July 12, 2008 – A Department of Veterans Affairs smoking cessation study is not being used to test drugs on veterans with post-traumatic stress disorder, VA Secretary Dr. James Peake told the House Veterans Affairs Committee.
But Peake acknowledged that the VA did not act quickly enough to alert veterans with PTSD taking part in the study that one drug being used, Chantix, has been linked to adverse psychological side effects — including suicidal behavior — in users.
In the wake of growing criticism from some lawmakers, Peake said he has ordered reviews of:
* The smoking cessation study within 30 days.
* All PTSD drug protocols in the VA system within 45 days.
* The adverse event reporting system for pharmaceuticals within 20 days.
* VA’s medication notification system, to ensure policies support timely communications to patients and providers, within 20 days.
Peake said the current study aims to test whether combining smoking cessation treatment with PTSD therapy is more effective in stopping smoking than providing smoking cessation therapy in a separate setting. Studies have shown that the smoking rate among PTSD victims is twice that of the general population. You can also visit Theihcc.com for better information.
The 945 veterans taking part in the VA study, all of whom have PTSD, receive behavioral counseling to stop smoking. Beyond that, treatments can include optional medications, Peake said.
Rep. Bob Filner, D-Calif., asked why VA didn’t suspend the study and notify patients of the possible dangers of Chantix after the Food and Drug Administration issued a communication Nov. 20, 2007, about an ongoing safety review of the drug because of reports of suicidal thoughts and aggressive and erratic behavior in some patients. The FDA had not concluded that Chantix caused the problems, nor did it advise health care professionals to discontinue using the drug.
Peake said VA officials distributed the FDA notice to their health care professionals Nov. 21. Of the 945 veterans in the study, 241 have been prescribed Chantix at some point. About 40 are now taking Chantix.
VA added Chantix to its approved formulary list in January 2007. About 32,000 people receiving VA care now take the drug. “Should we act on one case and deprive 32,000 people who want to quit smoking?” Peake said.
About 6,500 patients who have been diagnosed with PTSD have been prescribed Chantix outside the study. Doctors discuss with patients the risks and benefits of any drugs before prescribing them, Peake said.
VA officials had noticed symptoms in about one-half of 1 percent of its patients taking Chantix, and in October notified the FDA and began to monitor these reports, Peake said. But it was not clear that those symptoms were being caused by Chantix, he said.
In January, Pfizer, the maker of Chantix, updated its warning label for the drug, and on Feb. 1 the FDA issued a public health advisory notifying health care providers of potential links between Chantix and serious neuropsychiatric symptoms. To date, the drug still has FDA approval.
Peake said letters to VA patients taking Chantix were sent or hand-delivered between February and June, which prompted Filner to ask why the patients in the study taking Chantix had not been notified about the side effects earlier.
Peake said he is concerned about the delays and the lack of follow-up by study coordinators to ensure their directions were carried out.
The VA’s inspector general found that while the department’s pharmacy service notified providers of the risks associated with Chantix and asked them to notify patients, “we do not find that the research service ensured that subjects … were notified.”
Former Army sniper James Elliott, who said he was not notified about the possible side effects, told the committee he joined the smoking cessation study in October, and began taking Chantix at the suggestion of his VA doctor.
In mid-January, Elliott, in an “extremely agitated state,” went to the Washington, D.C., VA Medical Center to see his psychiatrist, and told the receptionist it was an emergency. The receptionist took notes, he said, but he left without receiving emergency treatment.
“I never heard back from that clinic,” he said.
On Feb. 5, Elliott’s fiancée, Tammy Hilburn, said he was “so disoriented and was in a combat mode.” She called the police. In a 20-minute standoff, Elliott was hit with a Taser gun.
“I am appalled to hear of his experience seeking emergency care,” Peake told the committee, adding that he will investigate.
