"Those in the VA who failed to properly notify America's veterans that their medication could produce fatal side effects must resign their positions," said Lisicki, a Vietnam combat veteran from Carteret, N.J. "If not, then the VA secretary must take decisive action to terminate their employment."
The VA’s smoking cessation research program uses the drug Chantix, which Food and Drug Administration officials say helps people to stop smoking. But according to a June 17 Washington Times/ABC News investigative report, Chantix has also been linked nationally to almost 40 suicides and more than 400 incidents of suicidal behavior. The drug's manufacturer and the FDA have recently cautioned healthcare providers about adverse side effects that could produce changes in behavior ranging from anxiety and depression to suicide.
As reported last month, all 940 veterans enrolled in the VA's smoking cessation program have PTSD. A test group of 143 was selected to receive Chantix, also known as Varenicline. However, as the Washington Times revealed this morning, the VA actually had 241 veterans participating in the Chantix test group – 68 percent more than they originally acknowledged – and 75 of them had reported 114 serious adverse side effects, to include 22 psychiatric events.
In addition to the 241 PTSD-diagnosed veterans in the smoking cessation program, the VA had also prescribed Chantix to 32,000 other eligible veterans. The Washington Times reported that an internal VA review – that began last October and concluded in mid-March – found that 27 veterans were admitted to VA hospitals for psychiatric problems, 11 had attempted suicide, one attempted homicide, nine had suicidal thoughts, and six were suffering from hallucinations.
Lisicki questions why VA clinicians, who knew of Chantix's hazardous side effects, would allow any patient to continue taking it. "Professional ethics and common sense just dictates that clinicians would stop their patients from taking the drug just to err on the side of safety for the veterans and their families," he said.
On May 21, the Federal Aviation Administration banned the use of Chantix by airline pilots and air traffic controllers. On May 30, the VA issued a bulletin to warn against operating heavy machinery while using Chantix because of the potential for impairing side effects ranging from loss of consciousness and seizures to hallucinations. On June 18, the VA updated its guidelines to doctors for prescribing Chantix, and on June 19, almost nine months after the VA first began collecting data on the potential side effects of Chantix, the VA issued a letter to warn its 32,000 patients of possible suicidal side effects.
The VFW national commander also questions the leadership ability of those who oversee these types of medical research programs, asks why the VA doesn't have a solid handle on the correct number of patients it prescribes medications to under medical research conditions, and wonders what other information has yet to be uncovered. Aside from Chantix, other drugs reportedly used to treat veterans with PTSD are the anticonvulsant Divalproex, and the antidepressants Paroxetine, Mirtazapine and Citalopram, all of which carry warnings of potential suicidal side effects.
"The VA is known for quality healthcare that is delivered by highly trained and educated medical professionals and staff, but in recent months, the American public has read stories accusing the department of not properly taking care of veterans with mental health problems, to include veterans attempting suicide under VA care. These stories, to include the well-documented veterans' claims backlog, are having a negative cumulative effect on the overall image of the VA," said Lisicki.
"This Chantix issue thrown into the mix indicates to me that it is time for massive changes within the VA, because there is ample evidence of a serious lack of leadership, management and accountability within the organization," he said.
Lisicki said this problem is not new, nor is it political, because elected leaders from both sides of the aisle have called for accountability; they just have not seen it coming from VA leadership.
"VA Secretary James Peake is an honorable professional who has only been at VA for seven months, but it is obvious that those he has entrusted to help him carry out VA’s mission are not doing their jobs," he said.
"The VFW and I, and probably most Americans, firmly believe that veterans have earned the right to better care than what was provided by the VA program managers and clinicians in this smoking cessation research program. These people knew for months that the use of Chantix could produce potentially lethal side effects in veterans diagnosed with PTSD, yet they did nothing to warn their patients. They must be terminated because they failed to do the right thing for veterans."
Lisicki also wants Congress to more aggressively exercise their oversight role of the VA, and to hold VA officials accountable when they do not receive full and timely answers to their questions. He said Congress should also look into the FDA's notification procedures for alerts and product recalls, with hopes of ensuring that patients, as well as clinicians, are notified when alerts are published.
"Those who are entrusted to care for America’s heroes must be held to a much higher standard than others," said Lisicki. "It is painfully obvious that many in VA leadership positions are not capable of that standard. America’s veterans of all wars deserve better."