UNITED STATES OF AMERICA
PRESIDENTIAL ADVISORY COMMITTEE
ON GULF WAR VETERANS' ILLNESSES
PUBLIC MEETING
January 12, 1996
Westin Crown Center Hotel
One Pershing Road
Kansas City, MO
MEMBERS IN ATTENDANCE
Joan Porter
Thomas Cross
Holly Gwin
Arthur Caplan
Michael Kowalok
Marguerite Knox
Joseph Cassells
I N D E X
MORNING SESSION
Introduction of Board..........6
Chris Kornkven.................7
Denise Nichols.................15
Jim Bunker.....................18
Lisa Montague..................28
Michael Buster.................35
Debra Smith....................43
Dr. Garth Nicolson.............52
Dr. Charles C. Hinshaw, Jr.....68
Marsha Lynn....................77
Denise Nichols.................86
Jim Brown......................88
Dr. Stuart Nightingale.........95
noon break ....................144
AFTERNOON SESSION
General Robert Belihar.........145
Dr. David Bales................165
Dr. Edward Martin..............188
Dr. Edmund G. Howe.............209
Alta Charo.....................226
Discussion and Recommendations.244
Certificate of Reporter........266
P R O C E E D I N G S
Morning Session
DR. CAPLAN: I'd like to convene this panel of
the Presidential Advisory Committee on Gulf War Veterans'
Illnesses. I'm Arthur Caplan and I'll be acting as chair
of the panel today. I want to thank those of you who've
made the effort to come to this meeting.
We try to move our panels and meetings around the
country. We're very pleased to be in Kansas City today,
especially to those who came from the east, so that we can
see the ground again. The, part of the reason that we've
come here is to allow people who may not be able to travel
to Washington, D.C. or other distant places, to have a
chance to meet and address and speak to the committee.
We're also concerned that the President's interests in
making sure that openness and accountability about what took
place in the Gulf is extended to all parts of this country.
And, so, our being here helps draw attention to what we're
trying to do in terms of examining the issues related to
Gulf War veterans' illnesses. And I'm pleased that many of
you were able to come, both to give us your thoughts and
provide us with testimony, and also to listen to some of the
things that we'll be examining today.
Before I introduce the people who are up here with me
on the panel, both my fellow committee members and some
staff, I also want to thank the staff for doing such a good
job under extremely adverse conditions and getting this
meeting together.
I know that the government has been closed due to
budget battles in Washington. And then the divinity decided
to intervene, as well, and bring government to a halt. Even
when politicians had decided, maybe, it should reopen,
nature decided that it should not. And staff has been in
there swinging, putting this together, despite both
political battles and climactic upheaval. So, I really
appreciate the efforts that Rob and Holly and everybody on
the staff made to get this hearing together.
The last bit of news I will present to you is, there's
been a slight change in the schedule, somewhat weather
related, in fact. General Belihar is going to go ahead of
Dr. Edward Martin this afternoon. He'll present at 1, and
then we'll have Dr. Martin at 1:45. We're going to flip
them around in the presentation schedule.
Our next meeting, so I don't forget it, this
committee, the whole committee, will be Washington, D.C. at
the Mayflower Hotel January 31st.
We have other meetings coming later and I know of one
more visit, for sure, to the midwest in the Chicago area.
I'm not sure exactly what the date is, but I know that's
coming as well.
That being said, let me go down to Joe on my left here,
and why don't we just introduce ourselves to the audience?
MR. CASSELLS: I'm Joe Cassells. I'm the senior
clinical consultant for the committee.
MS. KNOX: I'm Marguerite Knox. I'm a veteran
from the Gulf War. I served in the 251st Evacuation
Hospital during Desert Storm at King Khalid Military City.
MR. KOWALOK: I'm Mike Kowalok with the committee
staff.
MS. GWIN: I'm Holly Gwin with the committee
staff.
MR. CROSS: Tom Cross. I'm a Major in the Marine
Corps Reserve, a Gulf War veteran.
MS. PORTER: I'm Joan Porter, senior policy
analyst committee staff.
DR. CAPLAN: Thank you.
One of the things that this committee has tried to do
is to take testimony and listen to the experiences of people
who served in the Gulf, their spouses, others who are
concerned about their welfare. And that's what are going
to begin today's meeting with, is a period of public
comment. And I have a schedule in front of me.
There are many people who want to speak, which is often
the case at panels and committees of this sort. We have to
restrict time, basically five minutes presentation, and then
a brief period so that panel or staff may address questions
to those who present.
Many of you have given us written statements and, if
you will, read every word, so that there may be more than
you want to tell us, and I would urge you, if you haven't
sent us a written statement, to do so, but, nonetheless,
it's also important to have the opportunity to speak.
I have Chris Kornkven as a first the first presenter
today. And I would ask you, Chris, if you could come to
the podium, maybe to say a bit about who you are, and the
committee is pleased to have this chance to hear from you.
MR. KORNKVEN: Thank you.
My name is Chris Kornkven. I'm a Army veteran of the
Gulf War and I come from Oklahoma City. And I am the
president of the Desert Storm Justice Foundation and the
president of the National Health Corp Resource Center.
DR. CAPLAN: Please begin.
MR. KORNKVEN: Thank you.
My name is Chris Kornkven, like I said. I came here
today to provide a statement in my capacity as the president
of the National Gulf War Resource Center.
Our statement today is co-authored and endorsed by 17
organizations representing ten thousand plus Gulf War
veterans, family members and supporters. Endorsing
organizations are listed at the bottom of my written
testimony.
It is our contention that this committee is focusing
in matters that are minor and of a technical nature, such
as VA Hotline accommodations, items that have little
relevance to everyday concerns of Gulf War veterans. We
feel the committee can much better assist Gulf War veterans
and their families by conforming to your Charter and looking
into areas that are yet unresolved or have been given little
attention.
As has been stated by the Chair of this committee, your
intention has been to make the committee process as
"inclusive and open as possible" for all Gulf War veterans.
We believe this has not been the case in light of ignored
suggestions concerning the make-up of this committee,
requests for information provided to this committee, and
ignored suggestions for locations of these hearings.
Additionally, notice of committee hearings has
frequently been given only two weeks in advance, which has
prevented many veterans, particularly those on active duty,
from having time to travel to committee hearing sites.
To make this process as inclusive as possible for as
wide a range of veterans as possible, the veterans
themselves must be included in the committee process, the
entire committee process.
Nowhere in the Committee Charter does is state that
the public may not make reasonable inquiries and seek
clarification regarding committee schedules, policies and
procedures. Yet, many of our members have reported that
when requested, such information has not been forthcoming.
Additionally, response to public requests for
information under the Freedom of Information Act has been
somewhat unresponsive, and in some cases not fully compliant
with the law.
I must reiterate the importance of timely notice of
committee meetings. Often notice of meetings is not
announced more than two weeks to a month in advance. Active
duty personnel, those dependent on the civilian job market,
as well as disabled veterans with little or no resources,
cannot take cross country trips at a moment's notice.
Because they do not know where the committee will meet in
the future, some veterans have been forced to travel
hundreds or even thousands of miles to attend committee
hearings.
We request that the committee immediately publish a
list of cities where hearings will be held in the future
and that finalized dates for those hearings be announced a
minimum of 45 days in advance. This will allow veterans to
make plans in advance, request time off if they are working,
and budget for travel.
Your staff has commented that relatively few veterans
have attended some hearings, yet they continue to ignore
our suggestions which would make hearings more accessible
to those veterans. We thank your staff for being vigilant
in requesting no one smoke at the hearing rooms, however
the very presence of chlorinated water in the atrium of this
hotel makes this building poisonous to many Gulf War
veterans.
Further, the committee continues to meet in expensive
hotels, which are far beyond the means of disabled veterans
who have to travel to these meetings. Between the
scheduling and locations, is it surprising that few veterans
are able to attend?
The Resource Center and its member organizations are
quickly losing confidence in this committee and their
ability to objectively provide much needed information
concerning data and research on health issues which directly
affect us.
Unless the committee begins to allow an amount of time
equal to that of the DOD, VA, and other government agencies,
to private researchers, physicians, or other medical
professionals to provide their research data and testimony,
what confidence we have will be totally lost. Regardless
of your intention, when a Defense Department researcher is
given ten times as much times to testify as a private
researcher, an appearance of bias is created.
As a result, we are beginning to have serious doubts
concerning the credibility of this committee.
The committee has indicated repeatedly that their
charter only authorizes them to examine DOD and VA research
and programs and offer suggestions as to how those resources
can be better spent. However, after reading the charter of
the committee, this interpretation is not clear to us. The
committee was directed by Executive Order to "provide advice
and recommendations based on its review of the following
matters: research, epidemiological, clinical, and other
research concerning Gulf War veterans' illnesses." There
is nothing in the Executive Order restricting such review
to government sponsored research.
Such a restriction would make the mission of this
committee no more than that directing the Institute of
Medicine, which has already been given the mission of
reviewing government research.
Our contention is that to restrict the activities of
the committee to government reviews will, in fact, obscure
the full range and seriousness of the illnesses, given that
much valuable research has been conducted by private
researchers who have not been given a full opportunity to
present their results to the committee.
This committee has been seated at the direction of the
President to gather data and information concerning health
issues directly affecting Gulf War veterans. Gulf War
veterans are greatly concerned that in nearing the fifth
anniversary of the start of the air war with Iraq, we may
be no closer to obtaining what we have battled for since our
return. This belief is due to the fact that this committee
will be providing their final report to the President
through the Departments of Defense, Veterans' Affairs, and
Health and Human Services.
These are the very agencies we have been trying very
hard to work with in obtaining health care and information
since returning with relatively little success. With the
VA admitting that almost 3,000 Gulf War veterans have died
to date, we believe this committee, with the best of
intentions, and possibly a willingness to please, may
provide a report that is not completely objective or in the
best interests of those remaining veterans.
Despite our loss of confidence in the committee, we
recognize that the committee may respond, may choose to
respond to our grievances. We certainly do agree, the
committee, the committee's request for the National Gulf
War Resource Center to review a draft of your interim report
prior to submission is a very positive step in the right
direction.
However, every day there is a delay in the pursuit of
the truth of Gulf War situations, a terrible toll is paid
in the lives of the veterans and their families.
Unless there is a demonstrable and a significant
improvement in your activities, the National Gulf War
Resource Center, and the undersigned member organizations,
may find it necessary to boycott, picket, or publicly
protest future activities of the Presidential Advisory
Committee on Gulf War Veterans' Illnesses.
Thank you.
DR. CAPLAN: Thank you.
Let me open the floor for comments, questions from
fellow panelists.
One question that I would have to address is, I think
many of us have felt frustrated about the absence of a
schedule and being able to plan meetings, both from a
committee point of view as well as some of the Gulf War
veterans you're talking about in terms of making their plans
to get here, and I think the request for advance notice is
important. And I think if you would want to say something
about some of the specific hardships that you've seen, we've
tried to meet in different places, Kansas City, San Diego,
and so forth, but maybe you could say a bit more about
specifically what sorts of obstacles have been faced in
terms of getting voices heard who ought to be heard by the
committee.
MR. KORNKVEN: I certainly would like to address
that, Mr. Caplan. And one problem that we have noticed very
quickly, being in the midwest, is that many of the research
programs seem to be east of the Mississippi River. Many of
these committee hearings seem to be east of the Mississippi
River. Now, the one in San Diego or San Francisco, wherever
it was held out in California, was an exception. This one
here is a full panel meeting, okay.
Now, I do understand, and was aware, that there was
the possibility of having a full committee hearing in
Chicago. Okay, we have suggested some time ago that there
be a full committee hearing in Dallas. Due to the
facilities there, the transportation facilities and the
veteran population. And to this date we are not sure of
how solid that planned committee meeting may be.
Now, as to the hardships of veterans getting to the
committee hearings; many times what will happen is the
committee will provide the advance notice of the meeting
dates to many of the group leaders of the Resource Center.
But, still, with the two weeks notice that we have, we're
finding it very difficult to try to get these notices out
to our membership in a timely manner so they can plan for
travel, so they can plan to take time off of work, so they
can budget for this.
MS. KNOX: Chris, other than the time and the
place and the advance notice, can you tell us what we could
do differently that might assist you at this point?
MR. KORNKVEN: I firmly believe that one of the
biggest advantages that all of the Gulf War veterans have
had to date is that we are able to communicate with
thousands of Gulf War veterans over the Internet, over
Prodigy, over America Online, et cetera.
One of the most significant improvements you could make
in providing information and providing notice of these
meetings would be to establish a web site and post a lot of
this information to that site.
MS. KNOX: Is there anything other than that,
other than dealing with the location?
MR. KORNKVEN: If I could please defer to --
DR. CAPLAN: Sure. Please come forward. Just
tell us who you are?
MRS. NICHOLS: I am Denise Nichols and I am one
of the board members of the Resource Center, and also the
Desert Storm Veterans of the Rocky Mountains, one of the
undersigned organizations.
Some of the things that we find completely disquieting
is that notices are not being posted at the VA hospitals
where the veterans are seeking care. That could be a
definite improvement at the VA hospitals and at DOD
facilities. And I would highly, highly recommend that the
complete schedule be published within, I would say, 15 to
20 days from this meeting.
We need to know where the sites are and what the dates
are so that adequate arrangements could be made so that vets
can have a choice of, yes, they're going to be in my area,
or, no, I'm not going to be available at that time, I need
to budget to be able to go somewhere. And that needs to be
done.
Doing this piecemeal that has been done is a disgrace,
I feel, when you're trying to hear from vets, and we're
trying to get them here and assist the process of open
communication, and you are not helping the situation at all.
The recent Presidential Advisory Committee on
Experimental Radiation that turned in its material to the
President had a bad schedule. It allowed for the victims
of radiation to set up a meeting the day before the
Presidential Advisory so they could meet and share
information.
The other thing is the Internet site. The full
transcript should be put on a Presidential Advisory
Committee Internet site. That is not asking a lot.
We also want to protest the one in California that the
information we received is, you had huge notebooks. You
were referring by paragraph and page. No one in the
audience had copies of that, so it was very hard to figure
out what you were commenting on. That is not being open
and communicative.
I have a whole list of suggestions that I will type up
and provide to you. And I would like, item by item, within
15 days of when I present it to you, to have it addressed
and a reply back to us.
DR. CAPLAN: Let me see if I have any other
questions or comments from either staff or panel at this
point.
I'm going to thank you both for your suggestions and
remarks. I will assure you we will, I will personally make
every effort to make sure that we get at these schedule
problems and notice problems and distribution of information
in a way that's timely. And I did hear very clearly your
request about making places as environmentally accommodating
as they can be.
There are some constraints that the government imposes
about the places they can use to go to, but we'll try, we'll
push for that. I understand what you're talking about in
terms of making available places that all veterans can come
to.
So, I want to thank you for your suggestions and
comments and, dare I say it, directives.
MR. KORNKVEN: Thank you very much.
DR. CAPLAN: I've got Jim Bunker as our next
presenter. And again, I'm going to ask just that you say
a bit about who you are to the committee, the panel.
MR. BUNKER: I'd like to thank you for letting me
to be here.
My name's Jim Bunker. During operation Desert
Storm/Desert Shield I was with the field artillery. I was
an officer. And I worked in the battalion Tactical
Operation Center doing orders and targets, targeting of the
Iraqi positions. I was medically discharged shortly after
the war from the service after spending 14 1/2 years in the
uniform.
At present, I'm First District Vice for the State
Department of Kansas Disabled American Veterans. I'm very
active with the Disabled American Veterans and other
veterans' issues. I ask that I speak today, and I handed
to Mike earlier some pages of some comments that I wrote up
for you.
One of the main areas that I would like to talk about
is some of the treatments that veterans are receiving in
the VA hospitals. And each VA is slightly different, so
what I've been through may be different than what a lot of
other veterans have been through.
I've been going to the VA since 19 June of '92, and
I've seen a lot of different doctors. The main VA function
where I'm at is psychiatric care. The first thing they like
to do is say that everybody suffers from PTSD and it's all
in your head. So, the whole time that's one hurdle you have
to work on, to get over, because it's not all in my head.
I did have a couple of doctors at the VA that are
trying to help us out quite a lot, except they're running
into stumbling blocks. The last couple years, the one
doctor has been working hard with most of us Gulf veterans
over there, has been unable to receive any answers or any
results of any of the studies that have been done to date.
In talking with him yesterday, I asked him if I should
reiterate this and see if you guys would be able to help out
with this matter, and he had asked that I do so. Every time
he tries to find answers, he's asked not to bother with
them, it's not his area.
I'm well aware that the VA do have, does have doctors
designated for Gulf War Syndrome and their studies and the
evaluation programs in each VA facility. I've only seen
the doctor in our facility as a patient once. That was when
I was brought in on an emergency admission in October of '93
with a crippling headache. The doctor was the one on duty
at the time. If it was not for that, I don't think I'd have
ever seen her as a patient.
In June of 1994 I was hospitalized again for some
crippling headaches. At that time one of my doctors,
treating physicians, who is still working with me, sent a
referral down to Houston for me to be admitted there. I
checked into it six months later with the Persian Gulf
Coordinator for our hospital, a Dr. Welsh. She said there
was no such thing sent, even though I did have a copy of it
in my medical files that, after I requested it.
One year, one month after the doctor had request me to
be sent to Houston, I was finally accepted. On arrival to
the Houston VA, many tests were performed, 80 percent of
which I'd already had. No new findings were found, with the
exceptions of a mild lung disorder, which the VA in Topeka
was not able to find since they never ran tests on that.
They found some problems wrong with my blood chemistry.
And I, like many other Gulf veterans that were there at the
time, saw the doctor. And the doctor came into my room and
said that there was a problem. And I asked her, how, what
would cause that.
Her reply to me was that it was because I was a heavy
drinker for a number of years. My reply back to her shocked
her, and I could tell by the expression on her face, because
my reply was, is, I don't drink. And I don't.
So, the blood chemistry that she says she sees in heavy
drinkers and alcoholics went out the window. Her next
response then was, oh, this is something that we see in a
lot of Gulf War veterans.
I find it hard to understand why we could have doctors
working these studies who have attitudes and prejudices
against veterans, who classify us as being alcoholics and
drug addicts. That type of attitude with a doctor will get
us no place.
Other issues that had happened down in Houston is that
the problems with my headaches were never addressed until
two days prior to my discharge. They never addressed my
constant fatigue, though I asked about it many a time.
Excuse me, I'm going slightly off of what I've written
here. I do everything off the top of my head. I don't come
with everything pre-written down.
With the blood chemistry, with her knowing that the
blood chemistry being off, and also the fact that a mild
lung disorder was something they were seeing in a lot of
Gulf War veterans, these are traits that they should be
following.
What other common denominators have they noticed within
Gulf War veterans that they have not even bothered to put
into print? These are items that should be tracked. It
will help identify veterans, more veterans further down the
road.
Most of the doctors that I've dealt with, with the
exception of a couple at Houston in the last three years,
have been pretty good at trying to find answers. Though I
found that the doctor dealing with me in the Houston, and
the physician's assistant at the Houston Center for the Gulf
War Research, to be very poor. Part of this may be that
doctors in the VA system are overburdened with the workload.
It may be that she just didn't have all the time to look
into the records.
She would come in once a day, maybe talk for two or
three minutes, and be gone again. One time she came in and
told me my cholesterol was high. And I asked her how high
it was, and they said they didn't have the numbers. So, the
next day I asked her the same question, with the same answer
being given. On the third day when she returned I told her
what it was because I'd already, I knew it from the first
time.
Now, before the Gulf War my cholesterol was 170. After
the Gulf War my cholesterol was at 293. I know a lot of
other Gulf War veterans that their cholesterol level went
high. Is this another one of these underlying common
denominators that we can see to help pinpoint problems?
The only time that they started to look at my massive
headaches that I had was near the end of my stay there. I
was there for about five weeks. I started to have a real
bad crippling headache. And then they had the rehab
medicine doctors come in an look at me.
They figured that the headaches were either migraine
or tension, possibly caused by a tear in the rotator cuff
in my left shoulder, and that was also causing the pains in
my left arm. They gave me a shot of cortisone the next day
in the shoulder. And the day after that I was discharged
with no follow-up. They never done any tests or x-rays or
anything to see if there was a tear in the rotator cuff.
Is this called medicine by pulling things out of hats?
Is this going to help us? I don't think so.
When I returned to the Topeka VA, my medical records
took, I believe, in excess of a number of days to reach
here. Forty days after my return I had an appointment with
my doctor. When I walked into his office he told me that
all my records were down at Houston and he was unable to
treat me and he would have to wait. The records finally
showed up sixty days later.
This stops the care that I was receiving at one VA to
the next.
You need to do something to ensure that when a patient
is transferred from Phase II back to his own VA, that the
records are there automatically, even if you have to just
photocopy what was found out and send it back to that VA.
This will help provide better treatment for the veteran.
They suggested I do a lot of physical therapy and
started it when I was at the Houston VA. On my return to
Topeka, I have yet to be able to get that physical therapy
continued within the VA system. It seems like the VA
doctors from one facility to the other do not trust what
they're saying. And then, thus, some treatment is once
again lost.
As the issue with the doctors getting their
information; it has been presented earlier to you about
Internet pages and all that. I feel that if the VA's take
their systems, since I do know they have their mail and
everything goes out from Washington to all the VA's, and if
the doctors can take their findings and put it on this
system to allow other doctors to read it and also post some
of their findings, this would help facilitate the doctors
in finding cures and pinpointing problems. They would be
able to share information in a much more efficient rate.
Everything would be at their fingertips by just the use of
a computer system.
You don't have to set up the system up so that public
may have the access to it for patient confidentiality
reasons, but it would be one great tool to help facilitate,
and not only Gulf War, but all veteran issues.
DR. CAPLAN: Let me interrupt your statement,
because we do have the written version here and I want to
make sure that we get a chance for the panel to ask you a
couple of questions, if that would be all right.
MR. BUNKER: Uh huh, yes.
DR. CAPLAN: And I have one, but let me ask the
staff panel -- Joe?
MR. BUNKER: Yes, sir.
MR. CASSELLS: At the time you left the Houston
VA, you said your records were not transferred immediately
to Topeka, it came 60 days later. But were you interviewed
at the time of your discharge from Houston and given any
information about your evaluation and what your diagnosis
possibly could be?
MR. BUNKER: All I ever got were evaluations and
diagnosis was a one or two minute thing from the doctors
each day, which really wasn't saying much of anything. The
reason I, well, when I finally got to read my final
discharge summary, which they did mail me a copy of that,
there were things in there which I disagreed with, but they
never told me anything about.
They did not give me a good outbreak and, like, my wife
was told they would give them prior to my discharge. So,
it's more like, you're here long enough, go home. And that
was how you basically were treated.
I know some of the veterans that were there had some
problems due to finances, and I did address that in my
letter.
MR. CASSELLS: One other question; the problem
with getting physical therapy once you got back to Topeka,
is that a matter of scheduling and inadequate staff, or is
that a matter of disagreement between the two VA hospitals
as to the need?
MR. BUNKER: It becomes a little bit of both.
Part of it is the scheduling, but the other part is that
the VA here needs me to go back and see their physical
therapist in Topeka. But then that takes me six months to
a year before I'm going to be able to have that appointment.
So they want to, what they actually want is their doctors
to write the consult, even though I had one from the other
VA.
It's the same problem that you run into, because down
there I was given 13 different medications. And when I came
back to Kansas here, I had to have a doctor go through my
records, after my records came back from down there, to redo
half these medications, of which some of them did expire at
that time.
DR. CAPLAN: Yes, Major Cross.
MR. CROSS: Jim, what do you think is the source
of your particular illness?
MR. BUNKER: To pinpoint, it's going to be exactly
hard to say. There was over 20, I'd say about 29 different
toxins that were already present due, in the Gulf War by
natural occurrences and petroleum and all that.
A lot of people were talking about biological and
chemical warfare agents. I will not comment on that, though
it is a matter, it is a fact that the DOD, the Department
of Defense, has lied to veterans for over 50 years of
different things that have happened to them in times of war,
and also about their experiments.
One of the things that I wanted, that I addressed in
one of the papers there was that the problem with my left
arm started shortly after I did get the botulism shot in my
left arm. And up by Southpoint I know for a fact that, we
had air conditioned bunkers that the Iraqi, they knew the
Iraqi ammo point that we were at.
In reading off the Department of Defense link I have
found that air conditioned bunkers were where they stored
chemical and biological warfare agents. And that's, in that
area is where a lot of people in my battalion started
getting sick.
I was medivaced back, I was medivaced out of my
battalion up there on, what they had, and it was a letter
that the colonel had put into my medical files. And I was
reading that letter the other day. And most of the things
that he put on there is what now-a-days people are call Gulf
War Syndrome.
DR. CAPLAN: Let me thank you for drawing these
issues to our attention and your care and continuity of care
and the problem you've had in making sure that people are
following through from one place to another.
Thank you.
MR. BUNKER: Thank you.
DR. CAPLAN: Our next presenter I have on my list
is Lisa Montague.
And, again, Mrs. Montague, I'd just ask you to say a
briefly who you are, and welcome.
MRS. MONTAGUE: Good morning and happy New Year.
I represent Wounded Eagles. I'm pleased to speak to
you here in Kansas City. This is my home and I hope you
feel at home here, as well.
I'm a practicing occupational therapist of some 18
years. I also received a Masters in Public Administration
and Health Services Administration from the University of
Missouri at Kansas City. My Bachelor's is from the
University of Kansas.
Many of my classmates in my Bachelor program were from
the Leavenworth Community College, and they were a great
bunch of guys.
My role here today is to give the panel some history
of the misuse of psychiatry as a method of reprisal against
military whistle blowers. We now know this method is used
on military members and civilian employees complaining of
discrimination. We also have heard reports of the use of
involuntary psychiatric evaluations and incarcerations of
Gulf War veterans complaining of occupational illnesses as
a result of exposure to the yet to be known causes during
the Desert Shield/Desert Storm action of 1990 and 1991.
Eugene G. Laforet, Captain, Marine Corps, United States
Naval Reserve, spoke to this practice in his essay, "Limits
of Loyalty and Obedience: Does the Military Physician Serve
Two Masters?"
He writes, "Medical evaluations for administrative
purposes also test the limits of loyalty and obedience of
military medical professionals. A commander may find that
getting a troublesome individual out of his unit may be
accomplished more easily and expeditiously on medical
grounds rather than by administrative means. Here, it would
seem, the physician can easily become a double agent unless
he is aware of the possibility and has sufficient ethical
mettle to resist.
The price of ethical mettle is high. Medical providers
who resist, or complain of shoddy care, et cetera, have
become targets themselves. It is not uncommon for a
professional to find himself rendered unemployable as a
result of these reprisitory tactics. It is this reality
that gains the participation of doctors in human rights
abuses around the world. They know if they do not follow
orders, it will be done to them.
Few have the type of ethical mettle it takes to speak
up or to resist a direct order. Military culture around
the globe is prone to this abuse. For most, the price is
too high and there is nowhere to go for help.
It is the opinion of the majority worldwide medical
community that physicians should be able to have a special
forum through their own medical associations to assist them
when asked to participate or witness such abuses the world
community defines as torture and other inhumane treatment.
In 1992 the British Medical Association published its
report on this subject titled Medicine Betrayed. They
requested Medical Associations globally to contribute
information from their own countries' practices. The AMA
did not appear to have participated, nor was the United
States discussed in the text.
This brings me to this short history lesson. On
Sunday, March 22, 1992, The Dallas Morning News lead story
was headlined 'Whistle-Blowers say military waging
psychological warfare -- Officials deny using mental health
system for reprisals.'
The News had reviewed 50 such cases dating between 1992
and World War II. They found that the system did not
provide safeguards that protect civil rights. The use of
involuntary psychiatric fitness for duty exams as reprisal
against Civil Service employees was publicized and outlawed
by Congress during preceding years in the 1970's and 80's.
As a result of the article, a group met in June of
1992 as a forum for a discussion of the problem by vets who
were survivors of this treatment. They came from across the
United States. Some 100 people, mostly professionals,
former military, as well as defense related employees
attended. There were doctors, nurses, accountants,
engineers, managers, scientists, and a few other interested
parties, including one holocaust survivor who wanted to lend
moral support.
The meeting was announced on Nightline and the group
became known as The Wounded Eagles. Members of the media
covered that meeting, including Brian McCormick of the
American Medical News. Although I met him and he
photographed me at that time, nothing was ever published by
the AMA.
Through our efforts, the work of other organizations
and individuals, our message to cease this abuse and provide
for some redress for the wronged party has been heard by the
American people and Congress. Several network news programs
and print pieces have highlighted the problem. Some
testified before Congress. Others wrote letters of support
of a law that became 10 USC 1034 Section 546, enacted
October 1992.
This section established procedures for referral by
commands for mental health evaluations, set forth rights of
service members referred, and strengthened the protection
of whistle blowers prohibiting the use of psychiatric
evaluations as reprisal for protected disclosures. These
protections can include sanctions against the offending
party through the UCMJ.
'The Military Whistle Blower Protection Act, which is
10 USC 1034, was originally enacted in 1988 to prohibit
anyone from retaliating or taking reprisals against service
members who disclose information concerning government
fraud, waste and abuse to designated persons. This
protection also extends to reporting a danger to public
health and safety.'
These words were taken from the GAO study report
requested in 1992 by the Senate Armed Services Committee
and delivered February 2, 1995.
The GAO team did find instances of involuntary mental
health evaluations as reprisal. That the DOD IG had
completed few cases between 1988 and 1994 containing these
allegations. The regulations due in January 1994 to
implement Section 546 had not been issued by the military
services. Without such regulations, DOD has no assurance
that the services are consistently protecting whistle
blowers from reprisals. Those who allege discrimination
were to begin to receive the same protection as of January,
1995.
This brings us to the present and current problem.
Although Congress enacted the law, law enforcement by
the DOD and branches of services is lacking. By not issuing
the regulations for the law intended by Congress, there is
no law enforcement to speak of. The prevailing attitude
seems to be, we don't have to do what Congress wants. There
seems to be a constitutional breakdown at this juncture.
The GAO made some recommendations that, if implemented,
should help correct this glitch. We have requested an
update through Senator Thurmond's office, but to date know
of no changes having been made.
We of Wounded Eagles understand the truth spoken by
Sakorov, any use of psychiatry, not just hospitalization,
but any use at all for political or ideological reasons is
an assault on the mind and should not be tolerated. Those
of us who had, or were threatened with this experience, live
everyday with the harm and resulting anguish. It is cruel
and inhumane treatment for a healthy person. To subject
someone who is physically ill to this abuse is an atrocious
insult to their injury.
We humbly request that the President see to it, as
Commander-in-Chief, that the regulations are written
according to the intent of Congress. The laws must be
enforced. The process of law enforcement needs to be
monitored by an impartial private body, such retired Federal
judges.
Victims of unexpected health hazards in relation to
their government duty should be included for protection.
Health providers need a protected forum to report abuses
anonymously and to be given immunity from harm. Wrongdoers
need to be punished under the law, and those wronged need
to be made whole expeditiously.
It is difficult to tell the history of this problem in
five minutes. Labeling the messenger as crazy is an old
method used by Tzars and Kings as far back as the biblical
days.
I hope the materials we have provided assist you in
digesting the bitter pill of this reality. Please convey
our thanks and respect to the President for providing this
forum and the opportunity to be heard.
All we ask is that the pattern and practice be exposed
to sunlight and be eradicated ASAP.
Thank you for your time and attention. Please feel
free to ask questions you may have, including about my own
case.
DR. CAPLAN: Well, thank you. I think you did a
superb job in telling that story in five minutes.
Open the floor for comments.
One question I would have is, do you know of any
instances in which a whistle blower specifically raising
questions about issues pertaining to Gulf War Veterans'
illnesses was subjected to this kind of reprisal that you're
talking about?
MRS. MONTAGUE: It's difficult to say because
people with information about Gulf War illnesses tend to be
Gulf War veterans complaining of illness, so it's a Catch
22.
Is it reprisal because they're complaining, or is it
reprisal because they are the message?
DR. CAPLAN: All right. Thank you for drawing
this issue to our attention.
I have Michael Buster as the next person providing
testimony to the panel.
MR. BUSTER: How are you all doing today? Well,
I'm Michael Buster. I'm a Gulf War veteran. And I'd like
to tell my story about my ordeal.
I served with the 227th Combat Aviation Regiment, 1st
Calvary Unit. I served as a cook, turbine engine mechanic,
and I received three Bronze Service Stars, Army Commendation
Medal, Oak Leaf Cluster. And I'd like to say, you know,
there is no such name as a voluntary informed consent to the
medical treatment in the military.
Upon leaving for Saudi and, again, on arrival, we was
inoculated. Anthrax and other shots, and I don't even know
what they are. An Army physician later told me that one of
the shots that we had took was for biological and chemical
warfare.
In Saudi we took so-called nerve gas pills after near
misses by SCUD attacks, although we was not told what the
pills were supposed to, how the pill was supposed to affect
us.
In my unit everybody wasn't exposed to SCUD attacks.
Only once was our company hit, and that was in neutral zone.
And I was, as a member of the advance team, I was really
close to six or seven explosions and at least three
locations. After each explosion alarms went off and
everyone donned protective gear.
The first attack I experienced in October 1990, I began
to break out in rashes, fits of cough that's still bothering
me today.
Everyone exposed to the attack felt bad the following
days, the side effects of the nerve pill, including nausea,
headaches, cramps, especially in the women. They really had
a hard time. Everyone became more and more irritable. I
felt like I was in a daze most of the time.
At least two explosions were followed by purple rain,
which was explained to us as fall out from oil well fires.
After one explosion, about five or six miles away, five or
six days later you would see 20, 30 dead sheep, dead camels,
dead flies on them, you know, and they was just laying
randomly out.
You know, I think the beginning of my illnesses,
February of '91. I had increasing rashes, coughs, muscle
pain and incredible fatigue. I then began to have
confusion, memory loss, couldn't stay in conversations.
People had to repeat most of the time over and over again
before I got the message across.
In Germany in October of '92 I was examined for
restless sleep, joint pain, difficulty concentrating,
extreme fatigue, stomach pain, cramps, grinding teeth,
rashes. The neurologist there documented the same right
side weakness that I have today. It has also been
documented by VA, private physicians. The doctors in
Germany, they treated me kind, they treated me with respect.
My real problem began when I got to Walter Reed. Upon
arriving at Walter Reed, instead of neurology, I got the
mental ward. I brought to this committee a stack of
articles by the Dallas Morning News. (Hands to Dr. Caplan.)
DR. CAPLAN: We'll take those.
MR. BUSTER: Describing the government's failure
to treat Gulf War veterans' illness, and for the military
use of psychiatric diagnosis and treatment as a threat and
as a punishment, and mostly just a great discredit to your
family and friends.
My neuropsychologist tests, tested me in Germany,
showed severe impairment, memory loss, abstractive
reasoning, a 20 point loss of IQ, and significant damage on
the left side of my brain. When I got to Walter Reed in
Winter of '92, I had blisters on my chest. I sometimes
cough blood, and my legs would sometimes freeze up. The
neurologists in Germany was not taken seriously and I spent
most of my two months at Walter Reed locked up in a psycho
ward.
While I was there so many veterans got psychiatric
labels that three other wards was converted to psychiatric
wards. Because I had a normal CAT scan, EEG, and MRI, I
was diagnosed with somatical and pain disorders. Dr. Gert
was my psychiatrist and he looked me, you know, he looked
me right dead in the eye and he said, you're just imagining
this stuff is happening to you. It's a figment of your
imagination.
I've since learned that the MRI is not the right test
for this condition. The staff at Walter Reed did not want
to hear about chemical and biological weapons. They also
did not want to hear claims about nerve pills and
inoculations. I was, the staff more or less told me to keep
my mouth shut. I was allowed to leave the ward only when
I did just that.
The staff also gave me diagnosis of pre-senile
dementia. It carried a zero percent rating. I now know
that the diagnosis is just a good way for the government to
avoid liability for my illness. In February of '93 the
diagnosis was upgraded to 30 percent disability.
The staff continued to try to limit liability, gave me
papers to sign hinting that I couldn't leave, I couldn't
leave, you know, without signing. If I signed what they
wanted me to, I could go home. I could, I could get away
from the mental ward and the treatment that they seemed to
want to give you there.
I signed the papers stating that I understood all my
rights and options, which had been explained to me. This
was not true, but I signed so I could leave.
My problems did not end when I was put on medical hold
and moved to Arkansas and attended the VA clinic there. The
VA kept the diagnosis of somatic and pain disorder and
dementia. Although Ph.D. psychologists urged aggressive
medical exploration and refused to alter psychiatric
diagnosis, my neurological examination was torpedoed by a
senior medical student who failed to find the right side
weakness that all the other doctors found.
In December of '93 the VA gave me the diagnosis of
Muchasen's Syndrome. When I went to the library to look it
up, well, again, there was three other veterans standing in
front of me wanting the same book.
In February '94 another VA psychologist strongly
advised another neuro exam just to deny the diagnosis,
possible toxic exposure syndrome. However, the VA doctor
advised me to go mental. It was easier, it was faster, it
was better for everybody.
In December '94 I was fortunate enough to get an
another exam by a private doctor and to be a subject of the
research. I got the diagnosis of inflammatory myopathy by
T1, T2, MRI and neurotic process by brain spec scan. I had
abnormal pupil contractions, low levels detox, and high Sed
rate. I was unable to complete three difficult exercise
changes, challenges. And onn some tests, my legs just,
would just give out.
Under the pressure of this private opinion, the VA in
Arkansas put me right back in the mental ward again in
August '94, and included that the private opinions and
detailed in my records.
However, they also reported normal IQ's, normal spec,
and normal neuro exam. They upgraded the Muchasen's
Syndrome to unspecified mental disorder with musculoskeletal
complaints, rated 50 percent. Then they added peptic ulcer
disease, rated 10 percent.
DR. CAPLAN: Mr. Buster, all right, what did they
say when you got these first inoculations?
MR. BUSTER: It was a, well, when we received the
first inoculations, the anthrax and the gamma globulin and
all that before we went over there the day that we started
bombing Iraq, sometime in January, I can't remember the
date, they lined us up. And they said, take out your ID
cards and put your weapons right here. And I -- we didn't
know what was -- after four or five people went in and come
out the back side of the tent, they said they'd give them
shots. All right, so I go back and I get my shot records
and I take my shot records with me. So did four of five
more.
Well, we was just told to take the shot records and
put them back in our pockets and take the shots, shut up
and get out, and that's what we did.
DR. CAPLAN: Other comments, questions?
Marguerite?
MS. KNOX: Does your medical records today reflect
that you received the injections? Do you know if you
received anthrax and botulinum, or just the one?
MR. BUSTER: I have, I have my shot records. The
anthrax is on there. I don't know what the other one was.
MS. KNOX: Botulinum is the other one. Did you
have any immediate effects from first taking the bromide
tablets?
MR. BUSTER: Oh, the next day?
MS. KNOX: The next day.
MR. BUSTER: Yeah, the females, they would have
bad white discharge, cramps. And they just, everybody was
just schized out. I don't know how to explain it. They,
everybody was nervous.
They'd go do something, it would take them two or three
times to get something done, because they'd forget to take
something with them, they'd forget to do something over
there, and it would just -- it was real bad. We had
headaches and it was just hard to get yourself pulled
together.
MR. CROSS: Do you attribute the illness to, I'm
a little confused, I'm not so sure if you're saying it's
from the shots that you were given.
MR. BUSTER: Well, I'm confused to, sir, and I
don't know whether it was the shots or the SCUDs.
MR. CROSS: Oh, the SCUDS, yes, that was the other
part of my question. I think what you're really saying is,
you kind of did both, you know.
MR. BUSTER: YES.
MR. CROSS: You had some shots and took some pills
and somewhere along the line you were fired at. And God
knows what landed in front you.
MR. BUSTER: Yes.
DR. CAPLAN: Let me ask one more question,
something that's been troubling me; I, too, have seen these
reports that say there is no Gulf War Syndrome that have
come out recently, statements, different settings. When you
see that, your reaction is what?
MR. BUSTER: I don't want to say. (laughter)
You all have been watching me. I just get mad, you know.
I just get real angry.
DR. CAPLAN: So, one might say that these
government agencies need to be cautious about what they're
saying. They may not find a syndrome but there are going
to be different types of illness present, you feel.
MR. BUSTER: Definitely. You know, we all got
friends and we got family, we got children, and when you
destroy your credibility, you would destroy credibility like
that, you know, I've got no respect for them, you know.
Some of them, so do my friends, you know, you don't do that
to people. And all it does is making us look bad, you know.
We all want to do good. We didn't join to get made to look
what we're made to look like, you know. We're not proud of
this, you know. We're sick and we need help.
DR. CAPLAN: Okay, thank you.
Just before we take our break we have time for one more
presentation. I've got Debra Smith next. We'll call her
forward if she's here.
MRS. SMITH: Hi, Dr. Caplan and committee members.
First I'd like to thank you for the opportunity to speak in
front of you today.
When I met my husband, David, in the Fall of 1992, he
weighed 270 pounds and had won the New Jersey State Power
Lifting Championship that previous Spring.
When we began to share a home, I found that he suffered
from debilitating diarrhea and migraines. He had night
sweats so severe that at times we would have to remove the
damp bedding in the middle of the night. When he arose in
the morning I could hear his joints pop from across the
room. As the diarrhea continued, David's strength
diminished. He eventually stopped his weight training as
it was impossible for him to regain his stamina, even after
an evening away from the gym.
My husband found employment with a company that
manufactured arcade games. He soon was promoted to the
position of wood shop supervisor. The diarrhea continued,
causing him to miss work occasionally. These bouts were
explosive and accompanied by severe cramping. They left
David drained and weak. We experimented with deleting foods
to see if allergies might be causing his health problems.
Only Lomotil, which was prescribed by the VA, offered
any relief, and this was only temporary. He is still on
this medication two years later.
For two years David sought medical help for these
problems from our local VA, which is 110 miles away from
our home. The diarrhea continued. The number of
prescriptions being prescribed by the VA increased. We were
told not to worry about the strange discoloration spreading
across his legs and arms. They seemed unconcerned about his
continued weight loss.
In the evening of September 19, 1994, I found my
husband collapsed in front of the bathroom door. He was in
the fetal position and had been unable to control his
bowels. Tired of the VA's inability to provide answers, I
contacted our United States Senator, Dirk Kempthorne. His
office was instrumental in our quest for better health care.
Dr. Patricia Olson of the Senate Committee on Veterans'
Affairs informed us that David was possibly eligible for a
Persian Gulf Protocol Evaluation due to his undiagnosable
health problems.
David was admitted to the West Los Angeles Veteran's
Medical Center on October 25th, 1994. He was discharged on
December 2nd, 1994. The discharge diagnosis included
irritable bowel syndrome, hepatomegaly of unknown etiology,
hematuria, history of orchitis and depression.
Listed under procedures, an MRI revealed sphenoid sinus
thickening. A biopsy showed non-specific mass cell
infiltration and perivascular lymphocytosis.
It has been over a year since his discharge from West
Los Angeles Hospital, and David still has not been seen by
a consultation regarding these results or received any
further medical care from any VA facility other than
psychiatric.
In May of 1995 Family Circle magazine published my
request to correspond with any of their readers whose
spouses were ill since returning from service in the Gulf.
Before I could find this issue in our hometown, I began
receiving correspondence from women across the United
States. Two to three letters arrived daily for almost a
month. It became heartbreaking to open the mail.
Over and over I read of lives similar to my own. I
read of the pain when a loved one is ill and there are no
answers to be found. They shared the suffering of birth
defects, divorce, and financial ruin. Most told of
dissatisfaction with the VA and the lack of recognition
these health complaints receive.
Many, like myself, had been told that our husbands'
decline in health was due to depression or Post Traumatic
Stress Disorder.
These soldiers experienced diarrhea, joint pains,
sweats, seizures, sleep disorders and depression like my
husband does. I correspond with any who write. This is a
nightmare that continues, and we do not yet see an end.
My husband's illness has awakened me to the
idiosyncracies of a defense system. I have witnessed that
our soldiers willingly and undauntedly serve this country,
but this country is unwilling to serve them. My husband
has compensation claims pending. His employer would not
allow him to return to work because of the hazards of
operating power tools while on his medications.
After being unemployed for almost a year, Social
Security determined that medical evidence establishes that
David has severe residuals of Persian Gulf Syndrome,
dysthymia, and PTSD. He now receives disability benefits
monthly. How can the VA and DOD take so long to recognize
what seems to be a real problem to other governmental
branches?
My husband's health has continued to deteriorate and
our lives have changed drastically. We live on a poverty
level income. Before the war, David was able to provide
for a family. Now he is often too ill to play with his
sons. He has lost almost 75 pounds, and I am scared.
I have before you a file of the letters. These are
the initial letters that I have received. All of them are
not from Persian Gulf Syndrome wives. Some of them are in
support, offering just moral support for us.
Whatever the causes, or cause, of these health problems
may be, the veterans of Operation Shield and Storm deserve
better than this. I am scared, as are these women.
Thank you very much.
DR. CAPLAN: Thank you. (applause)
Questions, comments?
MS. KNOX: Can you tell us what your husband's
weight was at the beginning and what it is now?
MRS. SMITH: I believe that when he was deployed
to Saudi he was 264. They weighed him on a freight scale.
He was an athlete for the Marine Corps. His bio is in
there. He has a lot of championships. He was a power
lifter. And now we haven't weighed for about a month, but
at one point in November he was 190 pounds.
And that fluctuates as the diarrhea continues. You
know, he'll drop ten pounds sometimes in a week, and then
we just really eat a lot of bananas and potatoes. And I
found that he is multiple chemical sensitive.
The VA, when they did his protocol, did not do a test
for this even though it was on the protocol sheet. We have
addressed that issue. It has never been responded to us.
As this gentleman whose medical records, it took us
almost a month to get his medical records from LA to our VA
facility near our home. He still has not been seen by a
doctor regarding, you know, the bleeding that was in the
urine or the swollen liver or anything.
MS. KNOX: What VA did he go to?
MRS. SMITH: The Walla Walla Veterans' Hospital.
DR. NICOLSON: Could we have the units that these
veterans served in, please? What unit did he serve in?
DR. CAPLAN:
Is that in the documentation that you've got here, the
units?
MRS. SMITH: First Marine Division.
DR. NICOLSON: First Marine Division.
DR. CAPLAN: I have a question, which is,
obviously you've made a complaint to your Senator about what
has gone on here.
MRS. SMITH: Yes, I have.
DR. CAPLAN: What happened in terms of complaints
to VA and responses there? And I realize we may have a
finite amount of time here, but briefly.
MRS. SMITH: I was told that I was hysterical,
that I was a cage rattler. And at one point I was accosted
by a nurse in a corner who said, what precipitated your call
to a United States Senator? You should have called us
first. And I had dealt with this woman many, many times. And
I basically told her it my right, that I have the right to
contact my Senator when I felt that my husband was, and is
still receiving sub-standard care from the VA.
MS. KNOX: Did he receive the anthrax shots?
MRS. SMITH: Yes, he did.
DR. CAPLAN: All right. Thank you.
MRS. SMITH: Thank you.
DR. CAPLAN: At this point I would like to have
a brief ten minute break and we will reconvene here for
further testimony.
MS. KNOX: There's a question.
DR. CAPLAN: Yes, ma'am.
MRS. DENISE NICHOLS: Sir, in all due respect, at
the very first committee meeting six months ago in
Washington, I asked one thing for these vets. I asked to
have a table and a chair.
I've sat here and watched these vets holding on in
pain. This is just terrible treatment of our veterans, and
I'm a veteran, too. I suffer when I have to stand up and
hold on, and that has not been corrected in six months.
DR. CAPLAN: Good point.
MRS. DENISE NICHOLS: We have been mentioning
things and I, it tears me up to watch what's going on here.
And I think you should show some anger at how these veterans
are being treated.
DR. CAPLAN: Thank you. You're right.
All right, we'll take that ten minute break and
reconvene for further testimony after that.
MRS. DENISE NICHOLS: It's got to stop.
(Break.)
DR. CAPLAN: If those who are going to give
testimony would return to their seats. We're just doing a
little electronic work here, but, while we're doing that,
I did check during break and I know, I'm don't have precise
dates yet, but I established that we do have a full
committee meeting possibly at the end of March in
Washington, D.C. in May. And Chicago will be in July.
We'll keep pushing to get those dates nailed down so
that we can plan in advance, both as a committee and for
those who want to attend, to have time to get to those
meetings, for people who want to get there or listen or
provide testimony.
I also know that at least one or two individuals have
request a little bit of time to address the panel, and I
have decided to let that happen. We'll just add some
limited time, three minutes at the end for three people not
right now on the list. But I've got Anthony Buckner as the
next person to speak.
Is he here? (no response) Well, maybe not. Is
Anthony Buckner here?
All right, we'll put him, if he comes in, if someone
knows that he's in the room let me know and we'll put him
to the end of the testimony.
How about Dr. Garth Nicolson?
DR. GARTH NICOLSON: Yes, I'm here.
DR. CAPLAN: Dr. Nicolson, why don't you come to
the podium, or the table, and let us know who you are?
Some of us know who you are, but let all of know who
you are.
DR. NICOLSON: My name is Dr. Garth Nicolson.
I'm a Professor of Tumor Biology at the University of Texas
in the Anderson Cancer Center. I'm also a Professor of
Internal Medicine and a Professor of Pathology and
Laboratory Medicine at the University of Texas Medical
School in Houston, Texas.
I've authored over 400 papers in medical and scientific
journals. I served on 12 editorial boards. I'm an editor
of two journals.
I'm here today as a father of a Gulf War veteran who
has Gulf War illness, who had Gulf War illness until we
figured out what her problem was, and as a medical
researcher who has worked on this problem in my laboratory
with my wife, Dr. Nancy Nicolson.
We're going to need the slide projector, yes. (slides
shown)
I'm here today to tell you about our work on some of
the infectious agents that we've found in Gulf War veterans
and, in fact, quite a large proportion of Gulf War veterans.
These are chronic diseases that cause many of the symptoms
that you've heard about this morning.
And I was particularly taken by the testimony of the
three Gulf War veterans, or the two Gulf War veterans and
the wife of a Gulf War veteran, because we've seen this over
and over from a variety of military units.
And at the end of my presentation, I'll go over some
of the case histories of the people that we've worked with
and helped with their problems and now that they're
recovered.
Our hypothesis has been that the delayed casualties
from Desert Storm are principally due to two different
sources: exposure to chemical and biological agents.
Chemical agents, I'm not going to talk about. These
can have a variety of delayed effects and cause may of the
symptoms that you've heard about. I'm going to talk about
the biologic exposures. And these I put in two categories:
acute agents, such as bacterial pathogens. And, of course,
many of the soldiers that were immunized against some of the
possible acute agents that they may have encountered in the
Gulf, and chronic agents.
And of course, nobody received any immunizations for
chronic agents because, by and large, there are no vaccines
available for these chronic agents.
I'm going to concentrate my efforts in discussing a
disease that's cause by one of these chronic agents, a
microorganism, and I'll get into that in just a moment.
I hope this is an auto-focusing, because I don't have
a focus on this.
It's true, contrary to what the DOD has presented, that
the Gulf War veterans do suffer from a variety of different
chronic illness. And the CDC has actually done a case
control study on this, which appeared in morbidity and
mortality weekly reports. And these are just some of the
conclusions.
I'm not going to go into this, but just to show you
one of the pieces of data which I put from tabular form into
a graph, and again, I guess somebody's going to have to keep
focusing it, because it won't stay focused.
These are two Air Force units, and they have about
equal numbers that were deployed to the Persian Gulf and
that stayed behind. One is a National Guard unit and one
is a Reserve unit, both from central Pennsylvania. They
studied two other units in central Florida, but essentially,
the results were the same.
This data indicates that soldiers from the same units,
living in the same communities, that were deployed to the
Persian Gulf during Operation Desert Storm have a variety
of chronic illness, as shown here in the red bar, that far
exceeds their colleagues who stayed behind and were not
deployed to the Persian Gulf.
So, evidence like this convinced us that, in fact,
there are health problems associated with deployment in the
Persian Gulf Theater of Operations.
Again, I told you I got involved in this because my
daughter came back from Operation Desert Storm after service
in the 101st Airborne. She was on a Blackhawk helicopter
involved in some of the deep insertions into Iraq with
Special Forces units.
She came back ill. And we've, have been working with
her and other members of 101st Airborne, and also with
Special Forces units that were involved in these operations.
I'm going to give you some background on how we
approach this problem. We had to find out something about
their illnesses, so we came up with an illness survey form.
In fact, the longer version, I've given a copy to the
committee. Our shorter version is only about four pages.
The longer version is actually about 18 pages long, but it
covers a variety of different signs and symptoms that we
have found in our own studies seem to be associated with
deployment to the Persian Gulf.
I won't go through this, but essentially, we want to
document where the soldiers were, the chronic conditions
that they have, if they have any underlying or previous
medical conditions, any kinds of treatments that they
receive, vaccinations, chemical and environmental exposures.
And, also, very importantly, we want information on
their family members, because we found often that the
spouses and children of the Gulf War veterans who are sick
do become sick. And they become sick with quite similar
symptoms in many cases. Not always, but in many cases.
These signs and symptoms, which I'll go over in a
moment, are very consistent with Chronic Fatigue Syndrome,
or Chronic Fatigue Immune Dysfunction Syndrome. This is a
chronic disorder that's well documented in the medical
literature and, in fact, the case diagnosis was published
out of the CDC a few years ago, so this is a condition which
I think is accepted.
If you look at the signs and symptoms of Gulf War
veterans, as we did in this paper, the journal, in a paper
that we published recently in the International Journal of
Occupational Medicine and Toxicology, which I've supplied
a reprint of, we've kind of detailed some of the problems,
some of the hypothesis.
Basically, the symptoms of chronic, overlapping signs
and symptoms are almost identical to CFIDS. I'll show you
that in just a moment. They can include immediate family
members, including spouses and children.
There are multiple apparent causes, and we'll get into
one of the possible causes. And I don't think, and I feel
very strongly about this, that these are due to
psychological disorders. Although this may be a problem in
a fraction of the soldiers, most of the soldiers that we've
talked to were particularly disdainful of having a
psychological diagnosis put on their medical records.
And in dealing with the Officer Corps, they were really
upset about this, because most of them felt it was the end
of their career if they received a psychological evaluation.
We feel very strongly the chemical and biological exposures
by endogenous and exogenous agents probably led to many of
the conditions that we see.
Here's some of the data that we evaluated. And these
two bars, the pink and the blue here, indicate, the pink,
Gulf War illness. The blue bar are the published values
for CFIDS patients, and these are from two different medical
publications.
And you can see from these signs and symptoms here:
from aching joints, chronic fatigue, memory loss, sleep
difficulties, headaches, skin rashes, concentration loss,
depression, muscle spasms, nervousness, diarrhea, blurred
vision, anxiety, breathing problems, chest pain, the
symptoms almost fall exactly.
There's one exception on this particular slide, in
fact, it's on vision problems. In fact, we think that that
was just the way that that data was handled. And the other
difference here, light sensitivity, we feel that this is
under reported in Gulf War illness, that it's actually quite
higher. We tried to try to document this more recently.
But, going down the list in frequency: the dizziness,
nausea, stomach pain, other visual problems, light
sensitivity, as I mentioned, loss of balance, hives,
problems with urination and sex, hair loss. Chemical
sensitivities in this group of 650 Gulf War veterans wasn't
as high as we expected. It was only around 25 percent.
So many of these soldiers and veterans do have the
chronic conditions that we felt may not be related to
chemical exposure, they may be related to something else.
And, in fact, Major General Ronald Blanck agrees with
this, that the symptoms list does fit a CFIDS-like illness,
and that was published in the CFIDS Chronicle last year.
We feel, and this is our hypothesis, that the CFIDS-
like signs and symptoms are caused by infectious agents,
and these infectious agents can result in the production of
cytokines and interferons, which can cause many of the signs
and symptoms, chronic symptoms.
We're looking into the role of mycoplasmas. These are
small, bacterial-like organisms, kind of in between
complexity of bacteria and cells. The type of mycoplasma
that we have found actually penetrate into cells. It's very
difficult to detect. It's not found free in the
circulation, but we actually find it in the nuclear fraction
of the cells.
These penetrating mycoplasma, as shown here, can be
detected if we use two different techniques. I'm going to
show you one, the technique of gene tracking that my wife
actually developed, and the technique of polymerase chain
reaction, which should be well known to some members of the
committee.
By the technique of polymerase chain reaction, ordinary
PCR won't work, or what I call classical PCR, we had to use
forensic techniques. The forensic techniques work, but they
don't work with blood. They have to, they work with the
nuclear fraction, the leukocyte fraction of the blood. And
that's why a lot of the laboratories that have tried to
detect some of these organisms in blood have failed. And
gene tracking detects it quite nicely.
This is just to show you, the PCR profile, I won't go
into, we found in physically, mycoplasma infections in this
sub-set of Gulf War illness patients, about 55 percent of
the patients, and the predominate mycoplasma was of one
type, Mycoplasma Fermentans Incognitos strain. This is a
very unusual mycoplasma.
This type of mycoplasma can be treated with
antibiotics. And we've suggested the use of doxycycline,
200 milligrams per day, but we've also found that other
antibiotics, ciprofloxacin and azithromycin, were also
effective.
These antibiotics have to be used at high
concentration, because these mycoplasmas are penetrating
deep into cells in a variety of different tissues and it
requires a long treatment, six-week cycles. It has to be
treated like lymes disease, essentially. And this is really
how our treatment suggestions differ from a lot of other
physicians and doctors and researchers working on this.
We published a brief note on some of our results on 73
Desert Storm veterans with the CFIDS-like disorders and Gulf
War illness. And in this group there were several family
members who also had similar disorders. Fifty-five of these
that responded had completely recovered after multiple
cycles of the antibiotic therapy.
This seems to be related to deployment, because we
found that there's a very high proportion of the units, for
example, that were in certain areas that were under SCUD
attack or that were involved in some cases in the deep
insertions into Iraq or places and locations in Iraq where
suspected chemical and biological agents may have been
stored. That's another story that I won't go into.
I just have a few, four, just some cases that I want
to show you. And I think it's constructive because the
symptom, symptomatology is very similar to what you heard
this morning.
Subject "A" was a 38-year-old Air Force Major in
Military Intelligence attached to the 5th Special Forces.
He was deployed at King Khalid Military City. He was
present during the SCUD attacks.
After six months, when he returned to the U.S., he
presented with a variety of the chronic illnesses, including
chronic fatigue, skin rashes, diarrhea, headaches, and so
on. He was treated on doxycycline, 200 milligrams per day,
then a hundred milligrams per day. He had tested positive
for the mycoplasma fermentans. He recovered after three
cycles. Occasionally he relapses, but essentially he's
fully recovered.
Subject "B" was a 38-year-old Navy Lieutenant Commander
in charge the SEAL units in the 5th Special Forces. He was
deployed on the deep insertions into Iraq. He came home
with a variety of these chronic illnesses. His eyesight and
vision had deteriorated so far that they were scheduling him
for surgery at Womack Army Hospital. He had a terrible time
after flying and diving and extreme activity, which is very
hard for a SEAL.
He went on doxycycline, 200 milligrams per day for six
weeks. He had tested positive by gene tracking for
mycoplasma fermentans. After several cycles, actually it
should be four cycles, he completely recovered. His family
members who were also ill have completely recovered.
Subject "C" was a Marine Corps Colonel. He was on the
Central Command Staff, First Marine Division, deployed in
Saudi Arabia at Central Command Headquarters. Within nine
months after he returned he presented with chronic fatigue,
skin rashes, diarrhea, many of the same symptoms that you've
heard about.
He had also examined SCUD impact sites during his stay
in Saudi Arabia. Within 24 months his wife became ill with
similar symptoms. He's at Camp Pendleton in California.
They both went on doxycycline. They both tested
positive. They both have completely recovered, however the
wife relapses occasionally.
Subject "D" is a 34-year-old Army Captain in 101st
Airborne Division. He was deployed in Iraq near Base Eagle.
Within 16 months after his return he presented, again, with
a variety of the chronic symptoms and symptomatology.
His wife became sick with very similar symptoms,
including extreme uterine swelling and bloating. And the
7-year-old child came down with similar symptoms and failed
to gain weight.
After several doxycycline treatments they now have
completely recovered. The child is gaining weight, is doing
well in school again, and the family is back to normal.
Subject "D" is a 29-year-old Specialist in the Army in
a Graves Registration Unit in the 24th ID. She was deployed
at various locations in Iraq and Kuwait. She handled a
variety of KIA's.
After 12 months after her return she presented with a
variety of these chronic illnesses. She's partially
paralyzed, requires oxygen. She didn't do well on
doxycycline because of her multiple chemical sensitivity.
She went on ciprofloxacin. She tested positive for the
mycoplasma infection. After two cycles of cipro now, she's
improving. She's not yet recovered, but she's doing much
better.
I'll just skip this and just to go the conclusion.
The conclusions are that we've identified invasive
mycoplasmas in about half of the non-scientific selection
of veterans of Operation Desert Storm using gene tracking
and polymerase chain reaction. The soldiers that were
involved in the deep insertions into Iraq, or the ones that
were under SCUD attack, seemed to have the most health
problems. And that's one of the commonalities that we've
found.
Most soldiers display signs and symptoms of Gulf War
illness within months after returning to the U.S., but
sometimes it's as late as years after. They symptoms are
chronic, and some symptoms actually abate with time.
Immediate family members can present with almost
exactly the same symptoms, although in each individual the
symptomatology seems to be slightly different. This
suggests that some forms of Gulf War illness are contagious
and are being transmitted, probably by airborne means, by
close contact with immediate family members.
The immediate family members displaying similar
symptoms and testing positive for mycoplasma in their
leukocytes, when treated with the same antibiotics as the
veterans, recover, similar the soldiers with Gulf War
illness.
The antibiotics used to treat the mycoplasmal
infections, mainly doxycycline, ciprofloxacin, or
azithromycin, may not be the most effective antibiotics,
but we've found that they do work.
The diagnostic test for mycoplasmal infections must be
improved and streamlined, because right now it's a research
test that's really not a diagnostic laboratory test.
And, finally, a case control study should be performed
to confirm the possible role of mycoplasmal infections in
Gulf War illness. And I have pending a U.S. Army grant to
do just exactly this.
We have made contact, or actually the CDC made contact
with me. We plan to do a case control study with CDC
samples from those four Air Force units that showed you
previously.
In conclusion, I think that we do have a major problem
here and it's a major unrecognized problem. And that
problem is that Gulf War illness, at least the sub-set of
Gulf War illness patients, may be explainable because of
these chronic infections. And these infections are quite
treatable. They're difficult to treat, because they require
multiple courses of high levels of antibiotics, but I feel
that they can be successfully treated. And we have, now,
a number of people that have gone through these treatments
and have fully recovered their health.
Thank you.
DR. CAPLAN: Thank you. Open the floor for
questions, comments.
UNIDENTIFIED PERSON: One comment I'd like to make
--
DR. CAPLAN: Hold on, hold on here. Let me do
the panel first, then we'll see.
MS. KNOX: I just am curious, these veterans that
have chronic infections, do you look at their T-cell count
and also their humeral immune systems?
DR. NICOLSON: We don't do that because I don't
have enough money to do that. One of the problems is that
we're doing this without any funding source whatsoever.
I'm basically using my endowed chair to provide some of the
funding. And we don't have money to do all of the normal
tests that should be done.
MS. KNOX: Are you going to do that in your grant?
DR. NICOLSON: We're going to try and do that with
the grant, if it's funded. So far they've all been held up.
MS. KNOX: The patients that continue to have
relapses, have you tried prophylactic dose every day of
antibiotics for those?
DR. NICOLSON: Basically, what happens when people
relapse is we suggest that they go back on antibiotics. In
some cases they can go back on the same antibiotic that they
were using previously and the symptoms abate again.
In other cases, if they don't abate, we suggest
switching to one of the other antibiotics, and then it
usually is effective.
DR. CAPLAN: One question I have is; what is the
general knowledge out there about treating mycoplasmic
infections that are not just found in the Gulf and so forth.
What's the baseline, so to speak, about what's known and not
known about this?
DR. NICOLSON: Well, there's not a lot known,
actually, about mycoplasmal infections. I mean, this is
kind of a corner of infectious disease in medicine that's
not very well travelled, unfortunately. I think it may be
very under-recognized as an important chronic illness.
We're doing a study, a small study right now with the
CFIDS Association. We've looked at some CFIDS patients,
and there is a sub-set of CFIDS patients that we think
suffer from these chronic mycoplasmal infections. And they
could be treated just the same way as Gulf War illness, or
a limited experience suggests that they recover exactly the
same as the Gulf War illness patients recover.
This, by the way, I should say, is not the whole story,
because we think that there are multiple causes for Gulf War
illness. And this would be, I think, a good solution for
many people that have it, but probably not all.
DR. CAPLAN: And let me just follow that up again.
I want to follow something that Marguerite raised again;
could you just tell us your impression of the availability
of funds from Department of the Army, government sources,
wherever, what sorts of funding sources are out there and
the rapidity with which proposals to undertake studies in
your area have, what sort of response have you got?
DR. NICOLSON: Well, at the moment, there are
none. There, the U.S. Army did put out a request for
applications.
DR. CAPLAN: There's been an RFA?
DR. NICOLSON: There's been an RFA. I answered
that RFA. I put in an application August 22nd. I've
contacted the Army several times. It's, right now it's
still on hold. They indicated that the initial review may
take place sometime this month. That, generally, means,
since I actually have an active U.S. Army grant at the
moment, so I know what it means; that means the awards may
be made by the middle to the end of this year. It doesn't
move very quickly.
DR. CAPLAN: All right. My protocol limits tell
me that we don't take questions directly from the floor, so
I'm going to ask if any of the other panel members at this
point have any other questions. I think this is a very
interesting presentation. I appreciate the papers you left
with us and had a chance to see the JAMA articles, so, I
mean, I hope that the research proceeds expeditiously in
this area, so thank you.
DR. NICOLSON: You're welcome.
DR. CAPLAN: Thank you.
MS. KNOX: Thank you.
(applause)
DR. CAPLAN: I have Dr. Hinshaw as the next
presenter. Please proceed.
DR. HINSHAW: Dr. Caplan, Major Knox and Major
Cross, staff members of the Presidential Advisory Committee
on Gulf War Veterans' Illness, thank you for this
opportunity to speak before the panel this morning.
My name is Charles C. Hinshaw, Jr. I am a private
physician, Doctor of Medicine, practicing Environmental
Medicine in Wichita, Kansas. I am American Board of Medical
Specialty certified in Pathology and Nuclear Medicine. And
I'm also certified by the American Board of Environmental
Medicine, Incorporated.
In 1992, while President of the American Academy of
Environmental Medicine, I instituted the development of a
protocol designed to study the Gulf War Syndrome. Sixty-
two veterans were studied by this protocol. Some of the
results of this study will be used later in my presentation.
My purpose today is twofold. First, I hope to broaden
the concept and understanding of Gulf War Syndrome by
showing similarities between Gulf War Syndrome, Chronic
Fatigue Immune Dysfunction Syndrome, Sick Building Syndrome,
Breast Implant Syndrome and Multiple Chemical Sensitivities.
Second, I shall introduce to you a research protocol
for the study of Gulf War Syndrome, the design of which was
supported by a grant from the American Academy of
Environmental Medicine.
To begin, then, let us understand the meaning of the
word, syndrome. The syndrome is simply a group of signs
and symptoms that occur together and characterize a
particular abnormality. Recognition of a syndrome does not
require or imply an understanding of etiology, pathogenesis,
an invariable set of clinical findings, specific laboratory
tests, or definitive or curative therapy.
However, as you well know, those are the blanks we
would like to fill in.
On the appendix of my presentation, a copy of which
you each have been provided, I have compiled a ranking of
signs and symptoms grouped into body systems as recorded by
four independent sources. The American Academy of
Environmental Medicine, Dr. Claudia Miller, Dr. Jay Sanford,
and Drs. Garth and Nancy Nicolson.
I'm going to divert a little bit now from the written
presentation and ad lib a minute.
In this table, I want to direct your attention first
to the rankings under the heading, Gulf War Syndrome. And
those are the four sources, then, that I have mentioned.
As you can see, if we rank the order of symptoms into
systems, and then rank them from one through eight, there
is a marked similarity in these four sources in terms of
reporting symptoms. And this pretty well characterizes the
Gulf War Syndrome. I think you could look through the
medical literature and find close agreement with this.
The specific symptoms within each system are well known
to you and they're widely published in the medical
literature, as well as in lay publications.
By grouping the signs and symptoms into body systems,
we smooth out some of the differences in questionnaires.
For example, one questionnaire may inquire about the short-
term memory, another about spaciness, and a third about
periods of confusion. All are seeking information about
cerebral function.
In reviewing the table, then, notice the marked
uniformity in the rankings of body systems, a reflection of
the frequency of occurrence of signs and symptoms. This
speaks well to our characterization of the Gulf War
Syndrome, but does it tell us anything about our unanswered
questions of etiology, pathogenesis, testing and treatment?
Perhaps some clues are offered.
Continuing our examination of the table, notice how
closely the rankings of system involvement in Gulf War
Syndrome match the rankings of Chronic Fatigue Immune
Dysfunction Syndrome, Sick Building Syndrome, Breast Implant
Syndrome and Multiple Chemical Sensitivities.
The reference that I have numbered 5 to Drs. Garth and
Nancy Nicolson, is the reference, one of the references he
presented today, showing the similarity between Gulf War
Syndrome and Chronic Fatigue Immune Dysfunction Syndrome.
The similarities suggest a common pathogenesis, the origin
or development of the disease, but not necessarily a single
etiology.
In real life, many different etiologic factors may
impinge on the same body or structure, body organ or
structure, yet the body has only a limited number of ways
to respond.
For example, consider that a blow on the head, one
drink too many, a ruptured blood vessel, exposure to a
particular perfume, an argument with a boss or spouse, or
a brain tumor will all produce a headache. Multiple causes,
limited responses. Thus our thinking should not be
constrained by efforts to find a single, or even a small
number of known causes of Gulf War Syndrome. Better,
surely, to ask what body organs or systems might be damaged
by exposure to chemicals, infectious agents, vaccines,
pesticides, pyridostigmines, stress, depleted uranium, and
sand dust.
By assuming that Gulf War Syndrome may have multiple
causes, we then can begin to understand that different
treatments may be effective. Dr. Garth Nicolson, and my
text says will speak, but has spoken to you earlier about
his experience in treating Gulf War Syndrome patients with
an antibiotic, doxycycline.
Finally, in concluding this first part of my remarks
today, I would like to emphasize the difference in
susceptibility between individuals. This has been referred
to as the genetic substrate of disease.
In recent years we have progressed in our understanding
of genetics from observations on the outcome of
consanguinities matings, to chromosome analysis, to mapping
of the human gene element. Genetic differences help explain
why two soldiers sharing the same foxhole may respond
differently to the same environmental stimuli.
The second, and briefer part of my presentation this
morning, concerns research directions and recommendations
you might make in your report to President Clinton. As
mentioned earlier, the American Academy of Environmental
Medicine, through a research grant, has developed a Phase
II protocol for study of the Gulf War Syndrome.
This protocol is titled, "A Study of Gulf War Syndrome
From Environmental Medicine Perspective." The authors are
myself, Jill Ryan of the Fielding Institute, and Brother
Brian DeBoesky of the College of Santa Fe.
The protocol is designed to yield statistically
significant results, positive or negative, from a number of
soldiers participants as small as 20. It is a trial study,
but could easily be expanded to larger numbers.
The goal of our study is to determine whether toxic
exposures experienced by veterans of Desert Shield/Desert
Storm influences performance on objective tests of viral
infection, metabolism, and immune function. The protocol
includes a review of literature, help in epidemiologic
questionnaires, and recommendations and sources of specific
testing for mycoplasma, viral titters, immunology profile,
candida antibody testing, porphyria, organic analysis, stool
and parasite analysis, functional liver detoxification
analysis, oxidating phosphorylation disorder, and pyrorubate
carnase mutation.
This I'm holding in my hand is a copy of the protocol.
As you can see, it's a notebook. It's over 100 pages in
length.
My presentation this morning has demonstrated close
similarities between a group of poorly understood syndromes,
Gulf War Syndrome, Chronic Fatigue Immune Dysfunction
Syndrome, Sick Building Syndrome, Breast Implant Syndrome
and Multiple Chemical Sensitivities.
I propose that each of is a variant of what has been
termed, "chemical induced immune dysfunction syndrome."
The carefully constructed research protocol directed
towards the study of Gulf War Syndrome has been described.
This research proposal can be a turn-key project. It is
hoped that implementation and completion of this or similar
research projects will enhance our understanding of Gulf War
Syndrome.
Thank you.
DR. CAPLAN: Thank you. Let's open the floor,
again, for comments or questions from the panel or staff.
MS. KNOX: I'm delighted that that study is going
to take place. And I think DOD is aware of some of the
needs and some government funding has been given. I think
that it's, the notices to that request have not been made
yet. That might be something that we can follow up on
because we were told those would be made in January.
There has been another call for grant funding
concerning women in the military, which I think has long
been needed to look at, those efforts. So, unfortunately,
by the time your study is funded and the results come in,
the committee will have already finished their report.
DR. NICOLSON: Really, honestly, I'm not aware of
any potential funding from the government for this.
MS. KNOX: So you've not applied for a grant?
DR. HINSHAW: No.
MS. KNOX: But you're receiving a grant now?
DR. HINSHAW: No. The grant we did receive from
the academy has been completed.
MS. KNOX: Completed?
DR. HINSHAW: Uh huh.
MR. CROSS: Who's going to fund your future
studies?
DR. HINSHAW: Well, I don't know, but we are
applying to a research foundation in Oregon that has funded
another project in the environmental medicine field. There
is a research funding organization in Tucson, Arizona, that
has interests in this field, and I'm open to any
suggestions.
MR. CASSELLS: Is there some particular reason
you didn't apply or respond to the Army's call for
applications?
DR. HINSHAW: No, yes and no. At the outset, when
we were doing our first protocol we became aware of what we
had characterized the Gulf War Syndrome, and we offered to
the VA system and to the Department of Defense to send a
group of physicians at our own expense to various military
or veterans's hospitals to teach the physicians about
chemical sensitivities and the relationship to Gulf War
Syndrome. And we were, I guess, turned down. We certainly
spoke to a deaf ear.
So I think maybe our thinking that there would be any
help from the DOD or VA system was, that it wouldn't happen.
DR. CAPLAN: One quick question; I don't know
familiar you are with the NIH Institutes and their funding
mechanism, but if you are, do you feel they are homes there
in the standard NIH array of institutes to take this kind
of study, too, for funding?
DR. HINSHAW: I think it's possible, but somewhat
unlikely, but, yes. I think there are a number of
government supported institutes and so forth that have
funding which will support, give grants to support this type
of research.
This really, in my opinion, and I don't think I'm the
only one that shares this opinion, but in my opinion, this
is a very well, closely designed study. It may be that the,
we made this available to everyone last October, so it may
be that there is a grant pending on this and that a copy has
been obtained by the Department of Defense or someone. I
don't know for sure, but I hadn't, I'm not aware of it.
DR. CAPLAN: Okay. Thank you.
DR. HINSHAW: You're welcome.
DR. CAPLAN: Did Anthony Buckner come back into
the room? (No response)
All right. I had a request for opportunity to present
to this committee from Marsha Lynn. Is she here? She
wasn't on the announced list.
MRS. LYNN: Yes.
DR. CAPLAN: Okay, Marsha, thank you again for
coming. And could you please tell us a bit about who you
are. And I will remind you again about our five minutes.
MS. LYNN: My name is Marsha Lynn.
DR. CAPLAN: Right into the mike.
MS. LYNN: My name is Marsha Lynn and I'm an Army
Desert Storm veteran. I served with the 114th Evacuation
Hospital as a nurse. I, too, have a lot of the problems
that all the other vets are having.
The memory loss, in particular, has forced me to leave
the medical profession in, ethically, so I wouldn't hurt
anyone. I still have a lot of problems. Mine's
progressive. It's cyclic, I feel. Some days are worse than
others. And my concern is, there's not enough publication
about what's going on, what you people are trying to help
us.
I've been out of town, but because I read the paper
this morning and saw this little notice in here, that's why
I'm here today, because people like me don't get a chance
to talk.
I have a couple of comments. I was on a shot team that
gave those shots in Saudi. And my question is to the
Department of Defense people that are here; I want to know
why we were ordered to tell the troops that it was top
secret, and we were not allowed to write it on their shot
records?
The reason I'm asking this question is because, and I
have supporting documents for everything that I'm saying,
because I kept a journal as well every day while I was gone
so I could give you dates on a later time. But, we were
told the reason that it was top secret is because there was
not enough to go around to the Allied Forces, okay. And I
have documents substantiating that as well.
Also, we were threatened with Court Martials if we did
not take the anthrax shots. Colonel Edward Murphy of the
114th Evacuation Hospital, he was the hospital commander,
he was the one that initiated that to the troops, because
I refused to take them because I know it was an experimental
drug because I talked with the Michigan Department of
Health, who licensed the anthrax. And it is an experimental
drug, only given to people who generally work with cows,
because that's where it originates.
I also sent off to the Freedom of Information Act, both
of those in August of '95, requesting information about the
anthrax, where it was, the point depot in the U.S. before
it was transported overseas, because I have a background in
biology and chemistry. And I believe through my education
and my experience in the Gulf War, in the military and in
the medical field, that a lot of these illnesses,
particularly ones that I'm facing, come from something to
do with this anthrax shot. The majority of people that
you'll speak with that are sick took the anthrax shot.
To this date I've gotten no response from the
Department of Michigan Health Department, from the Freedom
of Information Act. And I requested this stuff in August
of '95.
I also called the Armed Services Committee, the Army
Surgeon General, and I received nothing from them, as well.
I want to know why it was top secret, if that in case
was the fact, that it was not enough to go around, and why
we couldn't put it on their shot records, okay. As a
medical professional, I know documenting everything is very,
very important. It's CYB, okay.
And, also, I was glad to see that. I apologize, I came
in late, because I just heard about this; but I was glad to
see that Dr. Garth Brooks was here because I am concerned
about that.
DR. CAPLAN: Nicolson.
MS. LYNN: I'm sorry. Garth Brooks. (laughter)
DR. GARTH NICOLSON: I wish I was.
MS. LYNN: Dr. Garth Nicolson, excuse me; because
I do feel, just from military past about all the things, the
experiments that have gone on with the U.S. troops.
There's a paper trail, the mustard gas in Korea,
Jacob's Ladder in Vietnam. And what did they do to us?
What were they trying to learn? That's my concern.
As I said, I do have documentation supporting this and
I just wonder why I haven't had any response.
And my biggest concern, I'm glad to see you here, my
biggest concern is that there's not enough of this going
around. And I do appreciate you taking this information
back to President Clinton. But, more importantly, I want
you to get it out to the American people because they don't
know what's going on. They're only hearing bits and pieces.
And that's the problem because they don't know what's going
on. They're hearing, they're getting what the government
feeds them. And I know from government experience, eight
years in the military, you can't believe what you see and
only half of what you hear.
DR. CAPLAN: Thank you, and I'm sure the staff
will speak to you after we conclude the morning session if
you want to provide them with some of those documents,
they'll tell you how to do that?
Questions, comments?
MS. KNOX: Did you document anywhere that the
soldiers received the anthrax vaccine?
MS. LYNN: Yes, I did, in my journal.
MS. KNOX: But was there a listing other than your
journal that you documented?
MS. LYNN: No, they wouldn't allow us to do that.
MS. KNOX: Okay.
MR. CASSELLS: Were any of these instructions that
you were given concerning the documentation and the top
secret status of these immunizations, were any of those
instructions in writing?
MS. LYNN: Yes, sir, and I have a copy of it.
MR. CASSELLS: Okay.
UNIDENTIFIED AUDIENCE MEMBER: Good.
MS. LYNN: I have copies of everything.
(applause)
I even have my own medical records because they've
conveniently lost a lot of the soldiers records.
I have a girlfriend who is also a nurse that worked at
KU, and she's experiencing the same problems. She moved to
Texas as soon as she came back from the Gulf, and they have
yet to find her medical records.
DR. CAPLAN: I was going to ask something I asked
earlier of a previous person providing us testimony; when
you were giving the shots, aside from the top secret
discussion, what were you told about their point, their
purpose?
MS. LYNN: We were told that these were
antibacteriological warfare, which we were told that there's
a strong possibility that it was laced on the warheads.
DR. CAPLAN: And do you recall how soon after
deployment it was that this was?
MS. LYNN: It was before the ground war. I do
have a memory problem and I'm, I'm really sorry, but it was
before the ground war started. And we were out, I was out
for two weeks in an ambulance with a group of doctors and
nurses. And we drove to different units in the desert and
inoculated them. Not everyone received the full regime,
which was three inoculations.
MR. CROSS: Are you saying there's cases where
you might have given one inoculation, then you moved on and
never went back to give a follow-up inoculations?
MS. LYNN: Exactly, because there was a two week,
two week plus waiting period after the first injection.
MR. CROSS: So there's a situation out there where
people got the full three shot regimen, and then other
people who only got, maybe, one shot or two shots?
MS. LYNN: Correct, correct. I only had two.
and not only that, I had A local reaction, which will be
documented in my medical records. And I also have a picture
of it, I took pictures, I shot 26 rolls of film over there,
of the local reaction.
I was on Demerol for several days because I couldn't
even raise my arm. Secondly, I had growing nodes, massive,
enlarged nodes, like, three or four days afterwards. And
I was told that I didn't have lymph nodes in that area of
my body by a doctor.
DR. CAPLAN: All right. Thank you for coming
forward.
I, again, will ask the staff to talk with you about
getting some of that documentation that you might be able
to supply them with.
We had two other requests for possible presentation
and, I guess, the committee has had a policy of not
repeating people talking, but I think we could have, if they
could keep it to three minutes, if Denise wanted to, Denise
Nichols and, I guess, Jim Brown wanted to make a statement.
I just ask you to keep it brief because we're going to
run up against our next speaker, but, Denise, why don't you
say who you are?
MRS. DENISE NICHOLS: Well, personally, I'm a
nurse that served over there. And I don't know if I've made
that clear before, but I served with the Air Force. I was
a flight nurse. And I, too, would not trust myself around
patients because of my memory problems. I don't think my
fatigue that comes, and it comes at closer cycles now, would
allow me to work as I did before the war as a nurse.
We are seeing that across the spectrum. I'm sorry that
I had to get angry earlier, but we have tried to communicate
with the committee of our needs. I think it's a criminal
shame, and I'll say strong words, that more publicity and
more coverage of these hearings, of these committee hearings
are not being provided.
There should be a massive media attack. If you want
the veterans to know, you need it in the newspapers. You
need postings at the VA hospitals, the DOD's.
There's no reason why you could not publish this
schedule in advance and mail it to every registrant that is
on the VA registry and on the DOD. I know that's a lot of
mailings, but we're asking for one mailing for the whole
committee schedule.
Time and time again we find vets that didn't know that
this was occurring. We try and share information as much
as we can. The ones of us that have organized and worked,
we're not getting any grants, any support from government
in trying to provide information for the vets. What we do,
uploading to Prodigy, CompuServe, America Online, to web
sites, to communications from the west coast to the east
coast, over to Hawaii, it's all done at our own personal
expense.
We have had been forced to form non-profit
organizations and go out in the community and try to beg to
get their support. And in trying to get the information out
to doctors, to nurses, to our veterans, and get help. We
have all done it independently at great personal expense.
We do it because we hear of our friends and ourselves
that know that this is happening and that it's real. It's
not psychological.
We have vets that we hear about, and the horror stories
are horrendous. There's a veteran in the hospital in
Oklahoma City, not getting VA help, in the University
Hospital with a brain tumor, 28 years old.
I have a veteran in Colorado Springs, both he and his
wife are Desert Storm veterans, served with the 41st Combat
Support Hospital, I believe. Carol Pico, her husband
dropped dead at the age of 28 outside the civilian hospital.
He was picking her up. They could not get him resuscitated,
28 years old.
I have been dealing with this for two and a half, three
years, trying to provide emotional support for our vets as
we try and seek care. And I am getting angrier and angrier
every day. I try to keep my anger, I try to stay organized,
but when I sit down and I try to write things in an
organized manner, which usually, I mean, additional duties
in the military, I wrote awards, history, I had to write.
I'm finding great difficulty doing that, and I fight it.
I get my husband to help me.
There's not a vet out here that can't tell you that
we're having problems that we never had before, spelling,
sentence structure, neurological functioning problems that
are not psychological. If there is psychological that
occurred in this it is because of what the government is
doing in the past five years. (applause)
The depression that we have is because we feel
abandoned by our government that we put our life on the line
for. You don't have to face our children and our families
as we struggle to keep going and we try to keep a good face
on it. Our children suffered enough when we left to go to
war. I left a four year old. And she's a brave little
girl, and I'm so proud of her. She's nine years old now.
She does not trust her government any more. She's seen her
mother suffer. She's seen her mother try and spend so many
hours helping other people that we've lost time together.
DR. CAPLAN: Thank you.
MRS. NICHOLS: This has got to stop. I'm pleading
with the President. I'm pleading with you all. Start
listening to some of our civilian doctors and researchers
that want to help us and give them money so they can help
us, because the VA, it takes two, three months to get in.
We tell them we're hurting. We wouldn't call them unless
we were desperate, and we're calling, we're going, we're
hurting really bad, we're in one of those cycles. Please
help us.
DR. CAPLAN: Thank you. Let me thank you for
sticking with it and taking the time, again, to present to
us.
Quickly, any comments, questions?
MRS. NICHOLS: Excuse me, I have to say, I get
upset when I see government money going into renting places
like this that I know are very expensive, and when we can't
get any money to help our vets maintain communication
better.
Isn't there something that could be done on an
emergency basis within a couple of months to help fund our
groups that are trying to work and trying to maintain
information flow? Isn't there anything?
DR. CAPLAN: We'll definitely pursue that to see
what can be done to help private groups facilitate
communications.
MRS. NICHOLS: People are going in debt.
DR. CAPLAN: I hear you.
MRS. NICHOLS: We have families that are getting
mortgages, you know, the mothers and fathers are getting
mortgages on their homes to try and provide the care from
civilians.
DR. CAPLAN: I hear you.
MRS. NICHOLS: I mean, this is not the way America
should be.
UNIDENTIFIED AUDIENCE MEMBER: That's right.
DR. CAPLAN: Let me thank you again for your --
that's quite all right, emotions are just fine here. And
I can assure that we did and we'll try to (applause) -- be
responsive to these challenges of communication and making
sure that we're accessible in terms of our meetings and
locations so that you and others can come and continue to
let us know where the problems lie.
I think, in the interests of keeping on schedule what
I'll have to do at this point is, I've got Dr. Stuart
Nightingale as our next presenter.
I'm going to ask him to come forward, but,
I did promise three minutes and I forgot, to Jim
Brown. We'll just bounce Stuart back for one second. I
just forgot.
And, again, let me welcome you and ask you to say who
you are to the panel and staff.
MR. BROWN: My name is Jim Brown and I'm a Gulf
War veteran. I was over in Saudi for approximately five
and a half months. This is my wife, Michelle, and we have
a picture of our daughter, Alex, who's four years old. And
she is hanging in there like a trooper, just like the rest
of them are.
Mostly what I want to cover today is three separate
things.
Firstly, I'm not sure if you have actually seen this
or not. This is a release from the United Nations, the UN
Special Commission on Iraq. The number on it is S-1995-
A64. It's approximately 40 pages worth of information.
And it goes over exactly what they have and have not found
that Iraq had during the war.
DR. CAPLAN: We have that. We know that, we have
that.
MR. BROWN: Yes, okay.
Secondly, I would like to present a suggestion for the
Gulf War veterans, the recognition of three specific colors
to signify, just like MADD and SADD have their own colors,
three colors that signify the Gulf War veterans plight. And
it's yellow for the sick soldiers, white for the innocent
family members and the babies who have suffered through
this, and black for the soldiers and innocents that have
already died because of Gulf War syndrome. It needs to be
recognized publicly.
Last, but not least, I have statements concerning the
pyridostigmine bromide, nerve agent pretreatment tablet.
I found through the research that I've been able to do
and the things that I have seen so far and this stack I've
got right here, most of which I'm going to turn in to you
guys, the fact that if you do not have an illness for this
pill to attack or a nerve agent for it to bind and present
against, it will find something to do in your body.
Essentially, what it comes down to is, it will actively,
excuse me, I have a problem speaking. It will actually
precipitate an alzheimer's like syndrome.
It stimulates the muscarinic receptor and your entire
body including in the brain. It does pass through the blood
brain barrier. And through this it will cause amyloid
protein precursor to be split into amyloid beta protein
precursor. It does present a huge amount in a very small
amount of time. Some people's bodies will take this out and
eliminate it. Some people will not. It just depends on the
individual.
This will start a cascade effect inside of the
individual's body that will cause CNS, central nervous
system disorders. And it will also cause renal system
failure and albuminolysis of your liver and your kidneys,
and it will clog up the entire system.
It will cause arterio and arteriosclerosis and also,
eventually, cascade into something close to multiple
sclerosis. All this is documented and it's been in the New
England Journal of Medicine, JAMA, quite a few different
sources. It's provable. And personally, I feel until they
can prove otherwise, this pill should be prescribed only for
myasthenia gravis, which is an autoimmune disease, and to
bring people out from under anesthetic. These are the only
two prescribed methods for use that the FDA says you can use
it.
Anything else would go against the Nuremberg Code, the
Helsinki Accord, and the common rule. It sounds looks like,
smells like and is human experimentation using individuals
who do not have the ability to say no, and that's in the
military. We are basically indentures servants. They tell
us what to take, when to take it. We do not have the
choice.
And I've talked to Dr. Nightingale a couple of times
about this. I hope to have a few minutes of his time
afterwards. And if there any questions concerning the
documentation that I present to you guys, please feel free
to ask any kind of questions. I, as I've said, have total
documentation on every claim I make.
DR. CAPLAN: Thank you. I'm not sure where your
public speaking problem came from, but it's not evident
here.
Let's open the floor to comments, questions. I have
one to lead up with.
Did you take PB?
MR. BROWN: Yes, I did.
DR. CAPLAN: And could you tell me, this seems to
be my droning, repetitive question, but, what were you told
when this was administered?
MR. BROWN: The commander of my unit actually
tried to back us up initially when we were deployed. We
did get informed that we got the botulinum and the anthrax
shot before we deployed, but we were told not to tell
anybody. We were informed about it. It was not annotated,
unfortunately, but we did get told.
When our commander came around with the NBC NCO, we
had a box full of these and a paper list of who did and who
did not take it. He handed the packet to each of us, asked
us to take it right then while he was watching. In my unit,
that constitutes an order, it's just, you understood. We
took it in front of him, and it was annotated that we did
take it, so a record was made and it's still kept at Fort
Drum, New York, where I deployed from.
When I took this, I essentially lapsed from what would
be considered mental consciousness. I had a blackout for
possibly an hour. I sat on my bunk and stared at nothing,
which is what one of my buddies had told me had happened to
me.
The majority of the people that did take this had
aggression and serious mental problems afterwards for a
short period of time. We, the people in my unit, were only
given one tablet and that was the end of it.
However, we were right in the middle of the 18th
Airborne, 101st Airborne, basically, 7th Corps. And the
majority of them had gotten anywhere between one and seven
in a continuous prescription on that.
Why we had only gotten one and everybody else got the
full regimen, so to speak, is still a mystery to me,
because, you know, they were only a quarter mile away from
us. How would they be more at risk than we were? That does
not add up.
And for DOD to say unequivocally that, you know, they
know it works and it's okay, we've got it in hand, that does
not wash with their methodology. If they knew what was
going on they would have sent people out. And after talking
to Carl Michael Dunn about the PB pill and how it was
supposed to be managed, things like that, he had stated that
in the chemical casualty management courses approximately
800 people have been trained by him and Dr. Sedell,
Frederick Sedell, in order to make sure that people did get
the word. There was informed consent, you know, people were
told what was going on.
On the ground, it totally fell apart. Nobody was told
anything. The only type of instruction we got was: 1,
commence taking only when ordered by your commander. 2,
take one every eight hours. 3, and it's underlined, it is
dangerous to exceed the stated dose.
That is our informed consent and our instructions, if
you took the time out to read it. But by the time you took
it, it was a little late, you know.
The other question that I have is, the package that I
have in front of me says, March 1987. It has 21 tablets in
it. It has a national stock number, which states
specifically it is in the military system.
Now, it's a normal thing you can order with a stock
number. It's manufactured in Amsterdam, Holland, however.
If this is an investigational new drug, why was this being
produced in the nice packaging instead of in bottles as a
new thing should be.
Why was it produced like this outside of our country
for our people, has a national stock number that's in our
system, and, yet, nobody seems to know anything about it?
It's produced by ICM Pharmaceuticals out in California under
the list name of Mestinon.
The VA and DOD prescribed this very often. In the VA
in Augusta, Georgia, I physically witnessed in their
pharmacy, eight bottles that are approximately this tall,
this big around, with 1000 tablets of 60 milligrams each.
Two of them were open and they were dispensing them at the
time I went in there to ask them, what is they mystery drug?
To which I've been told outside in the lobby, we have no
idea what it is.
When I get in the pharmacy, low and behold, there's
eight bottles of 1000 each sitting on their cabinet. You
know, something does not jive here. These are things that
need to be looked into.
DR. CAPLAN: Okay, thank you.
MR. BROWN: Thank you, sir. I also have this,
for the record.
DR. CAPLAN: Please make sure that one of the
staff back there gets that when we get to the lunch break.
MR. BROWN: Thank you for allowing me to speak,
sir.
DR. CAPLAN: All right, Dr. Nightingale, I'll
bring you back up here.
And, again, I'd ask you to identify yourself for the
panel. And we've asked Dr. Nightingale to address the
issue, now, that we're shifting over to, the interim final
rule that exists, determination that informed consent is
not feasible with respect to certain uses of compounds,
drugs, vaccines, and the waiver of informed consent rule
that came into play in the Gulf War.
DR. NIGHTINGALE: Thank you very much.
I'm Dr. Stuart Nightingale. I'm the Associate
Commissioner for Health Affairs at the Food and Drug
Administration. And I served as the agency level staff
contact with the DOD over the years for a variety of issues
and was very active in the Desert Shield/Desert Storm
activity in terms of serving as support for the agency in
its activities as a clearing house and a variety of other
activities to assist in the process of the development and
implementation of the regulation that we're talking about.
I very much appreciate the opportunity to present FDA's
perspective on our interim, final rule, 21 CFR Part 50.23
(D), Exception from General Requirements for informed
consent that permits the commissioner of FDA to make a
determination that obtaining informed consent from military
personnel for the use of an investigational drug or biologic
is not feasible in certain battlefield or combat related
situations.
The regulation allowing informed consent to be waived
during this operation was developed to allow what was
believed to be the best available medical treatment or
preventive therapy to be utilized under combat conditions.
FDA granted waivers for two products, pyridostigmine and
botulinum toxoid, because there was reason to believe the
products would be effective, because there was no available
satisfactory alternative therapy, and because the products
appeared safe for the intended use.
Now I'd like to turn to the development of the interim
final rule. During the months preceding the Persian Gulf
War, the Department of Defense had discussions with FDA
regarding the potential use of specific investigational
products in military personnel serving in the Persian Gulf.
We also had extensive internal discussions involving
technical and policy level staff, as well as with experts
from other Federal agencies and academia. It was thought
that the products discussed represented the best preventive
or therapeutic treatment for diseases endemic to the area
and for providing protection against the possible chemical
or biological weapons use.
The Department of Defense requested the assistance of
FDA in allowing the use of several of these products in
certain battlefield or combat related situations in which
they concluded that obtaining informed consent was not
feasible. It should be appreciated that the FDA
appropriately gave considerable deference to the Department
of Defense's judgement and expertise regarding the
feasibility of obtaining informed consent under battlefield
conditions.
In response to the Department of Defense request, on
December 21, 1990, FDA published an interim regulation
amending its current informed consent regulations. This
regulation allowed the Commissioner of FDA to determine,
upon receipt of an appropriate application from the
Department of Defense, that obtaining informed consent from
military personnel for use of specific investigational drugs
or biologics would not be feasible in certain circumstances,
and to grant a waiver from the requirement for obtaining
such consent.
The exception extended, on a case-by-case basis, only
to investigational drugs, including antibiotics and
biological products, for use in a specific military
operation involving combat or the immediate threat of
combat. The application was to include the justification
for the inclusion, made by physicians responsible for the
medical care of the military personnel involved that: 1,
the use was required to facilitate the accomplishment of
the military mission.
2, the use would preserve the health of the individuals
and the safety of the personnel, without regard for any
individual's preference for alternative treatment or no
treatment.
And, 3, the application contained documentation to
indicate that the protocol had been reviewed and approved
by a duly constituted institutional review board, or IRB,
for the use of the investigational drug without informed
consent.
Now, I would like to turn to FDA's internal process
for dealing with this.
Each application for waiver from the informed consent
requirements was assessed by the appropriate FDA review
division and by the agency's Informed Consent Waiver Review
Group, which I chaired at that time.
The ICWRG included senior management of the Center for
Drug Evaluation and Research, the Center for Biologics
Evaluation and Research, the Office of the General Counsel,
the Office of Health Affairs, and the NIH's Office of
Protection from Research Risks.
This ICWRG core was supplemented by technical experts
as appropriate for the particular investigational drug being
considered for exception. The ICWRG considered DOD's
justification supporting the request for the waiver and the
reviewing division's evaluation of the available safety and
efficacy data, as well as the proposed information to be
provided to the troops.
The ICWRG requested additional supporting information
in some cases and required changes in the information to be
provided to the troops in several rounds of iterative
exchanges with the Department of Defense. The ICWRG then
made a recommendation to the commissioner regarding whether
or not to grant the waiver.
The commissioner made a decision on the application
and informed the Department of Defense in writing, and as
you know, two of these were approved.
Now I would like to turn to some of the general issues
that we faced under the roof of the use of investigational
products for treatment purposes.
There are a variety of circumstances in which drugs or
biologics that are not approved for marketing by FDA can be
made available for prophylaxis or treatment of patients,
even though there is not yet enough information to support
marketing approval. In all these cases, the drugs or
biologics that are designated investigational are used only
to treat serious or life threatening conditions for which
no good alternative prophylaxis or therapy exists after FDA
concludes that there is sufficient evidence of efficacy and
a reasonable assurance of safety.
The use of such drugs is restricted or limited by
requirements for informed consent and IRB review, but the
use is not an experiment in the sense of an effort to
discover or verify efficacy.
For example, it has long been recognized that certain
investigational products, because of a lack of commercial
interest, will probably never be the subject of a marketing
application and will, therefore, never leave the
investigational category. The Center for Disease Control
has maintained longstanding IND's, or investigational new
drug applications, for a number of products of this type,
mainly special vaccines and drugs necessary to treat or
prevent conditions or diseases caused by rare infectious
agents.
This program is described in the article, which I've
submitted to the panel from the CDC, "Immunobiologics and
Drugs Available from the Centers for Disease Control,"
Journal of Pharmacy Technology, volume 5, pages 181-186,
1989.
Similarly, the possibility of using orphan drugs, that
is drugs of little commercial interest, for rare diseases
that, in general, lack effective therapy that are still
investigational, is recognized in the orphan drug statute
for the Food, Drug and Cosmetic Act. Drugs for various
cancers also have been designated for treatment use prior
to their approval, so-called Group "C" cancer drugs, since
the 1970's.
FDA has developed two formal expanded access mechanisms
for providing promising agents for treatment of serious
diseases which lack adequate alternative therapy. The most
wide-ranging mechanism dates officially from 1987 and is
known as the Treatment IND, which is described in detail in
the Journal article I've given to you entitled "The FDA's
New Procedures for the Use of Investigational Drugs in
Treatment," Journal of the American Medical Association,
259, pages 2267 through 70, 1988.
Similar expanded access programs, arranged informally
under emergency conditions, date from the late 1960's.
Investigational drugs from the treatment of HIV related
diseases have been made available under an expanded access
mechanism called the parallel track.
It was within the context of a long history of
treatment use of investigational drugs that FDA considered
submissions from the Department of Defense for
investigational drug treatment or prophylaxis use in
Operation Desert Shield/Storm.
I've also given you a paper which is entitled, "Access
to Investigational Drugs for Treatment Purposes," which
appears in the American Family Physician, volume 50, pages
845 to 847, 1994.
It should also be noted that although FDA performed
its own review and reached its own conclusions about the
products, we were aware that NATO and a number of our allies
also had made pyridostigmine part of their armamentarium for
a number of years. Similarly, FDA was well aware of the
various articles on this subject in the medical literature.
Of course, the most critical consideration was whether
the scientific evidence from animal and human
experimentation allowed FDA to make the determination that
it was reasonable to use the drugs as requested in Operation
Desert Shield/Storm. Attached to my statement are summaries
of how FDA decided to approve the use of these products in
Operation Desert Shield/Storm.
Now, I don't know if you'd like me to read that here
or not.
DR. CAPLAN: Not right now.
DR. NIGHTINGALE: Okay, and I would also just
mention parenthetically, that the full basis for our formal
decision does appear in memos that were prepared by the
Informed Consent Waiver Review Group and submitted to the
commissioner for decision. And those decision memos cover
each of the elements that appear in our regulation that need
to be considered before a determination is made by the
commissioner. And the commissioner signed both of the memos
for the product involved.
Now, let me turn briefly to a very important part of
the whole activity, and that is information dissemination.
It should be clearly recognized that although a waiver
of the need for informed consent was approved for both these
products, that did not free the Department of Defense of the
need to disseminate information about the drugs to potential
recipients. In both cases specific language was submitted
by the Department of Defense and, after further refinement,
approved by the Food and Drug Administration.
This specific wording was incorporated into the
material given to or read to the troops. This was our
understanding at the time of the approval. This information
was critical to FDA's agreement to the drug and vaccine
distribution plans, including the granting of the waiver,
because, among other things, it told the troops what these
products were expected to do and what they could not do to
protect them.
The Department of Defense was asked to make changes in
its training manuals to reflect the current level of
scientific knowledge about the agents approved for Desert
Storm/Shield, as well as other modifications to some of the
technical memoranda that they had that dealt with this
issue. Thus, and critically, although informed consent was
waived, giving as complete information as practical to the
troops was deemed a crucial ethical mandate and sine qua non
for this distribution system to be approved.
Now, FDA views the interim final rule as a medically
and ethically appropriate mechanism to handle
investigational products that offer the best prophylaxis
and treatment for chemical and biological warfare agents.
Thus, FDA plans, in the near future, with minor
modifications, to proceed with finalizing the interim final
rule.
I would be pleased to answer any questions that you
might have about my comments. Thank you very much.
DR. CAPLAN: Thank you. I'll open the floor for
comments, and let me take, go ahead.
MS. PORTER: Dr. Nightingale, in additional to
the waiver of informed consent, were other provisions of
the regulations waived or modified to allow the use of these
agents?
DR. NIGHTINGALE: Yes, and this is something which
no additional regulation was needed for, because the FDA
routinely looks at individual submissions of IND's. And if
there are parts of the requirements that are not practical
for the particular setting, exemptions for those specific
sections are granted. In this case there were a number of
other components that were, that had to be waived because
of the battlefield conditions involved.
MS. PORTER: So you can't characterize those?
DR. NIGHTINGALE: There's a long list and I would
not, I would be happy to submit all of them for the record,
but they deal with such things as labeling. They have to
do with the observations made and the inability to make
observations, for example, on troops, when the troops are
self-administering the pyridostigmine, for example, and
there's no intermediary to be observing what happens.
And FDA and DOD had discussed this at length. And when
the final decision was made, when the approval for granting
the waiver was made, it was a packet that included
everything from the treatment prophylaxis usages to the
various waivers or exemptions from other provisions. And
I'd be happy to submit that for the record to you so you
could see what they all were. But, these were obvious
issues that had to be dealt with and were part of the very
earliest discussions that we had with the Department of
Defense during that six month period prior to the issuance
of the regulation that was developed.
DR. CAPLAN: One of the, I have a set of questions
that I'm going to be asking you, because I know that one of
the things that's come up, given recent revelations from the
Radiation Commission and so forth about research involving
members of the military, is that it's certainly one of the
areas that leads to problems of distrust and fears that
people are not being treated with their rights being
protected, their dignity being preserved, and that's
something that we must do even in combat situations within
the military.
Let me ask you a couple of questions and then I'll give
the floor to others who may want to comment and come back
with some other ones.
One of the things that I'm troubled about in this
decision is that there seems to be a sort of wavering back
and forth about the treatment issue. Is it treatment, is
it research? We've got some explanation in your testimony,
about the ways in which investigational things may be
available.
I don't believe, although I may be wrong about this,
but there have been prior uses of agents for prophylactic
purposes. Most of the orphan drugs and making drugs
available to an AIDS patient, that seems to me to fall under
making something available for the therapeutic benefit of
the individual.
One of the issues that comes up here is, what sort of
intention, as best you can recall or at least as you see it
now as you begin to move towards this regulation, went to
the question of prophylaxis, because it seems to me in the
military setting, one of the reasons to allow these agents
and compounds to be used is to as much protect the group as
it is to protect the individual, a different ethical stance
than you might find if someone says, I want to get gene
therapy for brain cancer or some chemical to treat my AIDS
and I'm dying, that's for my benefit and no one else's.
So, I'm curious about how you then saw it and what you
think now about this prophylactic issue in terms of waiving
informed consent as opposed to treating an individual person
where you might--
DR. NIGHTINGALE: Yes, that is a complicated
issue. I would want to go back and review the 30 or more
treatment IND's, for example, that we have approved over
the years.
But, I would say that this was viewed as a protection
for the individual and the troops. In other words, it was
always, and perhaps not emphasized enough, but it was very
important that you were helping an individual, you were
trying to preserve the life and health of the individual,
as well as preserving the life and health of the troops in
general. So, you have these two issues, which, of course,
you don't have the troop issue in the ordinary treatment
IND.
So, from an ethical perspective the issue of, is it
any different to have a prophylactic agent part of the so-
called treatment IND approach? I don't really see that as
very different. The difference is the fact that you're
dealing with a military group and indeed, in the treatment
IND, of course, there still is the need for informed
consent. Informed consent is not waived.
But there are certain things that we do with the
treatment IND's, such as allow a central IRB rather than a
need to have local IRB's around the country approve it once
FDA has designed the treatment IND status. And that's a
change or a difference from the ordinary situation, but I
would be happy to go back and look further at the issue of
the prophylaxis.
DR. CAPLAN: Let me follow that with another
question then, which is; this panel, and indeed the
committee at other meetings, has heard statements and
testimony about the uneven notification or disclosure to
particular individuals who were getting some of the agents
that were allowed to be disseminated.
Do you have any comment at this point in time, or has
FDA been able to take any steps to either establish whether
notification met the intent of your directives when the
commissioner granted approval, or subsequently, and I'll put
this more into English; in combat situations, deployment
situations, can we expect, realistically, notification, much
less informed consent? Are people are going to be lined up
and passing through tents and told, roll up your sleeve,
it's a fine day, see you later.
DR. NIGHTINGALE: Well, of course, as I mentioned,
the ethical underpinning of this activity was as full a
disclosure as practical and that every individual who gets
either, was to receive either of these two investigational
agents, was supposed to be given the information that had
been approved as part of the package.
And as you've heard, and the DOD admits, this really
did not happen. So, of course, we were very disappointed
and felt that it did not really meet our requirements. And
any future activity of this sort, we would expect that there
was much more of an assurance that the individuals will be
informed.
One of the nice things about the prophylaxis part of
it is that there are, you can deal with these through
training manuals and a variety of other activities. And I
understand the DOD is actually doing a good job currently
in training currently and there have been revisions, I
believe, to both of the documents that had been considered.
And I would say that one of the issues that we are
looking at in terms of the proceeding to finalization of
the interim final rule is, do we need to put more into the
regulation that would assure this or not? And you can look
at this in different ways, because in the final analysis
it's up to the DOD to carry through on its commitments.
But, for example, one of the things that we had
discussed internally was should, is part of our, the
submission that would come if such a situation occurred
again, a requirement to submit in some detail the plan for
training and distribution and it might be, and what kind of
assurances might be made and how they might be made,
something that we did not do in any great detail in the heat
of the activity that surrounded the Desert Shield/Desert
Storm.
MS. KNOX: I have a couple of questions and maybe
you can clarify for the audience, because I think there's
some misconception; the only thing the FDA waived the
informed consent on was the pyridostigmine bromide and also
the botulinum toxoid.
DR. NIGHTINGALE: Right.
MS. KNOX: Would you speak a little bit about the
anthrax? My understanding is that it is licensed since
1972.
DR. NIGHTINGALE: Right.
MS. KNOX: And that it is the correct dosage to
receive your initial injection, and two weeks later receive
your second vaccine. Is that correct?
DR. NIGHTINGALE: It is a licensed vaccine. It
was licensed, I believe, in 1970. And I did not personally
pay a lot of attention to that particular issue. I don't,
I would prefer, I guess, the DOD for the specific course of
the immunizations, or I could get back to you on that. But
I believe they used it in conformance with the labeling, the
official labeling that the FDA had approved for the various
course of the vaccinations with anthrax.
So, it was something, I mean, there were a lot of drugs
and vaccines that were used outside of this particular
informed consent waiver issue. And today I centered mostly
on that part of it.
But, again, I could get back to you on that and get
you more from DOD.
MS. KNOX: Are there any waivers from FDA on any
medications right now for the Bosnian troops?
DR. NIGHTINGALE: We have had no, I am not aware
of any submissions on a request for that at this time and,
but you know what kicks off this particular thing is a
letter that comes to the agency with that request. So, to
my knowledge, and I think I would know about it, this has
not occurred.
MS. KNOX: So have you come up with a plan on how
you will evaluate notice not being given, that concern?
DR. NIGHTINGALE: Well, as I said, it's something
which depends in great part on DOD's, I wouldn't say just
good will, because they are interested in doing the right
thing, I think it depends on whatever DOD puts in place to
assure that the information is either given out orally or
written. So it is something that would, well, one, there
is work going on right now on the actual wording of the
documents, which is fine.
Exactly, and speaking because I understand it, it's
being used in training programs at DOD at the present time,
which we would view as being very important and very good,
exactly what assurances are going to be given and how
they'll be given is something I know the DOD is interested
in. And I would expect that Dr. Martin might address that
as part of his presentation this afternoon. So, I think
that is a critical part of the entire process.
Again, it is, it is what allows us to consider it to
be an ethical approach. Mainly, that as full information
as practical is being given out so people know what it is.
And it clearly needs to be in their records because, in
order to get information it needs to be done, both for
medical care and kind of useful research that might come
out.
For example, if, indeed, there were agents to be used
and one had a chance to get some information, clearly the
investigational status as such that we would be collecting
what we could collect as useful information as well. So,
we're very interested in that whole system operating
effectively.
MS. PORTER: I'd like to go back to the process,
for a moment, that was used in the decision making. Were
parties other than the Department of Defense and the Food
and Drug Administration and the Department of Health and
Human Services, employees involved in helping to devise this
process or make the final decisions?
DR. NIGHTINGALE: Okay, the process was an
internal one. I mean, we had to develop these things as we
went along, because we'd never really had this before, and
we had to develop a process as the regulations were being
written and cleared through the administrative bureaucracy.
And when it got, before it came out it had the highest level
of approval possible.
As you know, the final regulations does make allowance
for consulting with outside experts if it's deemed
appropriate to do it. It happened in that circumstance that
the kinds of contacts that had been made, and I can speak
really, primarily to FDA's contact, not to what DOD did,
although I know something about what they did, but again,
Dr. Martin might want to rather deal with that issue, but
we did have on our Informed Consent Waiver Review Group, Dr.
Arthur McCarthy from the NIH, Office of Protection For
Research Risk, who we viewed as being an extremely important
part of the whole operation.
In other words, at that time, and I think that office
still is, overall in charge of the government wide ethical
issues. And it was of great comfort to us as we went along
to know that he felt what was happening met his criteria for
being appropriate. And, furthermore, he had to sign on
since he was a member of our group. Now, that's outside
FDA.
There were informal contacts. I made a few telephone
calls myself, for example, about this issue with some people
who I thought, who were ethicists, who I thought would be
very useful to me in terms of what we were actually
developing. That was unofficial and it was just something
that was, I felt was helpful.
I also contacted the former, I guess the Assistant
Secretary of Health and the Department of Defense to sort
of fly the whole idea and ask that individual in terms of,
well, if you were there now what would you think of this
sort of thing? And, so, it was, it was comforting to have
informal views. And I think the issue, it depends on the
products that are involved.
In this case we had something that had been used for
years and years in terms of a, as a drug, and so we had lots
of information on it on the one hand. On the other, I
stated the botulinum toxoid had been used for 25 years on
a small scale. In both cases they were long-standing IND's,
much research had been done of certain types.
Primarily we did, of course, have animal data and some
human safety data. But it did not present us with a
situation where we felt we could not go forward without
having some kind of external review take place. And I think
you know from some of the comments that we got back, well,
there was at least one that said, you know, this should have
gone through some kind of department level ethics advisory
board, for example. But we did not even see a need to
really formalize any kind of a small group of people,
neither for the scientific issues or the ethical issues.
But you could, but if this were to happen again and
there were a different, different products were considered
under this waiver request, it's quite possible we might
convene a group. We would have that ability under the
regulations.
MS. PORTER: Are you considering that in the
rewrite of the final rules?
DR. NIGHTINGALE: Well, of course we're
considering all parts of the current rule there. By not
doing anything, by leaving that section, I think the fourth
part of it, by leaving it as is, it is permissive. It
allows us to go and do this sort of thing. I don't think
we would consider forcing ourselves to do that because I
think that would not be viewed as being something that was
facilitative or necessary based on current experience.
So, the way it's currently worded allows us to go to
the outside world to get formal views, but doesn't force us
to do it. And I think that's my own personal view because
we've not really, although we're proceeding to finalize it,
we haven't really come to grips with each segment of the
current regulations at this point in time. So I would find
it to be fairly well worded at the present time.
MS. GWIN: As you move toward a final rule, do
you plan to repropose it and allow public comment on it,
or are you going to move straight to the final rule?
DR. NIGHTINGALE: Well, that's a very interesting
question, because a lot of that, we've discussed it
internally at some length. It really has to do with the
amount of changes you're going to make. Our current
thinking is that there is only minor modifications that are
necessary, which would not trigger a need to go out and get
further views.
Clearly, well, we have, as you know, over 20 comments
that came in originally on the interim final. However, we
have the benefits of some hearings on this subject before
Congress. We have lots of articles in the lay press and in
medical journals on medical and scientific issues, as well
as on some of the ethical concerns that had been raised.
We certainly discussed this with the Department of
Defense. And the Department of Defense even has a
recommendation they made to us about what they'd like to
see.
Our view, and again, this is an informal comment
because there's no official agency position on this yet,
our view is that we really don't need to seek further public
comment on this. Clearly, what happens today with this is
something we're going to bring back to the Food and Drug
Administration, but I would say right now we do not see a
need for a further public comment.
Oh, by the way, I forgot to mention, there's been
extensive litigation over this as well, so, I mean, there,
we have decisions made in the courts about the
appropriateness of this as well. So, it's something which
has been very, very much discussed.
We have, the whole issue of the informed consent waiver
has been also looked at as well by us more recently because
of the concern about emergency research. And now there's,
we have a proposal out currently that suggests the
possibility of a waiver of informed consent for people who
are unable to get consent in emergency rooms or in the, who
are found on the street, for example, in terms of emergency
medical technicians or what have you.
So, I think there is an evolution, by the way, I'm not
tying these two things together, I'm just saying there's a
lot of discussion going on currently, and also there has
been more recently even some comments about some of the
international ethical codes as perhaps not being as attuned
to some of the current medical and scientific activities
that have occurred.
People, there are some concerns about, for example,
the Declaration of Helsinki not permitting the use of
placebo controlled trials, something which is the bulwark
of all drug trial work over the past years. And maybe this
is a bit far afield to mention it at this point, but it is,
some of the people who found what we were doing to be
ethically lacking pointed to some of these, the Nuremberg
Code, for example, also we don't view as being especially
pertinent to the kind of activity that's occurring here.
This is something, I'm not at all dismissing that, I'm
saying, for the particular situation at hand, some of the
international ethical thinking, I think, has progressed to
encompass some of these things.
Now, if you ask one another, and this is not really my
business, but if you look at what other countries have done
to handle some of these things, clearly, the pyridostigmine
was used by other, well, as I said, by NATO and by other
forces. What do they do about the informed consent issue?
Well, again, I'm not an expert on this, it's something
that Dr. Martin might want to tell you about, but I think
they make accommodations for, for example, pyridostigmine
as being a product which is appropriately fielded and used
and have mechanisms within their food and drug type statues
that would allow its use, not even considering it
experimental.
So, these are sort of background issues that are there
and are known by us. And I think all feed in somewhat into
our current thinking.
DR. CAPLAN: Let me put one more question to you,
we've had you up here a long time, and I'll preface it with
a short comment, which is; I, my personal impression is that
it still would be wise to allow some public comment, given
some of the other discussions and debates about research
involving the military. I think this policy is so sensitive
that it, personally I think it still might be wise to allow
for a public comment period before finalization of the
final rule, which I take it will be a consensual trick.
But, nonetheless, here's the final question I'd like
to put to you for this morning and it's this; as you
deliberated about this, most of the things that we've talked
about are procedures, were they adequate in terms of review,
expertise and so forth, is it right to try and put a waiver
on informed consent if you're going to rely on notification,
is that practical?
One other thing I just wanted to ask you about, and I
don't have the memo in front of me, but, to me, waiving
informed consent puts another obligation into place and
that's follow-up. That we follow people who were exposed to
things when they're not given the opportunity to consent and
try to see whether they suffer adverse consequences.
In the case of PB or in the case of botulism vaccine,
I don't know, but I'm of the opinion, perhaps, that the
follow-up was not either of all people exposed or a
significant sub-sample where it should be, and I'd just be
interested in your thinking about the degree to which we
have an obligation to aggressively follow what happens if
an individual is asked to assume a risk and not allowed to
consent.
DR. NIGHTINGALE: My view is that it's important
to have appropriate follow-up, both for medical reasons and
whatever might be learned. It is still technically an
investigational activity, even though it's a treatment of
purposes, and whatever new knowledge can be gained is
important, but, for the medical care of the individual it's
critical to have a good follow-up. So that's something that
we would very much encourage.
DR. CAPLAN: All right. Thank you for your
testimony and being so patient with our questions.
At this point I'm going to declare a recess for the
lunch break and we will reassemble here at 1.
(Lunch recess.)
Afternoon Session
DR. CAPLAN: I would like
to get us under way if I could. We are adhering
rigidly to our schedule, even though a large
number of our speakers cannot leave due to bad
weather back in the East, and I assume they'll be
available all night long to talk to anyone that
wants to speak with them. Looks like there's
another big storm back there.
We do appreciate, in fact, your effort, people
in the next panel, Dr. Martin, General Belihar, in
coming here and understanding the hardships of not
being able to go back.
We did switch the program and General Belihar
is going to present to us first. And we're
continuing the theme of waivers of informed
consent to the use of investigational, innovative,
experimental new drugs, devices and compounds in
combat and military situations. And I'd like to
ask Brigadier General Robert Belihar to talk to us
at this point.
GENERAL BELIHAR: Good
afternoon.
It's a pleasure to be here and offer my
particular view of the issues that you've
mentioned.
May I have the first slide, please? (slides
presented) I want to start off by saying, I am a
Gulf War veteran.
First slide. I am presently the commander of
the Human Systems Center in San Antonio, Texas.
I have been there since 1994. Now, prior to that,
for three years, I was the Command Surgeon for
Central Command two years prior to the war, and
then all during.
Many are not familiar with what a Unified
Command Surgeon does. These are my
responsibilities; formulating evacuation policy,
coordinating joint utilization of medical
facilities and preventive medical activities,
negotiating with host nation, arranging reposition
of medical equipment and supplies, but basically,
I was the principal medical advisor to the
Commander in Chief of Central Command.
I want you to know that we in the medical
community were aware of history. We were aware of
Agent Orange and the fact is, the people, the
Ranch Hand folks work for me. And I'm aware of
it, as is everyone in the medical community. So,
we were very sensitized to any sort of issues,
similar issues that may raise its head.
Pyridostigmine bromide, leishmaniasis,
occupational illnesses. And I mention this
because, keep in mind that there are a lot of
wartime responsibilities that are the same as
peacetime. We have to service equipment. We did
a lot of painting of heavy equipment and what was
deployed to the area. So, there are a lot of
occupational illnesses. Petroleum oil and
lubricants and so on, 2 pam, atropine, nerve
agents, ciprofloxacin, insect repellents,
ciprofloxacin that impregnated BDU's, topical skin
protectant, vaccinations, Kuwaiti oil fires, and
chem/bio agents. So, we were very attuned to the
potential for problems in this area and did
everything we could to address it before the fact.
I want to address bio-warfare concerns. We
have been taught, in fact, it's my first course in
nuclear, biological and chemical warfare. It goes
back to the early 70's, this is something that's
not new, but this is the first time that we had
found ourselves in a situation where bio-warfare
was a possibility.
We accessed, we tried to assess as best we
could, Sadam Hussein's capability and his intent.
And I will tell you that intelligence in this area
was lacking. We were aware that there were some
biological warfare activities, but we did not know
the extent.
We did not know about his strategy or his
tactics, if in fact he had these agents, how, what
would he use them? How would he use it and where
would he use it? And when would he use it? And
I want to address each of these issues.
Based upon intelligence that was made
available to us, clostridium botulinum and
bacillus anthracis were the two organisms that
were most likely. And I have provided some
information sheets on these subject to you.
Now, I want to tell you that this poses a real
challenge, because the real threat, based upon
intelligence, was chemical warfare, not
biological. But, again, I want to go back to the
earlier slide to tell you that we didn't want to
ignore these things, we wanted to be prepared. So
these are the two organisms that were likely.
Now, the question is, how would these be
deployed? How would he use them? Would he use
them as an aerosol, would he use it as a terrorist
weapon in our water supplies? There was a big old
pipeline that went from Al Jubayl along the coast
into Rhiad. You could access that water very
easily and poison a great number of people, so we
didn't really know who was at greatest risk. And
then in combat we used SCUDs, artillery, we used
aircraft, mortars, what have you. We didn't know
the answers to these questions.
Where would he use it? Would he use it on the
forward edge of the battle area? Would he use it
on the rear areas? Would he use it on the
population centers and other, why not back in the
States? There are all kinds of possibilities. We
didn't know the answers to these questions.
And when? Intelligence feedback was very,
very sparse. Would he use it as a last resort in
the final days of the battle? Would he use it at
the beginning of the ground campaign. Again, we
didn't know the answers to those questions.
Now, what about our biological warfare
preparations? Based upon the intelligence that we
had, we knew that we had no bio detection, no
active bio detectors. So, basically, the
possibility existed that the first indication you
would have biological warfare was being deployed
was, we'd start seeing sick people.
Now, going into the war, I wanted to tell you,
when we got there, even though our medical
personnel had been trained in treating chemical
casualties, we detected a certain insecurity.
It's one thing to train back home when you're
free of a real threat. It's quite something else
to be deployed in a theater when you might be on
the receiving end of chemical warfare. So we
brought together some teams, formed some teams and
went out and taught. And we had the luxury of
time.
We put together the medical management of
chemical casualty courses. We taught hundreds and
hundreds and hundreds of medical people. And,
keep in mind, that we had 41,500 medical people
deployed in this operation. 65 hospitals, major
hospitals, so there were a lot of medical people
to train. So we went to the, took on the task of
educating these people.
But what about the bio-warfare? I don't know
when the last time that you saw anthrax or you saw
botulinum, but I can tell you, I have never seen
a case of botulism, I have never seen a case of
anthrax, and yet we had people out there who may
be the first ones to diagnose it. So we went
forward with information packets to inform our
people, to train our people with the time we had
available to be able to make these diagnosis.
Also, we wanted to bring in lab diagnostic
capability, and we did that. We had a tremendous
laboratory capability set up in the theater.
We also knew that antibiotics were available,
so we looked at ciprofloxacin and, in the case of
our allies, vibramycin, to use as a treatment upon
possible exposure.
Again, bio agent detectors were not there. And
there is, one of the best protections we have
against bio-warfare is our chemical warfare
garment. Our Mission Oriented Protective Posture,
or MOPP gear, mask, and chem suit. And, of
course, vaccinations.
We had some field tests that we tried. That
wasn't all that successful. We also had the
opportunity to talk to some enemy prisoners of
war. And, in fact, we had some detainees, some
deserters that we sampled their blood to see if
they, in fact, had been immunized, although, in
fact, they had not, it didn't really tell us much
because those people were obviously conscripts
and viewed as expendable anyway.
Vaccinations. Now, what would we vaccinate
against? Well, anthrax and botulinum. And that
was based upon the intelligence that we had
gotten, that those were the agents that were
likely to be involved.
Now, keep in mind, we did not have
intelligence that told us that it had been
weaponized, or even tested. All we knew is that
that was active research going on in this area.
It's extremely important that this be placed
in context. Don't look at what is known now and
compare it to what, to back then. You must know
what we had access to at the time.
So, who do we vaccinate? Well, we had quite
a bit of anthrax vaccination, of vaccine, but we
had, we did not have nearly enough botulinum
toxoid to vaccinate everyone. So, we went to the
Commander in Chief and we said, sir, there's a lot
of information that we don't have. We have to go
on a best guess. How do we utilize this botulinum
toxoid? I said, sir, you've got to make the call
because you know the order of battle, I don't.
And I will tell you, this whole order of battle is
very close held. I said, sir, you make the
decision.
And I will tell you that I know that this is
something that he agonized over a great deal. And
if you're talking about who gets the vaccine and
who does not. So, I will talk a little bit more
about that in a moment.
Now, the botulinum toxoid is an
investigational new drug. It is not experimental.
It is not experimental. There's a difference.
Now, I want to put things, one thing in
context, and that is at the time it was, appeared
in the press that we were going to be using
experimental vaccines. This appeared in the Stars
and Stripes. It appeared in the media. Our
people do not live in an information vacuum. In
fact, one of the things that we try to do is make
available CNN and other sources. So there was
some rumors out there that some sort of
experimental vaccine would be used. I think
that's important to keep in mind.
Now, the waiver was granted by the FDA for use
in the Gulf War. As part of that agreement, as
part of that agreement, we were asked to provide
information. This we did. We provided
information sheets on bot and information sheets
on pyridostigmine bromide. We provided input to
the field to tell them what to do, to give them
direction.
And I have given you, I'm sure the committee
has, I think I've given it to Dr. Porter, a three
page list of messages, daytime groups and so on,
that document all of this.
We were told to provide this information.
I want to talk a little bit about bot. We did
not have enough vaccine to vaccinate everybody.
We were told to provide this information to the
vaccinees. So, I looked at that and I said, well,
wait a second. How do I document that? How do we
document the fact that that immunization has been
given? The answer is, you'll sign the sheet.
When you sign the sheet you say, I've read this
information, I understand it, and they sign it.
Any questions that were, could have been
raised, should have been answered on the spot.
Now, the question is, well, if we have people who
are at risk and we don't have enough vaccine to
vaccinate everybody, why make it mandatory? So we
added the consent factor to it.
So an individual who waived, the way this was
to have been applied or carried out, the
individual would be given the information sheet,
would read the information sheet, and would decide
whether or not they wanted to receive the vaccine.
If the answer was, no, then that was the end
of it. There was no, to be no Article 15's, no
punishment for not doing that. And if that were,
and by the way, if the vaccine were to be given,
entries were to be made in the international shot
record, yellow shot record. There was supposed to
be an entry, vaccine "A", which represented
anthrax, vaccine "B", which represented botulinum,
and also the lot number. That was the guidance
that was given to the field.
Now, and again, we can show that this was sent
out. Now, obviously, some of the testimony that
has been provided today indicates that something
other than that was done. I'm just telling you
what the Central Command policy was to the field
on this issue.
So, when you send, give an information sheet
to a troop and you say, here's this information
sheet, read it over, and it has kind of the pros
and the cons to the vaccine. I mean, these
people, even though many of them are just out of
high school, they think and they'll say, what do
I do here? I don't know what to do, but you've
given this information. You must allow them to
process it. That's my, that's my view. They
process it and say, yes or no, or what have you.
That was our approach to this.
The efficacy was uncertain. It was felt that
there would be some protection afforded by the
vaccine. Some protection at the end of the first
shot, more protection at the end of the second,
and more so at the end of the third.
We did not know, we did not know when the
ground campaign would begin. We did not know
that. That was very close hold, so we went ahead
with the intent of giving the full amount of
vaccine. And, as was said here, some people went
in not having had that third vaccine. Some may
have only had one, some only had two. We didn't
really, we really didn't know that, because these
vaccinations were carried out at different time
periods.
And, again I mention, there wasn't enough
vaccine for everybody. And it seemed reasonable
to give them the choice, based upon the fact that
you gave the information upon which to base a
choice. I mean, why do you give somebody this
information if not to process it to make some sort
of conclusion in regards to it? So that's kind of
the background regarding the bot.
There were other investigational new drugs,
pyridostigmine bromide. And I will tell you that
as a physician, we ground tested thousands and
thousands and thousands of air crew to make sure
they didn't have any sort of idiosyncratic
reaction or excessive side effects with this
medicine. We did it for years and years and years
with no untoward effects.
And we knew there was a high probability, or
not high probability, but high possibility that
chemicals would be used and so, and we had
adequate amount to distribute. So, for that
reason we went ahead with the pyridostigmine
bromide and did not have the consent on that. We
just went ahead and distributed it, because we
were, we were, if we had not, if we had not
provided pyridostigmine protection, and had a
nerve agent been used, I think the consequence
would have been significant.
Okay. Cana, diazepam, it was kind of
interesting on this. We gave this as a, as a
treatment following nerve agent exposure to
minimize the morbidity associated with seizures
following it. And I remember going to, forward
with the, to the command asking permission to do
this and we were supported. It made sense.
These are issues, the biggest issue I think
you've seen today is the issue of documentation.
That's extremely important. It was our intent,
from the CENTCOM Surgeon's perspective, to
document, document, document, because if you have
to go back and do epidemiologic studies, like
we're doing right now, the biggest pitfall you
have is the lack of information. We wanted to
avoid that, again, by a, by a up-front approach to
try to anticipate what these issues would be.
Preparation, where are we now? That's a
question that you have to ask yourselves, DOD has
to ask itself and, of course, we each have to find
out, where are we now and where are we going.
I want to explain one thing about command and
staff relationships. This is important. Many of
you, perhaps, don't understand how this, how these
relationships work.
In the Gulf, Schwartzkopf was Commander in
Chief. I was the Command Surgeon. I worked with
the component surgeons of the Army, Navy, Air
Force and Marines to make sure they understood and
carried out Command Surgeon policy, which was in
support of the CINCs policy.
This was not done in a vacuum. I worked very,
very closely with the senior leadership and they
were very active in this decision making. I
worked very closely with my supporting surgeon,
who happened to be the UCOM surgeon.
In Washington we had a variety of people. We
had the Surgeons General working for the
respective head of service. We had the Assistant
Secretary of Defense for Health Affairs. Again,
a dotted line.
This dotted line was really a lightly dotted
line. Most of my connection with Washington
occurred with this individual, the person who was
in the medical readiness position on the Joint
Staff. That was the strongest link with
Washington. And there was a free exchange of
information on that, on the telephone and even,
you know, classified or unclassified.
And I wanted to make one comment here that I
think is important to know. In fact, I need to go
over the next slide. Well, I don't; but there was
a question that we kept this thing top secret
because we wanted to shield the Allies from the
fact we were going to vaccinate. That is not
true. That is not true.
The fact of the matter is, one of the first
things that I realized when I got into the theater
was, we needed to cooperate, certainly, very
closely with the other services, and we did that.
We met very often to make sure that there was a
joint view on these subject. But there was the
issue of the Allies, because we found ourselves
with the Brits, with the French, and the medical
community with the Swedes, with Poles, with the
Armenians, with Bhrainanians. I can go on and on
and on.
It was important, so we had Allied meetings,
where we got people together to make sure we
talked about these things, because when you're in
combat and you're fighting side-by-side, you kind
of like to talk one another. It's a reasonable
thing to do.
So, we talked about this program with our
allies. And we told them we have a vaccine that
we're using for our troops. We don't have enough
for our own troops. This is an issue you're going
to have to deal with. But that was not the
reason.
The reason for the classified nature here is
because of the order of battle. Because the
patterns of vaccine administration would indicate,
perhaps, how those troops were going to be
employed, and we didn't want to do that. That
seemed like a reasonable thing to do.
We did not want to have that as an excuse for
failure to document. That's why we put vaccine
"A" and "B" entries in the shot record.
DR. CAPLAN: I'm just going
to urge you to pay attention to your time now.
Some of this we can do in question, too.
GENERAL BELIHAR: Okay.
Well, this is my closing.
This is today's warrior. We have troops that
are going in, they're arriving people fresh out of
high school. I've got a daughter that's about to
graduate. Am I going to send her to combat with
2 Pam, atropine auto-injectors, cana auto-
injectors, ciprofloxacin blister packs,
pyridostigmine bromide blister packs, perhaps
antimalarials and insect repellents, MOPP gear,
laser eye protection and 101 other things.
I will tell you, this is not an easy thing to
do. There's a big challenge on training in
advance, because you can't do it when you get over
in the theater. That's not the time to do it.
Okay. We need to accurately define the
threats to our soldiers, sailors, airmen and
marines. Provide maximum protection and minimize
risk, and do no harm.
I apologize for going over, but this is
something I feel very strongly about.
DR. CAPLAN: Let's open the
question/comment period to any panelist who wants
to do so or committee member.
MS. KNOX: I have a couple
of questions.
Sir, as a Gulf War veteran, did you, yourself,
take pyridostigmine bromide and anthrax and
botulinum vaccine?
GENERAL BELIHAR: I did
not, and the reason I didn't take it personally,
is because I would much rather see my bot tox used
by somebody in a higher threat environment than by
me.
I was in Rhiad and I want you to know, I
travel all through the entire AOR. I was in
Kuwait, I was in Iraq, I was at El Khafji. I
visited all these places. Not at the moment the
battle was being engaged, mind you. My
responsibility was to be in the command post, but
if you look at a scattergram of Rhiad, you'll see
that we took our share of SCUD hits, I will tell
you that.
So I did not, I did not take my pyridostigmine
bromide because the threat was rapidly eliminated
as a potential. I certainly had my mask, I had my
equipment and I felt that that was sufficient
protection until, you know, a safe indication was
made.
MS. KNOX: Can you help me
understand, too, why the order for PB was a unit
command?
GENERAL BELIHAR: I think
they're, you cannot, in the moment of battle,
coordinate through your component commander up
through the, you know, the CINCENT to the surgeon.
There are certain things that must be empowered at
the unit level.
And it seemed reasonable that that decision be
made on the spot by the commander. And it seemed
like a reasonable thing, and I think that was the
right way to go.
I will tell you, there are many people, I will
tell you that I was pretty insecure when the SCUDs
were coming in. I will tell you, if you're, and
I keep referring to young folks, because I kind of
relate because of my kids and what have you, but
there were a lot of young people, reservists, they
had other jobs, and here they are with the
potential exposure to chemical weapons. It's a
frightening thing.
And I will tell you, if you say, I want you to
take one of these tablets every eight hours until
told to do otherwise, well, I will tell you, when
they start flying in, you find you get to say,
well, if one every eight hours is good, two every
eight hours is better, this sort of thing.
And there is in the literature a pretty clear
tale of how these aberrations occurred in the
field. It is difficult to get the full
compliance.
It's very difficult in peacetime to give some
medicines to somebody and say, ma'am, take one
four times a day for the next ten days. How often
does that occur? It's frequently ignored.
And, so, to have hundreds of thousands of
people at risk and not having this kind of
departure from instructions is not unusual.
MS. KNOX: Well, and I
guess lastly, the comments that Dr. Nightingale
made before about FDA regulations; how do you plan
to evaluate what you did during the Gulf War
concerning the documentation and the notification?
I, myself, gave, you know, many anthrax
vaccines and none of the soldiers were given
notification.
GENERAL BELIHAR: As you
know, I have been, for the last five years, in the
position of the Command Surgeon, but I will tell
you I know for a fact that the DOD is looking very
hard at their policy to ensure that this
documentation occurs, that these decisions, which
are often times under pressure on the spot or made
in advance, I know this is being done. And I
think that's the right answer, I think they're on
the right track.
DR. BALES: And the anthrax
was an approved vaccine that was not under
investigational status and, consequently, did not
carry with it the weight of this notification and
follow-up. It's an approved drug. It's an
approved vaccine.
GENERAL BELIHAR: I want to
explain, when I tell you that I wanted to have
experts in the field, and that's why I brought in
experts in chem defense and also in bio-warfare.
And Dr. Bales was my right hand man as it related
to the bio-warfare issue.
And I hope I haven't cut into his time,
because I think he has some important things to
say, so if no more questions, I'll have a seat.
Yes.
MR. KOWALOK: I have a
question about your potential Agent Oranges.
GENERAL BELIHAR: Yes, sir.
MR. KOWALOK: In addition
to that list, one of the items that many Gulf
sites as being an exposure is to depleted uranium.
And I see that, too, is not on the list. Is
there?
DR. BALES: With
occupational exposures because they--
GENERAL BELIHAR: That's
included in that all-encompassing term.
Obviously, depleted uranium is used in, you know,
in anti, you know, antitank warfare. And that is
one of the occupation related issues.
DR. BALES: And there is a
lot data on that from the people who manufacture
those rounds, the occupational exposures that
occurred in that. And that, I think, has been
followed-up on extensively.
DR. CAPLAN: Let me ask one
question, General Belihar, then we'll go to you,
Dr. Bales; I think this issue of procedure
followed in making decisions about how to handle
the threat under extreme circumstances is one that
raises some tough questions about hard decisions
that just have to be made.
I'm curious, do you believe that it would be
possible, should have been done then, maybe should
be done now, to try to avoid these situations, you
said that PB was something people had given out
for many years. We do have information about its
use in myasthenia gravis and we know about the
anthrax vaccine having used both here and
elsewhere. I guess to put it simply; why were we
in a situation where we had to sort of scramble to
decide what to do in response to this threat?
Could we have taken the steps to put these
things through complete approval before we had to
make decisions in the field about what to do?
GENERAL BELIHAR: Well, the
status of the vaccine, and PB was known well in
advance. I think rather than reflecting back
then, I think we ought to ask ourselves that
question right now, is what are we doing to, you
know, to create either new classifications or
procedures that will allow this to be done in
advance.
There is no question in my mind that if, we
ought to provide, I do not believe we should
deprive people of information. The fact of the
matter is, as a general rule, you gain more out of
providing information than the lack of it. And we
need to, we need to be very proactive in doing
this and I know it's being done. Dr. Nightingale
pointed that out, that we are trying to find
solutions to this.
But, you know, I will tell you that we are not
going to create a research protocol that exposes
human beings to nerve agent. It's not going to
happen. And I will tell you that I never, I
never, viewed this as experimental. I did not
view this as being an opportunity for researchers
to take advantage of people in the field. That
was simply not our motivation.
I will tell you that General Schwartzkopf was
deeply committed to making sure his troops were
being taken care of. He, nor I, would do nothing
to intentionally harm our troops. I guarantee
that.
Had I been in the area that was considered to
be at increased risk for bio-warfare, I would have
taken the botulinum. There is no question about
it in my mind, none. I would have taken my
pyridostigmine bromide, no question in my mind
whatsoever. I would never ask somebody else to do
something I wouldn't do for myself.
I'm committed, in fact, these are very, very
necessary. I also understand that I, as a wearer
of the uniform, find myself in a situation where
I, there is some, you know, decreased latitude of
choice. I understand that, and I think all the
troops understand that when they come into the
military.
DR. CAPLAN: Okay. Thank
you.
DR. BALES: How much are
you going to give me? I'll be as quick as
possible.
First of all, after discussions with Dr.
Belihar last night, well, first of all, who am I?
My name is Dave Bales. I'm currently in private
practice as a primary care provider in Tacoma,
Washington.
I'm Board certified in Internal Medicine and
Infectious Diseases and Preventive Medicine. And
I went to Saudi within nine days of the invasion
and stayed there until the 1st of May.
So, my exposure was maximal, particularly
considering that I'd spent five and a half years
in Saudi Arabia before this.
Having said who I am, we had a discussion last
night and I showed my prepared statement to Bob
and he said, well, he didn't quite remember the
ethical end of it, those discussions being quite
as volatile as I have made it in my presentation
to you. And that is correct.
There was a virtual consensus on our approach
to this, readily. There were never any arguments
about putting out and requesting the informed
consent on the bot toxoid, despite the fact that
we were legally allowed not to.
I felt, and I think everybody else felt, that
if we were going to fall on the informed consent
sword, that it should be for something that; one,
we had more of. Two, was more efficacious, and we
had virtual assurance that it was 100 percent
efficacious. And, three, why give it to somebody
who didn't want it if somebody who did want it
would be left out?
So, what I'm going to read is with a five year
retrospective view. And it disagrees with
virtually everybody at some point or another.
I am a soldier. I'm a retired soldier, but I
am a soldier. I've sworn to protect and uphold
the Constitution of the United States against all
enemies, foreign and domestic. I have committed
to go in harms way and to die if necessary when
called by my country.
I consider this calling to be the highest
manifestation of citizenship, service and
patriotism. And I continue to believe that the
medical support of soldiers in combat is among the
highest callings, ethically, morally, and as a
citizen.
Given those feelings about soldiers, it is not
difficult to understand why I felt and feel
strongly about the waiver of informed consent for
soldiers who were prepared to die protecting the
rights of others.
Soldiers are citizens of the first order and
deserve all of the rights and privileges of
citizenship. To abdicate one of these soldier's
human rights because of a perceived threat is to
negate the blood spilled by soldiers protecting
those very rights.
Informed consent is required when human
subjects are involved in research of
investigational new drugs, or IND's. These
requirements are legislative through the
regulations of the Food and Drug Administration
and other government agencies.
It is also frequently required of those not
involved in research, but placed at significant
risk by medical interventions, such as surgery.
These requirements are less legislative and
more the result of professional organizational
ethical positions and tort law. Indeed, informed
choice is a goal of demand management in this era
of managed care.
To me personally, the necessity for informed
consent in the use of an investigational new drug
is cut in stone and should not be waived.
If this committee is concerned about the
informed consent, I have the same question you
have in the use of investigationals in Operation
Desert Storm.
Our basic question should be, why is the bot
vaccine still an IND? Biological warfare has been
a possibility for more than 50 years and bot
toxin, toxoid has been, excuse me, bot toxin has
been on the threat list for at least 20 years.
The vaccine has been, has been available and in
use as an IND for that long.
If biological warfare had been taken
seriously, the ethical dilemma of the use of this
particular IND without informed consent would
never have been necessary.
In addition, the inadequate production, use,
and storage of approved anthrax vaccine would not
have been an issue. I have a very biased,
personal opinion as to why all this happened.
There is also a General Accounting report
requested by Senator John Glenn on this issue that
was published in '92 or '93 concerning readiness
for BW after spending all the money on it.
I suggest that the use of an approved drug for
an unapproved indication is a dilemma that is
different and is faced by the medical professional
on a daily basis. Package inserts spell out the
uses of drugs, but actual uses vary widely based
on the beliefs and understanding of individual
practitioners.
Such variations are so prevalent with cardiac
drugs that the American Heart Association has
found it necessary to categorize in its Advanced
Cardiac Life Support, interventions by whether or
not the weight of evidence makes it more or less
probable that the intervention is safe and
effective. And that's all on approved drugs.
The determination of safe and effective
requires extensive clinical trials or
epidemiological data. The use of pyridostigmine
as a nerve agent protectant is theoretical, and
will remain theoretical, hopefully, because
clinical trials would be unthinkable and
epidemiological data will hopefully never be
available. The Tokyo subway being an exception.
It is, however, been such a strong theory that
it's become doctrine in chemical warfare defense,
first in the United Kingdom and subsequently in
the United States. It is not an investigational
new drug, any more than is diazepam, valium, or I
might point out after today's presentation,
doxycycline in that it is an approved drug.
And I would be willing to bet that there's a
number of people in this room who will take
doxycycline for an unapproved reason, the Gulf War
syndrome, as soon as they can find someone that
will prescribe it for them.
It should not be included in the same debate
about informed consent as an IND that has never
been approved. I suggest that the discussion of
the ethical, moral and legal use of approved drugs
for unapproved indications should take place along
the lines of the orphan drug discussions, or
decisions.
Now, what IND's were available in Operation
Desert Storm?
There were several besides the bot vaccine.
These included ribavirin for both treatment and
prophylaxis of Congo Crimean Hemorrhagic Fever,
Centoxin or HA1A for the treatment of Gram
Negative Sepsis Syndrome, and heptavalent bot
antitoxin. The drugs, along with the protocols
and points of contact or co-investigators, were
distributed to levels of medical support that were
prioritized based on the most likely need while
maintaining flexibility to respond to
unanticipated use.
I was the CENTCOM Staff Officer responsible
for the IND's in theater. A team from the United
States Army Medical Research Institute of
Infectious Diseases, or USAMRIID, distributed the
bot vaccine based on priorities established by
CENTCOM, and that's been discussed.
The program was a voluntary program and the
vaccine could be refused. Signed informed consent
was required. Follow up for side effects was to
have been by a postcard questionnaire that was to
be mailed back to USAMRIID by the individual
vaccine recipients.
This was a problem because the entire program
was classified secret, for the reasons just
mentioned, and documents concerning the program
had to be handled as classified documents,
including the postcard responses and medical
records of vaccine administration.
Add to this the anxiety of a soldier facing a
ground war, and it's no surprise that response to
a vaccine questionnaire was probably not a high
priority.
Discussion on the ethics of the waiver of
informed consent have taken place in the medical
literature since Operation Desert Storm. In
March, 1992 was the article by, it would be
Professor Ennis from Boston.
This discussion has provided a platform for
those who are opposed to any military
participation by medical personnel. I am,
therefore, compelled to use this forum to
reiterate that ethically I find no conflict in the
practice of military medicine. Providing for the
common defense is necessary, and will continue to
be necessary. Medical support of the soldiers
called to sacrifice for the common defense is not
only ethical, but an admirable calling.
The moral dilemma of waiving or cutting down
human rights in order to fight evil is a centuries
old dilemma that has been raised in the wake of
crime and civil unrest, such as the Oklahoma City
bombing. Individual citizens interviewed on the
street have suggested giving up a few rights to
keep this from happening.
When I hear these suggestions I always flash
back to a dialogue from a play, A Man for All
Seasons, by Robert Bolt with Sir Thomas Moore, and
I'll read that now.
"Roper," that's the name of the guy talking
with him; "So now you'd give the devil the benefit
of law?
Moore: Yes, what would you
do? Cut a great road through the law to get at
the devil?
Roper: I'd cut down every
law in England to get do that.
Moore: Oh, and when the
last law was down and the devil turned around on
you, where would you hide, Roper, the laws all
being flat? This country's planted thick with
laws from coast to coast, man's laws, not God's,
and if you cut them down, do you really think you
could stand upright in the winds that would blow
then? Yes, I'd give the devil the benefit of law,
for my own safety's sake."
Thank you.
DR. CAPLAN: Thank you.
Comments, questions?
MS. KNOX: I just want to
clarify something. I realize that anthrax was
already approved. This sheet that was distributed
to us, though, in my opinion was the notification
of what the soldiers were receiving.
And I think from public testimony prior to
this date, we've heard that soldiers were not told
what A1 and A2 were, so in that aspect, they
really didn't know.
DR. BALES: What are you
talking about in terms of notice? What are you
referring to?
MS. KNOX: This was the
document. It says, "You're receiving the first of
two shots to protect against anthrax, a potential
biological warfare agent." It what was sent from
CENTCOM.
GENERAL BELIHAR: I know
what you're talking about. The fact that they
were getting any anthrax and botulinum was
classified. Even though anthrax was an approved
drug it was still classified--
MS. KNOX: Right.
GENERAL BELIHAR: --
because of the reasons I've explained. When they
received the sheet, they were told that at least
one of the vaccinations they were getting was
botulinum. And they didn't know whether that was
vaccine "A" or vaccine "B". And, so they weren't
said, the other one you're getting is anthrax.
That was not done as far as I know.
MS. KNOX: Right.
GENERAL BELIHAR: And, by
the way, when people go through the line to get
their shots, more often than not, they roll up
their sleeve and say, have your way with me. You
don't know whether you're getting a DPT or a
meningococcus or what have you.
Again, if they said, what am I getting, I
don't see anything wrong with telling them. I
wasn't trying to keep them in the dark. But they
did know that they were getting a bot tox, because
they were given the information sheet, or at least
they should have by CENTCOM policy.
MS. KNOX: Yes. Past
testimony tells us that some of them were not told
what they were getting and that, because it was so
classified and they were not told, they were
suspicious of what they were receiving.
GENERAL BELIHAR: Yes.
MS. PORTER: Did any
service personnel actually decline to take the bot
tox vaccine?
GENERAL BELIHAR: Now, the
answer is, yes, and this is almost anecdotal,
because the refusal to take the vaccine was not
documented. I mean, there's, only people who
received it that had a documented informed consent
signed. So, but the estimates are that there were
thousands that refused it.
MS. PORTER: Having said
everything that you have in your presentations,
can you envision a scenario where the waiver of
informed consent provision would be necessary in
the future?
DR. BALES: I think we need
to get very good at readiness. I think that it
would not be necessary and I think even now, we
don't like to think about biological warfare, it's
dirty war, and it's not something that people want
to have on the top of their list.
It needs to be addressed, because just like
the Tokyo subway, that could have been anthrax as
easily as it was a nerve agent. And maybe the
next one in a Washington, D.C., subway will be
anthrax. So, we need to know more, we need to
have, there's a sub-unit vaccine that is probably
poorly funded.
If we take BW seriously, we should get on the
ball. And one of my, I spent the next three years
after Desert Storm as the TRADOC surgeon because
I wanted to have some input into the combat
development on some of these issues.
And biological warfare detection was a big issue
and continues to be.
I happen to think that for a long time to
come, sick soldiers are going to be the sentinel.
And how do you pick up on that in a rapid fashion?
You have to have very aggressive medical
surveillance. And I don't think we have that in
place right now. That's very simple. That's not
controversial, but we're not doing it very well
right now.
I don't say, I think everybody's intent is
excellent, but the execution, because of cutbacks
in funding, the cutbacks in people, there will be
cutbacks in training, and training is where this
needs to take place.
I feel like people ought to be vaccinated
against anthrax when they come in. Then it would
cease to be an issue about, for somebody else to
use it. I mean, why would anybody want to use it
if they knew that you were defended against it?
And the same with bot. Let's go ahead and get
it approved, if it's an orphan drug approval,
approve it along orphan drug lines, but use it.
And if you fight like you train, you going to have
to train with it.
GENERAL BELIHAR: I had a
slide that I didn't get a chance to address that
deals with research and development. I command an
organization that deals with research and
development and acquisition. It happens to be
human systems, but we do research and development
as dictated by the needs of the operator, and
mission plans and the functionary of plans are
what dictate what we do.
There are possible contingencies where we are
seeking an R&D solution, and we need to bring that
to bear. The timing is such that we have to field
that sooner than possible.
You say, rather than wait for a hundred
percent solution, let's go ahead and go with what
we've got. We saw that happen during the Gulf
War, for example. We tried to do some bio
detection and other things to accelerate the R&D
process.
So, the whole key lies with having an accurate
predecessment so that you can address these issues
well enough in advance that you could seek these
solutions and get the appropriate approval so
you're not rushed into this waiver of informed
consent issue.
DR. CAPLAN: I had two
questions. One for Dr. Bales.
Do you think, given the fact that five years
have now elapsed, that there were problems, as we
know, in implementing directives from central
command and out into the field, that it is ever
going to be possible to understand exactly what
the health side effects were of the distribution
of these agents that we've been talking about in
this session?
DR. BALES: I think it
would be very difficult. I, myself, in order to
be sure that the distribution of the I&D materials
for centoxin, ribavirin and the other thing, I
personally hand carried them to each of the
hospitals along Path Line road, because that was
the only way I could be absolutely sure that that
distribution made it to the people that it needed
to make it to.
The difficulty with classified documents, and
we even looked this up in our AR40-66 in terms of
classified material in the medical record and the
disposition of that, we, it's very difficult,
because the general rule of thumb is, you keep
around as few classified documents as possible.
You shred them as quickly as possible.
And when people are told, you can go home next
week, but you've got all these classified
documents that somebody's going to have to stay
behind and guard, I can bet that most of those
things were destroyed.
So, it would be very difficult, unless the
units adhered to the policy, which was to record
it in the medical record, then to code it, not too
good a code, mind you, but a coded fashion,
vaccine "A" and vaccine "B", that's what's in my
chart, because I received it, also.
I was wondering why Bob down the hall from me
didn't. But General Schwartzkopf got it. And his
comments to us were in reference to the monkey
study with the Cipro, he said, just make sure I'm
one of those nine monkeys that survived.
(laughter)
DR. CAPLAN: That actually
leads me to my follow-up question, although either
one of you can take a whack at this; if you were
assessing today military readiness in terms of
something like epidemiology or biostatistical
capacity, to really say in Bosnia or in future
deployment, we've got the kind of health
assessment we need prior to deployment, the
ability to follow-up and make assessments when
different agents are out there, be they on the
battlefield or related to standard maintenance
employment things or because we're fearful of the
chemical and biological agents, what do we need to
do? What should this committee be recommending to
prepare for this different era of warfare?
GENERAL BELIHAR: Well, we
had, I as CENTCOM surgeon, had two years to think
about these kinds of issues. We looked at
epidemiology. There is no doubt in speaking with
the gentleman just before, he was asking about
documentation. If you're, this is a, this is a
real epidemiologic problem. In order to find a
solution, you have to look at geographical
distribution and all these things we looked at to
come up with some sort of matrix to find these
common denominators.
There is no substitute for documentation, to
know who got what, how much and when, because that
sort of anticipation would make this current
exercise a lot easier.
And I'm sure that Dr. Martin can address what
is going on in R&D, but I do know that they're
committed to this end.
DR. BALES: I think that in
peacetime there needs to be an active medical
surveillance that, with a feedback loop to the
commander, so that if you went and asked the
infantry company commander or battalion commander
what his URI rate was, he would know, because he's
being told on a monthly basis.
That whole system is available. The loops are
not being closed, because I think it's just the
fear, not the fear, but the prejudice against
biological warfare. It's an issue that people
don't want to think about it, so it's not
instituted. The stuff is available. Whether or
not, it would be useful to have a company
commander know that when his URI rate doubled,
that he may have had a BW attack. And the sooner
he knows, the longer those people are going to
survive.
Those policies and procedures are available.
How strictly they're adhered to, it's a fit
between post support and utilizing your soldiers
for other things and a thousand and one details
that a commander has to look at.
DR. CAPLAN: Other
questions, comments from anyone?
Okay. Thank you, gentlemen.
Our next witness is Dr. Sam
Martin who's going to, excuse me, Edward Martin.
Sam Martin is a friend of mine, but he's not here,
Edward Martin is. And Dr. Martin is going to talk
to us about the waiver issue as he sees it now
from the DOD perspective.
DR. MARTIN: Thank you.
I've got a copy of the extended testimony,
which the committee members have. We've also left
copies outside for anyone else here who would like
to have a copy of it.
It goes into great detail. And what I would
prefer to do is touch on three issues. Number
one, to talk a little bit about the DOD positions
associated with the Gulf War Syndrome.
Number two, to very much summarize the
testimony and allow questions to be asked, because
I think most of that is detailed and technical.
I'd also like to talk a little bit about what
lessons learned. There's a lot, what General
Belihar and Dr. Bales alluded to relative to one
of the issues that came out of the Gulf War.
I think, critically I'd like to, first, let's
clarify some things that came up this morning
about "the DOD position." And this committee has
already heard testimony. You will hear a lot more
testimony about what the department has and is
doing associated with the Persian Gulf illness,
the Gulf War Syndrome, or whatever name is chosen
to identify it.
First of all, let's make it very clear, we in
DOD feel very strongly that there are some
significant number of people who came back from
the Gulf who are sick. There is no question about
that. A substantial number of those people have
illnesses that we understand, that we are able to
diagnose and we are able to treat. DOD does not
deny that.
Second, there are a number of people who came
back from the Gulf who have symptoms,
symptomatology, syndromes, as Dr. Nicolson clearly
articulated, that we do not know the cause for.
We do not, in many of those cases, apply
psychiatric or psychological or diagnoses and, in
fact, they continue to be unknown etiologies. The
whole idea of the research program is to find out
what that is. There was, I think, a very good
discussion of chronic fatigue syndrome by Dr.
Nicolson.
The fact of the matter is, I talked to Dr.
Blanck almost as, or a lot more than he does, and
I can assure you, we pay a lot of attention to
CFIDS. And this is not a trivial consideration.
What is the science and how do we approach it,
and we make sure, it is very important and it's
been a concern for almost a year. And Dr. Blanck
who, by the way, is responsible for our specialty
center, in this regard is publicly saying that
this is one that we have to rule out. So, in that
respect, we clearly are not in disagreement.
But, the issue about the IOM report, I think
Dr. Caplan alluded to the DOD being more cautious
about what it said.
Well, first of all, we didn't say it. That
was the Institute of Medicine. The Institute of
Medicine release a press release. And in this
press release, they drew a series of conclusions.
And I think we're getting two things confused, and
it's very, very important.
Their fundamental conclusion, which was most
important, is that DOD had not undertaken the
proper research or epidemiologic studies, or
completed them, relative to finding out the
causalities of these problems.
And they made it very clear that what our
program was, and that's what they were looking at,
and only that, the CCEP was, in fact, a program to
provide treatment and care, not a question of
causality. So, what gets confused is, when the
IOM says, the CCEP has not shown that there is any
causal relationship or there is any unique disease
coming out of the Gulf, it further says, but what
we have done, and evaluating, wasn't designed to
do that in the first place. It was designed to
take care of people, and that needs to be very
clear.
The fact is, there are a large number of
theories about what are causing some of the
illnesses that we can't define. Most people have
been diagnosed with illnesses that we can.
I think there are individuals, like Dr.
Nicolson and others, who have approaches to
identifying what that cause is. And I think that
we're working as aggressively as we can. We were
talking out in the hall.
By the way, the average NIH grant proposal
process lasts 14 to 16 months. We got the
proposal, 110 proposals in August, and we hope to
have them out in February.
For the government and research dealing with
human beings, that is a very expedited process.
And we're trying very hard, we have a keen
interest in supporting as many of those as we
possibly can. Money has been reprogrammed to
support as much looking into that. The fact is,
these are our beneficiaries and we are concerned
about them.
Going into the summary of the testimony
itself, I think, really, there's just a series of
points to add on to what's already been said in
addition to the technical stuff. And although we
were not in Saudi with General Schwartzkopf and
Dr. Belihar and others, I can assure you that from
the point of view of DOD, I was actively involved
in this issue from the first day on. There was
extraordinary concern in regards to BW and CW, as
there was with General Schwartzkopf. From the
first day we were extremely worried about it.
We were basically dealing with an individual
who had, in fact, used chemical warfare on unarmed
women and children in a Kurdish population, who
had employed chemical weapons for sure in the
Iran-Iraq war.
Without going into how much intelligence we
had versus they had in the theater, we felt that
there was a very strong probability that CW could
be used, and a distinct possibility that BW would
be used.
The fact is, now that we know that we've got
the reports from the United Nation, not only was
anthrax and bot tox developed, they were developed
in substantial quantities, they were weaponized
and they were deployed forward, as were very
substantial amounts of chemical warfare agents.
This is not hypothetical.
The second consideration we faced is a very
important one. Dr. Belihar is right on about
anthrax. The way you learn about pulmonary
anthrax is the troop coming in with the symptoms.
Pulmonary anthrax is a hundred percent fatal.
Weaponized anthrax cannot be seen, we cannot
detect it. If it is, in fact, utilized on us,
there number of the lethality was very
considerable. Over thousands of square meters,
this is a very lethal and almost certainly fatal
weapon. It is a very scary weapon, indeed.
As you know, sarin and sonan, which were by
the way imperfectly used by far in the Tokyo
subway, that was an amateur effort. We were up
against a professional.
There were estimates of casualties if these
agents were employed that were very substantial.
I mean, we were talking about thousands and tens
of thousands of casualties, because of a large
number of people being exposed. We were
definitely very concerned.
Nonetheless, as it's been amply documented by
the testimony in the other presentations made to
the committee, the issue of informed consent, the
issue of the legality, the ethical considerations,
drove the department to made a decision early on,
within the first day or so. And we have differing
opinions, as Dr. Bales pointed out, that many
people disagreed with them.
I felt that we had everybody disagreeing with
everybody there for some number of weeks, because
there were a lot of different points of view.
There were those people who said, look, when the
military were worried about our people in field,
informed consent, and who's the FDA? War fighters
don't pay as much attention to it as the medical
community.
The fact is, the secretary made the decision
that we are going to go by the rules, and we did.
We spent an extraordinary amount of effort and
time. We worked with the ethical community. We
worked with medicine, science, there were enormous
legal discussions. This was a major investment.
And the reason why is that in the ethical
balance, I think Colonel Bales made it very clear;
on one hand, when we do ask people to give their
lives for their country, we have a unique
obligation, and that is to be exhaustive in making
sure that if we're going to do something, at least
it's been looked as critically as possible, and
that we did.
There's no question from the medical and
scientific point of view, essentially all the
testimony is, particularly for anthrax and
pyridostigmine, given the probability of that
threat, we did the correct medical and scientific
thing. Legally, that's been clearly tested.
As a matter of fact, Dr. Hannas, who wrote the
article with Dr. Bales, testified, and others, as
you recollect, sued us. And we went all the way
to the Circuit Court.
And the conclusion of the courts were very,
very clear. Number one, FDA, DOD had followed the
law very, very clearly. And, furthermore, that
this was question of treatment.
And the research, the experimental drugs and
the Nuremberg doctors stuff, I think, is more
rhetorical than it is factual. So, from a
medical, scientific and legal point of view, it's
very clear.
I would submit, particularly to you, Dr.
Caplan, that the ethical question about it being
clear will only be clear when there's one emphasis
left.
I mean, there's not, there's not been a just
war since St. Augustine. And there's never been
a consensus in the ethics community about anything
to my knowledge, but we aggressively pursue that
issue.
I think, and very important, and I liked Dr.
Bales testimony very much, I think that we need to
be very worried about what we do. And I think
that we need to be very concerned about waivers of
informed consent. And I, personally, agree that
we should avoid waivers of informed consent. And
I think what we should do is get these
specifically approved for very specific purposes.
I do not think there's any conceivable chance
that within the future we think our troops are
going to go in against people that are going to
use organophosphates, that we are not going to use
pyridostigmine and the other, and the reason why
is that this is an extraordinarily lethal agent
and we're going to do everything we can to protect
our people. It just doesn't make sense to jump
through these hoops.
Then, I'd like to move quickly to some lessons
learned. Number one, you've had ample testimony
here, but it's been replete throughout the whole
process of looking at the Persian Gulf, the whole
issue about the information dissemination and what
people were told and what people were trained, I
think, is doctrinally one of the weak spots in our
readiness equation.
I think there is a lot of reluctance in BW and
CW. I think there's people who think, if you
don't talk about biological warfare and chemical
warfare, someway it won't happen.
We do not do an adequate job at training our
troops, sensitizing them to these kind of
considerations. And, in fact, since the
experience in the Gulf, we've done a lot more
aggressive things to change our training manuals,
to be much more aggressive about training people.
And I still think that we're going to have
difficulty when we large numbers of very young
people trying to be trained in something that,
very basically, most of us don't want to hear
about, and including especially the military. We
just don't want to think about it.
The issue of execution, at the risk of, you
know, snatching defeat from the jaws of victory,
I mean, we did win that war.
Now, what I think General Belihar and others
very clearly pointed out, it was basically because
our troops on the ground over there did an
extraordinary job, against, I might add, not a
trivial opponent.
In retrospect, it may look trivial, but we're
talking about the individual with the third
largest standing army in the world, with more T-
72 tanks than the Russians have. I mean, this is
not a trivial opponent. Our troops did a
fantastic job. I think our medics and people did
a good job on the field.
Did we have things that went wrong?
Certainly. I think lining up people and not
allowing them to know that they got "A," which we
all know is anthrax, was clearly contrary to the
kind of instructions that went down.
I must say that not recording in the shot
records was contrary to guidance, not only from
DOD, but from General Belihar.
You had 65 hospitals and 40,000 medical
personnel, there's no question in my mind that
some of the execution did not occur, and that is
a problem that we are working on aggressively and
have paid a lot more attention to, not just in
Bosnia, but actually in Haiti and Somalia.
The whole issue of how much anthrax we have
and how much bot tox, right at one of the things
the GO report said is, that if you would immunize,
stockpile. Have enough of it so that you don't
have to face this dilemma again. The department
has done a great deal in that particular regard.
The issue of intelligence; Dr. Belihar was
right on point. I mean, who are we facing, what
kinds of things do we have to worry about?
And I think lastly, the question about the
department's attempt to try to find answers to
this. And I, you know, depending on the audience,
you know, to whom you speak, you're going to get
different kinds of reactions.
The fact is, the overwhelming bulk of people
in the medical departments in DOD, and people,
particularly trying to take care of individuals
who are sick that came back from the Gulf, are
trying very hard. They are doing, in most cases,
a very good job.
That, I've not denied some of the anecdotal
examples that came up about where clearly that,
the people got substandard care, or are getting
substandard care. That's wrong.
It is certainly not DOD policy to have
somebody with a clear set of diagnostic
considerations wait here. It is not DOD policy,
in fact we are very specific on the point about
using psychiatric diagnoses as a way to "damage
individuals".
Now, has it happened in the past? Probably.
Is it an abuse that needs to be very clearly
guarded against? Yes.
But, to close with another important statement
by the IOM's, since this a very and emotional
issue for a lot of people, the fact is that a lot
of psychiatric illnesses can, in fact, be treated,
and they can be treated very successfully.
It is unethical and unprofessional for us to
pretend that there's no such thing. By pretending
there is no such thing, then that diagnosis cannot
be made and that individual cannot be treated.
That's very different than, without understanding
scientifically what's going on, labeling somebody
in a way to avoid the work of finding out what the
real problem is.
I'll stop and allow time for questioning.
DR. CAPLAN: Thank you.
I'll start down at this end and see if we have any
questions, comments?
It falls to me.
Let me start with a question about current
readiness in terms of having information for
employments, about the health status of troops
there. Are you satisfied with the lessons learned
from the Gulf War, some of the other deployments
to places like Haiti, Somalia, have put us in a
position where people understand that fighting a
war might be us important to do with a pencil and
a check off list about who's exposed to what,
who's been where, as carrying a weapon around. I
mean, that literally.
DR. MARTIN: Am I
satisfied? No, and I don't think any preventative
medicine or public health, I mean, I'm a career
public service officer. I was Dr. Koop's Chief of
Staff for seven years, and I can say, we're never
satisfied and we shouldn't be.
And the reason why is it's very important on
the ground. The medical departments in the
military support the war fighters. They have
things about guns versus pencils. They rightfully
believe that the wars are, in fact, won with guns
and other kinds of instruments of destruction, and
I think historically they're correct.
What is very difficult to make people
understand, that the vast majority of casualties
aren't wounded or killed in action. They are non-
battle injury related, they're occupational. And
I think, as very interesting, and in Dr.
Nicolson's first slide of his very good
articulation of the fact that, you know, as we've
mastered certain things of medical science, we're
beginning to come up against some very different
views of what the natural organism is.
The fact is, our environment is very
complicated. The fact is, we idiosyncratically or
differently react to it. We have very different
reactions to different kinds of things. There is
no question in my mind that across the spectrum of
individuals we've got to worry about that a lot.
He didn't use the word, "cark", but when they
were painting all those vehicles, "cark" is a very
toxic substance. Our soldiers are exposed to that
kind of stuff a lot. Whether you're on a ship or
you're a Marine or you're in the Army. I think
that we're continuing to push very hard.
Now, the two big changes that have occurred,
and General Belihar and I have had long
discussions about this, is that after the Gulf War
two things happened. First of all, before the
Gulf War the Assistant Secretary of Defense,
Health Affairs, had no clear responsibility for
policy oversight of readiness at all. That is
very different now.
Dr. Joseph, who you know, is explicitly held
accountable by the Secretary when the Joint Staff
are worrying about this. Needless to say, you
know, Steve Joseph, he is aggressively pursued
making sure that a very different policy has been
developed.
Within the first 800 people on the ground in
Bosnia were a prevent medicine team, a stress
management team. Every troop that went into
Bosnia received a pamphlet talking about the risks
of, written, presumably intelligibly, at three
different levels: command, medical, and for the
troops, about what they need to be worried about.
We used that in Haiti and Somalia as well.
We are attempting now to develop some kind of
surveillance system. The problem is that we have
to fit our efforts very much into worries about
mud, environment, rats, bridges, snow, mines and
other stuff. So, we sort of got to figure out a
way to make it as important.
I don't think the medics in DOD are ever going
to be satisfied. There's a lot more that we can
do, but we have done an awful lot since Desert
Storm/Desert Shield.
DR. CAPLAN: Please shift
gears, and I'm going to ask you one other question
about procedure.
I think a lot of Americans, when they look to
this committee and they say, the President has
asked us to make sure that accountability is where
it should be, that we're doing, you know,
responsibly what we can to assure the interests of
those who serve.
When you have the situations where, we're
going to do a waiver, for whatever reason, of
informed consent, practicality, shortage, whatever
it's going to be, we're going to be facing the
situation where, whether it's for a vaccine
against ticks or whatever the current new item is
going to be, we just don't have time, or it's not
feasible; is the review process using FDA, the
procedures that were constructed to handle what
took place in the Gulf, is it public, is it
accountable enough?
And what I'm asking in particular is, when I
look at this system and see DOD appointing an IRB
to take a look, I say to myself, is that
independent enough, is that distant enough so that
we can say, no, the citizens of this country
really stood back and said, we understand what
those troops are doing there, make that sacrifice,
waive the consent, we'll do what we can to follow-
up with you. And we had a board of people beyond
the DOD who took a look and said, okay. I'm
asking about procedural accountability.
DR. MARTIN: Well, first of
all, as you're well aware, Dr. Caplan, the FDA and
the National Institutes of Health and the HHS
philosophic approach to these questions are
dramatically different than DOD's. So, I would
have to say that overwhelming bulk of the external
review was, in fact, carried out by individuals
external to DOD. An IRB was really one of our
inputs to a much more complicated process.
So, the fact is, there were duly appointed
individuals representing a very different point of
view. As you know, Dr. McCarthy is not one who is
easy on these kind of issues. He, in fact, and
Dr. Nightingale, we did consult people on the
outside.
If you're asking me specifically whether I
would recommend that the Food and Drug
Administration have an external committee, it
would ultimately end up being appointed by us or
them anyway.
I think that the question of accountability
has to do with the assurance that we've gone
through that particular process. And I think
that, in fact, could be debated before the FDA
comes to a final decision.
Our solution that we are pushing very hard on,
and actually came up with the committee staff, and
Dr. Belihar touched on it, I think the way to
solve this, for pyridostigmine especially, is to
get proof for the purpose that it's intended, the
same as bot tox.
It was not mentioned, but what IND also means
is that an NDA is granted for commercial
distribution of a drug. If the manufacturer has
no interest in commercially doing it, they don't
invest the money to get an NDA. And that's one of
our problems right now. And we're trying to work
through that.
I think the real thing we've got to do is find
a way, particularly for those items, to not have
to waive informed consent.
I'm going to defer to FDA on the question of
who ought to be appointed to which group to
ultimately, and our national command authority, we
have a very short chain of command. It goes from
the President, to the Secretary of Defense, to
that CINC.
And right now, I mn if the decision were made
that we would do something like this, it would end
up being the Secretary of Defense and the
President of the United States. That's pretty
dramatically accountable in regards to at least
the public, I would think, after all these other
people go in.
DR. CAPLAN: All right,
thank you.
What I think I would like to do, in the
interests of some higher value, let's have a ten
minute break. I was going to say five, but
there's never been a five minute break that I know
of. And since I've listened to problems of
communication all day long, I'll say ten minutes.
But, that means ten minutes, so we'll take the ten
minute break. Please be back here right away and
then we'll hear from Dr. Howe and Professor Charo.
(Break.)
DR. CAPLAN: Let me ask
everybody to get ready to proceed here and to step
forward to the table. We're going to have in the
next session two presentations. The first by Dr.
Edmund G. Howe, who's a Professor of Psychiatry
and director of the Program in Medical Ethics at
the Uniformed Services University of the Health
Sciences. It's good to see you.
And we'll ask Randy if he will talk to us
first on the ethical considerations in waiving
informed consent, and then we'll follow that with
a presentation by Professor Alta Charo from the
University of Wisconsin School of Law.
Randy.
DR. HOWE: Okay. Let me
make sure I've get everybody out in the audience
sitting down or headed to the hall if you want to
keep jabbing.
This particular group is about responsive to
me as anyone else has been. (laughter)
Mr. Chairman and
distinguished members of the committee, I
appreciate the opportunity to discuss with you
today exceedingly difficult ethical questions
which arose in the Persian Gulf.
Much of what I have to say, because it refers
to ethical issues, has already been alluded to in
previous comments. And in that sense, some of it
is something of a summary of sorts, but I think,
nonetheless, if you put it together as a package
and present it with the rest, if you would like my
complete comments.
When the DOD first appreciated that Iraq,
anticipated that Iraq might use chemical and
biological warfare, the DOD was aware of the
profound dilemmas this situation posed, as has
been stated.
Consequently, the DOD immediately sought
consultation from other governmental agencies,
which included civilians outside the DOD, as has
also been stated.
One of the parties I would emphasize was the
Office for the Protection from Research Risks.
And the OPRR is responsible, as many of you know,
for monitoring and protecting the health and
welfare of humans and animals when they are used
as research subjects in behavioral and biomedical
research.
Guidance from the OPRR was particularly
valuable in terms of understanding the issues
pertaining to research. That's been discussed
before.
The OPRR pursued extensive discussion with
civilian ethicists outside the DOD in providing
input. The question, that was raised during the
last session. In the process, ethical issues
consisting of many hours of discussion with
multiple meetings by the DOD, with the OPRR, and
other experts. And I was fortunate enough to be
one of the civilians asked to participate in this
process.
The ethical issues posed were of enormous
significance, obviously, because they had to do
with, as Dr. Martin said, literally the
possibility of tens of thousands of person's lives
being at stake, in additional to autonomy.
It was known that the agents of, that were
being considered could help protect servicepersons
from the harmful effects of these weapons if Iraq
chose to use them.
Yet, as has been stated, they'd not been fully
tested for this purpose, no could they be. It
would, in fact, as has been stated, be unethical
to subject humans to the effects of chemical and
biological weapons to determine the extent to
which the vaccine and other agents would be
effective.
Thus, two questions arose which were
unprecedented. Should these agents be used at
all? And if they should be, should servicepersons
be given the opportunity to withhold consent?
The ethical justification for going ahead
without getting serviceperson's consent goes as
follows; for the sake of this discussion, it must
be assumed, I think, that the war was both
necessary and just in spite of the differences
that ethicists and others might have on that, as
Dr. Martin referred to in his story of St.
Augustine.
If this is assumed to be true, servicepersons
had unique obligations during the war, both to
their country and to other servicepersons with
whom they risked their lives during combat. That
is, servicepersons agree to sacrifice their lives
if necessary to further the military's mission or
to benefit the servicepersons serving with them.
They understand that they may have to
sacrifice, in addition, any number of personal
interest during combat when necessary. And they
know this when they enter the military. This
shift from the usual ethical priorities adopted by
civilians during peacetime is exemplified, this
may be familiar to all or most of you, the
principle of military medical triage.
That is, normally, during emergency situations
medical care providers give highest priority to
saving the lives of those patients who are worst
off. During combat, military physicians are
expected under extremely rare circumstances to do
the opposite, and this rarely occurs, but it has.
Namely, so that could shift priorities and treat
servicepersons who are better off and can return
to battle if and when this seems necessary to
further the likelihood of success of the
military's mission or to protect large numbers of
troops.
In actuality, this rarely occurs. But, in
principal, and it's the principal here that's
important, this shift is radical. It is this same
kind of shift in regard to the use of protective
agents which was necessitated by the threat of
Iraq's using chemical and biological warfare
against our troops.
Now, what is the underlying ethical
justification for this radical shift in
priorities?
Namely, unless the customary values are
sacrificed, far greater wrongs can occur. These
may include one country taking over another, such
as Kuwait, harming its people, genocide, as
previous wars have shown us. And even, of course,
ultimately the destruction of our own nation and
its people.
The different priorities in the military
during combat, accordingly, are not the
military's, but they're established by and
represent the country and the population whose
interests it serves.
Serviceperson's priorities differ, then, from
civilian's in that their individual interests are
subordinated to those of their mission and their
unit. Thus, although it would be in the
serviceperson's individual best interests to not
fight when they are ill, as from malaria,
commanders may send them to the front, regardless
of their illness, if necessary to benefit the
mission or other servicepersons.
Likewise, if an individual serviceperson does
not want to carry a canteen or wear a flak jacket
or be vaccinated against a disease, a commander
could not permit this serviceperson to exercise
autonomy in this manner, since this would
unnecessarily endanger the serviceperson and,
consequently then, the mission of the other
servicepersons in the unit.
Servicepersons are aware, then, that as they
approach actual fighting, their autonomy actually
may be, dramatically may decrease. They
understand that their commander may order them to
enter life threatening situations under enemy fire
and make other such decisions. This may include
their commanders requiring them to make use of
protective devices during combat.
When servicepersons join the military, they
agree to subordinate their autonomy when necessary
for the mission or the unit. And, most
significantly, the promise is reciprocated by the
military, as it's been stated this afternoon
earlier, that is; the military in turn, promises
all servicepersons that it will protect their
lives during combat to the maximal degree that
this is possible, contingent, of course, on the
needs of the mission.
Ethically, there are four arguments that
protective, the servicepersons could be given the
protective agents without having the opportunity
to refuse to consent.
First, this is necessary to maximize the
likelihood that the US military effort will
succeed. If, of course, US troops were decimated
after Iraqi's chemical or biological weapons,
hardly imaginable harms would've occurred.
Second, this may be necessary to protect
inordinate numbers of serviceperson's lives which
would be lost if Iraq used these weapons.
Third, and this is a, more of an ethicist
argument, I take it, but ethicists put importance
on promises, and it would be necessary for all
servicepersons to fulfill the implicit promise
they make to each other, that they will sacrifice
their lives if necessary for the mission for each
other's benefits. And the way this is referred to
is cohesion.
In this case, of course, the sacrifice
required to save the mission for other
serviceperson is not their lives, but their
autonomy to refuse to consent to taking these
protective agents.
And, fourth, this is necessary for the
military to fulfill its promise to all
servicepersons to do everything possible to
protect their lives.
What, then, are the opposing arguments for
requiring informed consent?
Well, first, it could be argued that all
protective agents which have not been fully tested
shouldn't be given at all. Whether, of course,
this argument should succeed, most would reach the
point, even in, well, ethicists might disagree,
should depend on whether an agents most likely to
save large numbers of serviceperson's lives if
Iraq used chemical or biological weapons, but do
little harm if they do not.
As stated, when the need for protective agents
initially became, was anticipated, medical experts
in the DOD and FDA reviewed the available data on
the effects of these agents on humans in other
contexts, and on animals, as has been stated. And
on the basis of this review, they determined that
the probable benefits were overwhelming and the
expected adverse risks, minimal.
If this has not been the case, or if the
benefit/risk ratio had even been slight,
significantly closer to marginal, the
justification for using these agents would, of
course, been more problematic, and there may not
have been justification at all.
Second, it can be argued that even if these
agents should be available, servicepersons should
be able to refuse to take them.
If servicepersons could refuse consent, this
would respect their autonomy. But several
important values would be violated. Basically, if
servicepersons could have refused, there would
have been two options available; servicepersons
who refused consent could have been excused from
combat altogether, or they could have remained in
combat without protection offered by these agents.
If servicepersons, and I want to consider each
of these very briefly, if servicepersons had been
excused from combat, this could have resulted in
US troops being significantly depleted.
We've heard today that that might have been in
the thousands. This could jeopardize the success
of the mission and increase the danger to the
servicepersons who remained in combat.
Further, if consenting servicepersons remained
in combat, this would violate the ethical
principal of justice or equity, that is, those who
took the agents would still be at risk of being
killed during combat by normal weaponry. Those
who did not take the agents would not.
If, on the other hand, the servicepersons who
refused consent remained in combat without these
protections, as is what occurred, and if Iraq had
used chemical or biological weapons, the
servicepersons without protection would have been
much more vulnerable to illness and death.
Again, as a result of the depletion in their
numbers, the success of their mission could have
been threatened and servicepersons taking
protective agents more greatly endangered. They
would be additionally endangered if they attempted
to help those servicepersons who had become ill
due to the chemical or biological weaponry.
Fortunately, as we know now, the degree to
which these agents would protect servicepersons
from the effects was never tested. Yet, as has
been stated, investigations suggested that Iraq
had the weaponry ready for use, and it may have
been only, for whatever reason that Iraq chose not
to use them. If they had used them, this question
remains; what would have happened?
The grim outcome which can be imagined
supports, I believe, the wisdom of the ethical
judgements actually made. It suggests, as well,
and these last comments are particularly important
to me; suggests, as well, several new needs, such
as to insure that servicepersons are protected as
much as possible in the future, and to establish
a means by which other countries' forces, Allied
Forces have been referred to, but also, what
hasn't been mentioned today, captured enemy
servicepersons and civilians, such as the
civilians who were in Kuwait, can be protected as
well.
These initiatives may go beyond the scope of
this discussion, but, hopefully, will be among the
ethically important outgrowths of this meeting.
DR. CAPLAN: Thank you.
Let's open the floor here for question, comment.
MS. GWIN: You just said
that you think hindsight supports the ethical
judgements actually made. How do you distinguish
now between the judgements made by headquarters,
that it was okay to waive informed consent, in
this case for a bot tox, and the judgement made
actually in the field, that you didn't need to,
and that given the shortages of the supply, it
was inappropriate to?
DR. HOWE: I think it's an
excellent question.
The judgements made initially were based on
the notion that there would be adequate supplies.
And there were certain premises that, or at least
the discussions that I was aware of weren't
saying, okay, what if we only have a one hundredth
of what we need, and so on and what happens there?
The judgements in the field, I take it, have
to be made with a number of exigencies, which are
real there. They included information, perhaps,
that they had in terms of what Iraq was going to
do or wasn't going to do, and that shifted and
there were judgements in terms of how much vaccine
there was, and then how many doses were needed.
And I think it would be very hard for someone
to second-guess those decisions that were made in
the field. The job of the people there is to make
their judgement as best they can.
One certainly could flesh out, and I would
think that indeed, this is not only something that
should be done, but that I am personally
interested in doing, is spelling out what the
different criteria are, which might warrant, if
any, judgements being made differently on the
field than those being made initially when all the
information is there.
Generally, the burden is on anyone making the
case that the judgements that these drugs and
agents should be given without consent, if that's
the judgement made after, and it has gone through
the courts and all that, that should be followed
through with the wisdom of that. The burden would
be on one making the case that because of the
exigencies, that justification is going in a
different direction.
It makes sense to me ethically that under some
circumstances, that burden might be met. In this
instance, as we've heard, it was the judgement of
the people in the field, whether that was the
right judgement or not, I take it there would be
different views on. It's certainly reasonable
that a different set of judgements might be made
in that instance, but that's a different analysis.
DR. CAPLAN: I have a
question for you, Randy.
Do you think, or what is your opinion, of the
circumstance in which a waiver of informed consent
is undertaken, is there an obligation to make sure
that if we say we're going to notify people, that
that be monitored, and that if that doesn't happen
after a week, two weeks, three weeks, a month, two
months, steps be taken to make sure that the
notification improves. And then what is the duty
generated to those who undergo the waiver by those
who ask it of them, to follow up and see what side
effects or problems they may have encountered from
exposure to the agent? Is there a very high fence
raised?
We've heard problems of notification, what
people were told, they persisted over time.
Should people have gotten on top of that? Were
they bound in a very strong way, and similarly, to
follow-up as best they could. I don't care if you
don't want to guard these records, you've go to.
That's what the price is of doing what we did.
What's your feeling about that?
DR. HOWE: Actually, I'm
surprised, it's a fairly easy question, to which
the answer is, yes, and, yes, I think very
clearly. The obligation of notification is a very
strong one after the sacrifice required, as is the
obligation to find out what I thought was a very
important question, what is, in fact, the effect
on the people who did take these protective agents
without consent. That's what I stated.
DR. CAPLAN: And less easy-
-
DR. HOWE: Uh huh.
DR. CAPLAN: --if there are
no penalties and no enforcement in this area, then
one might get the opinion later in a future
deployment that, well, these are conditions of
war, the waivers go through, we can let things
slide three months, four months, five months, we
won't have to worry whether the shot records are
being kept and notification, because they didn't
worry the last time, they're not going to worry
this time.
Do you have any opinion about the ways in
which this committee could make sure, or ought to
recommend that this obligation be taken seriously,
including by sanction? That is to say, you will
not be allowed to have waivers ever again if you
do not.
I mean, right now it looks like it's a fairly,
we failed, we didn't implement, we didn't follow
through, but, so what? If I was in the field next
time maybe I'd say, I'll take my chances here,
they're not going to come after me next time,
either.
DR. HOWE: The obvious
answer to that, I think, is as we enforce anything
else in our society, is the law. That is to say,
if one wanted to have certain requirements, this
will be done. And if the law were violated it
would force the repercussions.
The overriding value for both your earlier
question and this one is, that I think you want to
find ways to continue to offer protection for the
servicepersons, whatever is required, even if
there are other glitches in the system, and the
question is, how do you do that?
DR. CAPLAN: Last question.
I know you've invoked the names of many ethical
authorities, outside experts, and so on. This
committee has to struggle with the question
whether the procedure that is in place in making
these kinds of decisions is open enough.
Some would say there's a great gap between the
FDA and the DOD or other government agencies.
Other people look at it from, perhaps, outside the
beltway saying, they're all the same brush, they
carry around different alphabet names.
Independent enough or not?
DR. HOWE: That's a good
question. As I expect you know, I'm personally
advised in terms of having the procedure as above
board as can possibly be.
It would follow from that, you want to have as
representative a group of persons of different
specialties and emphasis as would be possible.
Whether the current policies would do that or not
is a factual call and a judgement call.
I'm not sure I have enough information about
that to be able to make that, but in spirit and
principal, the burden would be on the person
making the case, that, what is in now is
sufficient.
DR. CAPLAN: Well, I guess
people are tired of listening to me. Thank you.
We'll move on to Professor Alta Charo, who is
in the Program of Medical Ethics at the University
of Wisconsin at the School of Law.
Welcome.
MS. CHARO: Good afternoon.
Mr. Caplan, members of the committee, thank
you very much for the opportunity to speak with
you.
And, first some apologies, if any of my
comments are redundant, air traffic control seemed
determined to keep me in Wisconsin rather than
here listening to the prior speakers.
I'd like to take the opportunity today to
offer a very brief analysis of the policy that now
stands and to suggest some reforms that I think,
without unduly impairing military objectives,
would reduce some of the apparent deviations from
civilian norms for research and for innovative
therapy.
I am not going to, to your relief I'm sure,
repeat everything in that very lengthy document
that was sent to you by fax, but simply highlight
some of the arguments that are presented.
As a background matter, I think it's important
to keep in mind that, generally, both law and
ethics require much more caution in the area of
research than in the area of treatment,
specifically because of concerns about the intent
with which the professional approaches a
patient/subject, and the degree of which that
professional is primarily concerned with the
patient's or subject's best interests.
And, therefore, as you all know, the DOD's
choice to use investigational vaccines and other
compounds would be governed by different legal,
and to some extent, the ethical regimes depending
on whether or not you view it as research or as
therapy.
I suspect that you've had a discussion about
whether it's research or therapy and so I do not
want to go over that ground again, except to make
a few background points.
First, about the disparate legal and ethical
treatment of research and therapy, it is
especially important in the case of study
populations that we consider to be special
populations or particularly vulnerable.
Vulnerable is often meant to include things like
incompetents, such as children, they don't
understand. But it also means people who have a
restricted freedom of choice, which is why
prisoners are considered to be a special
population. Their status strips them of many
ordinary liberties and civil rights.
I believe that it is appropriate to consider
military personnel to be a special population with
regard to endeavors that look at all like
research, as well as special populations in
general in regard to medical treatment.
First, they do have the same kind of
restricted freedom of choice. Second, like
prisoners, many of their civil liberties and
remedies have also been stripped. I talk not only
about their inability to refuse an order, but I
talk, and this addresses to some extent Professor
Caplan's question to Dr. Howe, they have been
stripped of the ordinary avenues of redress that
exists for other civilians who have been treated
or experimented upon.
The government is immune from liability for
injuries inflicted on members of the service if an
injury is an incident to service. And an incident
to service has been interpreted extremely broadly,
so that even deliberate, secret, manipulative, and
obviously intentionally abusive techniques, such
as the secret giving of LSD to an unsuspecting
member of the service, have been ruled to be
immune from liability suits when soldiers have
consequently complained about this treatment at
the hands of their commanding officers and their
national government.
In other words, the very mechanism of law
built in to deter abuses and that can be used by
civilians in both a therapeutic and research
context, are denied to members or service.
Therefore, they not only have an inability to
refuse, they also lack an ability to get redress
after the fact. For this reason, I think there's
a strong argument to consider members of the
service a special population.
I also think that it creates an argument for
having the most stringent levels of protection in
a research, or research-like context, for members
of the military.
At the same time, however, these ethical
considerations are challenged by the demands, as
Dr. Howe mentioned, of military readiness and
discipline. And we all know that DOD, since 1972,
with the first insertion of this language in it's
appropriations bill, has struck a balance between
these concerns by requiring informed consent for
experimental treatment, but not for therapeutic
treatment of members of the service.
I think that it is true, I think that it's
appropriate that the Federal Courts found that in
the specific context of the Persian Gulf
situation, the actions did not meet definitions of
research or clinical investigation as they appear
in the law or in the Army regulations, nor can
they meet the definition of research as it was
used in the Belmont Report, which was the
underlying document that animated all of these
changes in the '70s.
I do think, however, it is important to note
that what did happen is something that happens all
the time in civilian therapy and in research, and
that is, we had a situation of what I will call
innovative therapy. That is something in which
the primary intent is, indeed, to be helpful to
the individual in front of you, to protect him or
her from nerve gas or from biological warfare
agents, but that there is a secondary motivation,
that is investigational. And that's to the extent
that's consistent with taking care of this
individual, one will try to learn from the
experience.
I think that's perfectly admirable. But, when
you're using an investigational drug, it also
makes what you were doing something that is
innovative. And innovative therapy is going to be
inherently less predictable than non-innovative
therapy using better documented, longer used
techniques or substances. And it's this intrinsic
unpredictability that argues for some effort at a
heightened level of concern for the individual's
privilege of understanding what's happening to him
or her and to exercise consent.
Now, despite this kind of argument, we know
that because innovative therapy will be treated as
therapy, DOD doesn't need consent at all.
However, I would urge the committee to consider
urging DOD to reexamine its policies with regard
to innovative therapy because reintroducing the
concept of information and consent would not
necessarily be inconsistent with military concerns
since emergencies have always provided an
exception for the requirement of both information
and consent.
While emergency has usually been interpreted
to mean that the person in front of you is going
to suffer a terrible injury because you do not
proceed, the person lying in the street who
obviously needs cardiac care.
This kind of thinking has also justified
public health measures in which, for the urgent
need to protect third parties, we have forcibly
detained people, or even treated people or, we
usually notify them, for their various infectious
disease and other kinds of threats. Mental
illness, in which they are a danger to others is
another example.
So that treating innovative therapy in a way
that's more consistent with the civilian norms of
informed consent would not necessarily prevent the
military from adopting a policy in which it could
waive that when there was a strong need.
However, given that we are operating in a
context in which this innovative therapy is
considered to be therapy and, therefore, not in
need of any kind of informed consent, the only
constraint upon the DOD at the time that these
events were taking place had to do with the FDA
regulations pursuant to the Food, Drug and
Cosmetic Act.
I understand Dr. Nightingale was here earlier.
I'm going to presume you're all quite familiar
with that regulation.
Again, however, I'd like to highlight two
phrases that will lead into some specific
suggestion that, for your consideration for reform
of this policy.
Now, FDA, when it was implementing the, its
enabling language in the statute, was given two
possible areas in which it could interpret need to
waive the informed consent requirement for
therapeutic use of what is still an unapproved
drug. The first was that it was not feasible to
obtain informed consent. The second was that it
was contrary to the best interests of the patient.
It's important to note that they did not
actually implement that second invitation to a set
of exceptions for the requirement for informed
consent. And I'm going to return to that in a
moment.
With regard to the not feasible language, we
see a lot of people talk about how, up until now
that has always been interpreted to mean, somehow,
that the subject is unable to communicate.
We know that this policy adopts a somewhat
different concept of not feasible, which
incorporates an idea of not, only not practically
possible, but also not wise. That's what's
invited in the concept of, we need it, there's no
alternative, it would be dangerous if we didn't do
it. And that interpretation, although it was
upheld by the Federal Courts, have not been given
any reasonableness.
It's also important to keep in mind that when
the Federal Courts in the Doe v. Sullivan decision
ruled in favor of the Federal Government against
the challenges, it was ruling based upon
consideration of separation of powers. That is,
under administrative law, if an agency is
interpreting its own enabling language in a way
that is not obviously capricious and irrational,
the courts will uphold the agency's
interpretation.
The court does not make a substantive
judgement that the interpretation the agency put
on, were it not feasible, is reasonable, wise or
something that should stay in place for a long
time. So, we should not overplay the importance
of those decisions and have that prevent our
freedom to critique the reasonableness of the
interpretation of not feasible.
I find two problems with it. First, it
combines elements of both emergency and, what has
not been mentioned up until now, so-called
therapeutic privilege doctrines, that have been
used to create exceptions to informed consent
requirements in both therapeutic and
investigational studies.
Now, the emergency exception, as I mentioned
before, is most often aimed at situations in which
it truly is in the interests of the individual
patient or subject in front of you to, I'm getting
close to the end, aren't I, to waive the consent.
And here, it clearly is being used in the more
public health sense of the word where the urgency
has to do with third parties.
In additional, there is an implication of a
therapeutic privilege, that is the privilege to
waive consent when, in your judgement, offering
information and asking for consent is actually
detrimental to the interests of the patients.
That refers to the language about where
withholding the treatment would actually be
contrary to the interests of the service member.
Second, therapeutic privilege has a long and
very contested history because it so easily can be
turned into something that is a loophole as well
as everything, it's really defined for the rare
situations where conveying information actually
can upset somebody so much it can trigger
something like a cardiac arrest.
In fact, the FDA in 1981 in the introduction
to its original interpretation of enabling statute
and the origin of the regulations in front of you,
specifically rejected therapeutic privilege. It
specifically rejected the invitation to write an
exception for informed consent into the
regulations when consent would appear to be
contrary to the patient's interest because of
their concern about the size of this loophole and
the degree to which it is used inappropriately.
And, I've reintroduced some of that material
at some length in the testimony that was sent to
you by fax. It's worth emphasizing that when FDA
specifically rejected this kind of thinking it was
not discussing research ethics, it was discussing
the ethics of therapeutic or treatment use of
investigational drugs.
When you combine the two, you get a further
problem, which is that if this therapeutic
privilege is now being invoked, not only in a kind
of parentalistic manner for the best interests to
service member himself or herself, but it imports
into that self-interest in the service member the
idea that it in the interest of the troop. In
other words, I am saying it is in your best
interests for you to sacrifice for other people.
That may be the case, but that kind of
judgement should be made openly and not implicitly
by virtue of the language that is adopted.
Overall then, it would appear that there's an
argument for rethinking the justifications for
the general military practice of not having
notification and consent as an ordinary part of
medical practice, particularly in the area of
innovative therapy, with appropriate exceptions
for emergencies, to make sure that this does not
become a problem in those situations.
Absent that, a more straight-forward means of
implementing the FDA waiver for military use would
be to explicitly repudiate the 1981 language that
the FDA used when it first set up these
regulations and implement the therapeutic
privilege exception that it is limited to military
situations and that openly acknowledges the
incorporation of third party interests into the
notion of patient interests to be protected.
If neither of these two approaches are
adopted, and I understand exactly how unlikely
that would be, I would like to suggest a few
narrow revisions for the existing policy, some of
which build upon revisions that were suggested by
Professor Caplan himself a year and a half ago or
so, I suppose when he testified before the Senate
Committee.
First, I think it's important that we break
down the phrase, informed consent, into its two
component parts of informed and consent. As
Professor Caplan himself suggested, even where
consent is not going to be obtained, a second
argument has to be made why information cannot be
conveyed.
The value of giving people appropriate notice
is both to acknowledge the degree of which they
still do have individual dignity and have not
handed over everything to their commanding
officers, they've merely temporarily rented their
autonomy to their commanding officers.
But, in addition, for very practical reasons
I think it would help members of the service to
look at their own condition, to check for contra-
indications, to check for side effects, et cetera.
I think, also, that we need very much to focus
on the need for notice of DOD's request for a
waiver of informed consent, as well as FDA's
granted waiver of informed consent, so that
members of the service who might be affected would
have a chance to challenge these before they're
confronted with an urgent situation in an eminent
combat or combat situation.
Not only is it better to resolve these
conflict early, I think that it is important to
acknowledge the psychological benefit of not
feeling completely powerless.
This is especially important, I think, in this
area where in innovative therapy with mixed
position motivations, there is room for suspicion
that one is not getting the best possible
individualized care.
In light of our history of medical abuses,
both by the military and civilian research
communities, these suspicions are understandable
and I would say even reasonable, even when a
particular situation does not warrant them.
Finally, I think that it is important to have
the most impeccable possible procedures for
reviewing the requests and the granting of these
waivers in order to attract that same degree of
suspicion about the quality of one's care. And
for that reason I'd further suggest the
institutional review board that originally reviews
the protocol that will then be sent forward to FDA
be independent of the Department of Defense. And,
I would suggest, independent of the FDA as well.
I understand that the FDA and various other
health, HHS agency personnel, were considered to
be the impartial backup to the DOD committees, but
again, in answer to your inquiry, I think that
reports in the press, I documented one of these
about the degree of pressure that FDA was under to
collaborate with the DOD in handling this problem
rapidly, combined with the reality of Washington,
in which there really is a lot of effort to
cooperate despite appearances these days, and the
simple question of appearances in the face of
suspicion, and whether or not they are warranted
today or premised on a long history of abuse, all
militate in favor of a truly independent IRB that
will look at these kind of waivers.
These suggestions might seem unduly intrusive,
by they're addressed to an aspect of national
security just as important as military
preparedness, and that is the trust of citizens
and soldiers in the integrity of their government
and their commanding officers and their
willingness to cooperate as a result of those
things. Military leaders are often quoted as
saying that the troops deserve the best. And in
medicine, respect can turn really competent care
into the best possible care.
Thank you.
DR. CAPLAN: Thank you.
I'll open the floor, again, for questions,
comments.
I have one question for
you, Alta. As you think about this notion of
independence and trying procedurally to make sure
that groups not connected either by, in the spirit
or at least even in terms of bureaucratic or
governmental cooperation reviewed this, I think it
was Dr. Martin who said, look, in the end we're
going to have to appoint them anyway, so how
independent can we be?
Do you have thoughts in terms of, again,
procedures, openness? This should be a group that
gets appointed where and has public open meetings,
taking the many questions and comments that this
panel does in it's public, I hope that was a joke
for those of you who are still here.
MS. CHARO: Okay. Within
the government, if one were working only within
the government for the moment, one could take
advantage of the existing standing committees that
have been appointed with reference to other
concerns, political or otherwise, because,
presumably, they could not have been appointed
with reference to the particular situation at
hand.
NIH, for example, has its own IRB's to review
intramurally funded research. And that kind of
standing committee process could help. At least
having members of that kind of committee appoint
a committee would take it a level down without
making it too complex.
I appreciate the fact that there's no way to
complete insulate, but to the degree that you can
isolate why people are being appointed from the
events that they're reviewing, you reduce the
conflict of interest.
With regards to the questions about openness,
I think you're flying upon very complicated
ground, because typically a great deal of data is
being discussed that is proprietary in one fashion
or another. And, so, typically, these meetings
are not open to the public.
I know this is true in the university context.
And that may run into some problems with the open
meeting laws that are relevant to this area. I
haven't looked at the regulatory language that
recently. I can't answer that.
I do believe it's possible to handle that by
having executive sessions where the proprietary
data is actually looked at followed by open
discussions based upon a kind of understanding
that, having looked at the data, it's either,
good, bad, indifferent, et cetera. That might
address some of these problems.
DR. CAPLAN: Thank you.
Thank your for making it here in spite of all
those obstacles.
At this point I'm going to thank both the
panelists for their presentations and we're going
to have one final discussion of the panel and
staff.
I'm going to ask Joan Porter if she will move
up to the lectern, or table if she chooses, and
we'll have a bit of discussion about possible
findings and recommendations based upon some of
the things we've heard today, some of the things
we've read, some minute statements and so forth.
And maybe, Joan, if you would, you might lead
us or get us going in that area in terms of
focusing our discussion, just for the rest of
today.
DISCUSSION AND RECOMMENDATIONS
MS. PORTER: I'll try to do
that.
We've heard considerable testimony today, and
at previous public meetings, concerning the issue
of decision making processes for use of
investigational agents in military exigency
situations without informed consent. And I think
the best we can say is that, I believe that there
is no clear-cut consensus on all of the facets of
what should have been done during the Gulf War,
and what we should do if we were faced with a
similar situation in the future.
But, there does appear to be some synthesis of
findings and possible recommendations that the
advisory committee can at least begin to consider
in this arena. And I would like to try to lay out
some possible findings and possible
recommendations for the advisory committee to
consider in this area that have been identified
during the course of our deliberations. And that
will, hopefully, work to balance the rights and
welfare of service personnel and make sure that
the rules are followed legally and ethically.
First of all, let me suggest some findings
that might come out of our deliberations.
The Food and Drug Administration and the
Department of Defense undertook an urgent but
orderly and not unreasonable course of action
under the circumstances to devise a means to
address the real threat of chemical and biological
warfare in the Gulf War. This course of action
ultimately withstood legal challenge.
Second, despite the continuing threat of
chemical and biological warfare, little progress
has been made in the past five years to address
public comment on the interim final rule, or to
address shortcomings identified in practice,
particularly with regard to communications and
understanding.
Third, records were not adequately kept on who
received anthrax and the botulinum toxoid vaccines
and PB in Gulf War theater. There appears now to
be little possibility of developing reliable data
about which or how many persons received anthrax
vaccine and investigational agents.
Next, the Department of Defense and the
Veterans Administration admit to problems with
missing or lost medical records, but neither
system appears to place a priority on correcting
these problems.
Those are some of the findings that I think we
have gleaned from today's deliberations and those
in the past. Shall I move on to some possible--
DR. CAPLAN: Let's stop
here and see--
MS. PORTER: --
recommendations, or would you like to proceed.
DR. CAPLAN: Let's just
stop here a second and see--
MS. PORTER: All right.
DR. CAPLAN: --if any of my
fellow panelists want to just comment on those
suggested statements or even staff, it would be
fine to offer comments since we're still, I
suspect, mulling over and absorbing some of the
things we heard today. Just for a second there.
One thing that occurred to me is that I'd like
to see some specific language maybe altered in
there to try and highlight the problem of
obligation to notify and to monitor this to make
sure that it is happening, or what is involved in
a particular situation.
And I think another one of the, I'm going to
put this in generic language and maybe we can
argue someday about how to refine it further, but
it seems to me that having an assurance that as
independent input as possible is part of this
decision making in as open a way as possible, even
though it didn't come out in English, that seems
to me to be a recommendation and suggestion that
I heard from some of the people who testified that
I would like to see us stress. That, that desire
to assure the public that and independent group
has been involved, as independent as could
possibly be, and do it in an open manner about why
a waiver is going on and what the threat is that
triggers it and that area.
And the last one I heard is that we urge that
steps be taken to make sure that we avoid these
situations, that we start to take some of the
threats of chemical and biological warfare
exposures to noxious substances and technological
war seriously in that we try to move these things
through approval, whenever possible, expeditiously
and that maybe we need to have some discussions
with FDA and other agencies to allow things for
protective or prophylactic purposes in the
military to be tested and put into market, even if
they're not going to be done commercially or some
other way.
So, steps taken to expedite the testing of
possible prophylactic agents before we need to get
at the waivers of emergency situations.
MR. CASSELLS: And to
follow on that, in a sense this, for intance, this
pyridostigmine bromide, there needs, since we
cannot test that ethically by exposing individuals
to organophosphate poisoning, that we have to look
at the possibility of surrogate end points that
could stand instead of the human trials to
determine whether or not the investigational
status could be removed for these purposes.
MS. PORTER: We've launched
into specific recommendations based on these
findings. Are there any comments that center on
the findings themselves? I guess they suggest
these other courses of action.
DR. CAPLAN: I'm pondering
that for a second. I have--
MS. PORTER: We can return
to those, certainly, but I, too, was making a list
of areas that might need further attention.
DR. CAPLAN: Let me, one of
the things, I guess, I'm finding, I suspect we
haven't said it so clearly, but we did hear
testimony, it seems to have stood up and you've
got a hint of it in the first set of things that
you've summarized, but just that oftentimes record
keeping was not clear and some of the rationales
for things being kept secretish or confidential
was not adequately explained.
I mean, we heard a discussion today I thought
was very telling about some fears that people have
about things being kept secret and the explanation
on why that was so, concerning order of battle and
tactical and strategic information being given
over to the opposition. And I understand what's
going on and I think that's a finding that needs
to be made clear, so that people understand
better. It's not just a matter of some top secret
experiment being done because we have our hands on
some troops.
MS. PORTER: So, a possible
finding might be the rational for secrecy of the
vaccinations and--
DR. CAPLAN: According to
the battlefield need and protecting the security
of the order of attack. I think we got some
clarification about what's going on there today.
MS. PORTER: It seems to me
that that's part of a more generalized educational
process about the possibility of involvement in
chemical and biological warfare.
MS. KNOX: Joan, and
actually, the statements that Colonel, I mean
General Belihar provided for us, was the
notification of that, which gave the explanation.
But the problem again there was, it was not
carried out and there's no protocol to regulate it
or to evaluate it.
MS. PORTER: Are you
suggesting that the communications in the field
were such that they weren't carried out well, or
even when they were carried out, they were not
well understood?
MS. KNOX: Well, I just
find it very interesting that, you know, between
Dr. Bales and General Belihar, I mean, if we're to
have an anthrax vaccine such that we do not put
others at threat and we don't want you put at
threat, you know, why didn't he have his anthrax
vaccine?
You know, what's good for one soldier should
be good for the other. And it should be
documented so that we have something to go back
on. So, it's, nothing is consistent, and I think
that's a big problem.
MS. PORTER: I think what
we heard today, too, was that complicating some of
the decision making was the lack of sufficient
supply for vaccination of all personnel.
MS. KNOX: Right.
DR. CAPLAN: Right. Well,
my understanding about some of the decisions about
where informed consent came into play, by my
understanding of it, was actually a response to a
rationing decision, not a waiver of informed
consent, so it's a different reason to go to get
a choice.
MS. PORTER: Another
suggestion which I heard was the need for improved
disclosure, not only in conveying information at
all, but conveying information in such a way that
it could be understood under fear of war
conditions.
MR. CASSELLS: Nor were
there any indications of sanctions for failure to
carry out those policies.
MS. GWIN: Could we talk
about that for minute, then? What would be an
appropriate sanction?
DR. CAPLAN: Well, I think
of things like, well, but I mean in performance
evaluation, promotion, those areas. I don't see,
necessarily rounding people up and calling them to
the brig for paperwork violations. And I think
it's one of those things you do, where you say,
you know, how well did you complete your mission,
your assignment, and how does that reflect on your
performance, your promotion, your command
abilities and so forth. That's what I was looking
more to.
MS. KNOX: Well, or your
ability to carry out an order that you're given in
the military.
MS. GWIN: So, if the
person in the field didn't, came back and most of
the troops testified that they didn't understand
what was happening to them, that might prevent his
rise in the ranks?
DR. CAPLAN: Uh huh.
MS. GWIN: That's what we
talked about.
MS. KNOX: Well, or if
whoever was giving that explanation did not have
it documented. I mean, sometimes you can explain
something to someone and they may not understand,
but at least if you have documentation that that
person was given that information and to the best
of their knowledge, they verbalized it back to
you, then at least you have something that shows
that you tried to do that.
DR. CAPLAN: You know, I
think it's also a matter of trying to get the
command to take seriously this notion that
documentation and follow through and notification
are key elements for keeping tabs on the cost of
conflict.
I keep having this image in my mind of someone
out in the field saying, roll up your sleeve and
do this and then just forcing the decision through
without notifications. I don't think that's
important. That's not something that they have to
give top priority to if they're the person in
charge, but I think it is.
And, so, one of the ways you want to get this
into performance evaluation and promotion is to
say, no, we've got to start doing this. This is
where risks and harms lie for people.
MS. PORTER: I'm glad
you've clarified what you meant by sanctions.
When the term, sanctions, was mentioned I was
thinking more of the interaction between the Food
and Drug Administration and the Department of
Defense; that is, what role does the Food and Drug
Administration have in assuring accountability.
When they have granted the waiver of informed
consent for use of these agents in a treatment
modality, there is still some expectation that
there will be surveillance and follow up. And if
this in not forthcoming, what can be done? What
should be done to keep the pressure on to make
sure that that loop is closed.
DR. CAPLAN: All right.
Reporting back requirements, that sort of thing.
When an institutional review board today asks
for informed consent on any research trial, there
is that further requirement, weakly applied, but,
nonetheless, on paper that there be reporting back
about the course of the experiment, how things are
going at some interval. And something like that
might be appropriate to insist upon here with a
higher level of performance. We want to see
feedback from DOD back to us about how you
implemented this.
There was a plan for follow up, I might add,
as well as notification, since we are beating that
drum a bit today, too.
MS. GWIN: Do you think DOD
ought to have to report back to FDA?
DR. CAPLAN: Uh huh.
MS. PORTER: In their--
DR. CAPLAN: I'd bet FDA
would agree with that, too.
MS. PORTER: --the process
reporting?
DR. CAPLAN: Yes.
MS. PORTER: Let me try to
lay out some possible general recommendations and
then maybe we can define them.
I think if we put out all of the options on
the table we could see clearly two poles. That
is, endorsing the interim final rule as it now
stands and saying, everything's fine, leave it at
that, no more discussion.
And at the other end of the pole is rescinding
the waiver of informed consent provision in the
Food and Drug Administration regulations
altogether and come out with a position that no,
under no circumstances ever use an agent in
investigational status for treatment purposes,
even in military exigency. If it's not approved,
don't use it or use it only with informed consent.
I don't see us at either one of those poles at
the end of this afternoon. I see us coming
someplace in the middle with refining the interim
final rule as it now stands to, as we suggested,
perhaps balance the rights and welfare in view of
the experience that we've had in Gulf War.
Let me propose these draft recommendations for
your consideration and see how these might be
worked into the advisory committee process.
Given that the Food and Drug Administration's
interim rule is still in effect, DOD should worked
to develop enhanced routine orientation and
training approaches for service personnel to alert
them to the potential requirement to take agents
in investigational status, that is, agents that
are not fully approved by the Food and Drug
Administration, in the event a conflict presents
a serious threat of chemical and biological
warfare.
So, the number one recommendation is, make
people aware of the situation and some of the
considerations in chemical and biological warfare.
Two, in preparation for future conflicts, the
Food and Drug Administration and the Department of
Defense should, in a manner that incorporates
public comment: 1, determine whether the interim
final rule has continued merit and should be
reissued without interim status.
And, 2, consider whether an approval standard
that recognizes surrogate end points and other
data indicative of efficacy for agents intended
for chemical and biological warfare defense can
constitute an alternative or supplement to the
interim final rule.
DR. CAPLAN: I must have
been here all day, because I actually understood
that.
MS. PORTER: Well, in
perhaps simpler terms, that is revisit the interim
final rule to see if it needs to be refined and do
that in a public process.
And, 2, work toward an approval standard for
chemical and biological warfare antidote agents
and similar, so that they are not forever in an
investigational status. That's the basis of that
condition.
Third, the Department of Defense should assign
a high priority to dealing with the problems of
lost or missing medical records. And this
recommendation really transcends our discussions
about documentation of investigational agents and
so on, and I think we've heard this theme
reiterated again and again.
A computerized central database is important.
Specialized databases must be compatible with the
central database. Attention should be directed
toward developing a mechanism for computerizing
medical data in the field.
DR. CAPLAN: I'd only
preface that maybe slightly differently, but we
obviously come back to this by saying, I'm of the
opinion, and this is just me personally, that some
of the epidemiology that we might wish to generate
from the PB, bot, anthrax experience isn't going
to happen, we're not going to be able to go
backwards and get this.
The situation was not one of epidemiological
pristineness.
And, so, this is why we're moving in this
direction. We might, simply, have to make the
concession that we can't reconstitute correlations
of disease, illness, symptoms and problems with
exposure in this area. We'd like to see that
rectified by the recommendation you just made, but
I'd like to put the preface in, because I think
the American people are going to want to know, so
should we continue to try and push to try and
establish linkages?
And from today's testimony here, I'm skeptical
in this area. It's not that I really don't want
to know the answer, but I'm very skeptical that
we're going to be able to do the five year
retrospective to find out, so we should enhance
records taken seriously.
MR. CASSELLS: Well, that
would constitute a finding followed by the
recommendation.
DR. CAPLAN: Right, but
let's get that finding back that way, so we'll go
that way.
MS. GWIN: I'm afraid, we
don't want to encourage them to quit trying.
DR. CAPLAN: Oh, no. I
don't know, but we've talked about that
undoubtedly forever, but it just may not be there
for us to be able to, we may be giving false hope
and not honest accountability if we don't 'fess up
and say, some of the things we needed, we haven't
got, they're lost, they weren't done, they weren't
followed through on and therefore, let's not do it
again.
But I'm not sure, I'm not saying about many
other agents, we heard about mycoplasma, too, I'm
talking specifically about the anthrax, PB
experience. I'm not talking about general
epidemiology studies and about exposure to all
sorts of things.
MS. GWIN: Because we are,
we have talked previously about making a
recommendation that really reinforces our support
for this unit, locator, database, that does, in
fact, try to pull together a lot of different or
an opportunity to--
DR. CAPLAN: Right. I
think that may prove useful for exposure, although
from what we've heard about shot keeping and other
records in this particular area, I don't know.
But, my skepticism maybe have only formed by
the lateness of the hour, who knows. Maybe I'll
see it different in the morning.
MS. PORTER: Let me go back
to the second recommendation for a moment, if I
might.
As it reads now, it's that FDA and DOD should
prepare to reopen the interim finding rule with
incorporation of public comment.
I suppose that the committee could make
recommendations on what types of things might be
addressed if the rule were reopened again, and
some of those might come from the list that we
prepared earlier. But perhaps the committee would
like to leave it less specific in areas that might
need attention.
DR. CAPLAN: Well, I mean,
one area for sure that I'd be, I've pounded this
drum all day long, is that IRB be independent.
The procedural aspect of who's involved in the
decision making and the degree to which it's open,
I think those are, those are areas of input.
I don't know, myself, that I've got an opinion
about what's the right way to do it, but I think
I'd like to have comments about that. And it does
seem to me, the other area that we heard opened
for comment in terms of the rule, is that the
circumstances be clearly defined about the
narrowness of the conditions that would trigger
it.
We don't want a situation where people aren't
putting things through testing, because they know
they have this opportunity for a waiver at the end
of the line. We want to encourage adequate
testing, so we may need comment about how to
narrow the definitions to keep this very rarely
used opportunity under very strictly defined
circumstances.
But I think input there, not just on what's
treatment and research, but what's emergency, what
can be done, when is it appropriate to seek this,
aside from when someone in DOD sends a letter.
MS. PORTER: Are there
other areas for clarification that staff need to
investigate, additional fact finding in this
general arena, or do you have suggestions on how
committee staff should proceed to address the
facets of this issue or relating issues?
Well, I think this is one thing that has to
sink in a little bit, too. We've had a great deal
of information presented today and intense and
compelling and sophisticated arguments, so
obviously the panel and the full advisory
committee's going to have to think carefully about
some of the things that are developing here.
DR. CAPLAN: Well, I think
you all did a great job trying to wrap up quickly
a long day's testimony.
What I'm going to do is have us adjourn, but
I'm going to say that I'm going to stay here for
a few minutes and if there are other questions
that anyone who's managed to hold out this long
would like put into this process, I'd be happy to
listen to them.
If you're also stuck here because you can't
get out and you want to tell me some things that
you didn't care that much about, but you're
willing to because you're here anyway, that's
fine.
I want to thank all of the speakers who came
and the people who presented to us this morning.
I want to summarize, not just what we heard about
the investigational uses, but we did hear things
about schedule and accessibility. We heard many
things from our public testimony about problems in
gaining access to good quality service.
I listened carefully and took notes about some
of the problems that people have brought to us
about making sure that they weren't being
dismissed or categorized as malingering or having
certain types of psychological or psychiatric
problems when, in fact, there was not a basis for
that judgement.
And I heard as well that we have to be open to
some of the issues of mental health and stress
that sometimes can happen from service in combat
situations. So I'm grateful for listening this
morning, as well as this afternoon, and I hope
that many of you will be able to come January 31
in Washington D.C. Assuming it has dug itself
out, that will be the next meeting of the full
committee. So, thanks to the staff and thanks to
you.
One more announcement?
MS. PORTER: I don't.
DR. CAPLAN: No other
comment?
MS. PORTER: I've been long
winded today.
DR. CAPLAN: We've beaten
them to death.
Okay, thank you, Joan.
(applause)
(Proceedings closed.)
CERTIFICATE OF REPORTER
I, JERRY W. DAVIS, C.C.R., C.S.R., C.V.R.,
C.M., R.S.S.C., Official Court Reporter for
Division Four of the Seventh Judicial Circuit of
Missouri, at Liberty, Missouri, do hereby certify
that I took down the entire proceedings had in the
within entitled cause, that I am neither counsel
for, related to, nor employed by any of the
parties to this action, and, further, that I am
not a relative or employee of any attorney or
counsel employed by the parties thereto, nor
financially or otherwise interested in the outcome
of this action, and that the foregoing 266 pages
constitute a true, correct, and complete
transcript of the ordered portion of said
proceedings.
Jerry W. Davis