June 17, 2008

Military Vets Used As Research Guinea Pigs

The Washington Times and ABC News have teamed up on an investigative report in which it's revealed that the VA has been enrolling Iraq vets and others as research subjects for drugs with dangerous side effects. Case in point: one vet with severe PTSD was placed in research for Chantix, Pfizer's star-crossed stop smoking drug, and completely lost control of himself and almost lost his life in a confrontation with police.

"Within a few weeks of his [James Elliott, former Army sniper] 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."

You have to wonder how widespread this sort of thing is within the VA and how much money the government is making in the bargain.

I know there's a place for the vets and the VA in research, but Chantix doesn't exactly scream "life saving cancer treatment" and you wish the VA would be a bit more selective in choosing who goes into what research projects. And, what kind of follow-up there is relative to side effects.

Then again, the military does have an odd history of testing substances on soldiers, with or without their knowledge such as famous episodes involving LSD and Agent Orange. Those are inexcusable, the Chantix episode is merely highly questionable.

Posted by Philip Dawdy at June 17, 2008 08:11 AM
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Yes, we agree- these drugs can be bad. But are you saying that no research should be done through VA? Va potentially may be a league more ethical than university-based research. Much VA reserch is done in conjunction with an academic institution, requiring TWO separate ethics review committees for any single study. VA has a vested interest in NOT harming their patients because VA is THE provider for the rest of the patients/subjects' lives. Adverse events can be tracked much more validly in the VA system because, again, they are providing ALL the care: cardiac, gastro, neuro, ER, etc. Also, VA reviews and assesses research priorities - they don't just give reserchers a blank check to go study whatever.

As a single example of very valuable resarch on ptsd, although it is barely utilized for this purpose (because there is no money to be made from an expired-patent medication), prazocin for sleep in people with ptsd has been clearly indicated based almost entirely on VA research (just put 'prazocin' and 'sleep' in medline).

What would you suggest other than IRB-approved, data-safety-monitoring-board-reviewed, academic-affiliation-involved research where the resaerch body is totally responsible for any and all follow-up health care costs?

Forgive my tone if all of this is new to you. But it is foolish to say that VA resaerch in general in the present day is the same as the military trying to secretly test new vaccinations on active military with no informed consent process.

Posted by: what? at June 17, 2008 11:42 AM

I'm not understanding the article.
It seems that after James Elliott took Chantix he was fine. At least this is what written in the third paragraph:

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

But he, of course, will have these war memories for the rest of his life.
At least it's what usually happens with vets from all wars either they are treated as "war neurotics" back on the Vietnam times or now PTSD.

The reason he decided to go on Chantix:

"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..

Healthy people volunteer do these trails for the same reason: money.


But, as he was diagnosed as having PTSD he cannot have the same reactions that other people who just took Chantix to quit smoking!

As he is a mental patient no matter what he do it will always be considered as a problem linked with his diagnose.

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

So Chantix had just exacerbated his inner feelings.

What about people who behaved violently because of Chantix?
Philip has a post on a man who felt almost the same after two weeks on Chantix.

Things are quite complex!

Posted by: Ana at June 17, 2008 02:12 PM

From the review "The Influence of Pharmaceutical Industry"
39.Many large-scale Phase II and III trials are currently being carried out in Eastern
Europe and elsewhere as a result of high costs imposed here.36 Dr Malcolm Boyce,who
runs a London-based Contract Research Organisation (CRO),stressed:
A strong pound sterling makes matters worse for overseas companies.For those
reasons,companies are increasingly placing their Phase II and III trials outside the
UK,in low cost areas such as Eastern Europe,Russia and India.37 p. 18

Some of these trials are carried on people who are on hospital without their knowledge.
We remember the TGN1412 case that was highly reported because it happened in London.
I wonder what is going on at some hospitals in India and other poor countries.

Posted by: Ana at June 17, 2008 02:22 PM
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