JMS Posted June 17, 2008 Share Posted June 17, 2008 Just when you thought you understood how low the Administration has taken the United States Governemnt. They suprise you and take it to a new level. http://www.washingtontimes.com/news/2008/jun/17/va-testing-drugs-on-war-veterans/ VA testing drugs on war veterans Experiments raise ethical questions The government is testing drugs with severe side effects like psychosis and suicidal behavior on hundreds of military veterans, using small cash payments to attract patients into medical experiments that often target distressed soldiers returning from Iraq and Afghanistan, a Washington Times/ABC News investigation has found. In one such experiment involving the controversial anti-smoking drug Chantix, the Department of Veterans Affairs (VA) took three months to alert its patients about severe mental side effects. The warning did not arrive until after one of the veterans taking the drug had suffered a psychotic episode that ended in a near lethal confrontation with police. James Elliot a decorated Army sharpshooter who suffers from post-traumatic stress disorder (PTSD) after serving 15 months in Iraq, was confused and psychotic when he was Tasered by police in February as he reached for a concealed handgun when officers responded to a 911 call at his Maryland home. For photos, video of James Elliott, official FDA documents and more, visit the interactive site for the Disposable Heroes report. Mr. Elliott, a chain smoker, began taking Chantix last fall as part of a VA experiment that specifically targeted veterans with PTSD, opting to collect $30 a month for enrolling in the clinical trial because he needed cash as he returned to school. He soon began suffering hallucinations and suicidal thoughts, unaware that the new drug he was taking could have caused them. Just two weeks after Mr. Elliott began taking Chantix in November, the VA learned from the Food and Drug Administration (FDA) that the drug was linked to a large number of hallucinations, suicide attempts and psychotic behavior. But the VA did not alert Mr. Elliott before his own episode in February. In failing to do so, Mr. Elliott said, the VA treated him like a "disposable hero." "You're a lab rat for $30 a month," Mr. Elliott said. One of the nation's premier medical ethicists said the VA's behavior in the anti-smoking study violated basic protections for humans in medical experiments. "When you're taking advantage of a very vulnerable population, people who have served the country, and the agency that's responsible for their welfare isn't putting their welfare first, that's a pretty serious breach of ethics," said Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania. In all, nearly 1,000 veterans with PTSD were enrolled in the study to test different methods of ending smoking, with 143 using Chantix. Twenty-one veterans reported adverse effects from the drug, including one who suffered suicidal thoughts, the three-month investigation by The Times and ABC News found. Mr. Caplan, who reviewed the consent and notification forms for the study at the request of The Times and ABC News, said the VA deserved an "F" and that it has an obligation to end the study, given the vulnerability of veterans with PTSD and the known side effects of Chantix. "Continuing it doesn't make any ethical sense," he said. The VA continues to test Chantix on veterans, even as reported problems with the drug increase and have prompted at least one other federal agency to take action. On May 21, the Federal Aviation Administration banned airline pilots and air traffic control personnel from taking Chantix, citing the adverse side effects. The VA responds VA officials defend their use of veterans in medical studies, saying that helping PTSD sufferers to stop smoking would prolong their lives. As for the three-month delay in notifying its patients about the Chantix problems, the VA said bureaucracy slowed down their warning because the alert letters had to be issued through an Institutional Review Board (IRB) that oversees the experiment at each VA location. "We don't have the authority to just send directly to patients material that has not been approved by the IRB sites,"said Miles McFall, director of the VA's programs for PTSD sufferers. "We did sense urgency. And we respond to that urgency doing just what we did here, which was, I think, incredibly quick response for a governmental institution. "We believe that we took responsible action by informing the clinicians who are the people most in touch with the patients to be on the lookout for any potential side effects and to respond appropriately," he said. While Mr. Elliott blames Chantix for his mental breakdown and confrontation with police, VA officials said they cannot be sure. "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," Mr. McFall said. Mr. McFall said the veterans with PTSD in the anti-smoking study "are at high risk to use tobacco" and the goal of the experiment is to determine how best to deliver treatment - through a mental health counselor or a smoking clinic. Chantix was one of several options tested on the veterans. "FDA approved, and that drug is available to help individuals stop smoking and VA makes that drug available," Mr. McFall said. "It does not deny access to them." Asked about adverse reactions now linked to the drug, Mr. McFall said: "We are certainly aware of FDA warnings and we took all precautions ... so it can be used safely. All drugs have side effects or potential side effects." Dark history of medical tests The government has a controversial history of using military personnel as human research subjects. Mustard gas was tested on the military during World War II, radiation during the early Cold War period, LSD in the 1960s, herbicide in Vietnam and Panama, and chemical and biological warfare drugs during the Gulf War, according to Senate testimony given by the Vietnam Veterans of America (VVA) on July 10, 2002. In most of those cases, few if any military test subjects were informed of the potential health consequences of the exposure. "We have a phrase to describe this phenomenon - the disposable soldier syndrome," said Richard Weidman, former VVA director of government relations. The most infamous government experiment is the Tuskegee Syphilis Study conducted by the U.S. Public Health Service from 1932 through 1972, which used 400 poor and uneducated black male sharecroppers who carried the sexually transmitted disease. The men were purposely undiagnosed and untreated for a disease that already had progressed to late stages, and were studied through autopsy. The government effectively blocked the unwitting participants, who also were drafted in 1940 to serve in WWII, from receiving medical treatment for symptoms they were told were caused by "bad blood." Of the participants, 28 men died of the disease, 100 others died from complications brought on by syphilis, and the disease spread to 40 wives and 19 children. Link to comment Share on other sites More sharing options...
China Posted June 17, 2008 Share Posted June 17, 2008 There are rules for protection of subjects in clinical trials. If the VA followed the rules, then no problem. It's not clear from the article whether the patients underwent proper informed consent procedures. From what you quoted it looks at least as if the patients were not informed in a timely manner of possible serious adverse effects, and it brings up the question as to whether the overseeing IRB was informed in a timely manner and if so, what, if any, actions they recommended. Link to comment Share on other sites More sharing options...
Tulane Skins Fan Posted June 17, 2008 Share Posted June 17, 2008 Yikes. Not exactly a liberal newspaper either. Link to comment Share on other sites More sharing options...
GibbsFactor Posted June 17, 2008 Share Posted June 17, 2008 Are we cropping the next McCain. :whoknows: Link to comment Share on other sites More sharing options...
Kilmer17 Posted June 17, 2008 Share Posted June 17, 2008 What a terrible title. You make it seem like they are doing it without their knowledge or permissiion. They are offering and paying them. When I was in the hospital, I had the opportunity to test something too. I declined, but the offer was made. Link to comment Share on other sites More sharing options...
Prosperity Posted June 17, 2008 Share Posted June 17, 2008 What's the problem here? Link to comment Share on other sites More sharing options...
Cskin Posted June 17, 2008 Share Posted June 17, 2008 Well...we should see a flood of "Oh Noes and OMGs!!" and "Bush lied / people died" Lefties entering momentarily. 3......2......1...... Link to comment Share on other sites More sharing options...
Tulane Skins Fan Posted June 17, 2008 Share Posted June 17, 2008 I think the paper is saying that the patients were never given proper information regarding the potential side effects. Even if you offer someone experimental drugs, there are rules for gaining the consent of someone you offer them to. I'm not saying I know those rules. I also wonder if these drugs are ONLY being offered to vets. and if so, why? Is the VA giving them less information than other hospitals give when they offer experimental drugs? Lots of questions... Link to comment Share on other sites More sharing options...
JMS Posted June 17, 2008 Author Share Posted June 17, 2008 You make it seem like they are doing it without their knowledge or permissiion. They are paying them 30$ a month and offering them drugs without telling the soldiers that their are "severe side effects like psychosis and suicidal behavior" with the drugs.. I think the title is accurate.... They are offering and paying them. 30$ a month!... When I was in the hospital, I had the opportunity to test something too. I declined, but the offer was made. Maybe they gave it to you in your water and you didn't even know about it... That would explain a lot. Link to comment Share on other sites More sharing options...
Kilmer17 Posted June 17, 2008 Share Posted June 17, 2008 1- If 30.00 isnt enough, they dont have to do it. 2- The point of clinical trials is to FIND OUT what the side affects are going to be if any. Link to comment Share on other sites More sharing options...
JMS Posted June 17, 2008 Author Share Posted June 17, 2008 I also wonder if these drugs are ONLY being offered to vets. and if so, why? Is the VA giving them less information than other hospitals give when they offer experimental drugs? The front page top pannel article in today's washington times says they were targeting veterins suffering from post tramatic stress disorder with drugs that induce psychosis and suicidal behavior. It's possible they targeted these soldiers because they were more suseptable to the negative side effects of the drugs and thus were better candidates for the study. The article doesn't make that conclusion... I just connected the dots. Link to comment Share on other sites More sharing options...
JMS Posted June 17, 2008 Author Share Posted June 17, 2008 1- If 30.00 isnt enough, they dont have to do it. Yeah but Billy, If I gave you 30$ a month to take an anti smoking drug you might consider it. Especially if I left out the part about it inducing psychosis and suicidal behavior..... What soldier suffering from Post Tramatic Stress Disorder do you think would be a good candidate for a drug which induces "suicidal behavior"? 2- The point of clinical trials is to FIND OUT what the side affects are going to be if any. Yeah these guys are likely a great cheap resource to the drug companies. I just wonder if the VA is looking out for the soldiers as I a tax payer would want, or if they are looking out after something I would deem less altuistic. Link to comment Share on other sites More sharing options...
Destino Posted June 17, 2008 Share Posted June 17, 2008 Kilmer stop ignoring the obvious - they didn't tell them about the side effects before giving the drugs to them. otherwise all I have to say is: damn the liberal media. Link to comment Share on other sites More sharing options...
Kilmer17 Posted June 17, 2008 Share Posted June 17, 2008 Once again for the "BUSH IS THE DEBIL" folks. The point of trials is to find out what the side affects could be. So tell us, how are they supposed to tell the Vets what the side affects will be, if that is the reason for the trials? Are you claiming that they KNEW what the side affects would be in advance, but thought a round of playing Mengele was intriguing to them? Link to comment Share on other sites More sharing options...
Vicious Posted June 17, 2008 Share Posted June 17, 2008 Just two weeks after Mr. Elliott began taking Chantix in November, the VA learned from the Food and Drug Administration (FDA) that the drug was linked to a large number of hallucinations, suicide attempts and psychotic behavior. But the VA did not alert Mr. Elliott before his own episode in February. Link to comment Share on other sites More sharing options...
Tulane Skins Fan Posted June 17, 2008 Share Posted June 17, 2008 Once again for the "BUSH IS THE DEBIL" folks.The point of trials is to find out what the side affects could be. So tell us, how are they supposed to tell the Vets what the side affects will be, if that is the reason for the trials? Are you claiming that they KNEW what the side affects would be in advance, but thought a round of playing Mengele was intriguing to them? I think you are the only one who has mentioned George Bush in this thread. Link to comment Share on other sites More sharing options...
JMS Posted June 17, 2008 Author Share Posted June 17, 2008 Once again for the "BUSH IS THE DEBIL" folks. Did bush actually say that... Debil? Like Nuclearure? or the Decider? The point of trials is to find out what the side affects could be. So tell us, how are they supposed to tell the Vets what the side affects will be, if that is the reason for the trials? Well I would say they should have called the food and drug administration which had alerady documented these drugs causeing "psychosis and suicidal behavior". But they didn't even have to do that, because according to the Article the FDA called them. Are you claiming that they KNEW what the side affects would be in advance, but thought a round of playing Mengele was intriguing to them? Yeah, now you are getting it. We don't know if they knew before the study started, they should have known.. But there is documented evidence that they knew early on during the study.... And yest Dr Megele thought he was doing good research too. Just two weeks after Mr. Elliott began taking Chantix in November, the VA learned from the Food and Drug Administration (FDA) that the drug was linked to a large number of hallucinations, suicide attempts and psychotic behavior. But the VA did not alert Mr. Elliott before his own episode in February. Link to comment Share on other sites More sharing options...
Kilmer17 Posted June 17, 2008 Share Posted June 17, 2008 "Just when you thought you understood how low the Administration has taken the United States Governemnt. They suprise you and take it to a new level." First line of the entire thread. Link to comment Share on other sites More sharing options...
JMS Posted June 17, 2008 Author Share Posted June 17, 2008 "Just when you thought you understood how low the Administration has taken the United States Governemnt. They suprise you and take it to a new level."First line of the entire thread. Yeah that was mine.. Link to comment Share on other sites More sharing options...
buenosdiaz Posted June 17, 2008 Share Posted June 17, 2008 The government is testing drugs with severe side effects like psychosis and suicidal behavior on hundreds of military veterans, using small cash payments to attract patients into medical experiments that often target distressed soldiers returning from Iraq and Afghanistan, a Washington Times/ABC News investigation has found. In one such experiment involving I think this is the disturbing part, liberal or conservative that is wrong, especially administering the test before the FDA has examined it Link to comment Share on other sites More sharing options...
Kilmer17 Posted June 17, 2008 Share Posted June 17, 2008 How SHOULD drug companies conduct trials? If not by paying people, and exposing them to potential, sometimes deadly, side affects? If there is another way, Im sure they'd like to hear about it. Link to comment Share on other sites More sharing options...
Tulane Skins Fan Posted June 17, 2008 Share Posted June 17, 2008 "Just when you thought you understood how low the Administration has taken the United States Governemnt. They suprise you and take it to a new level."First line of the entire thread. I stand corrected... I was looking for "Bush," but missed that. IMO, I dont like it to Bush, but still think this is shady dealing. Link to comment Share on other sites More sharing options...
Tulane Skins Fan Posted June 17, 2008 Share Posted June 17, 2008 How SHOULD drug companies conduct trials?If not by paying people, and exposing them to potential, sometimes deadly, side affects? If there is another way, Im sure they'd like to hear about it. Is it clear that these guys KNEW that they were part of a trial? Or did they just believe they were getting drugs that may or may not help them. Because you have to let people know you are experimenting on them in the first place. bottom line to me is that the article is a little ambiguous, but it raises questions. Link to comment Share on other sites More sharing options...
JMS Posted June 17, 2008 Author Share Posted June 17, 2008 I think this is the disturbing part, liberal or conservative that is wrong, especially administering the test before the FDA has examined it Correction, not before the FDA examined it. The side effects of the drugs were kown to the FDA before the study started and the FDA informed the VA of the side effects 2 weeks into the study. What I don't understand is who was doing the study? Who paid the 30$!! I think they are the yet to be uncovered scum bags. What exactly where they studying, and why did they target soldiers with PTSD. Link to comment Share on other sites More sharing options...
Kilmer17 Posted June 17, 2008 Share Posted June 17, 2008 You think the guys thought they were getting paid by drug companies (or whoever stroked the check) for something else? I think it's obvious they knew they were part of it. If not, I'll certainly change my stance. Link to comment Share on other sites More sharing options...
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