NOTE: Unedited

July 29-30, 1997

+ + +

Grand Ballroom
Buffalo Hilton Hotel
120 Church Street
Buffalo, NY 14202

Advisory Committee Members Present:

Agenda - Day One

Call to Order

Public Comment
CW3 John L. Bolton
Mr. & Mrs. William Bowman
Neal Cook
Robert J. Courson
James R. Little, Sr.
Andrew Place
Beverly Place
Robert H. Purple
Daniel M. Sibley
Daniel P. Sullivan
Richard Sullivan
Reverend Michael Tidd

Implementation: Waiver of informed consent for military exigencies
Ms. Mary K. Pendergast
Food and Drug Administration

U.N. inspections
The Honorable Charles Duelfer
Mr. Igor A. Mitrokhin
United Nations Special Commission on Iraq

Implementation: Medical Surveillance
Captain David Trump, USN
Department of Defense (Health Affairs)

Modeling and U.S. troop exposure for the Khamisiyah pit demolition
Dr. Bernard Rostker
Colonel Larry Cereghino, USA
Dr. Rick Babarsky, Department of Defense
Mr. Robert Walpole, Central Intelligence Agency


DR. JOYCE LASHOF: The Presidential Advisory
Committee on Gulf War Veteran's Illness. This meeting, this
morning is one of a series we've been holding since release of
our final report last January when the President extended the
work of the Commission to follow-up on possible further
exposures to chemical agents during the service in the gulf War
and also to further follow-up on the implementation of the
recommendations that were included in our final report that was
submitted to the President last January.
As usual, we begin our meetings with a period of
public comment of veterans who have asked to present before the
Committee. With that, I think we will begin the meeting.
Andrew Place is the first person.
May I remind you that you have five minutes to
present, a whole five minutes for questioning by members of the
Committee. We will unfortunately have to be fairly rigid about
the time because of the schedule of the meeting.
MR. PLACE: Okay. Good morning, ladies and
gentlemen. My name is Andrew Place. I'm a staff sergeant,
I served in Operation Desert Storm with one -- one
maintenance company from Rochester. While in Saudi, we were
stationed at an area called KKMC which is King Kaliem Military
City. It's up in the northern part of the country and prior to
traveling north, our unit spent a couple of weeks in an area
called Camp Jack just outside of Dhahran.
It was there we were exposed to a number of SCUD
attacks. I really don't remember how many. A couple of them
were fairly close to our camp. As a matter of fact, some of us
that were in the area brought some of the pieces back with us
which may have been a bad choice, you know, with hindsight.
But, I guess, it's just normal to take souvenirs from something
like that with something's that got that of an impact on your
life. There were some more SCUD attacks while KKMC. I don't
think that any of them were as close as what we went through at
Camp Jack.
You know, since I've been home, I've had numerous
problems with my health. My memory, which used to be pretty
good, is really now very poor. I got numbness in both eyes on
the outside part that actually that surfaced when I was in
country. That part on my legs where the numbness is, the hair
is falling off and I do get, that will get very sore, very
tired. It's always got a light numb tingling feeling in that
area. I've had trouble with my knees, my shoulders, both arms,
my back ever since I've been back.
I realize some of this may be attributed to age but I
can't see where everything has come on so fast in such a short
period of time. I've had problems with my stomach, headaches.
It just -- those are just things I have to put up with. With
the stomach problems, it's always like it's a unsettled thing.
I usually don't get nauseous. I don't throw up, but it's
always just that feeling.
Now, I -- I was 48 years old when I returned from
Saudi and I expected, you know, problems, you know, feeling
some aches and pains, you know, with getting a little bit
older. But like I said, it just seems to come on so fast, so
For a period of time here, I guess, my wife can
attest to it that for a year or so I was totally denying that
anything was wrong with me. It took her that long just to get
me to go into the VA to get the physical. But she's had a lot
of problems since I came back, too, and I don't know whether or
not there is a connection but the more and more I talk to
different people, more spouses are having problems than I
realized and that maybe some of the problems that my wife is
having are related.
I think my only hope is before too long something can
be done. I think, we've got a lot of young people being
affected and that's the part that bothers me the most. I don't
want to get to the thing, the stage where you see young people
that are having kids and they start having problems and it goes
on and on. I just hope they can get something done, some
medical studies done and a lot of these problems taken care of
because it's the young people in our country that's going to be
the future.
I've been out of work since last October. I'm going
to school now through the state trying to get rehabilitated so
I can get a job but I guess in retrospect, my problems are
quite a bit smaller than a lot of others. I know some people
can't work at all. They are having problems. I should still
be able to but I guess my main concern is just to get the
health that the medical treatment that so many of the people
DR. LASHOF: Are there questions, then?
MAJ KNOX: Have you been to the VA and placed on
the register?
MR. PLACE: I've been through the registry exam.
As far as any diagnosis, they think there might be a problem
with nerve conduction as far as the problem with my legs. I
really haven't received a whole lot as far as anything that's
substantially, you know, any name for anything. I have gone to
see a number of private doctors, too, which it's different
forms of arthritis, bursitis, but just, how everything is
coming on at once, I don't understand.
MAJ KNOX: Have you filed a VA claim?
MR. PLACE: Yes, I have but I just get the
periodic letter that says it's -- it's still there.
MAJ KNOX: But you are receiving treatment at the
MR. PLACE: Well, yes. I haven't -- I really
haven't been there in a while. I was getting some physical
therapy for a while but then the doctor cut that off. That was
helping but then the doctor cut that short, so.
MAJ KNOX: Why was that, do you know?
MR. PLACE: I really have no idea. He just set a
time limit on it.
MAJ CROSS: Mr. Place, just so that I get a sense,
how far do you have to travel to VA, if and when you do go?
MR. PLACE: The VA clinic is not far from where I
live. It's only about 15 minutes.
DR. LASHOF: Was the reason you lost your job
because of your health, that you've been depressed?
DR. LASHOF: Or were there other problems?
MR. PLACE: Well, see, I had, for my civilian job,
part of the requirement was that I belong to the National
Guard. Because I couldn't do the physical training and stuff
like that, I was released from the Guard and therefore I lost
my job as a civilian technician.
DR. LASHOF: Oh, I see. Okay.
MAJ KNOX: Do you have enough years that you are
able to maintain?
MR. PLACE: Yes, I am getting a disability pension
on the technician's side.
DR. LASHOF: Thank you very much, we appreciate
your coming.
MR. PLACE: Thank you.
DR. LASHOF: Mr. Daniel Sullivan.
MR. SULLIVAN: Good afternoon ladies and gentlemen of
the Advisory. I'm glad after all this time, after all these
years to finally be heard and have somebody listen to what's
been going on.
Prior to November of '91, when we were activated,
I've really never seen a doctor. I wasn't ill. I had no need
to -- never needed to see a physician. I didn't have one.
I put 15 years in at General Motors, now, I'm in and
out for the past 5-1/2 to 6 years with various illnesses. They
list them in there, in the booklet I've got but among the
symptoms is fatigue. I got the signs of problems with my skin.
I get headaches, muscle pain, neurological problems, big time
lapse in memory, sleep disturbances, and also diarrhea to where
it's gotten to be where right now I -- it's not like you take
Pepto Bismol and you're okay. You don't know from one time to
the next when you sit down whether you're going to go solid or
whether you're going to, you know, like turning on a faucet,
excuse me but that's the way it is.
I've signed for SSDI. I have an appointment next
week with a physician. If they're anything like any of the
insurance physicians that I've been dealing with, with work,
they don't know anything about the case. They don't know
anything about the Gulf War Syndrome. They look at you. They
see you. They have you walk back and forth inside of a 4x4
room, "Oh, you look fine to me."
But, I, you gave copies of Statement of Claims,
people who know me and love me and have known me before I went
in. I'm a totally different person from what I was when I went
in. I've been in and out of work for the past, well, 5-1/2 to
6 years. I finally went back out in October because I just
could not do it any more. I would go in for an hour. I would
leave and there's other people within our unit and other
information which you have, the Department of Defense has on
me, that I signed for the Incident Hot Lines and stuff, it's --
there are so many different things.
I have so many different unanswered questions, a lot
of unanswered questions. Also, there are so many programs open
to the Gulf War veterans but nobody knows where they are.
Right from Senator D'Amato's office all the way down. I've
called the Gulf War Hotline. They have told me all these
programs that are available. I called Human Health and
Services and got nothing.
That's for anybody who, you know, thinks any
different, I've had doctors -- doctors who no longer work for
the VA that related me to Persian Gulf Syndrome. They are no
longer working there, I'm not sure if my paperwork is still
with my files or not. But, as I said, my children are a
testimonial, my wife.
My wife works out. She does everything. I've got
neighbors cutting my lawn. I've got neighbors that plow my
driveway in the winter time. I can't, you know, even do the
housework. I get yelled at if I don't get all the vacuuming
done. But that's just -- you got good days and bad days and,
if you take advantage of a good day then you're going to have
three or four bad days after your good day and you go and spend
it as a normal human being.
Like I said, I've got Statements of Claims that are
available to the panel and they are all from people, my
children, my nephews, my nieces, my wife, co-workers,
supervisors going against company policy in order to write
anything, but if need be, they know that they've seen me over
the time I worked for the same supervisors before I left and
after I left and they see a 200 percent difference and they cry
out but they can't even help. I just hope somewhere along the
line that we will get help and that all of the propaganda
that's been put out that they help that we're receiving that
will end and they will actually come through with the programs
that are working because from what I heard, we have available,
I haven't seen any of it yet. All I'm doing is fighting
bureaucratic red tape. If anybody has any questions or
comments I --
DR. LASHOF: Are you being seen regularly at a VA
clinic now?
MR. SULLIVAN: I'm being seen regularly at a VA
clinic besides my own personal physician.
DR. LASHOF: And, are you receiving any medication
at all?
MR. SULLIVAN: I am receiving several CNS medications
which is for the central nervous system. All the pain-killers
and muscle relaxers that I've received in the past, I stopped
taking them because they were not doing any good. I figured,
you know, swallowing so many of these pills and sometimes you
double the dose and figure okay, well, if it's not working, but
then they still don't work.
I need a stomach, if not my health and my, you know,
I can't go anywhere any more. I mean, you sneeze or you cough
and you know, you feel like you should be wearing Depends, but
I don't think I've gotten to that point yet.
DR. LARSON: Mr. Sullivan, could you explain what
your role was in the Gulf War?
MR. SULLIVAN: My role, I was on a mobile maintenance
team that took us to several spots throughout Saudi Arabia.
Well, right out, I mean we were everywhere and anywhere. I
don't -- we never knew exactly where we were because we didn't
have any grid maps. We were just sent out, "Well, it's out
this way." And, so, we'd head out that way.
So, the vehicles that we worked on and there was
never any time on our travels that we ever saw any
decontamination points. So any vehicles that could have been
contaminated, we worked on those vehicles. We took care of
them. We were like the AAA. So, you know, whether that's
relevant or.
DR. LARSON: And, how long were you there?
DR. LARSON: How long were you in Gulf?
MR. SULLIVAN: I was there for seven months.
DR. LASHOF: Thank you very much, we appreciate
you're here.
MR. SULLIVAN: You're welcome.
DR. LASHOF: James Ray Little, Sr.
Mr. LITTLE: My name is SGT James Little, I served
with 134th in the Gulf. I got sent home early out of the Gulf
because I have a condition that was called psoriasis. While I
was over there, the psoriasis was got increasingly worse. I
was pretty nearly covered from head to toe with it. My health,
ever since I came back from the Gulf is just about
deteriorating all the way around and I have all different kinds
of skin rashes coming up.
Over there, I was senior recovery personnel. I was
one of the people who went out and pulled all the tanks back.
I pulled the enemy tanks back as well as the American tanks.
That was my job. I worked on the stuff. Anything that went
north, we had to fix it, get it ready to go.
As far as trying to remember stuff, there's a lot of
times you can't remember stuff. My civilian occupation is a
truck driver and I had to leave that last August. Since then,
I've not been employed. No one will hire me because I have a
back problem. The back problem, my personal family physician
said the only way that anything could be done, it might help
and it might not help is an operation. He said to go see a
I tried to get an appointment to see him. I don't
have the money for it. I don't have any kind of medical
insurance. I went to the VA. The VA just keeps giving me a
runaround. They tell me, well, you're going to see a
neurologist. We will make you an appointment. They have never
made me an appointment to see a neurologist.
Every time I go there, every other visit, I'm seeing
a different doctor. "Oh, that doctor retired, that doctor
left." No one can tell me where the doctor is and you can't
see the same doctor more than once. How can any doctors see
you once and tell you, "Okay, this is what is the matter."
As far as getting x-rays, my personal physician told
me, he says, "X-rays can tell you only so much. You need what
they call an MRI and all these other tests done." They are so
expensive, how can a person out of work for over a year afford
any of this kind of stuff.
It costs you $250 to see a neurologist. Just to go
in to see him for the first time. I can't afford it. I'm
about ready to lose my house. They want to take my home and
everything I own right now because it's been over a year since
I worked. And, it's all because I went to serve my country and
what's my country doing to me? That's all I got to say.
MAJ KNOX: So, did you have a back injury while
you were serving in the Gulf?
Mr. Little: I hurt my back over in the Persian
Gulf, yes. I hurt it twice.
MAJ KNOX: Were you treated for it while you were
in the Gulf?
MR. LITTLE: I was treated. They told me it was
just muscle strain.
MAJ KNOX: Do you have those records?
MR. LITTLE: I've got them at home.
MAJ KNOX: And, so, when you go to the VA are you
listed as non-service connected?
MR. LITTLE: No, they told me they related it all
the way back to 1973 when I was involved in an accident in
Germany, when I was in the regular Army.
MAJ KNOX: And, so, have you filed a claim or do
you receive any pension for that?
MR. LITTLE: I've filed a claim and when in '92
they gave me a 10 percent disability and said it was service
connected back to when I was in Germany. They don't want to
admit up to it's been since the Persian Gulf that I have had
this back problem.
MAJ KNOX: That you re-injured it?
MR. LITTLE: And, every time I go to see them, they
keep giving me antidepressants for a back problem. What are
antidepressants go to do to a back problem? How are they going
to straighten it out? My family physician says right now, I
probably have permanent nerve damage.
MAJ KNOX: And, you're going to the Rochester VA?
MR. LITTLE: I've been to the Rochester VA and I've
been to the Batavia (phonetic) VA. And every time the doctor
says, "Well, we'll schedule you for an appointment for a
neurologist." They never do. They never schedule the
appointments like they say they're going to.
I had a doctor at the Rochester VA tell me if I went
to see a psychiatrist, I would not have back problems no more.
He told me that and then he wrote up a different statement in
my records. I've got a copy of that.
MAJ KNOX: But, you've never had a CT or an MRI?
MR. LITTLE; I had an MRI done by family physician.
He pain for it. So, we could try and find out what's the
matter, so I could get back to work, so I would stop the
process going on and losing my home and my family.
MAJ KNOX: So, did he give you a diagnosis after
you had the MRI?
MR. LITTLE: Yes, he did. He said I have herniated
disks and they're pushing on the central nerve, right up and
down the spine, in the upper and lower back. The VA doctors
don't want to look at the upper back. They just saying it's in
the lower back.
DR. LASHOF: Thank you very much. Robert J.
MR. COURSON: Hi. My name is Robert Courson. I was
a 31-Kilo, that's a combat signalman. It was January, '91 and
I was on my way to Ft. Benning to deploy to DESERT
SHIELD/STORM. Most of us were single soldiers, not units.
While at Benning I got six air shots in the arm, one shot in
the behind and I was made to take a package of pills. There
were two 747s scheduled to pick us up from Benning. Twenty-six
hours from the time we took off from Ft. Benning we arrived in
Dhahran Air Field.
When both planes arrived, we were split up into two
groups. One group went to 101st Airborne and my group went to
7th Corps. I was a private E-2 at the time, no one ever told
me where I was going. I just followed orders and did what I
was told. Myself and four other guys went to link up with the
1st of the 17th Field Artillery.
Two days before the ground war started, they ordered
us to take Pyridostigmine Bromide pills. When I asked what
they were for, they told me it was to slow down our circulatory
system so we would have more time to react to chemical weapons.
So, I started taking them thinking they would help me stay
After we took our first pill, we developed stomach
cramps, blurred vision, watery eyes, diarrhea, headaches, chest
tightness, and some minor muscle twitching. We were pretty
sure it was the pills but we continued to take them as we were
made to.
A few days before the ground war started, our units
NBC alarms went off. We went to MOPP-4 and then we were given
an all clear. It was a false alarm. I asked my wire team if
this had ever happened before and they told me that before I
hooked up with them, they had several false alarms.
The day the ground war started, our unit was told to
go MOPP level 2 and stay that way until we were told otherwise.
We wound up fighting the entire war in the MOPP suit, never
leaving MOPP level 2 in the entire war. Along the way, we
encountered a herd of dead camels (there were no bullet holes
in them), oil fires, enemy artillery rounds, ammunition dumps,
and a lot of destroyed equipment.
I was comm, so, I heard cease fire come over the
radio. I heard my chief say we were two miles outside of
Baghdad. After the war, we moved back to Kobar Towers to wait
our turn to go back to the States. Because I was a private, I
was put on a few duties. I had to stand guard over a big hole
where they dumped cammo nets, poles, tents, plastic bags full
of MOPP suits, etc. When the hole was covered up, the detail
was over. I am unaware of most of the locations where I was
because I had never saw a map. I listened to my chief talk to
find out most of the locations where we were at.
In mid-April we finally came home to the States. I
moved my family to Ft. Sill where I was stationed after the war
until I would ETS, December, 1992. During the time at Ft.
Sill, I had several visits to the TMC for fevers, rashes, flu-like symptoms and diarrhea.
On my ETS physical, I complained of muscle and joint
pain and headaches. I was also put on a post paint detail
which consisted of grinding, sanding, and cleaning all post
vehicles to get them ready for DoD to paint them green again.
I was on that detail for about three months. There were three
shifts and we worked around the clock. The paint detail never
shut down until it was done. I made my E-4 the first 11 months
in service, so I'm certainly not a dead-beat.
It wasn't until January, '95, when I really started
going downhill and I could no longer ignore my symptoms. I was
in and out of VA and civilian hospitals for problem after
problem, test after test. Here is a list of my symptoms that
VA doctors said was all in my head: chronic diarrhea, blurred
vision, stomach cramps, food sensitivity, severe headaches,
muscle spasm, decrease in sexual drive, flu-like symptoms,
night sweats, muscle and joint pain, recurrent swollen lymph
glands, burning and numbness of legs, arms, hands, chest and
left side of my head, weight loss of over 20 pounds, loss of
appetite, severe chest pains, spontaneous pneumothorax (which
is a collapsed lung), watering of eyes in bright light,
frequent urination, lack of sleep, memory loss, sensitivity to
certain chemicals such as air fresheners, car exhaust, etc.,
mood swings, balance impairment, muscle weakness, lack of
concentration, chronic fatigue, and occasional blood in my
My wife has rashes and vaginal problems from my
semen. My family is sick because of my gear that I brought
home and a tapestry I bought in Saudi Arabia. The day that I
took the tapestry out of the bag, I hung it on my wall. We all
had no nose bleeds and sinus problems. I've also started
noticing some of the same symptoms that I have on my family. I
was told that the blood in the stool was caused by hemorrhoids
but what about my 8- and 12-year old kids.
I have not been able to work since April 24th, 1996,
when I finally collapsed on the floor at my job due to my legs
and lungs. Two months prior to this, my pulmonary specialist
told me to go on disability.
I used to run two miles in 13 minutes and 30 seconds.
I always scored better than a 260 on my PT test. Now, I can't
even run to you or provide for my family. You say our symptoms
are stress-related but I strongly disagree. We were taught in
the military to eat stress for breakfast. We thrive on it.
I will speak for all the vets in every war, the only
stress we get fighting a war is from our own government for
their screw-ups. They use stress to fall back on to keep
themselves out of trouble for as long as they can. I am
begging you, please do something about Gulf War Illness. We
need help.
DR. LASHOF: Thank you very much. Questions?
MAJ KNOX: The PB tablets, botulinum and also the
anthrax vaccines, did you take all of them?
MR. COURSON: The only thing I know about is the PB.
My shot records conveniently got lost and the two pills we took
in the little green packet, they were oval pills. They never
told us what they were for.
MAJ KNOX: You only took two of them?
MR. COURSON: Yes, there was two in a green packet
and they said, "Eat these," the day we got our shots.
MAJ KNOX: Did you have any symptoms on that
particular day?
MR. COURSON: No. As a matter of fact, after we
took the Pyridostigmine Bromide, it was probably about three
hours until we noticed. They told us that it would take -- we
would feel some slight side-effects from the medication.
MAJ KNOX: And, so, have you also been to the VA
here in Rochester?
MR. COURSON: Oh, yes. I've been to Buffalo VA,
Erie VA. I just got back from New Hampshire VA. There is hope
out there, there's a good pulmonary guy out there that knows
what's going on. They have taken nine tubes of blood from me.
I have had my entire body CT scanned, a colonoscopy, lower GI,
upper GI. I have had chest tube placement in my lungs. Three
inhalers, I have to take three medications to keep my food in
my system.
MAJ KNOX: And, so, have they given you any
official diagnosis?
MR. COURSON: Severe obstructive airways disease,
and now, they are thinking it is not asthma but what is the
other lung disease?
DR. LASHOF: Chronic obstructive pulmonary disease
MR. COURSON: Yes. No. It says they got severe
obstructive airways disease is what the VA said.
MAJ KNOX: And, so are you receiving any pension
for that?
MR. COURSON: Two and a half years ago, when my lung
collapsed, I quit ignoring this stuff and finally filed a
claim. I have been denied twice and it's still ongoing. I got
another letter saying that and this was 2-1/2 years ago. The
Social Security, the day I collapsed on the floor, I filled out
for that. I get the same denial and I still have seen no
monies from anybody.
DR. LASHOF: Did they give you any reason for the
MR. COURSON: In the beginning, it's because it was
all in our heads. We weren't contaminated or nothing. So,
when I got back from New Hampshire, my statement that the
doctor had written out fits nicely with these new laws so, I do
believe I'll be getting it, but when I don't know.
MAJ CROSS: You hit upon a key aspect of this VA
system. We hear this in every meeting we go to and it seems
like you hit the local VAs and I sense you got little or no
response, little or no interest in your case.
MAJ CROSS: You ended up in New Hampshire.
MAJ CROSS: You're somebody from New York and you
go to New Hampshire. You did mention that there's a good
pulmonary guy and I sense this is exactly what's happening
nationwide. Word gets out that there is a doctor at some VA
who kind of knows what's going on and takes an interest in you,
personally, and doesn't jump to the conclusion that it's in
your head --
MAJ CROSS: And, there is some physical ailment
and then it's up to you as a veteran to kind of spread the word
to fellow veterans --
MR. COURSON: Oh, I have been, trust me, I've been
on the front page of my local newspaper twice.
MAJ CROSS: Am I hitting on something that's --
MR. COURSON: Yes, and from there I'm going to Ohio,
where is it Cincinnati? I think it's Cincinnati because the
government gave them some money to study my semen, so they want
me out there. And, then from there, we're going to
Philadelphia at the VA because I guess there is a good
neurological doctor out there. So, I mean, it's finally but I
don't know if we'll ever get better. No one can give me an
honest answer because they've waited so long.
DR. LASHOF: Thank you very much.
MR. COURSON: Thank you.
DR. LASHOF: Richard Sullivan.
MR. SULLIVAN: My name is Richard Sullivan. I'm a
Vietnam veteran, air veteran and I served in the Reserves for
22 years. I'm giving testimony because I was the Persian Gulf
Outreach coordinator at the Buffalo VA Hospital and my
responsibilities were to go out into the community and contact
all the Reserve units in the area and to give them information
about the Outreach that the VA was doing at that time.
I visited most of the units and the number of the
people who probably saw me give brief presentations telling
them about the physicals we were doing and telling them about
the family support program. I went as far east as Rochester in
the maintenance company and down through Jamestown to the tank
company in Rochester and to the MP company and the Air Force
units up at Niagara Falls. My comments are generally that
there were a variety of symptoms reported.
I screened over probably close to 600 Persian Gulf
veterans when they came to the VA hospital. I would do a
social history and get them hooked up with the physician who
did the physical. We did a utilization review of the veterans
that came in and many of the comments that we found were
similar to the recent GAO study that recently came out
commenting about the information that they felt they were
receiving from the VA.
My big concern was that the continuity that VA
provided, after the Persian Gulf program was discontinued, left
a gap in which Persian Gulf coordinators could network and get
information out to Persian Gulf veterans. The network was
developed nationwide and we had monthly conference calls in
which we were updated through the VA network to get information
out, but then we were pulled back and the program was
discontinued. USHA became, within the VA at least, responsible
for providing good continuity to the Persian Gulf veterans.
We still continue to do the physicals at the VA but
the opportunity to network with the providers around the
country that were still seeing Persian gulf veterans and
getting information out wasn't there and those are my basic
comments. Thank you.
DR. LASHOF: Any questions?
MAJ KNOX: What would you recommend that the VA
do now?
MR. SULLIVAN: Well, I think that we need to continue
to do the physicals and try to provide -- the VA has continued
with the Persian Gulf review.
MAJ KNOX: Right.
MR. SULLIVAN: And, I understand that we are trying
to get that mailed out to every Persian Gulf veteran that
registered. I think we need to try to get the word out to get
as many Persian Gulf vets to come in and register because I
think you have a bigger number, you can do better research and
my main concern would be the networking and getting information
out as much education out to the veterans that were in the
Persian Gulf.
MAJ KNOX: The problem is if veterans have not
come forth and taken the physical at the VA, they're not really
listed on the registry.
MAJ KNOX: It's very difficult to identify those
500,000 or 700,000 people that were active duty during that
MR. SULLIVAN: Approximately, right now at the VA
we've done about -- between -- I think around 962 physicals or
at least registries. I would feel it's important for the VA to
continue to do some outreach in terms of getting the word out
to veterans to register.
DR. LASHOF: Thank you very much. Mr. Daniel
MR. SIBLEY: Good morning. Dear Committee Members.
During my service in the Persian Gulf, my unit and I
experienced many different signs of chemical and biological
weapons. On many occasions, chemical detectors were going off
and we were told that they were all false alarms. Also, on
several occasions, there were numerous dead animals littering
the desert.
My unit also had a pet dog that died shortly after
entering these areas and the dog died very abruptly and showed
no signs of being sick before we entered these areas.
Although, all these signs were present, we were still not
ordered to go into MOPP level 4. We stayed in MOPP level 2
throughout the war and a week or so after the war was over, we
were just told to send all our chemical suits in to supply.
After the war was over, my unit was assigned the task
of helping to destroy Iraqi weapon supplies. Although I never
did any of the demolitions operations, my unit and I were in
close proximity of all the areas targeted for demolition. Out
of all the demolition areas Kamissiyah was our biggest
demolitions operation. It was talked about throughout the many
units around us. I was told by members of my unit who were
part of the demolition operation that there were enough weapons
there to fill three football fields at least and to possibly
supply an army with a year's supply of ammunition.
My unit was less than 15 miles from the detonation
site and it is only logical that what goes up must come down.
Although we knew there were chemical and biological weapons in
the Iraqi arsenal, we were reassured from high command that
there was no danger of exposure.
Since my return from the Persian Gulf, I have had
many problems including headaches, fatigue, rash, memory
problems, tumors (I have had two tumors taken out of my neck),
gastrointestinal problems, joint pains, diarrhea, night sweats
and tremors, breathing problems and various other minor
problems. My son has also had problems that have been
undiagnosable since he was born. Since he was born, he was put
on the antibiotics for 18 months, the first 18 months of his
life he was on antibiotics. He stopped breathing shortly after
he was born. He was on a breath apnea monitor. Even today, he
continues to have problems, he under-sized, under-weight. He
has balding spots throughout his head. He gets the same rash
that leaves scars behind on his body and it's very unfair to
Until the government can come totally clean about
what exactly we were exposed over in the Persian Gulf our fight
will continue. We fought bravely and risked our lives for a
cause that we strongly believed in, freedom and liberty for
all. We hope our government doesn't forget this and resolves
this Gulf War Syndrome soon, so, families like mine have to
suffer no more. Thank you and God bless.
I also have a few questions of the committee that I'd
like to ask. What is the Department of Defense going to do
with the report from dependents of Gulf War veterans? The VA
did the exam on my son and they found his report to be his
illnesses were undiagnosable. The illnesses are present and we
still haven't heard anything from the government. I would like
to know what they're going to do about it. Are they going to
continue or are they going to increase funding? Give funding
for further tests or are they just going to deny like they've
denied everything else?
DR. LASHOF: Questions?
MR. TURNER: What unit were you in?
MR. SIBLEY: I was in Headquarters, 5th Engineers
Combat and we were attached to 24th Infantry Division, front
MR. TURNER: And during what period were you in the
Kamissiyah vicinity?
MR. SIBLEY: The exact date I really couldn't tell
MR. TURNER: Was that after the ground war had
MR. SIBLEY: It was right after the ground war
ended. Probably, roughly two weeks, three weeks.
MR. TURNER: Were you there during the demolition
operations? Did you see the explosions at Kamissiyah?
MR. SIBLEY: Yes, we did.
MR. TURNER: And, have you been contacted by the
Department of Defense?
MR. SIBLEY: Yes, I have. And that's another
question I wanted to ask.
MAJ CROSS: How were you notified? How were you
MR. SIBLEY: By letter, certified letter.
MAJ CROSS: Did it have a correct address on you?
MR. SIBLEY: Yes, it did and also, I received a
survey to fill out, a Kamissiyah survey and I still haven't
heard a response from that. I wrote down all the information
about it and I still have not received anything.
MAJ CROSS: When did you receive those materials,
MR. SIBLEY: Five months ago, six months ago.
MR. TURNER: You mentioned in your statement that
there were chemical weapons in some of these ammunition depots.
How did you know? Did you see any personally?
MR. SIBLEY: No, but we've had many accounts of
people in my unit said that the -- well, actually, yes, I did
encounter some. The containers we had to clear bunkers and
when we were going through the bunkers, there was containers
with skeleton crosses, yellow labels, red labels, and, you
know, universal code for biological and chemical weapons is
usually red labels, yellow labels, green labels, depending on
what kind of nerve agent or what type of agent it was.
MR. TURNER: You would clear these weapons out of
the bunkers and you would stockpile them somewhere else to be
blown up then?
MR. SIBLEY: No. The bunkers were cleared.
Normally, we were told that the arena that they did not have
any chemical weapons which figured otherwise but you're told by
your high command, you do what you're told or you get court
MR. TURNER: In your testimony, you mentioned
chemical detectors going off. Do you remember when that
MR. SIBLEY: Yes. Numerous times. My unit was
like I said on the front lines before the war started we were
15 miles from Iraq and near the KKMC and the dates as far as I
can reckon are very close to when Czechoslovakian units
detected the chemicals around the KKMC area. Then,
approximately a week or so after the war started, which the war
wasn't that far but we were around the Basrah area and it was
before we did the demolitions at Kamissiyah. We had numerous
chemical alarms going off.
DR. BROWN: Mr. Sibley, did you have any health
problems when you were in the Gulf? After you got back?
MR. SIBLEY: Actually, the headaches and the rash
started over there and the headaches started like everyone
else, we ordered to take the PB pill. that seemed to be the
start of the headaches and the fatigue and everything came
later. this has been a gradual process. I am totally
disabled, I'm 100 percent non-service connected. The
government's stated, "Yes, you're 100 percent disabled but not
by our fault." My headaches are debilitating. I was a welder,
a profession welder by trade. I was kicked out of my job
because of the headaches, the fatigue. I passed out and it's
against OSHA regulations to be on the medications that I was
on, so, therefore, I've lost work.
(Cont. from side A - therefore I have lost work.)
DR. BROWN: Have you had some kind of diagnoses or
- - -
MR. SIBLEY: They have given me approximately 12
diagnoses, all the way from stress related to cluster
headaches, migraine. The first thing they told me was like
they told everybody else, "It's all in your head. There is
nothing wrong with you." They sent me to see a shrink.
MAJ KNOX: Just in response to your first
question about DoD, I don't know the answer to that, but we do
have representatives here that are from DoD and you might ask
DR. LASHOF: Did they give you a reason for why
they felt it was not service connected with diagnoses they gave
you that claimed that it wasn't service connected?
MR. SIBLEY: They said that I've been denied twice
for service connection for Persian Gulf related illnesses.
Both times I was denied, it was stated in there that I didn't
put my claim in. They had a time limit set on it. You had to
have reported these symptoms within two years of service in the
Gulf. I never really reported my symptoms because like
everyone else, I was a young stud back then. I was an athlete.
I ran 10 miles a day. I used to be in to weight-lifting, body
building. I can't do any of that anymore.
DR. LASHOF: You know that Congress has extended
that and there's no longer a two-year --
DR. LASHOF: So, you can reapply then.
MR. SIBLEY: I'm aware of that. Yes, actually, I
didn't have to reapply. I received a letter from Department of
Defense and Department of Veteran's Affairs stating that they
were reopening my claim because of the Kamissiyah incident.
DR. LASHOF: Okay. Good. Thank you very much.
MR. SIBLEY: Thank you.
DR. LASHOF: I hope that gets straightened out.
Robert Purple.
MR. PURPLE: Ladies and gentlemen, I'm here today
for two reasons. First, my daughter went through school and
was good friends with a lovely girl who was hearing impaired,
the oldest child in her family. By using a combination of lip
reading and hearing aids, she graduated from high school and
college and now works with the hearing impaired.
The next child in the family, a daughter, had no
hearing and had to attend the residential New York State School
for the Deaf where she performed brilliantly as a student and
athlete and learned signing and lip reading. She obtained a
college degree and is now working with the deaf in business.
The third daughter had a little hearing and using
hearing aids, lip reading and signing, could survive in society
but had many problems in school. Their father had many
physical problems culminating in a kidney transplant when he
was near death. The family was financially against the wall
for years and forced to struggle repeatedly to keep the home
Now, I talk about this family, here. Simple. He was
a Vietnam vet who had been heavily involved with Agent Orange
in-country. For years, we knew his Vietnam service was the
cause of his problems, but our government refused to
acknowledge anything that would possibly put the blame there.
You know the history. Finally, years too late for the children
or his health, oh, yes, we will have to care for the Dioxin
Agent Orange sufferers.
The second reason is that Syracuse, New York, had a
Marine Reserve tank battalion called up for Gulf service.
Almost half of them are sick, now. Marines are not the
malingering type. They were in the front lines and served
valiantly, now they're sick.
I know them and I cannot stand by and see the Agent
Orange or nuclear radiation exposure or several many other
blots on the U.S. escutcheon repeated again. How can anyone
seriously wonder why I'm cynical and angry and concerned enough
to drive over four hours to testify?
Included in the testimony I faxed to the Committee,
is a letter to the Syracuse Herald Journal that says the Gulf
War Illness is not a mystery. The syndrome is known and
treated in the United States, written by a doctor of rehab
services, it strikes right home. I want to explain how my
testimony connects to it.
I served from mid-December, 1990 through July, 1991,
at al Karj Air Base, Saudi Arabia, first as Deputy Base
Commander and then Base Commander. It was the largest U.S.
airbase in the AOR and the last developed 60 miles southeast of
Riyadh. At peak strength, we had one Saudi liaison officer,
one U.S. Army ground liaison officer, and 5,000 U.S. Air Force
troops that included called up Air Force Reserve and National
Guard Forces, of which I was one.
We flew 24 F15C interceptors, 48 F15E fighter
bombers, 24 16As, and 18 FA16s used as basically ground
interdiction bombers. Three squadrons of C130 transports, and
had a huge strategic ramp for C5s and C141s.
The only things there when we got there in early
December were a huge Saudi built ramp, taxi way, and runway.
It was going to become the main Saudi Air Force base sometime
in the future "in Challah" and that's Saudi for "God willing".
There is a lot of "in Challah" connected with the Gulf War.
We had to truck or fly in or make there, everything
we used, wore, ate, drank, fixed, or delivered. Our ammo
storage was on one side of the runway and we also had charge of
the ammo depot, the largest in Saudi Arabia, on the other side
of the runway.
From early December to 17 January, everything was
done for war prep, brought in, assembled, put up, etc. Every
one was housed under canvas tents and it was pretty dreary. I
used to tell newcomers that it wasn't the end of the world, but
if you looked south, you could see it from there. We were
located on the north rim of the Rhuba Kali (phonetic) the empty
quarter which is very appropriately named. The initial
surroundings, so what was in this environment of Saudi that
could be harmful?
To begin with it was constant dust, dust everywhere.
It had wind blowing that dust constantly. Every day it went by
the compass, so what blew out of town in the morning came back
in the afternoon. The native streams, admittedly few, very
few, had the leishmaniasis vector which our medical people
thought prior to arrival would be the horrible medical problem.
It wasn't. There was malaria along the coast, the desert was
trash heap created by the Saudis who would simply throw or
leave out anything that broke or didn't work, tires, cars,
appliances, you name it.
There were five varieties of snakes, two kinds of
scorpions, all poisonous. There were flies and other insects
all aggressive and going for any water on the body, that is,
eyes, mouth, and so on. You could get comfortable there but
you could never stay comfortable long.
December and January saw night frosts and then
daytime in the 80s. When the summer came, it got hotter and
hotter, 130o-140o daily and 100o at night. Ever hear of a
thermal lull in weather? I never did until I got there.
Friendly fire.
So what did we Americans add to this environment?
How about burning all our garbage outside the base, paper,
plastic, wood, food waste, too tough to haul out. We had to
haul everything in, we didn't want to haul garbage out. So,
burn it in the pit, a big pit. But remember the wind, our
fumes would get us daily no matter where we put the pit.
We got all our food, bottled drinking water and milk
from the Saudis. Milk was irradiated, of course, and came from
the world's largest dairy farm on the desert some 20 miles from
All the food and water was tested constantly by our
bio environmental folks. The tank water was always put through
ROPUs (phonetic) and chlorinated before septic showers are
washing use.
We had insecticides for our clothing and tentages to
keep pests away. We had all taken huge immunoglobulin shots to
enter DAR. We indulged in an Air Force constant to keep the
flies down, insecticide in a diesel fog spray at least twice a
week throughout the camp.
We had constant fumes from the JP-8 from all the
aircraft, MOGAS and diesel fumes from the 100s of vehicles and
we used JP8 electrical generators to produce all our
electricity, later replaced by diesel generators. The noise
and the fumes were something, in camp from the generators, or
on the flight line from the aircraft.
The command post on the flight line was basically a
cardboard expandable building. It did not attenuate the noise,
believe me. Some American forces were told to take a course in
the P-tabs, just mentioned, before the fighting started, a
somewhat iffy experimental aid to doctoring for nerve gas,
organophosphates the same as insecticides, and we all carried
self-injectors of 2PAM chloride and atropine for use if nerve
gassed. These do nothing if the gases are mustard types or
blood agents, of course.
The carbon in our chemical biological mask filters
had to be disposed as hazardous material when time-dated as did
the carbon in our chemical warfare garments we wore during the
alarms. Besides that, we armed our aircraft with armor
piercing bullets. The depleted uranium was the ingredient that
helped the bullet pierce the armor and was also listed as
hazardous material. Then, the storms of war.
Now we come to the war itself and what it injected
into the environment. Apparently, the Pentagon is now
admitting that nerve and mustard gases were present. Just last
week, the story of 99,000 or so, getting it.
Before the war, medics were deeply concerned about
the bio-hazard anthrax. But apparently, this was like the
leishmaniasis bugaboo, it didn't materialize but the oil well
fires did and even 300 miles away, when the wind blew strongly,
as it did daily, the sky would go dark and your uniform would
feel greasy and you would smell the burning oil.
I'll return to the doctor's letter I mentioned
earlier. It's called multiple chemical sensitivity syndrome
which stress aggravates. And, look at the stresses, war,
fatigue, separation, strange dangerous environment, thermal
stress, but it's not post-traumatic stress disorder. The early
catch all our government put forth was the post traumatic song,
it is MCSS, that's what.
I detailed environmental whys. Let's stop the
arguing now and help. First, if possible, with these sick
people, detox them. If it's too late, that the damage is
already done, then relieve, support, comfort them, treat their
symptoms and if we can't cure them, pay for readjustments and
disabilities, make them whole in the eyes of all again.
They are not stressed out. They are not malingerers.
They are not simple mental and PTSD cases. They are war
veterans who have served honorably and have earned, deserve and
need our help, not our red tape strictures, our damning faint
praise and patriotic smoke, and our totally odious governmental
delay. Let's get to it. Thank you.
DR. LASHOF: Thank you, very much. Questions?
MAJ KNOX: If you ruled the DoD and the VA, what
would you do now, at this point?
MR. PURPLE: Now, it's time to get, well the
service expression, I won't use it, but we have to get
everything into one bag. We've got too many layered
bureaucracies that have information over here, information over
here, medical treatment over here, medical treatment here.
It's strange but when a chemical blows up in Texas or Arkansas,
OSHA rushes in and takes action that detoxes the people, puts
them on nutritional diets, chelation effects, different things
have medicine for it. I don't know if this has ever been
attempted with this because it's something, that's over there.
That's not over here, but I got this, the CIA doesn't tell the
Army whose blowing up the bunkers there's gas in it. It's
multi-layer bureaucracy. And, it's the problem that we all
face. One service doesn't talk to other. In the Army and the
Air Force, we use a different tech orders and everything for
chemical warfare defense. Use different things but what
remains are these sick people. That's what concerns me.
MAJ KNOX: Well, it's one thing to diagnose.
MAJ KNOX: And we recognize the problems. It's
another thing to give some specific recommendations at this
point about what needs to be done.
MR PURPLE: A program started several years ago
that was canceled on the dietary antichelation treatment for
like heavy metal contamination and things like that and it
stopped because there were no nerve gases or no need to do
that. But, what makes one person sensitive to a chemical, I
might be sensitive to oil well smells. Someone else maybe got
a little bit of the gas. For someone else it may be dust.
But, all these things. Let's try to use the many modes of
treatment and do something instead of saying, "Well, gosh, it's
unknown. Golly, you got to suffer." Admit that with the sick
ones it did come from Gulf instead of them having to prove it
came from the Gulf. I think with so many people, we've come to
the point that, yes, it did. Because I went through this Agent
Orange stuff and never again. This was criminal.
MAJ KNOX: I would just say to that, I would
think that DoD would say that, yes, they are admitting that
people were exposed and that they are providing --
MR. PURPLE: This is 1997 and they were exposed in
1991. Yes, they're admitting it now.
MAJ KNOX: And they didn't admit it until May of
1996, and that's been part of the problem because none of the
research has been done.
MR. PURPLE: Right.
MAJ KNOX: It's still --
MR. PURPLE: Our own government, our own people
shot themselves in the foot and these sick people, the people
who have been wounded still have looking for this aid and help
and I think, let's stop trying to say who shot John?
MAJ KNOX: Right.
MR. PURPLE: Let's not say CIA who didn't tell
somebody, this didn't happen here. Let's stop that. Let's go
for fixing the people. It's time we did that. Past time.
DR. LASHOF: Thank you very much.
MR. PURPLE: Thank you.
DR. LASHOF: Beverly Place.
MS. PLACE: Good morning. My name is Beverly
Place and I'm the president of the Persian Gulf Veterans Inc.
in Rochester, New York. I started the group when I saw my
husband having problems with his tiredness. He was a man who
used to be very energetic. As a matter of fact, we used to
follow a 50s band every weekend with our daughters and we no
longer do that. We haven't done it since the day he came home,
was the last time we saw that band.
I am going to speak on behalf of the spouses that are
having problems. I myself had the burning semen problem.
There is a quite a few in my husband's unit that the wives
have, you know, spoken to me about that. The stress of it all
is very hard to deal with. I think that there should be some
kind of programs for the spouses and the children. Their
tempers are varied. Their mood swings are varied, you know,
they're not the same.
I found with my husband that he didn't want to be in
the same room with the kids or if there was more than five
people sitting outside, he would go in the house and be with
himself. And, then, he would be very jumpy at the kids for
hardly no reason at all and then we would find ourselves in
arguments over it because I would stick for the children.
I think as far as VA in Rochester, we've had a very
good rapport with the physicians there. I think, they're
working with our veterans in Rochester. The thing is, we don't
have that many going there. There is only like 200 out of
maybe 2,000 of the veterans that left to go to Saudi and I
think the reason is that most of these people are federal
technicians and they are afraid of losing their jobs, just as
my husband did.
So, I wasn't prepared to talk. Like I said, there is
a lot of stress and I've been married to my husband 31 years
and I know it's not in his head. The man does not feel good.
He can't do anything around the house. We had to have our
older son move back in with us to do things around the house,
in the yard and stuff, because he can no longer do it. He's
not working. He's going to school but his memory loss is a big
problem and I don't really foresee, I hope he can stick a job
out because financially we need him to work.
I don't work because of my medical problems. I have
been diagnosed with fibromyalgia. I have the achy joints. I
have diabetes that I was on a borderline before he came home
and then when he got back, my diabetes is just all out of whack
and they can't control it. I've lost 100 pounds and being
losing 100 pounds, my diabetes specialist said that my sugar
should have come way back and it's no longer coming done.
I went through a bone marrow test because they just
don't know what's wrong with me. I just haven't felt good and
there are other spouses out there and I was glad to hear that
there is another spouse having the same problem that I am
that's here today, so I can talk to her and find out where he's
getting his semen checked and perhaps my husband can also find
out what's going on because that alone with a lot of the wives
that are having problems that, you know, they're not having sex
and it's creating problems. With the young ones, they don't
know how to deal with it.
I, myself, know my husband wasn't like that before he
left and I look at it as our government screwed up my husband
and it's screwing up our whole family life. That's all I have.
DR. LASHOF: Is he receiving disability now?
MS. PLACE: The only disability he is receiving is
he's receiving his disability retirement that we had to get our
Congresswoman to fight for because he got thrown out of the
Guards. And, that's not going to do us much good because, you
only get 60% of that and then in October it goes down to 40%
and I can't see how we're going to manage without maybe going
on welfare which I know won't do because he's that type of
MAJ KNOX: Talk to us a little bit about why you
think that others have not come forward who are federal
MS. PLACE: Because they'll lose their jobs, just
like he did. I mean, he could do -- he was well enough to go
over and fight for his country and I was behind him 100%. But
when he came back and he couldn't do that PT anymore because he
had to have surgery on his knees twice. His shoulders are bad
that he can't lift his arms and so, if you can't do your PT,
well, out you go. But the ones that didn't go are still
holding their jobs. Why? Is my question, why?
MAJ KNOX: So, these are federal technicians that
are still active Guard or Reserves?
MS. PLACE: Right. But they weren't able to go
over there but they're still hold their jobs. I have nothing
against these people because if they couldn't go, that was
fine. My husband was well enough to go. Now, he no longer can
do any of that stuff.
DR. LASHOF: You're saying he lost the job because
he couldn't do the PT? Could he do the job itself?
MS. PLACE: Yes, he could.
DR. LASHOF: He could do the job but it's the other
activities he couldn't do.
MS. PLACE: Yes, right.
DR. LASHOF: Thank you very much. Rev. Michael
REV. TIDD: Good morning. Thank you for allowing
me to testify even though I'm not on your schedule. I come to
you this morning as a DESERT STORM veteran, also as a student
chaplain at the Dayton VA Medical Center for a year and the
father of a child with birth defects, I believe, caused by my
involvement in DESERT STORM.
When I joined the Reserves in 1988, I came to a
recruiter and said, I want to come into the Army Reserve as a
minister of sorts. Tell me how I can do that. Little did I
know that I would serve my God and my country while fighting
for my daughter's life.
What has happened in my case is that I was called out
of my senior year of college to go to DESERT SHIELD. In the
process of that, live through Camp Jack as someone else has
mentioned. I served at that point as a chaplain assistant and
the chaplain and I, LTC Barry Walker (phonetic), traveled
extensively all over the theater of operations. I say that
because we went to southern Iraq. We were in Kuwait. The only
place we really didn't go because many of combat troops weren't
there was Riyadh. Other than that, if there were troops there,
we were there. I say that to because I don't dates of where we
I don't know specific situations, but I give you my
experience to tell you that I don't know because there were so
many alarms, what were true and what were false. I don't know
because we lived at MOPP level 3 for nearly the eight months
that I was there. One of the questions that I have and you may
or may not be able to answer this is, how long is a MOPP suit
good for? We were told 12 hours. We wore them 24 hours a day
for about six months. So, even if a chemical or a biological
attack were to happen, it would have been of no use anyway.
I was given this report this morning. This is your
report that you have brought up. Before coming today, I had
already read it and I tell you that I don't think we've gone
far enough. I think what we're saying in this report and I'm
not degrading your efforts in any means, but I personally
believe it's blowing smoke. I don't think, we've nearly gone
far enough.
I have done a little bit of research and I know that
my phone is being tapped because I'm asking people and
questions, things that should not be asked or definitely
answered. I'm trying to find out the truth and I know the
truth will set us free but is it the cost of our veterans and
our families of those who have to pay for that truth. I don't
believe so. I know that service organizations are set up to
support those troops who go and serve our country in other
areas of the world. I also know that our government has
historically set aside soldiers to test drugs on. One of the
questions that is in this book that we will address later this
morning, I've seen on the agenda, is why weren't we at least
told about the drugs that we were given, either that they were
unapproved or so we would have some idea maybe of what some of
the side-effects were.
One of the other veterans testified that he was told
to take them. Another one said that he was told to take them
and may have been given some idea of what the symptoms were. I
was told to take them and had no idea what they were. I
stopped taking them on my own behalf and I told the chaplain,
my colonel, I said, "If I'm going to die, I'm going to die on
own behalf because I served in a war, not because of drugs that
my government gave me."
We are called to accountability in the military, as
you know, we report to our section sergeants, our commanders,
whoever is above us. It's time that our government do the same
thing. The people who are above us are the people of the
United States of America. I call you attention to go to do
more than this reports says because as I said before, I don't
think it nearly goes far enough. I just moved to this area of
the country. I moved here from attending school in Dayton,
Ohio, and as I said, my experience has been that I was a
student chaplain at the VA. I had just started there about a
I went through the registry because I wasn't even, I
didn't even know about the registry, went there and was asked
four questions. No exam was given. No blood work was taken.
No x-rays were done. Nothing was done but four questions were
asked. That was my experience of what the registry was like.
I moved back here to Sugar Grove where I pastor two churches
and just within the last two weeks, I've been added to the
registry. I will get a physical in two weeks.
I have been talking with different DESERT STORM
coordinators and different VAs around the country and two
things they are saying. One, that when they call the
headquarters in Washington, D.C., they're not given the
information. They don't know how to really treat veterans and
their families.
The second thing is look at the turnover of DESERT
STORM coordinators in VAs. Why is it so high? Don't they know
how to treat? How are they functioning with veterans and their
families and what information are they being given? You know,
is it because that not enough veterans are coming out to
I can tell you why veterans aren't coming out to go
to these things, because they're scared to death, number 1 of
the VA because of the past negative views of what happens and
2, they look at it as bureaucratic policies that aren't going
to happen and aren't going to do anything for them anyway. I
can tell you that from the different veterans I've talked to.
So, I implore you and I beg you on behalf of God and
our country to do more than what you're doing. What you're
doing is great but please take the next step. Help us treat
our veterans not only those who signed the line voluntarily but
our families.
I deal on a daily basis with a two-year old who has
to take breathing treatments and drugs. We attend therapy with
her twice a week. We go to Pittsburgh Children's Hospital in
Pittsburgh which is a four-hour drive from where I live every
two weeks. It's not fair. I know life isn't fair but we must
continue to seek the treatment and the help that we as veterans
deserve and need only because it's been caused by our
government. Thank you.
DR. LASHOF: You said that you're asking questions
that haven't been asked and that for that reason you believe
you phone is tapped. Can you tell me what questions you feel
have not been asked?
REV. TIDD: One of the reasons is, I'm not on
line. I don't have a computer, so I don't know. I know
there's there Gulf link which had been started a few years ago.
One of the things I think veterans and myself included is that
we're not in the link. We're not part of that network. I was
asked a question this morning when I filled out the little
green piece of paper about tell us what information you want?
I don't know what's out there. How do I know what to ask, what
I want if I don't even know what's out there. So, I'm asking
these questions. Maybe other people have asked them. But I'm
asking them for myself because I don't what the answers are.
I'm trying to find out, you know, we've talked about the
different symptoms of what that is and how people are being
treated. I'm just trying to find out what some of the answers
are in my trying to find out what the answers are and what the
truth is, my phone has been tapped.
MAJ KNOX: Could you tell us a little bit more
about, I mean, those sound like pretty benign questions that
any vet would ask. Who do you think is tapping your phone and
why would they do that?
REV. TIDD: I don't know and I don't know who.
MAJ KNOX: I mean, what evidence do you have that
your phone is tapped. This is something we've not heard
REV. TIDD: I've heard it before of people who
have been asking questions similar to what I've been asking. I
don't know who. I know it's been started. It's usually from
when I call an individual or an organization to ask them
questions and the phone clicks on and then it clicks off during
that conversation.
Yes, I live in a rural area but I don't think the
phone lines are that rural that someone couldn't do that and
with our technological abilities I think we do that, you know,
I think people do that without others knowing.
MAJ KNOX: And who do you think is tapping your phone?
REV. TIDD: I don't know but I know someone who is
interested in knowing what questions I'm asking.
MAJ KNOX: And, who is that?
REV. TIDD: I don't know. I really don't know.
MAJ KNOX: Okay, your daughter was premature?
REV. TIDD: About three months.
MAJ KNOX: Right. That's tough. I work in a
hospital and I see a lot of premature babies. What makes you
feel that that was linked to the Gulf exposure, the premature
REV. TIDD: One of the symptoms that I have and
I've heard it termed as hot sperm, my wife has multiple
problems because of that. Our doctor, our OB-GYN doesn't know
and he is claiming that Hannah, my daughter's birth is due to
severe preeclampsia or toxemia but with the problems that she
still has almost two years later, he doesn't know if that's
been what the diagnosis was for her or if there are other
problems involved. She was born with a class I bleed on her
brain which means there is partial brain damage. She has
developmental delay. The whole left side of her body. She is
almost two years old and she's just beginning to walk. She
can't swallow right. She's not forming language skills right.
You know, these are things that my wife and I and my deal with
on a daily basis, it's not just something, you know, we do
every once in a while. This is what we live with.
MAJ KNOX: So, the prematurity was due to the
REV. TIDD: So the OB-GYN says, yes.
MAJ KNOX: Oh, you don't, you have a question about
REV. TIDD: I think that it could be because
that's the information he has. One of the problems is we've
talked about so many different things as symptoms, we don't
know what the real causes are and we don't know how to treat
them. I mean, we're saying that in my daughter's case, yes,
that's the diagnosis of why she was born three months early,
but we don't know that as a fact.
DR. LASHOF: Thank you very much.
REV. TIDD: Thank you.
DR. LASHOF: Mr. William Bowman has also requested
to talk, I understand.
MR. BOWMAN: I'm glad to be able to see you, again.
What I wanted to do, and out of no disrespect, but I do want to
dispute LTC Nalls' statements that were made last month in
Memphis. I've got basically two pages that covers my
background and experience as to why I can.
First, off, from firsthand U.S. Navy experience and
information given on the Marine breach and update as given on
24 June '97, about the al-Jaer bilocation incident between 1:30
and 3:30 a.m. on 19 January 1991.
My first hitch in the U.S. Navy was on the USS
Protector, AGR-11, radar picket ship, a converted Liberty. My
period of time was 1957 through 1963, I was on active aboard
ship '59-'61. This picket ship was a part of NORAD and
Strategic Air Command. Our command was Red Run II, Davisville
(phonetic), Rhode Island. Our primary objective was to
maintain a sea-going stationary line of defense.
I was also at Bay of Pigs, as it took us nine days
from station 12-Alpha in the North Atlantic to get there. With
experience in two years I became very well knowledged in the
use of 3" 50 manual gun mount. I do know something about
siting the aircraft on radar and by eyesight, all 360o, also
the elevation clock by direction from port to starboard, bow to
aft, all ways while standing watch.
I know that sonic boom does not leave a following
liquefied cloud of residue from fire flash under 1500 feet.
With that fire flash, at a range of two miles from northwest of
our base location as I was coming out of the Port of John that
night. I had to add back there the way I did that with that
fire flash being close to ten times that of an antiaircraft
shell from a 3" 50 at night.
With all that went on the night of 19 January '91,
I'm thankful to be here. As I continue, I suggest that there
be an effort to locate most of the people that have long-term
or prior military experience. Some of these people are now
retired or discharged out of the military. Some are even
retired from their jobs. Please present these questions for
their input which were -- the questions were directed from the
Rosker (phonetic) and Nalls Group.
I have continued to deteriorate, myself, with
increased medical dosages. I still have a remnant of rash
which I have now which I acquired since I saw you all last. I
am firm believer that our battalion was recalled for our
combined field of battle experience and education with
expertise. Over 8 percent of our people have a technical
background primarily in the east Tennessee/Alabama region.
Over 50% are previous vets going back to early Vietnam, early
Bay of Pigs, also possibly a few that were in Korea.
That's basically what I've got to state.
DR. LASHOF: Thank you very much.
MR. BOWMAN: By the way I got one thing to add. I
have some CT scans, like three sheets on myself which was just
done a couple of weeks ago and the doctor asked me when he saw
a single x-ray, "But what is it?", that I got from my family
doctor and when I go back I'll probably be looking forward to
surgery, so I don't know if I'll be back to see you all again.
DR. LASHOF: What did they find on the x-ray?
MR. BOWMAN: I don't know, it's just a bunch of
black spots in there that wasn't there before. I've got the x-rays if you'd like to look at them.
MR. TURNER: Has the Department of Defense
interviewed you? Have they come and talked to you about what
you saw at al-Jaber?
MR. BOWMAN: No, that was -- I had a couple of
people that were supposedly interviewing me but not from the
DoD, although that was representative I think that LTC Nalls
and Rosker may be contacted and he called me and I sent him a
copy of what I think were doctored logs. I have and I don't
know where they are at but I have the original logs where they
have been blacked out and declassified, primarily where the
individual names reported so and so. And, they do not
correlate with what logs they have background on. And, they
were talking about various different kind of logs. Well, the
logs I have cover all the units in theater. And, they came
right out of the Marine Barracks up there in Philadelphia.
MR. TURNER: Did you make those available to the
people that came and interviewed you? Those logs that you
MR. BOWMAN: I'm in the process of getting a
complete set from Victor Silvester down in Odessa, Texas. He
is supposed to get it from Spagnoli, I think, where he's got
them locked up.
MR. TURNER: Thank you.
DR. LASHOF: Thank you very much. We have a little
time. Is there anyone else in the audience who wishes to make
public comment at this time? Okay.
MS. BOWMAN: My husband and I traveled here from
east Tennessee and we saw you all in Memphis. And, I really
appreciate your -- all of the work you've done and I think
you've done an excellent job.
DR. LASHOF: Could you go over to the mike?
MS. BOWMAN: Yes, I'm sorry. We're from the east
Tennessee area, okay. My husband is with the CB Battalion.
DR. LASHOF: It won't stay down, oh, well.
MS. BOWMAN: Okay. All right. I was contacted by
several of the men who served with my husband and asked to
speak to you all if I could and I'm sorry I wasn't here early
enough to get my name on list. I will be short.
I don't care. They don't care what it was. If it
was an insect. If it was gas. If it was pills. If it was the
air. If was a plague. If it's their imagination. They need
to be treated. Our nation was built on a voluntary Army. We
are great because we have volunteer Army. Our people
volunteer to serve, to give up their lives, even their illness,
in agreement, the nation is supposed to take care of them.
I don't care what your findings are, they need to be
treated and not just treated in the letter of the law.
Congress passed a law saying if was undiagnosed illness, then,
they should receive 100 percent compensation for three years.
The VA took care of that very directly. It don't matter what
you got, you're going to be diagnosed and quickly. If nothing
else, you're going to gastroenteritis diagnosed, so, therefore,
you are now diagnosed and you're not eligible for a pension.
Do you understand what I'm saying?
DR. LASHOF: I understand what you're saying.
MS. BOWEN: Also, when the veterans go and these
are people who have served our country, one man, a Mr. Ed
Dickson had surgery, brain tumor. Several of our veterans are
having brain tumors. One has died with brain tumors. He went
to get on the register. He had been treated as a private with
a private physician. He only went to get on the register and
let them know that he was there. He just wanted to be a part
of it. When he went to be examined, he was examined by a nurse
practitioner at the VA Center at Johnson City, the James
Quillen Center. I don't have anything wrong with a nurse
practitioner, most of the time they take a better history than
a doctor because they've got more time. But this one happened
to say to him and I'm paraphrasing, "So, you're here to get you
a pension, huh? What's wrong with you guys? Do you all think
you got something in the Gulf? Don't you know, there's nothing
there?" These people shouldn't be treating our veterans and if
you don't do anything else could you at least make a
recommendation that a private person that doesn't have
affiliation with anybody review these VA. You know, they
should go in. They should be spot checked.
Also, one more thing. We have a saying in east
Tennessee, I don't know whether you all have it up here or not,
but if you do something wrong and then you have to go back and
redo, we call it licking your calf over. Well, the DoD has
licked their calf over. They've decided that there was some
exposure to a nerve agent. Well, let's let them lick that calf
again and again until they get it right.
Now, I want to also point out that all the people
that I have seen that testified, that have been investigating
for you, usually work for a bureaucracy that's position is that
there is nothing wrong. I don't have any wrong with those
investigators, but if I worked in my livelihood and my
advancement depended on that bureaucracy, I would certainly
find that there is nothing there. And, I want to thank you all
for all your hard work.
DR. LASHOF: Thank you.
MAJ KNOX: I just have a quick question about the MP
at the VA. Was that person reported or did you make a written
testimony of that to --
MS. BOWMAN: We were told to ask for a report from
him. When I talked to a lawyer to report this --
MAJ KNOX: Right.
MS. BOWMAN: The VA Medical Center in Johnson City
doesn't know that that form exists. They have no copies of
that form. It is impossible to get it.
MAJ KNOX: Did you write a letter to the director of
that VA?
MS. BOWMAN: Yes, they did.
MAJ KNOX: And did you get a response?
MAJ KNOX: And what VA was that?
MS. BOWMAN: The James H. Quillen --
MS. BOWMAN: -- VA. It used to be called Mountain
Home, up in Johnson City. That is also the one where the
director decided to put cameras in the public rest rooms over
the seats to make sure no one was stealing the paper, toilet
tissue. You'll have any other questions?
MS. BOWMAN: Now, I'm not stupid. I'm a graduate
of the University of Tennessee and I'm -- it may not -- you
might not think much about the University of Tennessee. I was
also a laboratory technician. I have worked for the United
States post office. I'm retired now. I'm only 47 years old.
I've worked since I was 13. I've worked my way through
college. I've worked my way through everything I did since I
was 13 years old.
My father was a veteran of World War II. He was
doused with radiation. Died with cancer of the colon in 1971
at the age of 46 years old. Never any cancer in his family. I
went to work and paid my way through school. There has been a
member of my family since the Revolutionary War to fight in
every war in this nation. Every skirmish, every little
undeclared battle, there has been someone.
I'm a member of the Daughters of the American
Revolution and I can trace my ancestry back before the
Declaration of Independence. I live on ground -- or mother
does -- that was part of a Revolutionary War Grant. Given to
one of my great-great-grandfathers. We have had to almost lose
that to pay for my husband's medical bill. That's not right.
I'm sorry, I'm getting to preaching, I'm sorry.
DR. LASHOF: Okay, thank you, very much. I believe
someone else indicated they would like to speak. We'll be able
to take one more before our break.
CW3 BOLTON: Morning, members of the Board and
everybody. I'm CW3 Bolton. I'm active duty, and I know a lot
of this talk was about the veterans from Gulf War. I served
with 3d Battalion, 5th Cavalry Regiment, Spearhead Division, 3d
Armor. We went through a lot of the areas that these guys were
talking about. We were stationed just south of Basrah. At the
time that the war ended we were about 50 kilometers from
Baghdad and a lot of the symptoms that these guys are going
through and they're having problems with with the VA, a lot of
active duty members are suffering the same thing.
Myself, I've been told everything from, I'm crazy, to
I had injuries to my skin from acne at a young age. I even
went as far as providing photos of my childhood to prove that I
never had a problem with acne, but after the Gulf War I went
into the mood swings. My body temperature has dropped. I
don't know if anybody have had that happen to them, but I grew
up in Florida. All my life the heat was not a problem. That's
why the desert was not a problem for me. Now if I'm in a room
and the temperature gets above 72 degrees I'm very
uncomfortable. I have to get out of the room and get somewhere
to cool off. I take maybe two or three showers a day to calm
the itching in my skin. A lot of the help that America is
seeing is out there to help us, it's not. I'm here to tell you
right now, it's not there. I currently see a psychologist at
Fort Drum because they said my internal body failures and body
functions and my skin problems is all in my brain. They said
because of the way that I think, the way that I feel, it's
afflicting me physically.
To be honest with you, as an active duty soldier, you
know I have to watch what I say, but I think it's all a crock.
You know, it's all a crock. I didn't come forward before and
get on the Desert Storm registry before 1996 because many of my
friends that -- we served in the same unit, they went and
registered for Desert Storm Syndrome, got on the registry, five
or six months later they were out of the Army. Some of these
guys had 18 years in the Army.
You know, and at the time I had just a little over 19
years and my symptoms got so bad with sleep impairments.
Sometime I would go three or four days without sleep and
there's nothing I can do. I've taken, at one time anywhere
from six to eight sleeping pills and they do absolutely nothing
to me, you know. Then sometime I can't stay awake, you know.
I've told this to all of the Fort Drum doctors because we have
to go to the active duty side.
I've called the VA Hot Line many times where I've had
depression states that just appear out of nowhere, you know.
The point that I'm making is as much as people want to believe
that there's nothing wrong with us, we know there is. Whether
the United States Government is going to pay to figure out
what's wrong with us and get us fixed or they're going to pay
to take care of our families after we're gone is irrelevant.
The point is is I laid my life on the line and I volunteered
for freedom and justice in America. Why is it that now that I
need help that my government has turned their back on me.
That's my question for you.
DR. LASHOF: Any further questions? (No response)
Thank you, very much. I thought I saw one more hand, and I
think we can take one more, but not -- but that didn't take
quite as long.
MR. COOKE: Hi. My name is Neil Cooke. I was a
staff sergeant in the Service, in the Army and when I went over
and fought for our country, got very sick. As soon as -- the
day I got home I was sick. Went to the VA, the VA laughed at
me and told me it was all in my head. I went through all these
tests. This was almost, well, five years ago. I've gone
through all kinds of tests and I'm still at the same point.
The only thing is I feel like a guinea pig. I feel that I've
been a test for the government before -- for medications. I
mean, here try this, oh it didn't work. Well, that's $2.00 or
$5.00 and then what would happen then is you end up with
another bottle of pills and nothing -- you know. Well, let's
try this one.
Granted, we don't know what it is, but I've got the
problems. I've filled out -- I've done claims for disability,
been denied. Granted, they say I do have the problems, but
there's nothing with the medication that's helping the
problems. It's a pacifier.
DR. LASHOF: You need to make -- what basis they
denied your claim?
MR. COOKE: They denied -- basically, what they --
when it came back, it came back from Buffalo stating that my
medical records shows that I have all these symptoms, but
there's no medical records showing I have any problems. That's
what came back to me and I do have copies of that. It's funny
(sic), yes, people laughed at it when they saw it.
DR. LASHOF: Are you able to work?
MR. COOKE: My boss knows me because I worked real
close with him. I work for a, you know, like a school district
and I was employed there prior to going over and I worked real
close with him. He knows it's not me and they -- and I can get
-- and he's vowed -- he said he would do evidence stating that,
yes, I've missed a lot of time. It's not me, and I was a
hundred percent before I went, or otherwise a lot of us would
never have gone, and another thing --
DR. LARSON: But you are working now? You are
working now?
MR. COOKE: I am working, because I'm not a type
of person -- I can't -- I'm sick. I have to give myself shots
all the time for the migraines. I'm on medication for my
stomach. I'm on Motrin, max dosage. Which medication, what's
it going to do to my body, you know. You, get sick of it after
a while. I go to the VA and like everybody else is saying, I
get there and they -- you know, one week I'll go for an
appointment, I'll see one doctor. The next time I go back in
it's a different doctor. Then you've got to go through the
spiel all over again. What -- you know, what's going on. It
makes it real hard. Yes, I had almost -- almost 14 years in
the military and sayonara, see you later. So, real sour taste
for the government.
MAJ CROSS: Do you get a -- do you get a sense
that every time you go you have to start all over again --
MR. COOKE: Yes. Yes.
MAJ CROSS: -- with the doctors? Do you get a
sense that --
MR. COOKE: Yes, I do.
MAJ CROSS: -- they don't know anymore than you
do? Or you probably end up knowing more than they do about the
MR. COOKE: Right.
MAJ CROSS: -- illness.
MR. COOKE: I do know -- I do know one thing. I
was -- they -- I was doing DHE (sic) shots. DHE-45 in the leg
and I could do max dosage of three shots a day. Well, it
wasn't working. So, they admitted me in to the VA. I'm in
there for a week. What do they do? I'm not a doctor, but
first of all, you don't -- they gave me an IV of DHE-45. I
mean, I'm already injecting it into my leg. How much more can
you get it into your system? It's not working. I had it out
with a doctor.
You know, I used to -- before I went over to the Gulf
I used to see a lot of Vietnam vets come out swearing and all
of this and that. That's me now. I'm angry and my kids, my
wife they see it all the time. I've gone to counseling to try
to calm my mood swings. I've -- if you want to come to my
house, you can come to my house and see holes in the walls.
It's not right. Any questions?
DR. LASHOF: Thank you, very much.
MR. COOKE: Thank you.
DR. LASHOF: We will take our recess now and resume
at 10:30.
(Board recessed until 10:30)
DR. LASHOF: I am very pleased that Mary Pendergast
from the Food and Drug Administration is here to discuss with
us the interim final rule. Can you begin by telling me why we
have an interim final and what that means?
MS. PENDERGAST: Yes. An interim final is a rule
that is permitted to go straight to final. That is to say,
it's operative. As soon as it's published in the Federal
Register and then the government agency is allowed to take
public comment after the rule is operative, and then it can
make changes to the rule. It's in distinction to the comm --
the more normal situation where first you put out a proposed
rule, get the comment and then take it to final.
DR. LASHOF: Thank you, very much. Go ahead with
the --
MS. PENDERGAST: Okay. Dr. Lashof, members and
staff of the committee, good morning. I'm Mary Pendergast,
Deputy Commissioner of the Food and Drug Administration and I'm
pleased to be here today to discuss the FDA's interim final
rule permitting waiver of informed consent for use of
investigational products in a military exigency. I want to
explain as well the public deliberative process that we are
undertaking to come to grips with the highly sensitive and
complex issues raised by this rule and some of the regulatory
issues related to the use of investigational products during
military exigencies.
My full testimony was submitted for the record. With
your permission, Dr. Lashof, I would like to summarize the main
points covered in the text. First, we recognize that this
committee is concerned about the apparent inaction of the
agency to open the interim final rule to public scrutiny since
it was first published in December 1990. We agree that it has
taken us a very long time for us to reopen the interim final
rule for public comment. But the issues raised by the use of
investigational agents in wartime present complex medical,
scientific, ethical, and logistical issues for which there are
no clear or simple answers. Even if we were to set aside the
national security concerns that form the backdrop of this
debate. These issues have been subject to intensive
consideration and debate within the agency and this scrutiny
has produced several different draft revisions of the rule, but
this work has not brought us to closure and we recognize that
we must go forward. The FDA has developed a plan for obtaining
public comment on that interim final rule.
The agency has carefully considered various options
pertaining to the interim final rule, as well as the types of
studies that would be needed to permit the approval of products
for which human effectiveness studies are simply not feasible.
We recognize that there will continue to be military combat
situations in which there may be a threat to the United States
military personnel from the possible use of chemical and
biological weapons.
The Department of Defense, therefore, has a
legitimate interest in safeguarding military personnel by using
products which may provide protection from such chemical and
biological agents. As you know, so that the Department of
Defense could act in these circumstances, FDA published the
interim final rule just before the Persian Gulf War.
The interim final rule permitted the Department of
Defense to use certain investigational agents during that war
without informed consent. It is a rule that has been wrongful
criticized by veterans, this committee, congressional
committees, and others for a variety of reasons. We recognize
that the interim rule did not work the way we anticipated it
would work and we have so informed the Department of Defense.
Moreover, the interim final rule is limited to military
exigencies and it does not provide a way to make these products
available to civilians, should the need arise.
To establish a public process for discussing these
highly sensitive issues, FDA will publish a request for written
comments in the Federal Register later this week. With any
luck a copy of that Federal Register notice will be on public
display today down in Washington, D.C. In this notice FDA is
requesting written comments on issues related to the use of
investigational products during military exigencies.
Specifically, the agency is soliciting written comments related
to the advisability of the agency revoking or amending the
interim final rule and identifying the evidence needed to
demonstrate safety and effectiveness for investigational drugs
and biological products that cannot ethically be tested in
humans for purposes of determining their effectiveness.
The questions we are asking involve three major
topics. Questions involving the interim final rule. Questions
regarding whether there are circumstances under which it is,
indeed ethical, to expose volunteers to toxic chemical and
biological agents to test products with the potential to
protect humans from those agents, and if the answer to that
second question is yes, what evidence would be required to
demonstrate the safety and effectiveness of such products.
We think that these questions will address the
recommendations made in this committee's interim and final
reports on disclosure, record keeping, follow-up and other
matters. At the end of the 90-day comment period, FDA might
decide to hold an open public meeting on a more limited set of
issues and the following step would be to publish a notice of
proposed rule making. These are complex and controversial
issues, but FDA anticipate publishing a notice of proposed rule
making during the first half of next year.
Second, I'd like to move on to concerns about what
happens before the FDA's action on the interim final rule
become final. We recognize that FDA must come to closure on
the interim final rule to remove the great uncertainty about
what might happen if there were another war and if the
Department of Defense were, once again, to ask FDA for a waiver
of informed consent. Although I cannot say precisely what
would happen. I can say with confidence that FDA would demand
that the Defense Department change some of the ways in which it
administers such a program. Let me explain briefly how
we have indicated to the Department of Defense the areas in
which changes would have to be made. On July 27, 1992, after
the Persian Gulf War, FDA officials met with Department of
Defense officials to examine what was learned from the
application of the interim final rule during the Persian Gulf
War and to discuss three additional questions. Whether and how
the FDA might finalize the interim final rule. How the
agencies might work together to be ready if the Defense
Department were to come forward with additional requests for
waivers of informed consent, and third, whether FDA could
approve other drugs and vaccines for military use.
Following that meeting the Department of Defense
submitted to FDA a contingency protocol that Defense proposed
to use if it were to ask FDA for a waiver of informed consent
for Pyridostigmine Bromide. FDA reviewed this contingency
protocol and determined that the proposed approach had several
deficiencies. FDA's response to the Department of Defense's
contingency protocol reflects the areas were FDA wanted to see
changes in the way in which the administration of
Pyridostigmine Bromide to military personnel during a war could
be accomplished. We detailed our concerns over the
information that would be given to military personnel, the
monitoring of adverse reactions, record keeping and other
matters. Thus, if you read that December 1994 letter, which is
included in my formal testimony, you will understand the types
of demands we would place on any further use of Pyridostigmine
Bromide or any other drug, before we would even consider
waiving informed consent. The Department of Defense has not
resubmitted a contingency protocol in line with the FDA's
There's another important issue as we move forward.
Standards for approval for products for military and civilian
exigencies. Although we expect to make additional progress
after receiving public comments, there's a couple of areas
where we have already made decisions on the scientific and
medical issues. `First, an FDA Advisory Committee has
considered the medical and scientific evidence that would be
needed to approve the Botulinum Toxoid Vaccine. From this FDA
Advisory Committee discussion, the Department of the Army has
clear direction on the top of studies it must conduct to
support the effectiveness of botulinum toxoid. FDA cannot
consider the approvability (sic) of Botulinum Toxoid Vaccine,
however, until the Army conducts these studies and submits a
product license application to the FDA. There is no such
application currently pending in front of the agency.
Second, we have decided on a legal and regulatory
framework that can be used for other types of drugs. As you
know, on May 24, 1996, the Department of the Army submitted a
new drug application for Pyridostigmine Bromide tablets. The
Army submitted this application under the FDA's accelerated
approval regulations. Which permit FDA to give approval based
on the surrogate end point that reasonably predicts clinical
The Army proposed that approval be based on the
surrogate end point of Pyridostigmine Bromide induced red blood
cell acetylcholine esterase inhibition. In short the operative
theory was that if Pyridostigmine Bromide could be shown to
inhibit red blood cell acetylcholine esterase and that
inhibition was shown to be a good surrogate for survival; by
showing that the inhibition was shown to be a good surrogate
for survival, by showing that the acetylcholine esterase
inhibition improves survivals in animals exposed to chemical
warfare agents, then the Pyridostigmine Bromide could be
approved without direct evidence that it improved survival in
Unfortunately, the data submitted were inadequate to
show that the red blood cell acetylcholine esterase inhibition
was a good surrogate and, accordingly, FDA Center for Drug
Evaluation and Research sent a non approvable (sic) letter to
the Defense Department on May 7, 1997. In response to that
letter the Department of Defense has notified the FDA that it
intends to amend its new drug application for Pyridostigmine
Bromide for protection against Sommad (sic).
Before closing I'd like to raise one additional
matter. It concerns the Defense Department's use of
investigational products and the waiver of informed consent
under the interim final rule, as well as other uses of
investigational products where informed consent was required.
FDA has reviewed and evaluated information from our ongoing
assessment of the use of investigational products in the
Persian Gulf, from our own inspection at Fort Detrick and from
recent General Accounting Office reports.
On the basis of our review and evaluation, FDA has
identified significant deviations from FDA regulations. In
particular the deviations in Bosnia where the Department of
Defense used a Tick-Borne Encephalitis Vaccine under an
investigational new drug application, show that the Department
of Defense has not corrected its procedures to prevent the
recurrence of the problems in the use of investigational
products that arose during the Persian Gulf War.
FDA informed the Defense Department of its regulatory
deviations in a letter dated July 22nd, 1997. That letter
asked Defense for additional information and directed them to
inform FDA of the steps they intend to take to conform with
FDA's regulations. We will be working hard with the Department
of Defense as they tackle these issues.
Let me conclude. We, at the FDA, take very seriously
our obligation to protect the rights and welfares of all
individuals who receive FDA-regulated investigational products.
We also recognize the importance of establishing these products
safety and effectiveness, if that can be done. To meet our
obligations we recognize that it is critical to obtain the
broadest public input -- input before making policy decisions
that will effect hundred of thousands of Americans. That is
why we are publishing the Federal Register notice on waiver of
informed consent and related issues. I'd be happy to answer
any questions you might have.
DR. LASHOF: Thank you, very much. Could you say a
little bit more about what were the deficiencies in DOD in the
use of the Tick-Borne Encephalitis Vaccine.
MS. PENDERGAST: Yes, the -- the deviations from
the protocol in Bosnia now -- it's important to remember that
this was an investigation of whether or not a vaccine against
tick- borne encephalitis would work and it was -- the
investigation where informed consent was obtained. This is a
not a waiver of informed consent situation. The deviations
included, first a failure to maintain adequate records showing
the receipt, shipment and disposition of the vaccine. A
failure to monitor the progress of the clinical investigation
while it was being conducted. A failure to ensure that the
investigation was conducted in accordance with the protocol.
Promotion of the investigational new vaccine.
In other words, there were representations made to
the troops that was effective, yet it was still under
investigation. Failure to obtain via (sic) the approval of
informed consent documents and then there's one question that
we need clarification on as to whether or not there was a
failure to meet the Department of Defense record keeping
DR. LASHOF: Thank you. One question before we get
into those about the interim final rule that I have is, under
what circumstances do we consider that you can get really
informed consent in the military? What do you at FDA require
to see about the process of doing informed consent for the
drugs that they're not asking for a waiver on?
MS. PENDERGAST: Excuse me. I think that it is a
complex ethical question, but at the present time we believe
that it is possible even within the military to obtain informed
consent. In that the situation within the military is not so
coercive, per se, that it would be impossible to conduct a
clinical trial with informed consent. I mean, the military has
a number of things for which service personnel are asked to
volunteer for. Whether it's donation to a charity or
participation in a clinical trial. We think that it is
theoretical possible to obtain informed consent in a military
context. Certainly the question of how you -- it is fraught
with more difficulty I would concede than in a civilian context
and it's something everyone has to be very careful about.
DR. LASHOF: Thank you. I know it's taken a long
time to notice a propose rule making, and I know how complex
those issues are. In developing that proposal did you work
with other agencies in HHS, DOD or VA in looking at the issues
that you did highlight in your notice -- notice rule making?
MS. PENDERGAST: We have certainly discussed these
matters within the Department of Health and Human Services, and
we have had conversations with the Defense Department over the
years as different issues came up or as were considering
different variations on what we might do.
DR. LASHOF: And is the current notice sort of a
consensus from a different -- parts of the government or is FDA
out there?
MS. PENDERGAST: I wouldn't call it a consensus
document. It is, basically, a document where we are doing our
level best to ask all of the questions, that not just we have,
but the questions that others have had about how the interim
final rule worked in practice. So, we are asking the questions
that were raised to the FDA in petitions that were raised by
veterans and by others. So, at this point we're trying to get
the broadest and frankest discussion of the issues possible for
purposes of our rule making.
DR. LASHOF: As I understand it, that you certainly
hope that within six months you would be able to put forward a
final rule.
MS. PENDERGAST: Right. In the first half of next
year. Which is slightly more than six months from now. If the
DR. LASHOF: It could be up to a year.
MS. PENDERGAST: Well, that's right. If the
Federal Register publishes this week and we give people three
months for written comment and then follow that with a public
meeting where we could have further debate or dialog on some of
the key issues, we would then go to the drawing board and write
a proposed rule that would need to be cleared through the
executive branch of government before it could be published.
That's why we anticipate that it would take through the first
half of next year.
DR. LASHOF: Thank you, very much.
MS. PENDERGAST: But that would be a proposed
rule, not the final rule.
DR. NISHIMI: That's right.
MS. PENDERGAST: We are committed to going -- our
next step will be a notice of proposed rule making. The one
thing you can rest assure that we will not do, is go straight
to final -- finalizing this interim final rule.
DR. NISHIMI: And how long might it take to get to a
final rule?
MS. PENDERGAST: That all depends on the number of
comments we receive. It's impossible to say. I've been
involved in FDA rule makings that received only a couple of
dozen comments, and as you know, our tobacco rule received half
a million comments. Obviously the more comments the longer it
takes to synthesize them and address them.
DR. NISHIMI: I guess what I'm trying to point out
is it's taken us seven years to get up to this point and I
would like a commitment from FDA that it's not going to take
another seven to handle comments.
MS. PENDERGAST: I certainly would hope not.
MAJ CROSS: And my sense is as long as the word
gets out you're going to get a vast amount of responses back
from this, because many of the veterans we've heard from for
the last year and a half consider the use of the drugs as, you
know, part of why they're sick today. Ms. Pendergast, I also
have a comment on the -- we talked about the informed consent.
Now, we've had this discussion before and when we talk about
the theoretical of how it should work and theoretically it
should work of conformed consent in the military, but I'll tell
you what in having -- a Desert Storm veteran myself, the
practicality of it is that it would never work in the military.
I just want to set --
MS. PENDERGAST: Obtaining informed consent.
MAJ CROSS: Yes. Yes. Theoretically, your
understanding of the way it should work, I agree with the
theoretical, it should work. Because as you say, the military
support's blood drives and charitable drives and everything and
they work fine. But in this particular instance, we've heard
it this morning in public comment where some of the soldiers,
you know, took the drugs because, guess what? They were told
to. No other information was given. No one was asked to sign
any waivers. No one was -- entries were not made in record
books. Practically thinking that's actually the way it
We also took it up to the present day, Bosnia, and I
understand we had the same scenario in Bosnia. There was a
famous baseball philosopher who said, it's deja vu all over
again. Now, I'm sitting here and I can't believe what you're
saying because, guess what? It's all over again, it's the same
thing. This committee among itself spoke a year ago that maybe
we could set some ground rules for a Bosnia syndrome, and I'm
saying to myself we may be at the tip of the iceberg of a
Bosnia syndrome. It just keeps happening and happening and we
never seem to learn from our previous mistakes.
MS. PENDERGAST: I'd like to comment on that. I
think that that's -- that's a certainly a fair concern. We too
-- we understood, I think it's fair to say, that the first time
the Defense Department attempted to field investigational
agents during a war, that is to say the use of Pyridostigmine
Bromide and botulinum toxoid in the Gulf War, that it was not
surprising that it did not go perfectly well. It was the first
time out and there were a lot of lessons that were learned from
that experience, and we accepted that. It was, after all, war.
They were, after all, doing it for the first time.
We had a much higher level of concern, regulatory
concern, when we saw the way in which the Department of Defense
conducted the trial for tick-borne encephalitis in Bosnia.
Because there -- we had the experiences of Gulf War. We had
the opportunity, or they had the opportunity to do it better
the second time. So, when we saw the same kinds of regulatory
deficiencies in Bosnia that we had seen in the Persian Gulf, it
caused a great amount of consternation at the agency. Which is
why we took the regulatory step that we did take. Because I
think you're right, if you don't learn from your mistakes you
will just keep repeating it and as a spokesperson from a
regulatory agency, that's simply not acceptable to us.
Now, with respect to informed consent. One of the
questions we are asking people to comment on is whether you can
obtain informed consent before people get into the military.
Right now we have a volunteer Army and although ethics are
split on this issue, one of the questions we would like a very
serious conversation about is whether or not there needs to
have that -- there needs to be a discussion about the use of
investigational agents as prophylaxis against chemical and
biological weapons before the person ever signs up to serve in
the military. Maybe that is a conversation that could take
place then when there is no coercion because the person isn't
part of the Armed Forces at that time. So, that's the kind of
thing we're trying to look at to address the problem that you
DR. LASHOF: Thank you.
DR. LARSON: We're really sort of talking about two
issues here and I want to clarify and separate those two. One
has to do with the interim final rule and the timing and the
question that Dr. Nishimi asked, for example. The other has to
do with the DOD's deficiencies and so forth in following the
regs and so forth. I'd like to focus for a minute, before we
skip around back and forth, on the timing issue. Okay, it's
been seven years. We have an interim final report. There'll
will be a 90-day comment period. Then there will be the
proposed rule making and you said in your testimony that you
might have public hearings. What I'd like to know is, what
criteria you're going to use for whether or not you're going to
have public hearings. If you have them that's going to add
another piece and I do share some of the frustrations that's
been expressed with the timing problems, which is an FDA issue.
Just one other example before you respond. In the
submission of the NDA for Pyridostigmine from the DOD, they
submitted on May 24th, '96. Your response back to them that it
was inadequate was a year later. So, it says May 7th, 1997,
they received a letter back. So, there's a timing problem
here, too. If it's an important issue and needs to move along,
would you talk about that one and then we'll deal with the DOD
MS. PENDERGAST: All right. First with respect to
the timing of the written comments, and a public hearing, and a
notice of proposed rule making to finalize the interim final
rule. Today is July 29th. If the Federal Register notice were
published some time in the next couple of days, so let's say
August 1st. Three months gives people August, September and
October to comment. It's then when we have a first pass at the
comments we will be reading them as they come in and we will
know whether or not we need to have a public hearing on some
focused issues. It depends. If the comments are very full and
complete we may not need a public hearing. If, however, no one
grapples, let's say, with some of the tough ethical questions,
or there's no pathway out because of the comments we've
received, we may hold a public hearing. But that would take
place in around December or January. That would not slow up
getting a notice of proposed rule making published in the first
half of 1998.
So then, your second question went to the year it
took the FDA to review the new drug application for
Pyridostigmine Bromide. I think that that one year is within
the prescription drug user fee guidelines for how long the FDA
should take for any new drug application that have been set out
by Congress. So a year is a -- is a normal amount of time for
the FDA to review a new drug application. New drug
applications are tens of thousands of pages. They involve
hundreds of scientific studies. They're quite intensive. They
have reviews from many, many different disciplines and they
take a long time.
DR. LARSON: Yes, I think some of us have been
involved in some of that, but nevertheless, this was a
highlighted public issue and Bosnia was going on. It just
seems like, obviously, it's legal to do it. It's within the
time, but it is -- a year is a long time. Let me just say why
I'm concerned.
In another field of FDA ruling, which is on
antisepsis and all that stuff that I deal a lot with, the first
tentative final monograph came out in 1974. Tentative final
monograph. The second tentative final monograph came out in
1994, with 90 days for comments and then there was going to be
a post (sic) final ruling. It's still -- it's 1997. So, this
is a typical timing problem and it is, I think, frustrating for
this committee to -- this is just another example of a problem
in FDA.
MS. PENDERGAST: There's no doubt that we have
vastly more work than we have people to do it. It is true -- I
think you're referring to our tentative final monograph as part
of the lieutenat colonel review. We were given the task of
reviewing 400,000 drugs and it has taken us a long time to do
the scientific review on those 400,000 drugs. You're
absolutely right.
DR. LARSON: How many people would it take to do
the work? I mean, are we doing it wrong?
MS. PENDERGAST: Well, that's certainly a debate
that many people in Washington and elsewhere in the country
have had over many years. I think it's fair to say that one of
the solutions to that was the Prescription Drug User Fee Act.
Which, basically, gave the FDA additional scientific resources
so that we would be able to review our new drug applications in
six months for priority drugs and one year for all other drugs.
We are now doing that and we are now, I'm pleased to say,
faster than any of the regulatory agencies in Europe. So, it
takes a long time everywhere in the world.
DR. LASHOF: Thank you.
MAJ KNOX: I have a question. You mentioned earlier
that FDA is a regulatory agency. So, do you or do you not have
the authority to immediately demand from DOD a suspension
concerning the TBE in Bosnia?
MS. PENDERGAST: We have the power to put a
clinical trial on clinical hold if certain specified criteria
in our regulations are met. I'm not aware of the current
status of the TBE Study in Bosnia. So, it's not clear to me
that there is, in fact, a study that's ongoing that would even
be available for stopping. I think they're over, but I'm not
certain about that. I'd have to get back to you.
DR. LASHOF: Okay. Joan? Oh, I'm sorry.
MAJ KNOX: I wanted to ask if the Department of
Defense have ever formally requested a waiver of informed
consent for the investigational use of the Tick-Borne
Encephalitis Vaccine?
MS. PENDERGAST: No, they did not.
DR. PORTER: Did you have informal discussions with
them about that?
MS. PENDERGAST: Not to the best of my knowledge
has the Department of Defense ever asked for a waiver for any
other product, although --
DR. PORTER: You mentioned the contingency --
DR. PORTER: Those are the contingency protocol
discussions, but were there any other protocols or products for
which a waiver was sought?
MS. PENDERGAST: I'm sure you're aware that there
were three originally, the Pyridostigmine Bromide, the
botulinum toxoid and a skin lotion called Multi-Shield, that
were all
-- waivers were asked for at the beginning of the Persian Gulf
conflict. The skin protectant turned out to be a bad product
and that request was withdrawn, but there have been no formal
waiver requests since that time by the Defense Department.
DR. LARSON: In your written testimony, but I don't
think in your oral testimony, you talked about the revelations
of Khamissiyah and the fact that you had made a request for
some data linking Pyridostigmine with the exposures. I wonder
if you would comment on your reaction to the DOD's response?
Did you feel it was an adequate response?
MS. PENDERGAST: (No response)
DR. LARSON: Is my question clear?
MS. PENDERGAST: Yes, your question's clear. I'm
not a scientist. So, I -- any personal response I might have
would not be terrible fruitful. I think it's fair to say that
it indicates the difficulties of assessing any kind of chemical
or biological weapon if you don't have toxicity showing. If
the troops aren't getting enough exposure to know they're being
exposed, it's hard to backtrack on that kind of information.
On the other hand, had the Defense Department been
able to surmount the concededly very, very, very difficult
challenge of figuring out what troops took Pyridostigmine
Bromide when there might have been some data that might have
been able to have been gathered, but there wasn't. So there
isn't and so we accept the Defense Department's response on
face value.
DR. LARSON: Well, and my interpretation of their
response is that they were all so concerned about being unable
to sort out synergistic effects or interactive effects, but I
still wondered if there wouldn't be a possibility, not that it
would, perhaps, be economically feasible now, but of doing some
kind of a case control study. Where one could use the
information coming out now to look at some of those other
things. I felt the response was less than I would have hoped,
DR. NISHIMI: I have another question for -- going
back to the issue of the TBE Vaccine in Bosnia. The letter of
deficiency was quite specific in questioning DOD's inability to
carry out its obligations under the regulations for IND's (sic)
annually, actually. Can you be a little bit more specific on
why it's FDA's perception that DOD just can't do this?
MS. PENDERGAST: It's not that we think they can't
do it. We feel as though they didn't do a particularly good
job in Bosnia and we are asking ourselves and asking the
Defense Department for their -- why that happened. We,
basically, realize that the best information on the structural
problems will come from the Defense Department.
We see, as we allude to in our letter, that there may
be some structural difficulties caused by the fact that when a
protocol is designed and set up, it's designed and set up with
mili -- military medical specialists at Fort Detrick or
elsewhere who are very familiar with conducting clinical
trials. Understand protocols, understand the importance of
following a protocol, keeping records, etcetera. But then the
actual operation, the actual conduct of the clinical trial
takes place a continent away without the clinical investigators
being present. By persons who don't necessarily have the same
level of understanding of the requirements, or the same level
of commitment to meeting them.
So, those are the kinds of things I think we have to
figure out in terms of, you know, what is that makes it
difficult to do. In addition to the fact that, you know, this
is taking -- these trials are being taken place in places like
Bosnia. Certainly if you look at the Defense Department
clinical trials that are conducted at Walter Reed or other
similar locations in the United States, you don't see these
problems. So, clearly it's any effort to conduct a clinical
trial is confounded and made far more difficult by being done
in a field location.
DR. NISHIMI: So, under those circumstances would
that argue in favor of just revoking the waiver of informed
consent entirely? Given that you already have one layer of
MS. PENDERGAST: It's certainly something to think
about. On the other hand, we also have to think through, what
then? What then would be done or could be done to protect
troops from chemical and biological weapon attack. This is a
situation where it's not as though the -- all the chemical and
biological weapons that ever happened or ever will be, are
known today.
Obviously, there -- one must presume there are people
out there trying to invent new chemical and biological weapons
and there will always be a time lag between the identification
of a new biological weapon and the conduct of the appropriate
animal and human trials to develop an antidote or prophylaxis
against that chemical or biological weapon. There'll always be
times when you don't yet have an approved product. So, we just
have an obligation for the sake of the troops to think through
those issues and that's what the public comment period is all
DR. NISHIMI: But it would be fair to say that the
issue of revoking the waiver of informed consent is something
that FDA fully recognizes is on the table?
MS. PENDERGAST: Yes, as we indicated in our
notice of -- our Federal Register notice.
DR. LASHOF: Let me follow that up a little bit
more. One of the things in the notice of proposed rule making
for -- under the -- yeah -- is the issue of whether or we ought
to have other surrogates or -- instead of human exposure. I
don't know of any ethical way to expose people to chemical
agents to find out whether something protects them or not if we
don't have awful good evidence.
Yet, operating under a waiver of proposed rule making
-- waiver of informed consent creates all kinds of
difficulties. Has FDA put forward some more defined ideas of
things that you could use, so that you could have these as
approved drugs without the human experimentation? I know
that's one of the questions open for public comment, but I'm
wondering whether FDA has done further thinking themselves and
has come up with some other criteria. Frankly, that's the way
I think.
MS. PENDERGAST: Yes, we have. Last October we
held a Public Advisory Committee from our ex -- biological
experts. Solely for the purpose of trying to define the kinds
of animal trials and human challenge studies that could be done
to ascertain the effectiveness of the Botulinum Toxoid Vaccine
without using conventional human effectiveness trials. The
advisory committee was able to come up with a blue print for
the kinds of trials that would need to be done to determine
whether or not the Botulinum Toxoid Vaccine could be approved
safe and effective.
DR. LASHOF: Is that moving ahead? Are they doing
MS. PENDERGAST: They are -- yes, they are in the
-- as I understand it from our staff, the Defense Department
has moved forward to conduct the trials that were recommended
by the advisory committee. With respect to chemical drugs as
opposed to vaccines, we have determined that you can use
surrogate markers like the acetylcholine esterase inhibition in
animals. You know, get the inhibition, expose the animals, see
if they're protected and then see if the same drug has the same
inhibition in humans.
So, it's a way of doing the medical and scientific
work without the conventional human ethicals (sic) trials. So,
we have a pair done in which the drugs could be approved and we
have a decision taken by our general counsel's office that we
could lawfully approve drugs without conventional human
effectiveness trials and that's something that is, basically,
new. So, we think that we can get there without any change in
the law and possibly even without any change of the
regulations, because we've already done two without difficulty.
But I would like to go back to your point. The
question of whether or not any human trials could be done is
something our scientists are quite serious in exploring. There
are many dangerous products for which clinical trials are done
in healthy volunteers. For example, there is challenge studies
for vaccines that might work against malaria. You give healthy
volunteers the malaria vaccine and then expose them to malaria.
Which is serious, but it's treatable.
DR. LASHOF: Treatable.
MS. PENDERGAST: One of the questions we have is
whether or not -- let's say take Pyridostigmine Bromide as an
example, you could -- you could give the prophylaxis and then
expose volunteers to incredibly low concentrations of the
chemical weapon. So, that you would just simply get a
biological response. It wouldn't be strong enough to do them
harm, but just enough of a response to see if the -- if the
persons who had the acetylcholine esterase inhibition did
better than the other ones.
So, what we're trying to ask the question of
scientifically, is it possible using volunteers to use -- and
using titrated doses of the dangerous agent you might be able
to get some information, while at the same time not cause any
MAJ CROSS: It's interesting you say that, because
part of the debate we've had here is that low levels --
possible low-level exposure to chemical weapons is what's
afflicting Persian Gulf veterans. But yet you're saying, well,
let's have a clinical trial where we do that. I think part of
what we've heard in the past is very little research has ever
been done on the affects of low-level exposure. A la, that's
why we have a Persian Gulf Syndrome, because we don't
understand it. I'm not sure I follow your thinking that, well,
let's just go ahead and do that.
MS. PENDERGAST: Well, it's not a, let's just go
ahead and do it. It would be a controlled clinical trial where
the risk would be spelled out, and the risk of the unknown
would be spelled out to the human volunteers. Then their --
the administration of whatever toxic agent it would be, would
be carefully controlled and monitored and the health impact of
that would be followed as part of the clinical trial. In other
words, a battery of tests would be given to the person before
and after and their health would be followed very carefully.
It's a way of finding out the answer to the question that
appears to bedevil many people. Which is, is this the
causative agent for some illnesses.
MAJ CROSS: So, the key word is volunteer.
MS. PENDERGAST: That's right, it's a key word.
MAJ CROSS: Now let's take it back to a large
scale clinical test. Seven hundred thousand troops volunteers
in a clinical test that ended when the ground war ended and
those troops were deployed back to the United States. Has
-- did disconnect then becomes -- there was no follow-up with
any of those troops, volunteers. There was no clinical follow-up or maybe I should say, the VA was presented with the
clinical follow-up, but we know they've done a terrible job
since then.
We hear, to this day, veterans that stand up and say
they have problems because they were part of that clinical
trial and the follow-up was terrible. What could the FDA do
today to correct that?
MS. PENDERGAST: I don't know that there's
something concrete we could do today in 1997 to improve the
conduct of the follow-up back in 1990 and 1991. What -- there
are others in government that are trying to search for the data
and try and figure out what the answers to the medical
questions you posed are. What we can do is try and improve for
the future so that the same insufficient record keeping and the
same lack of data doesn't happen another time. That's the
piece of the puzzle we can work on. Is fixing it so that it
won't happen a second time, or again.
MAJ KNOX: I would say that, you know, FDA should
think about doing that, what you just said. I mean, I would
challenge FDA to do a clinical trial with PB and low-level
chemical exposure to see what the response is. At these -- at
least then, these veterans who are suffering may have some
answers, because right now we don't.
MS. PENDERGAST: I can pass on the question of
whether that would be a good trial or not. It might be a very
excellent suggestion, but it's just that the Food and Drug
Administration doesn't have the statutory mandate over the
resources to actually conduct any trials. The trials that are
conducted by the Federal Government in our department are done
by the Centers for Disease Control and the National Institutes
of Health and, obviously, by others within the government. But
we -- in order to preserve our ability to dispassionately
review the results of others' trials, we don't conduct them
DR. PORTER: I have another Tick-Borne Encephalitis
Vaccine question for you. We've been discussing this morning
some of the deficiencies that were identified in the July 22nd
letter this year to the Department of Defense from the Food and
Drug Administration. Did you make any recommendations for
specific actions that you thought would help start to correct
the deficiencies?
MS. PENDERGAST: The -- what we did -- what is --
which is what we almost always do in these kinds of situations
is we ask the regulated entity here, the Defense Department and
often a drug company, to do an assessment of what went wrong
and why and get back to us in 90 days and then we will take it
from there to see what the results of that assessment are and
then begin to work with them.
So, first, especially since many of the questions are
questions about what did or didn't happen in Bosnia it's
important to get the Defense Department's information on that
piece of the puzzle as part of -- as the first step in an
assessment. One of the questions we are asking in our Federal
Register notice is -- and it's in the subsequent version than
the ones you have in your package, is are there specific things
that the FDA can require that would help in the monitoring of
clinical trials or help prevent regulatory deficiencies. So,
those are the kinds of questions we will also be asking as part
of that Federal Register notice.
DR. PORTER: But, specifically, for the Tick-Borne
Encephalitis Vaccine your expectation is then to have an
assessment from the Department of Defense within three months?
MS. PENDERGAST: Yes, that's right. It's in the
DR. PORTER: Then how would you follow-up to
evaluate that or work with the Department of Defense to make
sure that those particular deficiencies were corrected in that
particular trial and that some of that could be transferred to
other trials? Particularly concerning deployed military
MS. PENDERGAST: Well, the paragon that we would
use would be the same thing we would use if we came across a
drug company that was having trouble conducting clinical trials
in conformance with our regulations. First you do an
assessment of what the problem is. Then you try and figure out
what are solutions to those problems. Then you make sure that
regulated entity has a plan in place that addresses those
problems, that if followed would lead to doing it right the
next time. You also look to see what kind of management
controls have been put in place that are different from the
management controls the company -- or the regulated entity had
the time before.
Those are the kinds of things we will do to try and
make certain that the -- before another trial goes forward that
there is a capacity to do it correctly.
DR. LASHOF: I think with that, I want to thank
you, very much. We appreciate your coming. We appreciate the
effort that you put forward now and let us hope the interim
final gets to be a final one of these days, or gets dropped
altogether, because we'll have another method of dealing with
this (voice fades out).
MS. PENDERGAST: Thank you, very much.
DR. LASHOF: I'd like to move on now to the U.N.
Inspection Report and welcome the Honorable Charles Duelfer and
Mr. Egor Mitrokhin. Also, I think -- everyone's knowledge the
questions that related to DOD in relation to the experimental -- we can address this afternoon under medical surveillance.
GEN Parker is here and we'll ask him to join David (inaudible)
and respond to some of the questions we had that are more
referable to DOD. We believe Mr. Duelfer and Mr. Mitrokhin are
Okay, thank you, very, very much for agreeing to
appear before us again. You were extremely helpful to us on
your last appearance and I understand you've flown in from
abroad for this occasion and are flying back out of the country
again to Europe tomorrow or later today. We certainly
appreciate it and hope that you're not so jet-lagged that this
will create any problems for you, but you're probably an expert
at that now. Go ahead.
MR. DUELFER: Thank you, very much, Dr. Lashof.
Buffalo is much better than Baghdad, but as I -- as you've
mentioned, both Egor and I have just returned from Iraq. We're
happy to be here and we think the work you're doing is, of
course, very important and we're happy to contribute in some
small way to your work.
I am accompanied, once again, by Egor Mitrokhin, who
has worked for the Commission on the Iraq chemical weapons
program since 1991, and has a very deep historical
understanding of all aspects of our work and the Iraqi program.
Let me begin first by reminding the committee of the mandate
that the U.N. Special Commission. We are tasked by specific
United Nation Security Council resolutions with ridding Iraq of
its weapons of mass destruction programs and putting in place
some monitoring system to detect potential efforts to
reconstitute such programs.
Our mandate to operate in Iraq is strictly limited to
these purposes. The Commission has assisted inquiries into the
Gulf War Syndrome phenomena on a non interference basis as
appropriate. So, in other words, we're happy to help, but we
have to abide by the strictures of our particular mandate. We
have tried to be helpful within our limited resources, but I
would point out that our resources are very limited. We have
only full time, three experts in New York who work in the
chemical weapons field and their task has been to eliminate one
of the world's largest arsenals of chemical weapons. So, they
have been very busy just performing their normal activities.
I also must begin with a caveat and that is that what
we will present represents our best understanding as of the
moment. Future work may reveal additional details or revisions
to what we have and as I think everyone is aware, extracting
information from Iraq is not necessarily a smooth or even
process. But onto our presentation.
In Chicago last year we presented information
available at that time on 122 millimeter sarin-filled rockets
found by the Commission at Khamisiyah Ammo Depot. In addition,
since then in the period of this past spring we've provided
additional technical details required for the modeling purposes
which have been carried out by the task force. This has
included information on the purity of the agents at the time
and the construction of the warhead.
Since that time, the Commission has been able to make
further progress in the investigation of Iraq's chemical
weapons program. Some new information on the deployment of
chemical weapons in January 1991, has been obtained by UNSCOM
and it's that at which we think may be relevant to today's
meeting. In this presentation we'll focus on other facilities
where Iraq now claims 122 millimeter-sarin rockets and 155
millimeter mustard shells were deployed in January 1991.
As you've been briefed before, according to Iraq's
initial declarations provided to UNSCOM in the spring of 1991,
mentioned above, chemical weapons were distributed in the
following fashion. We'll have the first slide at this point.
That's the way Iraq declares it to us, (laughter) and this is
the way we interpret it. I wish it were that easy. (laughter)
At Muthanna State Establishment, and incidentally at exactly
one week ago, both Egor and I were at Muthanna State
Establishment, but at that location Iraq declared 6,160 122
millimeter rockets. At Fallujah Proving Ground they declared
6,394 155 millimeter shells. According to Iraq these had been
moved there from the Muthanna State Establishment.
At the Nassiriyah Depot Iraq declared 6,240 155
millimeter shells, these are mustard shells. Which had been
moved to the vicinity of Khamisiyah. Nassiriyah and Khamisiyah
are not terribly distant and they had moved them there for
protection purposes.
Lastly, Iraq had declared 2,160 122 millimeter
rockets, the sarin rockets, at the Khamisiyah Depot. Six
thousand, three hundred and ninety-four 155 millimeter shells
have been verified since then at the Fallujah facility in the
spring of 1991. If we can go to the next slides. This one is
-- I'm getting ahead of myself. This is a slide of the
Khamisiyah area where the 155 millimeter shells had been moved
to from Nassiriyah. Okay, next slide.
Now, these are the 155 millimeter rounds which we
found at the Fallujah Proving Ground. The individual in the
lower picture with the green -- sort of green shirt and funny
hat, is Egor Mitrokhin and I'm going to ask him to describe the
next series of slides which are images from -- from the
Fallujah facility.
MR. MITROKHIN: (Voice fades in and out) ... by the
deputy executive chairman of the Commission inspected this
facility -- I'm sorry. In September '90, '91 and as a result
of this inspection the Commission was able to make an
accounting of some 6,000 155 millimeter mustard-filled shells.
In order to verify the pay load of these shells the samples
were taken, the samples of mustard were taken and analyzed
later on. Next slide, please.
Here you can see the procedures used by the
inspection team for sampling of those 155 millimeter mustard
shells and in particular four shells were put and prepared
(inaudible) in plastic sleeves. Next slide. They were drilled
by our experts. Next slide. You can see also the normal
decontamination procedures which were a part of our activities
in '91, '92, and finally the samples were taken and later on
the samples were distributed to three laboratories in different
countries and we've had the very good results which did
(inaudible). In general, we found that the purity of mustard
taken from these shells were about 90 percent. Between 85 and
95 percent. Thank you. Next slide please.
Also, 120 millimeter CS mortar bombs were observed in
this site and later on in 1992. The Commission made an
accounting for this munitions. They were found at this
facility early in '91. Taking into account that they were
burnt heavily. The Commission didn't make an accounting in
'91, but came back to this site in '92.
MR. DUEFLER: Thank you. In the period from 1996 to
1997 the Commission has undertaken to investigate further the
history of the production, filling and deployment of the 155
millimeter mustard shells and also the 122 millimeter sarin
rockets. This, again, is for our purposes to assure that Iraq
has declared everything and that we have accounted for all the
munitions and they do not retain any kind of a covert supply.
Responding to questions addressed by UNSCOM to Iraq,
they submitted in the summer of 1996 a third official chemical
declaration. This is a process by which they are obligated to
provide, formal declarations to the Commission of their
activities. It's the third because each of the prior two had
been inaccurate and not complete. We are in the process of
attempting to verify whether this third one is, in fact, better
than the other two. It did, nevertheless, contain additional
information. On the basis of this new declaration and also
other information, including documents obtained by the
Commission, we've been able to derive the following
information. Go to the next slide here.
According to information provided in Iraq's
documents, Iraq had 13,500 mustard-filled 155 millimeter
projectiles prior to the Gulf War. They were filled with
mustard in 1990 prior to 15 October and the purity of the
mustard ranged from 85 to 95 percent when filled. Prior to 31
December 1990, a part of the 155 millimeter mustard munitions
stored in the bunker area of the Muthanna State Establishment,
there were 7,000 there and at the Muhammadiyat storage facility
where there was 4,500.
Also, all Soccer 18 122 millimeter rockets were
stored empty prior to November 1990. These are just facts
which we believe are accurate that we obtained from Iraq
documents. The locations are shown on that chart where these
depots are, as well as the distribution. Seven thousand 155
millimeter shells at Muthanna; 4,500 155 millimeter shells at
Muhammadiyat and then the various locations where unfilled 122
millimeter rockets were located.
Now to focus on the mustard shells for a moment. In
January 1991, Iraq's Military Industrialization Corporation,
what we call MIC, requested Iraq's Ministry of Defense to
provide 31 trailers to deploy these 13,000 mustard-filled
munitions close to the field of operation. They recommended
that the storage of these weapons be placed in the open.
According to Iraq now, they were deployed to Aukhaider Depot in
the amount of 6,394 shells and the Nassiriyah Depot in the
amount of 6,240 shells. For a total of 12,634, which I would
draw your attention is less than 13,000.
In the period of January to February 1991, 155
millimeter munitions from Nassiriyah were transferred to the
desert area not far from the Khamisiyah Depot, as I mentioned
earlier. It was at this location that they were inspected by
the special commission in October 1991. That's what we
described to you last year. By the end of 1991 they were
returned to Muthanna where they were destroyed under UNSCOM's
supervision. In total, UNSCOM supervised the destruction of
12,792 mustard-filled 155 millimeter shells at Muthanna during
the period of 1992 to 1994. This was at a facility we call the
Chemical Destruction Facility and that operated for those two
According to Iraq, 550 155 millimeter munitions were
destroyed during the war. This was only declared to us in
1996. However, Iraq has not provided us information on the
destruction locations. One thing you're going to note here is
that these numbers don't all add up precisely and there is some
uncertainty with respect to the margins for error.
Turning to the 122 millimeter rockets, in 1990 the
Iraqi Ministry of Defense ordered 8,320 122 millimeter rockets
to be filled with the sarin mixture of GB and GF. The filling
of the rockets began in Muthanna in December 1990. Seven
thousand Soccer 18 rockets were filled by 5 January and the
remaining 1,320 Soccer 18 rockets were filled by 9 January
1991. Our information is that around 60 tons of GB/GF mixture
were required to fill that number of munitions. Eight tons of
the mixture were produced by Muthanna in the fall of 1990. The
rest, around 50 tons, was produced after 18 December 1990. In the first half of January 1991, and this is
important because of degradation, that's when the degradation
would start in. In the first half of January 1991, sixty
vehicles were requested to deploy 8,320 filled rockets to
depots close to the anticipated field of operations. It was
recommended to store the rockets in bunkers. Among deployment
sites, Iraq declared the Khamisiyah Ammo Depot, which was to
have 2,160 rockets; the Aukhaider Ammo Depot, which was to
include 2,160 rockets; and the Mymona Ammo Depot, which was to
have 4,100 rockets. Again, the arithmetic is a little bit off.
That adds up to 8,420 not 8,320, but this is what Iraq declared
to us.
Previously Iraq had declared the Aukhaider Depot as a
CW storage area in the mid '80s, but not as a deployment site
in January 1991. Mymona -- in June last year Iraq declare that
Mymona was a deployment, a CW deployment site. That was for
the first time. Its specific location was not given to the
Commission by Iraq until January of this year, January 1997.
It has not yet been inspected by UNSCOM. So, what I'm saying
is these two deployment sites were not declared by Iraq until
last year.
These revelations -- put up the next slide now.
These revelations led UNSCOM to the inspection of the Aukhaider
Depot in April of this year, April 1997. During this
inspection three intact 155 millimeter projectiles, presumably
mustard-filled, were observed. The arrow points to the
locations there of the 155 millimeter rounds. Their location
is adjacent to the access road to bunkers supposedly used by
Iraq for CW storage. Can I have the next slide?
This is a line diagram that we have of the Aukhaider
Ammo Depot and the arrow points to the location which is shown
in the pictures and you can just barely make out where the road
is there on line diagram. According to the Iraqis the 155
millimeter mustard shells were stored on this road when the
bombing occurred. No CW or any other weapons were stored in
the surrounding bunkers during the bombardment. Iraq's
explanations concerning the bombardment of the road are
supported by photos of this area taken by UNSCOM in 1992, and
we can look at the next slide.
We have a couple of images from our helicopter. That
gives you the layout of the bunker area. You can make out some
of the craters. Including one to the right of the arrow, which
obviously, hits the road directly. There's a few other craters
in the area and the bunker has been hit. The arrow points to
the location of the 155 millimeter shells that we found in the
spring of this year. The next picture.
That's slightly a different picture, the same area.
At that time we were not prepared to do any sampling of those
rounds and it is yet for the Commission to examine those
particular three rounds to determine what, in fact, is inside
them. But we strongly assume that they are mustard rounds. If
Iraq's declaration on the accounting and deployment of the 155
millimeter mustard shells and the 122 millimeter sarin rockets
are correct, then the munitions at the Fallujah Proving Ground,
which we showed you earlier, could only have been brought from
the Aukhaider Depot.
Here I remind you, when Iraq first made its
declaration to the Commission in 1991, they did not declare
Mymona and Aukhaider. That is because there were no munitions
then located at either of those locations, according to the
Iraqis. Those munitions have, subsequently, been moved back to
either Fallujah or the Muthanna State Establishment. There is
supporting evidence for this explanation. One hundred and four
155 millimeter shells had been observed at the Fallujah area
were burned. We'll go to the next slide, 13.
Now, it could have happened during the bombardment of
the above-mentioned access road. However, the number of
damaged munitions at Aukhaider could not be confirmed. In our
estimate it could range from 104 to possibly 550, which is to
say the Iraqi number of -- this is getting confusing, I know
-- but the 550 which Iraq says were somehow destroyed during
the war, plus perhaps the 104 which we did see at Fallujah. We
can go to the last slide.
So to try to summarize what we're saying here is, on
the basis of the information available, the following
deployment scenario is suggested. It's a little bit hard to,
to read that chart but the green square areas are the locations
which we now believe Iraq deployed 155 mm. mustard rounds and
122 mm. sarin rounds during January of 1991. In other words,
Aukhaider, Nassiriyah, Khamissiyah and the Mymona depot. The
movement of those is indicated by the arrows. They had been
moved back to Fallujah and the Muthanna State Establishment
prior to UNSCOM beginning its work later in 1991.
The red arrows indicate the deployment that Iraq
followed in anticipation of the war. In other words, they
filled the rockets with sarin at the Muthanna State
Establishment and then ordered them deployed to the three
depots indicated. In addition, they took the mustard rounds
and followed a similar procedure.
Again, this information is based on data which we
have available to us at the current time. Future inspections
and discussions in Iraq may provide more detail or revisions.
I would point out that the commission has not yet visited
Mymona. Quite frankly, that has not been our highest priority
with respect to eliminating the weapons of mass destruction in
Iraq; however to complete and verify other factors that are --
or to verify Iraq's claim that it has no longer any munitions
that we will be visiting Mymona. I'm not sure exactly when.
With that, I think it summarizes the presentation at this time.
I would like to ask Igor Mitrokhin at this point if he has any
immediate comments but otherwise we can just take your
questions. Do you have anything?
MR. IGOR MITROKHIN: Thank you very much so just to
repeat again that this deployment scenario is related only to
the two types of munitions which we had been requested to
explain because the whole deployment scenario is much more
complicated, this type of the aerial munitions, the missile
warheads. Thank you.
DR. LASHOF: Thank you very much. That's fairly
complicated scenario. I think we're open to questions. Do you
have any evidence -- I think I follow this -- but do you have
any evidence that they've deployed any land mines that had
chemical weapons that could have been --
MR. MITROKHIN: We've seen nothing, absolutely
MAJ CROSS: Do you see any evidence where any
weapons were moved from the three lower depots, actually down
into Kuwait, maybe brought back at some time?
MR. DUELFER: We have seen no evidence of that and
Iraqis have said that no movements took place other than what
is described here.
MAJ CROSS: If I follow the time line it may
appear they didn't have the time to move it further down. It,
it seems that it was enough for them to just to get them down
that far. Is that a correct assumption, or --
MR. DUELFER: Well, if you're questioning, I mean,
this was as far as their dispersal took place, according to
what they have told us. They have specifically indicated that
they did not disperse them any further to units operating in
the more advanced positions.
MR. DUELFER: And again, I would emphasize that they
had stated quite categorically to us as recently as last week
that they did not use or employ any of these weapons.
DR. LASHOF: Does any of this add up to any other
inadvertent release by bombing during the war of nerve gas or
mustard that could have exposed our troops or do you feel that
the Khamissiyah is the totality?
MR. DUELFER: We have -- because our, the purposes
of our investigations are somewhat different, we ask ourselves
the questions a little bit differently. We, when we go to
sites we see is there any contamination of the area and, you
know, from 1991 on forward that is the question which we ask
ourselves when we visit areas. And there has been
contamination of other areas in addition to Khamissiyah that we
have visited but this is not a surprise. I mean, for example,
the Muthanna State Establishment, which is an enormous
facility, kilometers on each side with, you know, lots of
buildings and bunkers, was heavily contaminated when we first
arrived in 1991. It, it had undergone a lot of bombing.
Similarly, Muhammadiyat was also the target of some bombing but
these are areas which are, are quite far north. With respect
to the southern areas, as far as I know, the only areas which
indicated any contamination was the Khamissiyah depot.
MAJ KNOX: So if troops were deployed north at the
time of the war or even after the demolition of Khamissiyah,
they could have been contaminated with things that may have,
may have already been there. Is that what you're saying?
MR. DUELFER: Well, what I'm saying is that, that,
you know, the locations where we have indications of, of
contamination are roughly those three: Khamissiyah, Muthanna
State Establishment, and Muhammadiyat. Now, I mean,
geographically, I mean, Muthanna State Establishment and
Muhammadiyat are up closer to Baghdad, very close to Baghdad
and, you know, where the troops were, you would have to get a
definitive answer from someone else but so far as I know they,
they were not, they didn't stray that far north.
MR. TURNER: Can we just focus on a Aukhaider for,
for a minute Mr. Duelfer? Aukhaider is somewhat south of
Karbala. Is, is that right?
MR. DUELFER: It's, in the, in the area. You know,
we call it Aukhaider, I think during the war the Americans
tended to call it Karbala. They used that name itself but the
short answer is yes.
MR. TURNER: And the, the Iraqis told the UN that
they had deployed how many mustard rounds there?
MR. DUELFER: Six thousand three hundred and ninety-four, which is the same number which was then indicated at
MR. TURNER: And in your inspections there, you
found rounds that you believe were likely mustard rounds
although you have not -- the UN when I say you --
MR. DUELFER: I don't --
MR. TURNER: -- for example, those --
MR. DUELFER: -- those three rounds which we, we
buried, you know, we haven't haven't opened them so we can't
prove that they're mustard definitively but we have no reason
to believe they're anything other than mustard rounds.
MR. TURNER: Did the Iraqis give you indications
that Aukhaider had been bombed by coalition forces during the
air war?
MR. TURNER: And that at Fallujah in your
inspection work there, the UN found 104 mustard rounds that had
fire damage on them?
MR. DUELFER: They, they gave -- they looked like
they had been burned and damaged.
MR. TURNER: So even without contamination evidence
at Aukhaider, you do have some indications that there may have
been a release of that there during the air war?
MR. DUELFER: If you would make the assumption,
which is probably a very good assumption, that the rounds in
Fallujah came from Aukhaider, yes.
MR. TURNER: And again, working on the imperfect
knowledge that we have today, the range of likely is from 104
to the 104 plus 500 and --
MR. TURNER: Fifty. So 654 is the range of
munitions that may have been damaged by aerial bombing at
MR. DUELFER: Based on a statement by Iraq, of 550
for the number we're just -- that they claim were destroyed
during the war, plus the uncertainty associated with, you know,
the 104, as best we know right now, the upper range would be
the number you suggested.
MR. TURNER: Iraq also indicated to you that sarin
rockets were deployed or stored at Aukhaider, a couple thousand
I believe. Is that correct?
MR. TURNER: Is there any indication that those
were damaged or in any way involved in the aerial bombardment
MR. DUELFER: We have no information that they were
damaged. No.
MR. TURNER: Finally, on the second site that is
new, I believe which is Mymona --
MR. DUELFER: Mymona.
MR. TURNER: -- somewhat north of Basrah, the UN
has not visited there yet. Is that, is that correct --
MR. DUELFER: That's correct.
MR. TURNER: -- to do an inspection of this, these
most recent Iraqi revelations that chemical munitions had been
stored there.
MR. DUELFER: Correct, we have not yet visited that
MR. TURNER: Have the Iraqis given you any
indications that chemical munitions may have been damaged at
MR. TURNER: Thank you.
MAJ CROSS: Now, when you do go to Mymona, part of
your investigation is to sample the surrounding areas to see if
there was some contamination. Would --
MAJ CROSS: -- that be a normal procedure?
MR. DUELFER: I mean, because we have to establish,
I mean, if there were rounds there, if they were destroyed, we
need to account for them. So part of our inspection would be,
logically, to see if any of the rounds had been damaged.
MR. LONGBRAKE: What, what were the chemical munitions
at Mymona? What did they contain?
MR. DUELFER: They -- what, what Iraq declared to us
was the sarin-filled rockets.
MR. LONGBRAKE: Okay. And they, and what happened?
What did they do with them once they were --
MR. DUELFER: After the war, they moved them back to
the Muthanna State Establishment.
DR. NISHIMI: One other question to clarify on the
Aukhaider, so we're looking at potentially a range of a 104 and
4- to 654 mustard shells filled with agent of a purity between
85 and 95 percent? Is that a fair characterization of what may
have been stored at Aukhaider?
MR. DUELFER: You're drawing a conclusion which I --
is, is not unreasonable but what Iraq has told us is simply,
you know, five --
MR. DUELFER: -- hundred and fifty. They haven't
confirmed that these are, were filled at a certain point in
time. So, I don't know whether the, what the purity levels
would be.
MR. DUELFER: But, but, you know, what you're
suggesting is, is reasonable.
DR. PORTER: The committee staff provided you with
a list of 17 sites that were suspected chemical sites in the
Kuwaiti theater of operation. This list was one that was
circulated to US forces after the ground war. Have you had
occasion to have an inspection of any of these sites on the
list of 17?
MR. DUELFER: Now, we, I'm familiar with that.
We've been to, I think, two of them but I'll ask Igor to
comment on that specifically.
MR. MITROKHIN: Thank you, sir. We evaluated the list
that we received from the committee and we found that, in
total, we inspected four facilities listed in this document.
In particular, UNSCOM inspected, of course, Nassiriyah munition
depot, Khamissiyah ammunition depot, Tallil Air Field in 1992
and also underground storage bunkers which is entry number 12
on your list. This was inspected in 1994.
The results of following inspections at Nassiriyah
and Khamissiyah ammunition depots are well-known and we briefed
the committee on these results. Concerning Tallil Air Field
and underground storage bunkers which appeared to be the stores
of metal missiles were inspected and no evidence of chemical
weapons found there. Thank you.
DR. PORTER: Let, let me understand. There were
four sites of the 17 that UNSCOM visited.
MR. MITROKHIN: That is correct.
DR. PORTER: And of course one was Khamissiyah, we
know the Khamissiyah story, but at the other three sites, the
inspection revealed no evidence of chemical weapons or damage.
MR. MITROKHIN: Actually, yes. As it was explained by
Mr. Duelfer, 155 mm. shells were removed from Nassiriyah
ammunition depot prior to UNSCOM arrival and later on these
were found in the vicinity of the Khamissiyah ammunition depot
in the desert area. Concerning two remaining sites, Tallil Air
Field and underground storage bunkers, no evidence of chemical
weapons were found there.
DR. LASHOF: Are there any other questions? Not?
Thank you very, very much for coming. I know it's been a long
and torturous trip for you and off again but it certainly has
been helpful.
MR. DUELFER: Thank you very much. We wish you well
in your work. You have a difficult task as well.
DR. LASHOF: We will adjourn now for lunch and we
will have a fairly long break because we are a little bit ahead
of schedule. We will resume at 2:15.
DR. LASHOF: I believe we are ready to commence the
afternoon session. Captain Trump, welcome. You will address
the issue of medical surveillance and General Parker, happy to
have you join him when we're finished with the presentation on
medical surveillance, we'll open it up for some questions and
you will follow up on the issues we were discussing with
Pendergast this morning about the use of investigational drugs.
Thank you, go ahead.
CAPT DAVID TRUMP: Thank you. The first overhead
please. Madam chairman, distinguished committee members,
committee staff, on behalf of the assistant secretary of
defense for health affairs and the Department of Defense I
thank you for the opportunity to provide the committee with
information on the department's implementation efforts and
future plans for medical surveillance. I'm Capt. Dave Trump, a
public health physician who is director of military public
health within the Office of the Assistant Secretary of Defense
for Health Affairs. Next slide please.
In both the interim and final report, the committee
recommended prior to any deployment the Department of Defense
should undertake a thorough health evaluation of a large sample
of troops to enable better post-deployment medical
epidemiology. Medical surveillance should be standardized for
a course out of tests across all services including timely
post-deployment follow-up. The department strongly agrees with
the importance of pre- and post-deployment health assessment.
You received testimony at your June meeting regarding our use
of pre- and post-deployment health assessment questionnaires
for recent deployments. As noted during that previous
testimony, the department's position is that all deploying
service members of specified deployment should receive pre- and
post-deployment screening to include standardized health
screening questionnaires with medical follow-up as clinically
indicated. Next overhead please.
This medical surveillance initiative was just one
element of a comprehensive plan for medical surveillance during
deployments that were tested during Operation Joint Endeavor
and is being formalized in DOD policy. Implementation of a
medical surveillance program, especially in the pre- and post-deployment health assessment was a challenge for operations in
Bosnia. Such health assessments were not part of the military
doctrine, prior training or planning. Decisions on what to
implement and how to do it were made very late in the
deployment planning, and admittedly every single element of the
program was not well executed. For example, pre-deployment
health assessments which were initially proposed were not done
because many of the units had already deployed. Next overhead
The General Accounting Office's report defense health
care medical surveillance improved since the Gulf War but mixed
results in Bosnia that was released this past May serves as a
good assessment of our efforts. The report focused on the
steps the department has taken to improve medical surveillance
before, during and after deployments -- or after Operation
Joint Endeavor. The GAO does credit the department, the joint
staff and the commander in chief US European Command with
implementing a comprehensive program but -- next slide please --
the real world of implementation was not complete.
And I'll just highlight here in the next two sets of
overheads some, the GAO findings, in particular on this medical
surveillance. That information on who deployed was considered
inaccurate for the Air Force and Navy personnel participating
in that operation. That when they looked at Army personnel,
out of 618 medical, or, records, that they found that 24
percent did not receive in-theater post-deployment medical
assessments, 21 percent did not receive a home station post
deployment medical assessment and 32 percent had not received
tuberculin skin tests. Next slide please.
When home station post-deployment assessments were
done, they were performed on average 100 days after return
rather than the 30 days that had been prescribed at the
beginning of the program. And the documentation in the
individual's permanent medical records of in-theater post-deployment
medical assessments, medical service visits during
the deployment and for some, receipt of tick-borne encephalitis
vaccine was incomplete. Finally, reliance on pre-deployment
serum samples maintained in the central serum repository showed
that nine 9.3 percent of service members who deployed did not
have a sample in the repository and that many of those were
several years old. Next slide please.
We expect and we have acknowledged that there is room
for improvement in aspects of the medical surveillance during
Operation Joint Endeavor. It really was a -- we are a learning
organization. This really was an opportunity to test out some
of these ideas. There were also successes during the
deployment. There was regular surveillance of out-patient
visits and hospitalizations. That data was analyzed and use on
a regular basis in-theater and was reviewed routinely by both
the Joint Staff and, on at least a monthly basis, by the
assistant secretary of defense for health affairs and the
surgeon generals. Environmental sampling was conducted by Army
preventative medicine assets, in particular at the theater
medical laboratory that was deployed and preventable diseases
were kept at a low level. Next slide please.
One example just of the tracking that was presented
on a routine basis to -- at briefings in Washington was on the
out-patient visit rates which were tracked on a weekly basis
and again, routinely reviewed by the Joint Staff. And when
questions came up they were investigated, trends were assessed
also, not only for the total out-patient visits but for
specific diagnostic categories. Next one please.
Similarly, admission rates were monitored during this
period. The peak that you see here towards the end of the
graph was looked into. The analysis really suggested that
there was no single category of diseases that was accounting
for that increase; there was no change in the out-patient
visits at that time and really was coincident with the change
in the medical units that were providing services in-theater.
And in that transition it was felt that the different practice
patterns of the group and being new to the area accounted for
the increased change.
The other important piece of information is that the
Army medical surveillance activity under the US Army Center for
Health Promotion and Preventive Medicine has routinely
published analyses of the hospitalization experience. Their
most recent publication was "Hospitalizations: Operation Joint
Endeavor - Temporal and Demographic Correlates of
Hospitalization Risk" which appeared just in June, in the June
issue of their medical surveillance monthly report. Part two
will look at the specific diagnostic categories. Next slide
Members of the Army's 520th Theater Area Medical
Laboratory, the US Army Center for Health Promotion and
Preventive Medicine teams and other preventive medicine teams
conducted over 2,000 environmental samples of air, water and
soil that, to date, have produced over 125,000 separate
analyses. This was a wide-spread effort, much more intensive
at the beginning of the deployment but continues to date as
needed. And the real accomplishments will be in the years --
in the future when there, if there are any questions raised
about what service members were exposed to, this information is
in a central data base. Next slide please.
This is just to update you on re-deployment health
screening itself, up through July 11th. Looking at what we
have in the deployment surveillance team's database, phase one
are those that were done primarily in-theater evaluations and
to date there are over 33,000 of those records with the
deployment surveillance team, over 18,000 phase two evaluation
records which are those that are done upon return to home
station. And that for post-deployment screening, which is --
that over 76 percent of 30,000 service members who met the
requirements for post-deployment surveillance, they have at
least a phase one, phase two or potentially phase -- or both of
those forms in the database. Serum samples are also available
for 66 percent of those who required a post-deployment
surveillance serum sample. Next slide please.
Medical surveillance initiatives were being tested
during the Bosnia operation. We have learned lessons from the
Gulf War and we are trying to improve upon our performance. We
learned more lessons during Operation Joint Endeavor including
reinforcing our position that medical surveillance efforts need
to be integrated with our military doctrine, that's both
medical and operational doctrine, with the routine medical and
operational procedures and practices, the thing that we do on a
day-to-day basis, rather that just for a particular operation
or exercise. It really needs to be part of the training of
what our corpsmen, officers, enlisted expect as part of the
routine requirements in garrison when they're here in the
States and also during routine exercises. And then, probably
most importantly needs to be integrated into the operational
and medical information management systems, and the department
continues to move in such directions. Next slide please.
In previously received testimony on the DOD Directive
Joint Medical Surveillance. This does establish the Department
of Defense's policy for the Office of the Secretary, the
military services, for the chairman of the Joint Chief of
Staff, for the combatant commands, the commanders-in-chief of
those, for all defense agencies and field activities. It has a
companion instruction on the implementation and application of
that program which assigns specific responsibilities and
establishes some specific procedures to implement those. Both
are scheduled for publication in September of 1997. It's
important to emphasize I think, as you'll recognize from the
previous slides on Operation Joint Endeavor, that many of the
aspects of the DOD directive and instruction were already
implemented in Bosnia and even though the paper isn't there yet
at the DOD level, most of the pieces are already being put in
place. Next slide please.
I will just highlight the key elements of the medical
surveillance program and the DOD policies which is that service
members are to be physically and mentally fit to carry out
their missions, especially upon deployment. That medical and
personnel systems are to be designed and integrated to achieve
medical surveillance goals, which is to maintain the health,
assess the health, and protect the physical and mental health
of service members. And that such systems should be
continuously in effect, not only during deployments but during
all periods of military service. Next slide please.
That service members will be made aware of
significant health threats and the corresponding preventive
countermeasures, both those of individual importance and also
those that will be used at the unit level. And that the
commanders are responsible for ensuring that medical support is
available and that members of the units do receive training in
the countermeasures. Next slide please.
Medical surveillance before, during and after
deployments will encompass monitoring environmental,
occupational and epidemiologic threat from stressors, assessing
diseases and non-battle injuries, stress-induced casualties and
combat casualties including those from chemical, biological and
nuclear warfare agents, and assessing and reinforcing use and
effectiveness of command directed and personal countermeasures,
and ensuring also that there is delivery of optimal medical
care during and after the deployment. Next slide please.
Commanders are kept -- additional points are that the
commanders should be kept informed before, during and after
deployment of the health of the force, of the individuals in
their unit, of the health threats that are out there, that the
stresses and risks to their force on the health side are made
available, and also made aware continuously of the available
countermeasures. It will be DOD policy that a serum repository
be maintained for clinical diagnosis and when appropriate,
epidemiologic studies that will use joint technologies, joint
practices and joint procedures to ensure consistency among the
services. And that surveillance activities will include DOD
civilian and contractor personnel when appropriate. Next slide
I'll just go over these next slides which you have in
your packets. Basically, for each of the policy points and for
the instruction, the key elements tie into a matrix that really
shows that there's a continuum of many pieces that flow from
pre-deployment, during the deployment and after the deployment,
whether it's identifying the population at risk, rather it's
identifying the exposures -- next slide please -- whether it
is, in this case, what the exposure is pre-deployment, knowing
what the threats are in the area of operation and planning for
those specific threats, during the deployment, continuing to do
assessments, especially for occupational and environmental
exposures, analyzing the data that is collected in-theater.
And then after the deployment, updating the information so that
we have learned from the effort. Next slide please.
Similarly with protective measures is planning ahead
for those and incorporating those countermeasures into the
operational plan and then making sure the pre-deployment be
trained, equipped, supplied and immunized, provide briefings as
appropriate in preparation for the deployment, continue to
reinforce those during the deployment and then afterwards
identify where there might be new requirements. Next slide
And finally, really to continuously assess health,
pre-deployment, as far as understanding the health of the
force, the health of individuals, so that we are sure that
individuals are ready and units are ready to deploy, and
maintaining the serum depository, continuing to assess health
during the deployment. And then upon return, monitoring the
health of the force, both active and reserve, for the long
term, and providing if necessary specific screening and target
medical evaluations. Next slide please.
One element of the instruction was to charter a
working group to guide many aspects of this effort for the
assistant secretary of defense for health affairs. That group
is titled the Joint Preventative Medicine Policy Group. It has
already been chartered. It's executive council is formed of
the preventative medical officers from the service surgeon
generals at headquarters Marine Corps staffs. It has
preventative medicine representatives from the Assistant
Secretary of Defense's for Health Affairs Office,
representatives from the Joint Staff, and on a plenary council
has brought a representation that really represents many
different components of the Department of Defense including the
Office of the Under-secretary of Defense for Environmental
Security, which is responsible for environmental programs and
different agencies within the DOD such as the Armed Forces
Medical Intelligence Center. And then this assets that are
there within the services and also at the level of the
combatant command surgeons.
The Joint Preventative Medicine Policy Group has
developed a business plan for deployment surveillance for the
near term, of making consistent joint-deployment surveillance a
reality within one year. Under a series of deliverables such
as providing any preventive medicine appendix to NXQ, NXQ being
the health services support annex to operational plans.
You heard at the last, your last hearing about
Patriot Medstar and evaluating the pre- and post-deployment
screening program in that setting. Also, the migration of some
of the DOD medical surveillance functions, analysis functions
for deployment surveillance to the US Army Center for Health
Promotion and Preventive Medicine, the group that provides
currently for the Army publishes the, their medical
surveillance monthly report. Next slide please.
Also very short, near-term goal within the next year
of getting interim automated DOD immunization tracking system
in place for the active duty force with a longer term goal of
having a system that can serve all of our beneficiary
population. There are also aspects of other implementation
plans for force protection and particularly preventive medicine
chapter of the department's medical readiness and support plan
and also for the Joint Health Services publication, and provide
preventive medicine force protection input for that. The
longer term business plan for comprehensive medical
surveillance is being developed. Next slide please.
The deputy director of medical readiness, Rear
Admiral Cowan on the Joint Staff, sponsored in June of this
year a casualty prevention seminar to meet one of those
deliverables of the business plan and in particular to provide
input to the Joint Health Service's support strategy for force
protection, with its goal of minimizing disease and non-battle
injuries, to serve as a force multiplier and also to sustain
the combat effectiveness of the force. An element of that is
the documentation of all relevant exposures and medical events.
Next slide please.
Within this, some of the results basically have five
key elements that are felt to be very important to embedding in
joint strategy: the principles of disease non-battle injury
prevention, the medical surveillance as part of joint doctrine
and planning, stressing and emphasizing the casualty prevention
as a command responsibility, that comprehensive medical
surveillance is essential to assessing threats to the readiness
of the force, that the countermeasures that are available are
effective risk management tools from minimizing adverse effects
on readiness and that continuous casualty prevention must be
fundamental to military readiness. Next slide please.
In its very early stages, the department's
participation in the response to the presidential review
directive, DOD will chair the health preparedness working group
with the co-chairs being the acting principal deputy assistant
secretary of defense for health affairs and the deputy director
for medical readiness on the Joint Staff. And this group will
just be one of several that will help ensure support at the
highest levels within the department for medical surveillance
efforts. Final slide, please.
In summary, the Department of Defense is moving
effectively to implement a more comprehensive medical
surveillance program for all military members. We believe that
a joint policy in plan, incorporated in day-to-day health care
operations, information management systems, routine operational
training in routine deployments will best prepare the military
to implement successfully a comprehensive medical surveillance
program during the next major combat operation. To be
successful, the military has learned to train as we fight and
fight as we train, joint medical surveillance must be the same.
Thank you. Are there any questions?
DR. LASHOF: Thank you very much. Open for
questions. Elaine?
DR. LARSON: Just for comparison, in Bosnia 76
percent of Army personnel received an in-theater post-deployment
assessment. For example, the average time for the
home station assessments was 100 days. How does that compare
with the Gulf War? Is one -- I'm looking for, is there
improvement? Worse? Has it changed?
CAPT TRUMP: There was no program for post-deployment --
DR. LARSON: Yeah, the people had post-deployment
physicals, didn't they?
MAJ KNOX: Yeah, but it was really before they exited.
DR. LARSON: Before they exited.
CAPT TRUMP: There was the requirement for, prior
to separation, to have a physical evaluation, physical
examination, as part of the separation process. This is -- but
that did not apply to all the personnel who served in the Gulf.
Those who remained on active duty would have had no requirement
for any evaluation upon return because pre- and post-deployment
surveillance really isn't a new requirement that ideally
shouldn't be applied to all people who have deployed to the
theater, and for Bosnia met some requirements as far as their
physical location within Croatia and parts of Hungary, and also
had been there for at least thirty days.
DR. LARSON: In this joint preventive medicine
policy group, when was it started? Before or after Bosnia?
CAPT TRUMP: After it was really, it was an
outgrowth of what was becoming a very real effort tied into the
department's response to Gulf War illness concerns that there
needed to be a multi-service effort. The individuals who were
involved now on the joint preventative medicine policy group
were actually the ones who had gotten together without a title
to help craft the Bosnia deployment plan for the assistant
DR. LASHOF: When you state that among the 618 Army
personnel, as you say in your testimony, that 24 percent did
not receive in-theater post-deployment, 21 percent did not
receive a home station post-deployment, it leaves me a little
confused. I don't know whether the 21 percent who didn't
receive a home station post-deployment included the 24 who
didn't receive a theater post-deployment or were separate. I
don't know whether I'm supposed to add the 24 and 21 and come
up with 45 that didn't receive either or whether they're a
separate group.
CAPT TRUMP: That was from the GAO report. I think
those look, those, each of those evaluations independently but
I'd have to go back and double check those numbers.
DR. LASHOF: Okay. So you don't know how many they
assessed didn't have either home or --
CAPT TRUMP: It's in the report. I didn't -- I
don't have that number with me.
DR. LASHOF: We'll go back and check it. Thank
DR. CASSELLS: Earlier this morning we were talking
to the FDA about timing and the final rule. The first draft of
the (off mike) program that the committee saw was dated January
of 1995, which is two and one half years ago. Do you have any
comments as to why it has taken so long to get this directive
close to closure, since the substantive portions of the, of
evidence don't seem to have changed much.
CAPT TRUMP: Basically, I think it's an issue of
we, like other parts of government, are a bureaucracy and it
takes time to get things staffed through, to try to reach
consensus on what sometimes can be contentious issues. And for
this one is really opening up new areas, new requirements for
medical support, medical surveillance, which have not been
recognized as being important at this detail. And then it
takes some time to get through that. It also takes some time
for the actual staffing and I think I can reiterate the FDA as,
you know, there's more work than we have people to do the
things that we have to do.
DR. CASSELLS: Is it fair to say that there was no
contingent relative to the need, the contingent was over the
how to carry it out?
CAPT TRUMP: Yes, I think that's, you know, it's
the how, the details that go into what medical people in the
field are going to be required to do and the issue is one of
every time you add on a requirement, it either means the
individual is out there, the medical folks, you know, whether
they're in the field in Bosnia, whether they're on a ship or,
you know, trying to get more things accomplished and they're
not given extra hours in the day necessarily to do that and --
DR. CASSELLS: Let's move a little further along on
that, then. The committee had some nice things to say about
the briefings that we had received and the proposed medical
surveillance program, in our interim as well as our final
report. You've been quite straightforward today in your
testimony about the shortcomings in the Bosnia operation
relative to the implementation of the beginnings of that
medical surveillance program. And one of the things you stated
was how important it is that operational doctrine as well as
training doctrine incorporate medical surveillance activity
into the day-to-day operations. How confident are you that in
future conflicts this can in fact happen? Another way of
asking that same question is, how automatic can you make these
procedures? That they're not the first thing over the side?
CAPT TRUMP: Right. I think that's the challenge.
I think one of the key points in there is that we have to
integrate it into our data management systems, that we're not
collecting, doing things with paper and pencil that sort of has
to make its way back in an envelope in a soldier's or sailor's
hand to the medical record in the states, that it's electronic,
it's collected in the field, it goes electronically to a
central point that somehow ties it all together so we have an
electronic medical record, an electronic record that documents
everything that happens to an individual during their medical --
during their military career.
DR. CASSELLS: Let's follow that a little bit longer,
madam chairman, if I may.
DR. LASHOF: Sure, go right ahead.
DR. CASSELLS: What plan, once this directive is in
place, what plans does the department have to make sure that
this integration into operational thinking takes place? And I
mean thinking as opposed to writing the directive.
CAPT TRUMP: I think that it's a matter of steps.
One is to have the departmental directives and instructions in
place. The other step that I had mentioned there was making
this part of joint doctrine and also making the requirement one
of joint plan so that when there is an operation the script
basically is already written for what needs to be done. Once
those things are there though that, that also in turn will
drive what the requirements are for the people necessary to do
the job. That daily should feed back into the training
pipeline so that people who are being prepared as corpsmen,
medics, doctors, to go with units on deployments know that
there is a requirement to do medical surveillance, that there
is a requirement to do pre- and post-deployment health
assessments. It won't be an overnight evolution or success. I
mean, it really is a matter of making this a requirement for
the whole system and not just an add on that's done. And I
think --
DR. CASSELLS: The background to my -- the background
to my question and the reason for my concern in my experience
with making malaria prophylaxis a command responsibility in
Vietnam and how unsuccessful that was overall in achieving its
goal. But on the matter of a more practical basis of
integrating medical databases that you, you've heard at various
points as many as 125 different medical databases need to be,
in some way, incorporated and made to communicate with each
other. Do you really think that's feasible and what kind of
time line can that be done over and has anybody given any
thought to designing a system from the ground up?
CAPT TRUMP: I'm not the expert to answer those
DR. LARSON: Could I follow up a little bit on
that? There are three things in you testimony that I find
confusing, related to structurally how this is going to be set
up to make sure it doesn't fall through the cracks. First you
talk of it as joint preventive medicine policy group which
apparently is a fairly new group and as I read it, their role
is to develop this business plan with the deliverables and so
forth. Then one of the deliverables is the -- that the
analysis function for the medical surveillance will be housed
in the Army Center for Health Promotion and Preventive
Medicine. Then farther down, you talk about this health
preparedness working group which is talked about in the future
tense as another group whose job it is to, "... ensure support
of the highest levels for our medical surveillance efforts."
It sounds to me that there are several new groups being formed
and the concern, of course, is are they going to talk to each
other? What are their various roles? And you didn't even
mention those when answering that question.
CAPT TRUMP: I think those are some issues to be
resolved. They represent, I think, different levels of
coordination on the, you know, the health preparedness working
group is a much higher level organ -- body that --
DR. LARSON: Is it already in existence? Or is it,
it's in the future tense here.
CAPT TRUMP: I know that the principals have met.
Whether it's in existence -- but then that's only been in the
last week or so. With some of the others, it's a matter of
developing the connections of -- when we make a single service,
in this case the Army, responsible for deployment surveillance.
It does require tying in data from a variety of different
services, identifying what the staffing should be to support
that which really should be done on a tri-service with
representatives of the different services participating in that
DR. LARSON: But what's the evidence that that
group can handle this surveillance analysis function. In fact,
the data that we have isn't even from the DOD, it's from the
GAO. I mean, I'm just trying to figure out how all this is
going to work.
CAPT TRUMP: Okay. I had mentioned the one report
they had done on hospitalizations in Bosnia and I brought two
copies of that along if you'd like to take a look at it. I
mean, their efforts out there to look at hospital -- you know,
this deployment-related medical information to tie in as many
different databases that are possible to support that
surveillance effort. It really is, I think -- they have the
capability to do it. It's a matter of getting our different
systems to support them.
MAJ CROSS: Is that the surveillance -- the idea
is to take a look at the data and to spot trends of potential
diseases or potential disasters, is that what you're saying?
And who, who does the analyzing? Who can spot the trends? Is
it somebody in-theater or is it somebody here in the United
CAPT TRUMP: It's different levels. The system
really needs to be set up so that it's usable for the people
who are in-theater and they really, during this deployment,
have been able to use it to, you know, monitor their trends.
It's also a responsibility for the medical staff for the
commander-in-chief in that region to monitor that. And they,
you know, they have used it. We actually had this type of
surveillance in place to some degree during the Gulf War as far
as being able to look for how a real disease outbreaks and
respond early. And this is not necessarily looking for the
long -- some of this in-theater is not looking for the long-term result,
it's looking for problems now in the early stage
so you can intervene, you know, move the troops from the
hazard, provide the protective measures, change the procedures
or the food source or whatever it is as early as possible. I
think that's something that has been done. There's always a
responsibility of preventive medicine and medical people in a
military operation. What we're doing now is hopefully setting
up a system that will not only do that but then preserve that
data for the long term and then also taking on a new
responsibility of some long-term monitoring for, potentially
for any long-term health effects that might be associated with
the deployment.
DR. LASHOF: I think -- okay. We'll get --
MAJ CROSS: Is the VA tied into any of these
committees? Because the thought is, in terms of long-term,
once a person comes back and is discharged, just in the
civilian community. At some point, something shows up a couple
years down the road, obviously reports into the VA system. So
I don't know, are they tied in today to this program?
CAPT TRUMP: A lot of what I was telling you, it
has not been -- that is, you know, that's an issue with both
departments though as far as making this a sort of a seamless
transition from information that DOD has that relates to the
health of veterans to information that the VA will have access
to, and especially in the response to the presidential review
directive, I think that is a concern there. It's not just
DOD's issue or problem.
MR. KOWALOK: Okay. A quick question about the
working group, the health preparedness working group. As far
as making medical surveillance part of our doctoral thinking is
that working group with a policy setting group? Or encouraging
such element?
CAPT TRUMP: That group is just established. I
mean, just identified and I --
MR. KOWALOK: Will there be a representation for the
operational side, the house?
CAPT TRUMP: The co-chair there is the medical
director from the Joint Staff. I mean, he represents the
operating force.
MR. KOWALOK: And that's relevant to commanders in
the field?
DR. LASHOF: Any other questions for Trump?
DR. LASHOF: Okay. Let me just set policy. Let me
explain the policy here. I recognize you've had your hand up
but our policy is that the time for open presentation from the
public is the first thing in the morning. After that, it's an
opportunity for the committee to relate and ask questions just
on the staff, to the agencies or whoever we ask to testify.
It's not a time for people in the audience to ask further
questions or interrogate the people asking questions. However
-- let me finish -- if you have specific questions for the
committee, at the break you can speak to any one of us. If you
further statements you want to make that you want to submit for
the record we're happy to take them but we can not open up just
time and everything else, in fairness we can not open up the
floor to any member of the audience to enter into an
interchange with the people who are here to testify. I'm
sorry. That's been our policy for a year and a half and we
have to keep to it.
FLOOR: (Off mike)
DR. LASHOF: I think --
FLOOR: (Off mike)
DR. LASHOF: Well, I, I'm --
FLOOR: (Off mike)
DR. LASHOF: Right. He's talking to us about --
FLOOR: (Off mike)
DR. LASHOF: I'm sorry. This is not an opportunity
we can give you at this time. I would ask you to pass
statements to us, you can put it in writing to us, you can meet
with us at the breaks but we just can not open up. This is a
general forum. Okay.
I think we'd like to move to ask Gen Parker some
follow-up questions that came up this morning in relation to
the investigation on drugs and VA and specifically with what's
happening in Bosnia.
DR. CASSELLS: Gen Parker, one of the things that FDA
in the testimony this morning, as well as the GAO report,
identified as a problem with the clinical trials of tick-borne
encephalitis vaccine in Bosnia, was the absence of operational
doctoral acceptance into the program of necessary requirements
for conducting a field trial in a deployed environment. And
there were a number of deficiencies that were identified in the
letter that FDA sent to Dr. Martin at the end of July of this
year. What is the department, and particularly since the Army
has the IND for this, how does the Army intend to address the
deficiencies that were identified in that letter? And first,
is that clinical trial still in process?
GEN PARKER: Sir, let me start with the last first.
The TB encephalitis program stopped on the first of -- it will
stop completely on the first of September. There are no
vaccinations going on in Bosnia at the present time and the
closure of the program will occur on the first. Immunization
stopped a long time ago. It takes a little while to get the
paper and close the program. If I could take a moment and just
go through my testimony with you, I will answer a lot of your
questions. I'm trying to be quite frank, Dr. Lashof and
honorable members of the committee, with this Department of
Defense problem that we have. As you know, I'm the assistant
surgeon general for the Army and I will discuss the letter from
Dr. Friedman to Dr. Martin from our perspective in the DOD.
DR. NISHIMI: If you could limit it just to the TBE
portion Gen Parker and I think that would be most useful.
GEN PARKER: Okay. With respect to the
investigational vaccine for protection against tick-borne
encephalitis in Bosnia, we have investigated and we are
continuing to investigate the facts concerning the issues that
I will address below here. We will share our findings with the
Food and Drug Administration that's mandated within ninety days
as requested by Dr. Friedman and we will also share those
findings with you and the entire committee.
In consultation with both the Food and Drug
Administration and this committee we will take appropriate
corrective policy and operational actions regarding identified
problems with planning, the execution and the leadership in
this effort. We reviewed a report on the same issue from the
General Accounting Office that was dated May 13, 1997, and have
already concurred with its findings. There are several key
areas where we agree that major improvements are needed and
where particular attention is needed to ensure that regulatory
requirements are met in a field situation.
First, we will ensure full accountability and
recording of all doses of vaccine whether they are actually
used or destroyed if they become unusable during a field
storage situation. One of the findings was that the number of
doses shipped minus the number of doses given didn't add up and
there was no accountability for those doses of vaccine that
were either destroyed or just not given.
Second, we will ensure that all volunteers fully meet
the approved eligibility criteria and that we have documented
their informed consent in their permanent medical record. This
is a slight deviation from a standard IND protocol that you
would do at a medical center in the civilian world. Those
consent forms generally go into a file in the program
director's office who's running the protocol and they don't
really end up in a person's medical file. We will put it in
their medical record.
Third, we will ensure that commanders at all levels -- and this
speaks to Mr. Cassells' question very distinctly --
we will ensure that commanders at all levels, both medical and
line, commit in advance -- and that's a key term, commit in
advance, that's the key to this whole thing. If it's not front
loaded it doesn't work. We've learned that. We see it time
and time again. We need to commit in advance the necessary
time, the mission priority and the human and material resources
to ensure the successful conduct of such studies so that we
meet regulatory standards. From the senior leadership of the
Department of Defense to every subordinate level of command,
when we commit to conducting the evaluation of an
investigational medical product, we will ensure that all
responsible commanders identify and execute the responsibility
as a matter of emphasis.
Fourth, we will ensure that all informational
materials, counseling and forms are approved by the
institutional review board responsible for the oversight of
this particular protocol.
Finally, we will resource such studies with fully
qualified clinical investigation teams on-site with the
necessary authority and responsibility to conduct, monitor,
report and correct potential problems as the work proceeds, to
set in an oversight group, a committee that has not been formed
yet but the surgeon general of the Army will co-chair a group
with the assistant secretary of defense for health affairs.
The committee will include flag representatives from each of
the services both medical and operational. Appropriate legal
and ethical experts, key members of other government agencies,
for example the FDA and other civilian experts.
We and the FDA are ready to engage in a productive
dialogue to correct these transgressions that we have committed
in, not only with the follow-up on Pyridostigmine Bromide which
is a little different than the TB encephalitis program.
They're two different -- one is apples and one oranges but we
didn't do well with either one.
MAJ KNOX: I still am concerned Gen Parker. I think
that all soldiers would agree that if there's some type of
vaccine that's available to help us that we're all willing to
take it, and I think that was what was important, and it came
out at Desert Storm for those troops who were going to Bosnia
that we could learn from that lesson. However, we obviously
have not learned from that lesson. We still are not doing
things correctly and we still have deficiencies. Why would
this be -- this third chance be any different than the second
GEN PARKER: Well, I'm not here to make an excuse.
The facts are on the table; we did not do it well. Now, why
didn't we do it well? I think it goes back to one of these
things that for a long time the military services have expected
a lot from the medical departments and considered that if the
medical department was going to take care of it, it wasn't
necessarily one of those things a CINC or a task force
commander had to put in an operational order. And we are
gradually getting to the point, when I said in my testimony
that we want the command and the line involved, medical is not
an ancillary thing when you go into an operation. It has to be
in the ops order big and brilliant so that every commander from
the top to the bottom is checking and re-checking on how that
piece of the op order is being executed.
So, I think this is really getting at why we are
getting a little better and a little better and a little better
but we're not there yet. This is a major effort to have people
take a look at more than just the situational operational order
to maintain peace, to take a piece of land or something like
this. War is complicated. It is much different than World War
II or Korea. I think we have many, many more things on our
plates for our commanders. It's a complex task and we're still
learning how to execute a very, very complex task.
MAJ KNOX: Well unfortunately though, I mean, there
may be a presidential advisory committee that has to look now
at soldiers who served in Bosnia that agreed to take tick-borne
encephalitis vaccine. Sometime we have to learn from our
mistake and pay for it and it just is very disappointing, I
CAPT PARKER: Well, I think one of the things that
came out of the tick-borne encephalitis look, that we've
already done, was that you know when you're in a medical center
and you sit on an investigational review board and that
protocol director comes up and presents the protocol, presents
the consent forms and everything, it is scrutinized to the --
MAJ KNOX: Right.
GEN PARKER: -- to the punctuation. When you go
into a field situation and a junior physician or a junior
health care provider has trickle down affect of what this is
all about and only hears that he's got to educate a commander
and the troops of his unit about this vaccine and either give
it or not give it according to what the soldiers or airmen or
sailor says after the education thing and makes a small slip in
the presentation that this is good for you, breaks all of the
investigational protocol that we're all very used to. And this
is in the excitement of trying to do a job. And so therefore,
anybody that was in that room when that health care provider
said to that group take this, this is good for you, just did
not get good informed consent.
MAJ KNOX: Well, right there might just be evidence as
to why we can't have informed consent during wartime.
GEN PARKER: Well, I think we can. I think we can.
We have grappled with very tough problems in the past and I
think through our officer basic courses and our officer
advanced courses we can tailor the education that when you're a
military physician or a military health care provider, it is
much different than if you were working at the city hospital
downtown and this is why, and here's all the things that you
have to be concerned with. I think we can do that.
DR. CASSELLS: My question really was --
DR. NISHIMI: Okay. I have -- a question. Gen
Parker, I mean, obviously the committee and veterans have good
reason to be concerned by the content and the scope of the
FDA's letter of deficiency to DOD and I don't think I need to
point out to you the obvious but I'll repeat it for everyone
here is, that this president has also been particularly
concerned about ethical conduct of research involving human
subjects. That's what his apology to the Tuskeegee survivors
was about. That's what the Human Radiation Experimentation
Committee was about. That's what the National Bio-ethics
Advisory Commission is about. That's what elements of this
body's charge is about. And so you've heard a lot of
statements that perhaps DOD is incapable of conducting and
overseeing research involving soldiers during deployments. It
strikes me that someone needs to give this serious independent
scrutiny on how DOD is conducting this kind of research and
would you support a sort of full and open inquiry and review of
DOD's research involving human subjects on military personnel
by the president's Bio-ethics Commission?
GEN PARKER: I would welcome that. I have no
objection to that and I think it was said in this room this
morning that there are many investigational new drugs that are
being used in our medical centers and throughout our medical
system and the FDA feels that the compliance with the -- the
regulatory compliance with that is extremely good and we have a
very good track record at actually getting new drugs approved
and on the market.
Now, if I could take a minute, the consideration that
Pyridostigmine Bromide and Bot Tox was an investigational drug
when we went into Southwest Asia is true. Now, the reason is
was investigational was both of those items were being used for
things that the label did not say that it could be used for.
And so therefore, it became investigational not because it was
a new drug but it was an old drug being used for new purposes.
And the FDA and the DOD wrestled with that because that became
a forced projection -- forced protection issue.
What we did with the follow-up on PB and Bot Tox
could be shuffled off the table a little bit by saying well,
the war was a very fast war, big buildup, fast war and a fast
cleanup. We can't say that for Bosnia. We went into this
protocol just a little differently and the protocols are
totally different. The PB and the Bot Tox need to be separated
from the TBE protocol. I mean, there was a protocol that was
not followed in peacetime and I put those in two different
categories. So I would -- I welcome any outside help.
The emphasis for the Department of Defense is we will
have major threats in the future for our forces. We need to
protect them. We will probably be using investigational new
drugs or new drugs in the future and we've got to get over this
ethical difficult hurdle.
DR. LASHOF: I think that's an important point and
as I was discussing with FDA this morning, I think it's very
difficult for you to carry out a true clinical trial under
wartime conditions. I mean, we have enough trouble trying to
do them in civilian conditions and we've had major clinical
trials where some -- any doc -- just wants their patient in
this group and not in the placebo and maneuvers that way. And
so we know there are lots of problems and I think the real
challenge will be, is there a way we can identify what drugs we
need to use in the field and if contingency approval for them
rather than having them be investigational drugs and think we
can carry out experiments in the field when we're sure that the
benefits outweigh the risks. But it's how that in advance.
But the idea of a Presidential Commission on Bio-ethics looking
at this or some others looking at it in more
depth, it clearly will come up in the response to the notice of
proposed rule making all those issues ought to be aired. And
so, you know, we're not going to put this one to bed very
easily but it's something we need to resolve, hopefully before
the next conflict, although I'd much rather just have us not
have any more conflicts.
Are there any more questions? Orlando, did you have
any? Time? Thank you very much, appreciate your appearance
here and thank you Gen Parker for sharing that insights with us
GEN PARKER: Thank you, ma'am.
DR. LASHOF: We are ready to move to our next panel
which is a discussion of the modeling of the troop exposure at
Khamissiyah and the pit demolition. And I'm very please that
we have with us Dr. Bernard Rostker, Col. Larry Cereghino -- is
that correct? -- Dr. Rick Barbarsky and Mr. Robert Walpole. If
you'll all come forward together I think we can proceed to that
Dr. Rostker, I assume you will be kicking it off or
one of your --
DR. ROSTKER: Actually, Mr. Walpole will.
DR. LASHOF: Mr. Walpole, very good.
MR.ROSTKER: Let me just put it in a little
DR. ROSTKER: As you know, we have been working very
hard for a number of months to provide the best possible
estimate as we can as to what happened at Khamissiyah. This is
but one of three assessments that are currently under way,
either by the CIA and DOD or DOD alone. The special assistant
to the secretary of defense for intelligence oversight is
working on an intelligence assessment of Khamissiyah and any
other related sites in Iraq. His work is still forthcoming
although we have seen the raw material of his works in terms of
his review of the intelligence messages and databases.
We also have a completely independent assessment
under way of military operations around Khamissiyah and in
southern Iraq being done by the Army inspector general. In
that regard we have made sure that the Army inspector general
has all of the leads that we have and is addressing all of the
questions that we have in terms of who knew what when and what
were the operational responses. But as typical with an
inspector general operation, they have not shared with us their
findings except in general to say they don't expect that there
are any great surprises. But that full report is still
The issue of the explosions in Khamissiyah will be
the subject of this discussion. It is very important, in our
judgment, that we go -- had gone through this detailed
assessment especially six years after the fact because this is
the raw material of a lot of follow-on research,
epidemiological research in which we really needed to know who
may have been exposed to what and how much. And we feel that
this is as definitive an answer as is possible at this time
resulting from substantial testing and involvement of a myriad
of organizations both within and outside the Department of
Defense to ensure that we have the best possible assessment.
Bob Walpole will discuss the actions that the CIA
took to reduce uncertainty and then I will discuss the actual
plumes and our assessment of troops that may have been exposed.
Now, we're prepared to talk to you about the modeling and any
of the activities that went into that, particularly the tests
at Dugway and the follow-on tests at Edgewood in terms of
evaporation from soil and from the wood, the wooden crates that
absorbed a good deal of the material. And I think with that
Bob, do you want to start?
MR. WALPOLE: Dr. Lashof, members of the committee
and staff, I'm pleased to appear before you today to discuss
CIA's continuing efforts in support of the US government effort
on Gulf War illnesses and particularly to discuss Khamissiyah
and the pit release there.
This has been a joint effort with DOD in every sense
of the word, with significant coordination going on that's
included weekly joint meetings, hundreds of people in multiple
agencies, dozens of experts involved with expertise from the
upper atmosphere all the way down to characteristics in the
soil, as Dr. Rostker mentioned. If I can start with the first
In September, 1995, CIA analysts had determined that
Khamissiyah was a point that we needed to spend more attention
on. It was a site of potential chemical agent release. In
fact, you remember one of the analysts was listening to a
radio, a tape of a radio show in March of '96 and determined
that the bunkers that are being described here got to be the
Khamissiyah site. In May of '96, Iraq told UNSCOM inspectors
that the chemical weapons destroyed there -- we can go to the
next slide -- were destroyed by US forces.
Now, earlier UNSCOM had indicated coalition forces
had destroyed the bunkers and that's up in this area here. It
was '96 that they had indicated the pit area was one that
needed to be looked at. This committee and the staff of the
National Security Council directed us to begin modeling efforts
for both bunker 73 and the pit as well as al Muthanna and
Muhammidiyat which were mentioned earlier today. We were able
to complete the modeling in the al Muthanna and Muhammidiyat
and bunker 73 because they were all buildings and we had ground
testing from the '60s that told us how an agent would react
when destroyed inside a building. We did not have that kind of
data for what would happen in an open pit demolition.
Now, what you've got in your books, you've got a
package called uncertainties. That was a larger package we
prepared for a press conference a few weeks ago. I really
won't be referring directly to that today. You've got a
package called modeling, the pit issue, and that was dated the
24th. That was for last weeks press conference. I will be
drawing slides from that package as well as a brand new package
you were handed that started with the map and as basically
backup, you've graphed some photographs that I'll be referring
to. I've also brought a one-minute video of the Dugway testing
that I think some of you have not seen before so there will be
value there.
Now as we indicated before, we had great
uncertainties in what the agent would do. In addition to those
uncertainties we were uncertain about the weather, what the
weather was doing. If I can go to the next slide. We
increased the number of interviews that we were having with the
soldiers -- actually the number of soldiers, from two soldiers
to five, which is more than a 100 percent increase obviously --
and it helped us address some of the contradictions in their
stories. It helped us ascertain that the events all occurred
on March 10th. There was a log entry on March 12th of a
certain number of rockets destroyed. The soldiers unitedly
told us that the log was prepared after the fact and that we
should not place credibility on that date. They described the
events in all parts of the pit which gave us confidence that
yes, they did in fact do that. In fact, two of the soldiers
had left for Saudi Arabia after the 10th, so they could not
have done any of this activity on the 12th. So we're very
confident that it all occurred on the 10th.
We had the Institute Defense Analysis review panel
that went over the efforts that we had performed before, made
recommendations, they provided a significant amount of
meteorological expertise on this issue. We refined the source
term -- and I'm going to come into that in more detail, Dugway
testing I'll come into more detail as well -- on the new
sources for our meteorology. If I can go to the next slide.
This is one of those wonderful slides that you put up
and hope people simply believe you because to look at it you
can't see a whole lot. But what we have is soot patterns from
a bunch of bunkers that are blown up. We were able to identify
which bunkers were blown up on March 10th. And then tracking
the pattern of the soot, we're able to ascertain the direction
of the wind at the time of demolition. And the demolition of
those bunkers and the demolition of the pit occurred at either
exactly the same time or the pit was just a few minutes
afterwards. So the wind was, was the same. If I can go to the
next slide.
This next one is a helicopter shot, it's upside down
but it doesn't matter. What it basically shows is that yes, we
are talking about soot and debris and if you really studied
that one in your package you can study that closer, you see the
debris that was coming from the sites.
The next shot -- and you'll be able to tell this a lot
better in your individual packages -- the red arrows up here
are all the azimuth lines drawn. And so what was done, we took
the soot patterns, drew the azimuth and determined that the
wind was 335 degrees, coming from the north-northwest blowing
to the south-southeast. That was critical for starting any
modeling exercise. With al Muthanna and Muhammadiyat we don't
have the exact data at detonation so we don't know the
direction of the wind. We could not apply this model until we
have that sort of information. The next slide please.
I promised I would come back to the refining the
source term. We spent a lot of time determining how many
rockets were actually in the pit at the time. You could tell
from Mr. Duelfer's presentation this morning that the Iraqi
declaration numbers don't always add up. In fact, they
generally don't add up. So you have to do some interpolation
to make sense of those numbers. The Iraqi's, for example,
declared that there were 1.100 rockets in the pit at the time
of our demolition. They've recently declared that about half
the number at Khamissiyah, which you saw in Mr. Duelfer's
records this morning, 2,160 were in the pit. Well that would
be 1,080. We have always believed there were more than 1,100
in the pit.
We still believe there were more than 1,100 in the
pit based on those soldier's stories. They explain the height
of the stacks, there were thirteen stacks in the pit. Some
were over their heads, some were down at chin level. We, based
on photography and measuring the height of the stacks -- you
usually don't measure the height, you measure shadows cast by
the stacks and then use that to calculate the height -- and
with their testimony and the photography we have corroborating
which stacks were higher and which were lower, we calculate
that we have a best estimate of 1,250. Fourteen hundred is an
upper bound. It's a number that you've heard me use before and
that is assuming all stacks are the full height -- which we
know from the soldiers testimony they weren't and as well as
from the other information I described -- but that would still
be an upper bound.
Now, in the amount of agent for rocket -- oh, the
next slide shows you some of the efforts that we went through
with what the stacks looked like. These are huge stacks of
rockets. We've got a guy standing by one so you can see that.
And we, we had people going through various ways so they could
have the interviews with the soldiers and talk in a cogent
manner with what they were describing.
That's right, this is an artist's representation. I
mean, I think you can, maybe you can't tell from the back but
this is not a photograph. If we had a photograph like this
before the demolition, that would have been tremendous. We
don't have that. We're creating this information after the
Now on to the, on to the amount of agent per rocket.
The next slide please. Yeah, it's 6.3 kilograms per rocket.
We had carried 8 kilograms -- if you can do the next slide now.
This is a photograph and what I've got in my hand is, is a
piece of one of these, the point end, the one to the right.
This is one of the inserts. Now, in preparing for the Dugway
testing we had to have somebody manufacture some of these
inserts. In manufacturing the inserts we discovered that they
could not hold 8 kilograms of chemical agent; they could only
hold 6.3 kilograms. The 8 kilogram number we had been using
included the mass of the plastic inserts. So we had to revise
that information.
The next couple of slides show different views of the
warhead. This is one that we got from UNSCOM, cut-away view so
you can see what the warhead is like. This was essential --
the next slide as well -- of a breakdown view of the warhead --
essential for us to be able to do modeling at Dugway, or the
testing at Dugway, that would have any validity at all.
All right, now the last thing I was going to talk
about on source term is the agent purity. And the next slide.
The agent purity is 50 percent; that's what we used for our
model. The UNSCOM when they were there in October of '91 had
drilled a hole in one of the rockets and taken samples. Those
samples tested out at 10 percent purity. That was six months
after the demolition so we couldn't use that number. We knew
it was higher than that. Iraqis had claimed that they had 70
percent purity. We did not know at the time of the Iraqi claim
whether that was the upper bound or their average.
We've got Iraqi production records and that gives us
a range of 40 to 60 percent at the time of demolition. In fact
-- if you do the next slide -- you can see the curve plotted
from these production records. It starts up here at 55 percent
agent purity at the time of manufacture. You take the 10
percent that was detected during the test, the sample, and you
run the degradation curve on it. At the time of the
demolition, which was in early March, you're a little bit less
than 50 percent. Now, given uncertainties that we have, we go
ahead and use 50 percent as an upper bound for that number.
And we're fairly confident that was about the purity at the
time of detonation. Next slide.
Based on the soldier's descriptions, the rockets were
all, they were facing different directions. This was important
particularly as the soldiers began to describe how they place
the charges. They took the ends off the crates, placed the
charges on the end of the rockets. Some described they always
put it on the warhead; some described that they put it on
either end. One gave a description that he ran out of charges
before he got through half the stacks, so we know that that
description, he was mis-remembering somewhat. But to be fair,
this was six or seven years in the past and was going to be
hard for them to remember that.
The next slide, we did a random distribution for the
Dugway testing of where the charges would go, based on the
soldiers saying that we took the ends off and placed them
around some of the warheads. Next slide. This just shows you
placing of one of the charges by the warhead.
At this point, if we could run the video of Dugway,
what we've, we've got a long time of video on the video tapes.
We've extracted one minute worth of video for you to see some
of the single detonation, some of the multiple stacks. And you
will also note as you look at the video that we've got sensors
in towers and then there's cards placed along the desert floor
to pick up droplets and whatever comes down from the, from the
(Video) That was a single rocket there. This is
some of the towers from a different view, the same single
rocket. If I recall that was a stack. Was that a single or a
stack? (Off mike). That was a single again. Here's a stack
of nine. And the next stack you're going to see is a stack of
nineteen. Seen from a further distance; you are able to see
there the cloud going through the sensors that were able to
track the volume of simulated agent, which was tri-ethyl
phosphate. Is that the last one? (Off mike). Now you get an
overhead shot so that you can actually see how much of it
disperses and puddles on the ground and we'll be talking about
those percentages in a moment.
Okay. The next three slides that are also in your
package. This is a photo that one of the soldiers took or had
another soldier take of him standing by a destroyed stack. The
next slide is the same photograph focusing on the crates in the
pit with some enhancement to the photography so you can see
that some of the rockets are still -- some of the crates are
still stacked on top of each other.
The next slide is debris from the test at Dugway. So
-- and we did a lot of comparison of the photographs to make
sure that, yeah, what we were doing was replicating about what
had taken place in the pit. Okay, next slide.
Now, only those rockets that had a charge placed on
them burst to aerosolize the simulant, and that was 2 percent.
Two percent of it aerosolized as vapor in droplets, about 1
percent each. The soldiers were limited in the number of
charges they had; they only had four boxes as best we can
ascertain of charges. At thirty charges a box, that's about
120 charges. Even if you're off by a box, you're ranging from
90 to 150.
One percent of agent, as I said before, went as
aerosol and 1 percent is -- I'm sorry, 1 percent went as vapor,
1 percent as droplets. We were able to calculate that by using
the sensors I described, the cards spread along the desert
Many of the rockets were not harmed. That is what we
saw occur at Dugway and that's consistent with UNSCOM going in
in October '91 and finding that 750 of what we assessed to be
1,250 fifty, where the Iraqis claim was 1,100, were not harmed,
were not affected by the detonation. So, using our number
which is a greater number in the pit, we get 60 percent were
not, not affected.
Now, 15 percent of the agent then spilled into the
wood and of that, about two thirds evaporated -- I don't have
my, where is it? About two thirds evaporates over the next two
to three days, 15 percent spills into the soil and about one
third of that evaporates. Eight percent burns up on
detonation. You get a higher percentage when you're inside a
building because the buildup of the heat. Next slide.
This next pert -- and you can't read the numbers on
the axis but you can in your package -- on the outside axis is
the percentage of agent and if you total the numbers I gave you
before, you get about 18 percent of the agent that releases.
And this shows the distribution over a number of hours of how
that agent releases until you get to the 18 percent. And it
runs out -- I can't even read that number over there -- is that
about 100 hours? All right, we were running these, we were
running our simulations, our modelings for about 100 hours and
you can see why. By then, the release levels off. Next slide.
This is all that broken down, what I just said, in a
pie chart form which is easier for a lot of us to understand.
I learned once before -- oh, it works over here. Last time at
the Pentagon when I tried to use my red laser it didn't show up
on the dark blue. The, 30 percent of the agent did not
release. Now, what we did was took the number of rockets,
1,250 by the amount of agent per rocket, multiplied all that
out and get 1,882 gallons. That means that a little over 1,100
gallons did not release from the rockets.
UNSCOM took away those 750 rockets and made sure that
they were destroyed after the fact. So they're not still
running around. The other numbers of gallons, the ones I
described before, the 1 percent in vapor, 1 percent is
droplets, that's 19 gallons each. Then you get 108 gallons
that was spilled in soil but later evaporated. You get one 196
gallons spilled in the wood but later evaporated. And the rest
of these is what spilled in soil, wood, and destroyed in the
blast, so it didn't, didn't disperse as part of the plume.
Next slide please.
The last thing I was going to cover was the modeling
effort itself. We used multiple models. The IDA panel had
recommended, given the uncertainties in the meteorological data
and what they described in their paper as uncertainties in the
source term -- but they had not seen the Dugway testing, in
fact we had not even done the Dugway testing when they were
writing the paper -- they were concerned about the source term.
And when we got that information locked down, it wasn't quite
as critical. That said we use two different synoptic
meteorology models, the broad scale meteorological models, to
feed information into where we were going with this.
We used three mesoscale models, MM5 Omega and COAMPS,
that gives us a more localized time of events weather. And
then we linked those in five different ways with three
transportant diffusion models. NUSEE-4 was the model that CIA
had had its contractor use in the past. IDA was very concerned
that we had not linked that. And we had not directly linked
NUSEE to Omega. What we had done, or what our contractor had
done last year was linked Omega, right there, with VLS Track
and then force-fed the information to NUSEE-4. NUSEE-4 at this
point is not linkable.
To do the modeling, the new modeling effort, we used
a SKIPUFF which we linked with all three of the mesoscale. We
used NUSEE-4 which we worked with the Omega and then we used
VLS Track which was linked with COAMPS. Every one of these
produces a different, slightly different plume. That's to be
expected. Every one of these models has strength and all of
them has weaknesses. NUSEE-4, while it's not directly linkable
is one of the only ones that can handle multiple agents. Well,
it had some other, what IDA refers to as significant algorithms
that makes it advantageous to work in this effort. So by
putting these all together -- the next slide please -- we
developed what we call a composite or a union of the various
Now, UNSCOM had indicated that -- not UNSCOM -- IDA
had indicated that we needed to run perpubtions on the weather
because they were very concerned about uncertainties in the
weather and we did that. We ran the weather every which
direction it could go and then we eliminated those -- I've got
down here, runs inconsistent with observed weather patterns
were eliminated -- we eliminated those that just fell outside
observed conditions, the observed conditions being the soot
patterns. We also looked very closely at the smoke from the
oil fires and anything that ran completely inconsistent with
known weather date, we decided was not telling us what actually
That still left us a number of models to work with.
In fact, we ended up with five linkages that, that could tell
us with fairly good confidence, what we call our best estimate,
of where the plume went. We then drew the outline of that, the
union or composite of those plumes, to increase our confidence
that we'd captured where the plume actually went. And with
that -- I think that's my last slide, correct -- with that I'll
turn it over to Dr. Rostker.
DR. ROSTKER: Before I show you the, the plumes and
the lay down of troops, I want to make a few points on a dosage
curve so that as we go through this you can see what we are
talking about. Next slide please.
What we've illustrated here is a milligram unit per
cubic meter. And we were particularly interested in first
effects and the general population level. Many of you may have
heard me say that Khamissiyah was, for us, an enigma because we
could not understand why we never heard alarms, why we did not
have reports of people complaining about symptoms. And so what
we were particularly interested in is seeing where the exposure
would have been at the first effects level and then out to the
general population level. And we note, as we've said time and
again, that the lack of good research on low-level chemical
exposures, even low-level short duration chemical exposures
measured in hours and not repeated, and that leads us to our
On this chart, at dosage levels are the lethal dosage
and the dosage for incapacitation. Now, with those as
reference points let's take a look at the events at Khamissiyah
as we were able to recalculate them, or understand them. Next
First let me mention that in October, Department of
Defense identified an area of kilometers that we believed
would contain anyone who had had any first effects and we
surveyed that, that area. There were about 20 troops, we
believed at the time, in that area. That has been taken by the
popular press to be an estimate of who might have been exposed.
That's not, in fact, correct. It was an estimate of people who
may have had first effects and that we were interested in
surveying. In fact, the logic of that exercise was that we
believed we would see first effects in approximately 25
kilometers. We doubled it and because of the uncertainty of
wind patterns, we took a 360 degree circle and we sent
questionnaires to about 20,000 people.
Moreover, I indicated that this was our best
assessment at the time where people were. As we went through
this effort, it became quite clear that we had a quite
imperfect understanding of where the units were. And so for
the units immediately around Khamissiyah, the 18th Airborne
Corps, we started a series of conferences where we brought in
the S-3 and G-3s from those units that had fought there during
the war and recalculated, re-estimated where units were down to
company size units.
For example, in 24th Division we had about 1,100
observations of where a unit was during a, during that period 4
to 15 March. By the time we finished with the S-3 G-3s, we had
almost 12,000 observations. It allowed us to be precise down
to company level rather than having to make estimates at the,
at the battalion level. So we have for the 18th Airborne Corps
a much better understanding of where units were and they are
indicated by the dots on the map.
As we, as we got into this, we found that there were
units of 7th Corps and we still have to do the detailed work on
7th Corps. Some of it was done but some of it is planned for
September. So as we go to the people who may have been exposed
in the 7th Corps area, we probably have an overestimate because
we're working with larger unit aggregations at battalion level
rather than more precise estimates at company level. But that
talks to the 50 kilometers and the 20,000 people. And let's
take a look at where the actual plume was as we can best
reconstruct it through the efforts that we've talked about.
This is a blow-up of the immediate area around
Khamissiyah and we're looking at the units. The maroon area is
the area of first effects. You'll notice that it has a long
area and then a, a tail. That tail represents one of the five
runs and we included it in the union technique. It's not that
the wind was actually shifting.
Let me blow, let me blow this up a little more to
actually get to Khamissiyah and you'll see here the familiar
highway that ran through Khamissiyah. The people that placed
the charges were actually moved past the edge of the map, along
the highway. And you see a smaller area in which we believe
our chemical alarms would have sounded and here's a measuring
difference. Most of what we're talking about in terms of the
plumes are in terms of dosage. Our chemical alarms are not in
terms of dosage, they're in terms of instantaneous
concentration and they recycle every 20 seconds. So we have a
different scale here in terms of concentration over time
equaling doses versus instantaneous concentration.
And this map goes a long way to explain the enigma of
Khamissiyah, why didn't we hear alarms and why didn't we see
people indicating to us that they were, they were sick. And
the answer is that, as best we can tell from our unit locations
and here we're at company-level units, the plume, the cloud did
not go over any units. Moreover, the area that we would have
had sufficient concentration to hear alarms, there were no
units nearby and it's an area of just a few kilometers by a few
kilometers. That's and indication also in terms of
instantaneous, of where we would have required people to
immediately go into MOPP because of the imminent threat of, of
death. Next slide please.
On the second day, we see again an area of first
effects. We know of no one who went back into the Khamissiyah
area and we do not know of anybody who, who would have had
first effects at that point in, in time. And then on the third
day -- and I should say each day the units moved because we
have different unit locations -- and on the third day, we do
not believe there was sufficient concentration that would have
resulted in anyone having any symptoms. The third day is
significant because it was on the third day that the pictures
were taken that Bob showed you of a trooper standing by the
blown-up boxes. And again, we couldn't understand why three
days into the event there would have been no impact when we
knew things got into the soil and wood, and our work at
Edgewood indicates that by the third day we would have had all
the evaporation would have come out and we would not have
expected to see first effects.
Now we have, I mentioned, I mentioned that we had
surveyed 20,000 people around Khamissiyah and I want to share
with you just some of the, the results of this survey. We were
looking for anybody in our original database that was there
between 4 and 15 March, those were bracketed by the bunker
explosion and what we thought might be a period after an event
as late as the 12th of March. We sent out almost 20,000
questionnaires. We sent it out in several waves and
eventually ended up with about 74,000 responses.
One of the questions, question six, asks whether the
individual knew anyone or themselves had felt anything
medically out of, out of the ordinary during that period of
time. And we had about 300 or so responses. We, we tried to
contact every single one. We made at lease a phone call to
contact every single one on the list and accomplished over 200
contacts, and were able to sort out from the discussion of who
might have felt an exposure. We end, we're left with 90 -- or
we've concluded that 99.5 percent of the troops within 50
kilometers of Khamissiyah in that period of time did not feel
anything out of the ordinary. That's quite consistent with the
analysis we did which showed that no troops were under the
We do carry 26 veterans who had symptoms that could
be consistent with an exposure to a, an agent and that would be
wheezing, diarrhea, tightness in the chest. It's also
consistent with other, with other medical conditions. And we
are in the process of correlating their experience with the
CCEP and VA registries, with their presence on the, on the
battlefield and with their exposures. And we have encouraged
all of them who have not registered to go back and register.
Remember, we've talked to all of these, all of these
people. You know, we can, we can focus on the 26 but I think
the important thing is the 99.5 percent of the 7,000 who gave
no indication. And again, that being consistent with, with the
analysis that we had done. Next slide please.
We're now going to look at the general population
limits. At the far extreme, of course, we have the CDC's
statement of exposure. This is the 72 hour limit; we've
translated that 72 hour limit into a milligram minute. At the
other extreme are the, are the immediate effects. We call this
area, for notification purposes, the area of low-level
exposure. And we are notifying everyone in that area and it is
the subject of ongoing medical research. Next slide.
The light purple area is the projection as, as we've
been able to make for the first day, it's actually a little
less than a day. It goes from the explosion to about three
o'clock, three o'clock in the morning and consistent with the
wind patterns. Next slide please.
The second day, the wind shifts to the -- from the
east, starts blowing from the east to the west and the plume is
pushed towards the west. This is an interesting plume because
it is not an instantaneous release and then you watch the cloud
go down, down range. This cloud is being constantly fed,
substantially fed by the evaporation from the wood and from the
sand. And you see it moves substantially into Saudi Arabia,
crosses the tap line road and captures KKMC.
The next day, the wind shifts again. The plume is
continually being fed and it moves up the Euphrates Valley.
And on the fourth day, which is the last day there was any
release as best we can tell, the plume is in the immediate
vicinity of Khamissiyah but again, not at a level that would
indicate that anyone would have realized they were being
exposed to low-level chemical agents. Next slide please.
We have made a count based upon the location of our
units and then netted out for double counting. On the first
day the winds were blowing almost due south and we believe no
one was exposed to first notable effects, at least based upon
unit location. We can't be sure for every single individual
but that some 19,000, almost 19,000 troops may have been
exposed to low-level chemicals.
On the 11th, the wind was blowing from east to west,
thickening the cloud, moving it along the border, and that is
the day when 79,000 troops may have been exposed. The third
day along the, cloud is moving along the Euphrates Valley, an
additional 32,000 and then on the forth day we had two
battalions back in the Khamissiyah area and that resulted in
the potential exposure to 16,000 troops. Netting out the
doubles, we have almost 99,000.
Now for epidemiological work we will be able to
provide detailed time dosage or dosage patterns, concentration
over time, dosage being the integral of that curve, and we'd be
able to provide that for any unit that, or any individual that
based on the unit location becomes the subject for further
medical or epidemiological research. Next slide please.
We were very concerned in, in notifying our, our
veterans, we have, are in the process of sending letters to
anyone who may have been under the plume as well as anyone who
had any contact with our office and indicated any concern about
the events in Khamissiyah. And that includes all of the people
in the 20,000 who got a survey and we will then write them,
every one of them, whether or not they may have been exposed or
were not exposed. We bolstered our 800 contact effort -- next
slide please -- and I'll show you what we've done there.
We have 20 operators operating or receiving calls in
Monterey and we dispatched our veterans' contact manager who
supervised that activity. I can tell you that on Friday we had
90 phone calls concerning health and indicating people wanted
to register with the CCEP and that is about double of what we
would normally expect. And yesterday, we had 210 phone calls.
This is, while, while it's increased, it is less of an
increase, frankly, than we thought we would see and less of an
increase than we had when we sent out the initial notifications
in, in October that people, concerning concerns about
Khamissiyah that people would be surveyed. So we are able to
stay on top of this.
And then we have backup here, or in Washington for
the more difficult cases. We're prepared to provide follow-up
care as is the VA in meeting all of their demands. There are
things that we have yet to do. I indicate that, indicated that
we can provide a more precise estimate for those units in the
7th Corps and we will be doing those S-3 - G-3 conferences in
September based upon the work with 18th Airborne Corps, the
number should probably come down rather than go up since we'll
be able to create the database at the company rather than the
battalion level. And as I indicated in my opening remarks,
this is really critical for ongoing or new epidemiological
work, having for the first time a, a precise estimate of what
people may actually have been exposed to, given the Khamissiyah
incident. Next slide please.
Let me leave you with three important messages. We
know of no units that were close enough to experience any
noticeable health effects. And that really helps us understand
Khamissiyah and answer the questions of how did we, how did we
miss it if this was an event of the size we were depicting, why
didn't we see sick people, why didn't we hear alarms. We do
recognize that many soldiers were exposed to low levels of
chemical agent, sufficiently low that they would not have
realized they had been exposed. And this has to be the subject
of continued medical research.
And then most importantly, if anyone in this
population or any of our Gulf veterans have any concern for
their health, we encourage them to register with the CCEP or
the VA health registry. And these are the telephone numbers
that they can reach us and we can provide assistance in
arranging for those health, health check-ups and evaluations.
With that I'd be pleased to take any questions that you have.
MR. RIOS: Had you done any analysis on what, what did
we lose in doing the modeling say in 1997 instead of having
done the modeling say, in 1993? What, what was the impact of,
or what has been the impact on your modeling and your results
had we had this done five years ago instead of having it done
now --
DR. ROSTKER: Well --
MR. RIOS: -- because preparing your modeling is a
function of data or information that you have before you and it
seems to me that we lost a lot in having done it five years
after the fact.
DR. ROSTKER: I think the only thing we've lost five
years after the fact was the recollections of those who placed
the demolitions in the pit. We still -- the actual
demonstrations at Dugway and the like were extremely important
and would have had to have been done then as they were done now
because we did not appreciate the extent to which the dynamics
of those explosions would dominate the calculations. Our
earlier considerations were things like 100 percent
aerolization. We now know that that's not wrong. That is,
would have been a fact three years ago or five years ago as it
is a fact today. So the only thing that was really time-specific
in this is any change in the memory of the five
soldiers we were able to identify, in terms of what they did
and how they placed stuff in the pit. I'm, I might -- the
colonel headed the field activity at Dugway and I might as you
to comment on that, Larry.
COL. CEREGHINO: I think my work is well-reflected
in what Mr. Walpole has presented --
MR. RIOS: Well, if that is true, have you done any
analysis on -- well, what if, what if the recollection was of
the people that placed these, these what do you call them, the
charges. Any parameters as to whether if they had recalled and
said this is where we placed them versus this is where we --
this is how much, how much we placed there and so on. What,
what are, what are the consequences of that inaccuracy so far
as this whole modeling business.
COL. CEREGHINO: We, we can not and will not be
able to overestimate the value of the veterans explaining what
they did because we just don't have records on, on exactly what
they did. And last year when we were trying to sort this out,
we only had two veterans talking. When we got five of them
together in a room it was amazing what that did to their
memories and the way it brought their memories out. We were
talking to one of them and trying to get him to recall some
others that had worked on it. And we got two of them together
and one said, well I remember one guy that was doing some art
work on my helmet. The other one said oh, he's so and so. He
was in my unit.
So we, I called Bernie. They called me from where
they were interviewing him, called Bernie that afternoon, that
was a Friday as I recall and Monday morning they had found the
guy. And that was when we got all of them together and their
memories started to, to really gel.
So yeah, there's a lot lost in time. I think getting
them together and having them recall what had happened, doing
the artist's rendering as we described to help them remember
that, the photographs, we brought all the photographs, you
know, to bear on this but there, I don't, I'm not sure there's
a way to calculate, you know, the degree of what was lost.
We've done everything possible in the modeling to the point of,
of ascertaining, as I said before, that the rockets were facing
different directions, modeling various approaches for that and
modeling various random placings, of the charges, having the
soldiers say yeah this is, this is more like how we place it.
That, that's the best we can do.
DR. NISHIMI: What would be a fair assessment of
say, (off mike), that we would have four years of research on a
relatively well-defined (off mike) --
COL. CEREGHINO: You're talking about
epidemiological data.
COL. CEREGHINO: Different question.
DR. ROSTKER: No body, no --
DR. NISHIMI: That's what was lost.
DR. ROSTKER: Yeah. Nobody cries more than I do
that the time lost. It was unfortunate. You know that we've
laid out the history of the realizations of Khamissiyah in, in
two papers: the Khamissiyah Narrative that my office produced
and the, and the, I think, outstanding paper the CIA produced.
It, it was unfortunate that we did not recognize
these leads in 1992 and I think we would have all had a better
picture and, and understand more then than we, than we did the
possibility of low-level chemicals. I can only tell you that,
that as the President instructed us to leave no stone unturned
we've literally left no stone unturned from manufacturing the
warheads, from getting sand from southern, southern Iraq, to
manufacturing the wooden cases.
There were a lot of theories about what would have
happened from the metal, from the cases driving into the
warheads, setting them off. And after you get through this,
things that should have, you should have understood become much
clearer. In bunker 73 there are a lot of shell fragments where
the plastic is broken you can see the burster tubes where the
charges were through the middle of that and it, it's obvious
that they cracked and leaked into the soil because if they had
broken to aerosolize we wouldn't be looking at large pieces of
plastic. We would have seen the destruction of a warhead. The
fact that these warheads were not fused meant that they were
either consumed in the actual explosion or they broke open and
leaked or they stayed intact and UNSCOM hauled them away.
MR. RIOS: Let me ask you just as a follow-up on this,
would it be a, I mean, is it possible that say had we gotten
those five troops together in 1993, is it possible it could
give you, it could have given you a set of facts or a
recollection that presented a set of facts that would make this
modeling today totally inaccurate or irrelevant?
DR. ROSTKER: I don't believe so.
MR. RIOS: All right -- pardon me?
DR. ROSTKER: I don't believe so.
MR. RIOS: So that's highly unlikely.
DR. ROSTKER: Yes, sir.
MR. RIOS: The best you can say is that's highly
DR. ROSTKER: Because a great deal of the analysis
that followed was based upon the physics of the demolitions,
not on their recollections. And their recollections are very
strong on key issues like how they placed the charges. So, I
don't think that having done this earlier would have much of an
impact on the particular reconstructions and simulations that
we have been able to do.
MR. WALPOLE: That's right. And they were severely
limited in what they had to work with. They -- I have
indicated in my opening remarks they had four boxes of charges.
They were out of detonation cord. They were using Czech
detonation cord to pull off this demolition. They readily
admitted that they did not have enough material to destroy
these rockets completely.
DR. ROSTKER: I, I should say --
DR. LASHOF: May I ask why?
DR. ROSTKER: Sorry, ma'am.
DR. LASHOF: I -- that's a surprising statement
that we had a group going in to do demolition and they didn't
have adequate --
DR. ROSTKER: We were, we were --
DR. LASHOF: -- charges to --
DR. ROSTKER: -- totally overwhelmed by the extent
to which this unit at this place and other units at other
ammunition places were called upon to blow up ammunition that
Saddam Hussein had there. It was overwhelming.
We have a CNN tape about, I guess, 30 miles away on
the next day going through the same kind of think. It's a
funny tape because in the middle of the -- we identified the
attack unit and in our de-briefs of the crew that were there,
the soldiers that were there, they said, and as we were going
through there CNN arrives and we have the CNN crew actually
arriving talking to the same guy that we had in our field, in
our lead sheets. But they were faced with the same thing,
trying to blow up a massive amount. We just weren't prepared
for it. And the experience at Dugway will serve us extremely
well in understanding the issue of field expediency and open-pit
demolitions and how we have to handle a situation in the
future. We never had that kind of situation model before and,
and the procedures we had were completely different from the
field reality that existed there.
MR. WALPOLE: If you turn to the second map in my
package you'll see there's, there's three sites there. In
fact, we can pull that one up. There's the bunker 73 and
that's what they thought they were going to be destroying with
the bunkers. That's up here and all these are bunkers, that's
right. Down here is the pit, that's what we've just been
discussing. And then over here is the 155 mm. mustard rounds
that Mr. Duelfer mentioned this morning which they didn't find.
They were declared later and hauled away and destroyed. They
found the, the ones down in the pit as they were driving along
the road by the canal there and saw a piece of canvas flapping
in the breeze and thought, gee that looks strange, because
there was dirt on top of the canvas and it was kind of hidden.
So I, the site was large and if they thought they were only
going after the bunkers, that would explain why they didn't
have enough charges to do three piles let alone two.
MR. RIOS: Let me -- one more question and then I'll
pass it on to somebody else. Several times it has been
mentioned by both of you that we're trying to find out why we
didn't get more alarms. Why didn't people complain at that
time when it was occurring. It is possible that, that you
didn't get more notice or more alarms going off or more
complaints, is it possible that, that could be explained by the
exposures possibly being below the levels of the equipment that
was there? The detection levels of the equipment number one
and number two is it possible that they were exposed to the
levels that aren't, aren't, you don't have symptoms right away
but you could have over the long haul.
DR. ROSTKER: Well, that's exactly the point. On,
on the, on the alarms you're exactly right. The alarms were
set to a certain tolerance. The, the M8 alarms and they, the
area that the alarms would have gone off, given the amount of
material that went into the air was much smaller, we had no
troops, we had no alarms there.
MR. RIOS: And the symptoms could have been, I mean,
the troops could have had symptoms to the exposure but they
could be the type of symptoms that don't come -- manifest
themselves until after a long period of time.
DR. ROSTKER: That's why --
MR. RIOS: That could be the answer to that question.
DR. ROSTKER: Absolutely. And that's why we are
looking at the issue of low-level chemical exposure. We do
know, we have now 7,000 responses and we're questioning 26.
That's less that a half of 1 percent. We've talked to all of
the medics in the, in the units. People did not present
themselves. Even the 26, many of them did not present
themselves at the time and some of these characteristics could
well have been confused with flue and other symptoms.
Pieces are really, for us at least, coming in to play
here. We're much more confident, for example, to say yes,
chemicals were destroyed at Khamissiyah. It has always been a
hesitant -- a hesitation on our part because we couldn't
understand the alarms and the sickness. This just -- it all
falls in, into place: the survey results, the modeling results.
It's a nice, it's a much neater package than it was six months
ago for us.
MR. WALPOLE: If I could add just briefly too.
There are a lot of spinoff values to the modeling that was done
and one is this issue of alarms. One of the warnings CIA had
sent before the pit had been destroyed was that the munitions
would not be marked. Our forces are going to go into countries
in years to come where such munitions may not be marked. And
this modeling has shown us what the alarms will and will not do
and yet where the plume will go and we may need to design, as a
government, an alarm that can be placed downwind of a
demolition like this so that if it goes off, other precautions
can be taken. Because you're not going to always know what
munitions are there particularly if they're, you're, they're
doing something as quickly as they're doing here where they
were moving out fairly quickly and certainly couldn't go
through every one of the bunkers. The bunkers themselves were
booby trapped and they couldn't even get into them.
DR. LASHOF: Let me follow up on some of these
questions that we've just had, if I may. You mentioned the
26th, that say they had symptom that came out of the survey.
Do you know where they were located in relation to the plume
now? Were they within the 50, were they down, way downwind?
DR. ROSTKER: We know where some of them were. The
problem is on some of the units we have two locations and
that's because the units were moving. And I don't know how to
sort that out yet and so we need to do a little bit more work.
I can tell you that of the 26, 14 are in either the VA or DOD
registries. I can tell you that of the 26, they were in 23
separate units, that if you look at the unit population, what
we're talking about no more than 1.4 percent of a unit having
somebody report sick.
So we're back to that interesting problem of people
who may be, if you accept all of them are sick from chemicals,
you're talking about a reaction that 1 percent of a unit got
and 99 percent of the unit did not get. So, we're in that very
difficult area where people may have some predisposition, may
have some reaction but it's not a reaction that's going to be
shared by the vast majority of people in the unit.
DR. LASHOF: Or the 26 may have had something else.
DR. ROSTKER: Or the 26, given the benefit of the
doubt. But the 26 are still reporting, most of them are still
reporting symptoms that we would recognize and we will do in
the months ahead much further epidemiological work. In fact,
there's a conference with the VA on Wednesday on the, on the
results of this as it impacts on epidemiology and that goes
everything from the quite imprecise participation rates down to
specific diagnoses.
But again, for the first time we have a fair
confidence. These, this union footprint though is larger, you
appreciate, than any single model and we can be more precise
when we get into the models and, and have better, even
estimates for what the exposures may or may not have been.
DR. LASHOF: Let me ask a couple more, if you will
about the potential for epidemiology. I mean, this is the most
exciting data we've had to deal with this on the potential that
it could give us a handle. But let me get back to the, some of
the data you gave us on your preliminary -- on your survey of
the 50 kilometer radius and then 19,000 surveys went out and
the 7,000 returned. And then you say you did the telephone
survey follow-up and 99 percent recall no symptom.
Now, is the telephone survey follow-up on the 7,000
that were returned or did it include the 19,000? What do we
know of the 7,000 versus the 19,000?
DR. ROSTKER: It was question number six which asks
did you or did you see anybody who had a health effect, or knew
anybody. And again, we're not being precise because it's that
whole time frame. We had, I believe, 341 responses out of the
7,000. We tried to contact every one of them. We've
accomplished about 200 or so completed phone calls. So the 26
are of the 250 some odd that we have actually talked to. And
we've been able to ascertain -- most of them said well, I
wasn't sick but I remember somebody being sick. So we
eliminated that since everybody had an opportunity to respond
to the questionnaire. So the 26 are people who had symptoms
that related -- we can't rule out but they're spread under and
not under the plume. They're spread in no concentration.
Typically of the company size units, we're talking about 200
people and the most we had was two out of 200 and generally
it's one out of two hundred across the board. So there's, we
were looking for concentrations. We just could not, could not
find it.
MAJ CROSS: The 26, are they -- what was the
breakdown? On active duty still?
DR. ROSTKER: They're all active duty because these
were all active duty forces that were around Khammis --
effectively all active duty forces around Khamissiyah.
Remember, this is not the universe in, in Iraq. This was
people who were between the 4th and the 15th whose unit was in,
with 50 kilometers of Khamissiyah. So that would have been the
7th, the 18th Airborne Corps --
MAJ CROSS: Today, of those 26, are all 26 still
on active duty?
MAJ CROSS: That's my question.
MAJ CROSS: Do you know what the breakdown is?
DR. ROSTKER: I don't -- yes. I mean, I have, I
have a description of every one of the 26. I, we, for privacy
reasons can't be made public but we'll be happy to share it in
detail with the, with the committee.
MAJ CROSS: Because I, I, you know, I just want to
caution -- we've heard it this morning -- I sense there's still
individuals on active duty who won't come forward even though
this is to the benefit of all of us but they won't come forward
DR. ROSTKER: We understand that.
MAJ CROSS: -- you know, because of retribution, a
fear of retribution.
DR. ROSTKER: Well, they, they --
MAJ CROSS: It's slanted in one respect --
DR. ROSTKER: No question about it. That goes to
the issue of self, self selection but many of our
epidemiological work points out to large numbers of veterans.
For example, some work that was done at San Diego with the
Naval Research Center with Seabees had, they recorded for me
how -- I asked how many Seabees that had been deployed had
five, had symptoms and they gave me a count of five or more
symptoms of 100 out of about 600 that had been deployed and
only 12 had actually come into the registry. The others had,
had symptoms had complaints but had not come into the registry.
So I'm very, you know, and in these 26, only 14 have come into
the registries.
But again, I think the important thing is, is not to
dwell on the 26. We will as individuals to make sure they're
getting the care they need but the 26 are the residual of 99.5
percent and we're using it as a check on the analysis. I mean,
the analysis would be questionable if we had large numbers of
people on the survey who said that they were sick and we were
showing none of them were under the plume. That's not the case
here. So it's a, it's a common sense check as well as the
whole survey which was an attempt to gain insight as to what
might, might learn from people around Khamissiyah. Seven
thousand is not a particularly good response rate but, but I'm
sure people who didn't see or want to communicate with us or --
would be in the, in the residual 13,000 who never responded.
So I think we probably -- that the non-response bias is
probably in favor of those who felt they wanted to talk to us
about something they saw at Khamissiyah.
DR. LASHOF: Well, I was going to ask about the
non-response bias and the fact that of the 19,000 you only got
7,000 returned. Did you make any effort to take a sample of
those who didn't return and try to reach them by phone and get
any information --
DR. ROSTKER: Just, just in terms of --
DR. LASHOF: -- just to see how they resemble the
DR. ROSTKER: We just did one re-mailing. This was
not set out to be a great big scientific survey. We were
looking for patterns. We were looking for insights and
frankly, potential contacts. What we, we considered this a
screening survey to identify contacts for phone work, not to do
statistical work in terms of representing population. It
happened that it was a useful check in terms of the analytic
work but I wouldn't put more into it than, than a common sense
check rather than a, a detailed statistical analysis.
DR. LASHOF: Well, you said you're going to be
meeting with the VA and reviewing all this in terms of what
further epidemiology --
DR. ROSTKER: Yes, ma'am.
DR. LASHOF: -- can be done and obviously we'll
have a, we have a September meeting and I'm sure we're going to
be anxious --
DR. ROSTKER: Yes, ma'am.
DR. LASHOF: -- to know what epidemiologic studies
are going to be done, what we're going to be able to do from
the VA's 15,000 survey. Hopefully we will be able to get a
handle on which of those were really in this and whether you've
got a big enough sample --
DR. ROSTKER: I wish this Khamissiyah work was a,
was a panacea for the veterans that are ill.
DR. ROSTKER: But it isn't. It does give us a first
real agreement on an exposure that is, as you said, very
exciting for the potential for additional follow-on research.
DR. LASHOF: In, in relation to that and what it
means to the veterans and so on, obviously once Khamissiyah
came upon the scene and was written up in the press, everybody
jumped that chemical agents were the cause of the problem and
so forth. What do you intend to do to notify others who might
have felt they were near Khamissiyah, not within the 20,000
whom you said you were going to notify them whether they were
or they weren't? How big are you going to draw that circle to
get out to people to say look , we've modeled the plume and we
know you were generally in the general vicinity but don't
worry, you weren't there?
DR. NISHIMI: I'm going to have Dr. Rostker's
assistant throw up the day two plume, the one that you're
referring to. No. Day two of the low-level.
DR. ROSTKER: The low level. This has been a
discussion with, within the government and frankly, we have had
conflicting recommendations from risk communicators. One
school of thought is that we should throw the net as wide as
possible and another school of thought says that we'll be
scaring people and frankly, we have not come to a conclusion.
We did get one response, telephone response where the woman
said, every time you send a letter you scare my husband, even
though the letter was no, and please take us off the mailing
list and don't write us any more. That's, that represents one
viewpoint. Right now the immediate decision and where we are
logistically is the, the notice to the hundred thousand plus
anybody else who has, we have contacted before or has expressed
an interest in Khamissiyah. But we're prepared to discuss that
point, certainly.
DR. NISHIMI: I think the committee's interest is
that you've got this low-level plume going out about 300 miles
on, you have a lot of people who are actually quite close in
and it would be beneficial to inform these people that they
were not under the plume. I actually talked to two different
experts in risk communication on Friday, one from the private
sector and another that worked with another federal agency and
their opinion was that on this particular issue, Khamissiyah,
you can not over-communicate at this point, as long as you
communicate properly. So, so I offer that perspective.
DR. ROSTKER: Well, I'm --
DR. NISHIMI: Can you give us some sense if you draw
that circle 300 miles about how many troops are in there?
About twice as much it looks like, two and one half times
DR. ROSTKER: About 270,000.
DR. NISHIMI: And so that would involve notifying
about 170, 175,000 additional people.
DR. ROSTKER: That's right.
DR. NISHIMI: Is that correct? And is it your sense
that that's the way the Department of Defense is committed to
DR. ROSTKER: Well it isn't, it's not right now but
we certainly can, can discuss that. I can carry the view back
to the department. I do not have in my budget, immediately,
the funds necessary to do that but I'm sure those can be made
available and I will carry that message back to the department
and let you know. It will probably be about two weeks before
we can do it. We need to get the first mailings out but then I
think we can go ahead and do what you've suggested.
DR. LASHOF: My own sense of mis-communication and
playing with this is also that this would make sense. And
there may be the occasional person who -- well they'll just say
anything when he gets upset but -- I would think a well-written
letter that explains that we really do have some solid
information about where the plume went, where it was and that
you weren't there could be reassuring to an awful lot of people
and --
DR. ROSTKER: We have shared with the staff the two
letters, the notification and the other letter. The second
letter has been coordinated throughout the government and I'm
sure we can send that to a larger group. I'm very sympathetic
to your request and I'm sure we can, we can accomplish it.
DR. NISHIMI: Are you going to be in contact with
other coalition partners?
DR. ROSTKER: Yes, ma'am. In fact, we will be
visiting the British, French and Czechoslovakians -- excuse me,
Czech Rep -- Czech -- in September and in October Kuwait,
Egypt, Saudi Arabia and also Israel. And this will be part of
the -- we will be making presentations in each one of those --
DR. NISHIMI: Are you aware at this time whether any
of them --
DR. NISHIMI: -- were under the first effects plume?
DR. ROSTKER: We, we believe there may be a small
number of British troops based upon maps that they have
subsequently sent to us. We shared this with the British
immediately on last Thursday and we believe there may be some
Syrian and Egyptian troops that were in the 7th Corps area.
DR. NISHIMI: Under the first effects?
MR. WALPOLE: No, not under the first effects.
DR. ROSTKER: No. Nothing, nobody under first
DR. LASHOF: Other questions?
DR. PORTER: I'd like to actually go back to a
question Mr. Rios asked earlier to clarify my understanding of
what alarms do and what they don't do. Could you put up slide
number five which is the blow-up of day one?
MAJ KNOX: Day one first effects, right?
DR. PORTER: Threshold effects.
DR. ROSTKER: It's the blow-up of Khamissiyah with
highway eight and it has the small alarm area as well as the --
DR. PORTER: The big pink area.
DR. ROSTKER: -- the area of first effects, area.
Nope. Next one.
DR. PORTER: Am I to understand correctly that the
alarms will sound only in the small area shown and that at the
point at which the first health effects are experienced, as
shown on the depiction --
DR. ROSTKER: Yes, that's right.
DR. PORTER: -- the alarms will not sound?
DR. ROSTKER: Yes. And, and the reason is there's a
different scale here and that is, one is a dosage scale in
which we're talking about exposure over time and cumulative,
and the other is an instantaneous. So, if you can think of --
do we have a exposure, Larry? Let me show you what a, what a
pattern might look like --
MAJ CROSS: When you spoke to these five
individuals did they -- did you talk to them whether or not
they had alarms --
MAJ CROSS: -- turned on, turned off? What was
their recollection? Do you remember?
DR. ROSTKER: Larry, do you remember the five
individuals whether they talked about alarms being at the pit.
COL. CEREGHINO: (Off mike)
DR. ROSTKER: But they were, again, they were not
there during the demolition.
COL. CEREGHINO: They were outside that area.
DR. PORTER: Right. I understand that but what I'm
DR. ROSTKER: Let, let me. I think I can answer
your question. The, the, the issue of first effects is an
issue of dosage and what you have in dosage is the grey area
here and you can gain the dosage either by cumulative over time
or by amplitude in this curve by having a great concentration
all of a sudden. The chemical alarm works on concentration,
okay? And the area of first effects is an area of dosage so
that we are not looking at the same time scale when we go to
the previous example. So, in this particular case you might
have a dose -- you might have the alarm going off at this
point, and that would before somebody felt it because they
hadn't accumulated enough dosage to have a, a first effect.
I, I'm not a physicist or a physician and we
struggled how do we make that intuitively clear and it is
difficult and it really has to come back to curves that look
like this and it's the difference between the instantaneous
concentration that the alarm would detect, recycling every
twenty seconds, and the area of dosage which is cumulative
over, over time.
DR. PORTER: I understand that but I do think that
the depiction is confusing because it implies to people that
they're going to be exposed to something at a level at which
there would be low-level health effects and that the alarms
will never sound to protect them. That's the implication and
that's why I question how it was depicted on the chart.
DR. ROSTKER: It's again, it's a, our alarms are not
dosage alarms, they are instantaneous. They are alarms based
upon concentration.
MR. TURNER: Just to clarify Dr. Rostker, if I
understand what you're saying it is if you have a low level
exposure for a long period of time you may encounter first
health effect even though an alarm would not go off --
DR. ROSTKER: That's my understanding.
MR. TURNER: -- scenario.
DR. ROSTKER: That is -- that's my understanding.
Is that right guys?
(Off mike)
DR. NISHIMI: Please come to the mike.
MR. BARBARSKY: (Off mike) the dosage accumulated over
24 hours so it would, you know, it's questionable and Jack
probably should --
DR. NISHIMI: Please come to the mike.
MR. BARBARSKY: Come up here Jack.
DR. LASHOF: Yeah, let's get everybody into this
because this is an important and confusing issue.
JACK HELLER: I'm, I'm Jack Heller, US Army Center
for Health Promotion and Preventive Medicine. Okay, that first
slide Col. Cereghino had was of a -- put, just put the first
one up real quick for a second -- the alarm goes of at, I
believe, point two milligrams per cubic meter and you can see
we never did reach that dose. This unit, we wanted to see what
someone getting an acute exposure would look like. There was
no unit in the first effect zone but we put this unit five
kilometers from the Khamissiyah pit --
MR. BARBARSKY: It's actually not that one, it's the
next one, isn't it?
JACK HELLER: No that, that was the one we, I
believe, was the --
MR. BARBARSKY: That's it.
JACK HELLER: Oh okay. I'm sorry, you're right.
This is the one that was five kilometers from the Khamissiyah
pit. And potentially someone could get runny nose or rhinitis
from this kind of exposure and the alarm would never go off
because the concentration was never high enough
The way the model worked is an accumulated dose over
time so that first day you saw the, about eighteen kilometer
first effect zone, that was the one milligram minute per cubic
meter zone and that was accumulated over an eight hour period.
Now, that had been gotten over a ten or twenty minute period,
the way chemical agent works, they probably would have gotten a
runny nose or myosis. But since, the way the model works, to
make it very conservative and make a very conservative acute
zone, it just kept accumulating dosage over that, that whole
eight hour period. So they probably never got an instantaneous
dose that was high enough to cause that acute effect.
One of the things with chemical agent that's
important is, the time span you get that concentration at. So
if they'd have gotten that whole dose, that one milligram
minute per cubic meter maybe over a ten, twenty, thirty minute
period, they might have gotten a runny nose and a myosis. But
since that dose, the way the model works, accumulated over a
very long period of time, they probably would not have
experienced first effects, even though we're calling it a first
effect zone, to be very, very careful.
We wanted to be very careful that we absolutely got
anyone who might have had a first effect zone. So for each
period, the next day it was 24 hour period when we were
accumulating that, that same first effect zone and clearly, you
know, no one was in it but they would have had to have gotten
that dose over, over a much shorter period than we're showing
DR. ROSTKER: The insert chart at the bottom is a
unit placed in the general -- between first effects and general
population and you can see the difference in the dosage in the
scale. We're talking about the thickening of the axis. So
when we talk about low level, we're talking about low level
that is basically off the chart in terms of the exposures.
JACK HELLER: And you can see that is still over a
very long period of time when they, when they got that, that
low level. And still, this is over, this is over a period of
time of about six hours when they got that dose. As I said, if
they would have gotten it over ten, twenty minutes, they might
have gotten that first effect --
MAJ KNOX: That was hypothetical, that first one.
JACK HELLER: Yes because there was no --
MAJ KNOX: I wanted to make that clear.
DR. ROSTKER: This was an artifact to be able to --
DR. ROSTKER: -- to answer the question.
JACK HELLER: Right. We wanted to put a unit within
five K of the pit just to see what his dosage profile would
look like and see if he ever got a high enough dose over a
short enough period to potentially have caused that, you know,
that acute, that acute effect. So we're fairly comfortable
with the way the acute zone was portrayed. It was a very
conservative first effect zone.
DR. LASHOF: What does this tell us in relation to
everything we've heard all along about alarms going off
frequently and being false alarms and that the alarm was
extremely sensitive versus the fact that it could have been low
level at this level floating around other places and no alarm
going off?
DR. ROSTKER: Well, that's the, the issue of the
alarms --
DR. LASHOF: What are the implications of all of
DR. ROSTKER: The issue of the alarms are certainly
the issue of our repeated case narratives and we'll talk about
that later. But our, our general assessment on the M8 alarms
are that they were prone to false alarms because of a variety
of, of problems. And again, if you were to see a concentration
high enough to set the alarm off, and that gets towards the
issue of death and incapacitation, you should have seen first
effects because you would have been so high on that curve that
you would have gotten a dosage almost instantaneously to, to
kill you.
So I think the theory of the alarms are correct in
the sense of where the alarms are set and the protection they
provide the troops. As we've been able to portray it over
time, we have a very conservative estimate. If you were to ask
me are we sure we captured everybody who may have had a
low-level dosage, the answer is absolutely yes. If you were to
ask, are there people that we are saying had a low-level dosage
that might not have been exposed at all, the answer is also
yes. We clearly are erroring on the side of making sure we've
captured everyone that possibly could have been exposed.
DR. PORTER: I understand that now. I think it's a
complicated risk communication issue, however.
MR. WALPOLE: One of the things to point out too is
that while we portray this as colors on a map, the researchers,
those that will be doing the epidemiological research, as well
as those that will be looking into the alarm issue are going to
get contours with numbers. And all of this is going to be
numerically portrayed and they'll be able to make a lot more
sense of it in dosage and concentration, all of the above, to
sort out these questions. Colors don't lend themselves to
DR. ROSTKER: We still have the imprecision of, of
our best estimate of where a person was is where the commanders
say his unit was. And one of the things that we have to come
to grips with in the future is how do we do better in actually
monitoring the location of individuals as distinct from units.
MR. TURNER: Could I just ask a question about
alarms? Given the levels that you've portrayed in your
modeling and the limitations you've described in the M8, are
you suggesting there ought to be a lower level real time
chemical detector or is DOD still insisting that the M8 level
is adequate?
DR. ROSTKER: I think the M8 level is, is fine for
incapacitation and, and death. There is an issue of, of
monitoring low-level chemicals. That's why we're very
interested, Mr. Turner, in the Czech detections because they
were very sophisticated. They were more sensitive than the 256
kits. And if truly we only had two days of Czech detections,
then that tells us something about the potential of low-level
chemical exposure. If the Czech's detectors were on as we
believe and they never went off except for those two days, it
gives us another day to point, address the question of whether
the battlefield was saturated with low-level chemicals.
MR. TURNER: But you don't think US forces should
have a similar capability?
DR. ROSTKER: I do. I think part of the
environmental monitoring for the future should be low-level
chemical monitors just as we take soil and water samples and
the like.
MR. TURNER: Thank you, doctor.
DR. LASHOF: Are there any other questions? If
not, thank you very much. This has been extremely helpful and
we'll resume tomorrow morning at 8:30.