Apr112013
Hearing Transcript on Why Does the U.S. Department of Veterans Affairs Continue to Give a Suicide–Inducing Drug to Veterans with Post Traumatic Stress Disorder?.
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WHY DOES THE U.S. DEPARTMENT OF VETERANS AFFAIRS CONTINUE TO GIVE A SUICIDE–INDUCING DRUG TO VETERANS WITH POST TRAUMATIC STRESS DISORDER?
HEARING BEFORE THE COMMITTEE ON VETERANS' AFFAIRS U.S. HOUSE OF REPRESENTATIVES ONE HUNDRED TENTH CONGRESS SECOND SESSION JULY 9, 2008 SERIAL No. 110-96 Printed for the use of the Committee on Veterans' Affairs
U.S. GOVERNMENT PRINTING OFFICE For sale by the Superintendent of Documents, U.S. Government Printing Office
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COMMITTEE ON VETERANS' AFFAIRS |
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CORRINE BROWN, Florida |
STEVE BUYER, Indiana, Ranking
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Malcom A. Shorter, Staff Director Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public hearing records of the Committee on Veterans' Affairs are also published in electronic form. The printed hearing record remains the official version. Because electronic submissions are used to prepare both printed and electronic versions of the hearing record, the process of converting between various electronic formats may introduce unintentional errors or omissions. Such occurrences are inherent in the current publication process and should diminish as the process is further refined. |
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C O N T E N T S
July 9, 2008
Why Does the U.S. Department of Veterans Affairs Continue to Give a Suicide–Inducing Drug to Veterans with Post Traumatic Stress Disorder?
OPENING STATEMENTS
Chairman Bob Filner
Prepared statement of Chairman Filner
Hon. Steve Buyer, Ranking Republican Member
Prepared statement of Congressman Buyer
Hon. John J. Hall
Hon. Cliff Stearns
Hon. Phil Hare
Hon. Steve Scalise
Prepared statement of Congressman Scalise
Hon. Jerry McNerney
Hon. Timothy J. Walz
Hon. Harry E. Mitchell, prepared statement of
Hon. John T. Salazar, prepared statement of
WITNESSES
U.S. Department of Veterans Affairs:
Hon. James B. Peake, M.D., Secretary
Prepared statement of Secretary Peake
John D. Daigh, Jr., M.D., CPA, Assistant Inspector General for Healthcare Inspections, Office of Inspector General
Prepared statement of Dr. Daigh
U.S. Department of Health and Human Services, Paul Seligman, M.D., M.P.H, Associate Director of Safety Policy and Communication, Center for Drug Evaluation and Research, Food and Drug Administration
Prepared statement of Dr. Seligman
Elliott, James G., Silver Spring, MD
Prepared statement of Mr. Elliott
Pfizer Inc., New York, NY, Ponni Subbiah, M.D., M.P.H., Vice President, Medical Affairs
Prepared statement of Dr. Subbiah
Soldiers for the Truth Foundation, Lieutenant Colonel Roger G. Charles, USMC (Ret.), Vice-Chairman, Board of Trustees, and Editor, DefenseWatch, on behalf of Eilhys England Hackworth, Chairperson, Board of Trustees, Soldiers for the Truth Foundation
Prepared statement of Lieutenante Colonel Charles
SUBMISSIONS FOR THE RECORD
Koocher, Gerald P., Ph.D., Professor and Dean, School of Health Sciences, Simmons College, Boston, MA, statement
MATERIAL SUBMITTED FOR THE RECORD
Resolution:
Newspaper Articles:
"Veterans as 'Lab Rats'," The Washington Times Editorial, June 18, 2008
Post Hearing Follow-up, Questions and Responses for the Record:
Christine O. Hill, Acting Assistant Secretary, Office of the Assistant Secretary for Congressional and Legislative Affairs, U.S. Department of Veterans Affairs, to Hon. Bob Filner, Chairman, Committee on Veterans' Affairs, letter dated July 18, 2008, and attached report entitled, "Quality of Care Concern, Veterans Integrated Service Network 5, Veterans Affairs Medical Center, Washington, DC," Interim Report 2008-D-963, Office of the Medical Inspector, Veterans Health Administration, U.S. Department of Veterans Affairs, July 18, 2008, responding to a request from Congresswoman Berkley for follow-up information [The attached report will be retained in the Committee files due to confidential personal information included in the report.]
Hon. Bob Filner, Chairman, Committee on Veterans' Affairs, to Ponni Subbiah, M.D., M.P.H., Vice President, Medical Affairs, Pfizer Inc., letter dated July 14, 2008, and response letter dated August 20, 2008 [The attachment to the letter will be retained in the Committee files due to confidential personal information included in the attachment.]
Hon. Bob Filner, Chairman, Committee on Veterans' Affairs, to Hon. James B. Peake, M.D., Secretary, U.S. Department of Veterans Affairs, letter dated July 29, 2008, formally requesting a list of patients given the smoking-cessation drug Chantix®, and response letter dated September 26, 2008 [The attachments to the letter will be retained in the Committee files due to confidential personal information included in attachment.]
WHY DOES THE U.S. DEPARTMENT OF VETERANS AFFAIRS CONTINUE TO GIVE A SUICIDE–INDUCING DRUG TO VETERANS WITH POST TRAUMATIC STRESS DISORDER?
Wednesday, July 9, 2008
U. S. House of Representatives,
Committee on Veterans' Affairs,
Washington, DC.
The Committee met, pursuant to notice, at 10:05 a.m., in Room 334, Cannon House Office Building, Hon. Bob Filner [Chairman of the Committee] presiding.
Present: Representatives Filner, Brown of Florida, Snyder, Herseth Sandlin, Mitchell, Hall, Hare, Berkley, Salazar, Rodriguez, McNerney, Space, Walz, Cazayoux, Buyer, Stearns, Boozman, Lamborn, Buchanan, and Scalise.
OPENING STATEMENT OF CHAIRMAN FILNER
The CHAIRMAN. This meeting of the House Committee on Veterans' Affairs will come to order. And we have an important hearing today, but before we get started, we have a couple of housekeeping things that need to be done.
First, I ask unanimous consent that all Members may have five legislative days in which to revise and extend their remarks. Hearing no objection, so ordered.
We also have to consider a resolution to designate a new Democratic Subcommittee assignment to include our newest Member of the Committee, Don Cazayoux.
[The resolution appears in the Appendix.]
The CHAIRMAN. Don, make sure we do it right, okay?
Don agreed to fill the vacancy on the Subcommittee on Health, which was made available when Mike Doyle resigned from the Committee. The Democratic Members of the Committee agreed to the assignment on June 17th, and now it is before the full Committee to approve the actions of the Democratic Caucus. The list of the Democratic Members of the Subcommittee on Health are in front of you, and I would ask for a motion to approve the resolution.
Mr. BUYER. I so move.
Ms. BERKLEY. I second it.
The CHAIRMAN. We want to buy in Mr. Buyer on this. Motion made by Mr. Buyer, seconded by Ms. Berkley. All those in favor, say aye.
Opposed?
The motion carries unanimously.
Mr. Cazayoux, we welcome you to the Subcommittee on Health. We are looking forward to your participation.
Mr. CAZAYOUX. Thank you.
The CHAIRMAN. And from talking to you, I know—as a representative of a rural area, there are a lot of problems with access and we intend to be looking at this as a Committee, and in the areas that you represent.
Mr. CAZAYOUX. Thank you, Mr. Chairman and Members, as well as Ranking Member Buyer and Subcommittee Chairman Michaud.
I'm honored to serve on this Subcommittee. Obviously, it is a Committee I believe is essential for helping secure benefits for those who have put their bodies on the line every day, and I'm honored to be able to serve and I'll work hard as a Member of this Subcommittee to ensure that the veterans of this country achieve and are assured of the benefits that they deserve.
But thank you so much.
The CHAIRMAN. Thank you, sir, and welcome to the Committee. The Subcommittee will probably be meeting this week.
We thank all the Members of the Committee, our witnesses and those of you who are here to watch the proceedings. Like many people in this country, I was appalled when The Washington Times published articles revealing that the U.S. Department of Veterans Affairs (VA) was, and continues to use, the drug Chantix® in Cooperative Studies Program (CSP) 519 that is smoking cessation treatment for veterans with post traumatic stress disorder (PTSD).
[The Washington Times articles appear in the Appendix.]
The CHAIRMAN. Some veterans with PTSD, enrolled in the VA smoking cessation study were being, and continue to be, administered Chantix®. The drug did receive Food and Drug Administration (FDA) approval in May of 2006. However, on November 20, 2007, the FDA issued an early communication about an ongoing safety review of Chantix®. It revealed that FDA had received reports of "suicidal thoughts and aggressive and erratic behavior in patients who have taken Chantix®."
At this point, I believe a prudent course of action would have been for the VA to suspend the study and immediately notify all patients of the possible danger. The loss of any veteran to suicide is a tragedy. Since December 2007, this Committee has held two hearings regarding the issue of veteran suicide; and that is why I fail to understand why the VA did not react when the FDA issued the early communication concerning the dangerous side effects of Chantix®.
A few months later, in February of 2008, the FDA issued a Public Health Advisory stating, "Chantix® may cause worsening of current psychiatric illness, even if it is currently under control and may cause an old psychiatric illness to occur. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempted suicide." According to the records, the VA waited until the end of February 2008, that is, a month later, to send the letter and new consent form to study participants to notify them of the dangers associated with Chantix®.
The letter informed patients that they may experience an increase in psychiatric symptoms such as anxiety, nervousness, tension, depression, as well as untoward changes in behavior. It failed to mention in that letter that Chantix® may lead to suicide ideation or attempted suicide. That fact was buried in a consent form, and we have to put this in the context of issues that we have had with the VA on statistics about suicide, of taking the issue seriously.
We had two hearings where there seemed to be an attempt to downplay the numbers, a real lack of speed in giving this Committee information that the VA had; and downplaying, in fact, the sense that if you have 1,000 suicide attempts per month of veterans in your care, something is wrong. That is the context in which we are viewing this particular situation.
Whatever warning was issued was too late for Mr. Elliott, an Army veteran of Operation Iraqi Freedom. In February, as he will soon tell us he suffered a psychotic episode that led to a confrontation with the police.
And, Mr. Elliott, I appreciate you being here today. I know it is not easy to talk about these things, and we appreciate your interest in helping other veterans as well as yourself.
As I said, there are a series of incidents that have given us concern about this. Suicides in Dallas, for example; e-mails suggesting that VA providers downgrade the diagnosis of PTSD to adjustment disorder, to an e-mail downplaying the epidemic of suicides in the VA. They have caused all of us on this Committee to question the VA's accountability measures and the Department's dedication to addressing the mental health needs of our returning servicemembers.
So we want to look at not only the exact procedures for handling human research subjects and determining whether they were followed in design and execution of this smoking cessation study and explore whether there was adequate oversight of the study. I'd like also to find out about VA's responsibility to respond to the FDA advisories and VA's decision to continue to use Chantix®, a suicide-inducing drug, on veterans with PTSD.
But I think in a larger sense we use this hearing today to ask the VA to take responsibility and to hold people accountable for the numerous issues that have been identified over the last few months. Both e-mails that have become public because of legal action—not because they were just given to us—were explained by the VA with the term they were "unfortunate." These were more than unfortunate; these involve life and death of the soldiers and veterans under our care.
The Texas e-mail said: "Given that we are having more and more compensation-seeking veterans, I'd like to suggest that you refrain from giving a diagnosis of PTSD straight up, consider adjustment disorder." Four patients committed suicide in Dallas, and the psychiatric ward was forced to close. We keep hearing these things time and time again, but do not see any action or any sense of responsibility. Talk is cheap, especially when it comes to the safety and well-being of our veterans.
We have seen a pattern in all of these. It is deny, deny, deny. And then, when caught and confronted, it is cover up, cover up, cover up, and then minimizing the importance of the issue or showing that this particular veteran is merely an anomaly. No one is held accountable and the system goes on.
When questioned on this and in the various articles that have appeared, the VA immediately wants to defend the process that is being followed. This is not about the process. It is about the veteran. And the question really today is, when will the VA stop being the veteran's adversary in these processes and start being the veteran's advocate? We're talking about our veterans, our children. We want them defended.
I would recognize for an opening statement, Mr. Buyer.
[The statement of Chairman Filner appears in the Appendix.]
OPENING STATEMENT OF HON. STEVE BUYER
Mr. BUYER. Thank you, Mr. Chairman for yielding.
By way of opening, I'd like for you to know I'm very bothered by the title of the hearing. You've titled this hearing "Why Does the VA Continue to Give a Suicide-Inducing Drug to Veterans With PTSD?"
Now, calling an FDA-approved drug, Chantix®, a suicide-inducing drug, I believe, is inflammatory and it is misleading. And I believe by titling this hearing as you have done misses the mark. The issue I believe before us on which we should focus is Human Subject Research Protection and whether the protocols of the Common Rule have been followed by the VA.
Now, at the end of your opening, I agree with you; when you then finally began to focus that we really need to look at the execution of procedures, I agree. And the response to these advisory opinions that come out of the FDA—in other words, how does the VA respond, what is the VA's response to these advisory opinions and how is it followed through, and focus on accountability and responsibility, I agree with you and join on that.
With the possible exceptions of Drs. Boozman and Snyder, I doubt that anyone on this Committee, including myself, has the expertise to determine which drugs should be used by the VA and what drugs should be placed on a formulary. We defer to the experts on these matters. And Chantix® is an FDA-approved drug since May of 2006, and it is used by over 7 million people worldwide to help them stop smoking.
Again, what I think the Committee should investigate is whether the veterans who volunteered to be research subjects were treated properly. The VA Office of Inspector General (OIG) briefed our Committee staff prior to this hearing, and we know what their preliminary findings are.
I'm 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 study. It appears VA may have failed to disclose important facts veterans need to make informed decisions before participating in these studies. If they were not provided full information about the possible risks for their involvement in the VA smoking cessation study, this is a major problem, one that is made worse because this would not be the first time that the VA has found themselves in this position on not giving proper informed consent in VA research.
During the 108th Congress, while serving here as Chairman of the Oversight and 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 law, Public Law 108-170. The provisions of this law established within the Veterans Health Administration (VHA) an Office of Research and 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.
Now, Mr. Chairman, I recall, when the Committee passed this, the VA fought us on this. So with your opening about you're challenged by the VA, not only did they fight us on this bill, we had also sought that this be an independent office, and they didn't want that at all. So we ended up having to compromise on some of the legislation.
What gave rise to the legislation was an OIG report entitled, "The Alleged Research Improprieties, Informed Consent Issues at the Jerry L. Pettis Memorial Veterans Affairs in Loma Linda, California," issued on October 7, 1999, along with several hearings that followed on VA research and informed consent issues.
The Committee then was briefed on potential research misconduct at the Albany VA in 2003, and we were informed by the VA Inspector General that the VHA was conducting an inquiry into the matter. We monitored that situation and there was an actual criminal prosecution from that. And so—the Committee, I think, took very appropriate action to create this office; so the purpose of the legislation was to avoid the occurrence of situations like the unfortunate one we are discussing here today.
So, Mr. Chairman, "In August 2003, the VA initiated a Cooperative Studies Program integrating practice guidelines for smoking cessation into mental healthcare for post traumatic stress disorder," end quote. 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, the VA modified the protocol by adding Chantix®.
After FDA's approval of the drug for public use as of today, the 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 in 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 the VA Inspector General, requesting an investigation and immediate briefing on the allegations detailed in The Washington Times article.
On June 18th, I, along with Committee staff and representatives from Congresswoman Brown-Waite's office, attended a briefing by the Principal Deputy Under Secretary for Health, the Chief of Research and Development, the Chief Officer of the Office of Research and Oversight and the Acting Deputy Chief Research and Development Officer. At this briefing, we were provided a chronology of the events leading up to The Washington Times article.
The Committee staff again met with Dr. Kupersmith and Dr. O'Leary on June 19th and requested documentation of all amended informed consent forms for all study subjects, as well as all adverse drug reactions and serious adverse events related to this study that have been reported to VA's Cooperative Study Center in Albuquerque, New Mexico.
To date, neither the Committee staff nor I have seen the amended consent forms. I ask the Secretary to be prepared to explain the absence of these forms during the question-and-answer period during the testimony here today.
Because of the preliminary findings, on July 3, 2008, I further requested a nationwide investigation by the Office of Inspector General on human research subject protections. I will have much more to say about this when 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 that 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. This is a topic more appropriately addressed by the Committee on Energy and Commerce.
To attack a legal drug as being unsafe and to characterize it as suicide-inducing, I believe is irresponsible and inflammatory. We should be careful in making sensational public statements about the safety of an FDA-regulated drug without full information about such drug when it could be also an enormous benefit in saving lives in the cessation of smoking.
There are many, many drugs, and we all take some of these drugs that have tremendous side effects. For example, there is a drug that all of us take every day, Mr. Chairman. It is called aspirin. One of the side effects of aspirin is anticlotting action that can cause an unwanted side effect called bleeding on the brain. Now, do we want to say—title a hearing, "Why Is the VA Giving a Bleeding on the Brain Inducing Drugs to Veterans?"
So you could go down almost every drug that has a side effect, and you can turn it into sensationalism and be inflammatory. I think that this Committee has a more important and responsible role here, and we should hear the testimony of our witnesses and their answers to our questions; and then, only after a careful inquiry, can we make informed judgments on what occurred and what corrective actions and follow-up, Mr. Chairman, may be called for.
Make no mistake, I concur with your issues on accountability and responsibility and the question of whether our veterans are being well served.
With that, I will yield back to the Chairman.
[The statement of Congressman Buyer appears in the Appendix.]
The CHAIRMAN. Thank you, Mr. Buyer.
I would just note that while most of us here do lack so-called expertise on the efficacy of drugs, we are experts in being parents, we are experts in being family members and we should be experts in being guardians of the veterans under our care. And there is no more important role than safeguarding those veterans.
And I will tell you, as a father, that if I read that Pfizer advisory and my child was on Chantix®, I would immediately tell them to stop taking the drug. I don't need any more expertise than that.
I want to, once more, thank The Washington Times for the articles and the continuing story. Many of our most important work on this Committee for the last year and a half has been sparked by the media doing its job; whether it was The Washington Post dealing with Walter Reed, whether it was ABC News dealing with traumatic brain injury, whether it was CBS News dealing with suicides, and all the other media out there that have looked at these issues and done the work that many of us see as our work for oversight on this Committee.
We thank The Washington Times in this case, but the media in general for watching out for our veterans.
Mr. STEARNS. Mr. Chairman, point of order, just a question, if I may.
Normally, in hearings of this magnitude, certainly all Members should generally have an opportunity for an opening statement. I was wondering, are we going to proceed in regular order in which each Member, both the Republicans and the Democrats, have an opportunity for a 3-minute, 2-minute opening statement? Is that possible? Many of us would like that opportunity.
The CHAIRMAN. We have four panels. But at your request, I will be happy to do that.
Mr. STEARNS. Sir, I'm not just asking for myself. I'm—
The CHAIRMAN. I'll ask everybody else.
Mr. STEARNS. Well, I think it is important.
The CHAIRMAN. Going down the rostrum—Mr. Mitchell, if there is any opening statement any of you would like to make. Mr. Mitchell?
Mr. MITCHELL. I'll submit mine.
[The statement of Congressman Mitchell appears in the Appendix.]
The CHAIRMAN. Mr. Hall?
OPENING STATEMENT OF HON. JOHN J. HALL
Mr. HALL. Thank you, Mr. Chairman. I'll just briefly say that the drug in question, I'm looking forward to hearing the testimony on.
I don't think, with all due respect to my friend, the Ranking Member, that aspirin, which is probably one of the most studied drugs in history, can be compared in terms of our knowledge and experience with it to this one.
But the underlying problem of undiagnosed and untreated PTSD is really the story here, in my opinion. And yet again yesterday The New York Times had a story about alcoholism and self-medication by veterans who sometimes had to go through fatal traffic accidents, bar fights, winding up in jail, domestic violence that they were arrested for, et cetera, et cetera, before they sought or were given treatment for PTSD, because they were taught to be tough and to handle things and to deal with it as a man or as a woman. But it happens to be mostly men through the proportion in the armed services.
And we voted out of this Committee a bill, which would provide for—a presumed stressor for PTSD. It costs more not to treat it. In fact, the RAND study said that $6.2 billion in 2 years for undiagnosed is the cost to our society, to our country of undiagnosed and untreated PTSD—$6.2 billion in 2 years.
The Congressional Budget Office score for that section of the bill was $5 billion over 10 years. So it costs a fifth as much for us to treat it as it does not to treat it.
And I think that I will get back to the topic and allow the hearing to resume. But I hope that we'll all look at this in the big picture of medications that are being used to try to, in this case, stop smoking but are being used on people who—a large percentage of whom have undiagnosed and untreated PTSD. And that itself is a larger problem.
Thank you, Mr. Chairman.
The CHAIRMAN. Thank you, Mr. Hall. Thank you for your leadership on this.
Mr. Stearns?
OPENING STATEMENT OF HON. CLIFF STEARNS
Mr. STEARNS. Thank you, Mr. Chairman.
Mr. Hall, I have a list here from the Physician's Desk Reference which, as you know, is a physician's manual. There are over 200 drugs that are listed as suicide-related, and people who take these drugs will indeed have the feeling they should commit suicide.
So the Ranking Member, Mr. Buyer, mentioned aspirin. He could just as well have mentioned Albutirol, which people take for asthma. He could mention Paxil. I mean, they just go on and on and on. So Mr. Buyer is mentioning aspirin just to make a point, because I think his point is well taken. The title of this hearing is inflammatory, is not responsible; and here we are together as Republicans and Democrats and Independents looking to provide substantive credibility to this hearing. We don't want to start the hearing off with something that is so inflammatory it sounds like a campaign, a political campaign. This is not a political campaign. These are the lives of the men and women who are protecting us.
And to single out this drug is fine. I don't think there is anything wrong with having a hearing. But, Mr. Hall, if you want to read this list from the PDR, on almost every physician's table there are 200 at minimum that could cause suicidal thoughts, and they're listed right here. And I would venture to guess—and you and I are both adults—in our lives we've taken some of these drugs here and didn't even realize that they have a possibility of suicidal inclination.
The second point I would like to make is, the Department of Defense prescribes this same medicine to 67,000 military personnel. So this is not just something that the VA is doing. They are prescribing it to 32,000. So if we are really going to look at this, why don't we bring in some people from the Department of Defense and ask them, with 67,000 people, more than twice what the veterans are using, why don't we look at this drug in terms of their history and how it has functioned?
Now, if you look worldwide, there are 1.3 billion people that smoke. Out of that, 7.5 million use this drug today worldwide. Now, the problem is we have about—just under 500,000 people that die from smoking every year in this country, and this is a leading cause of a preventable death. So anything we can do as Americans to get people to stop smoking, so that roughly 500,000 Americans will live is important.
So I think we have to put in perspective what we're trying to do here. Sure, we've got to ask the question, why would the VA prescribe a drug that could worsen or magnify the symptoms of depression and anxiety to patients suffering from post traumatic stress disorder? I think that is worthwhile. But let's put it in perspective—perspective in dealing with the Department of Defense, worldwide; and what we're trying to do in this country is get veterans off smoking because it is a preventable death.
Thank you, Mr. Chairman.
The CHAIRMAN. Mr. Hare?
OPENING STATEMENT OF HON. PHIL HARE
Mr. HARE. Thank you, Mr. Chairman. I'm going to be very brief.
You're right, I think we are all parents and want the very best not only for our children, but for our veterans. This Committee, as I understand, has oversight over the VA and I'm not as concerned about the title of the hearing as I am with what has happened here. I'm committed to working with my colleagues on this Committee to get to the bottom so we can ensure that our veterans are treated humanely.
As is mentioned, we have a report out that approximately 1,000 veterans per month are attempting suicide. Is this part of it? I don't know. I'm not a doctor; I don't claim to be. I just want to get to the bottom of what we're doing so we can try to put an end to this.
Every person on this Committee, Republican and Democrat, I think wants to see the very best care given to our veterans; and if there are things we need to look at, I think we need to do that.
But I especially hope to find out the policies and procedures regarding research in human subjects that we are following in designing this CSP No. 519 and what oversight, if any, was involved. I also want to know if patients were adequately informed of the hazards of Chantix®. Did the VA respond in a timely fashion to the early communication, the Public Health Advisory for Chantix®? And why was consent not revised after the FDA's early communication? Finally, given new evidence of the risk associated with this drug, should the drug continue to be used to treat veterans of post traumatic stress syndrome?
So the bottom line here for me today is to find out what happened and what can we do, Republicans and Democrat alike. And when the Ranking Member mentioned aspirin and my friend, Mr. Stearns, mentioned all these other 200 drugs that are available, they could all have side effects, some very, very, destructive side effects; the fact of the matter is, to what degree, and particularly dealing with veterans with post traumatic stress syndrome, does this make this situation worse? That is what I really want to find out.
So what can we do to prevent the suicides that continue at record-breaking paces? My fear is, with more veterans coming back with post traumatic stress syndrome, this situation is going to get worse before it ever gets better.
Thank you, Mr. Chairman.
The CHAIRMAN. Mr. Boozman, any opening statement?
Ms. Berkley?
Ms. BERKLEY. Mr. Chairman, I'd like to associate myself with Mr. Hare's thoughtful remarks. I'm going to reserve my time for an opening statement and perhaps submit it in writing later, and I would like to get to the witnesses.
The CHAIRMAN. Thank you.
Mr. Lamborn. That's—okay, somebody next to you.
Mr. Rodriguez, I didn't see you. Mr. Salazar declined.
Mr. RODRIGUEZ. Just I'm ready to listen to testimony and look forward to it. My main concern would be to see how we can begin to hold the system accountable in terms of making things happen for our veterans and get to the witnesses.
The CHAIRMAN. Thank you.
Mr. Scalise?
OPENING STATEMENT OF HON. STEVE SCALISE
Mr. SCALISE. Thank you, Mr. Chairman. And the Ranking Member has a lot of concerns about the report. I definitely want to hear from the witnesses.
But I think our main concern should be about the process and if, in fact, accountability is going to show where the consent was requested because we have got veterans that were being subjected to participation and testing, which is not something new. But it seems that there is a big gap in the consent process from all the reports that have come before us, a real concern about the process of making sure that the veterans knew what they were doing, those who chose to participate in the testing; and if, in fact, medical personnel let them know what the side effects were and if consent was garnered, because in a number of cases, they haven't been able to produce signed consent forms.
And the fact that veterans may have been participating in research studies without proper consent leads to a number of major concerns; and I hope that gets addressed in the testimony, and I definitely have some questions as we get into that section. So I look forward to hearing it.
[The statement of Congressman Scalise appears in the Appendix.]
The CHAIRMAN. Thank you, sir.
Mr. McNerney?
OPENING STATEMENT OF HON. JERRY MCNERNEY
Mr. MCNERNEY. Thank you, Mr. Chairman. This is an important hearing because it appears that established principles in patient treatment have been ignored or pushed aside. We want to know if this was done because these are veterans or not.
Any patient who is given a drug is entitled to know what the side effects are, especially if the side effects are life threatening and especially if the patients are particularly susceptible to those side effects.
Since these subjects are veterans and the drug was administered by the Department of Veterans Affairs, it is our responsibility to investigate if wrongdoing took place, either intentionally or unintentionally. It should be dealt with. And we need to make sure that procedures are in place to prevent unnecessary sufferings of our veterans.
Thank you.
The CHAIRMAN. Thank you.
Mr. Walz?
OPENING STATEMENT OF HON. TIMOTHY J. WALZ
Mr. WALZ. Thank you, Mr. Chairman, Mr. Ranking Member. Thank you to our witnesses.
Mr. Elliott, thank you for being here. That combat infantryman badge (CIB) gives you the right and the privilege to sit right where you are at and tell us this, because our responsibility is to make sure that what you did to earn that, make sure we are doing our responsibility on this end to care for you and your family once you return.
A special thank-you to the VA and to Secretary Peake for taking time to be here. No one is more committed to the care of our veterans than the Secretary, who is concerned when we have lapses in getting them fixed.
So I look forward to today's testimony because the VA, while it provides some of the best care in the world, also has a unique responsibility in providing research and especially in some of our most vulnerable populations of PTSD and so forth. So I'm very concerned on that.
Now, this incentive to do the research and to get it right, especially in preventive medicine, whether it be smoking or whether it be diabetes, the VA is a leader and has a real unique role in that.
So this issue of—if corners were cut or protocols were skipped, it is tragic in terms of what happens to our veterans in their care. But it is also tragic if a very valuable treatment is out there and it doesn't get a fair shake to be implemented.
So I do think—and I associate myself with some of the remarks that my colleague, Mr. Stearns, made—there is a responsibility for us not to hype this or engage in thinking that would be gratuitous in terms of what we're talking about on this drug.
But I also think it means we have a responsibility to ensure that the VA follows all of the accepted protocols and the ethical conduct of these for the very reason as I stated earlier, the care of the veterans, as well as protecting the research mission that the VA has.
So I'm very much looking forward to this, and I also thank you Mr. Elliott for showing the courage to be here today to try to help us understand this.
So I yield back.
The CHAIRMAN. Thank you.
Mr. Cazayoux?
Okay, our first panel has two witnesses, James Elliott and Lieutenant Colonel Roger Charles. Mr. Elliott is a veteran from the Iraq War, who was given Chantix® by the VA and suffered severe side effects while taking the drug. He is accompanied by a friend, Tammy Hilburn, who has helped him and done a lot of research on the issue.
Lieutenant Colonel Charles, is the Editor of DefenseWatch, and helped Mr. Elliott after his experience. So we look forward to your testimony.
I know again, Mr. Elliott, this is not easy. But I think you're taking a position that you want to help other veterans, and we appreciate your courage in doing that.
Mr. BUYER. Mr. Chairman, may the witnesses be sworn in today?
The CHAIRMAN. We haven't done that in the past, but I don't mind and I don't think the witnesses mind.
If you'll stand up, the two witnesses, and raise your right hand.
[Witnesses sworn.]
The CHAIRMAN. Thank you all.
Mr. Elliott, please.
STATEMENTS OF JAMES G. ELLIOTT, SILVER SPRING, MD (IRAQ WAR VETERAN); ACCOMPANIED BY TAMMY R. HILBURN, SILVER SPRING, MD; AND LIEUTENANT COLONEL ROGER G. CHARLES, USMC (RET.), VICE-CHAIRMAN, BOARD OF TRUSTEES, SOLDIERS FOR THE TRUTH FOUNDATION, AND EDITOR, DEFENSEWATCH, ON BEHALF OF EILHYS ENGLAND HACKWORTH, CHAIRPERSON, BOARD OF TRUSTEES, SOLDIERS FOR THE TRUTH FOUNDATION
Mr. ELLIOTT. Thank you, Mr. Chairman. I have submitted my executive summary, and the diagram clearly illustrates that there was a vicious web that I was caught up in. That diagram is not part of my official testimony, meaning that it is—I haven't been allowed to use it as a PowerPoint presentation. I know that some of the other witnesses will be having those type of presentations.
And that is really all I have to say. Thank you.
The CHAIRMAN. I'm sorry. You have no further testimony today?
[The statement of Mr. Elliott appears in the Appendix.]
The CHAIRMAN. Colonel Charles?
STATEMENT OF LIEUTENANT COLONEL ROGER G. CHARLES (RET.)
Colonel CHARLES. Chairman Filner, honorable Members of the House Veterans' Affairs Committee, on behalf of Eilhys England Hackworth, the Chairperson of the Board of Trustees of Soldiers for the Truth Foundation, I am humbled to appear before your Committee.
Recent events show that this oversight function of your Committee is critical to ensure that the well-being of our veterans is, in fact, the highest priority of the VA. These events demonstrate that without Congressional oversight, true concern for the well-being of our veterans can deteriorate into mere lip service of an indifferent and self-serving bureaucracy.
I note that you have scheduled a most impressive group of experts on various medical and ethical issues related to human subject experiments as conducted by the VA. I do not bring their expertise to this hearing. What I do bring is the experience of a career Marine Corps officer who believes our Nation has a sacred responsibility to care for those who have manned the ramparts of freedom on our behalf. I also bring the skepticism of a journalist who, for 18 years, has investigated misconduct by various Federal agencies in the areas of defense and national security.
Let me now turn to today's hearing. While studying the experience of Army combat veteran James Elliott, I was struck by three major questions. My first question relates to the Hippocratic Oath and a physician's first responsibility to do no harm. How then did the VA physicians involved in planning and conducting this drug study fulfill their duties under this pledge?
Here are some related follow-up questions to consider: Would these physicians have subjected their own sons or daughters to such a high-risk drug study? And would they have failed to have informed their own children of the substantial risks this study entailed?
My second question relates to the Nuremberg Code and the fact that informed consent of all human subjects in medical experiments is an absolute requirement under this code. As you may recall, it was the exposure of the most heinous and gruesome medical experts by Nazi doctors that led to enacting the Nuremberg Code.
Our country's own history has, unfortunately, too many examples of medical experiments on unwitting subjects. The infamous Tuskegee syphilis experiment is perhaps the best known of such shocking violations by physicians of their own Hippocratic Oath. I have attached to this statement a Knight Ridder press report, dated July 7th, regarding the Federal criminal prosecution of a former VA staff physician at the Stratton VA Medical Center in Albany, New York. The Federal prosecutor asked the court to sentence this former VA physician—and I quote—"to spend a year in prison for his role in a drug research scandal that killed at least one veteran and victimized dozens more," end quote. I have subsequently learned that this Committee had a major role in that investigation. If it pleases the Chairman, I respectfully request this article be included in the record.
The CHAIRMAN. So ordered.
Colonel CHARLES. My last question for your consideration involves the participants themselves, the veterans with PTSD who were recruited by VA staff to become the subjects of this drug study.
Why were members of a group who by the VA's own diagnosis were struggling to return to mental health normality selected for this study? The mental health of these veterans was known to have been what a layman would term "fragile." Special caution and prudence should have been invoked before exposing them to a drug study where, by definition, unknown factors risked further damage to their mental health. Instead, the very VA physicians trusted to help these vets regain a more normal mental condition enticed the vets to join a game of mental health roulette while withholding critical information that would have permitted true informed consent to have been given.
Sir, this concludes my prepared statement. I stand ready to respond to any questions that the Committee Members may offer.
The CHAIRMAN. Thank you.
[The statement of Lieutenant Colonel Roger G. Charles and the attached article, appears in the Appendix.]
And if I may ask, Mr. Elliott, you have been diagnosed with PTSD?
Mr. ELLIOTT. Yes, Mr. Chairman.
The CHAIRMAN. And you're a heavy smoker?
Mr. ELLIOTT. Yes.
The CHAIRMAN. And how long were you taking Chantix®?
Mr. ELLIOTT. Less than 3 months.
The CHAIRMAN. And given the kind of advisories that have come out, that we have commented on, do you feel you were adequately informed of the side effects?
Mr. ELLIOTT. No, Mr. Chairman, not at all.
The CHAIRMAN. Would you mind describing the event that gave you so much publicity—probably unwanted—in terms of what happened to you?
Mr. ELLIOTT. The events of February 5th are very well documented, and that issue has been completely resolved in the courts.
The CHAIRMAN. In the what?
Mr. ELLIOTT. In the courts.
The CHAIRMAN. I mean, do you feel that the drug that you were taking helped provoke that or not?
Mr. ELLIOTT. I strongly feel that way.
The CHAIRMAN. And you believe that the drug led to this episode with the police?
Mr. ELLIOTT. That's correct, Mr. Chairman.
The CHAIRMAN. What would be your advice for other people taking the drug?
Mr. ELLIOTT. Anyone who is on an antidepressant should not take that drug. That would be my advice. Ask more direct questions to your doctor, demand direct answers, demand that this Committee help answer some of the questions that are going to arise.
The CHAIRMAN. Okay. Thank you so much.
Mr. Buyer?
Mr. BUYER. First by way of opening, let me thank both of you for your service.
Mr. Elliott, before starting Chantix®, had you tried any other smoking cessation aids or drugs?
Mr. ELLIOTT. Yes, Mr. Buyer, I did.
Mr. BUYER. Which ones?
Mr. ELLIOTT. Phase one of Smoking Cessation Program 519, it—the program that I signed up for, I began with the nicotine patch, 21 milligrams, and that did not work very well. It helped to a point, but it did not completely eliminate my smoking habit. And then from there, I went to nicotine gum and at one point, because my nicotine habit was extremely strong, I was given both in conjunction with one another.
Mr. BUYER. Can you define the word "strong?" How many cigarettes or packs a day did you smoke?
Mr. ELLIOTT. Two packs, pretty much two packs a day, 40 cigarettes.
Mr. BUYER. What type? What kind?
Mr. ELLIOTT. Marlboro Medium.
Mr. BUYER. Filtered or unfiltered?
Mr. ELLIOTT. Filtered.
Mr. BUYER. Are you still currently enrolled in a smoking cessation program?
Mr. ELLIOTT. Negative.
Mr. BUYER. Are you currently using any smoking cessation drug or aid at this time?
Mr. ELLIOTT. No.
Mr. BUYER. When you entered the study, do you remember signing an informed consent form?
Mr. ELLIOTT. I do remember that very well.
Mr. BUYER. At any time, did you sign an addendum to the informed consent form?
Mr. ELLIOTT. Absolutely not. That addendum was not sent until after this whole affair of February 5th. It was not actually sent until we had confronted them about the FDA warnings.
Mr. BUYER. Did your doctor at any time talk to you about the advisory that the VA had received from the FDA?
Mr. ELLIOTT. No, not one single time.
Mr. BUYER. Did your doctor at any time discuss with you a medical belief that your continuing use of cigarette nicotine—your continuing smoking would have an adverse impact upon their treatment for post traumatic stress syndrome?
Mr. ELLIOTT. No, they never said that by me stopping smoking it would help my PTSD diagnosis and symptoms.
Mr. BUYER. Let me ask, as a patient—you are in a program that will help you get better with your PTSD and cessation of smoking, and the purpose of the study is the medical belief that your smoking does not—that actually works against your PTSD treatment. Or didn't your doctor—so when you signed your original informed consent, wasn't that the purpose of your entering this program?
Mr. ELLIOTT. I entered the program, 100 percent, because I wanted to stop smoking. That was the one and only reason I entered that program.
Mr. BUYER. All right. But at this point, you don't recall conversations with your doctor with regard to how important it would be to do the cessation of smoking because they could better treat mental challenges?
You don't recall any of those discussions?
Mr. ELLIOTT. No. Those discussions never took place.
Mr. BUYER. Prior to the episode in which there was an arrest, did you have any success with Chantix®?
Mr. ELLIOTT. No, not at all. As a matter of fact, I had had a terrible reaction to it in the first week.
Well, Mr. Buyer, as far as stopping—you know, smoking cessation goes—yes, I had cut my habit in half overnight. It was miraculous, I will say this, Chantix® as far as more or less convincing your brain that you do not want to smoke anymore, that you get no pleasure from it, it works well.
I—overnight my smoking habits were cut in half.
Mr. BUYER. Thank you, Mr. Chairman.
The CHAIRMAN. Thank you, Mr. Buyer. Just as a reminder, I'm going in the order of Members who were here when we started the hearing, in order of seniority, then those who appeared later.
Mr. Hare?
Mr. HARE. Thank you. How are you doing now, Mr. Elliott?
Mr. ELLIOTT. I have been better. I've been worse. Be more specific, please?
Mr. HARE. Pardon me?
Mr. ELLIOTT. Be more specific about how am I doing right now?
Mr. HARE. You're no longer taking the drug?
Mr. ELLIOTT. No, I have not taken Chantix® since February 5th.
Mr. HARE. So, since February 5th, how have you been doing?
Mr. ELLIOTT. Well, I now know that many of the side effects do not occur until after you stop smoking Chantix®. I believe they are known as "withdrawal symptoms." And I have vomited blood on occasion, had massive testicular swelling; I continue to have skin problems.
Mr. HARE. When you stopped taking Chantrix, I'm assuming you were still under a physician's care?
Mr. ELLIOTT. No, not really.
Mr. HARE. So you didn't go to a doctor and say, I now have all of these post—
Mr. ELLIOTT. I have, absolutely, yes. It should be—in my VA medical files.
Mr. HARE. What did the physicians say to you when you told them you were having all these problems after you stopped taking the drug? What was their response to you?
Did they give you—
Mr. ELLIOTT. "Thank you, have a great day," that was pretty much their response.
You know, in fact, their response was so—I feel it was so inadequate that, you know, I will be going for outside medical care.
Mr. HARE. You will or you have?
Mr. ELLIOTT. I will.
Mr. HARE. So, in your opinion, all these problems that you encountered after you stopped taking the drug, you relayed those to a physician, and they basically said, you're on your own, there is nothing we can do about this?
Or did they advise you to start taking the drug again? I am confused because the drug causes the problems, you have more problems after you stop taking the drug, you see a physician; if I'm correct, the physician basically tells you, go have a nice day?
Mr. ELLIOTT. As far as psychiatric help goes, no, my original prescribing doctor, who prescribed me the Chantix®, we have no relationship at all now.
The doctor who was assigned in her absence, he has never really given me any advice as far as any of this goes. Off the record, he has told me just to be strong, bear through it.
You know, we discussed the fact that, you know, my PTSD has actually gotten much worse—you know, a lot of the paranoia, the things that the Chantix® increased, the PTSD symptoms that Chantix® increased, they have not, you know, decreased since I quit taking it, and in some cases, they may even be worse.
My primary care physician, him and I, we do not address psychological issues. That
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