ICFDA Warning on Drug Discontinuation

Taper off very, very, very slowly!!!!!!!!!!!!!!

Dropping “cold turkey” off any medication, most especially mind altering medications, can often be MORE DANGEROUS than staying on the drugs. With antidepressants the FDA has now warned that any abrupt change in dose, whether increasing or decreasing the dose, can produce suicide, hostility, or psychosis – generally a manic psychosis when you then get your diagnosis for Bipolar Disorder. Of course drug-induced Bipolar is temporary so you need to learn more about that if it has already happened to you. We have a DVD on explaining this and how to recover from it: “Bipolar? Are You Really Bipolar or Misdiagnosed Due to the Use of or Abrupt Discontinuation of an Antidepressant”: https://store.drugawareness.org/product/bipolar-disorder-streaming/

The most dangerous and yet the most common mistake someone coming off any antidepressant, atypical antipsychotic, or benzodiazaphine makes is coming off these drugs too rapidly. Tapering off VERY, VERY, VERY SLOWLY–OVER MONTHS OR YEARS (The general rule of thumb for those on antidepressants (ANY antidepressant, not just the current antidepressant – add up all time on any of them) for less than a year is to take half the amount of time on them to wean off and for long-term users for each 5 years on psychiatric drugs of any kind  the general rule of thumb is at least a year or more.), NOT JUST WEEKS OR MONTHS!—has proven the safest and most effective method of withdrawal from these types of medications. Thus the body is given the time it needs to readjust its own chemical levels. Patients must be warned to come very slowly off these drugs by shaving minuscule amounts off their pills each day, as opposed to cutting them.

WARNING: The practice of taking a pill every other day throws you into withdrawal every other day and can be very dangerous when you consider the FDA warnings on abrupt changes in dose.

This cannot be stressed strongly enough! This information on EXTREMELY gradual withdrawal is the most critical piece of information that someone facing withdrawal from these drugs needs to have.

A REMINDER: IT IS EASIER TO GET DOWN OFF A MOUNTAINTOP ONE GUARDED STEP AT A TIME THAN TO JUMP FROM THE TOP TO THE BOTTOM.

No matter how few or how many side effects you have had on these antidepressants, withdrawal is a whole new world. The worst part of rapid withdrawal can be delayed for several months AFTER you quit. So even if you think you are doing okay you quickly find that it becomes much worse. If you do not come off correctly and rebuild your body as you do, you risk:

  • Creating bouts of overwhelming depression
  • Producing a MUCH longer withdrawal and recovery period than if you had come off slowly
  • Overwhelming fatigue causing you to be unable to continue daily tasks or costing your job
  • Having a psychotic break brought on by the terrible insomnia from the rapid withdrawal, and then being locked in a psychiatric ward and being told you are either schizophrenic or most likely that you are Bipolar.
  • Ending up going back on the drugs (each period on the drugs tends to be more dangerous and problematic than the previous time you were on the drugs) and having more drugs added to calm the withdrawal effects
  • Seizures and other life threatening physical reactions
  • Violent outbursts or rages
  • REM Sleep Behavior Disorder which has always been known as a drug withdrawal state and is known to include both suicide and homicide – both committed in a sleep state.

Although my book, Prozac: Panacea or Pandora? Our Serotonin Nightmare!, contains massive amounts of information you can find nowhere else on these drugs, it does not have the extensive amount of information contained in the CD focusing mainly on withdrawal issues. The CD contains newer and updated information on safe withdrawal from these drugs. It details over an hour and a half the safest ways found over the past 30 years to withdraw from antidepressants and the drugs so often prescribed with them – the atypical antipsychotics and benzodiazapenes. And it explains why it is safest to withdraw tiny amounts from all of the medications at the same time rather than withdrawing only one at a time.

It also lists many safe alternative treatments that can assist you in getting though the withdrawal and lists other alternatives to avoid which are not safe after using antidepressants. And it contains information on how to rebuild your health after you have had it destroyed by these drugs so that you never end up feeling a need to be on these drugs again.

The CD is very inexpensive and will save you thousands in medical bills which far too many end up spending trying to do it on your own without this information. (One woman who decided she was okay coming down twice as fast as recommended paid a terrible price. After withdrawing she suffered the REM Sleep Disorder early one morning and attacked her husband with a baseball bat (for which she has no memory) and which ended their lifelong courtship and marriage. And cost her $30,000 to be in a psychiatric facility where they put her on five more drugs plus the antidepressant she had just withdrawn from! You can see why many have lamented that they wished they would have had the information on this CD before attempting withdrawal.

To order Ann Blake-Tracy’s book go to: https://store.drugawareness.org/product/prozac-panacea-or-pandora-our-serotonin-nightmare-2014-ebook-download/

To order the CD, “Help! I Can’t Get Off My Antidepressant!” go to: http://store.drugawareness.org/product/help-i-cant-get-off-my-antidepressant-mp3-download/

This is a CD doctors can also benefit from when attempting to withdraw their patients from these drugs which the World Health Organization has now told us are addictive and produce withdrawal. And doctors have begun to recommend the CD to their patients.

The Aftermath of Antidepressants

In 2005 the FDA issued strong warnings about changes in dose for antidepressants. They warned that ANY abrupt change in dose of an antidepressant, whether increasing or decreasing the dose….so that would include switching antidepressants, starting or stopping antidepressants, forgetting to take a pill, skipping doses, taking a pill one day & not the next, etc…. can cause suicide, hostility, and/or psychosis – generally a manic psychosis which is why so many are given a diagnosis for Bipolar Disorder after this withdrawal reaction that can so severely impair sleep leading to a psychotic break.

Clearly coming down too rapidly can be very, very dangerous. We encourage you to arm yourself with knowledge by downloading our CD on safe withdrawal.

http://www.drugawareness.org/wp-content/uploads/wpsc/product_images/thumbnails/helpicant.jpgclick here. order a CD download.

WARNING: In sharing this information about adverse reactions to antidepressants I always recommend that you also give reference to my CD on safe withdrawal, Help! I Can’t Get Off My Antidepressant!, so that we do not have more people dropping off these drugs too quickly – a move which I have warned from the beginning can be even more dangerous than staying on the drugs!

The FDA also now warns that any abrupt change in dose of an antidepressant can produce suicide, hostility or psychosis. And these reactions can either come on very rapidly or even be delayed for months depending upon the adverse effects upon sleep patterns when the withdrawal is rapid! You can find the CD on safe and effective withdrawal helps here: http://store.drugawareness.org/

Ann Blake Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org & http://ssristories.drugawareness.org
Author: ”Prozac: Panacea or Pandora? – Our Serotonin Nightmare – The Complete Truth of the Full Impact of Antidepressants Upon Us & Our World” & Withdrawal CD “Help! I Can’t Get Off My Antidepressant!”

 

10,535 total views, 5 views today

Report: Overdose of prescription drugs may have killed Michael Jackson

Thu, Jun. 25, 2009

Life & Style reports that Michael Jackson
was taking a cocktail of up to seven prescription drugs in the months
before his death.

The star had been taking prescription painkillers including
anti-anxiety drugs Xanax, Zoloft (SSRI Antidepressant) and painkiller Demerol in recent
months, sources close to Jackson told Life & Style. The insider
close to the star said he took a suspected overdose of drugs on
Thursday morning, which caused respiratory and cardiac arrest.

And a Jackson family lawyer told CNN he “feared” the drugs
could kill the pop star. CNN’s interview with the source follows the
jump.

Jackson
family lawyer Brian Oxman confirmed Jackson may have had trouble with
prescription drugs as he prepared for his London show.

“This was something which I feared and something which I warned about,”
Oxman said on CNN. “I can tell you for sure that this is something I
warned about. Where there is smoke there is fire.”

Mr Oxman compared Michael to Anna Nicole Smith, alleging that Michael had ‘enablers’ just like her.

CNN details Jackson’s long history of medical problems here.
At
a news conference, brother Jermaine Jackson said doctors and family
tried “for an hour” to resuscitate the performer. TMZ’s video of the
conference is here.

Meanwhile, Hollyscoop reports that doctors visited Jackson “daily.” THe site’s latest update:

While news of Michael Jackson’s death came as a shock to many, inside
sources tell Hollyscoop exclusively that the King of Pop “had doctors
visiting him daily.”

Michael went into cardiac arrest Thursday afternoon and was rushed to
UCLA Medical Center around 1pm. His personal physician was with him at
the time and accompanied him to the hospital.

At approximately 1:14pm when he arrived at the hospital, doctors and
emergency personnel performed CPR and tried to resuscitate him, but
were unsuccessful. He was pronounced dead at 2:26pm.

The cause of his death is still unknown, but an autopsy is scheduled
for this coming Friday afternoon. Michael was transferred from UCLA
Medical Center to the coroner’s office via a Los Angeles Sheriff’s
helicopter shortly after 6pm.

Posted on Thu, Jun. 25, 2009 08:41 PM

http://www.kansascity.com/stargazing/story/1282600.html

Jackson family spokesman Brian Oxman reacts to the news of
Michael Jackson’s death. He says he is “stunned” and adds that he
warned the family that prescription drug abuse might have contributed
to his death.

“If you think the case with Anna Nicole Smith was
an abuse, it’s nothing in comparison to what we have seen taking place
in Michael Jackson’s life.”

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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.

1,288 total views, 1 views today

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

556 total views, 1 views today

Get Off the Pharm – Written & Performed by Phil Garrison

Thursday, 18 December 2008

“Get Off the Pharm”

Sent to us by Pharmacy student Phil Garrison after taking a class where the book Prozac: Panacea or Pandora? by Ann Blake-Tracy, with an astounding 21 pages of references to medical research in the back, was required reading. Link to 2014 issue at half price: https://store.drugawareness.org/product/prozac-panacea-or-pandora-our-serotonin-nightmare-2014-ebook-download/

We are sure you will absolutely love this as much as we do!!!! I can still visualize the new drug rep he sings of in the bright yellow bikini with the names of the drugs all over it!!! LOL!!!

Please share and spread Phil’s message! In doing so we may be able to finally cut the extremely high rate of adverse reactions among medical personnel – doctors, nurses, pre-med students, etc.

Written & Performed by Phil Garrison of Five Branches University

(c) 2008
Two versions of a rap I did back in 2008 for my Pharmacology class at Five Branches University.

Lyrics (c) 2008 Philip G. Garrison
Produced by Philip G. Garrison

www.archive.org/details/GetOffThePharmLearn More

http://www.drugawareness.org/wp-content/uploads/wpsc/product_images/thumbnails/helpicant.jpg
Order Today

 

http://fbupharmacology.pbwiki.com/Get-Off-the-Pharm

Click on “Read more…

Get Off the Pharm

lyrics: (c) 2008 Philip G. Garrison

Five Branches

http://www.fivebr
anches.edu/

my other musical projects

http://www.myspace.com/wavespan

http://www.myspace.com/creepingbanditos

1st Verse

I went to the Doc to see what’s wrong with me,

He turned out to be a pill-pusher MD,

As he reached for his pen with the drug name on it,

I said, “Stop right there, mon frer, I don’t want it!”

He said, “You must be crazy,” as I broke for the door,

Crashed into somebody, and landed on the floor,

With a slutty type of woman lookin’ down at me,

She had the names of different drugs displayed on her bikini.

She said, “Hey Doc, I was hopin’ you were free,

‘Cause I’m the new Rep’ from the drug company.”

I thought, “Damn…this has gone too far,”

As I raced out the door and hoped into my car.

Turned on the radio, tryin’ to catch the news,

But…all that did was just give me the blues.

With a story of a mom who killed her whole fami-ly,

(While) she was on the same drug the Doc had tried to give me.

An S-S-R-I that made her crazy in the head,

Like Eric Harris was takin’ when he shot those kids dead.

So before you take a drug that might mess up your dome,

Think about Columbine and Google serotonin syndrome,

The human brain is more than just a chemistry lab,

‘n’ drugs can cause hallucinations like an LSD tab.

But drugs are big business in the U-S-A,

So they try to push ’em on you even if you’re okay.

2nd Verse

Before we get into hardcore pharmacology,

Let me break down some terminology…

An agonist is a drug with a response that may be

An increase or decrease in cellular activity,

(But) this all depends on the receptors it binds to,

Receptors all do different things: let me remind you.

Antagonists still bind, but their job is opposite,

Nothing can bind to the receptor where they sit

Efficacy is the degree of maximal effect,

Like…how hard a person tries to earn your respect.

Potency is similar but with a slightly different bent,

The amount of drug needed to produce a response of fifty-percent.

I went…to the pharmacology class,

Chillin’ out at school with my man Chris Ras.

The subject is vast–and requires concentration…

Like the Henderson-Hasselbalch equation,

Like Beta-2 receptors cause broncho-dilation,

If you give epinephrine to a member of the population.

And Beta-1 causes heart rate to get tachy,

‘Cause your body responds like you’re under attack, see?

And while we’re on the subject, one last thing I’d like to mention,

Beta blockers are the drugs often used for hypertension.

And if you’re unclear about how they work,

It’s like being stuck in line, while some big fat jerk,

Ties up the on-ly available cashier,

You don’t get the simile, let me make it more clear:

The cashier is the receptor and the jerk is the drug,

And my rhyme’s so tight, you might say it’s snug.

3rd Verse

I rock from A-to-Z: from Advair to Zocor,

Even though I pass on Flomax, I still flow more,

Than a river, non-toxic to your liver,

My delivery’s so cold it makes a polar bear shiver.

Don’t ingest Celebrex–I wrecks ill text,

You must hit the Prednisone, ’cause you look all vexed,

Whack cats sleep on this, like they’re dosed on Ambien,

Real heads peep on this, ’cause they know I came to win.

(If) MCs step I leave ’em dead like IV’s of Levophed

My rhyme’s like Oxycontin, many fools addict-ed.

I come harder than a senior on a dose of Viagra,

Take on drug companies, watch ’em fall like Niagra.

Just hit you with the facts, illest rapper on wax,

Val-i-um and Xa-nex try to help you relax,

But…trouble comes when it’s time for cessation,

Symptoms like anxiety, insomnia, and agitation.

You know how they roll, they say, “Take your medication,”

In every doctors office, in this medicated nation,

You’re probably better off just to take a vacation,

Or find another way to reach a state of elation.

Vaccination is a controversial topic we’ve discussed,

Many Doctors these days make you think they’re a must,

But your child’s life depends on in whom you place your trust,

That’s why I educate with the rhymes I bust.

Verse 4

Many people in our country have some type of chronic pain,

While it is their loss, it’s the drug companies gain,

They got: codeine, and morphine, and Vicodin too,

And depending on the pain, one of these drugs they’ll sell you.

Or…they might try an NSAID instead,

‘Till you pass black stools, ’cause you upper GI bled,

They inhibit prostaglandins, thus reducing inflammation,

But injure the GI and decrease platellete aggregation.

Cortio-steroids also work for many types inflammation,

Decrease of immunity is an important consideration,

A course of just 10 days, will suppress it for a year,

So if you have an infection, yell it in the doctor’s ear.

If you’re scheduled for surgery, you better tell them too,

‘Cause if you catch an infection, man, you might be through,

Inhibition of phagocytosis by neutrophils is serious

Cushing’s syndrome and psychosis: side-effects you might experience.

Heart disease is a cause of many deaths per year,

So drug companies try to use this fear,

If cholesterol is high, they want to put you on Statins,

But the ones who benefit are the ones who own the patents.

People need more education and nutrition advice,

Improper intake of food is a national vice,

So before you’re on a drug that makes you pay the price,

Change your life-style and diet, no need to think twice.

Digitoxin is a heart-drug from the foxglove plant,

For Congestive Heart Failure when you start pant,

Lasix helps water retention: another a goal of therapy,

As is improvement of cardiac contractility.

They work by inhibition of the Na-K pump,

But they still have side-effects so you still might crump,

‘Cause they mess with the way that your heart goes thump,

Better save yourself now and take that junk-food to the dump.

5th Verse

By now I hope you’ve learned just a little bit more,

About the nature of the game, I came to settle the score,

Anti-biotics that you’re on, create microbial war

You could become a casualty, without knowing what for.

Do your research, wake up, and make a choice for your health,

‘Cause the person you save — just might be yourself,

Don’t spend another dollar of your hard earned wealth,

For another empty vial on the medicine shelf.

You might think I’m a cynic for the rhymes I drop,

I’m just givin’ you the facts, and I just don’t stop,

Now you know who’s the master of medical hip-hop,

Rock mics skill-fully, when I flip I never flop.

You must be a sheep, if you’re still on the pharm,

I tried to liberate your mind, and reveal potential harm,

I guess maybe you’re just in a pharmaceutical haze,

Like the latest drug craze, I leave you all in a daze.

1,951 total views, 1 views today

08 Presidential Election

Warning: This is political – avoid if you wish

Thursday, 20 November 2008

We have had LOTS of wonderful information come out since we held a fast as a
group and I will begin sharing that with you over the next few days. One is
important enough, it all is, but this is very critical information so I will
get it right out tonight. I did not want to overwhelm you with it all at
once.

Now . . . those of you who know me well know that I do not get political . .
. UNTIL it comes to hurting people with these deadly drugs or killing
innocent people. And if you have read my book you know I do not hold back in
showing the connections between the Bush family and Eli Lilly. I have also been
vocal in George Bush, Jr’s meddling in the lawsuits families are filing against
the makers of SSRIs in an attempt to limit settlement amounts.

Party means ABSOLUTELY NOTHING to me and never ever has. A man stands on his
own merit. It should always be that way. We have not had a two part system
in this country for decades anyway! We are just told that we do.

This time on the eve of this election I will not hold my tongue! I want you
all to know a few things about Obama that you should know but may not know.
Things that are so inhumane that I could NEVER support him. But keep in mind
that this is in NO WAY WHATSOEVER an endorsement for John McCain – far from
it! Of all those left running in this election, at least Ralph Nadar has done a
lot for our cause. I refuse to vote for either of the major candidates. I
like sleeping at night and would not be capable if I voted for either one.

A couple of days ago I was shocked when speaking to a very close friend of
mine, who is very much aware of the dangers of these drugs, to learn that he
is supporting Obama. He was clearly completely oblivious to Obama’s connection
to the deadly Mother’s Act. So, I want to make sure all of you are aware of
that connection. But continue reading because it does not end with just the
Mother’s Act.

In June I accompanied a group of mothers to Washington DC to lobby against
the Mother’s Act as the Executive Director of the International Coalition for
Drug Awareness. You have all heard of the Teen Screen program that was put in
place to screen children in their public schools and drug them with
antidepressants. Well the Mother’s Act is the same type of program designed to
drug
pregnant and nursing mother’s with antidepressants and antipsychotics for any
sign of depression. In NJ where that is already law mothers are being
escorted by police to hospitals to “get help” (in other words to get drugged)
if
they show signs of depression. Can anyone say 1984? (If you are too young to be
familiar with that book, it would be good for you to read it right now!)

Now what connection does Obama have to the Mother’s Act? Obama is the
CO-SPONSOR, I repeat the CO-SPONSOR, CO-SPONSOR, CO-SPONSOR, not just a
supporter
or one voting for, but the CO-SPONSOR of this deadly Mother’s Act.

Is he just unaware of what he is doing? NO! Obama is doing this even though
he has admitted that he knows that Paxil causes potentially fatal birth
defects to the heart of the infant as all antidepressants can do. He admitted
this
face to face to Julie Edgington, who asked him, while he was campaigning
here in Iowa, to help her and her son who was damaged by her use of Paxil
during
pregnancy. Their story can be found in full along with pictures documenting
what happened at: _http://bigpharmavictim.blogspot.com/_
(http://bigpharmavictim.blogspot.com/)

Here is a shortened version of what happened to baby Manie at birth:

“As soon as Manie was born he began to turn blue. The more he cried the more
he turned blue. Our doctor did not know what was wrong with Manie. The
doctor thought that it might be his heart or his lungs.

“Manie was flown to a hospital an hour and a half away from where we live. I
had to stay at the hospital where I had Manie. The doctors called me when
Manie arrived and told me Manie had transposition of the great arteries.

“I was told that Manie had to have a procedure done to save his life. The
doctors went through the artery on the inside of Manie’s right leg. The doctors
snaked a balloon all the way through the artery to Manie’s heart. Once the
doctors were in Manie’s heart they blew the balloon up and ripped a hole in
Manie’s heart.

“In the days following the surgery Manie’s leg and foot started to turn a
dark purple. The doctors told us that Manie may have to have his leg amputated
because the procedure damaged the artery in Manie’s leg.

“Right before Manie’s open heart surgery the doctors put Manie on blood
thinners. Shortly after putting Manie on blood thinners they were able to
detect
a pulse in Manie’s foot. Manie kept his leg.”

Is Mania alone? FAR FROM IT!! Hundreds of similar lawsuits have already been
filed. And because I know what these drugs do and am always on the watch for
those with side effects I know of two mothers in my own small neighborhood
back in Utah, one mother on Prozac and one mother on Paxil, whose babies both
had to have open heart surgery in the first few months of life. HOW MANY MORE
are there that no one is noticing because, unlike me or unlike Obama who
told Julie he knows of this connection, are there this has happened to who are
completely unaware of this adverse reaction to antidepressants? I just found
another one, now 15 years old and related to a very well known senator, who
had never connected the dots between the hole in her heart at birth and her
mother’s use of Paxil.

Now if the connection between Obama and the Mother’s Act was not enough,
here is more. And I thank Marilyn, who has dealt with her own son’s
SSRI-induced
nightmare for years, for sending this information.

Whether you kill a baby before or after birth or as it is being born does
not matter to me. The fact that you kill babies or condone the killing of
innocent human beings (and I know of none more innocent than a baby) is enough
for
me to be vehemently opposed to you having anything to do with any position
of authority over me or my loved ones.

Abortion is a different issue, but know that I am completely opposed to it
and Obama supports it in every way there is. If you want that documentation
ask and I will send that on. But the following information makes me sick!

Obama voted against the Infants Born Alive Protection Act not once, not
twice, not three times, but FOUR TIMES. That is the act put in place to keep
anyone from assisting a baby that is born alive during an abortion. Instead
they
allow them to die by not feeding them or assisting them in any way or do more
to harm the child to encourage death.

He also voted against a ban on partial-birth abortion in the Illinois state
senate.

SOURCES: _http://www.bornalivetruth.org_
(http://paracom.paramountcommunication.com/ct/2590975:3055645234:m:1:121419987:F\
F3A4409A9DD08B7172281D9AA6EA603
)
Audacity of Hope written by Barack Obama
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!!! ()

439 total views, no views today

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.

1,716 total views, 1 views today

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\
dicines_agency_refuses_to_act.htm#
)

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#
)

469 total views, no views today

Sen. Grassley: Drug Companies “Bamboozled the FDA” on SSRI Antidepressants

Mon Nov 10, 2008

The following information should go out to every reporter and every other
human on the planet. Please. Please. Please help us get this information out to
as many as possible as a warning. [BUT in doing so always remember to warn
of the extreme potential danger of abrupt withdrawal with the FDA warning that
such can cause suicide, hostility or psychosis.

Please give them our 800 order line or website to download or order my CD, “Help! I Can’t Get Off My
Antidepressant!” so that they will have the formula for safe and almost
painless withdrawal and methods of recovery from the damage they have suffered.]
Now if you have read my book most of this will sound all too familiar and
old. But now the cold hard facts are coming out to the public with Iowa’s own
Senator Grassley leading the way because these drugs grabbed his attention
after overseeing many of the hearings on children and antidepressants. THANK
YOU

SENATOR GRASSLEY FOR YOUR EFFORTS!!!
Some of the most important points in the article to file in your memory
banks and repeat as often as possible to as many as possible are as follows:

#1 US HIGHEST USER OF ANTIDEPRESSANTS & ANTIDEPRESSANTS ARE AMERICA’S
MOST WIDELY PRESCRIBED DRUGS:

“Antidepressant prescribing is more rampant in this country than any other.
The US accounted for 66% of the global market in 2005, compared to 23% in
Europe and 11% for the rest of world, according to a December 2006 report by
Research and Markets.
“A June 2007 survey by the Centers for Disease Control of doctor and
hospital visits in 2005 showed that the most commonly prescribed drugs were
antidepressants, with 48% of the prescriptions issued by primary care
physicians. They have remained in the number one position ever since. Last year, 232
million prescriptions were filled for antidepressants worth nearly $12 billion,
according to a March 2008 report by IMS Health. . . .


#2 YET THE MANUFACTURERS KNEW AND HID THE FACT THAT THESE DRUGS INCREASE
THE RISK OF SUICIDE:

“For fifteen years, the SSRI makers fought against adding a warning about an
increased risk of suicidality, knowing all the long that the risk existed.
[We had the data in court cases for years but could not get the press to cover
it.] Now, the companies are making the irresponsible argument (in defense of
lawsuits claiming they failed to warn doctors and the public of the risk)
that the FDA did not require them to add a warning, so they are immune from
liability. . . .

#3 SINCE 1989 THE MANUFACTURER OF PAXIL KNEW THAT THIS DRUG INCREASES SUICIDE ATTEMPTS BY EIGHT TIMES MORE THAN PLACEBO!

“The report shows that Glaxo [makers of Paxil] knew in 1989, long before
Paxil was FDA approved, that people taking the drug were 8 times more likely to
engage in suicidal behavior than people given a placebo, or sugar pill. Now,
it stands to reason that even the most depressed person would decline to take
Paxil if given these facts. Also, parents certainly would decline if they
were told about the risks. . . .

“The FDA approved Paxil on December 29, 1992, with no warning to doctors or
patients of the significant increased risk of suicidal behavior,” he writes.
. . .

#4 SENATOR GRASSLEY FINDS THAT PAXIL MAKER “BAMBOOZLED” THE FDA PUTTING
PATIENT SAFETY AT RISK

“Senator Grassley has also asked the FDA to go back and review the clinical
trial data submitted on Paxil. In a statement on the Senate floor on June 11,
2008, he said: “Essentially, it looks like GlaxoSmithKline bamboozled the
FDA.”
“We cannot live in a nation where drug companies are less than candid, hide
information and attempt to mislead the FDA and the public,” he stated. “These
companies are selling drugs that we put in our bodies, not sneakers.”
“When they manipulate or withhold data to hide or minimize findings about
safety and/or efficacy they put patient safety at risk,” Senator Grassley said.
“And with drugs like Paxil, the risks are too great.”
Now I need to note here that the only reason Paxil is taking so much heat
and the only reason we have all of this inside information on Paxil is because
of the information obtained during the Wyoming murder/suicide case of Donald
Schell. Before that these companies were settling cases so that they did not
have to go to court and disclose all of this information to the attorneys
working in our behalf.
After waiting three long years for one attorney to decide if he would take
the case, it went to Andy Vickery’s office. Andy took the case and Glaxo
allowed it to go all the way into court instead of settling the case. The jury
heard and saw enough to rule that the two pills of Paxil that Donald Schell
took before getting up one morning and shooting his wife, his daughter and his
baby grand daughter before shooting himself was the main cause.
Glaxo did all they could to seal that information back up again, but it was
too late. The cat was out of the bag. And it is long past time to let the cat
out of the bag on all these other antidepressants as well!
#5 THE RESULTS OF SENATOR GRASSLEY’S INVESTIGATION OF THE LARGE PAYMENTS
AND KICKBACKS TO DOCTORS BY DRUG MAKERS

“According to Senator Grassley’s June 4, 2008 statement in the Congressional
record, although conflict-of-interest disclosure forms make it appear that
the Harvard psychiatrists only received a couple hundred thousand from drug
companies over the past 7 years, the true figures show Dr Biederman received
over “$1.6 million,” Dr Spencer “over $1 million” and Dr Wilens “over $1.6
million” in payments from the drug companies.

“Based on reports from just a handful of drug companies,” he states, “we
know that even these millions do not account for all of the money.”
“Senator Grassley also notes that Dr Schatzberg owns stock worth more than
$6 million in one drug company. Ed Silverman reports on Pharmalot that there
are “30 or so physicians at two dozen universities which the Senate Finance
Committee is probing concerning disclosure of grants from drugmakers.” The
names of those 30 doctors, along with the research mills they operate out of,
need to be made public. . . . .


#6 RESEARCH INSTITUTIONS AND ACADEMIA ON THE TAKE FROM DRUG MAKERS AS WELL
ACTING AS “APOLOGISTS FOR COMMERCIAL SCIENTIFIC FRAUD” – SENIOR ACADEMICS
PROSTITUING MEDICINE.

“It is no longer a case where Americans need only be concerned about the
amount of money the academics are pulling in. The pharmaceutical industry also
has a stronghold on most major research institutions in this country. Many
could not exist if the drug companies withdrew all their research funding, a
state of affairs that did not occur by accident.

“In fact, according to Dr Aubrey Blumsohn, who publishes the Scientific
Misconduct Blog, when all is said and done:

“The chief villains remain our academic institutions and medical leadership.
They have colluded with and have acted as apologists for commercial
scientific fraud. They have tolerated the telling of lies by senior academics.
They have encouraged the prostitution of medicine. They have allowed abuse of the
most fundamental safeguards of science. Most importantly, they have set
terrible examples for our students.”

#7 WHO TOOK THE MONEY TO PUSH ANTIDEPRESSANTS TO CHILDREN?

“. . . . While Dr Keller took the lead on pushing Paxil for children and
adolescents, Dr Emslie was the main man on the Prozac trials, and Dr Wagner was
the queen bee on Zoloft studies. The co-authors of papers that appear in the
medical literature encouraging the use of SSRI’s for kids include Drs
Biederman, Schatzberg, Wilens and, of course, Charles Nemeroff.
“Dr Nemeroff was recently forced to resign as chairman of Emory’s psychiatry
department after Senator Grassley’s investigation revealed that he failed to
disclose to his university more than a million dollars in drug industry
income. All total, Nemeroff had earnings of $2.8 million from drug companies
between 2000 and 2007, but failed to report at least $1.2 million. . . . .


#8 YET AMAZINGLY ENOUGH . . . .

“Shrinks on the take are so addicted to industry money that it’s impossible
to embarrass them. Last year, the press ran major stories when this report
came out, highly critical of how much money they were making. This year, the
average amount rose by 25%.

Now for some hard questions. . . .

*** When Glaxo knew in 1989 that Paxil was inducing suicide at a rate EIGHT
TIMES HIGHER than with a placebo and did not warn, is that not at least
negligent homicide?

Or is it not in some way contributing to a premeditated loss of life?

How often do we read in criminal cases where someone has died and someone
else did not assist that person in need but instead allowed the death to happen
and that person has then been prosecuted and given a prison term?

What is the difference here? The only difference I see is that these people
at Glaxo made a lot of money by keeping quiet and allowing these deaths to
continue!!

*** I have been asking this question for a very long time. Why is it okay
for our academic institutions to peddle drugs and use our students as guinea
pigs in studies?

Why is it okay for them to make so much money from drug companies? Much of
their operating expenses come from this drug company blood money.

Why would anyone be surprised, when seeing this close financial situation
with the drug companies and the academic institutions, that so many students
are placed on these same drugs by campus health centers often addicting them to
the drugs for many years to come?

*** How can shrinks be so stupid, or just plain “in your face” with it, as
to take even more money from these companies while they are already in the
process of being investigated for doing so???

Oh, that’s right we already know the answer to that one – they take more of
these mind altering drugs than just about anyone else! The psychiatric nurse
attending my lecture last year estimated that at least 75% of her colleagues
are on these drugs.

And why are they on these drugs? Because the drug reps are telling them all
that they are in a stressful profession and that sooner or later they are
going to be hit by the anxiety or depression that comes with the stress . . .
so they need to start on the drugs now so as to ward off “the pending
inevitable” anxiety or depression.

Of course then we need to ask the question, “How could they have fallen for
that old sales pitch?” That alone makes you wonder about their sanity!

But then you must ask if it is okay for a drug user to then be a drug pusher
even when we are discussing “legal” drugs? Because that is exactly what we
are seeing happen with this situation with antidepressants – doctors on the
drugs pushing them to others – no different than what you see in street drug
use where those hooked on the drugs are the ones pushing them to others. When
you see how similar in action these antidepressants are to LSD or PCP that
whole scenario becomes totally transparent.

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.scoop.co.nz/stories/HL0811/S00080.htm_
(http://www.scoop.co.nz/stories/HL0811/S00080.htm)

Pharmaceutical Industry Hustlers – Part I
Thursday, 6 November 2008, 1:25 pm
Column: Evelyn Pringle
Pharmaceutical Industry Hustlers – Part I
SSRI Antidepressants Pushers

By _Evelyn Pringle_
(http://www.scoop.co.nz/stories/print.html?path=HL0811/S00080.htm#a)
After twenty long years, it appears that the epidemic in mental disorders in
America might be coming to an end. It won’t happen because of any great
medical breakthrough but rather because the perpetrators of the greatest
healthcare fraud in history are finally being exposed. The demolition of the
giant “psycho-pharmaceutical complex” appears to be on the horizon.
For far too long, the focus has been on the drugmakers only. In recent
months, the spotlight has shown where it belongs – on the highly-paid
opportunists responsible for fueling the epidemic in prescribing of psychiatric drugs by
doctors in every field of medicine and the research institutions that enabled
the process.
The antidepressants known as selective serotonin reuptake inhibitors, or
SSRI’s, such as Prozac, Paxil, Zoloft, Celexa and Lexapro are at the center of
the storm. These drugs have been prescribed to more Americans than any other
class of medications over the past two decades. Cymbalta, Effexor and
Wellbutrin are often referred to as SSRI’s, but they are slightly different
chemically. However, the drugs all carry similar side effects and warnings.
The top sales pitch for SSRI’s has been the “chemical-imbalance-in-the-brain”
myth.

“There is no evidence whatsoever that depression is caused by a
biochemical imbalance,” says Dr Peter Breggin, one of the world’s leading
experts on psychiatric drugs and author of the new book, “Medication Madness.”
People take for granted pronouncements such as, “You have a biochemical
imbalance,” and “mental disorders are like diabetes,” he explains in the book.

“In reality,” Dr Breggin writes, “these are not scientific observations –
they are promotional slogans, so adamantly repeated in the media and by
individual psychiatrists that people assume them to be true.”
“The psycho-pharmaceutical complex fosters these falsehoods in order to
promote the widespread use of their products,” he says. “Reluctant patients by
the millions are pushed into taking drugs by doctors who tell them with no
uncertainty that they need medication.”

“If you have got a biochemical imbalance in your brain,” Dr Breggin advises
in the book, “the odds are overwhelming that your doctor put it there with a
psychiatric drug.”

All Eyes on Glaxo
At the moment, all eyes are on Paxil maker, GlaxoSmithKline (formerly
SmithKline Beecham), due to reports that the company is under investigation by
the US Department of Justice, as well as the Senate Finance Committee, with
Iowa’s Senator Charles Grassley, the ranking Republican on the Committee,
leading the charge.

The report that led to the investigation by Senator Grassley was generated in
litigation and was only recently made public after it was unsealed by the
court. It was submitted by Dr Joseph Glenmullen, a Clinical Instructor in
Psychiatry at Harvard Medical School and author of “The Antidepressant
Solution”

and Prozac Backlash: Overcoming the Dangers of Prozac, Zoloft, Paxil, and
Other Antidepressants with Safe, Effective Alternatives.” He was retained as
an expert by the Los Angeles-based law firm of Baum, Hedlund, Aristei & Goldman.
The litigation involves several Paxil-induced suicide cases, including a 13-year-old child.

The report shows that Glaxo knew in 1989, long before Paxil was FDA approved,
that people taking the drug were 8 times more likely to engage in suicidal
behavior than people given a placebo, or sugar pill. Now, it stands to reason
that even the most depressed person would decline to take Paxil if given
these facts.

Also, parents certainly would decline if they were told about the
risks. Dr Glenmullen explains that, by submitting what he refers to as “bad” Paxil
numbers to the FDA, Glaxo was able to avoid adding a warning about suicide to
the label when the drug was approved. “GlaxoSmithKline’s ‘bad’ Paxil numbers
carried the day: The FDA approved Paxil on December 29, 1992, with no warning
to doctors or patients of the significant increased risk of suicidal behavior,” he writes.

Instead, Glaxo listed suicide and suicide attempts that took place during the
“run-in” period of the studies as if they happened in the placebo group. The
run-in period, also called the “wash-out” phase, occurs when all patients
are taken off their existing drugs to let the old drugs wash out of their
systems, and all patients are given placebos. The rationale for washing out old
drugs is to prevent them from confusing the results of the study, so that
patients start out in a similar condition, according to the report.
The official trial only begins after the wash-out phase, once the patients
are assigned to receive either the antidepressant or a placebo. The patients
who continue to receive the placebo are referred to as the placebo group.

“Confusing the pre-study placebo wash-out phase with the placebo group in the
actual study is improper,” Dr Glenmullen writes, “especially when the
concern is a potentially lethal side effect.”

The “correct data shows that suicide attempts in patients on Paxil occurred
at a rate eight times higher than the rate in patients on placebo,” he notes.
Senator Grassley has also asked the FDA to go back and review the clinical
trial data submitted on Paxil. In a statement on the Senate floor on June 11,
2008, he said: “Essentially, it looks like GlaxoSmithKline bamboozled the
FDA.”

“We cannot live in a nation where drug companies are less than candid, hide
information and attempt to mislead the FDA and the public,” he stated. “These
companies are selling drugs that we put in our bodies, not sneakers.”
“When they manipulate or withhold data to hide or minimize findings about
safety and/or efficacy they put patient safety at risk,” Senator Grassley said.
“And with drugs like Paxil, the risks are too great.”

A good start as the Glaxo scandal unravels, the public will learn that other
antidepressant makers such as Eli Lilly, Pfizer, Wyeth and Forest Laboratories
are equally guilty. Likewise, there are many more supposedly independent academic
doctors who have been receiving substantial financial benefits from drug
companies than are currently identified in the media as being under investigation.

Exposing Harvard University’s Joseph Biederman, Thomas Spencer, Timothy
Wilens, Stanford’s Alan Schatzberg, Brown University’s Martin Keller, Melissa
DelBello at the University of Cincinnati, and Drs Karen Wagner and John Rush,
who operated out of the University of Texas, might be a good place to start, but
the trail of Big Pharma’s funding academic research for marketing
purposes certainly does not end with a handful of psychiatrists.

According to Senator Grassley’s June 4, 2008 statement in the Congressional
record, although conflict-of-interest disclosure forms make it appear that the
Harvard psychiatrists only received a couple hundred thousand from drug
companies over the past 7 years, the true figures show Dr Biederman received
over “$1.6 million,” Dr Spencer “over $1 million” and Dr Wilens “over $1.6
million” in payments from the drug companies.

“Based on reports from just a handful of drug companies,” he states, “we know
that even these millions do not account for all of the money.”
Senator Grassley also notes that Dr Schatzberg owns stock worth more than $6
million in one drug company. Ed Silverman reports on Pharmalot that there are
“30 or so physicians at two dozen universities which the Senate Finance
Committee is probing concerning disclosure of grants from drugmakers.” The names
of those 30 doctors, along with the research mills they operate out of, need
to be made public.

The new book, “Side Effects: A Prosecutor, a Whistleblower, and a
Best-selling Antidepressant on Trial,” by investigative journalist Alison Bass,
provides the inside scoop on the fraudulent SSRI research conducted at Brown
University by Dr Keller.

The book also supplies background information on the financial ties between
the so-called “opinion leaders” in psychiatry and the other antidepressant
makers. For instance, Ms Bass explains that Drs Schatzberg and Keller worked as
a team a decade ago to promote Bristol-Myers Squibb’s antidepressant Serzone.

In 1998, Dr Schatzberg was paid to moderate an industry-sponsored symposium
that touted the benefits of Serzone, and Dr Keller was one of the paid
speakers at the event. The same year, Dr Keller received $77,400 in consulting
fees from Bristol-Myers, Ms Bass points out.

Dr Keller later published a study in the New England Journal of Medicine also
touting the benefits of Serzone. The drug was removed from the market in
2004 after it was found to cause liver damage but not before a number of
patients died.

Ms Bass reports that Keller did not report any income from Glaxo on his 1998
tax return. But during her research for “Side Effects,” she discovered he had
earned personal income from Glaxo in 1998, as well as subsequent years.
Keller admitted as much during a September 2006 deposition for a lawsuit filed
against Glaxo, she says.

It is no longer a case where Americans need only be concerned about the
amount of money the academics are pulling in. The pharmaceutical industry also
has a stronghold on most major research institutions in this country. Many could
not exist if the drug companies withdrew all their research funding, a state
of affairs that did not occur by accident.

In fact, according to Dr Aubrey Blumsohn, who publishes the Scientific
Misconduct Blog, when all is said and done:

“The chief villains remain our academic institutions and medical leadership.
They have colluded with and have acted as apologists for commercial
scientific fraud. They have tolerated the telling of lies by senior academics.
They have encouraged the prostitution of medicine. They have allowed abuse of the
most fundamental safeguards of science. Most importantly, they have set
terrible examples for our students.”


U
niversities keep corrupt academics on board for good reason. “Side Effects”
reports that, between 1990 and 1998, “Martin Keller brought in nearly $8.7
million in research funding from pharmaceutical companies.”
The clinical trial industry itself provides a perfect slush fund. Spending in
the U.S. was an estimated $25 billion in 2006 and is expected to reach about
$32 billion by 2011.

Most of the money for trials comes from private
industry, and federal funding assumes a second place position, with the
National Institute of Health budgeting $3 billion for clinical trials in 2006, according
to the paper, “State Medical Board Responses To An Inquiry On Physician
Researcher Misconduct,” by Dr Stefan Kruszewski, Dr Richard Paczynski and
Marzana Bialy, in the Journal of Medical Licensure and Discipline 2008: Vol 94 No 1.
Paxil Study 329 “Side Effects” also covers the whole sordid affair on Paxil Study 329, the
most infamous fraudulent pediatric trial of all time. The study “offers a
landmark for the point at which science turned into marketing,” according to Dr
David Healy.

Dr Healy is a Professor of psychiatry and Director of the North Wales School
of Psychological Medicine at the University of Wales, and an outspoken critic
of the psycho-pharmaceutical complex, with 21 books to his name, including
“The Creation of Psychopharmacology.”

He explains that, in 1998, Glaxo’s original assessment of Study 329 had
concluded that it and another study had shown Paxil did not work for children,
but that it would not be “commercially acceptable” to publicize this finding.
“Instead the positive findings from the study would be published; they were in
an article whose authorship line contains some of the best known names in
psychopharmacology (Keller et al., 2001),” Dr Healy writes in the 2007 paper,
“The Engineers of Human Souls & Academia.”

Dr Keller gets most of the credit for the study, which was completed in
the mid-90’s. Keller et al had some difficulty getting it published at first,
but finally found a journal willing to take the bate in 2001, the Journal of
the American Academy of Child and Adolescent Psychiatry. In all, 20 academics
allowed their names to be attached to this ghostwritten infomercial, and not
one has stepped forward to acknowledge wrongdoing or to admit that a mistake
was made.

Long before the paper was published, the authors of study 329 were fanned out
all the way to Canada giving lectures and presentations to prescribing
doctors at medical conferences and seminars to promote the off-label use of
Paxil for kids. More than any other paper, Study 329 led to an epidemic in
pediatric prescribing. “After its publication, the use of antidepressants for
children skyrocketed,” Dr Glenmullen notes.

These handsomely paid key opinion leaders all deserve to have their names
in lights, especially Drs Graham Emslie and Karen Wagner from the University
of Texas.

Between 2000 through 2005, Glaxo paid Dr Wagner $160,404, but the only
payment she reported to the university was $600 in 2005, according to Senator
Grassley. Dr Wagner also failed to disclose earnings of more than $11,000 from
Prozac-maker Eli Lilly in 2002.

On August 18, 2008, the Dallas Morning News reported that a state mental
health plan naming the preferred psychiatric drugs for children has been quietly
put on hold over fears drug companies may have given researchers consulting
contracts, speakers fees or other perks to help get their products on the
list.

The Children’s Medication Algorithm Project, or CMAP, was supposed to
determine which psychiatric drugs were most effective for children and in what
order they should be tried at state-funded mental health centers, the Morning
News explains.

The academics who developed the CMAP include Drs Wagner and Emslie. Records
show Dr Emslie may have made up to $125,000 from drug companies since
2004, according to the report in the Morning News. While Dr Keller took the lead on
pushing Paxil for children and adolescents,Dr Emslie was the main man on the Prozac
trials, and Dr Wagner was the queen bee on Zoloft studies.

The co-authors of papers that appear in the medical
literature encouraging the use of SSRI’s for kids include Drs Biederman,
Schatzberg, Wilens and, of course, Charles Nemeroff.
Dr Nemeroff was recently forced to resign as chairman of Emory’s psychiatry
department after Senator Grassley’s investigation revealed that he failed to
disclose to his university more than a million dollars in drug industry
income. All total, Nemeroff had earnings of $2.8 million from drug companies
between 2000 and 2007, but failed to report at least $1.2 million.

A complete list of academics who should to be investigated can be found among
the authors of the SSRI papers and studies highlighted in the 2006 Third
Edition of, “Essentials of Clinical Psychopharmacology,” described as “a
synopsis and update of the most clinically relevant material from ‘The American
Psychiatric Publishing Textbook of Psychopharmacology,'” by none other than Drs
Schatzberg and Nemeroff.

Keep Following the Money
On July 10, 2008, Senator Grassley extended his investigation to include
psychiatry’s top industry-funded front group with a letter to Dr James Scully,
Medical Director and Chief Executive Officer of the American Psychiatric
Association, asking for “an accounting of industry funding that pharmaceutical
companies and/or the foundations established by these companies have provided to
the American Psychiatric Association.”

The Senator wants records from January 2003 to the present. According to the
July 12, 2008, New York Times, in 2006, the “industry accounted for about 30
percent of the association’s $62.5 million in financing.”
A factor rarely discussed in this debate is the amount of money doctors who
prescribe SSRI’s make during brief office calls charged at regular rates. This
practice has taken a tremendous toll on public healthcare programs and has
resulted in higher insurance premiums and overall healthcare costs for all
Americans.

In fact, the bilking of public healthcare programs is what led to the current
investigations by the Finance Committee, which has the responsibility of
overseeing spending in Federal programs. When doctors prescribe drugs for
unnecessary uses, public programs not only have to pay for the drugs, they must
also pay the fees of the prescribing doctors and for the medical care for
injuries caused by the drugs. Government spending tied to the prescribing of
psychiatric drugs has gone through the roof in the past decade.

While testifying before the House Committee on Oversight and Government
Reform on February 9, 2007, Lewis Morris, Chief Counsel at the Department of
Health and Human Services’ Office of Inspector General, discussed kickbacks to
doctors and told the panel:

“Kickbacks potentially increase the costs to Federal programs because they
encourage overutilization and may encourage the prescribing of more expensive
drugs when clinically appropriate and cheaper options (such as generic drugs)
may be equally effective.”

Mr Morris explained that, “kickbacks offered to prescribing physicians by
pharmaceutical manufacturers take a variety of forms, ranging from free samples
for which the physician bills the programs to all-expense-paid trips and sham
consulting agreements.”

Vermont is a rare state in requiring the pharmaceutical industry to disclose
the money paid to doctors. On July 8, 2008, Vermont’s Attorney General
William Sorrell released the state’s annual report on “Pharmaceutical Marketing
Disclosures,” which lists the payments made by drug companies in 2007. Of the
top 100 recipients, once again, psychiatrists received the highest payments.
Eleven psychiatrists received a total of $626,379, or about 20% of the total
value of payments made, according to the report.

Shrinks on the take are so addicted to industry money that it’s impossible to
embarrass them. Last year, the press ran major stories when this report came
out, highly critical of how much money they were making. This year, the
average amount rose by 25%.

The report also analyzes the payments based upon the drugs being marketed. Of
the top 10 drugs for which disclosures were reported, five are used to treat
mental illness and include Lilly’s Cymbalta and Forest Lab’s Lexapro.
Ironically, Cymbalta sales are also up 25%, according to Lilly’s latest SEC
filing.

Overall, estimates indicate that the drug industry spends $19 billion
annually on marketing to physicians in the form of gifts, travel, meals and
other consulting fees, according to a May 22, 2008, press release by Senator
Grassley’s office. In the November 1, 2007, New England Journal of Medicine
paper, “Doctors and Drug Companies Scrutinizing Influential Relationships,” Dr
Eric Campell, associate professor at the Institute of Health Policy at
Massachusetts General Hospital and Harvard Medical School, writes:

“Individual physicians can take some steps to maximize the benefits for
patients and minimize the risks associated with their own industry
relationships. They can start by recognizing that such relationships are designed to
influence prescribing behavior and by carefully considering the potential
effects that their own associations may have on their patients.”

“And they can bear in mind,” he says, “that the costs of industry dinners,
trips, and other incentives are passed along to their patients in the form of
higher drug prices.” Antidepressant prescribing is more rampant in this country than any other.
The US accounted for 66% of the global market in 2005, compared to 23% in
Europe and 11% for the rest of world, according to a December 2006 report by
Research and Markets.

A June 2007 survey by the Centers for Disease Control of doctor and hospital
visits in 2005 showed that the most commonly prescribed drugs were
antidepressants, with 48% of the prescriptions issued by primary care
physicians. They have remained in the number one position ever since. Last year, 232 million
prescriptions were filled for antidepressants worth nearly $12 billion,
according to a March 2008 report by IMS Health.

The top dogs in the pharmaceutical industry are literally laughing all the
way to the bank. For example, in 2007, Pfizer CEO Jeff Kindler’s pay package
was worth $9.5 million, according to the March 14, 2008, Wall Street Journal. A
previous CEO, David Shedlarz, left last year with an “exit package” worth
over $34 million. In 2007, the total value of Wyeth’s then-CEO Robert Essner’s
pay package was $24.1 million, the Journal reports.

In the meantime, state Medicaid programs are going bankrupt as a result of
the mental illness epidemic occurring only in the US. Attorneys General all
over the country are using consumer fraud statutes to sue the drug giants to
recoup the money lost due to the illegal off-label promotion of psychiatric
drugs and the concealment of their side effects.

For instance, Baum Hedlund has been litigating Private Attorney General
consumer fraud class-action lawsuits against Glaxo since 2004, on behalf of
individuals and entities such as insurance companies in California, Florida,
Illinois, Massachusetts, Minnesota, Missouri, New Jersey, North Dakota, Ohio and
Washington.

The cases are based on documents showing Glaxo promoted Paxil for kids, fully
aware that Paxil failed to out-perform a placebo in the clinical trials and
had higher suicidality rates. A national class settlement of individual
claims was reached in April 2007 in which Glaxo agreed to reimburse parents for
all of the money paid for Paxil prescriptions for their children. A national
class settlement on behalf of third party payors (insurance companies) was just
approved in September 2008.

If not for the few law firms willing to stay the course, the truth would
never have been revealed. Baum Hedlund has been pursuing the SSRI makers for
nearly two decades. Most recently, it has taken up the fight for babies born
with birth defects caused by SSRI’s.

Because the industry was so successful at keeping the original SSRI trial
data hidden, the drugs most serious side effects largely became public only
as a result of the bravery and integrity of such medical experts as Dr Healy, Dr
Glenmullen and Dr Breggin, who could not be bought and could not be bullied.

For fifteen years, the SSRI makers fought against adding a warning about an
increased risk of suicidality, knowing all the long that the risk existed.
Now, the companies are making the irresponsible argument (in defense of
lawsuits claiming they failed to warn doctors and the public of the risk) that the
FDA did not require them to add a warning, so they are immune from liability.
Worse yet, the industry-controlled FDA under the Bush Administration is
supporting this audacious preemption defense and siding with the SSRI makers
against private citizens in courts all over the country, telling judges to rule
in favor of the drug companies and throw out the SSRI cases before they even
make it to a jury.

Although not an SSRI case, the Supreme Court heard oral argument in a case
involving federal preemption, in Wyeth v Levine, on November 3, 2008.
*************
Evelyn Pringle
epringle05@…
(Written as part of the Paxil Litigation Round-Up, Sponsored by Baum,
Hedlund, Aristei & Goldman’s Pharmaceutical Litigation Department
_www.baumhedlundlaw.com_ (http://www.baumhedlundlaw.com/) )


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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.

View this table:
_[in this window]_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633v2/T1)
_[in a new window]_
(http://content.nejm.org/cgi/content-nw/full/NEJMoa0804633v2/T1)
(http://content.nejm.org/cgi/powerpoint/NEJMoa0804633v2/T1)
Table 1. Baseline Characteristics of the Subjects and Recruitment According
to Study Center.

View this table:
_[in this window]_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633v2/T2)
_[in a new window]_
(http://content.nejm.org/cgi/content-nw/full/NEJMoa0804633v2/T2)
(http://content.nejm.org/cgi/powerpoint/NEJMoa0804633v2/T2)
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)
View larger version (21K):
_[in this window]_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633v2/F2)
_[in a new window]_
(http://content.nejm.org/cgi/content-nw/full/NEJMoa0804633v2/F2)
(http://content.nejm.org/cgi/powerpoint/NEJMoa0804633v2/F2)
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:
_[in this window]_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633v2/T3)
_[in a new window]_
(http://content.nejm.org/cgi/content-nw/full/NEJMoa0804633v2/T3)
(http://content.nejm.org/cgi/powerpoint/NEJMoa0804633v2/T3)
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) ).
View this table:
_[in this window]_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633v2/T4)
_[in a new window]_
(http://content.nejm.org/cgi/content-nw/full/NEJMoa0804633v2/T4)
(http://content.nejm.org/cgi/powerpoint/NEJMoa0804633v2/T4)
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.
References
1. Benjamin RS, Costello EJ, Warren M. Anxiety disorders in a pediatric
sample. J Anxiety Disord 1990;4:293-316. _[CrossRef]_
(http://content.nejm.org/cgi/external_ref?access_num=10.1016/0887-6185(90)90027-\
7&link_type=DOI)
_[ISI]_
(http://content.nejm.org/cgi/external_ref?access_num=A1990EJ54500002&link_type=I\
SI
)
2. Birmaher B, Yelovich AK, Renaud J. Pharmacologic treatment for
children and adolescents with anxiety disorders. Pediatr Clin North Am
1998;45:1187-1204. _[CrossRef]_
(http://content.nejm.org/cgi/external_ref?access_num=10.1016/S0031-3955(05)70069\
-9&link_type=DOI) _[ISI]_
(http://content.nejm.org/cgi/external_ref?access_num=000076256400011&link_type=I\
SI
) _[Medline]_
(http://content.nejm.org/cgi/external_ref?access_num=9884682&link_type=MED)
3. Achenbach TM, Howell CT, McConaughy SH, et al. Six-year predictors
of problems in a national sample of children and youth: I. Cross-informant
syndromes. J Am Acad Child Adolesc Psychiatry 1995;34:336-347. _[CrossRef]_
(http://content.nejm.org/cgi/external_ref?access_num=10.1097/00004583-199503000-\
0002

0&link_type=DOI) _[ISI]_
(http://content.nejm.org/cgi/external_ref?access_num=A1995QK02500020&link_type=I\
SI
) _[Medline]_
(http://content.nejm.org/cgi/external_ref?access_num=7896676&link_type=MED)
4. Ferdinand RF, Verhulst FC. Psychopathology from adolescence into
young adulthood: an 8-year follow-up study. Am J Psychiatry 1995;152:1586-1594.
_<NOBR Full Text]_
(http://content.nejm.org/cgi/ijlink?linkType=ABST&journalCode=ajp&resid=152/11/1\
586
)
5. Pine DS, Cohen P, Gurley D, Brook J, Ma Y. The risk for
early-adulthood anxiety and depressive disorders in adolescents with anxiety
and
depressive disorders. Arch Gen Psychiatry 1998;55:56-64. _<NOBR Full Text]_
(http://content.nejm.org/cgi/ijlink?linkType=ABST&journalCode=archpsyc&resid=55/\
1/56
)
6. Pine DS. Child-adult anxiety disorders. J Am Acad Child Adolesc
Psychiatry 1994;33:280-281. _[ISI]_
(http://content.nejm.org/cgi/external_ref?access_num=A1994MT23000019&link_type=I\
SI
) _[Medline]_
(http://content.nejm.org/cgi/external_ref?access_num=8150802&link_type=MED)
7. Gurley D, Cohen P, Pine DS, Brook J. Discriminating depression and
anxiety in youth: a role for diagnostic criteria. J Affect Disord
1996;39:191-200. _[CrossRef]_
(http://content.nejm.org/cgi/external_ref?access_num=10.1016/0165-0327(96)00020-\
1&link_type=DOI) _[ISI]_
(http://content.nejm.org/cgi/external_ref?access_num=A1996VA95900004&link_type=I\
SI
) _[Medline]_
(http://content.nejm.org/cgi/external_ref?access_num=8856423&link_type=MED)
8. Shaffer D, Fisher P, Dulcan MK, et al. The NIMH Diagnostic Interview
Schedule for Children Version 2.3 (DISC-2.3): description, acceptability,
prevalence rates, and performance in the MECA study. J Am Acad Child Adolesc
Psychiatry 1996;35:865-877. _[CrossRef]_
(http://content.nejm.org/cgi/external_ref?access_num=10.1097/00004583-199607000-\
00012&link_type=DOI
) _[ISI]_
(http://content.nejm.org/cgi/external_ref?access_num=A1996UT65000012&link_type=I\
SI
)
_[Medline]_
(http://content.nejm.org/cgi/external_ref?access_num=8768346&link_type=MED)
9. Klein R. Anxiety disorders. In: Rutter M, Taylor E, Hersov L, eds.
Child and adolescent psychiatry: modern approaches. 3rd ed. London: Blackwell
Scientific, 1995:351-74.
10. Kendall PC, Treating anxiety disorders in children: results of a
randomized clinical trial. J Consult Clin Psychol 1994;62:100-111. _[CrossRef]_
(http://content.nejm.org/cgi/external_ref?access_num=10.1037/0022-006X.62.1.100&
link_type=DOI) _[ISI]_
(http://content.nejm.org/cgi/external_ref?access_num=A1994MW67500015&link_type=I\
SI
) _[Medline]_
(http://content.nejm.org/cgi/external_ref?access_num=8034812&link_type=MED)
11. Kendall PC, Flannery-Schroeder E, Panichelli-Mindel SM,
Southam-Gerow M, Henin A, Warman M. Therapy for youths with anxiety disorders:
a second
randomized clinical trial. J Consult Clin Psychol 1997;65:366-380. _[CrossRef]_
(http://content.nejm.org/cgi/external_ref?access_num=10.1037/0022-006X.65.3.36
6&link_type=DOI) _[ISI]_
(http://content.nejm.org/cgi/external_ref?access_num=A1997XA22300002&link_type=I\
SI
) _[Medline]_
(http://content.nejm.org/cgi/external_ref?access_num=9170760&link_type=MED)
12. Birmaher B, Axelson DA, Monk K, et al. Fluoxetine for the treatment
of childhood anxiety disorders. J Am Acad Child Adolesc Psychiatry
2003;42:415-423. _[ISI]_
(http://content.nejm.org/cgi/external_ref?access_num=000181706500007&link_type=I\
SI
) _[Medline]_
(http://content.nejm.org/cgi/external_ref?access_num=12649628&link_type=MED)
13. The Research Unit on Pediatric Psychopharmacology Anxiety Study
Group. Fluvoxamine for the treatment of anxiety disorders in children and
adolescents. N Engl J Med 2001;344:1279-1285. _<NOBR Full Text]_
(http://content.nejm.org/cgi/ijlink?linkType=ABST&journalCode=nejm&resid=344/17/\
1279
)
14. James A, Soler A, Weatherall R. Cognitive behavioural therapy for
anxiety disorders in children and adolescents. Cochrane Database Syst Rev
2005;4:CD004690-CD004690. _[Medline]_
(http://content.nejm.org/cgi/external_ref?access_num=16235374&link_type=MED)
15. Bridge JA, Iyengar S, Salary CB, et al. Clinical response and risk
for reported suicidal ideation and suicide attempts in pediatric
antidepressant treatment: a meta-analysis of randomized controlled trials. JAMA
2007;297:1683-1696. _<NOBR Full Text]_
(http://content.nejm.org/cgi/ijlink?linkType=ABST&journalCode=jama&resid=297/15/\
1683
)
16. Diagnostic and statistical manual of mental disorders, 4th ed., text
rev.: DSM-IV-TR. Washington, DC: American Psychiatric Association, 2000.
17. Kendall PC, Hedtke KA. Cognitive-behavioral therapy for anxious
children: therapist manual. 3rd ed. Ardmore, PA: Workbook Publishing, 2006.
18. Idem. Coping Cat workbook. 2nd ed.. Ardmore, PA: Workbook
Publishing, 2006.
19. Kendall PC, Gosch E, Furr JM, Sood E. Flexibility within fidelity. J
Am Acad Child Adolesc Psychiatry 2008;47:987-993. _[CrossRef]_
(http://content.nejm.org/cgi/external_ref?access_num=10.1097/CHI.0b013e31817eed2\
f&link_type=D

OI) _[Medline]_
(http://content.nejm.org/cgi/external_ref?access_num=18714195&link_type=MED)
20. Albano AM, Silverman WK. The anxiety disorders interview schedule
for DSM-IV, child version: clinician manual. New York: Oxford University Press,
1996.
21. Guy W, Bonato R, eds. CGI: Clinical Global Impressions. Chevy Chase,
MD: National Institute of Mental Health, 1970.
22. The Pediatric Anxiety Rating Scale (PARS): development and
psychometric properties. J Am Acad Child Adolesc Psychiatry 2002;41:1061-1069.
_[CrossRef]_
(http://content.nejm.org/cgi/external_ref?access_num=10.1097/00004583-200209000-\
00006&link_type=DOI
) _[ISI]_
(http://content.nejm.org/cgi/external_ref?access_num=000177597000006&link_type=I\
SI
) _[Medline]_
(http://content.nejm.org/cgi/external_ref?access_num=12218427&link_type=MED)
23. Shaffer D, Gould MS, Brasic J, et al. A Children’s Global Assessment
Scale (CGAS). Arch Gen Psychiatry 1983;40:1228-1231. _[ISI]_
(http://content.nejm.org/cgi/external_ref?access_num=A1983RP17500010&link_type=I\
SI
)
_[Medline]_
(http://content.nejm.org/cgi/external_ref?access_num=6639293&link_type=MED)

24. Miller RG. Simultaneous statistical inference. New York:
McGraw-Hill, 1966.
25. Rynn MA, Siqueland L, Rickels K. Placebo-controlled trial of
sertraline in the treatment of children with generalized anxiety disorder. Am J
Psychiatry 2001;158:2008-2014. _<NOBR Full Text]_
(http://content.nejm.org/cgi/ijlink?linkType=ABST&journalCode=ajp&resid=158/12/2\
008
)
26. Silverman WK, Pina AA, Viswesvaran C. Evidence-based psychosocial
treatments for phobic and anxiety disorders in children and adolescents. J Clin
Child Adolesc Psychol 2008;37:105-130. _[Medline]_
(http://content.nejm.org/cgi/external_ref?access_num=18814641&link_type=MED)
27. Beidel DC, Turner SM, Sallee FR, Ammerman RT, Crosby LA, Pathak S.
SET-C versus fluoxetine in the treatment of childhood social phobia. J Am Acad
Child Adolesc Psychiatry 2007;46:1622-1632. _[ISI]_
(http://content.nejm.org/cgi/external_ref?access_num=000251141800011&link_type=I\
SI
) _[Medline]_
(http://content.nejm.org/cgi/external_ref?access_num=18030084&link_type=MED)
28. Kendall PC, Hudson JL, Gosch E, Flannery-Schroeder E, Suveg C.
Cognitive-behavioral therapy for anxiety disordered youth: a randomized
clinical
trial evaluating child and family modalities. J Consult Clin Psychol
2008;76:282-297. _[CrossRef]_
(http://content.nejm.org/cgi/external_ref?access_num=10.1037/0022-006X.76.2.282&\
link_type=DOI
) _[ISI]_
(http://content.nejm.org/cgi/external_ref?access_num=000254539400010&link_type=I\
SI
) _[Medline]_
(http://content.nejm.org/cgi/external_ref?access_num=18377124&link_type=MED)
29. Chambless DL, Hollon SD. Defining empirically supported therapies. J
Consult Clin Psychol 1998;66:7-18. _[CrossRef]_ (http://content
.nejm.org/cgi/external_ref?access_num=10.1037/0022-006X.66.1.7&link_type=DOI)
_[ISI]_
(http://content.nejm.org/cgi/external_ref?access_num=000071929800002&link_type=I\
SI
)
_[Medline]_
(http://content.nejm.org/cgi/external_ref?access_num=9489259&link_type=MED)
30. Wagner KD, Berard R, Stein MB, et al. A multicenter, randomized,
double-blind, placebo-controlled trial of paroxetine in children and
adolescents
with social anxiety disorder. Arch Gen Psychiatry 2004;61:1153-1162. _<NOBR
Full Text]_
(http://content.nejm.org/cgi/ijlink?linkType=ABST&journalCode=archpsyc&resid=61/\
11/1153
)
31. March JS, Entusah AR, Rynn M, Albano AM, Tourian KA. A randomized
controlled trial of venlafaxine ER versus placebo in pediatric social anxiety
disorder. Biol Psychiatry 2007;62:1149-1154. _[CrossRef]_
(http://content.nejm.org/cgi/external_ref?access_num=10.1016/j.biopsych.2007.02.\
025&link_type=DOI
)
_[ISI]_
(http://content.nejm.org/cgi/external_ref?access_num=000250905800012&link_type=I\
SI
) _[Medline]_
(http://content.nejm.org/cgi/external_ref?access_num=17553467&link_type=MED)
32. Kiesler DJ. Some myths of psychotherapy research and the search for
a paradigm. Psychol Bull 1966;65:110-136. _[CrossRef]_
(http://content.nejm.org/cgi/external_ref?access_num=10.1037/h0022911&link_type=\
DOI
) _[ISI]_
(http://content.nejm.org/cgi/external_ref?access_num=A19667673600005&link_type=I\
SI
)
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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