred vision, abnormal ejaculation, impotence, and other male genital disorders. Fully 31 additional side effects with an incidence at least 1% greater than placebo were listed, including uncontrollable yawning.

Murder, suicide, and suicidality were NOT [emphasis added] included.

Nor were they on comparable lists for fluvoxamine, or sertraline. For fluvoxamine, suicide were separately listed as “infrequent.”

For fluoxetine, suicidal ideation was listed as a voluntary report not proved to be drug related. For sertraline, suicidal ideation and attempt were listed separately as “infrequent.”

The entry for venlafaxine was: “…the possibility of a suicide attempt is inherent in depression.” Not found in the was weight gain, which Cohen lists as a serious side effect.

Typical dropout rates in recent trials are claimed to be 5% (see below), but these must be short trials, or trials with a run-in period. In a meta-analysis of 62 earlier trials with a total of 6,000 subjects, the mean total dropout rate and the proportion of dropouts due to side effects appear comparable to results in general practice: total dropout rates of between 30% and 70% have been reported by 6 weeks, of which some 30%–40% are attributed to side effects and the rest to failure of treatment. Early findings of severe adverse effects by SSRI makers came to light only after the class was established. Of 53 healthy volunteer studies on fluoxetine, the results of only 12 were openly reported.

From 35 healthy volunteer studies on paroxetine, pre-launch, the results of only 14 appeared. From 35 pre-launch healthy volunteer studies on sertraline, only seven appeared. Among the unpublished trials, there was one in which all volunteers dropped out because of agitation (akathisia). In published work on sertraline, data excluded material on behavioral toxicity, including at least one suicide of a Adverse Effects of healthy volunteer, and in a different trial, 2 of 20 volunteers became intensely suicidal. This last is consistent with the dropout rate of 5% for agitation alone in actual trials. It is also consistent with Lilly’s animal studies, in which previously friendly cats treated with fluoxetine started growling and hissing—an unheeded warning.

Just a year after fluoxetine was introduced, Bill Forsyth of Maui, Hawaii, had taken it for only 12 days when he committed one of the first murder/suicides attributed to any SSRI.

In the same year Joseph Wesbecker killed eight others and himself in a Louisville, Ky., printing plant where he worked, after 4 weeks on fluoxetine. Yet as early as 1986, clinical trials showed a rate of 12.5 suicides per 1,000 subjects on fluoxetine vs. 3.8 on older non-SSRIs vs. 2.5 on placebo! An internal 1985 Lilly document found even worse results and said that benefits were less than risks. Such documents were released into the public domain by Lilly as part of the settlement in the Wesbecker case. Fifteen more “anecdotes” of murder/suicide, three with sertraline, were listed by DeGrandpre.

Lilly’s denials of a link to murder/suicide on national television and elsewhere cited a sponsored meta-analysis in in 1991, which exonerated fluoxetine as a cause of suicidal acts or thoughts without even mentioning actual murder or suicide. This study included only 3,067 patients of the 26,000 in the clinical trials it utilized. None of the trials had a declared endpoint of suicidality.

Some of the trials had been rejected by the FDA. No mention was made that Lilly had had benzodiazepines co-prescribed to minimizethe agitation that had been recognized with fluoxetine alone. The 5% dropout rate for anxiety and agitation (akathisia) would have taken out the most likely candidates for suicide. Nevertheless, the 1991 study had its intended effect. For example, in 2006 a 900-page tome entitled , which was aimed at attorneys, cited this study, and failed lawsuits concerning SSRIs. The 2007 meta-analysis by Bridge et al. may be influenced by indirect conflicts of interest that are hard to prove based on the financial disclosures.

Their paper pooled excess risk above placebo for “suicidal ideation/suicide attempt” from 27 trials. The excess risk was said to be 0.7% and statistically significant across all indications, but significant within each indication. Of the 27 trials, only five were sponsored by the drug maker, and one of these, the 2004 Treatment for Adolescents with Depression (TADS) study of fluoxetine, had the highest rate of suicidality—7% above placebo. Most of the same trials were used in a meta-analysis by the FDA, which found a statistically significant excess risk of 2% (4% vs. 2% on placebo, 1 in 50 more). Bridge et al. used a random-effects calculation, while the FDA used a fixed-effects calculation.

In commenting on the negative findings, Bridge et al. write: “No study [in our meta-analysis] was designed to examine suicidal ideation/suicide attempt as a study outcome, and in fact most trials were conducted in patients who had been carefully screened to exclude youths at risk.” No actual murders or suicides associated with SSRI use were reported. Did the designs of the studies preclude detection or reporting?

The Bridge meta-analysis was not just a vindication of SSRIs, as communicated to the by Gilbert Ross, M.D., Medical Director of the American Council on Science & Health. Ross went further, commenting that the FDA “Black Box warning” (see below) was counterproductive because it was discouraging the use of antidepressants! Ross speculated that the lethal rampage of the Virginia Tech shooter might have resulted from premature cessation of medications.

SSRIs in general have long lifetimes in the body. Fluoxetine and its active metabolite in particular have a half-life of 16 days, according to the 1996 . In a reexamination of trials in which suicides or attempts during the inadequate washout period were not blamed on the drug, it was shown that the relative risk (RR) of suicidal acts ranged from 3 for sertraline to 10 for fluoxetine.

A concurrent meta-analysis of 24 trials by Kaizar et al. utilized Bayesian statistics, a valid choice, in my opinion, because data do not have to follow a Gaussian or normal curve to yield valid results, and this method can be used to revise probabilities to determine whether a specific effect was due to a specific cause. They found an association between SSRI use and suicidality with odds ratios of 2.3 (95% confidence interval [CI] 1.3-3.8), when the diagnosis was MDD, not OCD, anxiety, nor ADHD. Non-SSRI antidepressants were said to have no association with suicide. This supports the FDA’s findings and requirement, as of October, 2004, for a Black Box warning for all SSRIs, to monitor children and adolescents for suicidality. Kaizar et al. were concerned that there were no completed suicides among 4,487 subjects in the trials; that the trial times were too short at median length of 8 weeks; and that in 10 of the 12 MDD studies, Again, there was no citation of actual suicides associated with SSRIs and no citation of Healy’s work.

Healy reviewed epidemiologic studies that have been cited to exonerate SSRIs. One was analyzed by Healy to show a threefold increase in suicidality compared with other antidepressants.While “treatment-related activation” has been considered primarily with regard to suicidality, it can lead to harm to others as well as to self. Healy summarized data on “hostile episodes” provided by GlaxoSmithKline from placebo-controlled trials with paroxetine in subjects of all ages: 9,219 on paroxetine and 6,455 on placebo. The rubric of “hostility” was used in the trial to code for aggression and violence, including homicide, homicidal acts, and homicidal ideation, as well as aggressive events and “conduct disorders.” No homicides were reported from these trials.

Overall, during both therapy and withdrawal, the RR was 2.1 for hostile events. In children with OCD the RR was 17. Separately, in healthy volunteer studies, hostile events occurred in 3 of 271 subjects on paroxetine vs. none of 138 on placebo. In trials of sertraline on depressed children submitted by Pfizer, 8 of 189 subjects discontinued for aggression, agitation, or hyperkinesis (a coding term for akathisia), compared with 0 of 184 on placebo. In clinical practice, the term akathisia has been restricted to demonstrable motor restlessness, but if that is the only effect, it would have been called dyskinesia according to Healy, who cites four studies linking akathisia to both suicide and homicide.

Actual suicides were combined with suicide attempts in a 2005 meta-analysis of 702 trials of SSRIs vs. either placebo or an active non-SSRI control. Studies were rejected if the citation was a review, a result of duplicate publication, too short, crossover, or had no reporting of actual or attempted suicide. The studies meeting the criteria included 88,000 patients. For attempted suicide, the RR was 2.3 for SSRIs vs. placebo (95% CI, 1.14-4.55). The number needed to treat to harm (sometimes called the “reverse NNT”) was 1 in 684. There was no difference in actual suicide. Of the 702 trials, 104 failed to report adverse events below a certain pre-set limit of 3%, 5%, or 10% of patients. Only 493 trials reported dropout rates, with a mean of 29%, and the mean follow-up time was only 11 weeks. Thus, there was clearly gross underreporting of adverse effects. PDR children and adolescents with an elevated baseline risk of suicide were excluded.

Journal of American Physicians and Surgeons Volume 14 Number 1 Spring 2009 9

More importantly, because actual suicides are involved, Healy cited a study by Donovan et al. that demonstrated a RR=3.4 ( <0.01) for SSRIs compared with all non-SSRI antidepressants involving 222 actual suicides, of which 41 were among patients who had an SSRI within a month of their suicide. Also the British Drug Safety Research Unit recorded more than 110 suicides in 50,000 patients taking an SSRI, an incidence of 219/100,000 compared with 96/100,000 for the non-SSRI mirtazepine (Remeron), an increase of 123/100,000, or 1 in 813 (Table 2). Thus the RR for actual suicide in patients taking SSRIs was 2.3 (or 2.8 for paroxetine). Even here, though, no murders were listed.

In another study cited by Healy, Jick et al. reported 143 actual suicides among 172,598 patients taking antidepressants. The relative risk of suicide in patients taking fluoxetine was 2.1, compared with those taking the tricyclic antidepressant dothiepin. The risk was not age-dependent. SSRI makers keep insisting that there will be more suicides if SSRIs are used as frequently as now. But the RR of 2–3 shown in studies is a number that the number of suicides that may have been prevented, so SSRI use is associated with more suicides, not fewer.

The International Coalition for Drug Awareness in cooperation with the Prozac Survivors Support Group has produced a website on which about 1,600 violent incidents associated with SSRI use are described ( www.ssristories.net ). The first column on the type of incident (murder, school shooting, etc.) is a hot link to a publicly available description of the incident, typically a local newspaper article. A selection of 10 entries (rows) is presented here as Table 3. About 360 suicides are tallied as well as about 400 murder incidents, many of which were multiple murders, each linked to 26 not net includesSSRIs Provide 1,600 Anecdotes of Violence SSRI use (Rosie Meysenburg, personal communication, 2008 .

As the number of “anecdotes” exceeds 1,600—hardly a small number—the association of SSRIs with murder/suicide, often combined, must be taken seriously. The SSRI website was searched to find combined murder/suicide incidents attributed to a specific SSRI. There were three for fluvoxamine, four for citalopram, 10 each for paroxetine and sertraline, and 31 for fluoxetine. Where the studies above substantiated suicide from SSRI use, the total on the SSRI website of 48 simultaneous murder/suicide incidents associated with SSRI use ties together SSRIs and murder. Since there were about two murders per suicide, we may infer that the murder rate on SSRIs could be about 250/100,000. Since no clinical trial involving multiple homicides is ever likely to be run, no firmer evidence is likely to be found. Healy noted that much of the evidence for suicide and murder came from the efforts of journalists and lawyers.
Note that the website carries a prominent warning that “withdrawal can often be more dangerous than continuing on a medication.” Nine violent events cited elsewhere—seven court cases of homicide (one attempted) and two assaults—were associated with specific SSRIs: three with paroxetine, three with sertraline, two with fluoxetine, and one with venlafaxine. Skeptics have cast doubt on whether the prescribed SSRIs were actually taken, especially since many medical records of juveniles were sealed. In the Columbine, Colo., shootings the toxicology report showed “therapeutic” levels of fluvoxamine in one of the shooters. The Red Lake, Minn., shooter had fluoxetine found, according to news items referenced on the website.

A 2004 editorial in by Simon Wessely, M.D., a spokes- man for Eli Lilly, and Robert Kerwin, Ph.D, cited only a single paper by Healy as a source of claims of suicidality that have found a receptive media audience. Tellingly, the only study described at length is by Jick et al. on the correlation of SSRI use and “attempted suicide,” in which the rates on dothiepin, amitriptyline, fluoxetine and paroxetine were not statistically different. Actual suicides in this study (seven on SSRIs) were not mentioned by Wessely and Kerwin, nor were the 143 suicides in Jick’s earlier paper. Jick et al. have been supported partially by GlaxoSmithKline and Pfizer. No study that reported actual suicides on SSRIs was described in detail, let alone refuted. Wessely and Kerwin wrote: “The problem is that depression is unequivocally and substantially associated with suicide and self-harm.” True, but this not the truth.

Table 2. Suicides Related to SSRIs or Mirtazapine

table_02_zoloftbusted1

The legal defense by Lilly, repeated by the media and others, is that any suicides are caused by the condition, depression, not by their drug—whether the violence is associated with short-term drug use, long-term drug use, increased doses, withdrawal, or rechallenge. There is no website, as far as I know, for violent acts committed by persons who never received SSRIs, or for total violent acts; hence the denominator for violent acts is not known. Also unknown is the fraction of potentially violent persons who are treated with SSRIs, or of persons treated with SSRIs who are potentially violent. The published studies on actual suicide, however, compare patients on SSRIs with similar patients on non- SSRI antidepressants or placebo. Children diagnosed with OCD, not depression, also became suicidal on SSRIs, as did healthy volunteers.

Actual two- to threefold increases in suicide rates have been demonstrated as well as they could be. How else could such effects be demonstrated? Who would submit, and what institutional review board or human subjects committee would approve a study explicitly designed to show whether assaultive, homicidal, or other violent behavior increases in subjects prescribed the study drug?

Denial by SSRI makers of culpability for these risks continues to this day. Whether physicians’ acting on the Black Box warnings of 2004 and 2007 for all SSRIs will diminish the incidence of murders and suicides is not yet known. Following the introduction of fluoxetine in 1988, only a year passed before an early user committed multiple murders and suicide; many other examples followed. More than 200 lawsuits have been begun by users of SSRIs and victims’ families charging wrongful death or failure to warn; these have had mixed outcomes. There is now legal precedent for SSRIs as a cause of murder, and the maker of the SSRI is potentially liable for damages, according to David Healy.

Eli Lilly responded with total denial to the lawsuits claiming a link between fluoxetine and violence. Several claims were settled out of court with secret details and no admission of guilt. The Australian David Hawkins was freed from a murder charge by a finding of temporary insanity caused by using sertraline. Tim Tobin of Wyoming won $6.4 million from SmithKline Beecham when a jury found that a murder/suicide committed by Donald Schell was attributable to use of paroxetine. There are four other homicide cases in which the SSRI was deemed to have contributed, resulting in a suspended sentence in one case and an insanity verdict in another.

One case of homicide, with a guilty verdict and a life sentence, followed a judicial ruling that akathisia was associated with SSRI use, but that a causal relationship with homicide could not be argued; thus the link of an SSRI with homicide was disallowed. This was in direct conflict with the findings of the four trials cited above. The SSRI website was searched to find murders related to a specific SSRI whose perpetrators were acquitted based on temporary SSRI-induced insanity. There were two cases with sertraline, four cases with paroxetine, and four cases with fluoxetine. So a precedent has been established for legal recognition that an SSRI can be a cause for murder, and that the drug maker can be found liable for damages. The notices of suicidality for the SSRIs found in the PDR or package inserts before 2004 did not really warn of actual suicide or murder.

200 SSRI-related Lawsuits

The Black Box warning of 2004 about possible suicide in children under 18 years of age did not cover adults or murder at any age, so potential liability for the SSRI makers still exists. In 2007 the warning was extended to persons under age 25 years. David Healy was quoted as saying that the warning was overdue, and that the risk was not likely to disappear above age 25. This was shown by the trials from GlaxoSmithKline on paroxetine cited above.

Antidepressants are extraordinarily difficult to assess for risks or benefits in trials. At most, 11%–30% of patients with depression or related conditions who take SSRIs actually benefited beyond the placebo effect on normal doses. Of the perceived benefit, 32%–67% can be attributed to the placebo effect. Adverse effects, mostly dose-dependent, will appear in up to 75% of patients on normal doses. Of these, studies suggest that suicidality will be observed in an additional 2%–13% (1 in 50 to 1 in 9) of patients on normal doses, beyond what is seen on placebo or many non-SSRI antidepressant drugs. This is sufficiently frequent that a typical prescribing physician should observe examples in routine practice.

The actual suicide rate could be about 123/100,000 (1 in 813) higher in patients on SSRIs than in those on tricyclics or placebo. Studies show that many more suicides are on normal doses of SSRIs beyond what is seen on placebo or many non-SSRI antidepressant drugs. Available data suggest that actual murders may be committed at about the rate of 250/100,000 (1 in 400) SSRI-treated patients beyond what is seen on placebo or many non-SSRI antidepressantdrugs, and that many more murders will be attempted on normal doses as well. While correlation does not prove causation, and results of court trials are not medical science, the data for suicide are solid, and the association of murder with suicide is very suggestive. Now that there is a stronger Black Box warning, physicians who ignore it may be liable for damages; the warning primarily protects the manufacturers of SSRIs. There is obviously great peril in drawing conclusions about causat i on from press report s or court decisions.

While manufacturers have a vested interest in exonerating their drugs, plaintiffs have an interest in blaming it, and defendants in exonerating themselves. We need careful, independent analysis of existing study data. In addition to randomized controlled trials, evidence from basic science ( neuropharmacology) and challenge/dechallenge/rechallenge investigations needs to be sought. Both the public and individual patients are imperiled by an incorrect answer to the pressing questions about these widely prescribed drugs. Future studies may show lower levels of murder and suicide with close supervision, and with better matching of this drug type to patient type.

Conclusionsattemptedsimultaneous
Joel M. Kauffman, Ph.D.

Acknowledgements:
Joel M. Kauffman, Ph.D., professor of chemistry emeritus at the
University of the Sciences, 600 S. 43rd St., Philadelphia, PA 19104-4495,
Contact: kauffman@bee.net.

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Frances E. H. Pane edited the manuscript. David Moncrief piqued my interest by providing a review copy of by Richard DeGrandpre.
The Cult of Pharmacology: How America Became the World’s Most Troubled Drug Culture

Journal of American Physicians and Surgeons Volume 14 Number 1 Spring 2009 11
Potential conflicts of interest: The author has neither a financial interest in any drug mentioned, nor in any alternate treatments for treating any mental illness.

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The Cult of Pharmacology: How America Became the World’s Most Troubled Drug Culture.
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Healy D. One flew over the conflict of interest nest. 2007;6(1):26-27.

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Wolfe SM, ed. SSRIs can have dangerous interactions with other drugs. 2008;14(1):2-5. www.citizen.org/hrg/. Accessed Feb 4, 2009.

JAMA BMJ, Over Dose: The Case Against the Drug Companies.
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JAMA
Prevention & Treatment
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Let Them Eat Prozac: The Unhealthy Relationship Between the Pharmaceutical Industry and Depression.
Worst Pills Best Pills News

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New York Times:Journal of American Physicians and Surgeons Volume 14 Number 1 Spring 2009

USA Trade Name Generic Name:
SSRIs
Celexa
Luvox
Paxil
Prozac
Zoloft
non-SSRIs
Effexor
Remeron
Serzone
Wellbutrin
(UK)
citalopram
fluvoxamine
paroxetine
fluoxetine
sertraline
venlafaxine
mirtazapine
nefazodone
bupropion
dothiepin USA Trade Name Generic Name
SSRIs
Celexa
Luvox
Paxil
Prozac
Zoloft
non-SSRIs
Effexor
Remeron
Serzone
Wellbutrin
(UK)
citalopram
fluvoxamine
paroxetine
fluoxetine
sertraline
venlafaxine
mirtazapine
nefazodone
bupropion
dothiepin

Physicians Desk Reference (PDR)
Joel M. Kauffman, Ph.D.
Table 1. Commonly Prescribed SSRIs and Other Antidepressants Selective Serotonin Reuptake Inhibitor (SSRI) Drugs:
More Risks Than Benefits?

Journal of American Physicians and Surgeons Volume 14 Number 1 Spring 2009 7 Physicians Desk Reference (PDR)
Joel M. Kauffman, Ph.D.
Table 1. Commonly Prescribed SSRIs and Other Antidepressants Selective Serotonin Reuptake Inhibitor (SSRI) Drugs:
More Risks Than Benefits?

Journal of American Physicians and Surgeons Volume 14 Number 1 Spring 2009 7

JAMAwhole12,69210,98313,74112,73450,15013,554

10 dead, 7 wounded: dosage increased one week before rampage
15 year old shoots two teachers, killing one: then kills himself
Columbine High School: 15 dead, 24 wounded
Four dead, twenty injured after Prozac withdrawal
Teen shoots at two students: kills his father
Jury finds Paxil was cause of murder-suicide
Man cleared of charges due to Paxil withdrawal defense
Not guilty by reason of Prozac induced insanity: mother kills daughter
Nine dead, 12 wounded in workplace shooting
11 year old hangs himself: lawsuit

Journal of American Physicians and Surgeons Volume 14 Number 1 Spring 2009

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ANTIDEPRESSANT WITHDRAWAL: Suicide: Recent Withdrawal: Michigan

Often there is the terrible withdrawal associated with the SSRIs. Unless patients are warned to come very slowly off these drugs by shaving minuscule amounts off their pills each day, as opposed to cutting them in half or taking a pill every other day, they can go into terrible withdrawal which is generally delayed several months. This withdrawal includes bouts of overwhelming depression, terrible insomnia and fatigue, and can include life-threatening physical effects, psychosis, or violent outbursts.

Paragraph 7 reads: “Fessenden disputes reports that his son was taking multiple prescription drugs. He said his son recently went off anti-depressants.”

Relatives remember Oceana man as generous person

by Chad D. Lerch | The Muskegon Chronicle
Friday July 03, 2009, 6:41 AM

Roger Fessenden

OCEANA COUNTY — Dale Fessenden says his son, who was found dead June 25 in an Oceana County pond, will be remembered as a caring person who always put others first.

His son, Roger Dale Fessenden, 40, of Rothbury suffered a back injury at work earlier this year when he fell 20 feet while cleaning a storage tank. He underwent back surgery in February, family members said.

Roger Fessenden was reported missing June 23 and was found dead two days later in a pond known by locals as Oceana Lake in Grant Township.

Dale Fessenden said his son often had a difficult time sleeping because of back pain. He said Roger would take prescription sleeping pills and then go for drives in his car. He suspects the sleeping pills affected his son’s judgment.

On the night he went missing, Roger Fessenden likely took sleeping pills before venturing out, his father said.

“He didn’t know what he was doing and just took off,” he said. “I’m convinced that’s what happened to him.”

Fessenden disputes reports that his son was taking multiple prescription drugs. He said his son recently went off anti-depressants.

Family members said they want Roger Fessenden to be remembered as someone with a generous heart.

Dale Fessenden said his son once went shopping for a stranger in the hospital — just because he wanted to help.

“That’s the kind of person my son was,” he said. “He was the most polite person in my life.”

Oceana County Sheriff Bob Farber said a toxicology report is pending in the investigation into Roger Fessenden’s death. The report could return from the lab in the next two weeks.

But in the meantime, the county coroner has ruled the cause of death as drowning. It remains unclear how Fessenden ended up in the pond.

Fessenden, a longtime resident of Ferry, is survived by his wife, Blanco Suarez, two stepchildren and his parents.

E-mail Chad D. Lerch at clerch@muskegonchronicle.com

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My Husband Took His Life on Zoloft

“I am convinced that SSRIs caused akathisia…driving him to suicide very rapidly.”

Dear all,

I am an emergency nurse in Ireland and I was married to Niall a 39 yr Nurse Tutor (psychiatry). Niall committed suicide on the 26th of December 2003 out of the blue, no note, no planning, against his beliefs and his character. Abandoning his 3 children (whom he adored) (5yr, 3yr and 10 months) in the house and my oldest boy (5yr) found him hanging in the garden shed. He was prescribed sertraline 50mg OD for mild depression after 4 days (adverse effects???) (I was not aware he changed drugs) the GP changed it to paroxetine 20mg OD which he took for 13 days before committing suicide. We had a lovely Xmas day and he was not suicidal then. I am convinced that SSRIs caused akathisia on the 26th driving him to suicide very rapidly, he had no choice or say in the matter. Frightening!!

Nuria O’Mahony
nurianiall@eircom.net

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