NOTE: UNEDITED DOCUMENT
1
PRESIDENTIAL ADVISORY COMMITTEE
ON GULF WAR VETERANS' ILLNESSES
PUBLIC MEETING
Thursday, October 19, 1955
9:05 a.m.
HYATT ARLINGTON (ROSSLYN) RAVENSWORTH ROOM
1325 WILSON BOULEVARD ARLINGTON, VIRGINIA
2
ADVISORY COMMITTEE MEMBERS PRESENT:
JOYCE C. LASHOF, M.D.
Committee Chair
School of Public Health
University of California at Berkeley
Berkeley, California
JOHN BALDESCHWIELER, PH.D.
Professor of Chemistry
California Institute of Technology Pasadena, California
ARTHUR L. CAPLAN, PH.D.
Director
Center for Bioethics and Trustee Professor of Bioethics
University of Pennsylvania
Philadelphia, Pennsylvania
ADMIRAL DONALD CUSTIS, M.D. (RET.) Senior Medical Advisor
Health Policy Department
Paralyzed Veterans of America Washington, D.C.
JAMES A. JOHNSON
Chairman and Chief Executive Officer Federal National Mortgage Association Washington, D.C.
CAPTAIN MARGUERITE KNOX, R.N.C, M.N., C.C.R.N
Clinical Assistant Professor
College of Nursing
University of South Carolina
Columbia, South Carolina
PHILIP J. LANDRIGAN, M.D.
Ethel H. Wise Professor and Chairman Department of Community Medicine Mount Sinai School of Medicine
New York, New York
ELAINE L. LARSON, R.N., PH.D.
Dean Georgetown University School of Nursing Washington, D.C.
3
ADVISORY COMMITTEE MEMBERS PRESENT (continued):
ROLANDO RIOS
Attorney
San Antonio, Texas
ANDREA KIDD TAYLOR, DR.P.H. Health and Safety Department United Auto Workers Detroit, Michigan
ADVISORY COMMITTEE STAFF PRESENT:
DR. JOSEPH CASSELLS
THOMAS C. McDANIELS, JR. ROBYN NISHIMI
HOLLY GWIN, ESQ.
ALSO PRESENT:
DR. FRANCES MURPHY
Department of Veterans Affairs
CATHERINE WOTEKI
Designated Federal Official
JOAN PORTER
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AGENDA
AGENDA ITEM PAGE
OPENING REMARKS: 6
JOYCE C. LASHOF, CHAIRPERSON
PUBLIC COMMENT TO THE COMMITTEE
DIANE DULKA 7
President
Gulf War Veterans of New England
QUESTIONS & ANSWERS
REP. FRANK MASCARA [D-PA] 15
[Introduces Mary Rhodes]
MARY RHODES
California, Pennsylvania 17
QUESTIONS & ANSWERS
CANDY SWEET LOVETT 24
Silver Spring, Maryland
QUESTIONS & ANSWERS
STAFF BRIEFING:
KATHY HANNA 32
FURTHER PUBLIC COMMENT
SONNY EVERS
Gulf War Veterans of Delaware 62
QUESTIONS & ANSWERS
RESEARCH ISSUES
HOLLY GWIN 74
Introductory Remarks
5
AGENDA (Cont.)
PRESENTERS TO THE COMMITTEE:
DR. TIMOTHY GERRITY
Research Working Group of VA and
Persian Gulf Veterans Coordinating Board 74
DR. HENRY FALK
Director of Division of Environmental
Hazards and Health Effects, CDC 94
DR. TIMOTHY GERRITY
[for Dr. Sphar] 103
QUESTIONS & ANSWERS
LTC GARY GACKSTETTER
Epidemiologist 155 DoD Health Affairs
DR. DONALD HELLER
Acting Program Manager
Health Risk Assessment Program U.S. Army Center for Health
Promotion and Preventive Medicine 167
QUESTIONS & ANSWERS
RECESS 214
6 P R O C E E D I N G S
CHAIRPERSON LASHOF: I think we are just about ready to get started. I think we are still expecting Dr. Caplan. But as is our habit, at every meeting of the committee, we've set aside time for public comment, and make that available for anyone who wishes to address any issues to the committee.
This morning, we have four people who have requested to present to the committee.
Our time schedule is to allow five minutes for presentation and five minutes for questioning, but, as always, the committee will accept longer testimony, additional material, anything that anyone wishes to submit for the committee's consideration, and that will be distributed to all members of the committee.
So although it does seem like we're giving you just a brief time to present, we'd like you to basically summarize and give the gist of your points that you'd like to make to the committee. But you should rest assured, that any additional
7 material you submit to the committee will be
distributed and reviewed by them.
We'll begin this morning with a
presentation from Diane Dulka, who's president of the Gulf War Veterans of New England. And Diane, if you'll come to the podium. There are some light signals on the podium which will flash, and let you know when you're getting close to your end time, and your end time. Thank you for coming.
PUBLIC COMMENT
MS. DULKA: I'd like to thank you all for hearing public comment.
Now my nightmare begins on February 27th, 1992. That's the day my son was born with cleft lip and pallet. My husband had returned 10 months earlier from his service in the Gulf. Joe died of pancreatic cancer last August, at the age of 37. He returned from the Gulf, 20 pounds lighter, and a feeling of not well, but he couldn't pinpoint exactly what it was.
And during his tour, his MP company was exposed to dead animals, flies, filthy, diseased
8 Iraqi prisoners, oil fires, the anthrax vaccine,
nerve pills, multiple pesticides, and benzene sprayed on the Iraqi prisoners to rid them of body lice.
Benzene is a known cancer-causing agent, by itself, never mind adding all the other toxins with it. The MPs were ordered to spray the prisoners after the medical company they were in in the POW camp refused to do so.
No warnings were given to the MPs and they were not told of any toxic effects of the benzene. My husband's blood work showed twice the normal level of benzene in his bloodstream, three years after he returned home from the Gulf and two weeks before he died.
The VA has denied our claim for benefits three times, stating that he did not have any symptoms during the two year limit.
Now, pancreatic cancer has no symptoms. Eventually, the tumor inside of him blocked off his intestinal tract, and that's how we found the cancer. It was the size of a baseball, before we
9 found it.
My story is very similar to many Gulf War
veterans. As president of the Connecticut chapter
of the Gulf War Veterans of New England, I hear from all over the country, different veterans.
I spoke with a veterans group last
weekend. They have seven Gulf War veterans in their unit. Four of them have cancer of the testicles and have had their testicles removed.
They're all in their 20's. They were all MPs. One of them has liver malfunction and another one just lost a new-born child. They were all MPs. They were all in the POW camps.
Now I've conducted a survey of my
husband's MP unit in October. 110 surveys were sent out, 46 of them were returned, 43 of them reported illness. A copy of that is inside of your books, if you want to take a look at it. It lists the symptoms.
Now the Association of Birth Defects is investigating unusual clusters of birth defects. I recently received a letter stating that 10 cases of
10 Goldenhar syndrome had been reported, and several
other cases may fit the Goldenhar pattern. There should have only been one to two cases reported per the amount of children born to Gulf War veterans.
Given the amount of documented toxic
chemicals these personnel were exposed to and the complexity of each person's chemical body reaction to each toxin, this panel will not find one cause for this illness.
The figures on sick and deceased veterans that you received from the VA are not accurate. You are only receiving figures on people who have died or were treated in VA hospitals. And most people do not go to the VA hospitals because they offer such poor medical care. My husband isn't even included in these figures. He died at home and he was treated by a civilian doctor.
A few months ago, I received a survey from the VA, asking him to complete it. The man has been dead for over a year and the VA hasn't even updated its files.
I also, the day before I left to come
11 here, received something else addressed personally
to him, from the VA. That's the last page of your pamphlets I've given you.
Now Captain Knox was concerned during the last hearings that the military did not receive adequate physicals before they left for the Gulf.
If the military can't provide adequate
physicals, how can they possibly report to you about the care they're giving the veterans, if they can't provide an adequate physical? It makes no sense. And also, how do you expect these military personnel to return to these doctors who couldn't provide an adequate physical for treatment? I certainly wouldn't.
Now the military felt these people were well enough to serve their country, but now they've turned their back on them. How many more have to die?
Why is it so difficult to get figures on Gulf War veterans? Most deceased veterans receive a military gravestone of some kind. Why can't the amount of military stones issued to Gulf War
12 veterans be requested?
I can guarantee the figure is much more
accurate than what has been reported.
Now, I personally called down to
Washington to try to find out how many Gulf War veteran stones have been issued. I did not get an issue. Maybe you all can get an answer.
I was told that gravestones for any war veteran were only issued for unmarked graves. This is not true. This is what they would like you to believe.
I have never known a veteran that does not have a footstone or headstone from the military. Now, I think that these figures can be gotten for you.
Now, I wrote to Mrs. Clinton about eight months ago, and I have yet to hear a response. I didn't get a letter. I did get one phone call clarifying something, but I never even got a letter in response.
Now if the President and Mrs. Clinton truly want the veterans of this country to believe
13 that they really do care, I'm challenging them to
look at my case personally, and to respond to it. My case is a good example of what is truly
going on with the VA. Thank you.
CHAIRPERSON LASHOF: Thank you very much. Are there questions any member of the
committee has for Ms. Dulka?
DR. BALDESCHWIELER: I would like to ask a question.
MS. DULKA: Yes?
DR. BALDESCHWIELER: Are you sure it was benzene that was used as a disinfectant?
MS. DULKA: Yes, I am. It's a form of Lindane, and it was in powdered form, and they were using pressurized cans and spraying the Iraqi prisoners with it. My husband was very concerned about it, so he wrote me home a letter, and wrote exactly what was on the side of the cans they were using.
DR. BALDESCHWIELER: And what did that say, again?
MS. DULKA: It said benzene. I don't have
14 the exact wording with me, but I can get that for
you, if you'd like it.
DR. BALDESCHWIELER: I think that would be
useful.
MS. DULKA: It is a form of Lindane, and
the U.S. Government has not denied that this was
used. It's a very clear and documented fact that it was used.
CHAIRPERSON LASHOF: Any other questions? DR. TAYLOR: I guess as a follow-up, you
said Lindane or--
MS. DULKA: Lindane.
DR. TAYLOR: Lindane.
MS. DULKA: Yes.
DR. TAYLOR: Okay.
MS. DULKA: Benzene is a form of Lindane. DR. TAYLOR: All right. We can follow on
that. That would be good.
CHAIRPERSON LASHOF: If there are no other questions, thank you very much, and we will be looking into, and considering the issues you've raised.
15 MS. DULKA: Thank you.
CHAIRPERSON LASHOF: Is Sonny Evers here? Congressman Mascara, has Sonny Evers arrived? Oh,
I'm sorry. He's with Mary Rhodes.
Well, I think if Sonny Evers has not arrived, then the next person will be introduced by Congressman Frank Mascara of the 20th District of Pennsylvania, who will be introducing Mary Rhodes. Thank you very much for joining us, Congressman Mascara.
MR. MASCARA: Good morning, and I very much appreciate the fact that you, the Presidential Advisory Committee on Gulf War Veterans' Illnesses, have given me an opportunity to introduce Mary Rhodes.
I also thank you for taking the time, and certainly, the President, for appointing this commission to look into these matters.
Mary is a hero in my district, in
Southwestern Pennsylvania, and she is a hero to me. She symbolizes all those who willingly and faithfully served their country during the Persian
16 Gulf War, only to return home, to discover that
their health may never be the same.
Mary is here because she has numerous
health problems similar to those being experienced
by tens of thousands of other Gulf War veterans. Her unit, the 14th Quartermaster
Detachment of Greensburg, which is in my district, had 13 members killed in February of 1991, in a scud missile attack. This unit suffered the greatest number of casualties in the war. She spent months in the hospital recovering from injuries as a result of that attack and has been in and out of hospitals with serious health problems ever since.
Although I'm sure she has lost her patience, on occasions, she has never lost faith in her Government. I was proud to take up Mary's cause. She deserves the admiration and support of all of us. I encourage you to listen to what she has to say. Maybe we can all learn something from her testimony today, and I thank you, Madam Chair.
Mary Rhodes.
17 CHAIRPERSON LASHOF: Thank you very much,
Congressman.
MS. RHODES: I want to thank you for
letting me speak today. You have to be very
patient with me, because with my illness, my speech
is very slow and I have a spelling disorder now. Hello, my name is Mary Rhodes of the 14th
Quartermaster, in Western Pennsylvania, Reserve Unit. 14th Quartermaster landed in Iran on 19 February 1991 with 69 soldiers. 14th Quartermaster landed back in Latrobe, Pennsylvania, on 9 March 1991, with 21 soldiers. 14th Quartermaster had numerous deaths and has suffered more causalities than any other unit in the coalition force.
We went to war, we knew the risks, and while I carry my loss for the rest of my days, all of us knew, going in, what we faced.
What we did not know was that we would bring something back with us, something so vile, that we'll never again be able to speak lightly about the worst thing in the world. It is killing us. It is killing our loved ones, our offspring,
18 and our comrades in arms.
Beverly Clark was my dearest friend. I
said goodbye to her on the night of 25th February
1991, as she lay, died in my arms, in the remains of [inaudible] in Iran.
Okay. In the past few years, I have often thought of Beverly, and sometimes I think she was the lucky one.
Now I'd like to read a letter that I wrote to my daughter.
"Dear Samantha: You have sacrificed quite a bit of your childhood. You have lost these good times and you have paid a price that no child should never have to pay, because your mother went to war. You lost, along with your childhood, Beverly and the others. But more than that, you lost your mother. I have never been the same since my return. I carry guilt because you have taken your time, the time you should have spent growing up. But you have to care for me. No one can ever make [up] this loss to you. In future years, you may think that instead of a happy childhood, you
19 hold the Gulf War illness."
"As your mother, I have wished that things
were different. I often wonder what your life
would have been, how you might have grown up in a normal environment, but that's only a lost dream. I'm sorry, my daughter. I'll always love you. Your Loving Mother."
That's all I have to say.
CHAIRPERSON LASHOF: Thank you very much. Are there questions? Andrea.
DR. TAYLOR: I am sorry about your loss, but I wanted to find out from you exactly--can you tell me what happened with your group, and were there exposures that you noticed while you were in active duty? And what actually went on?
MS. RHODES: Okay. I was with the 14th Quartermaster. We were in country only for one week when my unit got hit with a scud missile attack. We were the worst hit. Okay. I never really thought about it until I started talking with other people, because my memory's really bad
now. But the water there was really bad. Where we
20 had to take showers, it was hooked up to a sewer
system that came right in from another compound, from their sewer.
And then you brushed your teeth with it. And the mosquitoes were really, really bad. I remember one night, when I was pulling guard duty, they wanted me to stay in this area where there was dead rats and cats. I refused. I stood outside the area that I was supposed to protect.
I really don't know what happened over there. I don't know if it's from the scuds, the shots. All I know is my body's deteriorating, and my daughter's suffering from it.
DR. TAYLOR: Can you describe some of your symptoms.
MS. RHODES: Okay. When I first came home, okay, I had bleeding. I bled for a year. They kept telling me it's my ear--my head, because my unit, my squad was completely wiped out. I had to have a hysterectomy a year later. Okay. I started feeling more better, but I had the flu, and I was always tired. A year later, I had my
21 gallbladder out, okay, and I started getting a
little better. But I had the flu, and I was throwing up blood.
Okay, a year later, in 1994, I got almost sick, I died [sic], I woke up, I went to work, but I was just tired, and I started throwing up. And two weeks prior to that, I was at the VA for three weeks, where they kept telling me I was having bowel syndrome, blah, blah, blah, blah. Okay.
And I went to the local civilian hospital.
Do you know, they refused to treat me because I had the Persian Gulf syndrome? They kept me in the emergency room overnight, and I had to go to the VA the next day. I was hooked up to oxygen, and a lot of it's blurry. All I know is my stomach--I looked like I was nine months pregnant.
My liver axons [phonetic], were real high. I was still throwing up, and diarrhea. That's what I'm saying: they diagnosed me wrong with the hysterectomy and I've been sick since then.
And I get these lesions all over me, and my daughter's friends won't even come over to the
22 house to play with her because they're afraid it's contagious. And I can't even get out of bed some
days. Some days, I don't like to talk about it. It's embarrassing. But I mess myself. I throw up, and diarrhea. My daughter has to stay home and take care of me. I mean, it's bad enough my unit got hit. And now I'm suffering. You know, something's got to be done.
Does anybody else have any questions? CAPTAIN KNOX: Are you receiving any
compensation from the VA?
MS. RHODES: Ma'am, I'm filing at 100 percent disability, and you know, some people in my unit aren't sick, and they're saying that it's all in our heads. How can it be in my head? I wish I could go back. I love the reserves. If you called me back, I'd go back now. But I can't even get out of bed. Then my daughter is suffering. And it's not in my head.
I used to run 4, 5 miles a day, and now I can't even walk down the street and come back. And like I said, it's my daughter who's suffering. You
23 get a chance, read the Life magazine of November
1995. Read about them children.
I know I'm going to die. I really, truly
do. People tell me, don't talk about it. But I
know I'm going to die. But how do I know I didn't give it to my daughter or my loved ones? You have people out there, Persian Gulf vets, that won't admit it. They could be spreading this. It could be another AIDS. We don't know. That's why you've got to stop it now. Because I love my country, I went, but my daughter don't need to suffer no more.
She was an Army brat. Her attitude of the
military is really bad now, and I don't want her like that. Because I'm still patriotic. Like I
said I go now--I just got processed out of my unit, and it tore my heart apart. But please, please listen. Thank you.
CHAIRPERSON LASHOF: Thank you very much. MS. RHODES: Yes, ma'am.
CHAIRPERSON LASHOF: We'll proceed on to Candy Sweet Lovett. Can you help her arrange the mike, so that she can be heard.
24 MS. LOVETT: Good morning. My name is
Candy Sweet Lovett and I'm not here to talk about
myself today. I ask the committee's indulgence, to play a five minute videotape in lieu of my testimony. Remember, we are your children. Jason wanted to be an electrical engineer. He joined the Army because he felt it was his duty.
The woman who became his wife was his high school sweetheart. She knew he was sick, and she married him anyway. She is now suffering from this syndrome.
Over 7,000 vets have died from this illness. And that does not include the immediate family members. This illness is killing us, and more than that, it is killing those who would have been our children.
I talked to Jason on October the 16th, 1995, and he asked that I pass this one message to this committee. "There are thousands of vets in my condition."
And now we can just go ahead, and go on with the video, and I appreciate it.
25 [Videotape shown.]
MS. LOVETT: I'd like to thank you, ladies
and gentlemen, for letting me introduce this film,
and I really appreciate it.
CHAIRPERSON LASHOF: Well, thank you very
much for coming and bringing that to us.
Are there questions people have, that they
would like to address specifically to Candy?
DR. LARSON: Thank you, Ms. Lovett, for
your testimony. Two questions.
First of all, if you wouldn't mind, can
you tell us what your diagnosis is, and what the relationship is to the war.
MS. LOVETT: I've got documents as early
as June of this year from the VA that says I have a
germ war agent in me. I have a spinal disease
that's slowly paralyzing me. The VA, or the military, neither one want to touch me right now because of my neck problems, and stuff.
The other people that were with me--there was a total of 16 of us--the other 15 have died, and that was confirmed by my military lawyer at
26 Fort Hood, Texas, at the time. Now it's being
denied.
The thing that I lost the most is I lost
custody of my son because I couldn't take care of
him, and I think that's my biggest loss. I have hope for the future. I try to look at it and be realistic. I know that I'm going to die. But we're all going to die, you know. So I try to look at it like that.
General Blanc is very heavily involved in my case right now, with my private doctor. He's agreed to let me have consults with civilian doctors and let CHAMPUS pay for it.
I will not go back to the VA, will not go back to the military. In fact I was kicked out of the VA hospital in D.C. after three days. I was rushed to another hospital and was diagnosed with Parkinson's disease, drug-induced, because the military said this was all in my head.
For years, I spent numerous years back and forth on psychiatric wards, and because of it now I have Parkinson's disease also. I have brain
27 damage, and they think I have a tumor on my brain
right now
DR. LARSON: So the Parkinson's was
induced by the drugs that were given to you for an
alleged psychiatric illness?
MS. LOVETT: Yes, ma'am.
DR. LARSON: And you said your diagnosis
is that you have a germ war agent?
MS. LOVETT: Yes, ma'am. I can present
that later on to this committee. I can make copies
and present that later on
DR. LARSON: That would be very helpful, I
think.
MS. LOVETT: And it's from the VA in D.C.
And what I'd like to also say is I was represented
by the American Legion. The guy who represented me, Mr. Tracy Underwood, did an excellent job, and helped me to get where I needed to go, along with my senator, Connie Mack. My congresswoman, she was no help whatsoever. She just wouldn't help me. In fact she gave me an appointment, and refused to see me after the appointment was set
28 DR. LARSON: I have one second question,
and that is, you quoted that 7,000 vets have died
of Gulf War syndrome.
We need to get some statistics on that.
We seem to be having a little trouble getting
mortality statistics. And I'm not asking you to provide them, although it would be helpful, I think, if you could tell us where you got that statistic, and then our staff could follow upon that.
MS. LOVETT: The statistics came from, I believe, Major Haines, out of Indiana, and it's been sent to all the different Gulf War groups. I do have copies of that, too. And there are civilian people who are dying from this, too, who are very sick. I've passed this on to people I
used to live with in Massachusetts, and they've got the same things that I got--the sores, everything.
DR. LARSON: Well, anything you can
provide us would be helpful, and then we really do need to get those mortality statistics. Thank you. Appreciate it.
29 MS. LOVETT: Thank you.
CAPTAIN KNOX: Ms. Lovett, what unit were
you with during Desert Storm?
MS. LOVETT: I was with the 57th
Transportation out of Fort Drum, New York. I
wasn't with them in the States. I went straight from basic AIT right on over to the desert, and was attached to--my orders were cut in Dhahran. And in fact the first night I was there, the alarms went off. I mean, I slept the whole night with my mask on. But I was sent to be with 57th Transportation and out of that unit, one of the guys raped me, and I was blackmailed into dropping the charges. And to this day, nothing's been done, but supposedly if what I've been told is true, then he's dead and he's received his just reward.
CAPTAIN KNOX: So of the 16 people that are in your unit, you say 15 of those have died?
MS. LOVETT: That is correct. That is
what I was told, actually, in July of last year, in the military's office, military lawyer's office, and I wrote it down on my calendar. She told me
30 the Department of Defense brought me back to active duty--I was on TDRL--and she said they brought me
back to active duty to do an investigation to determine why, out of 16 people, 14, at that point, had been deceased.
The 15th is a non-confirmed death. It's not confirmed. But this has been validated. Numerous people have talked to this lawyer, and she has validated that story.
CAPTAIN KNOX: Robyn, I'd like to get the statistics on that as well.
CHAIRPERSON LASHOF: There's no question that staff will follow up and get this information.
MS. LOVETT: Okay.
CHAIRPERSON LASHOF: Thank you very, very much for coming.
MS. LOVETT: Thank you. I appreciate it. CHAIRPERSON LASHOF: Has Sonny Evers
arrived?
[No response.]
CHAIRPERSON LASHOF: Is there anyone else in the room who wishes to make a public comment at
31 this time?
[No response.]
CHAIRPERSON LASHOF: All right.
Apparently Sonny has not arrived, and there are no other people to make public comment at this time. So although our agenda originally called for our moving on to the research issues following the public comment, that's not scheduled to begin until 10:00. And so we'll move on to some of the committee work, specifically around the issues of the implementation.
That is the section that the committee agreed that one of our priorities was to have staff look at the various recommendations that have been made to DoD and VA by previous studies and reports, and begin to identify what the response has been to those previous recommendations.
So if Kathy Hanna from our staff will join us, and brief us on the staff work in this regard. Kathy.
Discussion of strategy for review of implementation
32 of recommendations from past reports
MS. HANNA: Good morning. If you look in your briefing good, there is materials in there that summarize some of the studies that staff have reviewed already, you'll notice in the charter that--
CHAIRPERSON LASHOF: What is the tab?
MS. HANNA: It's F. Sorry. One component
of the charter is that the committee is to review the recommendations that have already been issued by previous deliberative bodies, including the Defense Science Board, the Institute of Medicine and its committees.
There have been several reviews by the General Accounting Office and by the Office of Technology Assessment.
And many of these reports issue
recommendations to the VA, the Department of Defense, Health and Human Services.
And part of your charge is to decide how you want to follow up on those recommendations. That is, to what extent have the agencies gone
33 ahead and implemented either research programs or
outreach programs, or further investigative
programs in compliance with those.
So we're at the point, right now, where
we've reviewed those reports. We're still in the
process of reviewing several additional documents that have come out of the General Accounting Office, and really, at this point staff needs your guidance in terms of what's important for us to start out immediately on follow-up.
And the point here is to not reinvent the wheel. If other organizations have spent a great deal of time reviewing a body of literature, or hearing testimony or talking to veterans, or talking to people in any of the agencies, we don't want to do that all over again.
We really just want to follow up and see what's important to this committee in terms of documenting how that evidence was gathered, what the validity of it is, and what the follow-up has been.
So this is really just an opportunity for
34 you to give staff some feedback on what's
important. What are the first few things you would like for us to look at before the next meeting?
CHAIRPERSON LASHOF: I hope committee
members have had a chance to review the documents that are here under tab F. I think Kathy has done a thorough job in getting these outlined here for us, and the issue, as she said, is we want for our interim report, in February, to begin to focus that report, as we agreed at our previous meeting, around determining how well the agencies have acted on the previous recommendations made by other committees, before we start off with a whole new set of recommendations for them.
So, Elaine?
DR. LARSON: Kathy, a couple of comments. First of all, the way you categorize the recommendations on this table, I didn't bring our original charge with me.
Is this related to our original charge, or is this just to--in other words, we have eight components to our charge. One way to look at these
35 would be--I think it would be helpful to us if we
looked at them in relation to our charge as well. And also, you've got to look at them as you have, by time, because obviously the earlier ones are more likely to have made some progress.
I noticed a lot of overlap in the recommendations, among and between committees. So if we can look at, get a sense of the overlap as well, and then look at doing some kind of a time line or progress report. None of them will be
fully--well, maybe a few will be fully implemented. Some of them will be in progress, and so
we've got to have a way to look at which are fully implemented and are dealt with, which are in progress, and for which there seems to have been no action.
So first, I'd like to put it in the format of our charge, so that we can look at it that way. You've already made a start on that with your table.
MS. HANNA: If you look at the cover memo in that tab, it does have the wording from the
36 charge, that specifically names the Defense Science
Board report, the Institute of Medicine Reports, and NIH Technology Assessment Workshop, and the Veterans Administration's Coordinating Committee, so--
DR. LARSON: But what I'm suggesting is that we actually categorize the recommendations from each of those reports, in terms of our charge, so that we know what's already been recommended,
and we don't repeat what we've billed, on and check where the progress is, or isn't.
DR. NISHIMI: Just to clarify, Elaine. So you're suggesting that we take instead, a different cross-cut, research, and then DSB made a recommendation on research, NIH made a--is that what you're suggesting?
DR. LARSON: Yes, to see where they're the same, where they're overlapping. and to make sure that we don't, again, overlap.
DR. NISHIMI: I mean, I think on the left hand, that's what we've sort of done, but we can perhaps refine that.
37 CHAIRPERSON LASHOF: Yes. I think if I
understand, Elaine, our charge covered, you know,
the categories of, Is there adequate research?, Were there chemical-biological weapons? There were--what was it, six?
DR. NISHIMI: Outreach.
CHAIRPERSON LASHOF: Outreach, and so on. So if these were re-tabbed--and actually,
they're pretty close to it as far as I see it. Outreach is here. Medical care is here. I'm not sure if she hasn't already done that, if we go back to our original charge. Research, we had, you know, the vaccine issues, the chemical. There's nothing listed specifically on chemical-biological. So it might need a little more refinement. But this is pretty close to that.
DR. LARSON: All I'm saying is to divide, to actually take each recommendation and say, under Research, and maybe we could look at them as sub groups, and see how they're different or the same.
It says that, for example, IOMCCEP did a
recommendation on outreach in education. Well,
38 that's a bad example because that was the only one.
But say the first one, under Registries,
Medical Assessment Criteria, four reports had recommendations.
CHAIRMAN LASHOF: Yes.
DR. LARSON: Well, are they same,
different, overlapping, or what?
CHAIRMAN LASHOF: Yes.
DR. LARSON: So we could in sub groups, or
between meetings, look at those various
recommendations and do that for everything. Or staff can, too. You've probably already done that.
MS. HANNA: There's one other issue that
staff have discussed, and that has to do with some of the language in the reports, that don't necessarily result in a formal recommendation because perhaps the charge to that group did not ask them to make a recommendation in that area.
However, they uncovered some information
or they felt strongly enough about their findings to state it in the report, and in some cases, those findings that have been stated in the reports have
39 had more effect in the follow-up that an agency has
done than the actual recommendations, where either the importance of a research area has been emphasized or de-emphasized.
And so in looking through the summaries that have been prepared in there, I ask you also to look at the findings that are not stated as emphatically as the recommendation because there's a lot of information in there, that's somewhat hidden. Instead, we need to find out, on staff, how much of that you want us to find the backup information on that.
For example, if the IOM Committee made a fairly strong statement about vaccines, do you want us to find out what is behind that statement? Who did they talk to? What data did they review? So that we don't have to do it all over again. We've already done it.
DR. CAPLAN: I had two suggestions along those lines. Substantively, it seems to me one of the things that we're going to be moving too pretty fast is the epidemiology issue. And another is
40 possibly a look at the vaccine issue. So
recommendations in those two areas are of prime importance, because that's where we're headed next.
But even before that, the one
recommendation that keeps jumping out at me, as we listen to numbers go by about who's sick, and how many, is this one--I think it was the--yes, the Institute of Medicine, 1995 "Health Consequences", one, that keeps saying there's no real good registry.
And I want to know what's been done to get numbers, because you can get numbers--we've heard numbers that are all over the place. And it seems to me one of our charges is to make sure that the veterans and those trying to treat them, and those trying to assess whether the response is adequate, need to know whether we've done what various bodies have recommended, most notably this IOM group, on having good solid registries with good information.
So, to me, that's a top priority, to find
out how well they're carrying that out, because that's a baseline for us for almost everything
41 else. It certainly will be for the epidemiological things.
CHAIRMAN LASHOF: Yes, Andrea?
DR. TAYLOR: Going back over the area of
recommendation under Research Topics, I noticed
these are fine, that are listed, but I don't see anything regarding maybe other chemical exposures, even though the Department of Defense has said there was no chemical warfare. But I think maybe we should still keep them on the list.
CHAIRMAN LASHOF: Now I think we probably didn't have any recommendations on the chemical and biological because the previous ones that looked at it claimed there wasn't any.
DR. TAYLOR: That there wasn't any. CHAIRMAN LASHOF: And that is an issue
that we're going to take up later.
DR. TAYLOR: Okay.
CHAIRMAN LASHOF: But I think we might want to hold that until we get through looking at these that were recommended.
I think on the question you raise, Kathy,
42 about where they made a recommendation based on
extensive work, we do want to know what was the basis of their work, that led to that recommendation so we don't have to repeat that, and having reviewed that, can decide whether we agree with that recommendation or variant.
I think in proceeding on, if one does sort of take the recommendations, as you've done in the table, but then actually elaborate them by saying, you know, what did the Defense Board, the OTA, GAO, say on medical assessment criteria, together? How congruent were their recommendations, so that the same, or what the opposites-- and then which ones have been followed through.
In terms of trying to put some priorities on them, I guess it becomes almost a judgment call. Well, the earliest recommendations might be the first ones to look at, because they're the ones that are most likely to have been implemented at this point, and then determining, in the process, fully implemented in the process or not. And sort of grouping them that way, I think would be
43 helpful.
This issue of statistics is, you know,
obviously disturbing. I would have thought that
any veteran who dies, that the family would have notified the VA of death, because there are death benefits, aren't there, for any veteran?
MS. DULKA: No, there's not.
CHAIRMAN LASHOF: No--
MS. DULKA: Excuse me. I'm sorry. CHAIRMAN LASHOF: Go ahead.
MS. DULKA: I speak from personal
experience. Unless your spouse's death has been
service-related, there are no benefits for the VA--from the VA. Now, my husband, I reported him to
the registry, and also the VA is aware of it, and
they still continue to send him information,
surveys to be filled out. Obviously, their recordkeeping is not up to date. This was over a year ago.
CHAIRMAN LASHOF: Well, that's something we certainly have to look into, and talk about how we can get better records, and what they need to do
44 to get up-to-date records on every vet.
DR. LARSON: Let me just follow up on the
overlapping of the recommendations and how I think
we need to get a handle on it. For example, I'll just show you two. The April '94 NIH Technology Assessment Workshop, one of their recommendations was the VA should develop more responsive and effective approaches to diagnosis and therapy of
veterans affected by stress-related and stress-exacerbated illness.
And then in the IOM Committee report on
the DOD Persian Gulf syndrome, it says:
"Consideration of the prominence of stress and psychiatric disorders as diagnoses or contributing factors in the CCEP findings should be given."
So they're so overlapping, that's what I
think we need to do first, is flesh out, a little bit, the overlaps.
CHAIRMAN LASHOF: All right.
DR. BALDESCHWIELER: Could I comment also? It seems to me that we would be well
served by having two tables of this kind, one that
45 represented the findings, and one the
recommendations, because a lot of the important content is in the findings and conclusions. And another point that might help would be going across the rows, to literally put them in chronological order as to the earliest studies on the left going, and that, I think, would give us a sense of the flow of the findings and recommendations.
CHAIRMAN LASHOF: Yes; okay. In the book
they're in chronological order, but not necessarily in the table. Okay. Other suggestions?
MR. RIOS: Robyn, let me ask you, is the staff actively involved in getting a list of how many people died over there, a list of--I guess you might say a "death list"--how many people died over there, and what was the cause, and how many have died since?
Are we actively pursuing a list of that type, that we can have, and if we are, where are you on that?
DR. NISHIMI: Well, are we pursing a list of individuals per se? I would say no. Are we
46 trying to get a handle on the statistics, such as
Joyce said, you know--Who's saying this? Who's saying that? You know. What does the Department of Veterans Affairs say? What does the Department of Defense say? What do nongovernmental bodies say, the American Legion, veterans' activist groups, concerned citizens? We are collecting that kind of information, yes.
But in terms of, you know, John Doe, you know, Jane Smith--no, we're not doing personalized lists.
MR. RIOS: Why not?
DR. NISHIMI: It's a difficult task. I'm not sure--did you want to interrupt me?
CHAIRMAN LASHOF: Go ahead.
DR. NISHIMI: I think that the accuracy of an individualized, personalized list is just not within the staff's means to do, and I'm not sure how valid it would be.
CHAIRMAN LASHOF: Why would you want to try to get an individualized list, given what our charge is?
47 MR. RIOS: Just to know how many people
died and--
CHAIRMAN LASHOF: Well, the numbers, yes.
The numbers, we're trying, as Robyn said, to
collect all the data we can on what the different groups say that data is, and obviously, it's one of the real knotty problems here, and one of the disturbing ones, is that we have different statistics coming from different groups, and we do want to find out which are the correct statistics. But to get a list of names, and unit number, I think that's beyond the staff's capability, and I'm not sure what value it would be to the committee. But I'm open for further discussion of that issue.
Lois is a staff person who's worked on
some of the outreach in this data.
MS. JOELLENBECK: Yes. Just wanting to let you know that the Veterans Administration is carrying out a study on mortality, and some of the preliminary data from that is going to be available at the end of the month, at the APHA meeting. They expect a publication describing the mortality data
48 that they have thus far, and early next year.
MR. RIOS: For all the deaths that
occurred over there during the war and after the
war, that could be related to the--would that be by name, also, or is it just--
MS. JOELLENBECK: I do not know. I do not think so.
DR. CAPLAN: It would certainly be useful, and I think Robyn was hinting at this. I don't think it's our task, or job, to get names per se. But it seems to have been recommended to about 47,000 other agencies to go get these lists, and what I would find very helpful, just on these numbers, is Defense Department statement, VA's statement, Gulf War veterans' statement, New England Gulf War statement, hearsay, rumor, and let's see them all out on ranges, both during the time, after, rates, birth defects.
With that kind of table, about what people have said and claimed, what sort of effect they've made toward implementing this request for good solid registry information, that that paper will be
49 good, though people criticize it and say, Well,
that doesn't cover everyone because some people have clearly dropped out of the system.
So we need some penumbra of information about who else thinks they died, or was injured, but has sort of walked from VA or gotten away from the Government health care system.
So if we could put that into a kind of tabular and chart form, I think that would help us a lot. I think the question, in part, that we have to answer is can people trust these estimates, and when they give us reasons for doubt about what's related to what, we at least have to know what kind of information the agencies have pulled together to try and address those who distrust the numbers.
CHAIRMAN LASHOF: Will they--stay there
for the moment, Lois. In the VA's report, that they hope to have, and they've scheduled it to be released at the APAH meeting
--will they have it broken down, by unit, so that we could confirm or not confirm statements like "From our unit, there were 16 people, and 14 have
50 died."
Is there going to be a way to find out
whether that data is valid or not valid?
MS. JOELLENBECK: I suspect not, but I
would need to defer that, or get back to you on
that.
DR. MURPHY: We're going to get a
presentation on the research efforts and you'll get a full description of the mortality study.
CHAIRMAN LASHOF: That's right. Some of
this will come up as we get into the research discussion, because clearly, a mortality study and an epidemiologic study is part of the research, and that's later on in today's agenda, plus a special meeting in November, and it will be high on the agenda for our December meeting. Okay, thanks.
DR. BALDESCHWIELER: But somewhere in the
process, I mean, one really has to have access to the underlying data. That is, if you really want to check out statements about individuals and units, it seems to me there has to be a trail that goes back to the individuals.
51 CHAIRMAN LASHOF: Yes, I think we can talk
about that with the researchers, to validity of the research and validity of the data, and what kind of evidence we're going to want to have to be sure of
that. Yes, clearly, somebody's got to have a list. Other suggestions for Kathy as she
proceeds with the implementation aspects?
DR. CAPLAN: One other thing. I don't know if you can look into this, Kathy, but let me
just use the vaccine issues, and giving out anti-biological, anti-chemical warfare things.
I would be interested in seeing what the
agency responses have been since that time in terms
of policies and statements, not only specific to Gulf War events, but just in general on those issues. You know what I mean?
In other words, saying, Well, have they articulated, or had meetings or done anything, just as general responses to questions about experimentation involving troops, and that sort of thing. That might take you to the Radiation Task Force work, and so forth.
52 But it would be useful sometimes to see
what else has gone on on similar issues. And the
vaccine one, again, I think will be coming up fast, so--
CHAIRMAN LASHOF: Okay. Any follow-ups? Any other suggestions, questions, comments?
[No response.]
CHAIRMAN LASHOF: Kathy, maybe you can expand a little bit on your statement in the memo, that it is your intention to expand the matrix, and to include GAO reports and any other relevant public laws. You also state that you intend to begin evaluating through interviews, briefings, other inquiries, both federal and non-federal, implementation of recommendations made in this document, and you go on and ask for further guidance from us.
Are there specific questions you have as you pursue that, or would you like to expand a little bit on how you plan to do all that?
MS. HANNA: Well, there are several layers here, which makes this a little bit complicated,
53 and perhaps some of your eyes will start to glaze
over as we try to describe the process. There are several layers.
There have been public laws that have mandated certain activities and certain reviews across several agencies and most of those mandated studies are either completed or underway.
So at one level, we intend to try to determine whether those reviews or activities met the charge that was given to them in the public law.
Then we go one level down and review the activities of those various commissions or committees, or coordinating boards, to try and get a sense of what their activities are. And it will be largely through interviews, not only with the people that each agency has designated as their point person to deal with us on these issues, but also with some of the program people who might be dealing with issues that Art mentioned, having to do with vaccine policies or the development of future vaccine policies.
54 So beyond the recommendations, we are
going to try and get a sense of what other things
are going on in these agencies, if not to address the past, but to try and figure out how to improve the process for future conflicts or future vaccination policies, or whatever.
So at this point, we're very preliminary in that we'll spend the next two months in talking to people in all of the agencies as well as the staff who worked on the previous studies, to gain from their experience, and to try to come up on the learning curve with them as to what they already looked at.
CHAIRMAN LASHOF: Thanks. That is helpful. I think if you'll all look at the chart at the end of this tab, you know, which lists all the committees and the dates of appointment, and so on, you get some sense of the scope of the problem Kathy faces.
And one of the questions I have is as you talk to the agencies about recommendations, it's easy to say, oh, yes, we've implemented that
55 recommendation. The question is what degree of
evidence do we demand to see that they, indeed, have implemented it, and how do we make a judgment as to whether that implementation is sufficient, or partial, or really responsive, completely, to the recommendation? And that, I think, will be a tough challenge to you.
DR. NISHIMI: And I think one of the things Kathy can do is not, obviously--and she intends to not just talk to the agencies about what they say they've done, but talk to people who would be affected by those recommendations, as well as members of the independent Advisory Committee that they have, to see whether or not they believe that their recommendations were being held forth. So it's not just an agency and departmental centered interview process, but also end users, and, you know, sidebar individuals, if you will.
CHAIRMAN LASHOF: Robyn, how much staff efforts is assigned to this? Kathy can't quite do it all, I don't think. It looks like a big job to me.
56 DR. NISHIMI: She's quite capable, and
she'll get whatever support she needs to get it
done.
CHAIRMAN LASHOF: You heard her. She said
you'd get whatever support you need.
Other comments, questions, suggestions,
priority setting guidance, what have you?
DR. LARSON: Is the committee in
agreement, then, that they'd like, initially, to
look at the research issues as well as some of the vaccine issues? Does that seem a reasonable thing?
DR. LARSON: You mean whether or not the
research has been done?
CHAIRMAN LASHOF: Whether the recommendations about the research are--
DR. LARSON: Absolutely.
CHAIRMAN LASHOF: Yes. I mean, I think that's top priority. We'll get into that more, I'm sure, when we move into the research today, and that's certainly going to be a priority.
I think some of those that we can get out of the way quickly, that we've done a fair amount
57 of looking, as of today, on outreach, and we can
look at those recommendations and probably come up with something pretty definitive on that. The databases and the medical assessments probably are pretty easy ones to look at. The most complex ones, indeed, are going to be the ones over research and the ones over medical care.
My guess is at this point we would probably look to the research ones as priorities, and the medical care ones further on. Is that--
DR. LARSON: Why? I mean, why that
priority? We've been focusing, early on, until now, on access and coordination of care.
CHAIRMAN LASHOF: Yes, access and
coordination, but we have not yet gone into
satisfaction with quality of care and those issues that are going to be pursued further, as indicated yesterday by Joe Cassells, the kind of work he's going to do on focus groups, and so on.
DR. LARSON: I was going to ask what the time line is on this, because we need this finished by February, right? Totally finished?
58 CHAIRMAN LASHOF: Well, that's the
question: What do we need to finish by February? By February, we have our interim report on our first effort.
DR. LARSON: But it seems to me that by February, one thing we can and should do is give a status report on all of these recommendations that are already in existence, and then we can do an update in December.
But we ought to be able to do a status report on all of them, not just some.
CHAIRMAN LASHOF: Staff.
DR. NISHIMI: We'll take care of what we can do.
CHAIRMAN LASHOF: What staff are saying is that if you look at this, there's a tremendous number of recommendations to really follow through, and for them to determine how far they're implemented and whether they're satisfactory, et cetera, is going to be a big job.
And it may not be possible, by the
February report, to have reviewed them all. And
59 since we have a time line for digging into various
issues at different stages, I would have thought that if they concentrated first on those that were doing more work on them, in other words, on the medical care we've had meetings around access, and if there are recommendations around that, those ought to be in the February interim report. The outreach material would certainly be in the February interim report, and we're taking up next the research and we ought to be able to say a certain amount, although I'm sure it won't be our final word on research in February.
And whatever else they can do by the February report we should do. But it is an interim report, it is our first step, we still have a good eight months, nine months, after that, to do our final report.
Is there any problem with that approach from the committee?
MS. HANNA: I would just like to add, Elaine, that for some of these, it will be quite easy to determine whether changes have been made.
60 For example, changes in a questionnaire
for the registry were changed to include such
things as fertility problems or miscarriages, and if a recommendation was made that those questions be added to the survey, and they in fact have, that's an easy one to follow up on and determine whether in fact that's the case, and they're now collecting data in those areas.
The response might have been, from an
agency, "We agree with this recommendation," and so that it's going to be much harder to get down through the layers to find out what they mean by that.
DR. LARSON: Well, my point is, if I count correctly, there are 49 recommendations. That's not infinite, and many of them overlap, and there are two approaches here.
We could give an update in February on just some, and where they are, in which case we'll still have to do it again in our final report. Or we could just look at where they all our at this point in time to the best of our ability, i.e.,
61 some will say pending, or some will say this is
where we are.
I would tend to favor at least responding
to all of them, even if our response is "data still
in the collection phase."
DR. NISHIMI: Elaine, we're not in any
disagreement with you. That is the approach that
we intend to take. I just didn't want to leave you with the impression that the job would be done in February.
DR. LARSON: I misunderstood, Joyce. Thanks.
CHAIRMAN LASHOF: Yes. Okay, fine.
Let me ask the committee. The public witness who was not here before has now arrived, and if you really feel we've discussed this as far as we need to, we can go ahead and hear him now. Or if you want to discuss this further, we can ask him to wait a little bit, and go on.
Let's go ahead, Robyn, and ask Sonny Evers to come in.
All right. We will reconvene ourselves,
62 and Mr. Evers of the Gulf War Veterans of Delaware
will present his testimony now.
Further Public Comment
MR. EVERS: Good morning. Sorry I'm late. Dear Committee Members. Thank you for the
opportunity of bringing my issues before you regarding the Gulf War. My name is Warren W. Evers, Jr., nicknamed Sonny, from Wilmington, Delaware.
I was activated with the 736 Supply and Service Battalion of the Delaware Army National Guard on November 16, 1990. We were sent to our mobilization station, Fort Meade, Maryland, on November 24, and left for Saudi Arabia on December 25.
Even though I was declared not deployable, even though the National Guard's medical evaluation due to a profile which restricted my lifting capabilities, I was decided to be deployed at the mobilization station.
Our unit was assigned to King Khalid Military City, KKMC, for the duration of the Desert
63 Shield/Desert Storm. We were located near the
Saudi ammunition bunkers at KKMC.
After numerous visits to the Evac hospital at KKMC for neck and back pain from lifting 65 pound sandbags, I was sent back to the United States for a medical evaluation on April the 1st, 1991.
Upon return to Fort Meade, I spent over two months, April to June, on medical hold. During
this time, no tests were performed to determine the extent of my medical condition. At an informal medical evaluation on April 28th, my wife and I were told by the doctor that according to his examination and x-rays he reviewed, I simply had arthritis of my neck, typical of my age. The only x-rays he reviewed were the ones taken during the mobilization process in November 1990. The doctor's report was completed and I was transferred from active duty to the National Guard on June 3, 1991.
From June 1991 to present, my dealings with the Department of Defense, DoD, and the
64 Veterans Administration, VA, have been complex and frustrating.
I will condense this information in order
to stay within my allotted five minutes of time.
My dealings with the DoD first. I
appealed the informal medical evaluation given by
the United States Army at Fort Meade. A formal evaluation was conducted in October 1991 at Walter Reed Army Medical Center.
I was represented by a private attorney whose expertise was in military law, and an appointed attorney through the formal evaluation process. The board's decision was to grant me a medical discharge with a 10 percent rating, which would allot me a flat severance pay. My attorney and I agreed the decision was unsatisfactory and an appeal was filed.
In addition to the Army's medical
evaluation appeals, I have also begun processing through the Delaware Army National Guard an Investigator General, IG complaint, regarding a violation of my medical profile, which as I
65 mentioned earlier, restricted my lifting
capabilities. This IG complaint took over two and a half years to be concluded, and resulted in neither a substantiated nor a denied decision. During this time, I completed my 20 years military service for the Delaware Army National Guard.
In May 1992, a letter from the Army's Physical Evaluation Board, PEB, stated that my case was considered an administrative error and was being terminated.
I was told in the letter that I could appeal this decision through the Military Board of Corrections. I waited to file my appeal until May 1993, and am still awaiting a decision.
Now to tackle my experience with the VA. I began requesting medical treatment through the VA in June of 1991. Since then, I have undergone ten Compensation & Pension examinations, C&Ps, through September 21, 1995. I have requested treatment and compensation for neck and back condition, and high blood pressure as my major medical conditions, and some minor conditions.
66 Through the VA, I have had numerous
examinations, x-rays, EEGs, and have recently had
an MRI. I have been given physical therapy, pain pills, blood pressure pills, and a TENS unit.
My frustration has been with the length of time that transpires between examinations and the treatment. most of the extensive treatment I have received for my medical condition has been through private medical physicians, including neck surgery.
I received a 10 percent compensation for
my neck a year after my claim was file.d Two years after that, I have been receiving 40 percent compensation, 10 percent of my neck, 20 percent for my lower back, and 10 percent for high blood pressure. Even though I was medically retired in December 1993 from the civil service position I Held at a VA hospital in Maryland, the Wilmington VA still insists that I am not entitled to a higher compensation for my neck and back conditions, or 100 percent Individual Unemployability compensation.
Since my military experience in Vietnam
67 where little documentation was kept by any soldier,
I have learned to keep copies of everything. I now have over 10 two-inch binders full of documentation regarding my experiences with DoD and the VA since my return from Saudi Arabia.
Included in this documentation is a legal brief waiting to be presented in a hearing at Washington's Board of Veterans Appeal, and a legal brief waiting to be presented in a hearing before the Military Board of Corrections.
I feel that the issues brought before each of the Government agencies' processes flow into each other. If each agency doesn't do its utmost to abide by its own laws and regulations, giving the soldier the benefit of the doubt, then every issue will become more complex the further the soldier goes into these systems' processes, resulting in a high percentage of denials.
I thank you. Is there any Q&A time? CHAIRMAN LASHOF: Thank you very much. Questions for Sonny?
DR. LARSON: Mr. Evers, thank you for your
68 testimony.
Yesterday, we learned that sometimes
people were deployed despite the fact that they had a medical recommendation not to be, because of expertise or other things that they had.
Could you tell us why you were deployed when there was a--first of all, am I correct that there was a recommendation from a physician that you not be deployed and you were anyway?
MR. EVERS: That is correct. When I was deployed by the Delaware Guards I--
DR. LARSON: The question is why? In other words, what expertise did you have, or why were you deployed despite the recommendation?
MR. EVERS: I was told to go down with the rest of the units to my mobilization station on active duty.
DR. LARSON: Well, what I'm trying to get at is why you were lifting when--
CAPTAIN KNOX: Was it a unit command? Was it a command decision that you be deployed despite medical advice?
69 MR. EVERS: Yes, it was. How far it goes
up, i can only guess. I've heard, but that's--
DR. LARSON: Well, what was your job in
the war?
MR. EVERS: I was an E-7, a senior
warehouse supervisor in the Service and Supply
Battalion, but I went to Saudi Arabia, I didn't have a job. My first job while I was in Saudi Arabia, at KKMC, was with all deployed units coming up from down at the piers, they would go through my area. I had a tent, as big as a football field, and I would make sure the units would spend one or two nights in the area before they deployed on the front line.
I made sure they had food, water, latrine facilities, and tried to keep them up to date on the rating for MBC operations. They would usually spend one night, and then be deployed further. Once the war started, and the process was going on, then my second job, we closed that down. I was in charge of security at the PX at KKMC, and the post office area. But mainly the PX.
70 And because I was not allowed to lift
anything, already that time, I even recommended
that I would be in charge of security because of my background, and they took that as yes, we did--or they did.
DR. LARSON: So part of your job was not lifting the sandbags?
MR. EVERS: No, not at all. That's another wild story. But I was ordered to that detail for lifting sandbags. One of my complaints against the Board of Corrections, or Department of the Army, is with dealing with that issue. It's a two-inch binder thick of documentations.
The main factor of what I'm saying is that when I went to Saudi Arabia, it was noted in my records that I had C-2 and C-3 herniation. When I
came back from Saudi Arabia, I had C-5, C-6, and C-7, and they're the ones that were operated on.
That includes my lumbar from L-1 to S-1, is herniated and damaged.
Now I don't know if that was lifting the sandbags, or the environmental situation, or the
71 other situation which brought it on. It's up in
the air; it's questionable. I can't believe in that short period of time, that my damage would have been caused completely from doing what I had to do.
CAPTAIN KNOX: So help me understand. You were unemployed before you went to Desert Storm?
MR. EVERS: No, ma'am. I owned my own
business before I went to Desert Storm. I was making about $55,000 a year, and when I went to Desert Storm, I lost my business. I came back, I was unemployed for a whole year, and during that time I went through an operation of cervical fusion to my neck, and then in August of 1992, I got a job working at the Veterans Administration down in Maryland, and I stayed down there for almost 18 months, and where the VA wrote me a letter that they were going to terminate me due to my medical conditions.
I appealed the decision. I asked OPM for a disability retirement and I was approved in November of 1993 for a disability retirement. So
72 I've been out since that time.
DR. BALDESCHWIELER: Which VA? You were
seen at Wilmington, and where else?
MR. EVERS: I've been seen at Wilmington
and I've been seen at the Philadelphia VA Medical
Center. The Philadelphia VA Medical Center has been quite comforting in working with me with my pain. They have a pain clinic. Most of the doctors are from the University of Pennsylvania Medical Center.
The dealing with Wilmington has been more than frustrating, either for adjudication process or for medical process.
I am going through numerous medical
examinations. The treatment that I have received is in the form of physical therapy, which is heat treatment to my neck, medication, and biofeedback. That's it; nothing else.
ADMIRAL CUSTIS: Where was your surgery done?
MR. EVERS: I'm sorry, sir?
ADMIRAL CUSTIS: In what hospital was your
73 surgery done?
MR. EVERS: It was done in Christiana
Medical Center in Wilmington, Delaware, by Dr.
Peter Wong.
ADMIRAL CUSTIS: And your current
disability rating is what?
MR. EVERS: 40 percent.
ADMIRAL CUSTIS: Are you gainfully
employed now?
MR. EVERS: No, sir. I'm not.
CHAIRMAN LASHOF: Any other questions?
If not, thank you very much for appearing before us.
MR. EVERS: Thank you very much.
CHAIRMAN LASHOF: I think we'll take our break now, and reconvene at 10:15. So we'll have a little longer break than usual but the next witnesses were not expected to come until 10:15.
[Recess.]
CHAIRMAN LASHOF: Our session now is to deal with the research issues. Let me first ask Holly Gwin to make some brief remarks, and I note
74 Henry Falk and Timothy Gerrity have taken there
place, and we'll be hearing from your shortly. Holly, do you want to make just some
introductory remarks to the session?
Research Issues
MS. GWIN: Yes. We have asked for, actually, four different types of presentations today.
Timothy Gerrity will speak first in his capacity as a member of the Research Working Group of the Persian Gulf Veterans Coordinating Board, which is trying to integrate the research of DHHS, VA, and DoD.
Then we'll hear from Henry Falk about the HHS research programs specifically, and then we'll go back to Timothy Gerrity to hear about the specifics of VA's research program.
CHAIRMAN LASHOF: Fine. Dr. Gerrity, representing then both the VA and the Gulf Veterans Coordinating Board.
DR. GERRITY: Thank you, Dr. Lashof, for this opportunity to discuss with the committee the
75 activities of the Research Working Group of the
Persian Gulf Veterans Coordinating Board, in particular, development of the document called "A Working Plan for Research on Persian Gulf Veterans' Illnesses."
The Research Working Group is charged with assessing the state and direction of research, identifying gaps in factual knowledge, and conceptual understanding, identifying testable hypotheses, recommending research directions for participating agencies, reviewing research concepts as they are developed, and collecting and disseminating scientifically peer reviewed research information.
Membership on the Research Working Group consists of 13 senior research managers from the Department of Veterans Affairs, Department of Defense, Department of Health and Human Services, and the U.S. Environmental Protection Agency.
The Research Working Group meets on a monthly basis to carry out its functions.
Assessments in 1994 of exiting knowledge
76 and data by the Defense Science Board Task Force,
and National Institutes of Health Technology
Assessment Workshop, and the National Academy of Sciences Institute of Medicine, medical follow-up agency, which I'll refer to as the IOM, lead the Research Working Group to the conclusion that significant investments in research would be required to ascertain the nature, extent, and causes of illnesses among veterans of the Persian Gulf War.
Because of the multitude of putative exposures and potential health outcomes related to service in the Persian Gulf, it was determined that a research plan encompassing the federal research effort needed to be developed.
If constructed properly, such a research plan would help ensure that the right research questions are addressed, while, at the same time, avoiding unnecessary duplication.
Early in 1995, a subcommittee of the Research Working Group was formed to draft a working plan for research on Persian Gulf veterans'
77 illnesses.
The members of the subcommittee were
senior research and clinical managers with
expertise in clinical research, epidemiology and toxicology.
The final research plan was approved by the whole Research Working Group and concurred upon by top management of VA, DoD, and HHS.
As the subcommittee began its work, it recognized that important assessments of existing data had been performed and research recommendations developed by the Defense Science Board Task Force, the NIH Technology Assessment Workshop, and the Institute of Medicine.
Therefore, the findings of these panels
were critically examined and used as a guide from which the research plan took form.
In defining the course of research three goals were established.
One, establishment of the nature and prevalence of symptoms, diagnosable illnesses, and unexplained conditions among Persian Gulf veterans
78 in comparison with appropriate control populations.
Two, identification of possible risk
factors for any illnesses found among Persian Gulf veterans.
Three, identification of appropriate
diagnostic tools, treatment methods and prevention strategies for illness found among Persian Gulf veterans.
To the extent appropriate, and feasible, these goals would also apply to veterans' family members.
The approach of the plan was then to identify what knowledge would be required to reach these goals, clearly identify the knowledge either currently available or obtainable from ongoing research programs, and lastly, identify what additional research areas need to be covered to close the gap between what is known and what is needed.
In identifying the required knowledge, the subcommittee developed a set of 19 research questions.
79 The very first research question sets the
stage for all others, and that is, What is the
prevalence of illnesses manifested by signs and/or symptoms in the Persian Gulf veteran population? And how does this prevalence compare to that in an appropriate control group?
Illnesses will occur in any population
over time, but what we do not know today is whether Persian Gulf veterans are experiencing illnesses beyond what would be expected in such a population of relatively young, fit, men and women.
The Persian Gulf registries of both VA and DoD cannot alone answer this question. They are important tools for observing trends in the reporting of symptoms and illnesses, and for developing research questions, which will be discussed later.
As the research plan identifies, there are several ongoing and planned epidemiological investigations that address the questions. Important among these are the VA national survey, the VA mortality study, the Department of Defense
80 San Diego studies, and the Centers For Disease
Control study of Iowa veterans and Pennsylvania Air National Guardsmen.
Already the CDC study of Pennsylvania Air National Guardsmen has yielded results published in a recent morbidity, mortality weekly report, showing evidence of an increased prevalence of symptoms among Air National Guardsmen who served in the Persian Gulf War.
The final phase of the study, investigating risk factors, is still underway.
If these studies demonstrate an aggregate and increased prevalence of illnesses, then secondary questions regarding disease entity, or entities, must be addressed.
The plan identifies 18 secondary
questions. The questions are divided between
exposure-related questions and health outcome-related questions. This was done to isolate two
broad, interconnected questions.
One. What was the nature and extent of possible exposures experienced by veterans while in
81 the Persian Gulf?
And two: What specific adverse health
outcomes, if any, have occurred among Persian Gulf veterans, beyond what would normally be expected in
such a large adult population?
These two questions lead to a third question. Namely, is there a relationship or a set of relationships between exposure to the complex environment of the Persian Gulf theater and any excess morbidity or mortality that is consistent with established biological and toxicological principles, and with epidemiological data?
This last question needs to be addressed by investigating both exposures and outcomes. Investigations of exposures can lead to hypotheses about expected health outcomes based on the nature and extent of the exposures.
And investigations of health outcomes can lead to hypotheses about exposures.
The exposure-related questions and the outcome-related questions were generated, in large measure, by a critical examination of the findings
82 of the DSB, NIH, and IOM panels.
This approach was important and was
endorsed by the Research Working Group. It built
on the very substantial intellectual and financial capital invested in these three distinguished panels. The subcommittee first categorized the exposures and outcomes areas of concern considered by the panels. Exposure areas of concern identified by the three panels were: Infectious agents, smoke from oil well fires and oil spills; other petroleum product exposures; other occupational exposures; potential chemical and biological warfare agents; vaccines; pyridostigmine bromide; and psychological stressors of war.
Health outcomes of concern identified by
the three panels were nonspecific symptoms and symptom complexes, immune function abnormality, reproductive health outcomes, genital urinary disorders, pulmonary function abnormalities, neuropsychological and neurological outcomes, Leishmaniasis, cancer and neoplastic disease, and mortality outcome.
83 The subcommittee then assessed the
importance placed on each area of concern by these
three panels.
Areas of clear consensus among the panels
on exposures and outcomes were identified, and
issues for future research were then prioritized based on the consensus.
In areas of disagreement among the panels, the subcommittee discussed the scientific merits of each view and made a decision as to its priority.
Generally, the subcommittee included most
exposure and outcome areas where the panels disagreed. Not all areas were considered by all panels. In such cases, an inclusive view also prevailed.
In the interest of time, I will not enumerate the individual research questions as they can be found in the text of the research plan, which you have.
I will state, however, that many of the research questions are currently being addressed by ongoing research and much of that research is
84 focused appropriately along epidemiological lines.
Consequently, clear identification of
information gaps depends on the outcomes of many of
these studies that are in progress.
The research plan delineates some specific areas of inquiry needing special emphasis.
One. Information on the prevalence of symptoms, illnesses, and diseases within other coalition forces.
Two. Information on the prevalence of symptoms, illnesses, and diseases within indigenous populations within the Persian Gulf area, including Saudi Arabia and Kuwait.
Three. Information on the prevalence of adverse reproductive outcomes among Persian Gulf veterans and their spouses.
Four. Simple and sensitive tests for Leishmania tropica infections that could lead to quantification of the prevalence of L. tropica infection among Persian Gulf veterans.
And five, information on the long term, cause-specific mortality among Persian Gulf
85 veterans.
The research plan was released, publicly,
on August 4th, 1995. It has received broad
distribution, including publication in DoD's Gulf Link Home Page on the Internet.
I want to talk, briefly, about what kinds of input into the research plan we have received and anticipate receiving in the future.
The research plan was the product of a joint effort on the part of VA, HHS, DoD, and EPA.
As I have previously indicated, the
research plan had as its foundation the work of three expert panels composed of governmental and non-government scientists, and these were the Defense Science Board Task Force, the National Institutes of Health Technology Assessment Workshop and the National Academy of Sciences panel.
Each of these panels worked, and in the case of IOM, continue to work diligently at assessing a vast amount of diffuse information.
It was sound policy to use the findings of
these panels to inform our process of developing a
86 research plan.
We have not, however, stopped at their
recommendations. We have given our research plan
for comment to the Armed Forces Epidemiology Board. The AFEB is an advisory committee of government and nongovernment scientists to the Assistant Secretary for Health in the Department of Defense.
We've also given it to VA's expert scientific committee, which is a federally chartered committee established to advise the Secretary, and to the Institute of Medicine panel.
The Department of Defense has already
provided the presidential advisory committee the comments of the AFEB, which are being carefully
studied at this time by the Research Working Group. The Research Working Group will
periodically revise and update the research plan to reflect the acquisition of new information as well as comment and criticism from the research community at large.
The research plan includes much ongoing research. As you will note in the research plan,
87 the determination of the need and nature of future research awaits the output of this research.
However, the importance of the issue of
Persian Gulf veterans' illnesses does not allow us
to take a wait-and-see approach.
That is why many research efforts have
already begun, which ordinarily might be
implemented gradually.
For example, VA established three
environmental hazards research centers at Boston VA Medical Center, Portland VA Medical Center, and East Orange VA Medical Center.
These research centers are taking a broad approach to the problems of Persian Gulf veterans' illnesses, incorporating basic clinical and epidemiologic research centered on putative environmental exposures, but also investigating the effects of exposures to other agents such as stress and nerve agent prophylaxis.
By doing this research now, and not waiting for the findings of large scale epidemiological investigations, we will have a head
88 start on the follow-up investigations that will be required as results from other studies, both those conducted by the government and by outside
researchers becomes available.
With respect to guiding future research that has not yet begun, the research plan will be invaluable.
As you know, DoD issued a broad agency announcement soliciting research proposals for Persian Gulf veterans' illnesses.
This fall, independent expert scientific panels, including non-federal scientists, will be reviewing 111 research proposals submitted under the BAA.
Among other background materials, the reviewers will have the research plan to serve as a guide in judging the relevance of research proposals in addition to their scientific scores.
After these panels have reviewed the
proposals for scientific merit, they will be referred to a subcommittee of the Research Working Group for final funding recommendations based on
89 program relevance.
The conduct of this committee will be
similar to that of an NIH council where program
relevance plays a key role in close and difficult funding decisions.
Following the actions of the Research Working Group subcommittee for funding recommendations, the Research Working Group will survey the research portfolio, compare it with research plan recommendations, integrate that information with any new knowledge arising from ongoing studies, and identify any remaining knowledge gaps.
At that time, if there is an apparent need for additional research, the appropriate vehicles for conducting that research will be identified, for example, focused requests for applications.
Regardless of the vehicle, competitive
peer review will be the cornerstone for the selection of new research projects.
Until now, I have focused attention on how the Research Working Group oversees the research on
90 Persian Gulf veterans' illnesses.
History has shown that some of the best
science is done when scientists are the source of
new initiatives, based on their intellect and
inherent curiosity.
In the United States, investigator-initiated peer reviewed research funded through
competitive processes has been the archetypical
decision making process for funding the best science since 1945.
The process of getting answers to
scientific questions is, more often than not, circuitous. It has been said that science is the process of going down an alley in order to discover that its blind.
The history of science is rich in examples of discoveries arising from accident and serendipity. We, as research managers, must not delude ourselves into thinking that we hold the answers.
Yet in the context of Persian Gulf
veterans' illnesses, we have neither unlimited
91 resources nor unlimited time.
This means we must, to some extent, guide
the research. Importantly, we must create
opportunities for scientists to do what they do best.
In any of the mainstream biomedical research endeavors, such as cancer research, there is a critical mass of scientists across the country engaged in this research, such that the scientists sustain their own interactions through professional societies and journals.
They thus control and have easy access to their particular research domain. In a new and narrow area, such as research on Persian Gulf veterans' illnesses, a critical mass of scientists does not exist.
Consequently, we, in the Research Working Group, must do what many biomedical research communities do naturally, and that is, we must generate the energy and guidance that will sustain researchers.
This can be accomplished in a number of
92 ways, with information dissemination being one of
the most important.
With the VA as the lead agency, a database
of federally funded research projects on Persian
Gulf veterans' illnesses is being finalized.
This database will be periodically updated
and publicly released. Access to this database
will allow investigators one avenue by which they can be informed of activities and progress of other investigators.
In addition, we have established
opportunities for investigators to exchange ideas with other in person. This past June, the Research Working Group sponsored a two-day meeting of federally funded investigators.
This meeting included updates on ongoing research projects, an open forum discussion of problems in toxicology, clinical research and epidemiology.
On a more formal level, epidemiologists including members of the Research Working Group, have organized a session on Persian Gulf veterans'
93 research at the annual meeting of the American
Public Health Association to be held later this month.
As the research community moves closer toward the results phase of research, we foresee the need for a public workshop devoted to the subject of Persian Gulf veterans' illnesses.
Understanding Persian Gulf veterans'
illnesses will ultimately improve our ability to provide medical care to them. To get there, however, clearly requires research. Through a stewardship which recognizes often conflicting aspects of directed, mission-oriented research, the Research Working Group has been on the forefront of this effort.
I'd like to end my remarks right now, Dr. Lashof, and entertain any questions.
CHAIRMAN LASHOF: Thank you very much, Dr. Gerrity. We'll proceed to hear Dr. Henry Falk, and then return to you to present Dr. Sphar's testimony, and then we'll have questions of both you, in both roles.
94 Dr. Falk, go ahead.
DR. FALK: Thank you very much, Dr.
Lashof.
My name is Henry Falk and I'm the director
of the Division of Environmental Hazards and Health Effects at the National Center for Environmental
Health of the Centers for Disease Prevention and Control, or CDC.
I appreciate the opportunity to be here with you this morning.
The appendix of the working plan for research on Persian Gulf veterans' illnesses identifies three research activities being conducted by the Department of Health and Human Services and I wanted to briefly comment on those this morning.
Each of the three projects was devised for different reasons and they have been developed and funded through different mechanisms.
I will first discuss a very specialized technical project titled "Biomarkers of Susceptibility in Polycyclic Aromatic Hydrocarbon
95 Exposure in Urine and Blood Cell DNA from U.S. Army Soldiers Exposed to Kuwaiti Oil Well Fires."
The purpose of this project being
conducted by researchers at the National Cancer Institute of the National Institutes of Health is to determine if there was any increase in the level of polycyclic aromatic hydrocarbons in the blood or urine of a sample of military personnel who were in the Persian Gulf during the time of the Kuwaiti oil well fires.
Most government agencies are called on to provide support, particularly laboratory support in times of special need, such as the case in this situation, at the request of staff at the Army Environmental Hygiene Agency, special laboratory assays are being done.
Obviously, this is not a typical intra-extramural research activity that would go through
separate review processes and budget negotiations,
but instead provides laboratory support as part of a much larger study.
NCI participation was with the
96 authorization of the NCI internal review board, and informed consent was obtained from all
participants. The Army provided NCI $30,000 for this work.
The second HHS project is the CDC investigation of veterans in Pennsylvania, and that has already been referred to this morning.
In December of 1994, staff at CDC began investigating a report of illnesses among Persian Gulf War veterans in an Air National Guard unit in Pennsylvania.
This investigation was initiated under a CDC mechanism called an Epi 8 investigation, which is a mechanism used to facilitate intramural epidemiologic field investigations when certain conditions exist.
These conditions include such factors as the reported problem being of public health importance, and that acute timely response is required, and that it be an epidemiologic investigation.
It is a means for CDC to get out in the
97 field, to do something in a timely manner when it's necessary.
This investigation was initiated after the
Pennsylvania Department of Health, the DoD and the
VA requested assistance.
The request followed a report by a
physician at a VA hospital in Pennsylvania
describing a suspected cluster of what was believed to be Persian Gulf associated illnesses among members of the Pennsylvania Air National Guard unit.
During your August meeting, we reported on the results of the first two phases of the investigation.
To summarize, the results suggest there was a higher prevalence of reported symptoms, particularly diarrhea, fatigue and arthralgia among those deployed to the Persian Gulf from the members of the indexed unit in Pennsylvania than among members of three other units.
In each of the units studied, individuals deployed to the Gulf had higher prevalences of
98 reported symptoms than those not deployed.
The third phase, currently underway,
involves a case control study which will evaluate a variety of factors, all of which have been
postulated as possible causes of illness among Persian Gulf veterans.
And that is underway and hopefully, results will start coming in the near future.
Any studies, including Epi 8
investigations must be reviewed by an institutional review board, if the research involves human subjects.
For this investigation, the protocols for each stage of the study were reviewed by the CDC Institutional Research Board. The total cost of the investigation is estimated to be approximately $800,000.
The final project I will discuss is CDC's survey of veterans from Iowa. In this study, a telephone survey, investigators will question a random sample of approximately 1,500 military personnel who served in the Persian Gulf, and
99 approximately 1,500 Gulf era military personnel who
served at sites other than the Gulf, in order to assess a wide variety of self-reported health outcomes and exposures.
This study of veterans from Iowa was initiated at the direction of Congress and funded with a $2 million appropriation in FY 95.
It is being conducted through a sole source cooperative agreement between CDC and the Iowa Department of Public Health. Some of you may not be familiar with a cooperative agreement mechanism as opposed to a straightforward grant. It allows for a great level of interaction and cooperation between the grantee and the funding agency than does a traditional grant.
The cooperative agreement was directed to the Iowa Department of Public Health because this agency had the established links with veterans groups within the state, and could rapidly and cost-effectively carry out the study.
The Iowa Department of Public Health has contracted with the University of Iowa, whose
100 researchers are responsible for the scientific
design and conduct of the study. And the University of Iowa has subcontracted with a statistical laboratory at Iowa State University to do the telephone interviews.
A request for proposal was announced in the Federal Register as a sole source solicitation. The proposal received from the Iowa Department of Public Health was reviewed by three independent CDC scientists in order to ensure the scientific quality of the proposed study.
Modifications to the protocol and questionnaires were made based on discussions with the VA, DoD and OMB.
And the final protocol and questionnaires have been reviewed and approved by the Institutional Review Board at the University of Iowa.
Three committees have been established to provide internal and external oversight of this study. A public advisory committee composed of affected veterans and representatives from
101 veterans' service organizations was established to
provide coordination, liaison, and open
communication with the public. This group has met on three occasions so far, with the next meeting planned for November, and such meetings will continue through the conduct of the study.
An internal advisory committee composed of University of Iowa, Iowa Department of Public Health, and CDC investigators, was established to provide internal oversight of study progress. This committee meets every other month.
Finally, a scientific advisory committee composed of a number of scientists in the fields of epidemiology, reproductive health, psychiatry, environmental health, and infection disease was established to provide external scientific review of study methods and survey instruments. This committee meets twice during each year of the study, and I believe has met twice this year.
Data collection for the study began on September 25th, and the final results will be reported in August of 1996.
102 I might add, that during the first three
weeks of interviewing, the study seems to be
progressing well, and so far slightly over 90 percent of the veterans contacted have agreed to cooperate with the study and undergo the interviews. So I think that speaks well, hopefully, for future progress.
So as you can see, the method by which HHS became involved in each of these projects varies, and so does the mechanism by which the projects are reviewed, monitored, and funded.
Dr. Gerrity has given you an overview of the research plan. HHS staff were very much involved in the development of the plan, and with VA and DoD staff, created the document you see today. You asked for the Department's perspective on the key public health issues encompassed by the research plan, and HHS feels the plan should be viewed as a comprehensive effort to address basic science, clinical and public health issues, and it's necessary and appropriate that all these issues be addressed.
103 The public health focus is represented
primarily in the epidemiology studies noticed in
several parts of the plan. Such basic epidemiology studies may provide some answers, but may also generate hypotheses requiring additional research. I would add that the discipline of public health encompasses more than just epidemiology.
The perspective of public health may be broader than the immediate medical issues being faced, and this includes a potential for improved surveillance strategies and other efforts leading to appropriate prevention and control in the future.
This concludes my prepared remarks, and I appreciate, again, the opportunity to be here, and I'll be happy to address any questions. Thank you.
CHAIRMAN LASHOF: Thank you very much, Dr.
Falk. We will come back to you. Dr. Gerrity, do you want to pretend you're Dr. Sphar and give his testimony.
DR. GERRITY: Dr. Sphar apologizes for his inability to be here today. He was called to an
104 Office of Management and Budget hearing on our
research budget, and so he asked if I would stand in his place.
I am the deputy director of Medical Research for the Department of Veterans Affairs, and I will be now be speaking to you about VA's research efforts on the health of Persian Gulf veterans.
And I'm going to talk to you specifically about how our research relates to the research working plan developed by the Research Working Group of the Persian Gulf Veterans Coordinating Board.
What I'd like to do first, though, is to describe VA research, in general, so that you can fit VA's research on Persian Gulf veterans almost as into a broader context.
VA research has been an integral part of the Veterans Health Administration since World War II. Research is specifically designated by Congress as one of VA's four primary missions. VA research is an intramural program carried out by
105 approximately 1,500 investigators of whom 80
percent are also clinicians.
It is this latter fact that contributes to
making VA research the vital resource to the VA,
and to the country, that it is.
Of the 172 VA medical centers within the
VA health care system, approximately 80 have
substantial research programs, and by that, I mean research programs with appropriated research dollars in excess of half a million dollars each.
Most of these VAMCs have very close ties
to affiliated academic medical centers. VA research has been intimately involved with some of the most important medical discoveries of the last 50 years. This is exemplified by the fact that VA has two Nobel Prize winning scientists among its
cadre of researchers. The scope of the VA research program is very broad, extending from basic biomedical research to applied and outcomes oriented research, and to research on the health care delivery system itself.
The management and funding of VA sponsored
106 research is carried out by the Office of Research
and Development of which Dr. Sphar is the chief research and development officer. He reports directly to the Undersecretary for Health, Dr. Ken Kaiser. The Office of Research and Development is divided into three services. One, medical research; two, health services research and development; and three, rehabilitation research and development.
In fiscal year 1995, Congress appropriated $252 million for VA research. In addition, since 1987, VA medical research has benefited from additional funds appropriated to DoD for collaborative research between VA and DoD investigators, using VA mechanisms to award research funds.
The appropriated funds for research are primarily for direct costs. They generally do not cover clinician investigator salaries and other research infrastructural costs which are funded out of the medical care appropriation.
If one folds into this equation funds
107 brought into the VA by VA investigators from NIH,
private foundations, and pharmaceutical companies, approximately $1 billion is annually expended on research by VA investigators.
However, it must be emphasized that the Office of Research and Development only has direct control over its appropriated federal research dollars.
I'd like to focus now on the Medical Research Service, since it is within that service the current research on Office of Research and Development veterans' illnesses falls.
The scope of research in Medical Research Service runs from clinically relevant basic research to applied research such as multi-centered drug trials, including direct appropriated VA research funds, and DoD funds transferred to Medical Research Service.
Medical Research Service expended
approximately $128 million in investigator initiated peer review programs in fiscal year 1995.
These programs fall primarily under the
108 Medical Research Services's merit review program.
The merit review program operates in a manner similar to the NIH extramural RO1 program, except, of course, it funds intramural VA researchers.
Merit review operates 15 review boards
representing major biomedical science disciplines. The review boards are comprised of VA and non-VA scientists who have demonstrated expertise in the discipline of their respective boards. These boards meet twice yearly to review investigator initiated submissions.
As a measure of the competitiveness of our program, we are presently able to fund only 15 percent of all submissions.
Now that you have a picture of VA
research, in general, I'd like to narrow my focus down to research on Office of Research and Development veterans' illnesses research.
This research can be divided into three categories. Investigator initiated, those projects which are in response to Request For Proposals, and lastly, directly research.
109 The one common feature you will see among
these is the elements of peer review. Concerning,
first, the category of investigator initiated research. There are two kinds of research in this category. The first is research which was reviewed and funded under the merit review program which I referred to earlier.
Investigators developed proposals, submitted them to the merit review program through their local medical center research and development committee, and these were reviewed, along with other unrelated proposals, and approved for funding based on scientific merit.
The second kind of investigator initiated research project is the type which is not funded directly by research dollars, but is supported through the indirect cost of supporting research in the medical care appropriation.
This kind of research project may be a pilot project initiated by an investigator for the purpose of gathering preliminary data to support a more substantial submission at a later time, a
110 project which capitalizes on a clinical care
protocol, or an offshoot of another research funded program.
These research projects must, despite the fact that they were not submitted for funding from the Office of Research and Development, be reviewed by the local Research and Development Committee at each VA medical center, for scientific merit, and in the case of projects involving human subjects, undergo review by the local institutional review board.
In no cases do we sanction unreviewed research. In the research plan, we list 11 research projects in the category of investigator initiated. They are focused on an array of topics, including psychological and neuropsychological effects of Persian Gulf service, Leishmaniasis, effects on the immune system, and gastrointestinal illness in Persian Gulf veterans.
In the area of research programs resulting from responses to specific Requests For Proposals, Va research has sponsored two types: pilot studies
111 and three environmental hazards research centers.
In 1993, when virtually no research was being done on Persian Gulf veterans' illnesses, and there were very few firmly grounded hypotheses, Medical Research Service issued a call for proposals for pilot studies from its investigators in the field. Modest amounts of money, approximately $50,000 per project, for two years, were given to four pilot studies.
The selection of the pilot studies was done with a rapid turnaround, using the review panel of headquarters research staff. The four pilots selected were Birmingham VAMC for immunological research, Pittsburgh VAMC for neurobehavioral research, and Boston VAMC for psychological research and Jackson VAMC for research on birth outcomes.
Also in 1993, Medical Research Service issued a Request For Proposals for the establishment of any many as three environmental hazards research centers funded up to $500,000 per year for five years.
112 An ad hoc review panel of government and
non-government scientists reviewed 19 submissions
from which the best three were selected based on scientific merit.
These were Portland VAMC, Boston VAMC, and East Orange VAMC. These centers began their work in late 1994, and we are expecting some of the first results of the research in the near future.
The third category of research is
directive research. This is research directed to specific organizations within VHA for the purpose of carrying out research for which those organizations have unique research capabilities. The Environmental Epidemiology Service, headed by Dr. Han Kang, of the Office of Public Health and Environmental Hazards, is an example of such an organization.
This office is conducting the VA national survey and the VA mortality study, of which you will hear testimony at a later date. The mortality study, which is nearly complete, is being done at an expense of $100,000.
113 The first two phases of the national
survey, the mail survey and the telephone survey,
will cost VA research approximately $1.8 million. The cost of phase three, which includes
physical exams of selected participants in the survey, is still in the process of being determined.
In addition, VA research contributes approximately $240,000 to the salary and administrative costs of the epidemiology service devoted to Persian Gulf veterans research.
Although this research is directly funded
by VA research, it receives extensive peer review. A subcommittee of the VA expert scientific panel, led by Dr. Paul Stolie of the University of Maryland School of Medicine, provided extensive review of the national survey protocol.
Lastly, there are the costs associated with review and oversight of research. VA research contributes $250,000 per year to support the National Academy of Sciences, Institute of Medicine, medical follow-up agency, committee to
114 review the health consequences of service during
the Persian Gulf War.
Earlier, VA research contributed $30,000
to jointly fund the National Institutes of Health technology assessment workshop on Persian Gulf
experience and health. DoD and HHS also contributed to this effort. I want to discuss how these varied activities interact with the research plan which has already been discussed by me.
Investigator initiated research springs
from the minds of thoughtful, skilled clinician scientists who have direct contact with Persian Gulf veterans at their VA medical centers.
We, in the Office of Research and
Development, believe in the effectiveness of this approach and its importance to the overall research goals.
The early pilot studies were important in getting VA investigators involved in the problem of Persian Gulf veterans' illnesses. The pilot study at Boston led to their successful program embodied by the larger environmental hazards that are
115 located there.
The three environmental hazards research
centers, as a whole, and separately, constitute a
major unified effort at coherently addressing ideological factors, possibly contributing to Persian Gulf veterans' illnesses.
The national survey received its major impetus from a recommendation of the National Institutes of Health technology assessment panel.
With the research plan now available, we
will be able to effectively integrate research underway with planned future research.
VA will closely examine the results of the current DoD competition for research projects, and in conjunction with the research working group, evaluate the need for additional research and identify appropriate resources to bring, and to put to that research.
I will close my statement there, Dr. Lashof, and entertain any questions of the committee.
CHAIRMAN LASHOF: I'd like to open with a
116 question myself. First, I'd like to make sure that everyone understands that one of the major charges
of this committee is to review the research effort, and to determine whether this research effort is sufficient to answer the key questions.
I think there's no question, from your testimony, that the key questions that need to be answered have been well defined. My questions relate very much to how the research plan was developed and some of the procedures.
So let me be fairly direct. The actual research plan was published in August of 1995. The actual research included in that plan was practically all started well before that date.
So it's a plan, if you will, based on an after-the-fact review of research that was started on various ad hoc bases, I think, and correct me if I'm wrong.
Staff have provided us, and I would draw the committee's attention to the table which lists the research questions, and lists in a column the ongoing studies that are addressing those research
117 questions, and additional needed studies, as all
drawn from your plan. It is all based upon your work.
When this plan was developed, which
obviously had to look at everything that was ongoing, and say which of the questions will be answered by which studies, as you look down the list you find that there are a group of studies--10 studies that deal with the prevalence of symptoms and illness in the Persian Gulf veterans population.
Did your research group, when looking through it, and using just that one question as an example, and it could apply to all of them--say, Okay, here are all the studies that are going on in this. What is the quality of each? How generalizable is the data from each of these? Do we need all of these, and how compatible are they, or do we need some new studies?
Are there any studies that are ill-conceived and should be abandoned. Frankly,
reading reviews that you have had from the Army
118 Epidemiologic Board, from the subcommittee that Dr.
Stolie heads, and some of the peer reviews that have been undertaken for some of the studies that are underway, raise questions about the quality of some of these.
So I would like to know what the role of the Defense Coordinating Board is in reviewing all of those, and then deciding which ones should go forward, which might be stopped, which should be altered, and how you're proceeding on that approach.
DR. GERRITY: I think, in answer to your question, there were several parts to this question. The first part that I'd like to address is the timing of this research plan relative to the ongoing research that was already occurring.
I think that it was an evolution of events that led to, naturally, investigators wanting to get out very early on into this problem, and did so through the various mechanisms--I'll speak for the VA in this matter--in terms of doing either pilot studies off of their own research budgets that they
119 might have, or submitting through a merit review
process, proposals.
I would say one example of this is the
Fort Devin's reunion study, which is now, the
follow-on to that has been incorporated into the Boston Environmental Hazards Center.
The Fort Devin reunion study was a study that was conceived before there was any indication that Persian Gulf veterans were experiencing excess illnesses. Those investigators at Boston have an expertise in the study of post-traumatic stress disorder, and they felt this was an important opportunity to gather some additional scientific knowledge on PTSD by really looking at a group of veterans as they are returning.
So that kind of investigation clearly preceded the development of this plan.
The desire to institute this plan really came as a recognition that we clearly were not approaching any easy answers to these questions, and that there needed to be some coordinated guidance, and a map for the future, as much as a
120 map for the present.
Now with respect to the issue of looking
at the scientific quality of research projects
which are ongoing, the Research Working Group is not assembled, in a sense, as scientific experts in particular areas of research, although they have independent scientific expertise.
For example, my background is in the health effects of air pollution.
We tend to be more of a, if you will, a policy setting group, and really looking to see are the appropriate questions being asked.
I would hesitate to put ourselves in the role of being peer reviewers. We have mechanisms, all three departments have mechanisms for receiving peer review from appropriate bodies, both prospectively and well as retrospectively.
And so I hesitate to put the Research Working Group in the position of standing in, being, shall we say, the sole judge of scientific quality.
Now, clearly, I think one could argue that
121 there are things you could say that all reasonable scientists would either agree or disagree, you
know, that this is good, any particular study is good or is not good.
I think we're very hesitant to approach ongoing research and suggest that this research be stopped. The reason why I say that is because I think that we invite certain charges of ignoring potentially important issues.
I think that once something is going, it needs to proceed further. I think that what we have tried to do, and are trying to do, as I indicated in my testimony, is to create the appropriate situations that will allow these researchers to come together and interact, as well as interact with us, and so that hopefully protocols that can be improved and can be benefited by other people's findings, and ideas can be brought forward.
CHAIRMAN LASHOF: Let me follow this a little more. I was not suggesting that the Defense Coordinating Board be a super peer review, and peer
122 review each funding, but that should the
Coordinating Board, or do you think it's appropriate for the Coordinating Board to look at the peer reviews that have been done for the different studies, and see whether the investigators have reacted appropriately to those peer reviews?
And there are some that we've seen in here, where they've suggested that the study would not bring forward meaningful results, and could be abandoned.
I know how difficult it is to stop a study, and that you don't want to stop a study for fear of being accused of trying to hide something.
On the other hand, carrying out a study
whose results may be misleading would be a lot worse than stopping a study. I don't know how many fall into that category. Maybe it's one, maybe it's two. But my reading of both the Epidemiology Board, the IOM report, and some peer reviews of some of the studies that I have had a chance to look at, suggests that they aren't solid studies,
123 and how does that fit into the responsibility of
the Coordinating Board without it trying to do its own peer review?
DR. GERRITY: I think that is an approach which is certainly one worthy of consideration and particularly, I'd like to point out that the working group will, in essence, be in a position to be performing such a function, at least in a prospective fashion, although when we get the output of the review boards from the Department of Defense, we really are going to be primarily looking at them from the perspective of how well they fit in in terms of relevance.
I think that it is not unreasonable to suggest that we examine the quality of peer reviews as well, but I think we have to be very, very cautious of doing that, because we do set up, you know, our own bodies for doing peer review.
I think further along with your question, I couldn't say, in a blanket sense, that there is no research project out there that could not be improved.
124 I think that would be hubris on my part.
But I am confident that the majority of studies
that are currently being sponsored by--speaking for VA, but I think in terms of what the purview of the Research Working Group is--DoD and HHS--is that we're looking at some very good research that is going on, and that has received a lot of scrutiny.
Smaller pilot studies, certainly less so,
as I indicated, for example, for VA. If it's a pilot study, it's reviewed by the local Research and Development Committee at the VA medical center, but does not come into central office.
CHAIRMAN LASHOF: Well, I was not trying to imply in any way, that I thought the majority of studies were flawed, but, rather, that I was concerned to see that groups had raised questions about some studies, and I had not yet seen evidence that all of those have been evaluated, and I have been trying to just understand the role of the Coordinating Board in doing this, or whether it just falls back to the individual investigators. But maybe we don't need to belabor that much
125 further.
DR. GERRITY: Just one final point to make
is that the Coordinating Board developed a response
to the Institute of Medicine's report, which did
contain some of those assertions, and I would invite you, if you haven't done so already, to look at that response.
CHAIRMAN LASHOF: Yes, we have that, and I have had a chance to look at it.
Dr. Falk, CDC is sort of the epidemiologic arm of our Government. If some big epidemic happens overseas, it's CDC who runs to help solve it. I've been around government long enough to also know that in this country, however, CDC goes in when a state requests it to go in.
So that at this point CDC is really only involved, as I understand it, in Iowa and Pennsylvania. Is that correct? And as sort of an advisory role on the Coordinating Board. But in terms of your own active studies, CDC--
DR. FALK: Yes.
CHAIRMAN LASHOF: How large is the sample
126 in both Iowa and Pennsylvania? How representative
are they of the exposures that have been alleged to be the problem? I mean, have the groups from Iowa and Pennsylvania been in the areas where the problems have been?
How generalizable do you think to the groups, as a whole, do you think the Iowa and Pennsylvania studies will be?
DR. FALK: You know, each of those studies involves several thousand people, and many of the symptoms that concern people in those studies have appeared quite frequently in those groups. So we're dealing with more common types of symptoms that are at issue, plus the fact that I think that any factor which would lead to that high a symptom rate would probably have to have been widely distributed among the groups who were at the Persian Gulf, and the veterans from Iowa and elsewhere were also relatively widely distributed.
So I think for a relatively common
phenomena, which is the kinds of symptoms that we're looking at, I'm actually quite hopeful that
127 the groups, while not a pure representative sample
of the whole country, would actually be helpful in that regard.
I think if we were looking for very rare types of illnesses or symptoms, then, yes, there would be more of a concern about being limited, geographically.
CHAIRMAN LASHOF: Well, looking ahead to this committee's responsibility, not only of answering the question, What needs to be done?, but giving some advice for the future, would you care to comment on how, and whether it would be wise for CDC to be called in earlier on this sort of thing, and be asked to take the lead in national studies, much as you are when you're called overseas.
DR. FALK: Several points I'd like to make on that, and I think I spoke briefly about this at the last meeting.
First, I think that, in general, during my time at CDC, I've seen the studies on radiation exposed veterans, and Agent Orange, and now Persian Gulf. I think that, in general, the governmental
128 response has been more rapid, much more thorough,
much more aggressive on each of those occasions. So I see, in a sense, a trendline towards more rapid, more thorough response, which I think is all to the good.
In the 1970's, there was a lot of effort before things really happened, and I think in this instance people have really jumped on it a lot sooner. So that is all to the good.
Secondly, my sense is that work that is done on the veterans groups really has to be intimately done, together with Department of Defense and the Veterans Administration.
Having watched this on several occasions, the data systems are not the usual kinds of public health data systems, because they're very focused on the military groups, and records in the military system, and I think for anybody, whether it was CDC, or anybody else, to do any work in this area, it really has to be in very close collaboration with VA and DoD, and that's another positive that I think I've seen during my time. And the
129 Coordinating Board, with whatever questions you may
have, I think still is very positive, in the sense that everybody gets together.
The third point I would like to make is yes, I think it is possible to do more, and certainly one could contemplate that, and I think, you know, all of us--DoD, VA, and we, as we go along, are thinking of additional things that can be done, and can be done collaboratively.
And maybe some of these things can be implemented, you know, on future occasions yet more quickly than they are now.
In one sense, I would like to see that. I think it would be good for the veterans. I think it would be good for the country. But I would like to see that, collaboratively. I think CDC does have more epidemiologic resources. It's a very tight time for everybody now, but CDC has come forward, when we've been asked to respond, and I think we've always tried to do that.
But I would like to see something like that, whatever we do, be very collaborative.
130 CHAIRMAN LASHOF: Thank you very much.
We will open it up for questions now. DR. CAPLAN: Joyce, could I just follow on
that.
CHAIRMAN LASHOF: Sure.
DR. CAPLAN: You know, it seems to me one of the things that's going on is we're narrowing the time range between having events and trying to understand what happened in terms of health consequences from radiation to Agent Orange, and now here.
And I'm just curious if you think, in an ideal situation, would it be possible, or would you recommend--to follow what Joyce was asking--a standing link, so that there was expertise in CDC, people familiar with how Defense and VA operated, for surveillance purposes, and should it become part of our defense posture, to begin to do medical surveillance, try to assess health risks when people are deployed? It seems to me future conflicts are going to be high tech, with lots of consequences of high technology out in many
131 different environments.
And if this is an area where there's as
much risk from environmental or toxic exposure,
because of the weapons and the places that they're used, then shouldn't there be standing surveillance, ready to go in a coordinated way, so that we're not responding, we're proactively anticipating that we're going to have to do the health work?
DR. FALK: Again, there are several things that I would like to say about that. One is that DoD and VA are intrinsic to this process, and all the way through.
Secondly, I think in terms of a place like CDC, what I've seen is, on several occasions now, we geared up to have a unit that dealt with the radiation studies in the 1970's, and the unit then shrank down to one person, and was really just a holding pattern for a number of years.
The Agent Orange effort was very extensive at CDC, involved close to 50 people, and was built up with a lot of good people at CDC. I think we
132 made a real effort to, in a sense, draft people
from all over CDC to work on that project.
But again, you know, as of late 1980's,
1990, I don't know exactly when that ended--all
those people were dispersed. So yes, there is a learning curve in terms of working with DoD and VA. It would be great to have people who work with them on a regular basis, and then when these things happen, you know, we could support that effort a lot more quickly. I think that's correct, and I think all of us think more and more in terms of, prospectively, how would we do these.
There's nothing quite, I think, as frustrating to an investigator, as having to start late, when everybody's feelings are very entrenched, and there are strong feelings on each side, and when you come into it, it's very hard to start off fresh. So I think that's true for everybody and not just CDC, so--
DR. CAPLAN: And the reason I'm pushing about the proactive is, you know, we've already heard testimony today, there have been deaths,
133 people can't report, they can't answer the
questionnaires anymore, others, some feel that they have to turn away from the system. So by being proactive, we'd be ready to take information as it came in.
But again, I want to stress, because I know how tight the budget situation is, too, that it would be very helpful if both of you could tell us, or others within these units that have experience about working together, whether this is something that military policy should reflect, systematically, to be proactive, if that's the nature of future conflicts.
DR. GERRITY: I think both DoD and VA recognizes the need for instruments of surveillance that would allow one to be able to follow what might occur in the course of events with the help of individual service members during a deployment.
And we are beginning discussions on the
possibility of developing just those instruments. It's a difficult task and I would really defer to
DoD at this juncture, you know, to answer that
134 question. But it is something that we are acutely
aware of, and has been highlighted by the current events.
Could I just add a couple of things, because it came up earlier in testimony, just to clarify for the committee certain things.
One is that Dr. Caplan, you know, you raised, just actually a minute ago, the issue of mortality. The VA mortality study will be presenting preliminary results of that at the APHA meeting at the end of this month. Dr. Kang will be submitting a paper for publication, probably in the early part of this year.
Dr. Kang had done an analysis of mortality earlier, where he collected mortality data on service members that served in the Persian Gulf theater, and compared it to U.S. mortality statistics, and had found that at the time that he did this, that it was actually a lower mortality rate than the general population.
The desire to engage in this current study is that it will compare those statistics with a
135 comparable nondeployed veteran population, rather
than U.S. mortality data, because they certainly could be very, very different.
I would also point out that the Department of Defense, the U.S. Army did a mortality study that is now complete, where they looked at the noncombat-related deaths in country, and found that when they compared with a comparable group of individuals over the same period of time not deployed, that there was no difference between the two.
And I'd like to add just one more thing. You had mentioned the registry. I think it really needs to be emphasized that the registry is not an epidemiological tool in the strictest sense of the word. It's very valuable, as I said, to look for trends and develop hypotheses, but we must be careful about relying too heavily on it. Thank you.
CHAIRMAN LASHOF: Other questions?
MR. JOHNSON: Dr. Gerrity, towards the end of your initial testimony, you made a general
136 reference to, quote, unquote, the results phase.
Could you paint a picture for the
committee of what the results phase is going to look like, how it will unfold, over what period of time, with what kind of distributions, for what kind of expectations the committee might have as to when the findings of the various studies might be in place, and how we might therefore consider them in our deliberations?
DR. GERRITY: Yes. What I would like to do maybe is to suggest, so that I don't speak too much off of the top of my head in terms of specifics, is that we supply to the staff timelines as we know them for the various studies that are underway. But let me speak a little bit more generally.
We're now in a phase of ramp-up on information. We have the VA mortality study early results coming on board. With final results, in terms of actually cause-specific morality, probably available some time in mid to late 1996.
The national survey is in three phases
137 that is going to extend over approximately a 3-year
period of time. I'm not going to stick my neck out too far in terms of when the initial results are, but I will tell you that the pre-notification letter to the 30,000 participants in that survey has already gone out. The first survey instrument will go out around the first part of November.
So that phase is well underway. And the DoD, so- called San Diego studies, they, too, are going to be presenting at the APHA with some preliminary results on some of their projects. Other projects are going to take a longer period of time.
I would say that we're going to be getting significant information and have a lot more knowledge by mid to late 1996.
DR. LARSON: Let me add to that question. This list that you gave us of ongoing studies is fairly impressive and fairly inclusive. If I count right, there are 35 studies, right now, ongoing, funded. Of those, 16, according to what you provided us with, are either finished, or are
138 scheduled to be finished by December of 1995. I
just counted up. Okay. That's almost half the studies.
Now, of the 19 research questions that you generated, 11 of those have in the column "Additional studies needed, to be determined." My question is, your role as the Research Working Group, in deciding when there's been enough research done in an area--I mean, those of us who do research know that it can go on forever, and it can't in this case, nor should it.
So who's going to look at it and say, "This is enough, we have consistent results across studies," et cetera?
And it looks to me like for almost half these studies, they'll be finished within the next month.
DR. GERRITY: That's a reasonable
characterization of what is ongoing. The Research Working Group will be playing an active role in deciding the paths of future studies and areas of investigation that will be needed, and areas where
139 we feel that there is enough research that's been accomplished.
I think that was one of the most important
things about developing this plan, was to sort of
focus one's thinking along those lines, and injecting this group into that active process.
So, for example, as I had indicated, when
we come up on the final results of the scientific review resulting from the broad agency announcement, we will be assessing our entire portfolio at that time, in terms of what is being proposed, and what is ongoing, and what is coming to an end.
DR. LARSON: Let me just push on that a little bit, because there are at least six studies for which there are already several published papers. So we don't have to wait for some of these things.
And what's your timeline, when you say it will be reviewed? It seems to me you must be meeting monthly, or something, and looking at where we can make progress on answering some of these
140 questions now.
DR. GERRITY: I would agree.
CHAIRMAN LASHOF: John.
DR. BALDESCHWIELER: For Dr. Falk. I was
particularly interested in your comments on the
polycyclic aromatic hydrocarbon study which is underway, and it seems to me that this is of critical importance, because here is one case where we know there's massive exposure to products of combustion generated by the oil well fires.
And I thought I heard you say that you'd be measuring circulating levels of polynuclear aromatic hydrocarbons. And here, I wonder, I mean, this is long after the exposure, so does this make any sense? And secondly, it's in fact not the circulating aromatic hydrocarbons themselves, but their metabolites that are typically implicated in carcinogenesis, and I wondered if you could comment just on the content of the studies.
DR. FALK: I have to get back to you on that. That's an NCI study, not a CDC study, and I don't know exactly which metabolites, and when the
141 materials were taken that they're studying. So
I'll get that for you, in exact detail. I don't have that information in hand.
DR. BALDESCHWIELER: We would appreciate, because I think this is one case where the relationship is very clear and direct.
CHAIRMAN LASHOF: Dr. Gerrity, do you want to comment on that?
DR. GERRITY: I want to make two comments. One is, you will notice in the research
plan that we did not pursue, or did not suggest pursuing, at great depth, the issue of oil well fires, and I also want to point out that the U.S. response to the potential health effects of oil well fires was very early.
I myself was part of a team that had gone over immediately after the cessation of hostilities to actually do a health risk assessment on the oil well fires, and there is a lot of data that exists on that. And also to point out, though, that despite that, one of the environmental hazards research centers is conducting research on a,
142 looking at regulation of an AH receptor as a
possible biomarker for exposure to PAHs.
DR. FALK: Just to add to that, one effort which the CDC lab undertook at the time was to look at volatile organic hydrocarbons, volatile aromatic hydrocarbons in groups who were there, and we looked at the firefighters who did have elevated levels, for samples taken within one to two hours of exposure at the scene of the fires, and in soldiers in whom we could not detect elevated levels of the volatile organics.
So I don't know the specifics of the PAH but I will get that for you.
DR. BALDESCHWIELER: I mean, it seems to make much more sense to look at the aro-hydrocarbon hydroxylase, and I'm not surprised that you didn't find anything in the circulation that's different from the exposed and the control groups.
DR. GERRITY: Yes. I might add, just as a final comment, is one of the interesting things about the analyses of the air pollution in the vicinity of the oil well fires, was the
143 surprisingly low levels of PAHs that were in the
ambient air, suggesting that albeit not complete combustion, there was an awful lot of elemental carbon present.
DR. BALDESCHWIELER: I think those hydrocarbons are typically deposited on particulates.
DR. GERRITY: And I'm referring to analyses that took the particulates and looked at the PHA content of the particulates.
CHAIRMAN LASHOF: Art.
DR. CAPLAN: Just a couple of other questions.
One of the things that we heard a lot about at our meetings, from veterans, is their concern that cancer, birth defects, other problems, be examined thoroughly, controlled for age against reasonable baselines.
Are you sure that in the 35 or whatever studies that are out there, do you feel confident either in the ones that CDC is doing with the Pennsylvania Guard and the Iowa population, or in
144 that number of states that you get running, that
we're going to be able to get well-controlled, reasonable answers about incidence for all health effects--cancer?
DR. GERRITY: Cancer of course, is
difficult because most cancers have a long latency period. We certainly endorse a continuation of the collection of mortality data, out into time, so that we can, you know, if you will, surveil for any change in cancer incidence in this population as a function of time.
The Boston Environmental Hazards Center is also working with the state of Massachusetts to establish a cancer registry for Persian Gulf veterans, as they have done with the Vietnam veterans.
So these are certainly important and reasonable efforts.
On the issue of birth outcomes, several of the epidemiological investigations going on now are both probing this question through questionnaires of service members and their families, but also in
145 looking at, for example, in the national survey,
there is a subset of individuals on that survey who have physical examinations of themselves and their family members, as is I believe in the case of the Iowa study, and there is also quite a bit of activity within the, again, so-called DoD San Diego studies, looking at the issue of birth outcomes.
And I feel confident that they will be
able to give us a picture, probably not any one individual study, but when you aggregate them together, that one will be able to get a picture of what is occurring in the service members' families relative to birth outcomes.
DR. NISHIMI: If I could just follow up on something Dr. Gerrity said. You said that you would certainly endorse the notion of continued follow-up on, especially the issue of cancer, which we all know might not manifest itself for, you know, years or decades. Endorse is different from a policy guidance from the Coordinating Board, let's say, recommending that in fact the Federal Government will do that.
146 Isn't that something that the role of the
Coordinating Board might be?
DR. GERRITY: Oh, yes.
DR. NISHIMI: And has the Coordinating
Board made such a recommendation?
DR. GERRITY: We have not yet made a
formal recommendation on that matter, but I think
you're correct, Dr. Nishimi, that that is something reasonable, from a policy standpoint, for the Coordinating Board to take up, and make that kind of positive assertion.
DR. NISHIMI: And when might they do that? I mean, you knew I was going to ask that.
DR. GERRITY: Yes, of course! Well, we meet on a monthly basis, so I would say as an outgrowth of that question, you can probably foresee an answer fairly soon.
DR. NISHIMI: Thank you.
CHAIRMAN LASHOF: Other questions? Sure, Henry, go ahead.
DR. FALK: In terms of cancer, most cancers related to environmental agents generally
147 take 10, 20, or more years to develop. I think
after an episode like this, probably the most critical thing to do is to make sure that you've identified everybody who's been exposed, and so that if one wanted to do those studies six months
from now, 10 years from now, 20 years from now, the relevant population has been identified, can be found, and followed up.
For example, after Three Mile Island, what was done was just as census of everybody within, I think, five miles, and a questionnaire which simply had every conceivable way of finding people. And so if anybody wanted to do a study, it could be done. So I think it's not so critical, maybe, to make the decision about which cancer studies to do, but I think the efforts to put together the--that DoD has been working on, to put together a registry of everybody who was involved with the Persian Gulf, will enable one to recreate those studies later on.
In terms of birth defects, size makes a difference in terms of looking at specific birth
148 defects. It's one thing to say all birth defects
are high or low, but that's very hard to interpret, especially when one wants to look at uncommon defects. Size makes a difference.
So I would say that efforts where we would be asking about birth defects, let's say in the Iowa registry, we will be able to maybe identify if there are some unusual groupings of particular types, and we are working with the state health department and their birth defects registry, so we can verify diagnoses for children born in Iowa.
But I think that it's helpful, but
limited, and I think the efforts that the DoD is undertaking to look at births, you know, of military hospitals, or to work with state birth defects registries, and see where they can do case control studies out of that, would lead to a much larger population. So that's, hopefully, a lot more feasible. Hopefully, it will be feasible and will be a lot more reliable in terms of information.
DR. CAPLAN: One other point just on this,
149 if the Chair will indulge me one more minute. It
does seem to me, in looking at some of the studies that CDC is doing, some of the ones that the Defense Board is funding and coordinating, and so forth--it might be important to think about it--I just make this as a recommendation--the creation of some sort of data safety and monitoring board for this kind of work. Normally, we associate that with someone trying to let subjects know if a good result is being found early, or if something bad is going on.
But since here, there are many people who want information and may not want to wait all the way through to the final completion of the study, I would just urge you to think both about the need to perhaps have some midway points with data release, about what's been found to date, which may not be part of the normal protocols that people use, but might be important to do here, so that people know what's going on, even if it's intermediate.
And at the same time, you might also consider better feedback mechanisms to study
150 subjects that sometimes my colleagues at
universities put in place, so that they all find out what happened in the study.
CHAIRMAN LASHOF: Good point, Art. It's actually something we might also want to take up under the outreach, of how we get the information from studies out, who's doing it, at what point it should go out, and so on. And we might ask staff to take a look at that under the outreach effort.
Other questions? Elaine? And then
Marguerite.
DR. LARSON: Just real quickly. Some of the research questions are very specific, related to specific exposures. We heard testimony this morning about exposure to benzene and yesterday to the post-scud missile exposure to nitric acid. Are these going to get picked up in here?
DR. GERRITY: Comment on the benzene exposure. Lindane is a pesticide that is USEPA approved. It is possible it has a benzene ring in its structure. I'm not a organic chemist, so I can't assert that for certain; but that could be
151 the source of maybe possibly some misunderstanding
in this regard.
Lindane is not benzene. That was the
first question. I think you asked two questions.
What was the other one?
DR. LARSON: The other one was about the
scud missile nitric acid.
DR. GERRITY: I think that what might not
be an unreasonable exercise to go through--I mean,
none of us have really sat down and assessed this. But it certainly might not be an unreasonable, nor an impossible thing to do, would be to make estimates based on dispersion modeling, for example, of what the exposure might have been in various cases. It might not be an unreasonable exercise to undertake, and then go from there.
CAPTAIN KNOX: Dr. Falk, if you would just
clarify for me how you would go about identifying certain units that may have been exposed. I think with the unanswered questions about chemical and biological warfare, can you really say what units were exposed to certain toxins?
152 DR. FALK: My sense is that that would--you would
probably get the best answer from
Department of Defense people on that one, because I
think they've been going through the various units, and trying to set up a pattern as to which ones were exposed, in which areas. I'm not doing that directly and I'm not sure I could give the best answer to that.
CAPTAIN KNOX: The other thing that I would just like to add, in response to Art's comment about cancers and the exposures that veterans have had, even if you could identify that, the way the legislative reads right now is if you did not have that illness while you were in Persian Gulf, or if it did not occur within the first year or two after Persian Gulf, you cannot receive medical care or compensation for that.
DR. FALK: That's a general issue that comes up in terms of worker's compensation and outside the military as well. How do you define the time periods, and the reporting time periods may be so much beyond. That's an issue that's
153 important to consider.
DR. GERRITY: I just want to make a
comment, although I'm not a benefits person, so
I'll disclaim that right now. The legislation is really directed at undiagnosed illnesses. It does not preclude, at any point in time, a claim for something that could occur, or be attributable to service in the Persian Gulf. That case that you just described is not necessarily so.
CHAIRMAN LASHOF: Does that clarify it? CAPTAIN KNOX: Well, you might talk with
Dr. Murphy, because I did give her a denial of a claim that is exactly that.
DR. GERRITY: As I said, I might have stretched my authority on that.
CHAIRMAN LASHOF: We can have staff go into that more clearly and get a clear understanding of the difference between undiagnosed illnesses and diagnosed illnesses that might be related, or shown to be related in some way.
Are there any other questions that the committee would like to put forward to Dr. Falk or
154 Dr. Gerrity? John.
DR. BALDESCHWIELER: A comment. It seems
to me that there's a real possibility of a
significant increase in incidence of various environment, not only exposure-related cancers, on a time scale of several decades, and that it's important to understand, you know, how the Government should position itself with respect to this.
CHAIRMAN LASHOF: I think that's obviously an issue we'll be taking up further and we're anxious to hear what the Coordinating Board thinks about that issue.
With that, then, let me thank both Dr. Falk and Dr. Gerrity for their testimony this morning. We'll adjourn until 12:45, and then we will have further briefings on research issues by DoD.
[Whereupon, at 11:47 a.m., a luncheon recess was taken, the meeting to reconvene at 12:45 p.m.]
155 A F T E R N O O N S E S S I O N
[12:51 p.m.] CHAIRMAN LASHOF: I think we're ready to
resume our session.
This afternoon, we are pleased to have Lt.
Col. Gary Gackstetter from the Department of
Defense, Mr. Donald Hakenson from the Persian Gulf Registry Environmental Support Group, and Dr. Jack Heller from the Environmental Health Risk Model for the Center for Health Promotion and Preventive Medicine of DoD.
We'll start off with Lt. Col. Gackstetter, who will talk about the components of the research plan, and then we'll ask Mr. Hakenson and Dr. Heller to follow up on their specific areas of responsibility, and then we'll have questions to all of them together, or wait until all three have spoken before we open it to questions form the committee.
So Lt. Col. Gackstetter, if you would like to start.
LT. COL. GACKSTETTER: Thank you, Dr.
156 Lashof.
Good afternoon. My name is Lt. Col. Gary
Gackstetter. I'm an epidemiologist working within
DoD Health Affairs. I've been asked to present to the committee DoD's approach to competitive research awards concerning Persian Gulf illnesses.
I want to emphasize that although DoD
administers this program, that we're committed to a long-term partnership with both VA and HHS, through the Research Working Group of the Persian Gulf Veterans Coordinating Board.
Section 722 of Public Law 103-337 directed the Department of Defense to conduct and administer grants for studies of the health consequences of the Persian Gulf War.
The Congress mandated research in three major areas. The first, epidemiologic studies to determine the nature and scope of illnesses. Health consequences of pyridostigmine bromide use
during the Persian Gulf War. And finally, clinical research and other studies.
The Joint Appropriations conferees
157 directed the DoD to competitively award $5 million
to specifically non-federal agencies for such research.
The United States Army Medical Research and Materiel Command was directed by DoD to administer this program.
The U.S. Army Medical Research and
Materiel Command prepared three separate Requests For Proposals describing the specific areas of solicited research.
A broad agency announcement for the Request For Proposals was published in the Commerce Business Daily on May 26th, 1995.
As required by federal acquisitions
regulations, additionally, the broad agency announcement was announced at a Pentagon press conference and received full press coverage, including articles in many major newspapers.
The broad agency announcement was also faxed to each individual School of Public Health. DoD and VA jointly released an additional $5 million from a cooperative DoD/VA medical research
158 program element to the U.S. Army Research and
Materiel Command for either federal or non-federal agencies to conduct research into three solicited areas that I mentioned previously.
In summary, in addition to the ongoing medical research that continues with our program, about $10 million has been set aside for research into these three areas.
Non-federal agencies may compete for the entire amount, while federal agencies are restricted to that last $5 million that I just mentioned.
In general, the standard DoD review and awards process is two-tiered. First, an independent scientific review is performed. Then on the basis of scientific evaluations and programmatic considerations, a panel recommends proposals for funding.
Programmatic considerations include duplication of current research, cost, importance
of the problem to be addressed by the research, and likelihood of a direct benefit to the service
159 members or veterans.
The U.S. Army Medical Research and
Acquisitions Activity negotiates the final award
amounts with those selected for funding.
For Persian Gulf War illnesses, the Request for Proposals, the process will follow DoD standard procedures. We currently have about 111 proposals that were received in this response to the broad agency announcement by the closing date of August 23rd. That was a 90-day period.
These proposals are in the process of being reviewed right now by independent scientists contracted through the American Institute of Biological Sciences.
The American Institute of Biological Sciences' scientists will meet at the end of October in five research panels for group discussion and completion of the peer review process.
Each panel will provide to the U.S. Army Medical Research and Materiel Command written
evaluations and numerical scientific assessments of
160 the technical approach, researcher qualification,
research management costs, and overall research value, as well as comment on the relevance of each proposal to the health consequences of the Persian Gulf War.
Based on scientific merit, relevance to Persian Gulf veterans' health issues, and programmatic considerations, the U.S. Army Medical Research and Materiel Command will prepare a suggested ranking of the proposals within the three principal areas, both federal and non-federal agencies. The Research Working Group of the Persian Gulf Veterans Coordinating Board will review these rankings and recommend specific proposals for funding.
The final selection of proposals will be made by the full Persian Gulf Veterans Coordinating Board.
The U.S. Army Medical Research and
Materiel Command will notify those who submitted proposals of the final results of the selection process.
161 The U.S. Army Medical Research Acquisition
Activity will negotiate all awards. When all
grants or contracts have been awarded, a list of the awardees will be made public. Notification of the awardees is anticipated some time--let me say no later than January of 1996. Very soon.
The U.S. Army Medical Research and
Materiel Command, with the assistance of the American Institute of Biological Sciences, will monitor each proposal, each project's progress through the period of each award. This will be accomplished in a variety of ways, to include periodic scientific reviews, principal investigators, financial and research progress reports, comparison of progress reports with stated objectives, and site visits.
Reviews and reports specified by Section 722 of Public Law 103-337 will provide additional program oversight.
The final program, summary report of the combined research efforts, will highlight any of those key findings.
162 I've attached a list of DoD projects
involving current Persian Gulf health issues for
your information.
That concludes my presentation.
CHAIRMAN LASHOF: Thank you. Mr.
Hakenson.
MR. HAKENSON: Good afternoon, ladies and gentlemen. My name is Don Hakenson. I'm the director for the U.S. Army Joint Services Environmental Support Group. With me today, sitting in the back, is Robert Swartow, our project manager for the Persian Gulf Task Force.
And today I'm going to brief you on the background and the current status of the DoD Persian Gulf registry.
Public Laws 102-190 and 102-985 task the Department of Defense to build and maintain a Persian Gulf registry. This registry identifies all American service personnel with a potential for exposure to the fumes of burning oil well fires during Operation Desert Storm in the Persian Gulf.
The purpose is to provide personnel and
163 exposure data to the scientific community and to
provide service personnel with a measure of their potential health risk from exposure to oil well fire smoke.
The Army was named the executive agent, and the ESG was tasked with this project due to our
previous work in the Agent Orange and the post-traumatic stress disorder issues.
The DoD Persian Gulf registry is comprised
of two major components. The unit movement
database and the personnel database. The unit movement database is currently in development. The goal for the movement database is to obtain, at a minimum, with documentation permitting, a single location for each unit, down to the company level, for each day during the period January 15th, 1991 until that unit left the Persian Gulf.
The following unit movement information is currently being abstracted. Unit identification code, unit description, Julian date, military grid reference, MGRS, latitude, longitude, location name, and source document type.
164 The ESG's goal is to complete the majority
of the unit movement research by December 31st,
1995.
The personnel database contains the names
of 696,661 personnel that served in the Gulf, and
in support of the operation, of which 49,952 were women, 579,932 were active duty personnel, 72,919 were reservists, and 43,810 were Guard.
It also contains 64 personnel elements for each individual. This information has been consolidated and provided by the Defense Manpower Data Center located in Monterey, California.
An additional geographical location code is available for Air Force personnel. When all available unit movement data has been committed to the registry, this information will be merged with the health risk model being developed by the Center for Health Promotion and Preventive Medicine, CHPPM, in Aberdeen, Maryland.
The output of this model will measure a person's potential health risk from exposure to the oil fire smoke. The personnel elements that are
165 needed to perform these exposure runs include the individual's name, Social Security number,
individual's unit of assignment, and the individual's in theater start and end date. The personnel and unit movement databases can also be used in support of other scientific studies and health claims.
The ESG has received 713 Army Desert Storm boxes, and has indexed and researched 638 boxes, which equates to approximately 2.4 million pieces of paper.
The ESG is currently in possession of 243 boxes of Army Desert Storm records. We have already researched and sent 470 boxes of Army records to the Combined Arms Command, CAC, in Fort Leavenworth, Kansas.
We have also researched 72 boxes of Army records from the Army Center for Military History. We must still research approximately 425 boxes of CINCOM Desert Storm records and 66 boxes of AMC files located at the National Archives in Suitland, Maryland.
166 There are also 30 filing cabinets of
Military Traffic Command records located in
Arlington, Virginia.
We have researched approximately 99
percent of the Marine Corps records and we have
also completed research on approximately 98 percent of the available Navy information.
We have received a data tape from the Air Force that contains geographical location codes for 71,361 Air Force personnel.
We are currently waiting for another data tape to complete the Air Force portion. As a result, a total of 276,492 unique grid points, with latitude, longitude, and place names have been committed to the database.
Some of ESG's ongoing efforts include ensuring compatibility with the CHPPM health risk model, updating the personnel registry, coordinating with the Department of Veterans Affairs, and visiting various records repositories for additional records.
Currently, there are 30 civilians and four
167 military personnel assigned to the Desert Storm
Task Force. Liaison support for this project was provided by the Army, Air Force, Marine Corps, and the Navy.
In conclusion, we have identified all known records--key word--known records. We are currently researching these files. We have the necessary resources, and we are currently on target.
Thank you very much.
CHAIRMAN LASHOF: Thank you very much. Dr. Heller.
DR. HELLER: Good afternoon, Dr. Lashof, and distinguished committee members. I am Dr. Jack Heller, acting program manager of the Health Risk Assessment and Risk Communication Program at the U.S. Army Center for Health Promotion and Preventive Medicine. I am also the center's team leader for the Kuwait oil fire, health risk assessment, and other issues relating to environmental exposures in the Persian Gulf.
I have been actively involved with these
168 issues since January 1991, including numerous trips
to the Persian Gulf. I wish to thank the committee for the opportunity to describe our efforts in this area.
The destruction of more than 700 oil wells during the conflict in the Persian Gulf raise concerns about potential health effects to Department of Defense troops and civilians exposed to oil fire smoke.
Initial reports from the area, by groups conducting monitoring activities, such as the U.S. Environmental Protection Agency, the French, the Norwegians, and the Kuwait Environmental Protection Department, did not find significant quantities of pollutants of concern that would cause acute health effects, except for particulates, which are naturally high in the region.
However, the groups conducting the monitoring did stress that long-term health effects to individuals that were exposed to the pollution could not be determined because of insufficient data.
169 It was this concern with potential long-term
health effects that prompted this study. At
the request of the Department of Defense Health Affairs, the U.S. Army Office of the Surgeon General was tasked to chair a tri-service medical working group to evaluate the potential health effects of the oil smoke on Department of Defense personnel.
At the same time, the Army Office of the Surgeon General asked that a team from the U.S. Army Environment Hygiene Agency, renamed the U.S. Army Center for Health Promotion and Preventive Medicine, be dispatched to perform environmental sampling, and to characterize the risk of adverse health effects caused by the oil well fires in Southwest Asia.
The scope of this project consisted of two main areas, an environmental monitoring effort with subsequent health risk assessment, and a biologic surveillance initiative. The environmental monitoring study characterized the concentration of air and soil pollutants that Department of Defense
170 personnel were exposed to during their stay in the
Gulf region. The time period of exposure and the location where that exposure occurred were highly variable for the large number of Department of Defense personnel in theater, approximately 697,000.
As of the end of February 1991, there were a total of 605 oil wells on fire, and 46 gushing oil. The Environmental Hygiene Agency monitoring the effort commenced on 5 May 1991, and continued until 3 December 1991. At the start of our environmental monitoring, there were approximately 580 oil wells on fire. The data collection continued until the fires were extinguished on approximately 6 November 1991, and as stated above, continued until 3 December 1991 to obtain one month of background data.
The area occupied by troops during their stay in the Gulf region was extensive, approximately 880,000 square miles within Kuwait, Saudi Arabia, and Iraq. This made quantification of exposure by troop location very difficult.
171 Therefore, as a starting point for
exposure measurement, ambient air monitoring stations were established at four locations in Saudi Arabia, and four locations in Kuwait.
The locations were selected based on the
fact they were major sites where Department of Defense troops were stationed, long term. In addition to ambient air monitoring, soil sampling was done at the air sites to ensure that all potential exposure pathways and media were evaluated.
The data generated from the environmental monitoring activities were used to calculate the exposure point concentrations for the health risk assessment. The risk assessments were conducted for each of the air/soil monitoring sites where Department of Defense personnel were located.
The methodology selected for the risk
assessment is U.S. Environmental Protection Agency guidance developed for Comprehensive Environmental Response Compensation and Liability Act sites, also known as Superfund.
172 The calculations result made quantitative
estimate of health risk based on the contaminate concentrations. In addition to standard laboratory analysis conducted on the environmental samples, particulate analysis techniques were used in an
attempt to differentiate between oil fire-related contaminants, and natural, or anthropogenic background contamination.
Results from the health risk assessment report indicate low potential for long-term health risk for the monitoring period and locations studied when compared to current USEPA standards.
The biologic surveillance initiative was
conducted to refine the results obtained from the health risk assessment. The predictive results from the health risk assessment, which were generated from environmental data, were compared to the biologic surveillance initiative results from actual biological samples of potentially exposed troops.
This comparison assisted in reducing the uncertainty concerning the results of the health
173 risk assessment.
If I could just make a comment. The
samples Dr. Falk referred to, the urinary tetrols,
those were collected on the 11th Army Calvary Regiment in June, August, and October 1991. So they were not collected three years after the fact. They were collected before they deployed from Germany, when they were in Kuwait, and then, when they redeployed to Germany. In addition, we also collected blood samples for polyaromatic DNA adducts, to also look at polyaromatic hydrocarbon exposure.
The final health risk assessment report covering the entire monitoring period of 5 May to 3 December 1991 was transmitted to the tri-service Medical Working Group on 18 February 1994.
There are over 4,000 environmental and personnel monitoring samples representing over 40,000 laboratory data points for the contaminants of concern that were validated and interpreted for the final report.
In addition to the health risk assessment
174 report, this center is also involved in a joint
effort with the Department of Defense and Joint Services Environmental Support Group to consist in the construction of a Department of Defense Persian Gulf Veterans Registry.
In response to Public Law 102-190 and 102-585, the ESG has been tasked to compile a roster of
all Desert Storm veterans. This effort will include when the service member entered theater, when they left, and where they were during their tour of duty.
Our center is estimating their exposure to pollutants and will be conducting health risk assessments for various groups of service members that were exposed to oil fire emissions upon receipt of the ESG troop unit locator registry. This data will then be used to conduct the health risk assessments of military units operating in the Persian Gulf.
The technology selected to accomplish this mission is the Geographic Information System, a computer-based system capable of evaluating
175 multiple exposures and medical outcomes on a
spatial and temporal basis.
The GIS integrates data features to
include modeled air concentration from the National
Oceanic and Atmospheric Administration, satellite imagery data from the National Center of Atmospheric Research, exposure and toxicological data from the Environmental Protection Agency.
The system is termed the Troop Exposure
Assessment Model. The Troop Exposure Assessment Model currently contains over 1 million records
that comprise our system's database. Our center is currently scheduled to complete the oil well fire, troop exposure assessment model in April 1996, which includes loading the ESG data records, and analysis of the troop exposures and associated risks.
An expanded effort to assess multiple exposures of Persian Gulf veterans utilizing the GIS technology is currently under development at the CHPPM. The expanded Persian Gulf veterans health tracking system could evaluate potential
176 exposures veterans encountered, such as vaccines, pesticides, depleted uranium, pyridostigmine
bromide, and petrochemicals, to name a few.
These potential exposures, combined with the medical outcome from the Veterans Administration, the comprehensive clinical evaluation program, the use of CHPPM and other investigators, can be integrated and then spatially and temporally evaluated with the information from the Troop Locator System, and the GIS.
Another application of the GIS technology will be as the cornerstone of a future deployment medical surveillance system. With the expanded Persian Gulf veterans health tracking system as its nuclear, the use of CHPPM is initiating the development of a deployment medical surveillance system that would be capable of assessing multiple troop exposures and medical outcomes during deployments.
In the pre-deployment phase of a military operation, the system would also function as a medical countermeasure system. A pilot project is
177 currently being planned and coordinated in Kuwait
with the U.S. 3rd Army, with the assistance of the Kuwaiti government.
This ends my remarks. I would be glad to answer any questions from the committee members at this time.
CHAIRMAN LASHOF: Thank you very much. Before I open it up for the committee members' questions, let me also introduce Mark Brown to the committee members. You may not have met him. He has been working on these issues. I will ask Mark if he wants to make any comments.
DR. BROWN: Yes. I have a couple of questions. I guess for Dr. Gackstetter, first of all, in reference to the--I'm sorry. I'll come back to that. I want to talk about this environmental sampling that Dr. Heller mentioned.
You talked about some samples that were
taken during the course of the war, or just immediately after the war, both environmental samples, hair samples, samples of, I guess, blood and urine, of at least some troops.
178 And from the context of your remarks, it
sounded like you were looking specifically for the polyaromatic hydrocarbon issue. You're looking at
the smoke issue, the burning oil wells issue.
My question is, did anyone look for any other types of chemical, the signs for any other chemicals, environmental exposures that may have been present, either in the air, or in the other samples that you mentioned?
And second, were any of those samples archived, in any way, that we could go back now and look for other possible contaminants?
DR. HELLER: Our main impetus at that time, what everybody was concerned was oil well fire exposure. So the main thing we focused on were those organic chemicals. But we looked for heavy metals. We looked or volatile organics. And that was done in coordination with CDC.
As I said, we did blood and urine metals. We did chromatid exchange on peripheral lymphocytes, and the DNA/PAH adducts. So it was basically driven by oil well fire, industrial type
179 exposures.
And I believe a lot of those samples are
probably still archived at the Walter Reed Army
Institute of Research, but I would have to check that and see if there is, so additional samples can be there.
I would have to check with the other collaborators, in some places, for the blood volatile, I think, and the analysis uses the entire sample. But I believe there may be some of the samples from the 11th ACR. I can check on that.
DR. BROWN: A question for Dr. Hakenson.
We've heard a lot about the geographic locator information and some researchers that we've spoken to seem to have some big expectations about the value of this locator information in terms of looking for clusters health effects, for instance, in some of the troops during deployment.
And I think many people see it as a
potentially very valuable research tool. Do you have any plans at ESG, --
MR. HAKENSON: The Environmental Support
180 Group.
DR. BROWN: The Environmental Support
Group. Do you have any plans for making this
available to people who have legitimate research interests in the data, and specifically would it be available, for instance, as a product you could use on a PC?
And also, do you have any plans for providing training for researchers who might want to use that data for various epidemiology studies and other types of studies?
MR. HAKENSON: Well, at this point in time the only answer I can really give you is that the information will be available to anybody who requests information from the database. How it's going to be done, we really haven't decided at this point in time. It is Mr. Hakenson, not Dr. Hakenson. I'm sorry.
DR. BROWN: All right. When in doubt, err.
DR. NISHIMI: Just to clarify. But you expect to have it complete by the end of December,
181 is that not correct?
MR. HAKENSON: We're hoping to have a
large percentage of the Army records complete by
the 31st of December. What has happened, at the point in time when I said we would finish it all by the 31st of December, we have found these additional collections of records. But a large percentage, over 90 percent of the Army part will be done. The Navy part is completed and the Marine Corps is completed, except for just a little bit of cleaning up.
DR. NISHIMI: So when might you then be making it available to the public and when might you have some policies so that people will know?
MR. HAKENSON: On exactly what date it
will be available to the public?
DR. NISHIMI: Well, I mean, December's not too far away, so when might researchers be expected to have access?
MR. HAKENSON: To be honest with you, I would think as soon as we have the database complete, and so I would say in January of 1996.
182 DR. NISHIMI: And so when might the
committee be able to get information about what the policies will be governing outside users' access to
the database?
MR. HAKENSON: I don't know what the exact policy is going to be. The only thing I can guarantee is that there shouldn't be any problem for anybody to gain access to the data or request information from the database.
Now there might be issues dealing with Social Security and that type of thing, but there shouldn't be too many problems.
DR. NISHIMI: Right.
MR. HAKENSON: There are Privacy Act issues involved.
DR. NISHIMI: Well, I understand that, and so that's why I think the research community needs to understand what policies will govern this. Given that it may go and be available as early as January, it would be useful for the committee, and the research community to know what exactly they will have access to, and how, frankly, they might
183 gain access to it.
DR. HELLER: Okay. I have one quick
comment about that. I would think one of the
easier ways to access, although everything hasn't been worked out, when we get the tape from ESG, it will be on our Geographical Information System, and a researcher or an individual could make a query on that by Social Security number, or unit identification number, for any particular period, and hopefully be able to locate that group of troops, or those individuals, or trying to relate it to a particular exposure.
So one of the easiest ways to get at it may be through our system, when the tape is loaded on to our computer system.
CHAIRMAN LASHOF: Other questions from the committee?
I have one to follow up on, that we've been told the VA mortality study will be available shortly, and is almost completed. Has that been coordinated with the locator data at all, do you know? Have you worked in collaboration with the VA
184 mortality study, so that when we get a mortality
study it will deal with whether mortality was higher among troops in one location than in another?
MR. HAKENSON: We have not provided any location information to the VA in regards to the mortality study. They do have the personnel information from the DMDC tape.
CHAIRMAN LASHOF: Okay.
DR. HELLER: Right. We haven't coordinated with them either, but again, when we get the locator tape, and if they have Social as a unit identification, you can run a query against, you know, what the locations with that mortality study might be, where troops were located.
CHAIRMAN LASHOF: It would seem to be a
logical thing to do, wouldn't it?
MR. HAKENSON: Excuse me, ma'am. How the whole system is supposed to work, if there is a potential for exposure to someone who served in the Persian Gulf, if a guy files a claim through the VA, the VA would then send that guy's case to the
185 Environmental Support Group.
The Environmental Support Group would
check out his name, verify the unit he was assigned
to, the time frame he was there, where those unit locations are in relationship to the time frame in the unit, and then we would provide him an exposure score.
CHAIRMAN LASHOF: How else do you intend to use it? So you intend to use it, obviously, for claims. I've asked about the mortality, and obviously it would be logical for any mortality study, to go back and look at it. What about the relationship of this data to any of the other epidemiologic studies?
DR. HELLER: There are no plans. Our mandate under the public law was to work with ESG, set up the locator database, and look at it relative to oil fire exposure.
We think it has great potential to look at any of the other studies that have been done to correlate time, place, grouping. It's just a matter of, as long as they have an SSN, or a unit
186 ID, we could then look at where they were when
there were potential exposures, working with ESG. So I think the system has great utility for doing those kind of things with any researcher that had an interest in looking at time, location, and potential exposure, as long as you have good exposure data.
MR. HAKENSON: I would just like to add one small thing about that. As long as you know the name of the person, again the time frame and the unit, and where that unit was located, it can be used for anything, any model that someone would want to develop.
CHAIRMAN LASHOF: Thank you.
DR. LARSON: This is for Lt. Col. Gackstetter. The 111 protocols that are under review now are obviously new ones, and they're in one of three categories, one of them being the health consequences of pyridostigmine.
You already have two studies ongoing, one on pyridostigmine and synergism between various chemical agents, and the other one on male-female
187 differential.
What proportion of this research portfolio
is going to be on pyridostigmine? Have you set any parameters about the percentages of the various
kinds of studies that need to be done?
LT. COL. GACKSTETTER: It's too early to say anything specific about that. What will happen is, most pyridostigmine research will be grouped in a toxicological grouping, and so although we'll be able to say this is pyridostigmine, it is probably also some other exposures. So we were mandated by Congress to conduct that specific research and we will do that, but it will be done in the context of other exposures as well.
CHAIRMAN LASHOF: Lois?
MS. JOELLENBECK: Yes; thank you. I have a question for Dr. Heller about the Persian Gulf veterans health tracking system, the expanded version, and the timing on that, and how you might incorporate estimates of exposure to vaccines or pyridostigmine bromide. Would you be incorporating self reports of exposures?
188 DR. HELLER: Right now, that's in
development, and we're kind of taking that out of
HIDE. Since we started working with the Geographical Information System it looks like an excellent way to look at multiple exposures. We know, particularly for vaccines, there's information out there, you know, and records about units that got vaccines. We may not be able to find out exactly what person in the unit got a vaccine, but I think we may be able to find out which units got vaccines, at least, and assume the whole unit may have gotten the vaccine.
Some of the other databases, not so much self-reported, but, you know, we believe--and we haven't looked into all the databases. There is some information that various investigators have, various groups in the Department of Defense, to try to get a better handle on for pesticide exposure and potential PB exposure, what some units were taking, instead of just, you know, what is being done now.
That well, everybody got three tubes of
189 DEET or everybody got three, you know, cans of
permethorin to use, and so everybody used it. And we feel, though we haven't investigated it thoroughly, that we can get a better handle on really how much was used, by who. And so we're just in the investigative stage of looking at all those databases, but we think the GIS has a real utility, once we identify potential exposed troops, of looking for clusters of that.
DR. NISHIMI: Dr. Heller, you mentioned that you thought there might be biological samples stored somewhere. Do you have any idea about how many that would be?
DR. HELLER: The blood samples--there were about 1,500 people in the 11th ACR, but it was very time-consuming and expensive and very difficult to do some of the analysis, like the blood volatiles, we tied up CDC's entire laboratory capacity with about 35 samples from that unit.
So some of the more exotic tests would have only had small numbers of blood samples. So it might be 30, 40, 50. Although there may have
190 been some larger groups taken, but not all run, and
I have the point of contact at Walter Reed Army Institute of Research. So I can look at and see if any of that is archived, and how much of it would be archived.
DR. NISHIMI: So your impression is that 1,500 samples were collected?
DR. HELLER: No.
DR. NISHIMI: Okay.
DR. HELLER: There were 1,500 troops. DR. NISHIMI: Troops.
DR. HELLER: But for the biological
analysis, since it was so expensive and time-consuming, much smaller numbers were collected. If
I remember correctly, for blood and urine metals,
there may have been two or three hundred samples collected. And I don't know if the whole amount was exhausted in the analysis, but the person who did that work for us, I can easily contact and see if he has some of the serum left that could be looked at.
DR. NISHIMI: And those lymphocytes
191 weren't immortalized for any of those samples, or
do you know that?
DR. HELLER: I do not know.
CHAIRMAN LASHOF: Further questions? John.
DR. BALDESCHWIELER: Again for Jack Heller. Most of the preliminary monitoring results seem to indicate that the levels of contamination were surprisingly low.
First of all, is that a fair reading of what you said?
DR. HELLER: For acute effects, yes, and that's why there wasn't a big concern about troop exposure except for long-term chronic. That's correct.
DR. BALDESCHWIELER: And do you have a working hypothesis as to why it was so low, and when it was evident that there were huge amounts of combustion products that were air-borne?
DR. HELLER: There are two reasons. Depending on the meteorological conditions, we got there in May of 1991. At that point, with the met
192 conditions, what happened was the fires coming out
of the oil well fields consolidated into, you know, great columns of some, went up to about 12- or 14,000 feet, formed a super-plume over the Gulf. So the sun could be blocked out, but that didn't mean there was ground impact of the actual plume.
Now, during the earlier time frame, when
we were not there, there were a lot of troop reports, that instead of that happening due to the meteorological conditions, there were many more ground fumigations with oil fire smoke. I can only talk for the period we were there, and the period I was there, there was one ground fumigation in the whole period. One night at Camp Freedom, just like fog rolled in. Now we were told that that happened more frequently during that earlier two month period, and that's what we hoped the modeling and satellite imagery will show.
DR. BROWN: I have a question for Gary here, and I'll preface this question by saying I think it's probably a little unfair, but I'm going to take advantage of this format and ask it anyway.
193 And that is, I took a look at the broad
agency announcement, and the thing that impressed
me about it was the breadth of its scope. It was really touching on all areas that we've heard about in the last two days of exposure issues. It was looking at chemical agent, chemical weapon exposures on it, health effects of the families of veterans is on it, all other issues--stress, depleted uranium. It really touches every issue that we've heard about, that might be involved with the Gulf veterans' health.
So it's really setting the tone, I think, for what research is going to happen in the next year or two, coming years.
On the other hand, as you mentioned, there is only--I am a little unclear about how the funding works, but it's something like either 8 million or $10 million, in total, for all the research projects that are going to get funded, some fraction of that 111 projects that are going to get funded.
And that seems like a small amount of
194 money, to me, for--you know, a couple of
epidemiological studies will eat up the majority of that. And you know, what kind of an effort would you judge that as?
And I guess the real question in my mind is, when this money is spent and that research is done, what do you think we'll know? What will veterans know about their health and what will we, collectively, be able to say about what may be causing their health problems?
LT. COL. GACKSTETTER: You're asking me to look into the future and that's sort of hard to do. What we've got now is 111 proposals. I guess I can give you some kind of specific areas that they lie in, but they're out for peer review.
As soon as they come back, I'll be able to give you a much better sense, in a month or so, about what's in which category, and will fulfill our congressional mandate in those very specific areas.
As far as the reason we wrote the BAA the way we did is we did not want to exclude anything
195 out there. We think if you've got a wonderfully
high scientific merit score, that you deserve a look like any other proposal out there. So we specifically did not exclude.
The one thing that we did do as a modification to that was try and focus that BAA a little bit. And we did focus, to look at some indigenous populations, peripheral to U.S. troops, to try and get a sense of, epidemiologically,
what's happening in these groups that ought to have about the same exposures, and we need to have some of outcome there.
I think what I'd like to do, if I could, is defer the answer to that until after I get through my peer review process. Does that sound fair? Can I buy a month's time, or so?
CHAIRMAN LASHOF: Well, I'm sure you can, but while you're buying it, if you could provide us a clearer understanding of how these requests for research relate to all of the research that is already funded.
I mean, we have this long list, we have
196 the research plan, albeit a plan that was developed
after most of the research was started. Still,
it's at least an analysis, if not a forward-looking plan, at least an analysis and a breakdown of what studies are being done in what area. And how does that information and the work of this Coordinating Board relate to your decisions of what you're going to fund under this board announcement?
So I think clarification of that would be important. And I'd also like to add that we have been requesting a breakdown of the amount of money being spent on each of the research projects, and would like it sort of cross-referenced around the various research questions. We have 11 or more questions, with a gang of different research studies on all of them. It gets to be a pretty complex matrix, I must admit.
But it would be helpful for the committee to have a feel for the amount of money being expended to answer the specific different research questions. Others? Robyn.
DR. NASHIMI. Lt. Col. Gackstetter, so
197 that if I'm to understand what you just said,
correctly, following your peer review process, if there were to be a proposal with very high merit, that you would fund research related to chemical and biological weapons, is that correct? Because it appears to be part of your broad agency announcement.
LT. COL. GACKSTETTER: I don't think I'd exclude anything, but remember that we still have to prioritize, and so what we've said in our plan is that as soon as we have a point, or evidence to suggest some area in which to point our research, we would be more than happy to point our research in that direction.
We currently don't have that evidence. So we haven't closed any doors, but we go where we can get the most bangs for the buck.
CHAIRMAN LASHOF: Well, let me follow up on that. I mean, I know it's difficult. We've got this moving target. We have a whole gang of research projects ongoing. Some are going to be, at least have some preliminary results in the next
198 few months. Others, we aren't going to have
results for much further. And I'm trying to dig into how you determine where the gaps are going to be, so that you would know how to set some of those priorities, and I still don't get a feel for that.
LT. COL. GACKSTETTER: Sure. That's
exactly what the Research Working Group is for, and that's exactly why we wrote the plan the way we did. We wrote the plan with the best information that we had.
Now, as we move through time, more
information will become available and that plan will evolve toward that. the three big agencies all have equal share in the outcomes of that research. The three big agencies hammer out the best way to get there. And so I'm confused, you know, as far as process goes. The Working Group meets monthly, makes sure that we're meeting the demands and filling gaps and/or moving the process along in some way.
CHAIRMAN LASHOF: Well, with the broad agency announcement, it goes out, those come in,
199 proposals, you have 111 proposals in. They're
going to be reviewed for scientific merit.
LT. COL. GACKSTETTER: Exactly. CHAIRMAN LASHOF: Then are all of those
going to be looked at by the Coordinating Board to decide which ones fill which gap that may exist. And at what point in time will you do that, because some of the gaps, you won't know about whether they exist until you have results of studies that are ongoing now, and so forth.
LT. COL. GACKSTETTER: Exactly right.
CHAIRMAN LASHOF: It's a moving target and
it's difficult.
LT. COL. GACKSTETTER: It's a very complex issue and I think you've articulated it well. Here's what will happen. Those 111 proposals will come, some will have very high merit, some will have very low merit. It'll be pretty easy to go from there.
On top of merit, there is a relevancy, and so that relevancy's going to have to be hammered out, and that's what I hope to bring to you the
200 next time we meet.
DR. NISHIMI: But if I'm to understand the
research plan correctly--and quoting directly from
it--for chemical and biological warfare agents, quote, "further research is unwarranted unless credible data establishes that the exposure to CBW agents actually occurred."
So you are essentially saying, in your broad agency announcement, which was crafted before the research plan, so we have an April 1995 broad agency announcement where you did solicit proposal related to possible chemical and biological weapons research. You are now, currently, not planning on any funding. So any proposals that come in, related to CBW, regardless, will not be funded, regardless of scientific merit, is that correct?
LT. COL. GACKSTETTER: I think you're
unfair when you say that, because how can you exclude something before you get there? So let me at least review the protocols to see what I have, before I get anywhere near what you're suggesting.
CHAIRMAN LASHOF: I think Robyn's quoting
201 from documents that have gone forward, and all
we're trying to do is clarify whether those are still extent or whether the policy has shifted to where you will now consider certain studies, which previously we had understood were not to be considered. Is that correct?
DR. NISHIMI: That's entirely correct. LT. COL. GACKSTETTER: Okay. I stand by
how the research plan is written, and it is not chem-bio that also has some evidence.
We're looking for chem-bio among all of the other things out there. Leishmaniasis. You know, there currently is not a lot of evidence that Leishmaniasis is a problem. That would naturally fall lower on the priority scale. That's all we're saying.
There is nothing in that research plan that is being excluded. We are saying that some things deserve a higher priority than others.
DR. NISHIMI: I guess I would just
disagree. When I see the word "further research is unwarranted," I would argue that that means that
202 it's excluded.
LT. COL. GACKSTETTER: Well, remember that
we're moving through time, and that if every single
day new information becomes available--so that
document is not set in stone, it is a living document meant to evolve daily, if we need to.
DR. NISHIMI: So then it would be a fair
representation to say that DoD and the rest of the Research Working Group is willing to reopen the issue of whether or not it wound fund CBW?
LT. COL. GACKSTETTER: It has never closed any issue, that I know of. It is looking for evidence, and as long as the evidence is there, there's no topic that has been excluded.
CHAIRMAN LASHOF: Okay.
DR. BROWN: Just to follow up this hot seat motive here that you're in. To put this a different way, what would the Research Working Group do, if you get, in one of those 111 proposals that the broad agency announcement has solicited for, if you get one that scores very, very high on merit and very, very high on relevance, and has to
203 do with something such as chemical weapons exposure issues, which the Coordinating Board in the August document, as Robyn pointed out, seems to have
excluded from consideration--how much flexibility, then, does the Research Working Group have to make the final decision?
LT. COL. GACKSTETTER: I would hope that we would have unlimited funds and it could fund absolutely everything. That's an ideal world. It's not an ideal world. Because we have limited funds, things will fall into a very specific priority. If there are funds that can fund that
level--whatever topic we pick, I'm not particularly fond of that topic--whatever topic we pick, if it's high up in the priority, it will more than likely get funded.
If it does not have the evidence to suggest that further research is necessary, there's no reason to fund that ahead of things that we do need.
DR. NISHIMI: So to further pursue this line, you mentioned that there is a priority, and a
204 relevancy score. How are they binned, broadly
speaking, the topics? Can you help me out there? LT. COL. GACKSTETTER: I think we've
articulated that well, within the research plan. DR. NISHIMI: Well, you have 11, 12,
whatever number of questions. Is one the highest priority, then, or
--
LT. COL. GACKSTETTER: No; no. Those questions are not in any specific order.
DR. NISHIMI: Yes, I didn't think so, so-- LT. COL. GACKSTETTER: We go back to the
first question. First, let us define our case, define our prevalence, and see what's going on with a nice control group. From there, we can move forward.
CHAIRMAN LASHOF: I guess that's the problem, is that it's a kind of circular thing. There are certain studies that ought to give us very good answers around certain things, but some of those are the studies that we are going to wait the longest for. And so it's how you decide what
205 additional studies you do in the interim while
you're waiting for some of these.
I mean, it was one of my concerns this
morning--we don't mean to beat at you, but I beat
upon it this morning--is that when you look at this list of 19 questions and 35 studies, and half a dozen studies are addressing any number of the same questions--are you now looking in the broad group for additional studies under these 19 questions? Are there additional questions you're now asking, that weren't covered among the nineteen that are there? Have you identified some that the current studies you know aren't going to be sufficient, or what have you?
And I will ask Dr. Gerrity to come back since we were beating on him earlier this morning, and maybe let you off the hot seat, if that's beyond where you feel you ought to be, Dr. Gackstetter.
DR. GERRITY: In the summary and conclusions of the research plan, we listed several particular areas of research, that at that time
206 that plan had been developed, and I would hazard to
say at this current time, generally speaking, they apply. We identified several areas that we felt needed particular emphasis.
Those areas of particular emphasis would serve as a basis for a call on relevancy.
Does that get at your question?
CHAIRMAN LASHOF: Yes.
DR. GERRITY: I don't have the text in front of me right now. Things related to the prevalence of symptoms, illnesses, diseases, in coalition forces. The prevalence of symptoms, illnesses, diseases, in indigenous populations. Better testing for Leishmania tropica, et cetera.
CHAIRMAN LASHOF: Okay. Basically you
feel in the research plan you've identified some areas that you don't think are adequately addressed by all the ongoing research.
DR. GERRITY: Exactly.
CHAIRMAN LASHOF: And those will be the priorities in this broad announcement?
DR. GERRITY: That's correct. Keep in
207 mind, of course, Dr. Lashof, that then overlaying
that are certain other considerations, you know, that DoD has relative to its public law.
CHAIRMAN LASHOF: Yes. Okay.
DR. GERRITY: I just want to clarify this point on the chem-bio.
CHAIRMAN LASHOF: Sure. Yes.
DR. GERRITY: You know, we did not intend to imply that we would not ever consider this. What we were trying to do in this, you know, generally, was to make an attempt to be able to say, you know, these are the areas we think we should focus on, these are the areas we think that at this point in time don't merit the investment of additional funds. And the emphasis there is on additional funds.
As Dr. Gackstetter pointed out, you know, that could change, easily, as a function of time. Indeed, if one wants to fantasize, someone proposes a study that could give one a definitive understanding of whether or not such exposures actually had occurred.
208 I'm not saying there is, but we would
certainly be interested if there was a compelling
proposal that could answer that question. CHAIRMAN LASHOF: I think the issue of
that one, just to pursue it a little bit, came to the front, because, you know, frankly, not only your group, but other outside groups that previously reviewed it--the Science Board, the Lederberg Committee, et cetera, have said there wasn't any, and they were quite satisfied, and you would likely and logically put it aside and not fund any research.
Then this morning, we heard from the investigative arm, that one of the things they're looking at was all the reports on biological/chemical warfare. That suggests that at least in their mind it wasn't a closed issue yet, and so that raised the question.
Obviously I think I'm gathering from all of you, that if that investigative arm comes up with something that suggests that maybe the previous conclusion was premature, and they've got
209 some new data, that then you would pursue it.
But it's unlikely, that if they don't come
up with something that would suggest new data, you probably are not going to pursue it.
DR. GERRITY: I think that's an accurate
characterization. That investigative arm--I need
to be careful because I don't want to speak for DoD--but there job is to pursue not from a research, science based, but more from a detective base.
CHAIRMAN LASHOF: Yes. They're going to be detectives, and if they turn up something that needs to be researched, you're going to have to research it.
DR. GERRITY: Exactly.
CHAIRMAN LASHOF: I think that's fair enough.
DR. NISHIMI: If I recall correctly, though, Col. Koenigsberg's testimony made reference to the fact that researchers--not just the investigative team--were looking at the issue of the Nicholsons and mycoplasma. So could someone
210 tell me what's going on vis-a-vis that?
LT. COL. GACKSTETTER: Let me address that
because I think that's important. His particulate
concern is with mycoplasma, and what we've done is offered him the ability to submit in the BAA system, and I assume that he has done that. He as specifically given that opportunity, provided the information necessary to do that.
Dr. Gerrity, did you want to discuss the meeting that he had?
DR. GERRITY: Dr. Nicholson, you know, has put forward a certain hypothesis, and at one level you certainly don't casually ignore someone of that stature, as Dr. Nicholson is. So we certainly wanted to hear what Dr. Nicholson had to say, what preliminary work that he had done.
We invited him to come and present to Department of Defense, VA, HHS, et cetera, on his idea and on the preliminary work that he had done.
I would add that nothing that he'd
presented did we find compelling evidence to
suggest that there was a mycoplasma infection since
211 everybody was self-reporting to Dr. Nicholson's
study. However, a connection was made at this meeting, I think, you know, potentially one--I don't know what, at this time, fruit it will bear, but Dr. Nicholson was brought into contact with an epidemiologist at CDC who was looking at the Pennsylvania Air National Guard, and discussions ensued about the possibility of exchanging serum samples.
I don't know how much that has evolved. But here is an example where maybe something, relatively inexpensively, if you will, could have at least been looked at.
CHAIRMAN LASHOF: To follow up, do you know whether he has submitted to one of the 111 proposals you've gotten in, whether there is one from Nicholson for pursuing the mycoplasma?
LT. COL. GACKSTETTER: I have no idea. I assume that he has, but I have no idea.
CHAIRMAN LASHOF: Other questions by anyone?
If not, thank you very much, but I would
212 like to remind DoD, we do want the budget
information.
All right. Let me, before closing this
meeting, ask if there are any other questions,
comments, any members of the committee want to make. The thing that we had scheduled for later this afternoon was the implementation material which we were able to cover this morning when our public comment period was relatively short, and I think we've covered everything on implementation, that we needed to at that time. Unless anybody's had some further thoughts over lunch, or over the afternoon session.
If not, then let me just review with everybody the next meetings that we do have scheduled. At this point we do have a subcommittee on the epidemiology research issues, which we will go into even greater depth than we did on this point, and follow up on a number of the issues that we raised today.
That will be held November 7th and 8th in San Francisco. The next full committee meeting
213 will be in San Diego on December 4th and 5th. The
actual hotel sites and all those logistic
arrangements, frankly, are on hold, because we're not allowed to do it when we don't know whether the government will have a budget after November 15th, and until we get clearance that the government is going to be functioning and there's a budget, we can't lock everything in place.
So bear with us while Congress decides whether the government continues or not.
After that I think we've distributed a tentative list of meetings for the rest of the year to all committee members. I urge you to look that over, and put aside those dates, and we'll get back, and let staff know if you see any problems, although they've been arrived at from the material you submitted to staff.
With that, I thank you all for coming and ask staff if they have any further announcements they'd like to make? Cathy Woteki from OSTP, any final word?
If not, thanks again. See some of you in
214 November. Whoops.
MS. WOTEKI: Unfortunately, only I can
adjourn the meeting.
CHAIRMAN LASHOF: Oh, that's right. I
don't have the right to adjourn this meeting.
MS. WOTEKI: You are now adjourned.
[Whereupon, at 1:52 p.m., the meeting was adjourned.]