June 18, 2008 -- At least three more members of Congress are calling for an immediate suspension of government tests on veterans involving an anti-smoking drug that has been linked to suicide.
"Nearly 40 suicides and more than 400 incidents of suicidal behavior have been linked to Chantix, yet the VA has chosen to continue the study and administer Chantix to veterans with PTSD," said Congressman Bob Filner (D-CA).
"The VA must immediately suspend this study until a comprehensive review of the safety of the protocol is conducted," said Rep. Filner.
Rep. Filner along with Rep. Ed Markey (D-MA) and Rep. Paul Hodes (D-NH) sent a letter to the Secretary of Veterans' Affairs today expressing their concern over the ABC News report and asking, among other things, for copies of consent and notification forms related to the study.
"Allowing, even encouraging, military veterans who have already made enormous sacrifices for our country to participate in drug studies that may cause serious, long-lasting health effects is tantamount to breaking our national promise to honor and support our veterans," said Rep. Markey today.
Yesterday, a report on Good Morning America revealed that mentally distressed veterans from Iraq and Afghanistan are being recruited for government tests on pharmaceutical drugs linked to suicide and other violent side effects. The report was the result of a joint investigation by ABC News and The Washington Times.
In one of the human experiments, involving the anti-smoking drug Chantix, Veterans Administration doctors waited more than three months before warning veterans about the possible serious side effects of Chantix, including suicide and neuropsychiatric behavior.
"Lab rat, guinea pig, disposable hero," said former US Army sniper James Elliott in describing how he felt he was betrayed by the Veterans Administration.
Elliott, 38, of suburban Washington, D.C., was recruited, at $30 a month, for the Chantix anti-smoking study three years after being diagnosed with Post Traumatic Stress Disorder. He served a 15-month tour of duty in Iraq from 2003-2004.
Months after he began taking the drug, Elliott suffered a mental breakdown, experiencing a relapse of Iraq combat nightmares he blames on Chantix.
Veterans groups are also expressing their anger over the study.
Veterans groups are also expressing their anger over the study and are also calling for the studies to be ceased and for an investigation.
"Our nation's veterans are not guinea pigs," said Paul Rieckhoff, executive director of Iraq and Afghanistan Veterans of America. "It is unacceptable for even one veteran to have been misled about the possible side effects of Chantix."
The executive director of Veterans for Commons Sense said that this is yet another example of the VA failing America's veterans.
"VA should have done a better job protecting the human rights of our veterans," said Paul Sullivan of VCS.
"While VCS supports research to assist veterans, VA must bear a heavy burden of responsibility with these experiments on veterans diagnosed with PTSD," said Sullivan, who is also calling for an immediate suspension of the study.
Meanwhile, the VA is calling the ABC News/ Washington Times report "inaccurate and misleading".
"In our PTSD and smoking cessation study, our research is to learn if it is easier to stop smoking when smoking cessation treatment is combined with PTSD therapy, or whether the two therapies are more effective if they are provided separately," said a statement posted on the VA website.
"In either case, patients are receiving treatment recommended by their own doctors using counseling with or without FDA approved medication that includes Varenicline (Chantix). Participation in this program is voluntary, and all participants are closely monitored clinically by mental health professionals who provide smoking cessation methods patients agree to use," the VA statement said.
The VA also said that it passed on warning about Chantix in a timely manner in November of last year after the FDA issued a statement on Chantix.
'VA immediately passed along that concern to practitioners at all of our medical centers. On February 1, FDA issued a 'Public Health Advisory,' to providers, providing more information on potential side effects of which clinicians and patients should be aware. VA distributed this alert to pharmacists in its system on that same day, and to researchers on February 5," said the statement.
The VA also said that it wrote a letter to participants that while not specifically warning of the suicide links, requested that they discuss possible side-effects with their doctors. The VA said the team that wrote the letter "felt that the issue of suicide should be discussed in a clinical setting, not in a mailing to a group of patients."
Chantix is one of the drugs being used in an estimated 25 clinical studies using veterans by the VA.
Pfizer maintains that 'the benefits of Chantix outweigh the risks" and that it continues to do further studies on the drug.