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

lone bugler

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im not sure if this has already been posted but i am disgusted hope it ends right now and that it will never happen in Canada
link: http://abcnews.go.com/Blotter/story?id=5180437&page=1

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.
Mentally distressed veterans are recruited for questionable drug trial.

The report will air on Good Morning America and will also appear in The Washington Times on Tuesday.

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.

"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.

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

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.

"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.
 
lone bugler said:
im not sure if this has already been posted but i am disgusted hope it ends right now and that it will never happen in Canada

And how do you think clinical trials should be (are being) conducted? Is your disgust due to the aggrieved participants being veterans or that a drug trial would use patients who may suffer from a particular condition?  It is very common these days to “sell” a story or point of view by connecting it to “veterans” or “soldiers”.  While I would question the conduct of the researchers in the Chantix study, there is not enough information given in the story to determine whether the study participants gave “informed consent”, but my first impression is that it did not meet the requirements.  It would not be the first or last time that a pharmaceutical company or a doctor conducting a study cut corners.

As to the number of clinical drug studies that are, according to the story, being conducted at the VA -- not surprising.  One of the most important parts of a clinical drug trial is patient (study participant) recruitment.  Not only must the study recruit enough patients for the study, those that are recruited must complete the study.  Using a large institutional patient base, like that provided by the VA, is often the most effective method of recruiting sufficient study participants.  Similarly, studies often recruit on colleges and prisons.  They have relatively stable participant bases that can be predicted to remain in the area (for a measured period of time) and generally their medical care is centralized and thus can be monitored.
 
So one guy "snapped" and another 140 people (also diagnosed with PTSD) are on the same drug with no problems so far?  Hmmm.  Make you think, eh?
 
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