Mr. Chairman, Thank you for yielding.  I appreciate you calling this hearing so quickly. 

The title of this hearing, “Why Does VA Continue to Give a Suicide-Inducing Drug to Veterans with PTSD,” is certainly an attention getter, however, Mr. Chairman; I think it misses the mark. 

With the possible exception of the physicians on our committee, doctors Boozman and Snyder, I doubt that anyone on this Committee, including myself, have the expertise to determine which drugs should be used by VA.

I’ll defer to the experts on that matter, and Chantix has been an FDA approved drug since May 2006 and is used by over 7 million people world-wide to help them stop smoking.  What I think this Committee should investigate, is whether VA failed to protect veterans who volunteered to be research subjects.

The VA Office of the Inspector General briefed our committee staff prior to this hearing, and we know what their preliminary findings were.  I am very disappointed that long-standing problems with the VA research program have apparently not been corrected. 

Those problems relate to strict human research subject protections that require fully informed consent of patients before they participate in any research studies.  It appears VA may have failed to disclose important facts veterans need to make informed decisions before participating in the study.

If they were not provided full information about the possible risks of their involvement in the VA smoking cessation study, this is a major problem, one that is made worse because it is not the first time there has been an informed consent problem in VA research.

During the 108th Congress, while serving here as the Chairman of the Oversight & Investigations Subcommittee, I introduced H.R. 1585, to establish the Office of Research Oversight within the Department of Veterans Affairs. 

The language of this bill became Public Law 108-170.  These provisions of this law established within the Veterans Health Administration (VHA) an Office of Research Oversight to monitor, review and investigate matters of medical research compliance and assurance in the VA, including matters relating to the protection and safety of human subjects and VA employees participating in VA medical research programs.

What gave rise to the legislation was an OIG report entitled “Alleged Research Improprieties and Informed Consent Issues, Jerry L. Pettis Memorial Veterans Hospital, Loma Linda, California” issued on October 7, 1999, along with several hearings that followed on VA research and informed consent issues. 

The purpose of the legislation was to avoid the occurrence of situations like the unfortunate one we are here to discuss today.

The committee was briefed on potential research misconduct at the Albany VA in January 2003.  We were informed that the VA Inspector General and VHA were conducting an inquiry into the matter. 

The clinical trial drug company sponsor detected clinical results inconsistent clinical trial data being submitted by the VA’s principal investigator and brought that to his attention. This notification to the principal investigator turned out to be a flawed process, as senior managers were not apprised of this situation till much later and launched an internal investigation. 

We closely monitored the progress of this investigation, but were informed that further updates would be limited as this had become a federal criminal investigation. 

This situation and many more incidents revealing weak departmental oversight in the protections of veterans in human and animal subjects research led me to create and legislate an independent oversight board to insure greater protections to vulnerable veterans that have volunteered to serve their country and volunteered to be subjects in clinical research.

Mr. Chairman, in August 2003, VA initiated a cooperative studies program, “Integrating Practice Guidelines for Smoking Cessation into Mental Health Care for Posttraumatic Stress Disorder (PTSD).” 

This research project was to compare effectiveness of integrating smoking cessation with mental health treatment versus keeping them as separate treatment programs.  The protocol medications for this research project included the nicotine patch and nicotine gum. 

In January 2007, VA modified the protocol by adding Chantix after FDA’s approval of the drug for public use.

As of today, VA has approximately 32,000 patients on Chantix, and the Department of Defense has approximately 67,000 patients on Chantix.

On June 17, 2008, an article appeared on the front page of the Washington Times detailing the use of the drug Chantix in the VA study, and the subsequent effects that may have been caused by this drug in one veteran in particular.  That same day, I wrote a letter to the VA as well as to the VA Inspector General’s office requesting an investigation and an immediate briefing on the allegations detailed in the Washington Times’ article.

On June 18, 2008, I, along with Committee staff, and a representative from Congresswoman Brown-Waite’s office attended the briefing with the Principal Deputy Under Secretary for Health; the Chief of Research and Development; the Chief Officer of the Office of Research Oversight; and the Acting Deputy, Chief Research and Development Officer.  At this briefing, we were provided a chronology of events leading up to the Washington Times’ article. 

Committee staff again met with the Chief of Research and Development and the Acting Deputy, Chief Research and Development Officer on June 19, 2008 and requested all documentation of all amended informed consent forms for all study subjects, as well as all Adverse Drug Reactions (ADRs) and Serious Adverse Events (SAEs) related to this study that have been reported to VA’s Cooperative Studies Center in Albuquerque, New Mexico. 

To date, neither the Committee staff nor I have seen the amended consent forms.  I asked the Secretary to be prepared to explain the absence of these forms during the question/answer period following his testimony.

Because of the preliminary findings, on July 3, 2008, I further requested a nation-wide investigation by the Office of the Inspector General on human research subject protections.  I’ll have much more to say about this when the Dr. Daigh of the Inspector General’s office testifies. 

The FDA and Pfizer are going to be testifying to inform the Committee about Chantix.  They are the only witnesses here today who can be considered experts or authorities on drug safety and Chantix. 

I caution my colleagues that this committee lacks the expertise as well as the jurisdiction over the FDA and drug safety, for a topic more appropriately addressed by the Committee on Energy and Commerce. 

To attack a drug as being unsafe and to characterize it as suicide-inducing is at best premature.  We should be very careful in making sensational public statements about the safety of an FDA regulated drug without full information about it, when it could be of enormous benefit in saving lives. 

Let us not jump to conclusions that we are poorly qualified to make.  We should hear the testimony of the witnesses and their answers to our questions, and then only after careful inquiry make informed judgments on what occurred and what corrective actions and follow-up may be called for. 

Make no mistake, we are all about accountability and if veterans have not been well served, I for one will not hesitate to aggressively seek appropriate corrective measures, including actions against VA officials.

Mr. Chairman, as you are well aware, the safety of patients at the Department of Veterans Affairs is of primary importance to those of us here on this Committee. 

Thank you again, Mr. Chairman, and I yield back my time.