Michael Moore – Reveals the real cause of Columbine.


Michael Moore obtained a copy of Ann Blake-Tracy’s book, “Prozac: Panacea or Pandora? – Our Serotonin Nightmare” at the premier of “Bowling for Columbine” in Denver, CO. After learning more about these drugs, see his statement from the movie he recently appeared in with Ann Blake-Tracy, Mark Taylor, Neal Bush, and others in the Gary Null production “The Drugging of our Children” Full Video http://video.google.com/videoplay?doc… OTHER SCHOOL SHOOTINGS go to. http://www.ssristories.org/index.php AntidepressantsKill.com

Michael Moore obtained a copy of Ann Blake-Tracy’s book,

“Prozac: Panacea or Pandora? – Our Serotonin Nightamre”

at the premier of “bowling for Columbine” in Denver, CO.

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Columbine Anniversary Brings Columbine & Red Lake Together

Monday, 20 April 2009

PRESS RELEASE:
Columbine Anniversary Brings Columbine & Red
Lake Together
DATE: APRIL 20, 2009
TIME: 5:00 – 6:00 PM
Place: Clement Park, Littleton,
Colorado
INFORMATION CONTACT:
Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
INFORMATION INCLUDED:
– Joint statement from the family of a Columbine victim & the family of
the Red Lake, MN school shooter – total dead 25, total wounded 31
– FDA testimony of Columbine shooting victim Mark Allen Taylor
– Statement by Michael Moore about the cause of Columbine after making
the movie, “Bowling for Columbine”
– New Medical Article Linking Antidepressants to Murder/Suicide in
the Spring Issue of the Journal of American Physicians and Surgeons
COLUMBINE & RED LAKE COME TOGETHER AT COLUMBINE
ANNIVERSARY
Donna Taylor: Mother of Mark Taylor, the first boy shot at Columbine High School on April 20, 1999 as Eric and Dylan, on their way into the school, shot at those gathered to discuss scriptures outside. Eric Harris shot Mark 6 – 13 times with 9mil bullets. Mark survived earning himself the title of “The Columbine Miracle Boy.”
Tammy Lussier: Daughter of Officer Daryl (Dash) Lussier of the Red Lake Police Department and aunt to Jeff Weise who shot and killed Tammy’s father, his own grandfather, and eight others before taking his own life with his grandfather’s police firearm.
Our Message: Here we are together at the 10th Anniversary of the tragedy at Columbine High School. So, why would a family member of a school shooting victim and a family member of a school shooter come together? We want the world to know that antidepressants cause violence with the most popular antidepressant on the market today listing “homicidal ideation” as a potential side effect.
Many shot at Columbine have learned to do is to forgive Eric Harris and Dylan Kleebold for doing what they did to them. We have just celebrated the glorious Easter season filled with the reassurance that through the mission of Jesus Christ we can overcome death and live again. As we remember Columbine we feel it is crucial to recall
that as Christ hung on the cross He plead with His Father in Heaven for those who were in the process of taking His life from Him “Father forgive them for they know not what they do.” In forgiving Eric and Dylan we believe that we are forgiving them for the same reason Christ asked for those taking his own life to be forgiven – they did not
know what they were doing April 20, 1999 when they took 15 lives, including their own, and injured 24 more.
Although USA Today attempted to rewrite history this past week and erroneously reported that the Columbine shooters were not on antidepressants we are here to remind the world that Eric Harris was on the antidepressant Luvox. Whether Eric was sharing his meds with Dylan, which is far too common with kids, or was on his own prescription we will never know as his records were sealed. In the Red Lake school shooting Jeff Weise was taking
the antidepressant Prozac. Our statement today is that minus antidepressantswe feel sure that the shootings at Columbine High School and Red Lake, MN High School would never have happened and neither would the
majority of the other school shootings and workplace violence shootings (see www.ssristories.drugawareness.org for a long list of documented cases).
Antidepressants push the user into a dream state leaving one to act out nightmares. Columbine was a nightmare acted out by Eric Harris and Dylan Kleebold, just as Red Lake was a nightmare acted out by Jeff Weise which took another 10 lives and injured 7 more. We do not believe they were conscious and coherent enough to fully understand what they were doing because of the adverse effects of antidepressants.
Over the past two years Donna has watched her son Mark go from a normal boy to someone she does no longer recognize because he was given two short bouts of similar drugs given to Eric Harris. Now Mark is living and
experiencing firsthand similar adverse reactions to what Eric was when he shot Mark. How ironic and tragic!
See Mark’s powerful statement below given before the FDA about these drugs that have now robbed him of who he is or was. [UPDATE: Please see the following video to see what has happened to Mark since this press release: http://www.drugawareness.org/mark-taylors-fight4columbine/ ]
If we want the shootings of Columbine and Red Lake to end we MUST learn the truth about the potential dangers of antidepressant medications.
____________________________________

Mark Taylor’s testimony before the FDA
9/13/2004

I am Mark Allen Taylor and I am a victim of the SSRI antidepressant era. I took six to thirteen bullets in the heart area in the Columbine High School shooting when Eric Harris on Luvox opened fire that now infamous day.

They almost had to amputate my leg and my arm. My heart missed by only one millimeter. I had three surgeries. Five years later I am still recuperating.

I went through all this to realize that SSRI antidepressants are dangerous for those who take them and for all those who associate with those who take them.

I hope that my testimony today shows you that you need to take action immediately before more innocent people like me, and you, do not get hurt or die horrible deaths as a result.

As Americans we should have the right to feel safe and if you were doing your job we would be safe. Why are we worrying about terrorists in other countries when the pharmaceutical companies have proven to
be our biggest terrorists by releasing these drugs on an unsuspecting public?

How are we suppose to feel safe at school, at home, on the street, at church or anywhere else if we cannot trust the FDA to do what we are paying you to do? Where were you when I and all of my classmates got shot at Columbine?

You say that antidepressants are effective. So why did they not help Eric Harris before he shot me?

According to Eric they “helped” him to feel homicidal and suicidal after only six weeks on Zoloft. And then he said that dropping off Luvox cold turkey would help him “fuel the rage” he needed to shoot everyone. But he continued on Luvox and shot us all anyway.

So, why did these so called antidepressants not make him better? I will tell you why. It is because they do not work!

We should consider antidepressants to be accomplices to murder.

_____________________________

To listen to Michael Moore’s statement about the cause of the Columbine tragedy after making the movie “Bowling for Columbine” – go to http://www.drugawareness.org/michael-moore-cause-of-columbine/

______________________________________

“Selective Serotonin Reuptake Inhibior [SSRI]
Drugs: More Risks Than Benefits?”

Journal of American Physicians and Surgeons: Volume 14: number 1: Spring 2009, there is an article by Joel M. Kauffman, Ph.D., [Professor of chemistry emeritus at the University of the Sciences, Philadelphia, Pa.]
In regard to the International Coalition for Drug Awareness, the study reads on page 10: “The International Coalition for Drug Awareness in cooperation with the Prozac Survivors Support Group has produced a website on which about 1,600 [now 3,000] violent incidents associated with SSRI use are described (www.ssristories.drugawareness.org/index.php).”
In regard to SSRI Stories www.SSRIstories.net documenting the link between thousands of cases of multiple murder/suicides and antidepressants, Dr. Kaufmann made the following statement on page 10: “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”.To read the full article and see the data go to the journal’s websitehttp://www.jpands.org/jpands1401.htm or http://www.jpands.org/vol14no1/kauffman.pdf

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PAXIL: 85 Year Old Man Kills Wife: No History of Violence

PAXIL: 85 Year Old Man Kills Wife: No History of Violence

Wed Nov 12, 2008 7:26 pm

“Paul Deyoub, a forensic psychologist with the Arkansas State Hospital in Little Rock, testified for the state that he didn’t believe Basham was delirious when he killed his wife.

“He said he didn’t believe Basham’s contention that he didn’t remember anything about the killing, and that his first memory that day was waking up in the hospital. He said nearly all defendants charged with domestic homicide that he has evaluated claim to have no memory or some loss of memory of thecrime.”

Well Mr. Forensic Psychologist just for your information (which I am sure drug companies have paid enough to your institution of higher learning to assure you never learn), the reason that ” . . . nearly all defendants charged with domestic homicide [that you have] evaluated claim to have no memory or some loss of memory of the crime” is because the large majority of those
defendants charged with domestic homicide are on SSRI or SNRI antidepressants which affect memory so adversely that “amnesia” is listed as a frequent side effect. WAKE UP!!! If they cannot even remember who they are, how can they remember what happened?!!!

And if this case was prosecuted by the same prosecutor I went up against in Fayetteville a few years ago, who could not make one statement without first reading it from the SSRI Prosecutor’s How to Manual, it is no wonder the courts’ time is still being wasted prosecuting such cases when they should be immediately dismissed and apologis and settlements issued directly from the
drug manufacturers to these families! How very tragic for this poor old man and his family!!!

[The SSRI Prosecutor’s manual is distributed by the drug manufacturers in criminal cases to make sure that anyone who commits a crime, while under the influence of their drugs, goes immediately to jail . Why? So that their drugs remain “innocent” and therefore lucrative because who would want to use a drug that a court has just said produced a suicide or murder or other violent crime? Is providing such a manual illegal? No, but probably should be. Is it unethical? Without a doubt!!!!

But it was obvious to me when testifying in these cases that this manualexisted due to prosecutors asking the same questions of me, almost word for word in every case, no matter which SSRI was involved or where in the country the case was tried. So, while working as the defense attorney on Christopher Pittman’s case, Andy Vickery asked for the manual as evidence and got a copy
for us. If anyone would like to waste their time reading it let me know and I will gladly send you a copy.]

Now back to this elderly man’s case:

As you read through the next two paragraphs understand why I gasp when I hear that this man was given an SSRI while suffering from anxiety, pneumoniaand sleep apnea. You see, anything that increases serotonin – as the SSRI antidepressants are designed to do and all antidepressants do – shuts down the lungs thereby cutting off oxygen to the brain. This is how these drugs produce brain damage, the cutting off of the oxygen supply.

[If you would like to test out this idea on your own, do what I do. Every time you see someone who is not elderly, but generally is overweight and is
carrying around an oxygen tank, ask them which antidepressant they have been on and how long. Then explain to them that the main function of serotonin is the
constriction of smooth muscle tissue which includes the lungs and bronchial tubes [and all major organs] which is why they now need oxygen. And then give
them our website because they are going to want to know what else these drugs have done to their health. But always stress that abrupt or rapid
discontinuation of the drug/drugs is very dangerous.]

Paragraph 4 reads: “Ross testified that in an attempt to explain how Basham, who never had a reputation for violence and always got along with his
wife, could have committed such a bizarre act, she concluded that Basham suffered from delirium.”

Paragraph 7 reads: “Ross pointed out that Autry Basham had pneumonia, took the drug Paxil for anxiety

and suffered from obstructive sleep apnea. All those factors, which were present on the day of Marie Basham’s death, inhibited his ability to get
oxygen to his brain. A lack of oxygen can trigger delirium, she said, especially in the elderly.”

Congratulations are in order for Dr. Ross for being able to understand the real reason for Autry Basham’s delirium was lack of oxygen!!! I wish more
doctors would work a little harder to see what is actually happening in these cases to produce such out of character behavior rather than following the old
school where the drugs involved were very different. Perhaps lack of oxygen leading to delirium is an easier conclusion to arrive at in an elderly patient,
but it does happen in all age groups and is a huge contributing factor in these tragic cases. It is also another reason why hyperbaric oxygen treatment
is so very helpful after using these drugs and subsequently suffering from elevated serotonin levels.

There should be grave concern in our country about such tragic cases as this one where a couple has had a long and loving marriage relationship and in an
instant it is ended in such horror because of what we call “medication”! For those of you who are younger and sadly may not be aware, things like this
DID NOT HAPPEN in the world we grew up in!!!! Cases like this (which I now see far too often) were basically non-existent before the widespread use of
serotonergic drugs.

As it states on the front cover of my book, these drugs have literally turned our world upside down! For this we owe the younger generation and those
generations to come our deepest apologies for the extensive damage we have allowed to occur. I fear we have left you a terrible, terrible legacy that at
this point I do not know if we can make restitution for it.

Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org(http://www.drugawareness.org/) &
www.ssristories.org (http://www.ssristories.org/)
Author of Prozac: Panacea or Pandora? – Our
Serotonin Nightmare & the audio, Help! I Can’t
Get Off My Antidepressant!!! ()

http://www.nwanews.com/adg/News/241972/
(http://www.nwanews.com/adg/News/241972/)

SEBASTIAN COUNTY : Sides dispute delirium led to husband’s killing of wife
BY DAVE HUGHES

Posted on Thursday, October 30, 2008

GREENWOOD ­ A Fayetteville psychiatrist said Wednesday that 85-year-old Autry Basham suffered from delirium brought on by pneumonia and a sleep
disorder when he slashed the throat of his 83-year-old wife last year.

The testimony of Dr. Robin Ross in Sebastian County Circuit Court in Basham’s first degree murder trial bolstered the defense’s contention that Basham of
Mansfield is innocent of murder because of a mental disease or defect at the time he killed his wife of 64 years, Lola Marie Basham, on Aug. 27, 2007.

The jury trial before Circuit Judge James Cox began Monday and is expected to wrap up today.

Ross testified that in an attempt to explain how Basham, who never had areputation for violence and always got along with his wife, could have
committed such a bizarre act, she concluded that Basham suffered from delirium.

She said tension and anxiety Basham may have been feeling over the falling out between his wife and son Jerry Basham didn’t play a role in triggering
the delirium.

Prosecutors have told jurors they believe Basham killed his wife after they argued the weekend before about her failing memory and her belief that their
son didn’t pay as much attention to them as he should, given the financial and other help they gave him over the years.

Ross pointed out that Autry Basham had pneumonia, took the drug Paxil for anxiety and suffered from obstructive sleep apnea. All those factors, which
were present on the day of Marie Basham’s death, inhibited his ability to get oxygen to his brain. A lack of oxygen can trigger delirium, she said,
especially in the elderly.

Delirium was defined as a disruption of consciousness and a change in perception that can come on rapidly and can come and go over time. It would
have been possible for Basham, she said, to be delirious and still carry out a sequence of events in killing his wife.

In rebuttal, the prosecution called Little Rock forensic psychiatrist Raymond Molden who testified there was no direct evidence that Basham suffered
from delirium.

He said the fact that Basham called his son and daughter-in-law before killing his wife and then carried out the series of actions in killing his wife
showed that he took steps in a logical sequence to bring about a result.

Following a logical sequence of steps, he said, was inconsistent with aperson suffering from delirium.

Paul Deyoub, a forensic psychologist with the Arkansas State Hospital in Little Rock, testified for the state that he didn’t believe Basham was
deliriouswhen he killed his wife.

He said he didn’t believe Basham’s contention that he didn’t remember anything about the killing, and that his first memory that day was waking up in
the hospital. He said nearly all defendants charged with domestic homicide that he has evaluated claim to have no memory or some loss of memory of the
crime.

As you read through the next two paragraphs understand why I gasp when I hear that this man was given an SSRI while suffering from anxiety, pneumoniaand sleep apnea. You see, anything that increases serotonin – as the SSRI antidepressants are designed to do and all antidepressants do – shuts down the lungs thereby cutting off oxygen to the brain. This is how these drugs produce brain damage, the cutting off of the oxygen supply.

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Strattera Deaths (German TV Request) False Reports from Eli Lilly

Wed Nov 12, 2008

We have received a request from a German TV crew who is doing a special on Lilly’s newer ADHD medication, Stratera. These investigative reporters from Germany are doing a 45 minute piece and looking for experiences of tragedy /suicide or severe adverse reactions in children treated for ADHD with this drug. I know we have had reports, but I do not keep close track anymore of which drug is involved after so many cases because all these drugs work basically the same way. An antidepressant is an antidepressant no matter what you callmit or what you prescribe it for or how you explain its supposed uniqueness. So if you or someone you know has been through a Strattera-induced nightmareand would be willing to help get some exposure of this in the press, please get in touch with me so that I can put you in touch the reporters.

O nce you read the following article on Strattera deaths you will see how very important it is to get information about this drug out to the public –

especially throughout the UK and Europe. What is going on here IS CRIMINAL!!
And here is just one example out of the article below that is full of data on how
the government agency in the UK who oversees these drugs is ignoring
critical information – even fatalities, and doing NOTHING but making excuses
for their own behavior:

MHRA has for almost three years been in possession of data showing that
Strattera in many cases actually can cause or worsen the œcondition it is
claimed to alleviate. More than 700 reports were submitted to the manufacturer,
Eli Lilly, about Strattera inducing “œpsychomotor hyperactivity. Lilly called
this an exacerbation of the “œunderlying ADHD”. If we would apply this to
the area of real medicine and to diabetes we could say that the patient got a
diabetes medication with resulting heavy increase in blood sugar level. Such a
medication would probably be withdrawn very fast from the market. But the
MHRA has not yet, after three years, succeeded to get even a bad quality review
of these cases done not even from the manufacturer.

Do read the rest of the information because it is clearly eye opening!! This
newer ADHD drug, Strattera, which is really an SSRI antidepressant, is
getting away with murder right under everyone’s noses. So definitely if you
know someone who is willing to talk to this news crew about their experience with
this drug, please do let me know ASAP.

Thank you,

Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
_www.drugawareness.org_ (http://www.drugawareness.org/) &
_www.ssristories.org_ (http://www.ssristories.org/)
Author of Prozac: Panacea or Pandora? – Our
Serotonin Nightmare & the audio, Help! I Can’t
Get Off My Antidepressant!!! ()

_atracyphd1@…_ (mailto:atracyphd1@…)

_http://www.newmediaexplorer.org/sepp/2008/10/20/strattera_adverse_effects_uk_
medicines_agency_refuses_to_act.htm#_
(http://www.newmediaexplorer.org/sepp/2008/10/20/strattera_adverse_effects_uk_me\
dicines_agency_refuses_to_act.htm#
)

October 20, 2008
_Print this article_
(http://www.newmediaexplorer.org/sepp/2008/10/20/strattera_adverse_effects_uk_me\
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Strattera adverse effects: UK Medicines Agency refuses to act
By Sepp Hasslberger

Categories
_Pharma_ (http://www.newmediaexplorer.org/sepp/pharma.htm)

Janne Larsson, an investigator and reporter in Sweden, has obtained
information about adverse event reports on Eli Lilly’s ADHD drug Strattera,
using the Swedish freedom of information laws. The data, coming from both the FDA’s
adverse reaction database and from reports to the UK’s Medicines agency, shows
numerous adverse effects and scores of deaths by suicide.

Yet the agency, even after repeated prodding by Larsson to initiate action,
has refused to budge or even acknowledge that there is a problem. MHRA
apparently accepts the drug’s producer Eli Lilly’s data rather than its own and
the
FDA’s adverse event reports.

Image credit: _Monheit Law_
(http://www.monheit.com/strattera/contact_lawyer.asp)

Larsson says: An investigation of MHRA™s handling of the harmful effects of
the ADHD drug Strattera has proven the following:

MHRA has ignored data about instances of death among children in connection
with Strattera treatment. At least 41 children have died. The agency has not
investigated the reported cases and does not even have a compiled summary of
cases with fatal outcome. Further the agency has allowed the manufacturer Eli
Lilly to give false information about the number of fatal cases and has
taken no action against the company once the false information was revealed.

MHRA has for almost three years been in possession of data proving that
Strattera can cause agitation, mania and psychotic reactions with hallucinations
among children. Yet no warning has been issued to doctors and parents. The
agency has withheld these disastrous consequences despite clear evidence. Due
to bureaucratic procedures no warnings have been issued even if Eli Lilly reluc
tanly conceded to include these harmful reactions in its information to the
public almost a year ago.

MHRA has for almost three years been in possession of data showing that
Strattera in many cases actually can cause or worsen the œcondition it is
claimed to alleviate. More than 700 reports were submitted to the manufacturer,
Eli Lilly, about Strattera inducing œpsychomotor hyperactivity. Lilly called
this an exacerbation of the œunderlying ADHD. If we would apply this to
the area of real medicine and to diabetes we could say that the patient got a
diabetes medication with resulting heavy increase in blood sugar level. Such a
medication would probably be withdrawn very fast from the market. But the
MHRA has not yet, after three years, succeeded to get even a bad quality review
of these cases done“ not even from the manufacturer.
The background data for these conclusions can be found in the following text
and in the linked documents. When reading the data below please remember the
promise from the MHRA: we take any necessary action to protect the public
promptly if there is a problem._MHRA, About us_
(http://www.mhra.gov.uk/Aboutus/index.htm) [1]

Note that the linked documents (within letters described below) in most
cases could not be obtained in UK where the issuance of them would be deemed as
prejudicing œthe ability of the Assessory body to offer impartial advice and
where the MHRA wants to allow marketing authorisation holders the chance to
respond to regulatory action and make commercial decisions before data are
in the public domain. (MHRA, e-mail about FOIA-request, 29th September,
2006). However the documents could be obtained in Sweden, even if the MHRA has
tried to stop the issuance of them by implying that publication could threaten
the relations between Sweden and UK.
Deaths among children in connection with Strattera treatment

In May I submitted detailed data about cases of Strattera death to the MHRA.
1st October I finally got an answer from the Scientific Assessor of the
Vigilance and Risk Management of Medicines (VRMM). 7th October I got an answer
from Professor Kent Woods, CEO of the MHRA, referring to the letter sent by the
Scientific Assessor.

My data about Strattera deaths can be found _in the letter_
(http://jannel.se/Strattera.death2.pdf) Strattera: Eli Lilly gave false
information about
deaths from Strattera treatment “ a request for full investigation from 15th
May. [2]
The answer from the Scientific Assessor shows that MHRA is continuing to
ignore data about instances of death among children and adults in connection
with Strattera treatment. Despite limited resources and having to rely on data
released by reluctant medical agencies I had been able to produce a summary of
reported cases of Strattera death. Thats much more than the MHRA, with its
immense resources, had been able to do.

The agency was provided with specific data about instances of death forming
an excellent starting point for a full investigation. But instead of using
the data the MHRA used its energy to explain why it is impossible to
investigate these cases further, and in doing so presents some remarkable
comments.

The Scientific Assessor states _in the letter 1st October_
(http://jannel.se/Reply.from%20MHRA.Assessor.October.pdf) [3]:

in order to calculate the total number of reports with a fatal outcome
it is not simply a case of adding up reports with a fatal outcome mentioned
in our assessment reports of the PSURs [Periodic Safety Update Reports] and
those available on the FDA website as these different sources may contain
duplicate information. [Emphasis added.]

I fully agree and it takes only a casual reading of my letter from 15th May
to find out that much care has been taken to exclude possible duplicates. It
is quite easy to see that the data presented about fatal cases in my letter
is NOT simply a case of adding up reports with a fatal outcome. The only
way to come to another conclusion would be not to look in the first place and
it is a condemnation of the effectiveness of the agency to state the following
in the letter:

We have looked at the data you have sent us to see if they can add insight
to the statutory sources of data we have received and do not think that they
are of benefit as we cannot verify their source or accuracy. (p. 3)
[Emphasis added.]

I must add to all the data provided in my letter 15th May that the our

of the information about fatal cases is FDA™s Medwatch system and the PSURs
(submitted directly to the MHRA). I must make it clear that is very easy for
a lay person to find out that almost all reports about fatal outcome from
Strattera treatment submitted to the FDA came from Eli Lilly!

Thus the our of the information about fatal cases was in most of the
cases the manufacturer itself“ Eli Lilly. And yet the MHRA has not been able
to verify the source or accuracy of the information. The MHRA Scientific
Assessor states in the letter:The sources of data that regulators use such
as company data, spontaneous adverse reaction reports and literature are set
out in European and national law.
My FOIA request earlier this year to get a compilation of fatal cases in
connection with Strattera treatment was answered 12th August:

Thats very good and now we know that the data I submitted to the MHRA about
all fatal cases from Strattera treatment “ in the absolute majority of cases
were known by and reported via the manufacturer Eli Lilly.
The MHRA holds no data other than that previously released to you [the
misleading data from Eli Lilly in November 2007, see my letter from 15th May
for
more data] which was the data provided by the company. If you have any
questions about FDA data or the data provided by the company, you should
contact those organisations.

In other words the MHRA didn’t have a compiled summary of cases with fatal
outcome in August and the agency has not to this point been able to compile
such a summary.

As the agency has not been capable of getting the data or not even been
capable of using the specific data submitted for its use in a full
investigation NO action is taken despite the many verified deaths among
children in connection with Strattera treatment. This disregard for the safety of children is a scandal which should lead to a full formal investigation by the
Department of Health.

Drug induced agitation, mania and psychosis with hallucinations

Ive been contacted by parents asking if Strattera can induce mania and
psychosis with hallucinations. Their children have had such symptoms. The
parents have not found any warnings about it and their childrens doctors don’t
think that the symptoms are caused by the drug. The parents were desperate.

However the MHRA has known for almost three years that Strattera can cause
agitation, mania and psychotic reactions with hallucinations among children,
but has refused to issue warnings about it.

The Scientific Assessor from the MHRA _in the letter of 1st October_
(http://jannel.se/Reply.from%20MHRA.Assessor.October.pdf) [3] now confirms my
earlier arguments that the agency had knowledge about these effects a long time ago:

following an initial request in the assessment report for the Periodic
Safety Update for the period (dates 27-05-2005 to 26-11-2005) we asked Eli
Lilly for more information to enable us to review this issue in more detail. (p. 2)

This means that in the period ending 26th November, 2005 at the time when
Strattera was approved only in UK and four other European countries, but not
in the 22 additional European countries where it is now approved Eli Lilly
and the MHRA had knowledge about these disastrous effects in children taking
Strattera. But neither the MHRA nor Eli Lilly told anything about it and
Strattera was approved in 20 additional European countries in April 2006.
Image credit: _Wikimedia Commons_
(http://commons.wikimedia.org/wiki/Image:Strattera_atomoxetin.jpg)

Professor Kent Woods, CEO of the MHRA seems to be very misinformed by his
staff when answering about Strattera in a recent _letter of 7th October, 2008_
(http://jannel.se/answer.kent.woods.pdf) . In the letter Professor Woods
states [4]:

The MHRA is committed to ensuring that all safety concerns are subject to
robust scientific assessment and the best possible regulatory action is taken
in a timely manner. We strive to maintain the highest standards of work and
review our practices to ensure these standards are maintained or improved
upon where necessary. (p. 1)

In their 3rd March, 2006 report Psychiatric Adverse Events Associated with
Drug Treatment of ADHD: Review of Postmarketing Safety Data [5], the FDA
stated that there was compelling evidence for a likely causal association
between [Strattera/amphetamine drugs] and treatment emergent onset of signs and/or
symptoms of psychosis or mania, notably hallucinations, in some patients.

(p. 17) 360 reports about the drug inducing these effects had been received
up to June 2005.

From this FDA report the MHRA had knowledge about the œcompelling evidence for Strattera causing these effects on or about 3rd March, 2006 but did nothing.

In August the same year (2006) the MHRA requested the same data set from Eli
Lilly that was submitted to the FDA and which formed the basis of the FDA
report for Strattera. The data was sent to the MHRA some days later. But the
agency then decided not to do anything with the information. Instead it was
decided that Eli Lilly the manufacturer should do an analysis of the data
and submit its conclusions to the agency.

Professor Kent Woods says in his letter: An important aspect to this [ robust scientific assessment, highest standards] is ensuring that data from all available sources have been consider This may be true in some other area but it is definitely not true for the
safety work around Strattera. A very good example of this is the complete
rejection of the robust scientific assessment of Strattera in the FDA report.
Answering the question why the agency did not use the compelling evidence for harm in the FDA report _an official at the MHRA declared in a letter_
(http://jannel.se/mhraanswer.pdf) [6]:

Changes to European product information are based on assessment by EU
regulators, agreement between member states and in line with legal requirements
about product information, not on conclusions of FDA assessors. (25th May,
2007) [Emphasis added.]

Responsible officials at the MHRA had instead decided to rely completely on
the analysis of the manufacturer of the drug Eli Lilly. (In an article in
the Daily Mail this summer, Andrew Herxheimer, editor of the Drug and
Therapeutics Bulletin, and emeritus fellow of the Cochrane Centre commented:
Asking a drug company to review its own product is crazy, but it goes on quite a lot.
) [7]

At the end of 2007/beginning 2008 Eli Lilly submitted its review of
Strattera induced agitation, mania and psychosis with hallucinations to the
MHRA. It was a complete whitewash.

In summary: FDA was very clear about the psychosis-inducing effects of
Strattera; the MHRA did not listen. Instead the MHRA turned to the
manufacturer. Eli Lilly tried to explain away all the bad results found in its review. For
the full history about MHRA’s failure in this area and for a comparison of
the FDA report with the Lilly report, please see the following letter: _The
ADHD drug Strattera“ actions needed now_
(http://jannel.se/letter.mhra.strattera.jan08.pdf) [8] from January 2008, and
the letter _The ADHD drug Strattera“
an analysis of reports of drug induced mania, psychosis and hallucinations_
(http://jannel.se/strattera.mhra.March.08.pdf) [9] from March 2008.

In the letter from March [9] Eli Lilly’s whitewash report for the period up
to November 2007 is presented. At the end of that report Lilly says [10]:

Nevertheless, Lilly will consider adding language regarding psychotic symptoms
including hallucinations to its product information sheet. (p. 1279)

Larsson – _Suicides & Psychiatric Drugs_
(http://www.newmediaexplorer.org/sepp/suicide.psychiatricdrugs.pdf)

And so we come to October 2008 and the letters from Professor Kent Woods and
from the Scientific Assessor for Strattera. We are reassured that the MHRA
is acting to ensure that Strattera is used as safely as possible that

all safety concerns are subject to robust scientific assessment and the best
possible regulatory action, that any new safety signals are evaluated in
an independent, scientifically robust manner (Woods); we are told that

discussions between European Member States and Eli Lilly are ongoing to agree
on the most appropriate information to be included in the product information
for patients and prescribers; we are told to be patient, to understand that
it takes time from the point where œupdates have been agreed for inclusion in
the product information to the point where these will appear in the packs
in the market place due to movement of stock in the supply chain, and that
the appearances are estimated to be within the next 6 months (Scientific
Assessor).

It is probably hard to find a more obvious violation of the promise¦ we
take any necessary action to protect the public promptly if there is a
problem than the case described above. The worried parents still have no answers if
Strattera can induce the symptoms they find in their children. And the MHRA
knew about it three years ago but withheld the data. This should be
included in the investigation of the agency by the Department of Health.

Strattera causing hyperactivity“ the condition it was supposed to alleviate In my earlier letter to the Department of Health (29th August) I took up the data about the 700 forgotten cases of hyperactivity. I referred to my _letter 2nd January to the MHRA_
(http://jannel.se/letter.mhra.strattera.jan08.pdf) [8] and gave data about the
fact that Eli Lilly had withheld sensitive information and classified harmful effects as an exacerbation of the underlying ADHD.

The logical solution would have been for the MHRA to request all data about
this security risk, followed by an independent review of the data. But this
was not done and as expected nothing is still done. MHRA asked Lilly for an
explanation about this signal stemming from Periodic Safety Update Report
5 (dates 27-05-2005 to 26-11-2005) but got no answer. Three years later the
Scientific Assessor from the MHRA writes in the letter from 1st October:

The information submitted by the MAH [Market Authorization Holder] has been
evaluated and the MAH will be requested to provide further detailed
information within the next 2 months to ensure the issue has been investigated
in a thorough and scientific manner. (p. 2) [3]

The MHRA got this safety signal almost three years ago and is still in
the process of getting some sensible answers from Eli Lilly.

————

I again request the Department of Health to take action. This does not
concern only the children in UK; it concerns the children in the whole of
Europe, indeed it concerns all the children of the world.

The failure of the agency will also mean that psychiatrists within The
Guideline Development Group in NICE can push through more treatment with
Strattera and other ADHD drugs. The MHRA is withholding the clear evidence for
harmful effects and the psychiatrists with close relations to the manufacturers
of the drugs can unimpeded recommend these medicines to unsuspecting
doctors and parents.

The answers given by Professor Kent Woods and the Scientific Assessor did
not in any way handle my concerns. On the contrary, they finally proved that a
full formal investigation of the matters raised above is needed.

Yours sincerely,

Janne Larsson

Reporter – investigating psychiatry
Sweden
_janne.olov.larsson@…_ (mailto:janne.olov.larsson@…)

[1] MHRA, About us, _http://www.mhra.gov.uk_ (http://www.mhra.gov.uk/)
[2] Larsson, Strattera: Eli Lilly gave false information about deaths from
Strattera treatment“ a request for full investigation, May 15, 2008,
_http://jannel.se/Strattera.death2.pdf_ (http://jannel.se/Strattera.death2.pdf)
[3] MHRA, Re: letter of 9th September 2008 to “Assessor responsible for
Strattera, October 1, 2008,
_http://jannel.se/Reply.from%20MHRA.Assessor.October.pdf_
(http://jannel.se/Reply.from%20MHRA.Assessor.October.pdf)
[4] MHRA, Re: Open letter to Pr. Kent Woods (10th August 2008), October 7,
2008
_http://jannel.se/answer.kent.woods.pdf_
(http://jannel.se/answer.kent.woods.pdf)
[5] FDA, Psychiatric Adverse Events Associated with Drug Treatment of ADHD:
Review of Postmarketing Safety Data, released March 3, 2006.
_http://www.fda.gov/ohrms/dockets_
(http://www.fda.gov/ohrms/dockets/AC/06/briefing/2006-4210b_11_01_AdverseEvents.\
pdf
)
[6] MHRA, answer FOI request, May 25, 2007,
_http://jannel.se/mhraanswer.pdf_ (http://jannel.se/mhraanswer.pdf)
[7] Daily Mail, Heart attacks and suicides… yet the dangers were all kept
so quiet. So how CAN you trust your medicine? July 7, 2008,
_http://www.dailymail.co.uk/_
(http://www.dailymail.co.uk/health/article-1033132/Side-effects-include-suicide-\
heart-attacks-So-prescribed-drugs.html
)
[8] Larsson, The ADHD drug Strattera – actions needed now, January 2, 2008,
_http://jannel.se/letter.mhra.strattera.jan08.pdf_
(http://jannel.se/letter.mhra.strattera.jan08.pdf)
[9] Larsson, The ADHD drug Strattera – an analysis of reports of drug
induced mania, psychosis and hallucinations, March 9, 2008,
_http://jannel.se/strattera.mhra.March.08.pdf_
(http://jannel.se/strattera.mhra.March.08.pdf)
[10] Eli Lilly, Cumulative review of Spontaneous Case Reports of Mania,
Psychotic Disorders, Hallucinations, and Agitation, Appendix 16 to Periodic
Safety Report 9 for Strattera, 2008,
_http://jannel.se/Lilly_psychosis_strattera.pdf_
(http://jannel.se/Lilly_psychosis_strattera.pdf)

See also:

_Doctors told to curb use of Ritalin in hyperactive children_
(http://www.timesonline.co.uk/tol/news/uk/science/article4813727.ece)
_Children’s suicide attempts raise concerns about ADHD medication_
(http://www.theglobeandmail.com/servlet/story/RTGAM.20080703.wadhd03/BNStory/spe\
cialScie

nceandHealth/home)
_The ADHD drug Strattera: Lilly to issue warnings about psychosis,
hallucinations, mania and agitation_ (http://jannel.se/strattera.psychosis.doc)
_Strattera side effects_ (http://www.bonkersinstitute.org/stratteraffex.html)

_Strattera – 10,988 adverse “psychiatric reactions” reported in less than
three years_ (http://www.24-7pressrelease.com/view_press_release.php?rID=16662)
_Attention Deficit Hyperactivity Disorder? No, they’re just naughty, say
experts_
(http://www.dailymail.co.uk/news/article-1031436/Attention-Deficit-Hyperactivity\
-Disorder-No-theyre-just-naughty-say-experts.html#
)

435 total views, no views today

NEJM: On Zoloft Homicidal Ideation Frequent In Those 17 & Under

Since I believe that people should always get credit for the hard work and contribution they make in life I want to give our thanks to Rosie Meysenburg for getting this out to us today and for her comments on it. Rosie has done so much, along with her husband Gene, in posting our years and years worth of work gathering these SSRI & SNRI cases together for the _www.ssristories.drugawareness.org_
(http://www.ssristories.drugawareness.org) site.

“This Adverse Event Report, from a study appearing in the New England Journal of Medicine, shows that of 133 children 17 & under on Zoloft there were 2 who reported “Homicidal Ideation”. There were no reports of “Homicidal Ideation” in the placebo group.

[According to the Physicians Desk Reference, a Frequent adverse reaction is one that occurs in 100 people or less.  Homicidal Ideation occurred in 1 in 66 children on Zoloft aged 17  and under.]

“According to the Physicians Desk Reference, a Frequent adverse reaction is one that occurs in 100 people or less. Homicidal Ideation occurred in 1 in 66 children on Zoloft aged 17 and under.

“This Adverse Event Report was the appendix for this study in the New England Journal of Medicine.”

adverse event report1.pdf

This Adverse Event Report was the appendix for this study in the New England Journal of Medicine:

http://content.nejm.org/cgi/content/full/NEJMoa0804633

And with this new information from the New England Journal of Medicine I want to include information out of Australia which is that Pfizer, the maker of Zoloft, along with the Therapeutic Goods Administration (TGA similar to our FDA), recommends that any SSRI antidepressant should not be prescribed to Australians under the age of 24. Funny, but I missed that warning from Pfizer for Americans under 24, didn’t you?

Next I will send that article that just came out over the weekend because it ties in so closely with this new information on Zoloft. And because there is so much to read in this article alone I am going to cut my comments at this point and let the article speak for itself.

Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
_www.drugawareness.org_ (http://www.drugawareness.org/) &
_www.ssristories.org_ (http://www.ssristories.org/)
Author of Prozac: Panacea or Pandora? – Our
Serotonin Nightmare & the audio, Help! I Can’t
Get Off My Antidepressant!!! ()

_atracyphd1@…_ (mailto:atracyphd1@…)

_http://content.nejm.org/cgi/content/full/NEJMoa0804633_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633)

Published at www.nejm.org October 30, 2008 (10.1056/NEJMoa0804633)
Cognitive Behavioral Therapy, Sertraline, or a Combination in Childhood
Anxiety

John T. Walkup, M.D., Anne Marie Albano, Ph.D., John Piacentini, Ph.D.,
Boris Birmaher, M.D., Scott N. Compton, Ph.D., Joel T. Sherrill, Ph.D., Golda
S. Ginsburg, Ph.D., Moira A. Rynn, M.D., James McCracken, M.D., Bruce Waslick,
M.D., Satish Iyengar, Ph.D., John S. March, M.D., M.P.H., and Philip C. Kendall, Ph.D.

ABSTRACT
Background Anxiety disorders are common psychiatric conditions affecting children and adolescents. Although cognitive behavioral therapy and selective serotonin-reuptake inhibitors have shown efficacy in treating these disorders, little is known about their relative or combined efficacy.

Methods In this randomized, controlled trial, we assigned 488 children between the ages of 7 and 17 years who had a primary diagnosis of separation anxiety disorder, generalized anxiety disorder, or social phobia to receive 14 sessions of cognitive behavioral therapy, sertraline (at a dose of up to 200 mg per day), a combination of sertraline and cognitive behavioral therapy, or a placebo drug for 12 weeks in a 2:2:2:1 ratio. We administered categorical and dimensional ratings of anxiety severity and impairment at baseline and at
weeks 4, 8, and 12.

Results The percentages of children who were rated as very much or much improved on the Clinician Global Impression “Improvement scale were 80.7% for combination therapy (P<0.001), 59.7% for cognitive behavioral therapy (P<0.001), and 54.9% for sertraline (P<0.001); all therapies were superior to placebo
(23.7%). Combination therapy was superior to both monotherapies (P<0.001).

Results on the Pediatric Anxiety Rating Scale documented a similar magnitude and pattern of response; combination therapy had a greater response than cognitive behavioral therapy, which was equivalent to sertraline, and all therapies were superior to placebo. Adverse events, including suicidal and homicidal
ideation, were no more frequent in the sertraline group than in the placebo group. No child attempted suicide. There was less insomnia, fatigue, sedation, and restlessness associated with cognitive behavioral therapy than with sertraline.

Conclusions
Both cognitive behavioral therapy and sertraline reduced the severity of anxiety in children with anxiety disorders; a combination of the two therapies had a superior response rate.

(ClinicalTrials.gov number,
NCT00052078 _[ClinicalTrials.gov]_
(http://content.nejm.org/cgi/external_ref?access_num=NCT00052078&link_type=CLINT\
RIALGOV
) .)

____________________________________
Anxiety disorders are common in children and cause substantial impairment in
school, in family relationships, and in social functioning._1_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R1) ,_2_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R2) Such disorders
also predict adult anxiety disorders and major depression._3_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R3) ,_4_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R4) ,_5_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R5) ,_6_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R6) Despite a high
prevalence (10 to 20%_3_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R3)
,_7_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R7) ,_8_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R8) ) and substantial
morbidity, anxiety disorders in childhood remain underrecognized and
undertreated._1_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R1)
,_9_

(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R9)

An improvement in outcomes for children with anxiety disorders would have important public health
implications.In clinical trials, separation and generalized anxiety disorders and social
phobia are often grouped together because of the high degree of overlap in
symptoms and the distinction from other anxiety disorders (e.g., obsessive compulsive disorder). Efficacious treatments for these disorders include cognitive behavioral therapy_10_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R10) ,_11_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R11) and
the use of selective serotonin-reuptake inhibitors (SSRIs)._12_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R12) ,_13_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R13)

However, randomized, controlled trials comparing cognitive behavioral therapy, the use of an SSRI, or the combination of both therapies with a control are lacking. The evaluation of combination therapy is particularly important because approximately 40 to 50% of children with these disorders do not have a response to short-term treatment with either monotherapy.
_14_(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R14) ,_15_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R15)

Our study, called the Child “Adolescent Anxiety Multimodal Study, was designed to address the current gaps in the treatment literature by evaluating the relative efficacy of cognitive behavioral therapy, sertraline, a combination of the two therapies, and a placebo drug. This article reports the results of short-term treatment.

Methods

Study Design and Implementation

This study was designed as a two-phase, multicenter, randomized, controlled trial for children and adolescents between the ages of 7 and 17 years who had separation or generalized anxiety disorder or social phobia. Phase 1 was a 12-week trial of short-term treatment comparing cognitive behavioral therapy, sertraline, and their combination with a placebo drug. Phase 2 is a 6-month open extension for patients who had a response in phase 1.

The authors designed the study, wrote the manuscript, and vouch for the data gathering and analysis. Pfizer provided sertraline and matching placebo free of charge but was not involved in the design or implementation of the study, the analysis or interpretation of data, the preparation or review of the manuscript, or the decision to publish the results of the study.

Study Subjects

Children between the ages of 7 and 17 years with a primary diagnosis of separation or generalized anxiety disorder or social phobia (according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision
[DSM-IV-TR]_16_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R16) ),
substantial impairment, and an IQ of 80 or more were eligible to participate. Children with coexisting psychiatric diagnoses of lesser severity than the three target disorders were also allowed to participate;
such diagnoses included attention deficit–hyperactivity disorder (ADHD) whilereceiving stable doses of stimulant and obsessive compulsive, post-traumatic stress, oppositional defiant, and conduct disorders. Children were excluded if they had an unstable medical condition, were refusing to attend school
because of anxiety, or had not had a response to two adequate trials of SSRIs or an adequate trial of cognitive behavioral therapy.

Girls who were pregnant or were sexually active and were not using an effective method of birth control
were also excluded. Children who were receiving psychoactive medications other than stable doses of stimulants and who had psychiatric diagnoses that made participation in the study clinically inappropriate (i.e., current majordepressive or substance-use disorder; type ADHD; or a lifetime history of bipolar, psychotic, or pervasive developmental disorders) or who presented an acute risk to themselves or others were also excluded.

Recruitment occurred from December 2002 through May 2007 at Duke University Medical Center, New York State Psychiatric Institute Columbia University Medical Center New York University, Johns Hopkins Medical Institutions, Temple University University of Pennsylvania, University of California, Los Angeles,and
Western Psychiatric Institute and Clinic University of Pittsburgh Medical Center. The protocol was approved and monitored by institutional review boards at each center and by the data and safety monitoring board of the National Institute of Mental Health. Subjects and at least one parent provided written informed consent.

Interventions

Cognitive behavioral therapy involved fourteen 60-minute sessions, which included review and ratings of the severity of subjects’ anxiety, response to treatment, and adverse events. Therapy was based on the Coping Cat program,_17_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R17) ,_18_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R18) which was adapted for the
subjects’ age and the duration of the study._19_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R19)

Each subject who was assigned to receive cognitive behavioral therapy received training in anxiety-management skills, followed by behavioral exposure to anxiety-provoking situations. Parents
attended weekly check-ins and two parent-only sessions. Experienced psychotherapists, certified in the Coping Cat protocol, received regular site-level and cross-site supervision.

Pharmacotherapy involved eight sessions of 30 to 60 minutes each that included review and ratings of the severity of subjects’ anxiety, their response to treatment, and adverse events. Sertraline (Zoloft) and matching placebo were administered on a fixed flexible schedule beginning with 25 mg per day and adjusted up to 200 mg per day by week 8. Through week 8, subjects who were considered to be mildly ill or worse and who had minimal side effects were eligible for dose increases.

Psychiatrists and nurse clinicians with experience in medicating children with anxiety disorders were certified in the study pharmacotherapy protocol and received regular site-level and cross-site supervision.
Pill counts and medication diaries were used to facilitate and document adherence. Combination therapy consisted of the administration of sertraline and cognitive behavioral therapy. Whenever possible, therapy and medication sessions occurred on the same day for the convenience of subjects.

Objectives
Study objectives were, first, to compare the relative efficacy of the three active treatments with placebo; second, to compare combination therapy with either sertraline or cognitive behavioral therapy alone; and third, to assess the safety and tolerability of sertraline, as compared with placebo. We hypothesized that all three active treatments would be superior to placebo and that combination therapy would be superior to either sertraline or cognitive behavioral therapy alone.

Outcome Assessments
We obtained demographic information, information on symptoms of anxiety, and data on coexisting disorders and psychosocial functioning using reports from both the subjects and their parents and from interviews of subjects and parents at the time of screening, at baseline, and at weeks 4, 8, and 12.

The interviews were administered by independent evaluators who were unaware of study-group assignments.
We used the Anxiety Disorders Interview Schedule for DSM-IV-TR, Child Version,_20_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R20) to establish diagnostic eligibility. The categorical primary outcome was the treatment response at week 12, which was defined as a score of 1 (very much improved) or 2 (much improved) on the Clinical Global Impression Improvement scale,_21_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R21) which ranges from 1 to 7, with lower scores indicating more improvement, as compared with baseline. A score of 1 or 2 reflects a substantial, clinically meaningful improvement in anxiety severity and normal functioning. The dimensional primary
outcome was anxiety severity as measured on the Pediatric Anxiety Rating Scale, computed by the summation of six items assessing anxiety severity, frequency, distress, avoidance, and interference during the previous week._22_(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R22)

Total scores on this scale range from 0 to 30, with scores above 13 indicating clinically meaningful anxiety. The Children’s Global Assessment Scale_23_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R23) was used to rate
overall impairment.

Scores on this scale range from 1 to 100; scores of 60 or lower are considered to indicate a need for treatment, and a score of 50 corresponds to moderate impairment that affects most life situations and is readily observable. Agreement among the raters was high for anxiety severity (r=0.85) and diagnostic
status (intraclass correlation coefficient= 0.82 to 0.88) on the basis of a videotaped review of 10% of assessments by independent evaluators that were performed at baseline and at week 12.

Adverse Events
Adverse events were defined as any unfavorable change in the subjects’ pretreatment condition, regardless of its relationship to a particular therapy. Serious adverse events were life-threatening events, hospitalization, or events leading to major incapacity. Harm-related adverse events were defined as thoughts of harm to self or others or related behaviors. All subjects were interviewed at the start of each visit by the study coordinator with the use of a standardized script. Identified adverse events and harm-related events were then evaluated and rated by each subject’s study clinician.

This report presents data on all serious adverse events, all harm-related adverse events, andmoderate and severe (i.e., functionally impairing) adverse events that occurred in 3% or more of subjects in any study group. The data and safety monitoring board of the National Institute of Mental Health performed a quarterly review
of reported adverse events. Given the greater number of study visits (and hence more reporting
opportunities) and the unblinded administration of sertraline in the combination-therapy group, the test of the adverse-event profile of sertraline focused on statistical comparisons between sertraline and placebo and sertraline and cognitive behavioral therapy.

Randomization and Masking
The randomization sequence in a 2:2:2:1 ratio was determined by a computer-generated algorithm and maintained by the central pharmacy, with stratification according to age, sex, and study center. Subjects were assigned to study groups after being deemed eligible and undergoing verbal reconsent with a study investigator. Subjects in the sertraline and placebo groups did not know whether they were receiving active therapy, nor did their clinicians. However, subjects who received combination therapy knew they were receiving active sertraline. The study protocol called for independent evaluators who completed assessments to be unaware of all treatment assignments.

Statistical Analysis
On the basis of previous studies,_10_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R10) ,_11_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R11) ,_12_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R12)
,_13_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R13) ,_14_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R14) ,_15_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R15)
we hypothesized that 80% of children in the combination-therapy group, 60% in either the sertraline group
or the cognitive-behavioral-therapy group, and 30% in the placebo group would be considered to have had a response to treatment at week 12. We determined that we needed to enroll 136 subjects in each active-treatment group and 70 subjects in the placebo group for the study to have a power of 80% to detect a minimum difference of 17% between any two study groups in the rate of response, assuming an alpha of 0.05 and a two-tailed test with no adjustment for multiple comparisons.

Analyses were performed with the use of SAS software, version 9.1.3 (SAS Institute). For categorical outcomes (including data regarding adverse events), treatments were compared with the use of Pearson’s chi-square test, Fisher’s exact test, or logistic regression, as appropriate. Logistic-regression models included the study center as a covariate. For dimensional outcomes, linear mixed-effects models (implemented with the use of PROC MIXED) were used to determine predicted mean values at each assessment point (weeks 4, 8, and 12)
and to test the study hypotheses with respect to between-group differences at week 12.

In each linear mixed-effects model, time and study group were included as fixed effects, with linear and quadratic time and time-by-treatment group interaction terms. Each model also began with a limited number of covariates (e.g., age, sex, and race), followed by backward stepping to identify thebest-fitting and most parsimonious model. In all models, random effects included intercept and linear slope terms, and an unstructured covariance was used to account for within-subject correlation over time. All comparisons were planned and tests were two-sided. A P value of less than 0.05 was considered to indicate statistical significance. The sequential Dunnett test was used to control the overall (familywise) error rate._24_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R24)

We analyzed data from all subjects according to study group. Sensitivity analyses were performed with the last observation carried forward (LOCF) and multiple imputation assuming missingness at random. Results were similar for the two missing-data methods. We report the results of the LOCF analysis because the
response rates were lower and hence provide a more conservative estimate of outcomes.

Results
Subjects
A total of 3066 potentially eligible subjects were screened by telephone
(_Figure 1_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#F1) ). Of these subjects, 761 signed consent forms and completed the inclusion and exclusion evaluation, 524 were deemed to be eligible and completed the baseline assessment, and 488 underwent randomization. Eleven subjects (2.3%) stopped
treatment but were included in the assessment (treatment withdrawals); 46 subjects (9.4%) stopped both treatment and assessment (study withdrawals).

On the basis of logistic-regression analyses, pairwise comparisons indicated that subjects in the cognitive-behavioral-therapy group were significantly less likely to withdraw from treatment than were those in the sertraline group (odds ratio, 0.33; 95% confidence interval [CI], 0.13 to 0.87; P=0.03) or the placebo
group (odds ratio, 0.24; 95% CI; 0.09 to 0.67; P=0.006). Of the 488 subjects who underwent randomization, 459 (94.1%) completed at least one postbaseline assessment, 396 (81.1%) completed all four assessments, and 440 (90.2%) completed the assessment at week 12. Subjects were recruited primarily through advertisements (52.2%) or clinical referrals (44.1%).
(http://content.nejm.org/cgi/content/full/NEJMoa0804633v2/F1)
View larger version (30K):
_[in this window]_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633v2/F1)
_[in a new window]_
(http://content.nejm.org/cgi/content-nw/full/NEJMoa0804633v2/F1)
(http://content.nejm.org/cgi/powerpoint/NEJMoa0804633v2/F1)

Figure 1. Enrollment and Outcomes.

Subjects who are shown as having withdrawn from treatment discontinued their assigned therapy but continued to undergo study assessment. Subjects who are shown as having withdrawn from the study discontinued both therapy and assessment. CBT denotes cognitive behavioral therapy.

Of 14 possible sessions of cognitive behavioral therapy, the mean (±SD) number of sessions completed was 12.7±2.8 in the combination-therapy group and 13.2±2.0 in the cognitive-behavioral-therapy group. The mean dose of sertraline at the final visit was 133.7±59.8 mg per day (range, 25 to 200) in the combination-therapy group, 146.0±60.8 mg per day (range, 25 to 200) in the sertraline group, and 175.8±43.7 mg per day (range, 50 to 200) in the placebo group.

Demographic and Clinical Characteristics
There were no significant differences among study groups with respect to baseline demographic and clinical characteristics (_Table 1_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#T1) ). The mean age of participants was 10.7±2.8 years, with 74.2% under the age of 13 years.

There were nearly equal numbers of male and female subjects. Most subjects were white (78.9%), with
other racial and ethnic groups represented. Subjects came from predominantly middle-class and upper-middle-class families (74.6%) and lived with both biologic parents (70.3%). Most subjects had received the diagnosis of two or more primary anxiety disorders (78.7%) and one or more secondary disorders
(55.3%). At baseline, subjects had moderate-to-severe anxiety and impairment (_Table
2_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#T2) ).

Given the geographic diversity among study centers, there were significant differences among sites on several baseline demographic variables (e.g., race and socioeconomic status). Overall, these variables were equally distributed among study groups within each center; however, three centers had one instance each of
unequal distribution for sex, race, or socioeconomic status.

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Table 1. Baseline Characteristics of the Subjects and Recruitment According
to Study Center.

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Table 2. Key Outcomes at 12 Weeks.

Clinical Response
In the intention-to-treat analysis, the percentages of children who were rated as 1 (very much improved) or 2 (much improved) on the Clinical Global Impression–Improvement scale at 12 weeks were 80.7% (95% CI, 73.3 to 86.4) in the combination-therapy group, 59.7% (95% CI, 51.4 to 67.5) in the cognitive-behavioral-therapy group, 54.9% (95% CI, 46.4 to 63.1) in the sertraline group, and
23.7% (95% CI, 15.5 to 34.5) in the placebo group (_Table 2_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#T2) ).

With the study center as a covariate, planned pairwise comparisons from a logistic-regression model showed
that each active treatment was superior to placebo as follows: combination therapy versus placebo, P<0.001 (odds ratio, 13.6; 95% CI, 6.9 to 26.8); cognitive behavioral therapy versus placebo, P<0.001 (odds ratio, 4.8; 95% CI, 2.6 to 9.0); and sertraline versus placebo, P<0.001 (odds ratio, 3.9; 95% CI, 2.1 to 7.4). Similar pairwise comparisons revealed that combination therapy was superior to either sertraline alone (odds ratio, 3.4; 95% CI, 2.0 to 5.9; P<0.001) or cognitive behavioral therapy alone (odds ratio, 2.8; 95% CI, 1.6 to 4.8; P=0.001). However, there was no significant difference between sertraline and cognitive behavioral therapy (P=0.41).

There was no main effect for center (P=0.69); however, a comparison among centers according to study group revealed a significant difference in response to combination therapy but no differences with respect to the response to sertraline alone (P=0.15) or cognitive behavioral therapy alone (P=0.25).

Further evaluation of response rates revealed that the average response rate for combination therapy at one center was significantly lower than at the other centers (P=0.002). A sensitivity analysis of site response rates showed that when data from the one site were removed, the average response rate of the other sites was consistent with that of the full sample.

The mixed-effects model for the Pediatric Anxiety Rating Scale revealed a significant quadratic effect for time (P<0.001) and a significant quadratic time-by-treatment interaction for cognitive behavioral therapy versus placebo (P=0.01) but not for either combination therapy or sertraline versus placebo. In other words, as compared with placebo, cognitive behavioral therapy had a linear mean trajectory (_Figure 2_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#F2) ). Planned pairwise comparisons of the expected mean scores on the Pediatric Anxiety Rating Scale at week 12 revealed a similar ordering of
outcomes, with all active treatments superior to placebo, according to the following comparisons: combination therapy versus placebo, t=–5.94 (P<0.001); cognitive behavioral therapy versus placebo, t=–2.11 (P=0.04); and sertraline versus placebo, t=–3.15 (P=0.002). In addition, combination therapy was
superior to both sertraline alone (t=–3.26, P=0.001) and cognitive behavioral therapy alone (t=–4.73, P<0.001). No significant difference was found between sertraline and cognitive behavioral therapy (t=1.32, P=0.19). The same magnitude and pattern of outcome was found for the Clinical Global Impressio Severity
scale and the Children’s Global Assessment Scale.
(http://content.nejm.org/cgi/content/full/NEJMoa0804633v2/F2)
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Figure 2. Scores on the Pediatric Anxiety Rating Scale during the 12-Week
Study.

Scores on the Pediatric Anxiety Rating Scale range from 0 to 30, with scores higher than 13 consistent with moderate levels of anxiety and a diagnosis of an anxiety disorder. The expected mean score is the mean of the sampling distribution of the mean.

Estimates of the effect size (Hedges’ g) and the number needed to treatbetween the active-treatment groups and the placebo group were calculated. Effect sizes are based on the expected mean scores on the Pediatric Anxiety
Rating Scale, derived from the mixed-effects model. The number needed to treat is based on the dichotomized, end-of-treatment scores on the Clinical Global Impression–Improvement scale with the use of LOCF. The effect size was 0.86 (95% CI, 0.56 to 1.15) for combination therapy, 0.45 (95% CI, 0.17 to 0.74) for
sertraline, and 0.31 (95% CI, 0.02 to 0.59) for cognitive behavioral treatment.

The number needed to treat was 1.7 (95% CI, 1.7 to 1.9) for combination therapy, 3.2 (95% CI, 3.2 to 3.5) for sertraline, and 2.8 (95% CI, 2.7 to 3.0) for cognitive behavioral therapy. Treatment and Study Withdrawals
Most treatment and study withdrawals were attributed to reasons other than adverse events (43 of 57, 75.4%) (_Table 3_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#T3) ).

Of the 14 withdrawals that were attributed to an adverse event, 11 (78.6%) were in the groups receiving either sertraline alone or placebo and consisted of 3 physical events (headache, stomach pains, and tremor) and 8 psychiatric adverse events (worsening of symptoms, 3 subjects; agitation or disinhibition, 3; hyperactivity, 1; and nonsuicidal self-harm and homicidal ideation, 1).
View this table:
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Table 3. Subjects Who Withdrew from Treatment or the Study.

Serious Adverse Events
Three subjects had serious adverse events during the study period. One child in the sertraline group had a worsening of behavior that was attributed to the parents’ increased limit setting on avoidance behavior; the event was considered to be possibly related to sertraline. A child in the combination-therapy
group had a worsening of preexisting oppositional defiant behavior that resulted in psychiatric hospitalization; this event was considered to be unrelated to a study treatment. The third subject was hospitalized for a tonsillectomy, which was also considered to be unrelated to a study treatment
(_Table
4_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#T4) ).
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Table 4. Moderate-to-Severe Adverse Events at 12 Weeks.

Adverse Events
Subjects in the combination-therapy group had a greater number of study visits and therefore significantly more opportunities for elicitation of adverse events than did those in the other study groups, with a mean of 12.8±4.0 opportunities (range, 1 to 22) in the combination-therapy group, as compared with 9.9±3.6 (range, 1 to 14) in the sertraline group, 10.6±2.0 (range, 1 to 14) in the cognitive-behavioral-therapy group, and 9.7±4.2 (range, 1 to 14) in the placebo group (P<0.001 for all comparisons). Rates of adverse events,
including suicidal and homicidal ideation, were not significantly greater in the sertraline group than in the placebo group. No child in the study attempted suicide. Among children in the cognitive-behavioral-therapy group, there were fewer reports of insomnia, fatigue, sedation, and restlessness or fidgeting than in the sertraline group (P<0.05 for all comparisons). For a list of mild adverse events that were not associated with functional impairment, as well as moderate and severe events, see the _Supplementary Appendix_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633/DC1) ,

available with the full text of this article at www.nejm.org.

Discussion
Our study examined therapies that many clinicians consider to be the most promising treatments for childhood anxiety disorders. Our findings indicate that as compared with placebo, the three active therapies combination therapy with both cognitive behavioral therapy and sertraline, cognitive behavioral therapy alone, and sertraline alone — are effective short-term treatments for children with separation and generalized anxiety disorders and social phobia, with combination treatment having superior response rates. No physical,psychiatric, or harm-related adverse events were reported more frequently in the sertraline group than in the placebo group, a finding similar to that for SSRIs, as identified in previous studies of anxious children._12_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R12) ,_13_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R13) ,_25_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R25)

Few withdrawals from either treatment or the study were attributed to adverse events. Suicidal ideation and homicidal ideation were uncommon. No child attempted suicide during the study period. Since they were recruited at multiple centers and locations, the study subjects were racially and ethnically diverse. However, despite intense outreach, the sample did not include the most socioeconomically disadvantaged children.
Subjects were predominantly younger children and included those with ADHD and other anxiety disorders, factors that allow for generalization of the results to these populations.

Conversely, the exclusion of children and teens with major depression and pervasive developmental disorders may have limited the generalizability of the results to these populations.The observed advantage of combination therapy over either cognitive behavioral therapy or sertraline alone during short-term treatment (an improvement of 21 to 25%) suggests that among these effective therapies, combination therapy
provides the best chance for a positive outcome. The superiority of combination therapy might be due to additive or synergistic effects of the two therapies. However, additional contact time in the combination-therapy group, which was unblinded, and expectancy effects on the part of both subjects and
clinicians cannot be ruled out as alternative explanations.

Nonetheless, the magnitude of the treatment effect in the combination-therapy group (with two
subjects as the number needed to treat to prevent one additional event) suggests that children with anxiety disorders who receive quality combination therapy can consistently expect a substantial reduction in the severity of anxiety. An increased number of visits in the combination-therapy group resulted in increased opportunities for elicitation of adverse events. Consequently, the potential for expectancies among subjects, parents, and clinicians regarding the side effects of medications in the context of more visits may have increased the rate of some adverse events in the combination-therapy group and may limit conclusions that can be drawn regarding the rates of adverse events in combination therapy.

The positive benefit of cognitive behavioral therapy, as compared with placebo, adds new information to the existing literature._26_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R26)
The number needed to treat for cognitive behavioral therapy in this study (three subjects) is the same as that
identified in a meta-analysis of studies comparing subjects who were assigned to cognitive behavioral therapy with those assigned to a waiting list for therapy or to sessions without active therapy._14_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R14)

Our study’s test of cognitive behavioral therapy included children with moderate-to-severe anxiety and addresses criticism of previous trials that included children with only mild-to-moderate
anxiety._14_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R14)
Before our study, cognitive behavioral therapy for childhood anxiety was considered to be
“probably efficacious.”_26_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R26)

This evaluation of cognitive behavioral therapy and other recent studies_27_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R27)
,_28_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R28) suggests that
such therapy for childhood anxiety is a well-established, evidenced-based treatment._29_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R29)

Given that the risk of some adverse events was lower in the behavioral-therapy group than in the sertraline group, some parents and their children may consider choosing cognitive behavioral therapy as their initial treatment.

The results of our study confirm the short-term efficacy of sertraline for children with generalized anxiety disorder_25_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R25) and show that
sertraline is effective for children with separation anxiety disorder and social phobia. The number needed
to treat for sertraline in our study (three subjects) was the same as that previously identified in a meta-analysis_15_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R15) of six
randomized, placebo-controlled trials of SSRIs for childhood anxiety disorders._12_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R12) ,_13_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R13) ,_25_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R25)
,_30_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R30) ,_31_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R31)

These studies and others_27_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R27)
suggest that SSRIs, as a class, are the medication of choice for these conditions. The titration schedule that we used, which emphasized upward dose adjustment in the absence of response and adverse events, suggests that the average end-point dose of sertraline in this study is the highest dose consistent with good outcome and tolerability. No adverse events were observed more frequently in the sertraline group than in the placebo group. In contrast to the apparent risk of suicidal ideation and behavior in studies of depression in children and
adolescents,_15_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R15) our study did not demonstrate any increased risk for suicidal behavior in the sertraline group. Given the benefit of sertraline alone or in combination with cognitive behavioral therapy and the limited risk of adverse events associated with the drug in our study, the well-monitored use of sertraline and other SSRIs in the treatment of childhood anxiety disorders is indicated.

Cognitive behavioral therapy and sertraline either in combination or as monotherapies appear to be effective treatments for these commonly occurring childhood anxiety disorders. Results confirm those of previous studies of SSRIs and cognitive behavioral therapy and, most important, show that combination
therapy offers children the best chance for a positive outcome. Our findings indicate that all three of the treatment options may be recommended, taking into consideration the family’s treatment preferences, treatment availability, cost, and time burden. To inform more prescriptive selection of patients for
treatment, further analysis of predictors and moderators of treatment response may identify who is most likely to respond to which_32_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R32) of these
effective alternatives.
Supported by grants (U01 MH064089, to Dr. Walkup; U01 MH64092, to Dr.
Albano; U01 MH64003, to Dr. Birmaher; U01 MH63747, to Dr. Kendall; U01 MH64107,
to Dr. March; U01 MH64088, to Dr. Piacentini; and U01 MH064003, to Dr. Compton)
from the National Institute of Mental Health (NIMH).

Sertraline and matching placebo were supplied free of charge by Pfizer. Dr. Walkup reports receiving consulting fees from Eli Lilly and Jazz Pharmaceuticals and fees for legal consultation to defense counsel and
submission of written reports in litigation involving GlaxoSmithKline, receiving lecture fees from CMP Media, Medical Education Reviews, McMahon Group, and DiMedix, and receiving support in the form of free medication and matching placebo from Eli Lilly and free medication from Abbott for clinical trials funded by the NIMH; Dr. Albano, receiving royalties from Oxford University Press for the Anxiety Disorders Interview Schedule for DSM-IV, Child and Parent Versions, but not for interviews used in this study, and royalties from the Guilford Press; Dr. Piacentini, receiving royalties from Oxford University Press for treatmentmanuals on childhood obsessive compulsive disorder and tic disorders and from the Guilford Press and APA Books for other books on child mental health and receiving lecture fees from Janssen-Cilag; Dr. Birmaher, receiving consulting fees from Jazz Pharmaceuticals, Solvay Pharmaceuticals, and Abcomm, lecture fees from Solvay, and royalties from Random House for a book on children with bipolar disorder; Dr. Rynn, receiving grant support from Neuropharm, BoehringerIngelheim Pharmaceuticals, and Wyeth Pharmaceuticals, consulting fees from Wyeth, and royalties from APPI for a book chapter on pediatric anxiety disorders; Dr. McCracken, receiving consulting fees from Sanofi-Aventis and Wyeth, lecture fees from Shire and UCB, and grant support from Aspect, Johnson & Johnson, Bristol-Myers Squibb, and Eli Lilly; Dr. Waslick, receiving grant support from Baystate Health, Somerset Pharmaceuticals, and GlaxoSmithKline; Dr. Iyengar, receiving consulting fees from Westinghouse for statistical consultation; Dr. March, receiving study medications from Eli Lilly for an NIMH-funded clinical trial and receiving royalties from Pearson for being the author of the Multidimensional Anxiety Scale for Children, receiving consulting fees from Eli Lilly, Pfizer, Wyeth, and GlaxoSmithKline, having an equity interest in MedAvante, and serving on an advisory board for AstraZeneca and Johnson & Johnson; and Dr. Kendall, receiving royalties from Workbook Publishing for anxiety-treatment materials.

No other potential conflict of interest relevant to this article was reported.

The views expressed in this article are those of the authors and do not necessarily represent the official views of the NIMH, the National Institutes of Health, or the Department of Health and Human Services.
We thank the children and their families who made this study possible; and J. Chisar, J. Fried, R. Klein, E. Menvielle, S. Olin, J. Severe, D. Almirall, and members of NIMH’s data and safety monitoring board.
* The study investigators are listed in the Appendix.
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#RFN1)

Source Information
From the Johns Hopkins Medical Institutions, Baltimore (J.T.W., G.S.G.); New York State Psychiatric Institute–Columbia University Medical Center, New York (A.M.A., M.A.R.); the University of California at Los Angeles, Los Angeles (J.P., J.M.); Western Psychiatric Institute and Clinic University of Pittsburgh Medical Center, Pittsburgh (B.B., S.I.); Duke University Medical Center, Durham, NC (S.N.C., J.S.M.); the Division of Services and Intervention Research, National Institute of Mental Health, Bethesda, MD (J.T.S.); Baystate
Medical Center, Springfield, MA (B.W.); and Temple University, Philadelphia
(P.C.K.).

This article (10.1056/NEJMoa0804633) was published at www.nejm.org on
October 30, 2008. It will appear in the December 25 issue of the Journal.
Address reprint requests to Dr. Walkup at the Division of Child and
Adolescent Psychiatry, Department of Psychiatry and Behavioral Sciences, Johns
Hopkins Medical Institutions, 600 N. Wolfe St., Baltimore, MD 21287.
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Appendix
The following investigators participated in this study: Steering Committee:
J. Walkup (chair), A. Albano (cochair); Statistics–Experimental Design: S.
Compton, S. Iyengar, J. March; Cognitive Behavioral Therapy: P. Kendall, G.
Ginsburg; Pharmacotherapy: M. Rynn, J. McCracken; Assessment: J. Piacentini,
A. Albano; Study Coordinators: C. Keeton, H. Koo, S. Aschenbrand, L. Bardsley,
R. Beidas, J. Catena, K. Dever, K. Drake, R. Dublin, E. Fontaine, J. Furr, A.
Gonzalez, K. Hedtke, L. Hunt, M. Keller, J. Kingery, A. Krain, K. Miller, J.
Podell, P. Rentas, M. Rozenmann, C. Suveg, C. Weiner, M. Wilson, T. Zoulas;
Data Center: M. Fletcher, K. Sullivan; Cognitive Behavior Therapists: E.
Gosch, C. Alfano, A. Angelosante, S. Aschenbrand, A. Barmish, L. Bergman, S.
Best, J. Comer, S. Compton, W. Copeland, M. Cwik, M. Desari, K. Drake, E.
Fontaine, J. Furr, P. Gammon, C. Gaze, R. Grover, H. Harmon, A. Hughes, K.
Hutchinson, J. Jones, C. Keeton, H. Kepley, J. Kingery, A. Krain, A. Langley,
J. Lee, J. Levitt, J. Manetti-Cusa, E. Martin, C. Mauro, K. McKnight, T. Peris, K.
Poling, L. Preuss, A. Puliafico, J. Robin, T. Roblek, J. Samson, M.
Schlossberg, M. Sweeney, C. Suveg, O. Velting, T. Verduin; Pharmacotherapists:
M. Rynn, J. McCracken, A. Adegbola, P. Ambrosini, D. Axelson, S. Barnett, A. Baskina,
B. Birmaher, C. Cagande, A. Chrisman, B. Chung, H. Courvoisie, B. Dave, A.
Desai, K. Dever, M. Gazzola, E. Harris, G. Hirsh, V. Howells, L. Hsu, I.
Hypolite, F. Kampmeier, S. Khalid-Khan, B. Kim, D. Kondo, L. Kotler, M.
Krushelnycky, J. Larson, J. Lee, P. Lee, C. Lopez, L. Maayan, J. McCracken, R.
Means,L. Miller, A. Parr, C. Pataki, C. Peterson, P. Pilania, R. Pizarro, H. Ravi,
S. Reinblatt, M. Riddle, M. Rodowski, D. Sakolsky, A. Scharko, R. Suddath, C.
Suarez, J. Walkup, B. Waslick; Independent Evaluators: A. Albano, G.
Ginsburg, B. Asche, A. Barmish, M. Beaudry, S. Chang, M. Choudhury, B. Chu, S.
Crawley, J. Curry, G. Danner, N. Deily, R. Dingfelder, D. Fitzgerald, P.
Gammon, S. Hofflich, E. Kastelic, J. Keener, T. Lipani, K. Lukin, M. Masarik, T.
Peris, T. Piacentini, S. Pimentel, A. Puliafico, T. Roblek, M. Schlossberg, E.
Sood, S. Tiwari, J. Trachtenberg, P. van de Velde; Pharmacy: K. Truelove, H.
Kim; Research Assistants: S. Allard, S. Avny, D. Beckmann, C. Brice, B.
Buzzella, E. Capelli, A. Chiu, M. Coles, J. Freeman, M. Gringle, S. Hefton, D.
Hood, M. Jacoby, J. King, A. Kolos, B. Lourea-Wadell, L. Lu, J. Lusky, R. Maid, C.
Merolli, Y. Ojo, A. Pearlman, J. Regan, S. Rock, M. Rooney, N. Simone, S.
Tiwari, S. Yeager.

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Zoloft, Wellbutrin, and Klonopin for Brother’s Bad Marriage

“His life has been tragic since he was prescribed these medications.”

I am so excited and saddened to find this web site!?

My brother was in a bad marriage and went to his doctor for depression (I think he was in the beginning of a nervous breakdown). His doctor prescribed Zoloft, Wellbutrin, and Klonopin.

After about 3 weeks my brother started drinking and had never had a drinking problem before. He then saved the Klonopin and tried to kill himself by overdosing and taking 50 within two days of each other but I found him and his wife took him to the hospital.

He has gone through somewhat psychotic periods mainly when he is drinking. It has been 4 months of absolute torment for him and all of us as his family members. Now he has separated from his wife and is still drinking about a half-gallon of Vodka a day. What can we do? Is there any legal repercussion that can be taken by these victims. His life has been tragic since he was prescribed these medications. He has lost his job, destroyed his vehicle and distanced his children due to his alcohol problem.

Thank you for telling others and for this web site. I thought this was a possibility after reading about serotonin and the way it works. I also think that the genetic predisposition of lack of serotonin is not being taken into consideration by MDs. My dad was an alcoholic and I truly believe he had a problem with hypoglycemia also, he died at the age of 42. In my research and praying for answers to various problems in my family I think genetics has a lot to do with the depression and the drugs made it worse for my brother. If the doctors would research backgrounds of family history by asking the simple questions about alcohol addiction my brother might not be going through this right now.

Thank you once again and if there is anything that you think would help please e-mail me.

Thank YOU

Carol Harper
rharper@otelco.net

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4/29/2001 – NY-CITY AGENCY'S PSYCH DRUGS IMPERIL FOSTER KIDS

About three years ago the Seattle Times or the Seattle PI did a series of
articles on the drugging of foster children and the number of deaths as a
result of that deadly practice. Now the New York Post has given us another
article detailing the same problem in the East. Several years ago I learned
that we too have the problem here in the Rocky Mountain area.

My children are adopted and they have always wanted a younger brother or
sister. We looked for several years for a child we could make a part of our
family. We were not able to find one available that was not being drugged for
a variety of reasons. I asked an agency if they had any children available
who were not on drugs, explaining that drug withdrawal is not where I would
want to begin a relationship with a child.

The woman at the agency lowered her voice and said, “Isn’t it horrible?! We
have a doctor in charge here who is drugging all of these children and there
is nothing we can do about it!”

In my opinion, to do this to the most helpless among us – a child alone with
no family to protect them from the drugging – is the most damning statement
against our society there is.

In the news this past weekend we all heard about tragic death of an adopted
child, little Candace Newmaker, who died during a controversial “rebirthing”
therapy in Colorado. She was being given this “treatment” for the diagnosis
of “attachment disorder.” As you read about her death you learn that the
expert witness in this case could not say if it was the therapy that caused
her death or the drugs – Rispirdol being taken at her death AFTER a long
period of treatment with antidepressants. Because the increase in serotonin
shuts off the bronchial tubes it can produce death by asphyxiation – the
cause of death in Candace’s case. We also know that when the serotonin is
increased to too high a level by these drugs it leads to Serotonin Syndrome
which includes multiple organ failure.

Now I invite you into Candace’s drug-induced world – the same world which you
will see was obviously what produced the symptoms that led her and her
desperate adoptive mother into this controversial therapy. As you read the
list of symptoms of increased serotonin and decreased serotonin metabolism in
the document on our site called The Aftermath
(http://drugawareness.org/Archives/Miscellaneous/MRAfter.html) you will see
everyone of the side effects Candace was having that left her mother reeling
from the experience.

Excerpts from the Denver Rocky Mountain News:

* When the local social services workers contacted her with information
about Candace, she was told the girl had a “strong temperment,” that she was
prone to uncontrollable outbursts. Candace had been through six foster homes
by the time she was five, and her birth family had neglected her, Newmaker
was told.

* One night in the spring of 1999, Newmaker woke at 2:30 a.m. and smelled
smoke, she said. She ran down the hall to Candace’s room, but it was empty.
She opened the next door to the guest room and found her daughter.

* “She was sitting on the bed in the guest room with spent matches all
around her,” Newmaker said, crying. “I’m so frightened for her. She could
have hurt herself, killed herself.”

* Speaking publicly for the first time about Candace’s death during that
therapy, Jeane Newmaker said her daughter’s psychological problems were so
advanced that she started a fire in their home, once sexually assaulted two
children, and would fly into hourlong rages.

* “I thought she was deteriorating before my very eyes,” Newmaker said. “I
was not prepared for the level of dysfunction I saw in Candace.”

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org

http://www.nypost.com/commentary/28629.htm

CITY AGENCY’S PSYCH DRUGS IMPERIL FOSTER KIDS

By DOUGLAS MONTERO
——————————————————————————

MOTHER’S NIGHTMARE:
Erline Kidd, with sons Devon (left) and Von, is fighting to stop the city
from medicating her little girl, who’s in foster care. “My daughter is like a
zombie,” she says.
– Yechiam Gal

April 16, 2001 — ERLINE KIDD doesn’t want her 8-year-old daughter to end up
like a boy named Cecil Reed – a corpse at the city morgue.
Kidd fears for the life of her daughter Shaevonnah – “Shae” – because she’s
in the custody of the city’s Administration for Children’s Services – just
like Cecil was.

And just like Cecil, ACS is allowing doctors to give Shae a cocktail of
psychiatric medications that Kidd feels is harming her baby.

Kidd’s objections are being ignored, just like those of Cecil’s father, who
stopped complaining April 7, 2000, when his 16-year-old son suffered a heart
attack triggered by a combination of four drugs, and died.

“I was begging them to stop,” said Cecil Reed Jr., a city worker who lives in
The Bronx.

“Jesus,” said Dr. Peter Breggin, an author and critic of psychiatric
treatment of children. “They were treating him like you would treat a raving
psychotic.”

ACS says it doesn’t know how many of its 31,000 children are on psychiatric
medication, but advocacy groups say complaints from parents arrive at their
offices on a “regular basis.”

A state audit of 401 randomly selected kids last year found that more than
half were being treated for mental problems – and that most likely means
medication.

Some advocates charge the foster-care agencies contracted to care for nearly
90 percent of ACS’s children use medication to “control” the emotionally
troubled kids.

Parents like those of Tariq Mohammad, 16, face medical-neglect charges in
Family Court if they object too vigorously.

Tariq was on medication for schizophrenia, an illness he says he never had,
and its side effects made him violently ill. The family sued ACS in civil
court and won after a court-appointed psychiatrist determined Tariq didn’t
need any medication.

“I am outraged, not just for me, but for many kids that are being medicated,”
Tariq said. “It really screwed me up. I guess they do it because they don’t
want to deal with us.”

Tariq, who lived in the foster system since he was 11, says his pleas for an
alternative treatment were summarily ignored.

The ACS says parents are entitled to get a second medical opinion or hire a
lawyer to fight the case in court.

The mad rush to medicate, a nationwide phenomenon, is especially delicate
with foster kids. The ACS relies on the judgment of doctors subcontracted by
its 60 foster agencies to evaluate and treat children, agency spokeswoman
Jennifer Faulk said.

The ACS is supposed to monitor the treatment, but overworked caseworkers
can’t – or don’t – micromanage each kid, so they defer to doctors.

Hank Orenstein, the director of the advocacy agency C-Plan, said the ACS
exhibits a “naivete” in mental-health services.

“It’s a relief to have other professions make the decision but as you can see
some children are not always best served with medication,” said Orenstein,
whose group is part of Public Advocate Mark Green’s office.

Parents end up becoming helpless watchdogs handcuffed by bureaucracy and
poverty.

“I hated it,” said Cecil Reed’s father, a Baptist church deacon, describing
the slow medication death of his son at the Bronx Children’s Psychiatric
Center.

Reed began noticing a problem with Cecil’s treatment three years before his
son died. Reed, who was threatened with medical-neglect charges, said Cecil
was “sleepwalking” after the hospital began serving the boy cocktails.

Doctors said Cecil had schizoaffective disorder and post-traumatic stress
disorder but his father claims his son wasn’t insane, just a strong-willed
kid who like any youngster would lash out after being separated from family
and friends.

“Daddy, I don’t want to take medicine anymore . . . They are just using me as
a guinea pig,” Reed remembers his son saying.

When the usually cooperative Reed questioned the medication in late 1999, the
hospital simply got consent from the ACS behind the father’s back, he
charged. Faulk didn’t respond to the allegation.

He learned about the deadly cocktail the day after his son died.

The autopsy report notes Cecil’s body contained “potentially toxic” levels of
pindolol, a heart-damaging drug never tested or recommended for children.

Breggin said serving these cocktails to children is “so dangerous and
experimental that it wouldn’t be permitted under any legitimate rule of
research.”

The ACS, the state’s Office of Children and Family Services and the state
Office of Mental Health, which runs the Bronx facility where Cecil died,
refused to comment because the family plans to sue.

Erline Kidd’s face sunk when she was told about Cecil. Kidd charged she
always learns about the drug cocktails her daughter gets after the fact. All
contact with her daughter’s doctor is arranged by the ACS.

Kidd, a reformed cocaine addict, is fighting two wars: to get her daughter
back from the ACS, like she did with her two sons, ages 12 and 9, in January,
and to stop the drugging of the girl.

Little Shae is on Seroquel and Thorazine for psychosis, and four other drugs.

“I just know it’s too much – my daughter is like a zombie,” the mother said.
“One time I saw her and I wanted to grab her and run.”

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4/09/2001 – Ghostwriting Articles for Medical Journals

Dennis Silver, who serves as webmaster for the Prozac: Panacea or Pandora?
website (members.aol.com/atracyphd), has just brought to our attention an
amazing article from CBS Health Watch. In the ten years I have been fighting
this battle to get the truth out to the public about what goes on behind the
scenes in medcine this strikes at the heart of the issue like no other!

As I did the research for my book I was appalled at the difference in the
studies on serotonin BEFORE the development of the SSRIs and the studies
being published on serotonin AFTER and during the development of the SSRI
antidepressants. It was clear to me that the drug companies were manipulating
the science to build a market for their drugs. It was as if the new studies
were contradicting the old studies. Truth is consistent not variable. It was
clear something had changed. I say BRAVO!!! to CBS and to Dr. Marcia Angell,
former editor of the New England Journal of Medicine, who has worked hard to
expose this situation over the last year or so! Thank you for demonstrating
that integrity still exists in our country by exposing those with no
knowledge of what integrity is.

Note how the spokesperson for Wythe Ayers justifies their criminal behavior
with the same old line: “well everyone else does it too.”

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org

http://cbshealthwatch.medscape.com/medscape/p/G_Library/article.asp?RecId=2381

64&FA=1&SP=undefined

Ghostwriting Articles for Medical Journals

April 5 (CBS) Amidst the billion-dollar competition to create the newest
blockbuster drug, there’s one thing worth more than all the ads money can
buy: a single positive mention in a respected medical journal. Doctors rely
so heavily on what’s printed in journals that a drug’s success or failure may
be directly affected.

Now, many drug companies are actually writing those articles and then paying
doctors to sign their names to them. It’s called ghostwriting, reports CBS
News Correspondent Sharyl Attkisson.

“The articles are written by drug company researchers, given to an outside
doctor to review and sign his or her name to, and then submitted to a
journal. In effect, it’s like washing dirty money,” explains Douglas Peters,
a medical malpractice attorney.

It’s not illegal, but it can be misleading.

Critics say that’s just what happened when Wyeth-Ayerst wanted to create a
market demand for its “fen-phen” diet drug, Redux.

Wyeth hired a middleman, a company called Excerpta Medica, to write and get
published nine medical journal articles on Redux. Excerpta paid doctors to
review and sign the articles, then submitted them to journals with no mention
of Wyeth. Excerpta claims it told the doctors that Wyeth was behind all of
it.

But Dr. Richard Atkinson, a professor of medicine and nutritional sciences
and the director of the Beers-Murphy Clinical Nutrition Center at the
University of Wisconsin Madison Medical School, says he wasn’t told. He
reviewed and signed one of those Redux papers thinking Excerpta was an
independent researcher, he says.

“If I knew that a drug company had some role, whatever role, in sponsoring a
talk, an article, a symposium, whatever, I think I would be more on my guard
to make sure that there was not any bias introduced,” says Atkinson.

Biased literature can make a drug sound better or safer than it really is.
And unbeknownst to most doctors, it’s even finding its way into the most
respected medical journals.

Dr. Marcia Angell, former editor of the New England Journal of Medicine, says
that as time passed she was getting more and more ghostwritten papers.

“A drug company that controls the data and has a ghostwriter writing the
paper may neglect to write about the side effects of a drug,” says Angell.

In a deposition on January 15, 1999, former Wyeth executive Jo Alene Dolan
said all drug companies ghostwrite, but it doesn’t mean the articles aren’t
accurate.

When questioned about Atkinson’s article, she said, “Apparently we wrote this
article for him.” She was then asked if it was bought and paid for by
Wyeth-Ayerst and replied, “I’m not sure that’s the way I would characterize
it. It was funded by Wyeth-Ayerst.”

Yet Wyeth’s middleman, Excerpta Medica, claims it doesn’t ghostwrite. It says
it “facilitates,” that doctors always know about drug industry involvement,
and that “the author has final editing authority.”

Atkinson did tell Excerpta that article may make Redux “sound better than it
really is” and suggested some changes. But before the article could be
published, Redux was linked to heart and lung problems and pulled from the
market.

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I Traded Depression for Paxil Psychosis

“I never had a single psychotic episode or symptom until I had taken Paxil and started to become aggressive and delusional.”

 

Hi. I am a 27 year old male with clinical depression, about four months ago my therapist had a Dr. that she works with prescribe me an anti-depression regimen of Paxil, Klonopin, and later Zyprexa.

I had no idea why an anti-psychotic was later included in my treatment until I began doing a little research on SSRI’s. I never had a single psychotic episode or symptom until I had taken Paxil and started to become aggressive and delusional.

I discontinued the Zyprexa (the Dr. did not like that) after reading the prescribing information and found it also had a serotonergic enhancing effect, since it was in my opinion the effects of excess serotonin which were causing my psychotic symptoms in the first place. The combination put me in a dream like state and was causing me wild mood swings ranging from extreme euphoria to severe depression with suicidal thoughts.

I also acquired a bizarre craving for aspartame and would secretly eat it right out of the Equal packets at work.

I also did terrible things to my coworkers like intentionally breaking or tampering with their tools without a hint of guilt because I decided they deserved it. I knew I would never be suspected of it since lying came so easily for me with the medication.

My doctor said there were no drug interactions with the “new generation” antidepressants and over the counter products are all O.K.. Well, I don’t believe that is exactly the case, after taking a cough syrup containing dextromethorphan (HBr) I developed symptoms which I now think were serotonin syndrome. I became very euphoric in a sort of drunken giddy way, felt like I had a fever and was sweating, my joints all hurt and my right hand was clenched and painful to open as well as my jaw, I was dizzy and felt anesthetized (like the feeling of taking a narcotic painkiller like Percocet) and confused, I was having mild hallucinations/visual disturbances ( I went right through two red lights on my way home from work while looking right at them), my pulse kept fluctuating for no reason between bradycardic and tachycardic, my hands and ankles had also swollen and I could not remember what I had done 5 min before. I had difficulty standing and spent the rest of the night sitting in a chair in the dark staring and at some point I suspected something was wrong. My muscles felt very tense so I took 4 of my clonazapam and a doxylamine tablet (I thought maybe I was having an allergic reaction and it was the only antihistamine I had in the house).

Well, I made it through the night and gradually over the next day my symptoms faded. I had seen my doctor the day before when these symptoms were just beginning and tried to explain it to him. He seemed to think I may have been imagining these symptoms and said he couldn’t do anything for me if I was not going to take the medication. He told me that all medications have side-effects, and gradually they diminish (but mine were getting worse).

This all happened a week ago and I have been tapering off them with my doctor’s reluctant approval. I still feel a little strange he (Dr.) said I will for at least several days while my body adjusts to being without the drugs.

I am not so sure which was worse depression or psychosis! I guess it’s a toss-up to which symptom you are more willing to put up with.

KPK

 

1/1/2001

This is Survivor Story number 8.
Total number of stories in current database is 34

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Paxil, Klonopin, Zyprexa and Cough Syrup-A Deadly Mix

“I am not so sure which was worse–depression or psychosis.”

 

Hi I am a 27 year old male with clinical depression. About four months ago my therapist had a doctor that she works with prescribe me an anti-depression regimen of Paxil, Klonopin, and later Zyprexa.

I had no idea why an anti-psychotic was later included in my treatment until I began doing a little research on SSRI’s. I never had a single psychotic episode or symptom until I had taken Paxil and started to become aggressive and delusional.

I discontinued the Zyprexa (the Dr. did not like that) after reading the prescribing information and found it also had a serotonergic enhancing effect, since it was in my opinion the effects of excess serotonin which were causing my psychotic symptoms in the first place. The combination put me in a dream like state and was causing me wild mood swings ranging from extreme euphoria to severe depression with suicidal thoughts.

I also acquired a bizarre craving for aspartame and would secretly eat it right out of the Equal packets at work I also did terrible things to my coworkers like intentionally breaking or tampering with their tools without a hint of guilt because I decided they deserved it and I would never be suspected of it since lying was so easy with the medication.

My doctor said there were no drug interactions with the “new generation” antidepressants and over the counter products are all O.K.. Well, I don’t believe that is exactly the case, after taking a cough syrup containing dextromethorphan (HBr), I developed symptoms which I now think were serotonin syndrome. I became very euphoric in a sort of drunken giddy way, felt like I had a fever and was sweating, my joints all hurt and my right hand was clenched and painful to open as well as my jaw, I was dizzy and felt anesthetized (like the feeling of taking a narcotic painkiller like Percocet) and confused.

I was having mild hallucinations/visual disturbances (I went right through two red lights on my way home from work while looking right at them), my pulse kept fluctuating for no reason between bradycardic and tachycardic, my hands and ankles had also swollen and I could not remember what I had done 5 min before. I had difficulty standing and spent the rest of the night sitting in a chair in the dark staring and at some point I suspected something was wrong my muscles felt very tense so I took 4 of my clonazapam and a doxylamine tablet (I thought maybe I was having an allergic reaction and it was the only antihistamine I had in the house) made it through the night and gradually over the next day my symptoms faded.

I had seen my doctor the day before when these symptoms were just beginning and tried to explain it to him, but he seemed to think I may have been imagining these symptoms and said he couldn’t do anything for me if I was not going to take the medication. He said all medications have side-effects, and gradually they diminish (but mine were getting worse) this was a week ago and I have been tapered off them with my doctors reluctant approval.

I still feel a little strange he (Dr.) said I will for at least several days while my body adjusts to being without the drugs. I am not so sure which was worse–depression or psychosis. I guess it’s a toss-up to which symptom you are more willing to put up with. Anyway I will continue with therapy maybe wait for the “next generation” of depression medication before I take that route again.

 

Years 2000 and Prior

This is Survivor Story number 51.
Total number of stories in current database is 96

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