House Committee on Veterans' Affairs

"I am troubled that this Committee continues to learn about serious issues from the media," stated Chairman Filner. "This lack of transparency from the VA, coupled with what seems to be an institutional lack of accountability, simply does not do justice to the service of our veterans. It is time for the VA to take full responsibility for caring for our veterans."

The current smoking cessation study at the VA compares different courses of treatments for veterans suffering from post-traumatic stress disorder (PTSD). Chantix, also known as varenicline, received approval from the Food and Drug Administration (FDA) on May 11, 2006, and is one of the drugs being prescribed to participants in the VA study. On November 20, 2007, the FDA issued an early communication about an ongoing safety review of Chantix and reported "suicidal thoughts and aggressive and erratic behavior in patients who have taken Chantix." The FDA then issued a Public Health Advisory stating that symptoms of Chantix may include "anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempted suicide" on February 1, 2008. Not until February 29, 2008, did the VA send a letter and new consent form to study participants to notify them of the dangers associated with Chantix. The letter did not mention the added risk of suicidal thoughts.

"I am very concerned about the process VA has in place for protecting veterans participating in research studies," said Chairman Filner. "In no way do I want to diminish the value or necessity of research conducted at the VA. It is, however, the responsibility of this Committee to ensure that the safety of veterans is never overshadowed by the

research mission at the VA. Congress has mandated that medical research at the VA be monitored and reviewed, but this process has not been executed properly in this case. Secretary Peake is not being well served by the government workers who oversee these research programs. These VA employees are entrusted with the care of our veterans and our veterans deserve better."

VA Department Secretary James Peake estimated of the 32,000 veterans that have been prescribed Chantix, 6,000 have been diagnosed with PTSD. Of the 945 veterans enrolled in the smoking cessation study, 241 veterans have been prescribed Chantix over the course of the study. As of June 18, 2008, a total of 158 veterans were taking Chantix.

Chairman Filner urged the VA to personally reach out to the veterans in the study. "There were only 945 veterans in this study. Why didn’t the VA just call them immediately?! As a father, if I read that Pfizer advisory and my child was on Chantix, I would immediately tell them to stop taking the drug. I lack the so-called expertise on the efficacy of drugs, but we are all expert in being parents and family members, and we should be expert in being guardians of the veterans under our care."

In his testimony, Secretary Peake discussed the letter that was sent to veterans participating in the study which was written by a team of psychiatrists and psychologists who "felt the issue of suicide should be discussed in a clinical setting, not a mass mailing, when patients reported to their study coordinator for regular follow ups. It did explicitly advise patients that they should inform their doctor or the study staff immediately if they noticed any changes in their mood or behavior, or if they would like to stop using the medication."

The Secretary expressed concern "about the time that elapsed at a number of study sites between the receipt of the letters and consent addendums by IRBs [Institutional Research Boards], and when they were received by veterans." He went on to criticize "the lack of follow-up by study coordinators to ensure that their directions were carried out. There is a clear need for improved follow up in this area."

"The issue in front of us today is to ensure that the veteran patient receives a complete picture of the risks of any drug prescribed by a VA doctor, especially those drugs administered to patients participating in VA research studies," commented Chairman Filner. "We heard earlier testimony that one of the participants in this smoking cessation study could not get an emergency appointment while in an extremely agitated state and he was not kept apprised of the emerging risks of the drug he was taking. Mr. Secretary, the process that you laid out in your testimony did not work."

Dr. Thomas Puglisi, Chief Officer of the Office of Research Oversight, shared a number of concerns about this study. He said, "I have concerns on the level of this particular study and I have concerns system wide. In terms of this particular study, I am concerned that it appears that at least some veterans who were prescribed Chantix had never received written information about Chantix. I am concerned that at some of the study sites there appeared to be an undue delay in getting information to study participants. I am concerned on a systemic level, that we apparently don’t have the required mechanisms to make sure these things are done in a timely fashion. I am concerned any time informed consent appears not to have been adequate because that is one of the keystones of human subject protections… The Secretary has asked my office to look at this study in great detail, as well as all of the studies involving PTSD patients, and we will make very specific recommendations about how the system needs to be changed to make sure this doesn’t happen again and we will make specific recommendations relative to accountability of individuals who appeared not to have fulfilled their responsibilities."

George J. Lisicki, the national commander of the Veterans of Foreign Wars of the U.S., demanded accountability from the VA and released the following statement, "Those in the VA who failed to properly notify America’s veterans that their medication could produce fatal side effects must resign their positions. If not, then the VA secretary must take decisive action to terminate their employment."

"Every quote I have read in the newspapers from the VA on this subject says that this study is going to continue," concluded Chairman Filner. "It is as if the train has left the station and nobody wants to stop it at all. In this controlled study, questions have been raised and I will continue oversight until they have been answered. I believe Chantix, or any drug that could cause a recurrence of a past psychotic episode, should not be given to the veterans in this controlled study. I plan to work with Secretary Peake to ensure that the VA operates in accordance with Hippocrates and ‘does no harm’."

The opening statements of all the witnesses and a link to the webcast are available on the Committee website at http://veterans.house.gov/hearings/hearing.aspx?NewsID=270.