Friday, June 20, 2008

Veterans Used To Test Suicide-Linked Drugs

[2 articles]

'Disposable Heroes': Veterans Used To Test Suicide-Linked Drugs

http://abcnews.go.com/Blotter/story?id=5180437&page=1

An ABC News and Washington Times Investigation Reveals Vets Are Being
Recruited for Government Tests on Drugs with Violent Side Effects

By BRIAN ROSS and VIC WALTER
June 17, 2008

Mentally distressed veterans from Iraq and Afghanistan are being
recruited for government tests on pharmaceutical drugs linked to
suicide and other violent side effects, an investigation by ABC News
and The Washington Times has found.

The report will air on Good Morning America and will also appear in
The Washington Times on Tuesday. (click here to read the Washington
Times coverage of "Disposable Heroes")

In one of the human experiments, involving the anti-smoking drug
Chantix, Veterans Administration doctors waited more than three
months before warning veterans about the possible serious side
effects, including suicide and neuropsychiatric behavior.

"Lab rat, guinea pig, disposable hero," said former US Army sniper
James Elliott in describing how he felt he was betrayed by the
Veterans Administration.

Elliott, 38, of suburban Washington, D.C., was recruited, at $30 a
month, for the Chantix anti-smoking study three years after being
diagnosed with Post Traumatic Stress Disorder. He served a 15-month
tour of duty in Iraq from 2003-2004.

Months after he began taking the drug, Elliott suffered a mental
breakdown, experiencing a relapse of Iraq combat nightmares he blames
on Chantix.

"They never told me that I was going to be suicidal, that I would
cease sleeping. They never told me anything except this will help me
quit smoking," Elliott told ABC News and The Washington Times.

On the night of February 5th, after consuming a few beers, Elliott
says he "snapped" and left his home with a loaded gun.

His fiancee, Tammy, called police and warned, "He's extremely
unstable. He has PTSD."

"Do you think that he is going to shoot or attack the police?" the
911 dispatcher asked.

"I can't be certain. I don't know," she said. (click here to hear
part of Tammy's 911 call)

"He was operating as if he was back in theater, in combat theater,"
she told ABC News. "And of course, a soldier goes nowhere without a gun."

When police arrived, they found Elliott in the street, with the gun
in the front pocket of his hooded sweatshirt.

"Are you going to shoot me? Shoot me," Elliott said, according to the
police report. (click here to see the police report)

Police used a Taser gun to stun Elliott and placed him under arrest.

It wasn't until three weeks later that the Veterans Administration
advised the veterans in the Chantix study that the drug may cause
serious side effects, including "anxiety, nervousness, tension,
depression, thoughts of suicide, and attempted and completed suicide."

The VA's letter to the veterans, on February 29, 2008, followed three
warnings from the FDA and Chantix' maker Pfizer, that were issued on
November 20, 2007, January 18, 2008 and February 1, 2008. (click here
to read the FDA warning and click here to read Pfizer's statement on Chantix)

"How this study continued in the face of these difficulties is almost
impossible to understand," said Arthur Caplan, director of the Center
for Bioethics at the University of Pennsylvania.

Doctors at the Veterans Administration say they acted as quickly as
they could.

"This didn't justify an emergency warning at that level," said Dr.
Miles McFall, co-administrator of the VA study.

Dr. McFall said there is no proof that Elliott's breakdown was caused
by Chantix and he sees no reason to discontinue the study. Some 140
veterans diagnosed with Post Traumatic Stress Disorder continue to
receive Chantix as part of a smoking cessation study.

Dr. McFall says the VA decided to continue the Chantix study because
"it would be depriving our veterans of an effective method of
treatment to help them stop smoking."

Caplan, one of the country's leading medical ethicists, said he was
stunned by the VA's decision to continue the Chantix experiment.

"Why take the group most a risk and keep them going? That doesn't
make any sense, once you know the risk is there," he said.

Chantix is one of the drugs being used in an estimated 25 clinical
studies using veterans by the VA.

Pfizer maintains that "the benefits of Chantix outweigh the risks"
and that it continues to do further studies on the drug.

The FAA has prohibited commercial airline pilots from using Chantix
because of its possible side effects.

--------

Test nearly lethal, veteran says

http://www.washingtontimes.com/news/2008/jun/17/test-nearly-lethal-veteran-says/

Anti-smoking medication linked to psychotic, suicidal episodes

Audrey Hudson
Tuesday, June 17, 2008

James Elliott thought his recurring nightmares of exploding bombs,
dogs eating corpses, a child's head blown off its body and other war
horrors from his Iraq tour had ended in 2004 when he returned to his
home in Silver Spring.

The Army veteran sniper was earning high grades in college and got
engaged to be married. His post-traumatic stress disorder (PTSD) had
disappeared.

He even signed up for a Veterans Affairs experiment to kick his habit
of nearly three packs of cigarettes a day using the drug Chantix, and
was succeeding.

But after two weeks on the drug, his night terrors returned with a
vengeance, and his fiancee built a wall of stuffed animals across
their bed to serve as a security buffer.

"I just thought she really liked stuffed animals," said Mr. Elliott, 38.

Within a few weeks of his taking Chantix, VA officials learned the
drug was causing serious side effects across the nation, including
psychotic behavior, suicides and suicidal tendencies. But the agency
took three months to get that warning through its system and to the
veterans in the study.

Night after night, Mr. Elliott violently thrashed against the plush
toys in his sleep, shouting for air strikes, replaying the horror of
watching friends bleed to death.

"This went on for 2 1/2 months. It just got worse night by night,"
Mr. Elliott said.

He stopped eating and drank massive amounts of coffee or Mountain Dew
to stay awake. Then the nightmares turned to hallucinations. He saw
strangers in the neighborhood wearing suicide vests and was certain
that nearby cars were tagged with improvised explosive devices (IEDs).

"They couldn't come and get me if I was awake and waiting for them,"
Mr. Elliott said.

His fiancee called the police on Feb. 5, concerned he might hurt
himself. She called police a second time when she discovered his
pistol was missing from its holster. As a skilled marksman, he was an
even bigger threat to the police, she thought.

"I don't want him to hurt anybody," she told the 911 dispatcher, but
added "he has talked in the past about killing himself."

After spending several days in jail and weeks in a veterans hospital,
Mr. Elliott now says it was a miracle the police did not kill him.
Instead, officers used a Taser to subdue him. In his pocket, they
found a loaded .40-caliber pistol with one live round in the chamber.

In an interview with The Washington Times weeks after he was
arrested, Mr. Elliott pondered his actions that lead to his being
Tasered - "why did I put the gun in my pants, suicide by cops?" he asked.

JAMES ELLIOT PHOTOGRAPHS Iraq war veteran James Elliott of Silver
Spring is seen here in Baghdad. Mr. Elliot was taking the
prescription drug Chantix to help him stop smoking. The drug has been
linked to psychotic and suicidal behavior.

According to the police report, Mr. Elliott shouted, "Are you going
to shoot me? Shoot me!" after the officers ordered him to show his
hands. As Mr. Elliott was being transported to a nearby police
station, he asked the cops why they did not shoot him.

"I would have shot me," he said.

Mr. Elliott stopped taking the drug and received several weeks of
treatment, blaming the drug for his outburst. He pleaded guilty to
criminal charges resulting from the confrontation with police and was
given probation this month.

Though hallucinations and suicidal tendencies have been declared
potential side effects of Chantix, VA officials involved in the study
are unwilling to blame the drug for Mr. Elliott's breakdown.

Dr. Miles McFall, director of the VA's programs for PTSD sufferers,
told The Times and ABC News during a joint investigation that "we
don't know that Chantix was the cause of this, first of all. And it's
presumed that that's the case. We don't know that to be a fact."

"Suicidality and aggressive impulses [are] part and parcel of their
disorder," Dr. McFall said of PTSD patients.

Mr. Elliott's fiancee called the police on Feb. 5, concerned he might
hurt himself. As a skilled marksman, he was an even bigger threat to
the police, she thought.

After Mr. Elliott's breakdown, he and his fiancee reached out for
help to retired Marine Lt. Col. Roger Charles, editor of
DefenseWatch, the Internet newsmagazine of Soldiers For The Truth
(SFTT), www.sftt.org, a nonprofit educational foundation founded by
the late Col. David H. Hackworth and his wife, Eilhys England, to act
as an advocate for front-line troops.

"This idea that you would take people that already are diagnosed with
mental issues and then give them a drug that appears early on to have
some likelihood of exacerbating such issues. I understand why they
want vets to quit smoking - for financial, health and moral issues -
but I don't understand why they would give it to men and women
struggling for mental normality," Col. Charles said.

"For veterans who serve their country, and in doing so, picked up
mental issues, I would think you would go the extra mile to keep them
from jeopardizing their ability to function normally," Col. Charles said.

Mr. Elliott says "the carrot they dangled in front of my face" to
join the study was $30 a month for the three-year program, which he
initially began with the use of nicotine patches and chewing gum.

"I knew it was a research project, but I also needed the money," Mr.
Elliott said.

Veterans are now warned that Chantix "may make current psychiatric
symptoms that you are experiencing worse, or may make old psychiatric
symptoms return."

But that warning came three weeks after Mr. Elliott suffered his
breakdown and tangled with police.

.

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