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Handling of drug trials an 'unacceptable' failure
Iraq war veteran James Elliott smokes a cigarette outside of the Veterans Affairs Medical Center in Washington D.C., Thursday April 10, 2008. James was taking the prescription drug Chantix to help people stop smoking. The drug has been linked to psychotic and suicidal behavior, and deaths. (Rod Lamkey Jr/The Washington Times)
The Veterans Affairs Department is responsible for numerous "unacceptable failures" in ensuring safeguards for soldiers with post-traumatic stress disorder who were enrolled in a medical experiment to help them stop smoking, an internal review found Friday.
Despite the stinging report, the agency has decided to proceed with the experiment, including allowing participants to take a drug that carries risks of suicide and other psychotic behavior, officials said.
The investigation, prompted by a series of stories earlier this summer in The Washington Times as part of a joint investigation with ABC News, said that the smoking cessation study "did not adequately fulfill VA's singular responsibility to maximize safeguards for veterans who volunteer to participate in research."
The review by the VA's Office of Research Oversight (ORO) also found "unacceptable failures to maximize safeguards for the veterans who had volunteered to participate" in the study, including the lack of a system in place to alert researchers and participants when drug safety warnings are issued.
Researchers responsible for the smoking cessation study first failed to notify internal review boards that oversaw the experiment at 10 locations when the Food and Drug Administration (FDA) first publicized concerns in November that the drug varenicline, commercially known as Chantix, may induce suicidal thoughts or actual suicides.
Read the full story here
IWanttoQuitSmoking.com Hypnosis
http://www.washingtontimes.com/news/2008/sep/19/report-safety-lax-va-experiment/ Link
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Iraq war veteran James Elliott smokes a cigarette outside of the Veterans Affairs Medical Center in Washington D.C., Thursday April 10, 2008. James was taking the prescription drug Chantix to help people stop smoking. The drug has been linked to psychotic and suicidal behavior, and deaths. (Rod Lamkey Jr/The Washington Times)
The Veterans Affairs Department is responsible for numerous "unacceptable failures" in ensuring safeguards for soldiers with post-traumatic stress disorder who were enrolled in a medical experiment to help them stop smoking, an internal review found Friday.
Despite the stinging report, the agency has decided to proceed with the experiment, including allowing participants to take a drug that carries risks of suicide and other psychotic behavior, officials said.
The investigation, prompted by a series of stories earlier this summer in The Washington Times as part of a joint investigation with ABC News, said that the smoking cessation study "did not adequately fulfill VA's singular responsibility to maximize safeguards for veterans who volunteer to participate in research."
The review by the VA's Office of Research Oversight (ORO) also found "unacceptable failures to maximize safeguards for the veterans who had volunteered to participate" in the study, including the lack of a system in place to alert researchers and participants when drug safety warnings are issued.
Researchers responsible for the smoking cessation study first failed to notify internal review boards that oversaw the experiment at 10 locations when the Food and Drug Administration (FDA) first publicized concerns in November that the drug varenicline, commercially known as Chantix, may induce suicidal thoughts or actual suicides.
Read the full story here
IWanttoQuitSmoking.com Hypnosis
http://www.washingtontimes.com/news/2008/sep/19/report-safety-lax-va-experiment/ Link
Hypnosis Basics (video below)
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posted by Mark Barrus (888) 865 -1870 @ 2:29 PM
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