By Leonard J. Selfon, J.D., CAE
A recent ABC News / Washington Times investigative report has disclosed that the U.S. Department of Veterans Affairs (VA) has been using veterans to test the effectiveness of drugs that have been shown to have potentially life-threatening side-effects. Worse still, the VA has hidden or downplayed the risks of taking these medications while recruiting veterans to participate in such tests.
Last fall, the VA offered veterans of the wars in Iraq and Afghanistan who suffer from post-traumatic stress disorder (PTSD) $30 a month to participate in a smoking cessation study. About 1000 veterans participated in the study and 143 were given the antismoking drug Varenicline (Chantix). In November 2007, the U.S. Food and Drug Administration (FDA) issued an alert that linked Chantix to suicidal thoughts, psychosis and violent behavior. Following the FDA’s announcement of Chantix’s dangerous side effects, the Federal Aviation Administration banned the use of Chantix among pilots and air traffic controllers. Nevertheless, the VA waited more than three months before warning veterans about the possible side effects in a letter sent to the test participants.
During the course of the study, 26 veterans who took Chantix reported that they had experienced “serious” side effects, including hallucinations, violent outbursts and suicidal thoughts. One veteran had to be tasered by police and was arrested after his fiancé reported that he had retrieved his gun and was acting strangely.
The VA’s letter to the veterans warned of psychiatric side effects, but did not discuss suicidal thoughts as being one of the dangers. In defense of its continuing to use Chantix in the program, the VA maintained that the notification letters had been tied up in the bureaucracy and that a three-month lag time does not constitute an unreasonable delay. The VA explained that it did not mention suicide as a risk of using Chantix because some veterans who had taken it were elderly or had eyesight problems.
This kind of human drug testing is not new to the VA. There have been similar programs in the past since a 2000 Government Accountability Office report forced the termination of a VA clinical drug trial in Los Angeles where the VA failed to warn participants about the dangerous side effects of the drug that was being tested. The VA is currently engaged in more than 20 drug testing programs using veterans.
The VA’s drug testing practices have been severely criticized by leading medical ethicists. They categorically deplore the VA’s continued use of known dangerous drugs, the delay in warning veterans that drugs they have been given have potentially life-threatening side effects and the pathetic excuse that veterans may be too old or visually impaired to understand a meaningful warning notice.
Meanwhile, members of Congress have ordered the suspension of the Chantix testing program and an investigation by the VA Inspector General into that study and other VA drug testing programs.
Although offering a small amount of money as a recruitment incentive for participation in clinical drug trials is a common practice in government and private drug testing programs, offering nominal payments to often lower-income veterans seems unfair and manipulative, This is especially true when they suffer from a psychiatric disorder such as PTSD which already predisposes them to violent and suicidal behavior. No matter how well intentioned or beneficial these programs may be, the VA must balance their advantages against health risks to its patients. The VA should be held accountable for any direct or indirect violation of the first rule of medical practice: Do No Harm.
VetsFirst strongly encourages any veterans who has participated, or is currently participating, in any VA drug testing program to keep all of the paperwork associated with the test and to document the drug(s) taken, the dosage and any short- or long-term side effects experienced. This information will be useful if the veteran subsequently develops a disability as a result of the drug taken and pursues a claim for VA compensation and/or health care in the future.
Leonard J. Selfon is United Spinal Association’s Senior Vice-President for VetsFirst.
