NOTE: UNEDITED DOCUMENT
UNITED STATES OF AMERICA
PRESIDENTIAL ADVISORY COMMITTEE
ON GULF WAR VETERANS' ILLNESSES
PUBLIC MEETING
Tuesday, December 5, 1995
VOLUME II
Wyndham Emerald Plaza 400 West Broadway Crystal Ballroom
San Diego, California
8:00 a.m.
APPEARANCES:
Advisory Panel Members:
JOYCE C. LASHOF, M.D., Committee Chair
School of Public Health
University of California, Berkeley
Berkeley, California
JOHN BALDESCHWIELER, Ph.D.
Professor of Chemistry California Institute of Technology Pasadena, California
MAJOR THOMAS P. CROSS, USMCR
Bell Industries
Meriden, Connecticut
ADMIRAL DONALD CUSTIS, M.D. (Ret.) Senior Medical Advisor
Health Policy Department
Paralyzed Veterans of America Washington, D.C.
CAPTAIN MARGUERITE KNOX, R.N.C., M.N., C.C.R.N. Clinical Assistant Professor
College of Nursing
University of South Carolina Columbia, South Carolina
ROLANDO RIOS
Attorney
San Antonio, Texas
ANDREA KIDD-TAYLOR, Dr.P.H. Health and Safety Department United Auto Workers
Detroit, Michigan
Staff Members:
Holly Gwin
Mark Brown
Lois Joellen Beck, Ph.D.
Joe Cassells
Joan Porter
Thomas McDaniels, Jr.
215
I N D E X
SPEAKERS: PAGE
Holly Gwin, Staff Member 235
Report on Chemical and Biological Weapons
Joe Cassells, Staff Member 270
Report on Medical Examinations
Stephen C. Joseph, M.D., M.P.H. 309
Assistant Secretary of Defense
for Health Affairs
Washington, D.C.
Joan Porter, Staff Member 352
Report on Ethical Issues
Tom McDaniels, Staff Member 376
Report on Outreach Issues
Holly Gwin, Staff Member 412
Report on Implementations of
Recommendations of External Reviews
216
1 P R O C E E D I N G S
2 (8:06 a.m.)
3 CHAIRPERSON LASHOF: Good morning, Lois. Where
4 did we leave off, people? I think we left off --
5 MS. NISHIMI: Finding six, I think.
6 CHAIRPERSON LASHOF: Yeah, it was finding -- which
7 tab are we on?
8 MS. NISHIMI: We're on tab B.
9 CHAIRPERSON LASHOF: Tab B in our books, and we
10 were up to a discussion on the occupational safety and
11 health issues and ready to talk about -- Well, I guess --
12 MS. NISHIMI: Finding six and the recommendations.
13 CHAIRPERSON LASHOF: We hadn't finished the
14 recommendations under epi studies, had we?
15 MS. NISHIMI: No, we hadn't.
16 CHAIRPERSON LASHOF: We're really on page eight,
17 possible recommendations for epi studies. You want to go
18 through those recommendations and then we'll proceed to the
19 finding seven.
20 Okay. Now if everybody gets themselves back into
21 the swing of it. Page eight, recommendation one, "Study
22 Coordination." We'll have a minute of silent reading.
23 DOCTOR KIDD-TAYLOR: We're at the recommendations,
24 Joyce?
25 CHAIRPERSON LASHOF: Yeah. Recommendation one
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1 deals with the "Study Coordination."
2 MS. NISHIMI: This relates to the discussion that
3 we had towards the end of the day on finding --
4 CHAIRPERSON LASHOF: Five.
5 MS. NISHIMI: Finding four which we then captured
6 another finding and kind of made finding five a
7 recommendation.
8 CHAIRPERSON LASHOF: That's what as I was
9 wondering. As I look at this, does the recommendation we
10 came up with instead of finding five essentially take -- be
11 that recommendation one here?
12 MS. NISHIMI: It might be that there are elements
13 of one that you'd like to incorporate. It would be useful
14 for the staff to then just sprawl those into the previously
15 agreed to finding.
16 CHAIRPERSON LASHOF: Yeah.
17 DOCTOR KIDD-TAYLOR: What I am understanding is
18 that we're sending finds in this report versus
19 recommendations.
20 CHAIRPERSON LASHOF: We're doing both.
21 DOCTOR KIDD-TAYLOR: Both.
22 CHAIRPERSON LASHOF: Remember, what we're going to
23 do -- the basic structure of the report will be a discussion
24 of the issue with enough background so as you understand the
25 finding, then specific findings, then recommendations based
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1 on those findings. So, at this point, we turn finding five
2 on the bottom of page seven into a recommendation. We now
3 have recommendation one which has some of that but it has
4 some different elements in it, and I think should
5 probably -- I think finding five should become
6 recommendation one and recommendation one, with some
7 modifications, should become recommendation two, because
8 recommendation one talks about deciding which studies and
9 ongoing monitoring and so on.
10 Recommendation two, which is now -- which on page
11 eight is called recommendation one, is really talking about
12 getting some uniformity but not rigid uniformity, but enough
13 uniformity that one can look across studies and know that
14 you've got data that you can utilize. And I think the
15 sentence that "A reasonable goal would be to make common
16 questions worded the same way so that the results from
17 different studies, perhaps with different populations, could
18 be meaningfully compared." I think that's the key element
19 in there. And that the Coordinating Board could facilitate
20 this rather than depending on OMB.
21 The background of this was that in San Francisco,
22 when we reviewed the studies, we had a presentation from OMB
23 and what OMB's role had been in reviewing survey
24 questionnaires before they were sent out. And OMB really
25 got into comparing surveys from different studies and trying
219
1 to get them to be more comparable, and we really think the
2 researchers ought go be doing that and not OMB. But,
3 frankly, it was a good service that OMB did the researchers,
4 I think was the feeling. Would staff agree with that
5 summary of what we heard, or want to add anything to that?
6 DOCTOR BECK: Yes. An issue that arises is the
7 extent of uniformity that's appropriate, and that's where
8 there's some differences of opinion between researchers and
9 I think the Coordinating Board, and I think OMB. That's
10 something they would have to work out. I suspect that we
11 would agree with the researchers that too much uniformity is
12 not appropriate.
13 CHAIRPERSON LASHOF: Right.
14 MR. BROWN: But I'm not sure that we'd agree with
15 the Coordinating Board that any researchers -- or any
16 coordination is a bad idea.
17 CHAIRPERSON LASHOF: Yeah.
18 MS. NISHIMI: But that's what the recommendation
19 goes to.
20 CHAIRPERSON LASHOF: And we try to walk that line,
21 so you all might take a good look at it again and see.
22 That's why I think the way that you've worded that that some
23 common questions so that they can be, but not limit and put
24 people in a straightjacket, just because the first
25 questionnaire was designed some way every other
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1 questionnaire has to look like that one. That would be
2 disastrous.
3 MS. NISHIMI: So modify it to indicate that a
4 certain level or some?
5 CHAIRPERSON LASHOF: Yeah. I think the wording
6 here catches that.
7 MS. NISHIMI: Okay. You think that's reasonable,
8 what's there now?
9 CHAIRPERSON LASHOF: Yeah, I think so. Do you --
10 Does everyone think that that's wording is okay?
11 MS. NISHIMI: Because it does say "make common
12 questions." It doesn't say, "make some common questions,"
13 which is what I heard you say.
14 CHAIRPERSON LASHOF: No. Well, that depends how
15 you read this. What I read that as, for those questions
16 that are common, let's make the wording the same.
17 MS. NISHIMI: That's what it is saying, and when
18 you -- you threw in a "some" there and so I wasn't --
19 CHAIRPERSON LASHOF: Well, I meant some questions
20 should be common questions.
21 MS. NISHIMI: And they should be worded --
22 CHAIRPERSON LASHOF: And those -- Maybe you have
23 to clarify so we don't get that confusion.
24 MR. BROWN: If it can be misunderstood it will be.
25 CHAIRPERSON LASHOF: That's right, so let's try to
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1 make it, "Some questions should be common and those
2 questions should be worded so that they are pretty much the
3 same and can be comparable, but not all questions."
4 Okay. Recommendation two was: All epidemiologic
5 studies aimed at Gulf War veterans' issues benefit from
6 outside input and ongoing interaction with appropriate
7 experts throughout the study process. External scientific
8 review should be planned in the study designs and analysis
9 procedures.
10 I agree with that but did we have a finding that
11 indicated that that wasn't happening? I mean, I thought our
12 problem was that they had external review but they weren't
13 listening to the results of the review.
14 DOCTOR BECK: It's kind of in the text but there
15 isn't a finding that the external review varied. To some
16 extent this might be the results of the Coordinating Board
17 coming in, as we'd talked about later, after a lot of
18 research had already begun. It may be that making this
19 recommendation is a little bit, not redundant but
20 unnecessary at this point. I hope it is.
21 CHAIRPERSON LASHOF: Yeah.
22 MR. BROWN: But in some cases, in some of the
23 studies, the review is a bit ad hoc and it seemed it was
24 only in response to other events that took place.
25 CHAIRPERSON LASHOF: Okay. Yeah, I guess actually
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1 in some the study was already started before the review took
2 place and then the study directors had real problems because
3 they couldn't -- they couldn't respond to the external
4 review because they had already printed the survey or
5 something. Okay.
6 MS. NISHIMI: We can highlight the area of text
7 related to it so they can feel more comfortable with its
8 finding.
9 DOCTOR KIDD-TAYLOR: May I ask a question about
10 this first?
11 CHAIRPERSON LASHOF: Sure.
12 DOCTOR KIDD-TAYLOR: For studies that have not
13 begun are we recommending that there be an external review
14 process before they begin it?
15 CHAIRPERSON LASHOF: Yeah.
16 DOCTOR BALDESCHWIELER: But shouldn't the
17 recommendation track the finding?
18 MS. NISHIMI: Right. And that's what I mentioned,
19 there is test related to that and we will make it a stronger
20 link.
21 DOCTOR BALDESCHWIELER: But I thought the
22 principle point of the finding was that, although there are
23 reviews, there were not executive decisions being made on
24 the basis of the reviews, and so the Coordinating Board or
25 the --
223
1 CHAIRPERSON LASHOF: But that recommendation we
2 took care of.
3 DOCTOR BALDESCHWIELER: But that's a --
4 CHAIRPERSON LASHOF: And now this recommendation
5 goes to the fact that some studies didn't even get a review.
6 DOCTOR BALDESCHWIELER: But that was --
7 MS. NISHIMI: Huh?
8 DOCTOR BALDESCHWIELER: We took care of a finding
9 and the recommendations should track the finding.
10 CHAIRPERSON LASHOF: Yes. Well, I was going to
11 say I think we have to discuss at some point the order of
12 recommendations. The way we have them laid out for us in
13 this book now is that we've had a series of findings and
14 then we've got a series of recommendations. I think when we
15 put it together we need to discuss whether we shouldn't have
16 background, finding, recommendation; background, finding,
17 recommendation, and each of them track that way and then I
18 think this will be clearer.
19 MS. NISHIMI: There is a finding to that
20 recommendation, though.
21 DOCTOR BALDESCHWIELER: But the emphasis here is
22 the reverse of the finding. The finding implied that there
23 was, you know, perhaps --
24 CHAIRPERSON LASHOF: Well, there are two findings.
25 There's one finding that there were external reviews and no
224
1 attention was paid. There's also another finding that some
2 studies the external review wasn't done until after the
3 study was started, and so, you know, that finding probably
4 should come first that all studies should have an external
5 review before the study is launched.
6 DOCTOR KIDD-TAYLOR: Should that be a finding or
7 recommendation?
8 CHAIRPERSON LASHOF: Well, the finding was that
9 some -- the recommendation is that they all should, then you
10 have a finding that when reviews were done the
11 recommendations weren't always followed, and then there's
12 the recommendation that there ought to be this ongoing
13 monitoring.
14 MR. BROWN: I think we got the idea behind this,
15 the way to structure it.
16 CHAIRPERSON LASHOF: Yeah. I think we'll leave it
17 to staff.
18 DOCTOR BALDESCHWIELER: In terms of literal
19 findings, it's only finding five.
20 MS. NISHIMI: But there is text in there that
21 would be pulled out to link it more strongly to this
22 recommendation. There is test in the body right now.
23 CHAIRPERSON LASHOF: Yeah. You're right, we
24 didn't have a finding highlighted here as -- but staff get
25 the picture?
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1 MS. NISHIMI: Yes.
2 MR. BROWN: Okay.
3 CHAIRPERSON LASHOF: That's why we're going
4 through it and they'll do it. If they haven't done it on
5 the next go around, we'll hit them again.
6 Okay. Now we have recommendation three. It says,
7 "At this stage no case definition derived in a single
8 population can be applied widely. In all studies case
9 definitions developed as working case definitions can be
10 useful as investigators develop and test hypotheses about
11 illnesses and can be considered steps in the evolution."
12 I'm not sure what the recommendation is there.
13 DOCTOR BECK: Maybe we don't need a recommendation
14 about that but just, you know, there's reference to case
15 definitions earlier and maybe that can just fall into
16 background.
17 CHAIRPERSON LASHOF: I would think so myself.
18 MS. NISHIMI: Okay. Let's just back --
19 CHAIRPERSON LASHOF: Anyone else feel that we need
20 a recommendation around that issue?
21 DOCTOR KIDD-TAYLOR: I don't think so. I mean,
22 this doesn't actually state it as a recommendation.
23 CHAIRPERSON LASHOF: Yeah.
24 DOCTOR BALDESCHWIELER: Is this meant to track
25 finding six?
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1 DOCTOR KIDD-TAYLOR: No.
2 MS. NISHIMI: No, it's meant to track --
3 CHAIRPERSON LASHOF: The discussion on --
4 MS. NISHIMI: -- information prior to finding
5 three, on page six.
6 CHAIRPERSON LASHOF: Where there is a discussion
7 on lack of case definition, where we had a discussion about
8 working case definitions and, John, we had a discussion with
9 you about what was an evolving case definition. This one
10 follows that but I don't think we need it as a
11 recommendation. We'll just get the sense of it in the body
12 of the text.
13 DOCTOR BALDESCHWIELER: Because I still struggle
14 with finding six, that is what it is.
15 DOCTOR KIDD-TAYLOR: I think we agreed to talk
16 about --
17 DOCTOR BALDESCHWIELER: But what is it that we
18 think, that we lack -- I mean, there are plenty of
19 hypotheses about the cause and yet the studies don't really
20 deal with each individual -- each are not focused on those
21 hypotheses and --
22 CHAIRPERSON LASHOF: That's right.
23 DOCTOR BALDESCHWIELER: And that's because the
24 hypotheses are not sufficiently well defined to make the
25 effort?
227
1 CHAIRPERSON LASHOF: Yeah, and because at this
2 point we don't have the kind of data that would allow us to
3 track it to a specific -- without exposure data, without
4 location data, the current studies cannot link it to some of
5 the specific hypotheses.
6 DOCTOR BALDESCHWIELER: So the finding is that the
7 studies that are underway are broad; there exists a large
8 number of hypotheses, but at present we don't feel that --
9 CHAIRPERSON LASHOF: There is any single
10 hypothesis that we can focus in on at this time.
11 DOCTOR BALDESCHWIELER: Because of lack of
12 exposure data, the tox --
13 CHAIRPERSON LASHOF: Toxicological data.
14 DOCTOR BALDESCHWIELER: -- and other leads.
15 CHAIRPERSON LASHOF: I think we pretty well
16 explored it and I think we've got the sense of your
17 concerns.
18 DOCTOR BALDESCHWIELER: I understand that, and
19 recommendation three says --
20 CHAIRPERSON LASHOF: Well, we're going to drop
21 recommendation three.
22 DOCTOR BALDESCHWIELER: Okay.
23 CHAIRPERSON LASHOF: And build that into the
24 discussion of the background that would lead to finding six.
25 DOCTOR BECK: Except there is no finding six.
228
1 MS. NISHIMI: There's no finding six.
2 CHAIRPERSON LASHOF: There's not going to be a
3 finding six now?
4 DOCTOR BECK: It's back into --
5 CHAIRPERSON LASHOF: It's going to be back into
6 general discussion?
7 DOCTOR BECK: On the case definition for
8 discussion we'll add it. It needs to be highlighted but not
9 as a recommendation, just as reinforcement of the --
10 CHAIRPERSON LASHOF: Right. Okay. I think we're
11 on track and obviously we'll get another crack at this when
12 staff tries to pull that together. But they think they know
13 what we're thinking.
14 MR. BROWN: I think we understand the gist of
15 that.
16 CHAIRPERSON LASHOF: Okay.
17 MAJOR CROSS: The situation is tricky actually.
18 CHAIRPERSON LASHOF: Very.
19 MAJOR CROSS: Think someone will ask, well, we
20 have all these hypotheses why don't we follow up on them?
21 Why isn't something being done to, you know, to really track
22 down pyridostigmine and, you know --
23 CHAIRPERSON LASHOF: Well --
24 MAJOR CROSS: And all the other possible things
25 that --
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1 MR. BROWN: There are some studies actually
2 that --
3 DOCTOR BECK: Mostly tox studies seem more
4 appropriate at this time to try to find out if these are
5 reasonable hypotheses to then pursue.
6 CHAIRPERSON LASHOF: And that was the finding we
7 did agree on yesterday, that we reworded the toxicology to
8 say these were important on themselves specifically to get
9 at that. And, after we get through the interim report,
10 we'll be discussing the rest of our work plan for the rest
11 of the year and one of them is to look at a lot of those
12 other studies that we haven't discussed yet. So we don't
13 want to say much about them now but there are a number of
14 smaller units looking at some of the specific hypotheses
15 trying to explore the issues that exactly you're concerned
16 with. The big epi studies are not those but there are
17 others.
18 DOCTOR BALDESCHWIELER: Virtually every reader
19 will have his own favorite hypothesis and will ask, you
20 know, why isn't that --
21 CHAIRPERSON LASHOF: By the time of the final
22 report we will have dealt with all of that, but we can't do
23 it all in this one.
24 Okay. Now we're going on to the occupation and
25 safety and health issues. We had a general discussion of
230
1 what was in the meat of this, I think, but we haven't gotten
2 to the findings. Do you want to say anything more? Does
3 anybody need their mind refreshed or want to do some more
4 silent reading?
5 (Pause.)
6 CHAIRPERSON LASHOF: Well, the finding was, the
7 two findings kind of try to summarize the points made in the
8 text obviously, and finding seven becomes -- and obviously
9 the numbers will all change so don't worry about that.
10 "Health and safety studies carried out by DOD and
11 others before the Gulf War on key risk factors such as
12 depleted uranium, military vaccines, and protective drugs,
13 et cetera, will be an important source of information for
14 evaluating possible health outcomes in Gulf War veterans."
15 I don't know what that tells us a finding. I mean, it's
16 sort of self-evident that if you have information that's
17 going to be useful --
18 DOCTOR KIDD-TAYLOR: You know, I was wondering,
19 this goes back basically to the key questions above in the
20 text, the key factors in evaluating them --
21 CHAIRPERSON LASHOF: Put your mike closer to you.
22 MAJOR CROSS: The key questions on page nine?
23 DOCTOR KIDD-TAYLOR: Yes, the key questions,
24 correct. I think that's what the finding is specifically
25 referring to: How did they evaluate agents in anticipation
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1 of their use? And so should there be a statement of -- of
2 the question above? So I don't know if -- is it actually a
3 finding where you have it here, in finding seven, or should
4 that be a recommendation or --
5 MR. BROWN: Yeah. It's sort of a description of
6 an approach --
7 DOCTOR KIDD-TAYLOR: Okay.
8 MR. BROWN: -- that we're thinking of as much as a
9 finding. I guess it's an observation.
10 DOCTOR KIDD-TAYLOR: Yes.
11 CHAIRPERSON LASHOF: It's more an observation than
12 a finding. And the question is, does it need to be
13 highlighted as a finding or -- I don't know, is there a way
14 formatting these things where you have some general
15 discussions and you might highlight some --
16 MS. GWIN: Sure.
17 CHAIRPERSON LASHOF: -- you know, italicize some
18 specific things without going into findings?
19 MS. NISHIMI: In the background section, yes.
20 DOCTOR BALDESCHWIELER: Isn't the issue here
21 whether you make a value judgment or not? I mean, are those
22 background studies adequate or aren't they, or do you
23 not want to say?
24 MR. BROWN: Just to go over this again quickly.
25 There are two parts to this really. One is to evaluate the
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1 quality of the health and safety evaluation that DOD did:
2 Was it a good evaluation? Did it protect soldiers against
3 certain exposures? That's one issue.
4 The other issue, though, is that did this need
5 exist in a general sense? There's health and exposure data
6 about some of these risk factors in general; maybe in
7 civilian sources, maybe from EPA relative to pesticides, for
8 instance, and we can use that existing body of data to
9 evaluate risk factors. Is that clear? So there's two
10 issues there: The quality of the occupational, safety and
11 health reviews, and then what the data itself tells us.
12 CHAIRPERSON LASHOF: But we have no real findings
13 or recommendations dealing with either of those.
14 MS. NISHIMI: I think we can dispatch with seven
15 and eight and incorporate it into text and highlight it as
16 important factors in the background discussion.
17 CHAIRPERSON LASHOF: That would be my temptation
18 because I think it's hard to highlight some things as
19 findings unless we're prepared to make some recommendations
20 and some value judgments, and if we follow that as a
21 principle as we go through them.
22 MS. NISHIMI: I agree.
23 DOCTOR KIDD-TAYLOR: At this point we don't have
24 enough information.
25 CHAIRPERSON LASHOF: Right. Don't forget, this is
233
1 interim and we don't have to have covered the water front in
2 the first four months of the work of this committee.
3 Okay. Anything else? This then would cover the
4 section on research and epi, is that correct?
5 DOCTOR BECK: Yes.
6 CHAIRPERSON LASHOF: Does anyone feel that there
7 are other things that have come up during work over the last
8 four months that aren't captured here that should be
9 captured?
10 (No response.)
11 CHAIRPERSON LASHOF: If not --
12 DOCTOR BALDESCHWIELER: This section is meant to
13 cover not only epidemiological studies but all federally
14 funded research?
15 CHAIRPERSON LASHOF: Only that which we've looked
16 at, and I think it does need some statements in here about
17 how far we've gone and what we're covering at this point in
18 time. And, you know, the formatting of all of that I think
19 we can discuss later, John, as to whether in the
20 introduction, you know, we make some kind of blanket
21 statement and sort of give a general summary of what were
22 the things we've looked at and what things this report will
23 deal with, what things this report will not deal with.
24 DOCTOR BALDESCHWIELER: But is this section is
25 supposed to cover federally funded research, then we have to
234
1 say something about that; how big it is, how adequate it is,
2 whether it covers key areas, whether it doesn't.
3 CHAIRPERSON LASHOF: But, John, we haven't looked
4 at all the federal research yet so all we can talk about is
5 that which we've looked at.
6 MS. NISHIMI: And it will.
7 MR. BROWN: In the introduction we'll put
8 something to clarify what we have yet to do.
9 DOCTOR BALDESCHWIELER: Okay, because --
10 CHAIRPERSON LASHOF: I mean, there's a lot more
11 research going on than we've looked at. There are new calls
12 for additional research that have gone out. So, at this
13 interim report, we should not being saying what additional
14 research needs to be done till we know what all has been
15 done.
16 MR. BROWN: And, for instance, John, we have only
17 begun looking at the tox research. We've only just begun
18 taking a look at that, and we'll make that clear that any
19 remarks we make about it are in the context of just a
20 beginning.
21 DOCTOR BALDESCHWIELER: Okay. Because evaluating
22 the research that's ongoing is a major enterprise.
23 CHAIRPERSON LASHOF: Yeah.
24 DOCTOR BALDESCHWIELER: And it's not even touched
25 in this section.
235
1 CHAIRPERSON LASHOF: Yeah.
2 DOCTOR KIDD-TAYLOR: There's so much that we
3 haven't looked at and reviewed that's going on right now.
4 CHAIRPERSON LASHOF: Okay. We'll be sure that
5 strong statements are made about what we're attempting to
6 cover in this report, what we haven't covered and what we're
7 not doing, as well as what we're doing. Okay?
8 Okay. Holly, that's right, the next thing we're
9 going to do is discuss really what appears in tab F in our
10 book on chemical and biological weapons.
11 HOLLY GWIN, REPORT ON CHEMICAL AND BIOLOGICAL WEAPONS
12 MS. GWIN: The Advisory Committee's charter
13 specifically calls out chemical and biological weapons as a
14 risk factor that should be looked into. As Joyce said, the
15 staff memo on this is at tab F, the briefing book. In the
16 discussion we had yesterday, Mark described the difficulties
17 in assessing contributions of any risk factor whether it's
18 sand, petroleum products, or insecticides to Gulf War
19 Veterans' illnesses. And these are all risk factors on
20 which there is general agreement that exposure did occur.
21 There's no such agreement in the case of chemical and
22 biological weapons, which I'll refer to as CBW from here on
23 out.
24 And to get at the question of whether exposure
25 occurred and the question of whether CBW exposure could be
236
1 contributing to Gulf War veterans' illnesses, the staff has
2 developed a research plan that breaks the issue out into
3 five main area:
4 First. We're examining Iraqi CBW capabilities and
5 doctrine during the Gulf War with a special emphasis on a
6 new findings of the U.N. special commission on Iraq, UNSCOM.
7 Second. We're talking a look at U.S. and allied
8 CBW detection systems that were deployed to the Gulf.
9 The third thing we'll look at is alleged incidents
10 of direct CBW exposure.
11 Fourth. We'll examine the evidence for
12 collateral, meaning unintended CBW exposures.
13 And, finally, we will see what we can find out
14 about the health effects of low level CBW exposure from
15 existing data from occupational settings and toxicologic
16 tests. And the point there is to try to determine whether
17 there are any data relevant to studying Gulf War veterans'
18 illnesses.
19 For the interim report, we have focused on the
20 first two issues, and first I'd like to go over our findings
21 and one recommendation concerning Iraqi CBW capabilities and
22 doctrine.
23 Our first finding is that DOD maintains the
24 position that there was no widespread use of chemical or
25 biological weapons during the Gulf War; however, DOD has
237
1 shown a new willingness to reexamine the issue in recent
2 months as events by the establishment of the Persian Gulf
3 investigation team, PGIT, which is under the direction and
4 the control of the assistant secretary of defense for Health
5 Affairs.
6 Part of the PGIT's mandate is to investigate
7 possible exposures to CBW agents during the Gulf War, and
8 they are drawing on all sources of information, including
9 eyewitness account that they receive on a toll free incident
10 reporting line and a review of all operational and
11 intelligence records.
12 Our next finding is that in parallel with the PGIT
13 investigation one analyst in the CIA is conducting an
14 independent review of CIA intelligence documents to
15 determine whether the agency's previous conclusion that CBW
16 was not used during the Gulf War still stands.
17 The CIA limited its review to its own documents
18 and has excluded consideration of operational records,
19 eyewitness accounts and intelligence reports that were
20 produced by DOD or our Gulf War allies.
21 Findings three and four highlight new information
22 revealed by UNSCOM. On the issue of capabilities, UNSCOM
23 has revealed that Iraq's CBW arsenal was quite advanced and
24 that Iraq produced and weaponized mustard agent, at least
25 four nerve agents, and three biological agents.
238
1 On the issue of doctrine or intent to use CBW
2 against U.S. forces, UNSCOM's executive director wrote in
3 his October '95 report that "Certain documentation supports
4 the contention that Iraq was actively planning and had
5 actually deployed its chemical weapons in a pattern
6 corresponding to strategic and offensive use through
7 surprise attack against perceived enemies. The known
8 pattern of deployment of long-range missiles support this
9 contention." And that's the end of the quote.
10 Based on our review of this documentation of Iraqi
11 CBC capabilities and our review of the U.S. response to this
12 new information, the staff has developed one preliminary
13 recommendation for your consideration and that's instead of
14 conducting two parallel investigations DOD and CIA should
15 undertake a coordinated review of all available data
16 relating to whether coalition troops may have been exposed
17 directly or indirectly to chemical or biological agents
18 during the Gulf War. Analyst from both agencies should
19 examine the full range of available information both
20 classified and unclassified.
21 In preparation for the interim report, we have
22 also assessed the CBW detection systems that were deployed
23 in the Gulf. I'll briefly review our findings and
24 recommendations in that area. Our first finding concerning
25 CBW detectors is at the M8A1 automatic chemical agent
239
1 detector alarm, which was the primary U.S. system for early
2 warning, suffered from a number of deficiencies, and these
3 included an inability to detect mustard agent which Iraq was
4 known to possess, and a high false alarm rate which we can
5 attribute to the fact that the alarm sounded in response to
6 vehicle exhaust, smoke, dust, rocket propellent and other
7 battlefield interference, and would also sound when battery
8 levels were low.
9 Our next finding is that all of the chemical agent
10 detection and warning systems deployed in the Gulf were
11 designed to detect nerve agent concentrations that would
12 have an immediate impact on troop functioning; levels that
13 would cause death or acute symptoms. Battlefield detectors
14 could not measure the types of low level exposure that DOD
15 regulations guard against in non-battlefield situations.
16 Next we find that DOD is taking action to address
17 some of the deficiencies in the chemical detection systems
18 that were deployed to the Gulf. A new automatic detector
19 alarm currently under development will, if it works up to
20 specifications, be capable of detecting mustard agents, will
21 identify the category or type of agent detected, and will
22 not false alarm or malfunction during or after exposure to
23 commonly occurring battlefield interference.
24 However, we also find that DOD has not addressed
25 the issue of low level exposures to chemical warfare agents.
240
1 The joint service requirements' documents for the new system
2 notes, and I quote, "The current automatic chemical agent
3 alarm, the M8A1, is not sufficiently sufficient to
4 adequately monitor protection shelters for detecting
5 sustained low levels of chemical agent and for monitoring
6 personnel contamination." Yet the new system is designed to
7 have the same nerve agent detection threshold as the system
8 it replaces.
9 Concerning biological agent detection systems we
10 find that no real time systems were deployed during the Gulf
11 War. Britain, Canada, France, and the United States all
12 deployed air samplers that take several hours to produce a
13 result. These provide only retrospective information about
14 biological attacks. In an effort to remedy these
15 deficiencies, DOD is currently developing two biological
16 detection systems.
17 Our final finding that we've considered in this
18 area is that veterans of the war continue to be concerned
19 about a number of apparent anomalies. These include the
20 clustering of chemical agent alarms around the start date of
21 the air and ground campaigns; reported detections of low
22 levels of nerve agent in the air by Czech and French
23 equipment; and inconsistencies between DOD's official
24 position and entries in declassified operations' log that
25 are now available.
241
1 The staff has developed three preliminary
2 recommendations concerning our findings about CBW detections
3 during the Gulf War, for your consideration.
4 The first is that we believe the Persian Gulf
5 investigation team should pay particular attention to
6 resolving veterans' concerns about apparent detections of
7 chemical agents in Iraq.
8 Our next recommendation would be that DOD should
9 devote more attention to monitoring low level subacute
10 exposures to chemical agents in order to provide exposure
11 data that will assist in assessment of the health effects of
12 CBW exposure.
13 And the final recommendation that we submit for
14 your consideration is that DOD should continue to invest in
15 the development of a biological point detector alarm system
16 that can detect and identify biological agent aerosols
17 rapidly enough to enable troops to take protective measures.
18 But, admittedly, this task entails a major technological
19 challenge.
20 That's a brief summary of what we've been looking
21 at. To conclude, I would like to say we have just looked at
22 two elements of our research plan for getting ready for the
23 interim report, and that's CBW endocrine capabilities and
24 CBW detection systems. We have not looked at the last three
25 areas which are incidents of direct CBW exposure, evidence
242
1 for collateral exposure, or the health effects of low level
2 CBW exposure.
3 CHAIRPERSON LASHOF: Okay. Open for questions.
4 DOCTOR KIDD-TAYLOR: I have one question about the
5 French and Czech equipment. Will there be the possibility
6 that you will get a chance or DOD will get a chance to
7 review the information that was collected on their
8 monitoring equipment?
9 MS. GWIN: Yes.
10 DOCTOR KIDD-TAYLOR: And I guess the question I
11 have about that, I notice that you do mention about the
12 detection of chemical agents in Iraq and I was wondering
13 maybe in a recommendation that we -- or is that already
14 understood that they're going to review it? Do we need to
15 make a recommendation, in other words, regarding
16 investigating French and Czech equipment air monitoring
17 results?
18 MS. GWIN: Well, the recommendation that we
19 propose here that PGIT investigate the anomalies of concern
20 to veterans would encompass a recommendation that they look
21 at the French and Czech detections.
22 DOCTOR KIDD-TAYLOR: But it's not stated, that's
23 what I was wondering is if maybe we should possibly state
24 it.
25 MS. NISHIMI: Well, it's built into the finding
243
1 and so the recommendation generally holds to that whole
2 finding and I would think that would be --
3 DOCTOR KIDD-TAYLOR: Okay.
4 MR. RIOS: What is the PGIT?
5 MS. GWIN: The Persian Gulf Investigation Team.
6 It was established by the Department of Defense earlier this
7 year to do a number of things, one of which is to look at
8 the -- they established this incident reporting line where
9 veterans, or others with special knowledge, can call in and
10 report incidents of CBW exposure which the investigation
11 team then goes out and collects whatever information they
12 can on it. We heard testimony from Colonel Konig's group at
13 our October meeting.
14 MR. RIOS: Let me ask you, your sources of
15 information on possible exposure, have your sources of
16 information all been the U. S. government: CIA, DOD?
17 MS. GWIN: No. We have testimony from veterans
18 that's been included in here, and records from the Congress.
19 We have had some conversations with veterans as well. We
20 have some information from people who are, in fact, federal
21 employees but who are speaking as independent citizens when
22 they provide us with information.
23 MR. RIOS: And have you gotten any information
24 from other governmental sources, other governments that were
25 in the area, say, the French or any other governments'
244
1 agencies other than U.S. government agencies?
2 MS. GWIN: We have not received information
3 directly from any other governments.
4 MR. RIOS: Have you sought it? Have you tried to
5 get it?
6 MS. GWIN: No.
7 CHAIRPERSON LASHOF: Let me clarify where we are,
8 though, on this. At this point, if we look at page one of
9 tab F, you begin with the first of the five areas that we're
10 going to look at. The first one has to do with the Iraq
11 capabilities and especially with UNSCOM. The second is with
12 detection systems, and it's only those two that you feel
13 that you've done enough work on that you're prepared to say
14 some findings and recommendations?
15 MS. GWIN: That's correct.
16 CHAIRPERSON LASHOF: And what I want to know is on
17 these two, do you feel you've done all you're going to do or
18 will we be doing more?
19 MS. GWIN: Well, since UNSCOM has not finished its
20 work, there may be more that is learned throughout the
21 committee's work about CBW capability so I can't say that
22 this completely forecloses future discussion on that issue.
23 And we intend to monitor the DOD contracting process for the
24 new detector system. So it was not our intention to stop
25 looking at numbers one and two, it's just those are the only
245
1 ones we felt like we had done enough work in it to have
2 anything to say about.
3 CHAIRPERSON LASHOF: Okay. And as far as number
4 three, Rolando, which you were asking about, the alleged
5 incidents, that we're not even discussing here because
6 they've just begun to look at that, and you have not
7 exhausted all your sources of information, let alone dug
8 into many sources of information as far as the alleged
9 incidents, is that correct?
10 MS. GWIN: That's correct.
11 CHAIRPERSON LASHOF: Okay. So, in response to
12 Rolando's question about who you've heard from, this is what
13 you've heard at this point but you've got a lot more work to
14 do on that regard?
15 MS. GWIN: Correct.
16 MR. RIOS: In that regard, are you planning to see
17 if there's any sources other than the U.S. government? By
18 that I mean the possibility of hearing from other
19 governments that were there?
20 MS. GWIN: I guess it will surprise me if
21 information that other governments hold on a classified
22 basis would be available to us, but we can certainly look
23 into it.
24 MR. RIOS: I was just wondering if you were
25 planning to do that?
246
1 MS. GWIN: No, I hadn't thought of it. We can
2 certainly add that to the agenda.
3 CHAIRPERSON LASHOF: I guess one of the questions
4 I have at this point is whether we have enough on one and
5 two that we have something important enough to say to even
6 address the CBW issues in this interim report or whether the
7 interim report should just lay out the five areas that we're
8 going to look at and say those will be handled later?
9 What do you feel we gain by including the
10 discussions of items one and two in the interim report?
11 MS. GWIN: I think an opportunity to acknowledge
12 the fact that DOD has reopened the issue of whether CBW
13 exposures could have occurred is an important thing for the
14 committee to do.
15 MS. NISHIMI: I think also recommendation one,
16 flowing out of findings one, two, three, and four, related
17 to the UNSCOM data, the recommendation, to repeat,
18 "encourages DOD and CIA to undertake a coordinated review,"
19 would be an important contribution for the committee to
20 take, particularly at an early stage and in an interim
21 report, otherwise, we may lose the, you know, ten months of
22 time.
23 CHAIRPERSON LASHOF: Okay. Okay. Now I have
24 questions about the wisdom of the recommendation one. Just
25 for the sake of argument, one could make an argument that
247
1 two parallel investigations might be a worthwhile way to go,
2 that if they're combined you only have one investigation.
3 And it may be easier if they come out with a finding that
4 isn't what some people would like it to be that, well, they
5 just put their heads together and all agreed and they really
6 didn't investigate this thoroughly. That having two
7 different investigations going on somewhat independently and
8 see whether -- I mean, it's possible if they were two
9 independent that they might come out with different
10 conclusions.
11 MS. GWIN: I think what --
12 CHAIRPERSON LASHOF: I don't know. I mean, I'm
13 thinking aloud and I'm not sure.
14 MS. GWIN: What you may lose if they go ahead
15 under the current plan is a more thorough analysis by the
16 CIA which has limited its review to its own documents, and
17 there is a vast universe of documentation, both intelligence
18 and operational, that they are not even looking at. And
19 this was an attempt to get another group of talented
20 analysts looking at the complete universe.
21 MR. BROWN: And the concern is that the two pieces
22 of data independently, in the two different groups, might
23 not mean much but together they might add up to something
24 significant.
25 CHAIRPERSON LASHOF: Okay.
248
1 MS. NISHIMI: Just to reemphasize, I think your
2 point is something for the committee to consider to parallel
3 but the real issue is the data sets that both are employing
4 are not the same, and so the committee might want to
5 separate process from the body of knowledge that should be
6 evaluated.
7 CHAIRPERSON LASHOF: That's what I was wondering
8 about, whether if what we're really after is for CIA not to
9 be so narrow in its investigation rather than the necessity
10 that they both work completely together, whether the
11 recommendation should be that the CIA should not limit its
12 investigation only to its own documents but should have
13 complete freedom to review all documents and broaden its
14 search. Now, if we recommend that the response back from
15 DOD, they'll say, "Well, what's the point of that? We're
16 doing that and it's just duplicating us." So, if we're
17 going to make that recommendation, we either have to go with
18 the kind of recommendation that you're saying or justify why
19 we think that there ought to be two investigations but both
20 ought to be complete and see if they both end up with the
21 same conclusion or different conclusions.
22 MS. GWIN: Well, during the next six weeks I think
23 we have more testing of this recommendation to do on the
24 departments themselves. You know, to see what objections
25 they would raise to a complete sharing of documents, and so
249
1 I understand your reluctance to commit to a
2 recommendation -- these exact words at this time, but I
3 think it is something to be --
4 CHAIRPERSON LASHOF: We are caught in a time bind
5 situation, in a way, aren't we, that you really haven't done
6 as much delving into the implications of this as you'd like
7 to feel secure about it. Is that the way I'm reading what
8 you're telling me?
9 MS. GWIN: I think that during the review
10 process -- We know at this point that there will be some
11 objections raised by the departments to the phrasing of this
12 recommendation because they do have normal channels through
13 which they operate, traditional methods of going about their
14 business, and I would -- This was an attempt to see where
15 the committee felt like it would be willing to go so we
16 could go forward in testing these things with the
17 departments and come back to you in the next iteration with
18 what we feel like is a workable --
19 CHAIRPERSON LASHOF: What's your major goal here,
20 to broaden CIA's investigation? Should we be more
21 straightforward, instead of saying this just say that we
22 believe that CIA should not be limiting its investigation
23 and should broaden it, and see if that flies?
24 MS. GWIN: Sure. Sounds good.
25 CHAIRPERSON LASHOF: What do people think? How do
250
1 you feel about this one, because this is, you know, a hot
2 and difficult issue.
3 DOCTOR KIDD-TAYLOR: I think paralleling the
4 investigations, making them one, saying that they should
5 undertake a coordinated review will create some problems and
6 even before -- so, you know, again going back to why they
7 should be conducting -- instead of two why there should be
8 one. I mean, we could make that recommendation that they
9 coordinate their review; however, it might be that we'll get
10 more if there are two separate investigations and letting
11 the CIA broaden theirs to more than --
12 MS. GWIN: I'm not sure it's an issue of "letting
13 them."
14 DOCTOR KIDD-TAYLOR: I mean, not letting them,
15 recommending that they -- I know. Sure.
16 CHAIRPERSON LASHOF: Requiring that they be
17 allowed to I guess is the issue. Are there limits to what
18 CIA can look at in this country when there don't seem to be
19 any limits to what they can look at elsewhere?
20 DOCTOR KIDD-TAYLOR: I don't think so.
21 MS. GWIN: I don't think that's the -- I think
22 it's the resources that CIA thinks it would require them to
23 devote to the effort if they were to broaden their search.
24 They have one analyst doing this review, so we would be
25 recommending that they give more.
251
1 CHAIRPERSON LASHOF: Okay.
2 DOCTOR BALDESCHWIELER: That's a significantly
3 different recommendation, isn't it? I mean, I must say I'm
4 attracted to the idea of, you know two different groups
5 looking at the data.
6 CHAIRPERSON LASHOF: John, would you talk more
7 into your mike. I can tell from the signs I'm getting from
8 our reporter there that he's having trouble.
9 MS. NISHIMI: John, but are you comfortable with
10 the recommendation that CIA should broaden its data set?
11 DOCTOR BALDESCHWIELER: Sure. I mean, that seems
12 to make good sense.
13 CHAIRPERSON LASHOF: Okay.
14 MAJOR CROSS: Joyce, I would like to just say --
15 CHAIRPERSON LASHOF: Sure, please, Tom.
16 MAJOR CROSS: -- it seems to me let's just hit the
17 nail in the head and just make that a recommendation.
18 MS. NISHIMI: Okay. I think the staff knows where
19 the committee's at on this.
20 DOCTOR BALDESCHWIELER: There are two details I
21 think worth mentioning. One is virtually every one of our
22 testifiers who has commended on this issue has spoken about
23 dead animals. I would certainly like to see what kind of a
24 rationale we can find for that.
25 CHAIRPERSON LASHOF: That comes under three.
252
1 That's why I want to be very clear which points in the CBW
2 we're discussing at this time. We really are only
3 discussing the question of what investigations have gone on
4 and will go on, and specifically about Iraqi capabilities,
5 and that two is on the detection system. Now, the question
6 about alleged incidents, the dead animals and so on, really
7 does deal with alleged incidents. And that's not what we're
8 going to discuss in this interim report. We haven't dug
9 into that whole problem, and we will and plan to dig into
10 it. But recommendation on investigation and review actually
11 does deal with the alleged incidents, doesn't it? I mean,
12 what we're recommending about CIA broadening and so on
13 really, although it's under --
14 MS. GWIN: It comes under the finding that DOD is
15 not moderating its position but is reopening its own
16 investigation of what Iraqi CBW capabilities and doctrine
17 were.
18 MS. NISHIMI: And the recommendation as it now
19 stands, even if you only narrow it to CIA, does point out
20 that it should point out the newly released UNSCOM, et
21 cetera, et cetera, and then it says, "and eyewitness
22 incident reports." And so I do think that recommendation
23 encouraging CIA does account for the issue you just raised.
24 CHAIRPERSON LASHOF: Well, but that's my problem.
25 It actually is a recommendation dealing with item three, the
253
1 alleged incidents, which we say we're not going to deal with
2 at this time.
3 MS. NISHIMI: It doesn't deal with our -- the
4 committee's analysis of alleged incidents. It deals with
5 what DOD is collecting and tells CIA to account for DOD.
6 It's not the committee's analysis of the alleged incidents.
7 MS. GWIN: It helps us do a better job on our
8 number three.
9 CHAIRPERSON LASHOF: Okay. I think we need to
10 frame it in some way that we're making clear that we
11 aren't -- we have not looked at the problem of alleged
12 incidents yet, we intend to, in order for us to do that.
13 DOCTOR BALDESCHWIELER: I don't know. The dead
14 animal issue has come up so frequently.
15 CHAIRPERSON LASHOF: Yeah.
16 DOCTOR BALDESCHWIELER: That I would appreciate,
17 you know, is there something different in the customs of
18 Saudis or Kuwaitis in terms of how you deal with dead
19 camels?
20 MS. GWIN: Well, we have had some briefings on
21 different issues and if you -- the next time you come to
22 Washington, if that is a particular area of interest to
23 you --
24 DOCTOR BALDESCHWIELER: It's just that it's come
25 up so often.
254
1 MS. GWIN: Yeah. We can arrange for you to have a
2 briefing on that, and any members of the committee who would
3 like a specialty briefing from DOD on that.
4 DOCTOR BALDESCHWIELER: I'm not sure I want to
5 spend a day on dead animals but --
6 MS. GWIN: No.
7 DOCTOR BALDESCHWIELER: But just in here
8 somewhere -- I mean, again, it's come up so often.
9 CHAIRPERSON LASHOF: John, my problem is what we
10 include in this interim report, what will get into later
11 reports. We've heard information on dead animals. The
12 staff have begun to look at it but don't feel that they've
13 carried it far enough to come up with some findings and a
14 full discussion for us. They will in time and we will
15 address.
16 DOCTOR BALDESCHWIELER: At least as part of the
17 working -- you know, for part of the working brief I think
18 that should be in there because we've heard it so often.
19 MR. BROWN: You mean you think there should be an
20 explicit reference to that issue?
21 DOCTOR BALDESCHWIELER: Well, I mean, that --
22 MS. NISHIMI: Again, in describing the work plan
23 for the next ten months, as with the research section, there
24 will be text pertinent to what is planned and certainly
25 alleged incidents, including the reports of the dead
255
1 animals, will be mentioned in that kind of text.
2 DOCTOR BALDESCHWIELER: And then one other detail.
3 Your item eight on page five, you raise the level of
4 detection systems for low level agents. Those of course
5 exist, are used routinely at Edgewood, and they're typically
6 integrating sensors in which one has a column through it.
7 You know, you draw -- you sample for long periods of time.
8 Much like environmental sampling detectors.
9 MR. BROWN: The nice thing about that
10 recommendation is that that technology, as you point out,
11 exists so it's not a matter of inventing something new.
12 DOCTOR BALDESCHWIELER: And it's my impression
13 that that kind of technology typically is not deployed with
14 the troops.
15 DOCTOR KIDD-TAYLOR: Right.
16 DOCTOR BALDESCHWIELER: And maybe the
17 recommendation could be made that it would be useful to do
18 that. I mean, just for this kind of issue.
19 MR. BROWN: Didn't we make that. Isn't that
20 covered in the finding --
21 MS. GWIN: We say that DOD should devote more
22 attention to monitoring low level --
23 DOCTOR BALDESCHWIELER: Yes.
24 MS. GWIN: And so we can add in there that they
25 have the technology that would make that possible.
256
1 CHAIRPERSON LASHOF: Maybe a finding is that
2 they're not utilizing all technology that is available.
3 It's a little close. Something stronger.
4 DOCTOR BALDESCHWIELER: In the current, you know,
5 it's set up for laboratory and under well controlled test
6 range conditions.
7 MR. BROWN: It's well to do it. It's not the
8 problem of inventing it from scratch or something.
9 CHAIRPERSON LASHOF: Well, we certainly could be
10 more explicit about technology has been available in the
11 laboratory that has not yet been utilized in the field and
12 that we would recommend that that be looked into as its
13 applicability for field use.
14 DOCTOR BALDESCHWIELER: And, just to be sure, I
15 would recommend you check that out with someone at Aberdeen
16 to be sure that my impression is on target.
17 MR. BROWN: I think we do have a little bit of
18 information about that and you're correct, there is some
19 technology for monitoring low levels. Storage facilities,
20 for instance.
21 DOCTOR BALDESCHWIELER: Yeah.
22 MS. NISHIMI: Okay. I think the staff knows where
23 to know on these.
24 CHAIRPERSON LASHOF: Okay.
25 CAPTAIN KNOX: Holly, I just have a question
257
1 about -- in the findings, on number one on page two -- you
2 mention there a toll free number that veterans can report
3 isolated incidents. I don't remember that toll free number
4 being discussed. Are our veterans aware of that number
5 and --
6 MS. GWIN: Well, we had testimony on that at our
7 October meeting.
8 CAPTAIN KNOX: Okay.
9 MS. GWIN: So the committee has had some
10 information on it. They gave us a sheet of paper, you know,
11 with their statistics. In fact, it may have been included
12 in your last package as part of our out reach evaluation.
13 CAPTAIN KNOX: Right. Okay.
14 MS. GWIN: And they are getting calls.
15 CAPTAIN KNOX: Okay.
16 MAJOR CROSS: Is that still active, that --
17 MS. GWIN: Yes.
18 MAJOR CROSS: -- phone number?
19 MS. GWIN: And Colonel Koenigsberg is here.
20 MAJOR CROSS: So it goes to say that the
21 investigation is continuing because the information --
22 MS. GWIN: Oh, yeah.
23 MAJOR CROSS: -- is still rolling in.
24 MS. NISHIMI: And Tom McDaniels in his briefing on
25 the out reach, he'd be able to discuss that further. And
258
1 there is information in the October briefing book about what
2 types of incidents --broadly categorized -- have been
3 reported so for and the number of calls they've received.
4 CHAIRPERSON LASHOF: Okay. Are there other things
5 you want to say about that first recommendation? I think
6 we've covered that one pretty thoroughly and we're now
7 into -- we've started into a discussion of the findings and
8 recommendations relating to the detection. And where I'm
9 having trouble is with the recommendation, page six, we can
10 look at the recommendation, that PGIT should pay particular
11 attention to resolving veterans' concerns about apparent
12 detections of chemical agents in Iraq. What are you trying
13 to say there?
14 MS. GWIN: That there are many things that concern
15 veterans that should be of primary interest to the PGIT,
16 like the Czech and French detections and the sounding of our
17 chemical alarms around the start of the air and ground
18 campaigns. We want to highlight the fact that veterans'
19 concerns should be an important part of the PGIT's
20 reexamination of the records.
21 CHAIRPERSON LASHOF: But isn't the whole reason
22 PGIT has been put in place is because of those concerns and,
23 again, doesn't this relate -- I'm trying to separate out
24 very clearly what we feel we have enough information to say
25 something specific about in items one and two -- questions
259
1 one and two versus question number three which is the
2 alleged incidents.
3 MS. GWIN: We've tried to --
4 CHAIRPERSON LASHOF: And whether this
5 recommendation really relates to the alleged incidents part
6 that we're not wanting to discuss. I'm trying to walk this
7 line between where we are and where we're aren't.
8 MS. GWIN: You don't see in this finding about
9 what's of concern to veterans, the stuff about dead animals,
10 because it has nothing to do with the functioning of the
11 detection equipment that was deployed to the Gulf. We had
12 limited in our finding the questions that concerned the
13 veterans that have to do with anomalies in the detectors.
14 CHAIRPERSON LASHOF: Okay. So what you're saying
15 is the key word, that I'm glossing over somehow in this
16 recommendation, is the word "detections?" It's their
17 concerns about their equipment going off.
18 MS. GWIN: They have other concerns.
19 CHAIRPERSON LASHOF: They have lots of other
20 concerns but this recommendation is only about --
21 MS. GWIN: A limited --
22 CHAIRPERSON LASHOF: -- that concern?
23 MS. GWIN: Correct.
24 DOCTOR KIDD-TAYLOR: It's my concern about the
25 recommendation it doesn't make clear the fact that we are
260
1 interested in reviewing the Czech or French results that
2 they've gotten from their equipment. It goes back to what
3 you just said about the concerns of veterans, and I'm not
4 sure if that takes care of the recommendation of we want
5 PGIT to investigate the monitoring results, the air
6 monitoring results of other chemical detectors from other
7 countries, like the Czechs and the French.
8 CHAIRPERSON LASHOF: But, if we do that, then we
9 are into the alleged incidents stuff. How do we keep this
10 recommendation limited to the two issues we're willing to
11 discuss at this point and the fact that we're not willing to
12 make recommendations or any finding about the number of
13 alleged incidents? And it's a very fine line and I don't
14 know how -- and that's why I had a concern about doing
15 anything on CBW in this interim report because trying to
16 say, "Well, we've only looked at this piece and here's this
17 whole piece," and how we walk that fine line, I'm having a
18 lot of trouble with it.
19 MR. BROWN: It may be splitting hairs but I guess
20 the thought was that the -- for instance, the Czech
21 detections, specific high level incidents, you know,
22 veterans are particularly concerned about that issue and yet
23 it has to do with detection systems; the quality of the
24 detection that was involved; the accuracy of the detection,
25 and so forth, and it's related in that sense. I agree it
261
1 may be splitting hairs but it may be worth, on the other
2 hand, focusing --
3 MS. NISHIMI: Are you more comfortable than with
4 only recommendations three and four?
5 DOCTOR KIDD-TAYLOR: It still doesn't get at the
6 issue of what other findings or what other detection methods
7 of broad results -- what other results were.
8 MS. NISHIMI: Right. But based on the staff's
9 work to date.
10 DOCTOR KIDD-TAYLOR: To date, okay.
11 MS. NISHIMI: Keeping in mind that we don't
12 foreclose additional information coming in from any area.
13 MR. BROWN: Another thing to consider is --
14 DOCTOR KIDD-TAYLOR: We are comfortable with the
15 staff having sufficient background information presented
16 here to make, to suggest those possible recommendations.
17 MS. GWIN: We don't really -- I mean, we may want
18 to recommend just to make sure that the committee goes on
19 record, but we don't need to recommend that they look at the
20 French and Czech detections because, in fact, they are.
21 DOCTOR KIDD-TAYLOR: They are, okay.
22 MS. GWIN: And so the point of this recommendation
23 was more toward emphasizing the committee's belief, if it
24 exists, that the PGIT has a role in explaining these things
25 to the veterans satisfactorily, as best they can, more than
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1 what work they ought to be doing.
2 MS. NISHIMI: And it's done in the context of
3 detection.
4 CHAIRPERSON LASHOF: I think it's going to be very
5 hard to keep it clear that that's what we're talking about
6 without it looking like we're getting into the other and yet
7 not doing an adequate job. I'd be happier to limit three
8 and four, and don't see that two adds an awful lot. I mean,
9 clearly, the whole work of the PGIT and our work and
10 everything else is designed to deal with the concerns the
11 veterans have, and I think it muddies the water, in my mind.
12 MS. GWIN: Okay.
13 CHAIRPERSON LASHOF: But further -- Anyone agree
14 or disagree with me?
15 DOCTOR KIDD-TAYLOR: Well, I guess the other part
16 is the checks that's there will still remain so removing
17 that recommendation I think will not --
18 MS. NISHIMI: Well, but you -- I think you need to
19 consider finding ten and whether or not you want that.
20 DOCTOR KIDD-TAYLOR: Oh.
21 CHAIRPERSON LASHOF: Yeah, I was going to ask
22 about that, too, because doesn't finding ten really relate
23 to alleged incidents?
24 MS. GWIN: Incidents of detection.
25 CHAIRPERSON LASHOF: But --
263
1 MS. GWIN: And incidents that challenge the
2 reliability of the detection equipment.
3 CHAIRPERSON LASHOF: But the problem is that from
4 the veterans' point of view the equipment went off;
5 therefore, there were exposures. Those are the basis for
6 their saying there were alleged incidents. The response has
7 been, "Those weren't alleged incidents. Those were the
8 alleged detection equipment." And to say, "Well, it's
9 detection equipment, not alleged incidents, would require
10 our having looked at the alleged incidents and be satisfied
11 that, indeed, it was detection equipment and not alleged
12 incidents. Because that's a concern. The veterans aren't
13 concerned about whether the equipment is good or bad -- I
14 mean, they are -- but they're really concerned because the
15 equipment went off and, in their mind, that means there was
16 an alleged incident, and it's very difficult to separate a
17 discussion of the technical capability of the instrument
18 from the broader issue of the alleged incidents. And trying
19 to separate these two issues is just difficult for me.
20 MS. NISHIMI: If the staff could get a sense then
21 whether or not -- and my staff is that the committee is
22 comfortable with three and four -- if the staff could -- if
23 the committee could give the staff, if you will, a clear up
24 or down on ten and two.
25 DOCTOR KIDD-TAYLOR: So, at this point, Joyce,
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1 what I'm hearing is that maybe we should remove ten and two
2 at this time since we have not --
3 CHAIRPERSON LASHOF: I'm tempted to but, you know,
4 I don't want to dictate this.
5 DOCTOR CUSTIS: May I offer a minority opinion?
6 CHAIRPERSON LASHOF: Pardon?
7 DOCTOR CUSTIS: May I offer --
8 CHAIRPERSON LASHOF: Please. I don't really --
9 DOCTOR CUSTIS: Listening to this conversation, it
10 seems to me you ought to consider -- You know, after all,
11 there's a satisfactory volume of material already available
12 for the interim report without getting into too much detail
13 about CBW. Why not consider just a statement of where the
14 staff is at the present time regarding CBW and saying that
15 findings and recommendations will be dealt with in detail in
16 the final report? If, at this point in time, a few
17 recommendations are offered based on tentative findings, it
18 just invites criticism for inadequate reporting on the part
19 of the readers.
20 MS. NISHIMI: I would argue that the findings
21 related to both the UNSCOM data -- on the staff's behalf I
22 would argue -- and the findings related to the detection
23 systems, five through none, aren't tentative and that they
24 do support the recommendations three and four.
25 DOCTOR CUSTIS: I'm not arguing the point, I'm
265
1 just saying can't this be better dealt with in the final
2 report rather than getting into that level of detail in the
3 interim report?
4 MS. NISHIMI: Certainly that's something for the
5 committee to decide, whether or not they want to address
6 CBW. The staff's recommendation at this point is that it be
7 included in the interim report, but there's no reason that
8 it couldn't be addressed in the final report.
9 CAPTAIN KNOX: I think veterans are looking to see
10 what we have to see about CBW so I think it's a very
11 important thing to put in the interim report just so they'll
12 know that we're looking at it.
13 DOCTOR KIDD-TAYLOR: And I really don't have any
14 problems with it being included in the interim report. As
15 you mentioned earlier, it will be a start. We want to give
16 them some information in this report and the recommendations
17 that are made, if remove two and finding ten, I believe are
18 good ones for DOD and CIA to consider at this point, from
19 what we know from what the staff has done.
20 DOCTOR BALDESCHWIELER: Which ones are you in
21 favor of?
22 DOCTOR KIDD-TAYLOR: Recommendations one, two,
23 three, and four, and removing the finding ten and two.
24 MR. BROWN: Recommendation two.
25 DOCTOR KIDD-TAYLOR: And recommendation two. I'm
266
1 sorry. Recommendation two and ten can be found on page six.
2 DOCTOR BALDESCHWIELER: It seems to me that
3 recommendations three and four make good sense.
4 MS. NISHIMI: Okay. I think the staff --
5 CHAIRPERSON LASHOF: My own view, as I said at the
6 start, my first temptation was to save all of this. Staff
7 have convinced me that the statement about CIA is important
8 and could have an impact now; therefore, I'm willing to but
9 CBW in. I'm still torn whether we would limit it to that
10 part -- I'm sorry, drive you nuts over there, won't I.
11 Sorry about that. The detection equipment stuff, if one
12 starts in it, whether you can separate it. I guess you
13 could if we stick to recommendations three and four, leave
14 out finding ten.
15 MS. NISHIMI: And recommendation two.
16 CHAIRPERSON LASHOF: And leave out recommendation
17 two. Yeah, I guess that does it because we deal then just
18 with --
19 MS. GWIN: Technology.
20 CHAIRPERSON LASHOF: -- technical things and
21 technology, and limit ourselves. And then we say here's all
22 the things we've got to do later.
23 DOCTOR KIDD-TAYLOR: And, as John mentioned, there
24 are -- there is capability for low level monitoring. It's
25 not in there so we can add that.
267
1 DOCTOR BALDESCHWIELER: If you're going to get
2 into the equipment business there, it seems to me there's an
3 important, I guess overall systems architecture that is
4 useful to think about rather than focusing on an individual
5 sensor. There's a whole series of sensors, in a cascade,
6 all of which typically have a high false positive rate, and
7 what you want to avoid is -- And, for example, it starts
8 with a simple paper, and that's issued essentially to every
9 soldier, and that's nothing more than a PH sensor and it has
10 a response of if some aerosol falls on you that causes the
11 paper to change color, then you put on your mask fast and
12 find out what to do next. And then at the next level of
13 organization there, you know, are somewhat more
14 sophisticated detectors, until finally you get to the Fox
15 vehicle that has a mass spectrometer which is definitive.
16 And so, you know, it's in this kind of cascade you don't
17 want to have a mass spectrometer issued to every platoon.
18 And so I think, you know, you'll find efficiencies, in a
19 sense, at every level and the important thing is that they
20 be on the side of false positives instead of false
21 negatives. I don't know how deeply you want to go into the
22 philosophy of setting up the systems architecture but it's
23 perhaps worth, you know --
24 MR. BROWN: Well, we've had briefings on what's
25 called chemical weapon doctrine, which is exactly what you
268
1 described. There's a whole -- I mean, these things aren't
2 independent. There's various detections that are supposed
3 to operate an integrated whole. The problem is that there's
4 no part of that integrated whole that is looking at low
5 level detections. It's all oriented towards --
6 DOCTOR BALDESCHWIELER: That's absolutely right.
7 MR. BROWN: And so what we could look at is --
8 DOCTOR BALDESCHWIELER: And I think the other part
9 of the philosophy -- You're right on target, that is to say
10 that is focused on battlefield operations and, you know, if
11 you're going to carry out your mission then low field
12 exposure is not relevant at --
13 MR. BROWN: At that time.
14 DOCTOR BALDESCHWIELER: -- that time. Now, other
15 countries have designed it differently. My understanding of
16 the Soviet system is that they have detectors in their
17 cascade that go to lower levels.
18 MR. BROWN: I wasn't aware of that.
19 DOCTOR BALDESCHWIELER: Yes.
20 CHAIRPERSON LASHOF: That's very helpful. So you
21 would feel comfortable that we go the way you want with
22 maybe staff getting some more of that --
23 DOCTOR BALDESCHWIELER: The overall system --
24 CHAIRPERSON LASHOF: -- thinking that you've just
25 expressed?
269
1 DOCTOR BALDESCHWIELER: Yeah, the --
2 MR. BROWN: We have a start on that. We've got --
3 CHAIRPERSON LASHOF: Incorporating in their
4 finding or discussion?
5 MR. BROWN: We could do that.
6 DOCTOR BALDESCHWIELER: Yes, the overall systems'
7 architecture and sort of the rationale behind that.
8 MR. BROWN: We didn't have time to get into that
9 in this document but we have some work on that that we could
10 add.
11 CHAIRPERSON LASHOF: Good. Okay. Staff pretty
12 clear where we stand? Is the committee pretty clear where
13 we stand?
14 DOCTOR KIDD-TAYLOR: Yes, I'm clear.
15 CHAIRPERSON LASHOF: Okay. Very good. All right.
16 That finishes up CBW.
17 Moving right along. Thank you, Holly, very much,
18 and Mark. That's really great.
19 The next one is tab C on "Medical Examinations," -
20 - "Clinical Issues," rather.
21 Okay. Take a -- excuse a couple of people and let
22 a couple of people in.
23 (Pause.)
24 CHAIRPERSON LASHOF: Okay. We welcome Joan Porter
25 and Joe Cassells to the table to join Holly. Who's kicking
270
1 it off, Joe or Holly? Joe. Okay, Joe.
2 JOE CASSELLS, REPORT ON MEDICAL EXAMINATIONS
3 MR. CASSELLS: Thank you very much. The charter
4 calls to the Advisory Committee to provide advice and
5 recommendations on the medical examinations and treatment in
6 connection with Gulf War veterans' illnesses and we intend
7 to do that by focusing on three main issues related to
8 medical examinations and treatment.
9 One we have title "Access to Care for Veterans,"
10 for ease of relationship to it, but access to care not only
11 involves is quality care available and is it effective but
12 also what makes up that care, what are the components of the
13 clinical evaluation, how easy it is for veterans to avail
14 themselves of those services.
15 You've heard at our previous meetings public
16 testimony, and as late as yesterday, about perceived
17 difficulties and real difficulties in gaining access to
18 medical care, and we are taking a close look at this by not
19 only taking the testimony but also conducting site visits.
20 We have completed two site visits to date. We have another
21 one planned this week, and then we have several others
22 planned later in December to take a look at what is
23 available in the facilities themselves.
24 We already know that there has been problems,
25 there have been problems in the beginning in the
271
1 implementation of the treatment programs as they were coming
2 on line and variabilities between institutions, and some
3 evidence of some institutional biases in terms of the kind
4 of diagnoses that were made, particularly in the area of
5 psychological examinations. That seems to have settled down
6 a bit as the program has gotten more in place but we want to
7 take a closer look into the evolution of that.
8 It appears that the major difficulties in access
9 have occurred at the initial access points more often than
10 they have occurred at the second and third levels of
11 referrals.
12 We know that when we make site visits that we're
13 going to be shown the best elements of the operations that
14 we see, and it is up to us to inject our own interpretations
15 of what we're being told and what we've been seeing. But,
16 to follow up on what we've seen in the site visits, we're
17 also intending to -- by using a contract with an experienced
18 organization not yet determined -- conduct focus groups to
19 assess what the veterans themselves feel about access to
20 clinical care and the quality of that care. Rather than
21 relying upon the public testimony that we've heard so far,
22 we would like to have a randomized sample done by people
23 whose business it is to conduct focus groups so that we can
24 put this package together with some certainty of what the
25 findings are.
272
1 We do know that there has been a failure to
2 communicate to the veterans' organizations and the veterans
3 themselves what the exact meaning of "priority care" is.
4 "Priority care" means that there is no means test. It reads
5 to the utterings, in many instances, that "priority care"
6 means head of the line privileges and that has led to a
7 massive misunderstanding on the part of the Gulf War
8 veterans when they initially access the system.
9 One of the things that we have been interested in
10 pursuing --
11 CAPTAIN KNOX: Go ahead and interject there since
12 we didn't get that clear there about the "priority care"
13 being extended.
14 MR. CASSELLS: Okay. The question came up
15 yesterday about the extension of "priority care" to the
16 veterans of the Gulf War, which was due to expire at the end
17 of this year. Legislation has been passed by the Congress
18 which extends that eligibility at least through 1998. And,
19 as you heard yesterday, Doctor Kizer indicated that there
20 was no intent on the part of the Veterans' Administration to
21 do otherwise.
22 CAPTAIN KNOX: Thank you.
23 MR. CASSELLS: One of the things that we have not
24 taken a look at yet in any kind of depth but one that we
25 feel to be very important is psychological stress and its
273
1 physiological sequela.
2 We all know that reactions to stress, stresses of
3 all sort, do produce physiological reactions that do result
4 in illnesses and that those illnesses are very real. We
5 also know that the veterans that we have been dealing with
6 in the Gulf War veterans era are reluctant to accept stress
7 as the predisposing factor or the cause of any illnesses
8 that are being manifested at this point. We want to take a
9 good look at stress and at the physiological sequela of
10 stress and draw what conclusions we can from that
11 information. We want to do that by convening a workshop or
12 seminar to look at stress and its sequela not only from
13 combat stress but the stress associated with relocations,
14 and there was a great deal of disruption and relocation of
15 individuals during the deployment to the Gulf War, as well
16 as other elements of stress and the body's reactions to that
17 stress and how it manifests itself as illness.
18 We feel that for the focus of the interim report
19 that we should confine ourselves to the issues surrounding
20 mobilization because the mobilization policies and
21 procedures have been very well looked at now and I think we
22 can make definitive conclusions and recommendations, and
23 those are outlined for you at tab C.
24 The successful conduct of military operations,both
25 in the Gulf War and in the future, are going to require
274
1 increasingly reliance upon the reserve and the guard forces.
2 With the downsizing of the active duty military and with the
3 ending of the cold war, this is inevitable. With that in
4 mind, policies and procedures that were extent at the time
5 of the Gulf War deployment are important and things that we
6 need to take a look at, and they have been looked at.
7 There was a DOD -- is a DOD instruction in place
8 which specifies the medical and physical standards for
9 active duty personnel as well as reserve and guard, and
10 those standards are the same for both elements.
11 Prior to 1986, the standard against which physical
12 medical fitness was determined was worldwide deployability.
13 In 1986 worldwide deployability was no longer the standard
14 and individuals who had medical conditions that could be
15 treated and were consistent with continuing to perform their
16 military duties in garrison were allowed to be retained in
17 the reserves and on active duty, and they were supposed to
18 be profiled or have the limitation on their deployability
19 included in their records.
20 At the time of mobilization for the Gulf War
21 individuals who were mobilized were screened prior to going
22 to the mobilization site and, in many instances, individuals
23 were determined to be non-deployable and were replaced by
24 other individuals in order to have a full compliment of
25 members to go to the mobilization site. We don't know,
275
1 because the data no longer exists, if it ever did, how many
2 of those people there were. At the mobilization sites, all
3 of the services required medical screenings and we also know
4 that not in every instance were those medical screenings
5 carried out.
6 Members of the guard and the reserve were required
7 to have physical examinations every four years at the time
8 of the Gulf War deployment, and annually they were required
9 to submit a statement of their medical status. Those
10 statements were required in writing, in some services, and
11 not in writing in others, but they were to be determined.
12 There was no quality control mechanism to ensure that what
13 was the policy was actually being implemented, and we have
14 much evidence that was, in fact, not happening.
15 Physical fitness, for instance, which is an annual
16 requirement for members of the reserve and active duty, were
17 carried out but physical fitness testing, even when there
18 were failures, there was documented evidence that some of
19 those failing marks were changed to passing marks and that
20 was not a matter of record.
21 We also know that the DOD instruction required
22 that the physical fitness of the reserve and the guard, as
23 well as the active duty, were to be reported on an annual
24 basis to the Department of Defense, but that was not
25 enforced and that was not happening.
276
1 During the period of the deployment both active
2 and reserve personnel who developed medical problems were
3 evaluated in the field, they were treated and returned to
4 duty or they were hospitalized and returned to duty, or they
5 were evacuated from the theater of operations. Interactions
6 with the medical care system, in the theater of operations,
7 were documented in various ways but the documentation of
8 those interactions and any immunizations that may have
9 occurred in the field, or any other medications that may
10 have been taken, do not continue to exist in any systematic
11 fashion. The lack of documentation and the missing medical
12 records have been a major factor in the veterans' believe
13 that the absence of that information is perhaps evidence of
14 cover up. That lack of documentation is a serious problem.
15 At the time of demobilization, it was DOD policy
16 that each member of the ready reserve who was released from
17 active duty was required to comply with the requirements for
18 their separation physical examination. The Army extended
19 that requirement to both active duty and reserve members,
20 and the published guidance did take in the components of the
21 post-deployment physical examination where promulgated.
22 The Air Force authorized a separation physical
23 examination if the member requested it. If the member's
24 previous physical examination was less than five years old
25 the scope of the exam consisted of a medical history and a
277
1 focused physical examination if something was turned up to
2 be of note.
3 If being returned to a drill status, the medical
4 record was reviewed and the reservist was asked if there was
5 any change in his health status. If not, the member signed
6 a statement to that effect and was released. We've had many
7 accounts of inadequacies in that demobilization process.
8 The General Accounting Office, in it's 1994
9 report, titled "Reserve Forces DOD Policies Do Not Ensure
10 That Personnel Meet Medical and Physical Fitness Standards,"
11 identified a number of problems, most of which are the ones
12 I've already outlined for you, and made a number of
13 recommendations to correct them.
14 DOD concurred with those GAO findings in large
15 part and agreed to take the necessary actions to correct
16 some of the problems.
17 The Assistant Secretary of Defense Health Affairs
18 has mandated the use of a report of medical assessment, a
19 standard report of medical assessment, for all service
20 members separating or retiring. His memorandum, which is
21 dated May 10, 1995, also directs any separating or retiring
22 service member who desires a complete physical examination
23 is entitled to receive that examination.
24 There is in circulation now a draft DOD
25 instruction titled "Joint Preventive Medicine Support of
278
1 Military Operations," and that is included in your tab C at
2 the back of this memorandum, and it states: "It is DOD
3 policy that the military departments shall conduct joint
4 preventive medicine support of military operations to
5 include comprehensive medical surveillance. Surveillance
6 shall be in effect continuously for each individually
7 service member throughout their entire period of military
8 service in a manner consistent across the military services.
9 The surveillance process shall be specifically configured to
10 assess the effects of deployment on the health of the
11 service member. An accurate exposure history of each
12 individual service member shall be maintained throughout
13 their military service."
14 DOD has also informed the committee that they are
15 rewriting their exaction and retention standards and that
16 review -- that construction is currently under development.
17 It is my understanding that the recommendation that GAO made
18 that the Department of Defense returned to the standard of
19 worldwide deployability was not accepted by DOD, but I do
20 not know what that standard is currently since we have not
21 seen the draft instruction. That leads to the two findings
22 you find on page four, under tab C. The first one:
23 "It is clear that there was no uniformity among
24 the services and their predeployment policies and procedures
25 and little evidence of good quality control procedures in
279
1 order to ensure that what policies were in force were
2 actually being carried out." As a result, the committee
3 finds that it cannot definitely answer the question: Were
4 the troops healthy when the arrived in the Gulf? Were they
5 healthy when the deactivated?
6 It may be that pre-existing conditions are
7 responsible for some portion of the Gulf War illnesses
8 reported but the committee does not have data to support
9 that surmise.
10 Finding two. Both DOD and VA have admitted to
11 problems with missing or lost medical records but neither
12 system presently had appeared to place a priority on
13 correcting these problems. At the committee meeting in
14 September, the comment offered was, "It's amazing how often
15 the records do finally marry up." The issue of accurate
16 medical and vaccination records is central to the concerns
17 of many ill veterans and their absence has been suggested by
18 some as evidence that the government is engaging in a cover-
19 up of it's own predeployment practices because those very
20 practices are causes for illness.
21 We make three proposed recommendations:
22 Recommendation one. That DOD should assign a high
23 priority to dealing with the problem of lost or missing
24 medical records. Medical records should be computerized to
25 the maximum extent possible, and that various databases must
280
1 be compatible. Attention should be directed toward
2 developing ID cards with microchips containing medical
3 information. The DOD draft instruction, rather than
4 referring to a medical microchip, refers to a device. We
5 may want to modify our language as well.
6 Recommendation two. DOD should develop a uniform
7 set of policies and procedures to govern the mobilization,
8 predeployment, in-service medical monitoring -- that is the
9 medical surveillance -- post-deployment, and demobilization
10 of guard and reserve personnel.
11 And I particularly feel that recommendation three
12 is appropriate, that DOD should establish a quality
13 assurance program to assure compliance with the established
14 policies in those procedures in recommendation two.
15 The draft instruction is not clear as to that
16 quality control mechanism.
17 Joan Porter is going to follow me with a
18 discussion of how we intend to approach the issue of the
19 ethical questions surrounding the waiver of informed consent
20 for the use of botulinum toxoid and pyridostigmine bromide
21 as a pretreatment for treatment to nerve agents. Joan.
22 CHAIRPERSON LASHOF: Before -- Well, just as a
23 matter of process, I think before we dig into what Joan's
24 going to cover, it's really quite different and separate, it
25 seems to me, and maybe it would be more efficient, or at
281
1 least keeping our minds on track, to go ahead and discuss
2 what you've presented in these recommendations and then go
3 to Joan. It helps us focus who can't focus on too many
4 things at one time.
5 MR. CASSELLS: Whatever the committee likes.
6 CHAIRPERSON LASHOF: Thanks, Joe.
7 CHAIRPERSON LASHOF: Okay. Reactions to the
8 findings?
9 MR. RIOS: My first reaction is in finding A, the
10 last sentence, "It may be that pre-existing conditions are
11 responsible for some portion of the Gulf War illnesses
12 reported but the committee does not have data to support
13 that surmise." I'm wondering why you have that sentence
14 there. Is there some kind of a concern that a lot of these
15 illnesses that are being complained of may have existed
16 there before the deployment?
17 MR. CASSELLS: There is some concern. We do not
18 know how many people went to the Gulf with pre-existing
19 conditions that may be the explanation for the illnesses
20 they are describing now. That's a question that we cannot
21 answer and that's why it's there. The problems with the
22 information surrounding deployment and the problems in the
23 deployment mechanisms lead to that conclusion, that's why I
24 say there's an absent piece of information.
25 CHAIRPERSON LASHOF: Yeah, but I don't -- I'm with
282
1 you, Rolando.
2 MR. RIOS: I don't really -- I mean, I think it's
3 premature, too, because I think one of the reasons we're
4 here is to see if we can provide a service to the veterans,
5 and this sounds like -- at least publicly it could sound
6 like, you know, the committee's looking at the possibility
7 that maybe these are problems that existed before, and I'm
8 just not sure that that's something that we want to put out
9 there at this early a stage.
10 CAPTAIN KNOX: Rolando, I think that was to show
11 that the physicals for predeployment were not really
12 physicals, they were just screenings, and so when you came
13 home and you got an exit physical there were problems there
14 but you had no way to validate that they weren't there
15 before because you didn't get that kind of physical prior to
16 deployment. And I really think that was to show the -- I
17 don't want to say how poor the predeployment physical was
18 but they don't balance.
19 MR. RIOS: Well, I think maybe we ought to say
20 that obviously the preexisting physicals were inadequate and
21 add to the confusion as to what happened while they were
22 over there. I think that's what I would be willing to say.
23 MR. CASSELLS: We can certainly modify the
24 language.
25 CHAIRPERSON LASHOF: I share that concern, because
283
1 it implies the say that's worded, Joe, it implies that a
2 fair number of people think that that's really the answer,
3 that these people were really sick before they went and
4 that's what we're dealing with. I don't know that that's a
5 widespread feeling even among those who may not feel there
6 is such a thing as the Gulf War Veterans' Illness. I've not
7 heard and maybe you have, so you could tell me more, that
8 many feel that their actual illness is due to the fact that
9 they were that sick before.
10 DOCTOR CUSTIS: Just a point for clarification. I
11 think any veteran who is concerned that perhaps it could be
12 proven he had a preexisting situation, that that might
13 compromise the opportunity for compensation based on his
14 physical condition at the time of discharge. That is not
15 true. He should be reassured that that's not true, because
16 if he is accepted, whether or not an adequate physical exam
17 had been performed, if he is accepted for duty and it turns
18 out that there was a preexisting condition in his record, in
19 a record, he still is subject to review for compensation
20 from the standpoint of aggravation.
21 MR. CASSELLS: Precisely, yes.
22 MAJOR CROSS: And I agree with that. I think
23 there is a lot of confusion that exists for what Doctor
24 Custis just said, and that really needs to be clarified to
25 the veterans.
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1 MR. CASSELLS: Does the committee want to put
2 language into the interim report to that effect?
3 CHAIRPERSON LASHOF: I don't know whether it fits
4 particularly, and we're --
5 MAJOR CROSS: Personally, preexisting condition, I
6 just -- in my mind, I want to get back to some of the
7 comments I've heard from veterans. It's more that service
8 in the Gulf initiated physical problems that they didn't
9 have before. When I start hearing about preexisting
10 conditions, I was familiar with a number of cases of that.
11 In my mind, I just need to separate that preexisting
12 conditions, one, became evident during the call-up and,
13 number two, may have been aggravated by the call-up and,
14 therefore, made itself present. Again I still, in my mind,
15 I need to separate for a lot of those people, you know, they
16 did not necessarily suffer from a Gulf War Syndrome, per se,
17 they had a preexisting condition which may have been a heart
18 condition that was just aggravated by the whole process of
19 call-up and deployment.
20 MR. CASSELLS: It's a fact that whatever the
21 diagnosis is in a veteran who has returned from the Gulf,
22 let's say, whatever that diagnosis is, you still have to
23 answer the question of, "Did service in the Gulf exacerbate,
24 in some way inflame, in some way make worse the condition
25 that you took to the Gulf?" That's an issue on the
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1 compensation side of the equation but that, you know,
2 service in the Persian Gulf could aggravate preexisting
3 conditions. Those are compensable.
4 CAPTAIN KNOX: Well, and I think there are some
5 veterans who did have preexisting conditions that were not
6 validated prior to being deployed who really should not have
7 been deployed.
8 MAJOR CROSS: Oh, without doubt that absolutely
9 happened, because -- Especially in my experience a lot of
10 service members who invest a lot of time in reserves and
11 when the call-up began, they will not necessarily stand up
12 and say, "Hey, I got a problem. I don't want to go."
13 Because everyone got caught up in the shuffle to go.
14 Everyone wanted to go, so a lot of people hid the fact of
15 conditions.
16 MR. CASSELLS: What we're trying to highlight here
17 is the problematic nature of the deployment.
18 CAPTAIN KNOX: Of the predeployment screening.
19 CHAIRPERSON LASHOF: Right. And I think we would
20 do it better, Joe, if under that finding -- The first
21 sentence of finding eight is clear and is well stated, but I
22 think the next three sentences don't really express what I'm
23 hearing as well as we might. I think what we just want to
24 say flat footedly there is that the finding is that the
25 predeployment physicals, policies and process were not
286
1 adequate. First, they're not uniform but then they were not
2 adequate to prevent people with preexisting conditions.
3 DOCTOR CUSTIS: You do want to say in all cases,
4 don't you, Joyce, "were not adequate in all cases?"
5 CHAIRPERSON LASHOF: Yeah. Yeah. I mean, you
6 know, we don't want to say none were adequate. You know,
7 they weren't adequate in all cases to prevent deployment of
8 people with preexisting conditions that should not have led
9 to deployment. Obviously you can clean up the wording. I
10 think that's really all we have to say. I don't think we
11 have to speculate here as to whether these conditions are
12 responsible for some of the illnesses we're now seeing or
13 not. You know, that may be something we'll get into at a
14 later date but we haven't dug into that enough.
15 Holly's got a question?
16 MS. GWIN: I have a slight logic problem related
17 back to the charter that I don't want to hold up as a
18 barrier but if we are not, as a committee, making some
19 connection between predeployment problems with the
20 physicals, and things like that, and the outcome, the fact
21 that some Gulf War veterans are now inexplicably ill, it may
22 be beyond our scope to be delving in depth into the
23 predeployment procedures. Our charter calls for us to look
24 at medical treatment related to Gulf War veterans'
25 illnesses, not the best expanse of medical treatment in the
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1 military.
2 CHAIRPERSON LASHOF: Yes, yes, yes.
3 CAPTAIN KNOX: Can you really look at one without
4 looking at the other? I mean, if you're looking at a Phase
5 I physical you have to have some type of baseline to compare
6 that to.
7 CHAIRPERSON LASHOF: Yeah. I think Holly's
8 concern, though, is that we did very clearly say if you get
9 into clinical issues you could look at the whole VA system,
10 the whole DOD system, and we clearly don't want to do that.
11 CAPTAIN KNOX: All right.
12 CHAIRPERSON LASHOF: We're trying to focus our
13 concerns on those aspects of the VA and the DOD system that
14 impact on Gulf War veterans' illness, otherwise we could do
15 a ten-year study of VA hospitals, DOD and so on. But I'm
16 not sure that here, since we're talking about predeployment
17 physicals, that's clearly related to Gulf War. It's not
18 related to anything else. Now, does it have to show that
19 it's related to the illness, per se?
20 CAPTAIN KNOX: Not necessarily.
21 CHAIRPERSON LASHOF: Aren't we splitting hairs a
22 little bit, Holly?
23 MS. GWIN: If you feel -- I mean, it's certainly
24 within your purview to do this. I'm just saying it's
25 something that has raised itself as a concern in my eyes,
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1 that we not grope too far for recommendations to make about
2 predeployment if we don't honestly believe there's some
3 relationship to the breakdown in these predeployment
4 practices and the outcome that we're concerned about, which
5 is Gulf War veterans' illnesses.
6 DOCTOR KIDD-TAYLOR: There may be some
7 relationship but we don't have the data or the --
8 CHAIRPERSON LASHOF: Well, that's what he's trying
9 to say there and, I guess, how do you say that to cover your
10 point without making it sound like we think that these
11 preexisting conditions are the problem and, you know, if we
12 had just done better physicals we wouldn't have a problem
13 today. We don't think that.
14 DOCTOR KIDD-TAYLOR: No.
15 CAPTAIN KNOX: No.
16 CHAIRPERSON LASHOF: And, so --
17 DOCTOR KIDD-TAYLOR: I think taking out what you
18 mentioned, which would be from -- the questions, beginning
19 with "as a result," that would take care of that. In my
20 mind it does, if you remove "as a result" to the very end of
21 that statement. That's --
22 CHAIRPERSON LASHOF: I guess, you know, what I was
23 substituting for those three sentences was something to the
24 effect that as a -- you know, that the inadequacies or the
25 lack of, whatever, led to some being deployed who may not --
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1 should not have been and could have contributed to some of
2 their problems. You know, just to those. Something like
3 that.
4 MS. GWIN: You had language before that, "Could
5 not prevent deployment of people with preexisting
6 conditions."
7 CHAIRPERSON LASHOF: And then you could add, to
8 satisfy you, something to the effect, "and this could have
9 contributed to some of their problems," and, you know, not
10 to all Gulf War illness but to some of the problems that
11 those particular people who got sent over -- You get the
12 sense of what we're trying to say?
13 MR. CASSELLS: Yes.
14 CHAIRPERSON LASHOF: I'll let you play with the
15 English.
16 DOCTOR CUSTIS: I have another comment, Joyce.
17 CHAIRPERSON LASHOF: Please.
18 DOCTOR CUSTIS: Concerning recommendation number
19 one. Joe, I head from the Navy Surgeon General several
20 months ago that the Navy does have under development ID
21 cards with microchips.
22 MR. CASSELLS: They've been looking at it for --
23 all of the services have been looking at it for some while,
24 and the DOD instruction, as I say, also mandates that the
25 services develop a device for monitoring and carrying
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1 medical information interactions through the system.
2 DOCTOR CUSTIS: But this sounds like we're telling
3 them to do something they haven't started doing, "attention
4 should be directed toward developing." Don't you want to
5 say something -- is your language what you want there?
6 MR. CASSELLS: Until this new draft instruction is
7 signed and the services have drafted instructions
8 implementing it, I think that the committee is certainly
9 within its rights to make recommendations.
10 CAPTAIN KNOX: Well, I think Don, that the Navy is
11 indeed, but is the Army and the Air Force and the Marines,
12 are they doing that?
13 MAJOR CROSS: Well, the other thing is we're
14 making a value judgment of that's the best system, and, for
15 each of the services, I'm not sure that is the best system.
16 I automatically think that computerized medical records
17 could simply be a faster way to do it and might even be less
18 expensive than the microchip on an ID card. I just what I'm
19 saying is I understand what you're saying and it makes sense
20 to me, but I don't know as a committee we want to tell the
21 services exactly what to do.
22 CAPTAIN KNOX: Right.
23 MAJOR CROSS: I think we just need to touch the
24 subject and say --
25 MR. CASSELLS: Well, we can substitute --
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1 CAPTAIN KNOX: The device or --
2 MR. CASSELLS: The device or mechanism, or
3 something.
4 MAJOR CROSS: Instead of specifying, right, let
5 them come up with a better system. Let's say a better
6 system. If you want to say, "such as," I --
7 DOCTOR BALDESCHWIELER: And, you know, the there's
8 another point on recommendation one and that is you need a
9 quality assurance -- a QA step in getting the data into the
10 system. I mean, there's an enormous garbage in problem in
11 here, and it seems to me one of the ways you can help to fix
12 that is to have the individual at least have access to those
13 records so he can see a readout and see a if what's in there
14 really corresponds to what he thinks he's had. And also, it
15 seems to me, there will be many instances where people are
16 in the field where you don't have the computer connection
17 and so will there have to be a paper backup anyhow? How do
18 you deal with, you know, assignment to places where you
19 don't have a high band with --
20 MR. CASSELLS: Well, the burden of the draft
21 instruction, if you will read it carefully, is the services
22 are directed to develop a system that they can take to the
23 field for this interaction. We've not seen that final
24 instruction. We've not seen the services' implementation
25 instructions, either. So we don't, at this stage of the
292
1 game, know what that's going to look like.
2 DOCTOR BALDESCHWIELER: I think I'm standing in
3 the same place Tom is.
4 MAJOR CROSS: Yes, absolutely. And I just thought
5 of something. If you put a microchip on an ID card, if the
6 individual gets -- steps on a landmine and it's destroyed,
7 you've automatically lost the medical record. So you do
8 need a backup in that sense. I'm back to -- I don't think
9 we necessarily need to dictate to the services exactly what
10 system they should use.
11 CAPTAIN KNOX: I agree. I don't think we need to
12 dictate it but I think we know we need to state that it
13 needs to be done, and how they go about doing it is their
14 business.
15 MR. CASSELLS: So why don't we think in terms of
16 mechanism?
17 CAPTAIN KNOX: To change the word "microchip" to
18 "mechanism," I agree.
19 MR. CASSELLS: And with the appropriate modifiers.
20 DOCTOR BALDESCHWIELER: I mean, certainly having
21 somewhere a central computer database is enormously useful
22 because if the records are lost you can reproduce them.
23 MAJOR CROSS: You know, the systems already done
24 for pay records, for a lot of personnel records already, and
25 so it leads to the question, "What about the medical
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1 records?"
2 CHAIRPERSON LASHOF: I think our problem here,
3 Joe, is that we've looked at the predeployment physicals, we
4 know that medical records aren't in great shape. We haven't
5 dug deeply into all the different possibilities of how one
6 can deal with medical records to make them better. We all
7 know that computerization is logical but, beyond that, we
8 probably aren't in a position to make definitive
9 recommendations in this area, nor do I think we need.
10 I guess I do think that saying something about the
11 importance of a central, a good computerized central
12 database is essential and that the mechanism for developing
13 and maintaining that, you know, an be left open. You know,
14 they've got to determine what's the best way to do that.
15 But, from the point of view of trying to look at
16 the part that's our charge, again here's another question
17 where you have to relate it to the problem of identifying
18 illnesses that happen after the war, and the problems we're
19 into on it are, epidemiologic search and so forth, really
20 are around the fact that there's no decent centralized
21 computer database that enables us to easily do some of the
22 epidemiologic that we'd like to do. And I think that's some
23 of what you're getting at here.
24 MR. CASSELLS: Okay. We can certainly modify
25 recommendation one along those lines, emphasizing the
294
1 importance of a centralized database and then drop the
2 specifics of how you do it.
3 DOCTOR CUSTIS: And how you get that information
4 to the field.
5 CHAIRPERSON LASHOF: Yeah.
6 MR. CASSELLS: Right.
7 CHAIRPERSON LASHOF: Holly?
8 MS. GWIN: Do you even want to drop reference of
9 computerized or is --
10 CHAIRPERSON LASHOF: There's no way you're going
11 to have a central database unless it's computerized, and I
12 know, for instance, that John White would love us to say
13 they've got to do something about their computer system.
14 MS. GWIN: So that's not too specific?
15 MR. CASSELLS: How about recommendations two and
16 three?
17 DOCTOR BALDESCHWIELER: On recommendation two, do
18 you feel that the policies as they exist are adequate? I
19 mean, we only have two issues. One, are the policies and
20 procedures adequate and, two, are they executed? And I
21 think you deal with the execution adequately but, in number
22 two, "develop a uniform set of policies and procedures,"
23 should there be better or different?
24 MR. CASSELLS: Well, they should develop it better
25 as well as uniform.
295
1 DOCTOR BALDESCHWIELER: And better, in this case,
2 would be more thorough?
3 MR. CASSELLS: More thorough.
4 CHAIRPERSON LASHOF: Yeah, do we want to be more
5 specific? I find that's so wishy-washy, I mean, "develop a
6 uniform..." They could develop it uniformly bad or
7 uniformly inadequate. It could be uniform and not very
8 good. What is it we're really trying to get at? What you
9 really want is a set of policies that will guarantee, as
10 much as one can, that people who shouldn't be deployed
11 aren't deployed.
12 MR. CASSELLS: That's correct.
13 CHAIRPERSON LASHOF: That's what you're really
14 saying.
15 MR. CASSELLS: And that the reserve and guard
16 components and the active duty military components meet the
17 medical and fitness standards required for whatever the
18 deployment rationale is.
19 CHAIRPERSON LASHOF: What we're really
20 recommending is that their policies be reviewed and upgraded
21 to assure that, exactly what you just said. Don't you
22 think?
23 Tom?
24 MAJOR CROSS: I fully agree with that. I think
25 most of the services, I know for a fact the Marine Corp
296
1 recognize right away that the predeployment physicals and
2 all the other predeployment stuff was totally inadequate.
3 And most of the services, if not all, have already taken
4 steps to avoid that again in the future.
5 MR. CASSELLS: They are beginning to, but I think
6 it's important for this committee to recognize those
7 problems existed.
8 MAJOR CROSS: They're probably still ongoing. Let
9 me just play a little devil's advocate here. Prior to call-
10 up of a lot of the reserves, to me, there were a lot of
11 policies and procedures. Good policies and procedures in
12 place for predeployment workups. But I think the system
13 broke down, again, in the haste of calling up a lot of
14 personnel. When people reported to their mobilization sites
15 there weren't enough medical facilities, there weren't
16 enough medical doctors and other resources to actually put
17 them through all these physicals to ensure that's happening.
18 DOCTOR CUSTIS: May I interject right there? A
19 point that you just make, there weren't enough doctors to
20 accomplish the quantity demand. Again, it's the question I
21 put to Ken Kizer, "Are you not now in a position to offer
22 resources at the head of the line in addition to the tail-
23 end of the line?" At the present time there are reservists
24 complying with their duty requirements, their two week on
25 duty, going to VA hospitals. Why can't -- When the military
297
1 physician manpower is being cut back so drastically, why
2 can't these VA hospitals assist in maintaining physical
3 standards for the reserves? Or for that matter,
4 predeployment physical exams and clearance. I think the VA
5 is in a position to be of a lot of help other than receiving
6 casualties at the end of the line.
7 CHAIRPERSON LASHOF: It's a very good point.
8 Would you like to include something in the findings about
9 the inadequacies of staff and that this is a possibility,
10 and then put something in the recommendations to the effect.
11 MAJOR CROSS: That's absolutely accurate because,
12 you know, predeployment, a lot of these units did not have
13 the resources to tap into for medical help.
14 MR. CASSELLS: That is correct. Yes, you're quite
15 correct. The questions is, does the committee want to make
16 the recommendation about using the VA?
17 CHAIRPERSON LASHOF: It will be interesting.
18 MS. GWIN: I think that's scary.
19 MAJOR CROSS: I'm inclined to agree. You know,
20 the VA becomes a valuable resource that, as Doctor Custis
21 says, it's really only used at the end, but there's a lot of
22 things going on at the VA that no one taps into until it's
23 too late or it's after the fact.
24 CHAIRPERSON LASHOF: Holly, your concerns?
25 MS. GWIN: I think that would require substantial
298
1 more work on the committee's part to make a recommendation
2 like that because we're in a time when VA resources are
3 under attack. Essentially we are suggesting a broader role
4 for them which --
5 DOCTOR CUSTIS: Holly, on the other hand, the VA
6 is interested in providing services and obtaining
7 reimbursement for those services.
8 MS. GWIN: I'm not disputing the quality of the
9 recommendation. I'm just saying we don't have the
10 background at this point in time to know what the
11 implications of such a recommendation would be for budgets
12 or other resources.
13 CHAIRPERSON LASHOF: What about something, Holly,
14 to walk this line -- I know this isn't something we've
15 discussed thoroughly and it's come up just here, but that's
16 one of the advantages of having on the committee people like
17 Don and Tom. -- That they explore -- We would recommend that
18 DOD explore the feasibility of calling upon VA services at
19 the time of predeployment to assist in manpower. Have a
20 finding that there wasn't adequate manpower to do the job
21 that needed to be done on rapid call-ups and that a
22 recommendation is that we explore this feasibility. That
23 seems to me appropriate.
24 CAPTAIN KNOX: I think that is a big task. If you
25 look at the VA hospitals, the medical personnel, nursing
299
1 personnel, have a very strong military sense, so
2 particularly at the DOM Veteran Hospital in Columbia, South
3 Carolina, the OR shut down during the war because it took
4 all their people. So with the downsizing in both the guard
5 and reserves, I mean, we have one medical unit left in the
6 State of South Carolina. I just don't know if you would
7 have the FTEs to do that kind of job during war. I mean, at
8 that time it was poor. There just is so few medical and
9 nursing personnel left in the guard and reserves, because of
10 the downsizing, I don't know if you could do it.
11 MAJOR CROSS: I hate to say, you know, let's not
12 investigate it. I just -- In a reduction of forces across
13 the board and in cutbacks in government, each and every
14 agency is then forced to relook at their mission and
15 redefine their mission, and the VA is going through the same
16 thing. I've got to believe, though, that the VA is
17 redefining their mission and I think it's worthwhile for
18 them to look into it and maybe something like this becomes a
19 new charter in their mission.
20 DOCTOR CUSTIS: You know, at the present time the
21 VA and DOD have in operation joint venture hospitals. The
22 Air Force and the VA share a hospital in --
23 MR. CASSELLS: Arizona, I believe.
24 DOCTOR CUSTIS: And they have plans for developing
25 other shared hospitals in the future. You know, it's absurd
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1 if the VA and DOD have shared staff in a hospital why there
2 should be such a severe cleavage as to who takes care of
3 whom. It just -- It's part of tomorrow, it seems to me.
4 MAJOR CROSS: There's another issue I just
5 realized. The Coast Guard Academy happens to be near my
6 home and that uses another arm of the government which is
7 the Public Health Service, so, I mean, that's another
8 untapped resource there.
9 CHAIRPERSON LASHOF: That's really being cut.
10 We've closed all the Public Health Hospitals before and
11 we're cutting the commission corps terribly, but, you're
12 right, I think we could say all governmental resources could
13 explore with VA and other governmental resources methods for
14 whatever.
15 DOCTOR CUSTIS: I think Holly's got a point,
16 though, Joyce. You know, that it brings us the spectrum of
17 territoriality and all that jazz. It opens a can of worms,
18 in one sense.
19 DOCTOR BALDESCHWIELER: This is a large peak
20 demand issue and it seems to me that you bring into play
21 what resources you've got. Makes sense to me.
22 CAPTAIN KNOX: So, Don, do you think this would
23 help the VA? Maybe DOD and the VA could look at their
24 funding and this would give them more funding to do this,
25 more resources to do this?
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1 DOCTOR CUSTIS: Starting several years ago with
2 the mission to -- I forget the exact -- It's the mission of
3 the VA to reorganize, reassign missions and so forth. One
4 of the recommendations they came up with is the VA should
5 look for other sources of funding than their own budget.
6 And this is also true of military. Both the military
7 hospitals and VA hospitals, or rather both DOD and VA are
8 requesting Medicare reimbursement. They're looking for
9 other sources of funding. The whole business of VA urging
10 congress to authorize VA taking care of CHAMPAS
11 beneficiaries. The reason for that was: Looking for more
12 sources of funding.
13 CHAIRPERSON LASHOF: Yeah, but in a rapid
14 deployment situation, if DOD needs additional docs to do
15 physicals and calls upon VA, are you suggesting that DOD
16 would then reimburse VA for reassigning their people
17 temporarily to duty?
18 DOCTOR CUSTIS: I don't know enough about --
19 CHAIRPERSON LASHOF: We certainly shouldn't get
20 into that aspect of it anyway so maybe --
21 DOCTOR CUSTIS: I don't know in that particular
22 instance whether reimbursement would be appropriate.
23 CHAIRPERSON LASHOF: No, I wouldn't think so.
24 DOCTOR CUSTIS: I only say that VA is clearly
25 interested in developing new missions, new sources of
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1 service and hopefully reimbursement to accompany it.
2 CHAIRPERSON LASHOF: This one I wouldn't think
3 would help in reimbursement, but I do think it is a resource
4 that ought to be looked upon. If the problem in the
5 predeployment was that we didn't have enough doctors to do
6 the exams, just telling them they ought to do them doesn't
7 help because where are they going to find them, and
8 suggesting that they at least look into the feasibility. Do
9 you have a problem with that, Holly? We word it in terms of
10 looking into the feasibility of VA?
11 MS. GWIN: I don't have a problem with going back
12 home and looking into the feasibility and then saying how
13 much sense I think it makes as a recommendation when we get
14 further into drafting. I'd hate to lock the committee in at
15 this point in time, since that's such a new idea for staff
16 to start looking at, to saying this is a recommendation
17 we're going to make in our interim report.
18 CHAIRPERSON LASHOF: Okay.
19 MS. GWIN: I think it has -- I think Doctor Kizer
20 told us yesterday his staff is being cut by 25-percent. I'm
21 afraid --
22 DOCTOR CUSTIS: That's central office.
23 MS. GWIN: Well, I don't know myself at this point
24 how far that spreads out into the VA field, and I just want
25 to be real careful about making any recommendations that
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1 have serious --
2 DOCTOR CUSTIS: Military medicine is also -- will,
3 after it's all over, will have been cut, the physicians, 33-
4 percent.
5 MS. GWIN: You are possibly prescribing a new role
6 for VA at a time when they don't appear to have exorbitant
7 resources to take care of their traditional mission.
8 CHAIRPERSON LASHOF: But, Holly, we're also saying
9 that DOD ought to be doing more predeployment and better
10 predeployment physical at a time that they're being
11 downsized and where they say the problem and the reason they
12 didn't do this was because they didn't have the personnel.
13 MS. GWIN: But that's their mission is to send
14 healthy soldiers to fight wars or keep peace or whatever.
15 We are possibly prescribing a new mission for VA.
16 CHAIRPERSON LASHOF: I see. Okay.
17 MS. GWIN: Which I'm happy to look into. I just
18 am real nervous.
19 CHAIRPERSON LASHOF: I hear you loud and clear.
20 Okay.
21 DOCTOR CUSTIS: VA has a mission. It's called
22 contingency backup to military medicine. Now, how do you
23 define the circumstances if contingency backup is something
24 else again? But it's already there, they've got the
25 mission.
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1 CHAIRPERSON LASHOF: Okay. There's the thing for
2 you to hang your hat on.
3 MS. GWIN: Sure.
4 CHAIRPERSON LASHOF: With that and further
5 discussion between you and Don Custis, we'll see what you
6 can come up with on the next draft, how's that? You got our
7 sense that, you know --
8 MS. GWIN: It's an intriguing idea.
9 CHAIRPERSON LASHOF: It's an intriguing idea and
10 I'd like to use the input of two of our key people around an
11 issue of importance at this point in time. But there is the
12 problem, it says, "interim report." It's first crack. But
13 this is an area we thought we had looked at enough that we
14 were going to put to bed in the interim report and not
15 pursue in the later report.
16 So, let me ask, before we wrap this part up, I
17 want people to go back and look at finding B. We got into
18 the recommendations and I want to know whether you're happy
19 with the wording in the sense of what we say in finding B.
20 I'm not sure what's to be gained by putting in the
21 meeting that the account was offered, "It's amazing how
22 often records to finally marry up."
23 MR. CASSELLS: We could strike that.
24 CHAIRPERSON LASHOF: And I think the other
25 sentence I was trying to worry about, whether we say that
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1 the fact they didn't have records could be used as a cover-
2 up, but I think that we did hear that.
3 MAJOR CROSS: We did hear that.
4 CHAIRPERSON LASHOF: And I think you, know, that's
5 probably worth saying that when you don't have records
6 people are going to read things into it that aren't related,
7 and that makes it even stronger.
8 Okay. So, one, we've reworked; two, we've
9 suggested some reworking of that.
10 MR. CASSELLS: Right.
11 CHAIRPERSON LASHOF: And, three, that there should
12 be a quality assurance program. I think no one would argue
13 with that.
14 CAPTAIN KNOX: Right. And I think John wanted to
15 include both one and two instead of just two. I think that
16 was a good suggestion.
17 CHAIRPERSON LASHOF: I'm sorry, Marguerite, I
18 didn't follow.
19 CAPTAIN KNOX: On recommendation three, DOD should
20 establish a QA program to assure compliance with established
21 policies, and one and two above rather than just two above.
22 CHAIRPERSON LASHOF: Oh, and one and two above.
23 Yeah. Right. Absolutely.
24 DOCTOR BALDESCHWIELER: Then one final concern.
25 CHAIRPERSON LASHOF: Sure.
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1 DOCTOR BALDESCHWIELER: You mentioned early on in
2 the session the issue or priority access to VA care, and
3 that's clearly a major concern for everyone we've heard
4 from, but it doesn't appear either as a finding or a
5 recommendation.
6 MS. GWIN: It comes up in our outreach discussion
7 that will occur after we hear from Doctor Joseph.
8 CHAIRPERSON LASHOF: We'll get to that.
9 MS. GWIN: We considered it more a communications
10 issue.
11 DOCTOR BALDESCHWIELER: Uh-huh, but is there
12 something of substance here as well? Do we really --
13 CHAIRPERSON LASHOF: Well, the substance is clear
14 already, they do have priority care. The problem has been
15 in understanding what that term means, which is a
16 communication issue. We can revisit it if you have concerns
17 after we -- We can discuss it there.
18 DOCTOR BALDESCHWIELER: I mean, they don't really
19 have priority care in the sense that --
20 CHAIRPERSON LASHOF: In the sense -- but that's
21 the legal language that Congress wrote and, unfortunately, I
22 would love to see the word struck and it might be nice to
23 tell Congress they should rewrite the law and not use that
24 term "priority" that is --
25 DOCTOR BALDESCHWIELER: They have access to care.
307
1 CHAIRPERSON LASHOF: But priority care, as said in
2 the legislation, means that they do not have a means test,
3 and that's what that means and it's a legal definition and
4 we'll have to clarify that in the communication and make
5 sure everybody understands that that's what Congress is
6 talking about.
7 DOCTOR BALDESCHWIELER: Do we want them to have
8 "head of line" privilege or not?
9 DOCTOR CUSTIS: I wouldn't be surprised but some
10 of the logic that went into that decision is based on the
11 fact that it's believe that the service-connected veteran
12 who has been to war, has been injured, you know, and had a
13 service-connected disability should not be pushed back for
14 someone whose situation has yet to be proved. The non-
15 service-connected veteran who is cared for after having
16 passed a means test, it seems to me, could well stand aside
17 for the Persian Gulf veterans' examination. Now, that would
18 require a further statement as to his priority status. The
19 implication of just eliminating the means test for the
20 Persian Gulf veteran just puts him into the same category,
21 the same priority as the non-service-connected veteran and
22 behind the service-connected veteran. You may want to
23 recommend that only the service-connected veteran have
24 higher priority. Something like that.
25 CHAIRPERSON LASHOF: I'm not sure that I want to
308
1 get into a discussion of who gets the first appointment, who
2 gets the second appointment. You know, that gets very
3 complicated. I frankly think that's a decision an
4 individual unit ought to be making -- the facility ought to
5 be making around medical need. I mean, the guy who comes in
6 with a heart attack needs to be seen no matter which other
7 classification meets -- sooner than the guy who comes in
8 with irritable bowel syndrome. But, you know.
9 And I don't think we ought to get into that, but
10 I'm looking at time and I don't want to cut this off too
11 much but I think we've pretty well settled this and, unless
12 there are further reservations, Joan, we're going to get you
13 after the break. I think we're going to take a break for 15
14 minutes.
15 Doctor Joseph will be here promptly at 10:30 so we
16 must be back. He's here. He just walked in the door but
17 we're going to take our break for 15 minutes. At 10:30
18 Doctor Joseph will be on and following Doctor Joseph we'll
19 come back to Joan and the ethical issues.
20 (A short recess was taken.)
21 CHAIRPERSON LASHOF: I think we will resume our
22 deliberations and than Doctor Stephen Joseph for joining us
23 this morning, and we're very pleased you could come and
24 share with us your thoughts about where things stand in
25 relation to the Department of Defense's efforts and the Gulf
309
1 War related illnesses.
2 STEPHEN C. JOSEPH, M.D., M.P.H.
3 ASSISTANT SECRETARY OF DEFENSE FOR HEALTH SERVICES
4 DOCTOR JOSEPH: Thank you, Madam Chairperson and
5 members of the committee and staff, I'm please to be here in
6 San Diego. This is San Diego?
7 CHAIRPERSON LASHOF: This is San Diego.
8 DOCTOR JOSEPH: To reaffirm the Clinton
9 Administration's commitment to taking care of our military
10 service members and their families and determining the
11 causes of Gulf War veterans' illnesses.
12 What I'd like to do today is discuss the
13 Department of Defense Medical Research Program concerning
14 the Gulf War veterans' illnesses. I have organized my
15 presentation into three major area.
16 First, I do want to give you some background
17 regarding our medical efforts since the war, then I want to
18 mention our Comprehensive Clinical Evaluation Program
19 findings, and finally, I will discuss our extensive medical
20 research efforts. And I'll be happy to respond to any
21 questions or comments that you have in any of those areas,
22 or any other areas that you wish to raise.
23 Let me emphasize that, from the beginning, in both
24 the clinical and scientific research areas, the Departments
25 of Defense, Veterans Affairs, and Health and Human Services
310
1 have cooperated and coordinated all health initiatives
2 through the Persian Gulf Veterans' Coordination Board. I'm
3 sure we'll talk more about that in a few minutes. These
4 integrated efforts will continue until we better understand
5 the complex medical issues surrounding the Persian Gulf War.
6 Before I discuss the Department's clinical program
7 and our medical research efforts, it's important to frame
8 this presentation by teeing up once again some background
9 information. Approximately 697,000 service members were
10 deployed to the Persian Gulf during 1990 and '91 in support
11 of Operations Desert Shield and Desert Storm. The vast
12 majority of soldiers, sailors, marines, and airmen returned
13 from this large deployment healthy and remain healthy today.
14 Since with war with Iran, most Gulf War veterans
15 seeking medical care have had readily diagnosable illnesses, 1 6 the same types of illnesses that would be expected in such a 1 7 large population of adults. However, a number of service 1 8 members have illnesses that are not easily explained, and it 1 9 is this group on which we are focusing our medical research 2 0 efforts. 2 1 To better understand why some veterans were 2 2 reporting diverse symptoms that were not readily explained, 2 3 the Department of Defense established the Comprehensive 2 4 Clinical Evaluation Program, CCEP, in June of 1994. This 2 5 program was initiated to provide a systematic, in-depth
311 1 medical evaluation for all military health care 2 beneficiaries who were or are experiencing health 3 consequences that may be related to the Persian Gulf War. 4 Since June 7, when the program began, the DOD has 5 enrolled approximately 27,000 participants in the CCEP. 6 These participants are either seeking medical care, that's 7 21,000 of them, or simply have concerns about possible 8 future health issues. Diagnoses have been tabulated and 9 grouped into related categories for over 18,000 patients who 1 0 have completely gone through a diagnostic work-up and whose 1 1 records have been reviewed and quality validated. About
1 2 6,000 individuals have registered themselves in the CCEP, 1 3 but have either elected to decline an examination or are not 1 4 actively seeking an examination. 1 5 Communications with our health care beneficiaries 1 6 regarding this program have been extensive from the 1 7 beginning. Our messages have been sent through command 1 8 channels; our own print, radio and television media; 1 9 publications targeting the military beneficiary population; 2 0 beneficiary advocacy groups and their publications. 2 1 Additionally, through questionnaires, we asked the CCEP 2 2 patients themselves if they were pleased with the care they 2 3 had received. Although 33-percent chose not to respond to 2 4 that questionnaire, of those that did respond, 93-percent or 2 5 over 15,000 people indicated that they were satisfied with
312 1 the care that they had received. 2 In addition to that satisfaction index, we plan 3 to randomly sample the current active duty force with a 4 survey instrument now in development. This proposed 5 telephone survey is expected to included both Persian Gulf 6 War veterans, as well as those who did not deploy to the 7 Gulf. Major survey objectives include: 8 Determining the degree of knowledge concerning our 9 health programs related to the Persian Gulf War;
1 0 Identifying the most effective outreach 1 1 mechanisms; and, 1 2 Gaining opinions about Persian Gulf illnesses and 1 3 DOD's efforts related to those illnesses, with a focus on 1 4 how those opinions and perceptions may be related to future 1 5 deployments. 1 6 I should issue a word of caution, here. Because 1 7 CCWP was designed to provide medical care, and was not 1 8 designed as a research project, and because the CCEP results 1 9 are derived from a self-selected population of patients, the 2 0 distribution of illnesses cannot be directly related to the 2 1 overall population of almost 700,000 Gulf War veterans. 2 2 Even thought the CCEP and the comparable VA Registry were 2 3 designed in close cooperation, the specific distribution of 2 4 diagnoses cannot be compared directly to the VA registry 2 5 because of differences in demographic characteristics
313 1 between the two registries. Although qualified by these 2 factors, the CCEP nevertheless provides a substantial
3 information base about the type of illnesses that are 4 affecting Gulf War veterans who present for an evaluation. 5 This is so because it yields a consistent, comprehensive, 6 medical assessment along with the ability to collect data. 7 We are currently in the process of the final 8 analysis of those findings from that more than 18,000 CCEP 9 patients. That analysis will be completed and early in 1996 1 0 a report will be presented. I will ensure that copies of 1 1 our report are provided to the Presidential Advisory 1 2 Committee. 1 3 We have made the following observations based on 1 4 our review of over 10,000 CCEP participants completing 1 5 evaluations. 1 6 First, those preliminary results of the CCEP are 1 7 consistent with earlier conclusion of the National 1 8 Institutes of Health Technology Assessment Workshop, I'm 1 9 sure you've seen that, "no single disease or syndrome is 2 0 apparent, but rather there are multiple illnesses with 2 1 overlapping symptoms and causes." The specific distribution 2 2 of illnesses in this non-randomly selected sample, however, 2 3 I repeat, cannot be generalized to the entire Gulf War 2 4 veteran population. 2 5 Second, infectious diseases account for relatively
314 1 few diagnoses, and do not represent a major cause of illness 2 among CCEP patients. Leishmaniasis was one of the 3 infectious diseases of particular concern in evaluating
4 Persian Gulf veterans. Since the Gulf War a total of 32 5 culture-confirmed cases of Leishmaniasis have been 6 identified among Persian Gulf veterans -- 12 cases of 7 viscerotropic disease and 20 cases of cutaneous disease. 8 All of these cases were identified prior to initiating the 9 CCEP. Thus far, we have not found any additional CCEP 1 0 participants diagnosed as having Leishmaniasis. 1 1 Three, approximately 18 percent of the CCEP 1 2 participants have psychologically-related medical 1 3 conditions. Many of these participants also have physical 1 4 conditions. Most of the psychologically-related conditions 1 5 are relatively common in the general population and include 1 6 such diagnoses as depression, anxiety, tension headache,, 1 7 and stress related disorders. As with all our patients, 1 8 these patients have been provided appropriate treatment. 1 9 Fourth, about 18-percent of patients who have 2 0 completed their CCEP evaluations have ill-defined symptoms 2 1 that are also commonly seen in civilian medical practice, 2 2 such as fatigue, headache and sleep disturbances. These
2 3 patients also are receiving care for their symptoms but they 2 4 may require further evaluation and follow-up care by DOD. 2 5 Finally, severe disability, as measure in terms of
315 1 self-reported lost work days, is not a major characteristic 2 of CCEP participants. Eighty-one percent, for example, of 3 participants, have not missed more than six days of work
4 because of illness or injury during the 90 days prior to 5 their initial evaluation. About seven-percent of CCEP 6 participants report missing a week or more of work due to 7 illness. However, these findings may contain a selection 8 bias whereby those who were severely disabled may have 9 separated from the service and thus would not have had the 1 0 opportunity to participate in the CCEP. In n effort to 1 1 further ascertain the degree of disability among CCEP
1 2 participants, each service has been asked to verify the 1 3 disability disposition status of all those who were deployed 1 4 to the Gulf. 1 5 The CCEP will continue to provide comprehensive, 1 6 high quality health care to eligible Gulf War Veterans and 1 7 their families; along with maintaining an ongoing search for 1 8 any unique symptom or illness pattern. In addition to care, 1 9 the CCEP has generated a database which has become a 2 0 valuable reservoir of clinical information that will be most 2 1 beneficial to those conducting scientific research in the 2 2 future. We plan to make that database available to those 2 3 scientists who present valid research proposals. 2 4 Furthermore, the CCEP may also identify scientific 2 5 hypotheses which can be incorporated into our current and
316 1 others current and future medical research programs. 2 Parallel to the Clinical program, we have 3 initiated a number of research studies to better understand 4 any health consequences resulting from the Persian Gulf War. 5 From the beginning, as I'm sure Doctor Kizer talked about 6 yesterday, the Department has worked closely with the 7 Departments of Veterans Affairs and Health and Human 8 Services in a coordinated and intensive scientific research 9 effort to assess any health consequences of military service 1 0 in the Persian Gulf. 1 1 Through the Persian Gulf Veterans' Coordinating
1 2 Board, DOD VA, and HHS have led the way in the conduct of 1 3 research concerning Persian Gulf veterans' illnesses. These 1 4 three departments have individually and collaboratively 1 5 initiated numerous scientific research studies to assess the 1 6 health consequences of military service in the Gulf during 1 7 Operations Desert Shield and Desert Storm. The vast scope 1 8 of Persian Gulf health-related research topics necessitated 1 9 an integrating mechanism to focus relevant research issues 2 0 and avoid unnecessary duplication. Our current Working 2 1 Plan, which I believe you've seen, is that mechanism and is 2 2 a guide for decision makers in establishing research 2 3 spending priorities. The Working Plan provides a path to 2 4 pursue the following goals: 2 5 One. Establishment of the nature and prevalence
317 1 of symptoms, diagnosable illnesses, and unexplained 2 conditions among Persian Gulf veterans in comparison to 3 appropriate control populations. 4 Two. Identification of possible risk factors,
5 beyond those expected to occur, for any illnesses found 6 among Persian Gulf veterans, and, 7 Identification of appropriate diagnostic tools, 8 treatment methods, and prevention strategies for any 9 illnesses or conditions found among Persian Gulf veterans. 1 0 The Persian Gulf Veterans' Coordinating Board has 1 1 designed a Research Working Group -- has designated a 1 2 Research Working Group as the primary coordinating body for 1 3 Persian Gulf related research. The Research Working Group 1 4 is charged with: 1 5 Assessing the state and direction of the research; 1 6 identifying gaps in factual knowledge and 1 7 conceptual understanding; 1 8 identifying testable hypotheses; 1 9 recommending research directions for the 2 0 participating agencies; 2 1 reviewing research concepts as they are developed, 2 2 and; 2 3 synthesizing results, and collecting and 2 4 disseminating scientifically peer-reviewed research 2 5 information.
318 1 DOD's research activities span a broad range of 2 areas. Eight large epidemiologic studies are comparing 3 morbidity and mortality on Persian Gulf veterans with 4 military personnel of the same era who were not deployed to 5 the Persian Gulf. Initial results from four of those 6 studies were presented at the American Public Health 7 Association Meeting on October 31st, 1995. I know you were 8 there, Doctor Lashof, and here's a snapshot of some of those 9 preliminary results: 1 0 Hospitalization rates for more than 1.2 million
1 1 service members were compared. In 13 of 14 broad ICD-9 1 2 categories, there were no significant differences in 1 3 hospitalization rates between Gulf War veterans and era 1 4 controls. The one category that did have a slightly higher 1 5 hospitalization rate for the Gulf War veterans was mental 1 6 disorders, of which alcohol and drug-related diagnoses were 1 7 the most frequent. 1 8 Other projects include studies to assess 1 9 reproductive health and birth outcomes using hospitalization 2 0 records of more than a million service personnel. Birth 2 1 outcomes of Gulf Ware veterans were compared to a non- 2 2 deployed control group. The preliminary analysis of over 2 3 40,000 births in military hospitals are complete and do not 2 4 indicate an increased risk of birth defects to couples, 2 5 either spouse of which served in the Persian Gulf. However,
319 1 more research is needed in this area. 2 A study involving early adverse reproductive 3 outcomes such as infertility and miscarriages will begin as
4 soon as OMB clearance of the survey instrument is obtained. 5 A third DOD birth defect study using data from 6 civilian databases that have active birth defects registry 7 programs is underway. 8 DOD also is collaborating with the VA to conduct a 9 large, randomized epidemiologic study of 30,000 veterans. 1 0 Data collection is underway, and initial results are 1 1 expected in the fall of '96. 1 2 Other DOD studies in progress include infectious 1 3 disease projects, especially tropical disease research. We 1 4 are particularly interested in research directed at 1 5 obtaining screening and other diagnostic tools, as well as 1 6 effective treatment methods, for Leishmaniasis. You 1 7 probably know that there is no effective, reliable screening 1 8 test. Research has also begun to identify the health 1 9 effects of exposure to depleted uranium. Of 22 service 2 0 members who were accidentally reposed to embedded DU 2 1 fragments, early results have shown no adverse effect from 2 2 the DU exposure. However, long-term follow-up is necessary, 2 3 will be necessary, to fully evaluate the health effects of 2 4 such exposure. 2 5 Troop locator data collection and validation is
320 1 progressing as quickly as possible. In my mind this is 2 possibly the most single important effort going on. In 3 January 1996, we expect to incorporate these data into our 4 Geographic Information System, a sophisticated, spatial 5 analyses project. Initially, we will estimate any health 6 risk associated with exposure to oil well fire smoke. I'm 7 sure you all know that the first studies of that issue done 8 by the army in '93, I think, showed no additional health 9 risks. But having this geographic locator system will, in
1 0 effect, give us a time, space unit-specific element day-by- 1 1 day, mile-by-mile, square-mile-by-square-mile in the Gulf, 1 2 and against that we can run any variable that might be 1 3 appropriate. As rapidly as possible, we will incorporate 1 4 other exposure data and assess other possible health risks. 1 5 Research currently is progressing to identify 1 6 possible interactive effects of certain chemical compounds 1 7 with pyridostigmine used during the Gulf War. These studies 1 8 will not only evaluate the health consequences of the 1 9 Persian Gulf war, but will also contribute to the 2 0 development of programs and specific interventions to 2 1 protect the health of military personnel during future 2 2 deployments. 2 3 The Department is working with and through the 2 4 Persian Gulf Veterans' Coordinating Board to identify 2 5 Persian Gulf related, medical research proposals totaling
321 1 $5, in FY95 dollars, submitted by agencies and institutions 2 external to the federal government. Competitively bid 3 research projects will be selected after the proposals have
4 been independently, peer-reviewed for scientific merit. We 5 are working jointly with Veterans Affairs and HHS, through 6 the Coordinating Board to select the best scientific 7 research studies in three specific areas: 8 First. Epidemiologic studies. 9 Two. Studies involving pyridostigmine bromide, 1 0 and, 1 1 Three. Clinically related and other research 1 2 projects. 1 3 The broad agency announcement and the request for 1 4 proposals were published last May, with a final proposal 1 5 submission date of August 23rd, 1995. We expect to begin 1 6 the funding of these non-federal research projects early in 1 7 calendar '96. 1 8 In addition to the scientific research that is 1 9 purely external to the federal government, both Defense and 2 0 Veterans Affairs have agreed to supplement that research 2 1 with an additional $5 million, in FY95 dollars. Projects in 2 2 this group potentially could come from agencies external to 2 3 the federal government as well as agencies within the 2 4 federal research system. 2 5 In addition to the $12 million spent by DOD on
322 1 Persian Gulf related medical research in fiscal '95, we are 2 also committed to designating $12 million for such research 3 in fiscal '96. 4 We've provided this committee the Coordinating 5 Board's "Working Plan for Research on Persian Gulf Veterans' 6 Illnesses." There are several important points I'd like to 7 make concerning that working plan. DOD, VA, HHS, and the 8 EPA, through the Persian Gulf Veterans' Coordinating Board, 9 are committed to supporting quality research to better 1 0 understand the health consequences of service in the Persian 1 1 Gulf War. Research by its nature leads to refinement in 1 2 understanding specific topics. The Working Plan was 1 3 specifically designed to evolve, and will be updated 1 4 periodically in response to new findings and conclusions. 1 5 The Persian Gulf Veterans' Coordinating Board will continue 1 6 to identify research gaps and prioritize the need for 1 7 specific scientific protocols. 1 8 In closing, the Department of Defense will 1 9 continue to provide high quality, compassionate medical care 2 0 to Gulf War veterans and their families. This remains our 2 1 number one priority. Parallel to providing outstanding 2 2 medical care, we will continue to seek answers from the 2 3 scientific community. The aim of our research program is to 2 4 evaluate and understand the health consequences of serving 2 5 in the Persian Gulf, and to develop and enhance our current
323 1 programs to protect the health of military personnel during 2 future deployments. President Clinton is committed to 3 determining the causes and providing effective care to those 4 Gulf War veterans who are ill. We take that mission very 5 seriously. The mission of our research program is to 6 provide answers to our troops, their families, and their 7 commanders. Working through a strong Persian Gulf Veterans' 8 Coordinating Board, the agencies will continue to pursue the 9 answers wherever they may take us. 1 0 Thank you for your interest and concern for the
1 1 health of the Veterans of the Persian Gulf War and your 1 2 active support of military medicine. We welcome your 1 3 assessment, your frank assessment, of our research program 1 4 as we continue to use quality science to provide the answers 1 5 to what indeed are a very complex set of health issues. 1 6 I'd be happy to respond to your comments on this 1 7 or any other issues. 1 8 CHAIRPERSON LASHOF: Thank you very much, Steve. 1 9 It's open to questions from any member of the panel. 2 0 Rolando? 2 1 MR. RIOS: You mentioned that, I think you said 2 2 that 33-percent of the veterans that underwent the CCEP 2 3 chose not to respond to your questionnaire? 2 4 DOCTOR JOSEPH: To the satisfaction of the 2 5 questionnaire.
324 1 MR. RIOS: Do you have any idea why? 2 DOCTOR JOSEPH: Sure. 3 MR. RIOS: I mean, it seems like a pretty high 4 percent. 5 DOCTOR JOSEPH: No, actually I think that's a 6 pretty low percentage for that type of question survey 7 instrument. I think any time you get back 50-, 60-percent 8 on a crude survey questionnaire for satisfaction you'll get 9 that kind of answer. Now, what I can't tell you is whether 1 0 the proportion of dissatisfaction in the people who didn't
1 1 respond was higher than those that did, there's just no way 1 2 to do that. But that's not an unusual proportion. 1 3 MR. RIOS: When you say they didn't respond, in 1 4 other words, you mailed something to them and they didn't 1 5 respond? 1 6 DOCTOR JOSEPH: That's right. 1 7 MR. RIOS: Oh, okay. Okay. That's different from 1 8 when you asked them -- 1 9 DOCTOR JOSEPH: No, these were not refusals to 2 0 give information. 2 1 MR. RIOS: I see. 2 2 DOCTOR JOSEPH: Not non response. 2 3 MR. RIOS: Is the present deployment going to 2 4 provide us with any opportunities to get intelligence or 2 5 information that will help us evaluate as to what happened
325 1 to the Gulf War veterans? 2 DOCTOR JOSEPH: Let me respond to that in very 3 general terms because -- for a number of reasons. A 4 deployment actively underway and operational requirements 5 being worked out through the chain of command, and 6 classified issues, it really would be inappropriate here to 7 go into any detail, but clearly, as I think I've talked 8 about before with the committee, or some of the members, 9 there are lessons that we take out of this experience that 1 0 will be and have been of enormous value to us in planning
1 1 for all future deployments. Let me give you some of the 1 2 areas that this is obvious in: 1 3 One. Predeployment health assessments; 1 4 Post-deployment health assessments; 1 5 Health Education and awareness of the troops when 1 6 they deploy; 1 7 Placement on the ground of preventive medicine, 1 8 epidemiologic surveillance teams; 1 9 Combat stress and related personnel in theater. 2 0 In all of these areas, none of which are new. 2 1 These areas have been worked for quite some time in past 2 2 deployments, but I think that in Bosnia and in future 2 3 deployments we will have a much more sophisticated system of 2 4 both preparing our troops, supporting our troops, assessing 2 5 the need for and providing necessary services after
326 1 deployment, and also looking on the ground for early warning 2 signals of environmental, behavioral, or infectious, or any 3 other kind of threats that may be in place. 4 MR. RIOS: Let me ask you one other question. You
5 said in the studies that were released in October, there was 6 a higher incidence mental problems when you compared Gulf 7 War veterans to the rest of the sample. Is that correct? 8 DOCTOR JOSEPH: No. I think it's very 9 important -- I think we all try to underscore every time we 1 0 talk about this -- that you cannot compare the clinical 1 1 findings in the CCEP group with the entire 700,000 troops 1 2 that served in the Gulf. 1 3 Secondly, one of the real dilemmas here is there 1 4 is no ready-made or ideal control group. I mean, what 1 5 group, what prior study, what group of citizens would you 1 6 say is a control group for those who served in the Gulf? So 1 7 I think you have to be very cautious at drawing comparisons 1 8 between any level of findings in one of these groups and 1 9 some other general populations. 2 0 What I did say in the testimony is that when you 2 1 look in ICD-9 categories among people who -- as hospital 2 2 diagnoses among people who served in the Gulf, who deployed 2 3 to the Gulf and same era veterans who did not, that was one 2 4 area where there was an increased frequency of hospital 2 5 diagnoses. I guess discharge diagnoses. To understand what
327 1 that means you would have to know a lot more about exactly 2 how those people are different who deployed from those who 3 didn't deploy. And while there are some easy things to look 4 at in terms of demographics, and age, and sex, and 5 occupation, and the rest, the subtle differences between 6 groups are, you know, are far beyond this sort of level of
7 data. I think that's the kind of thing that makes so
8 important what we're going to do in terms of making our CCP
9 database available to scientific investigators, because
10 there will be people in the scientific community who are
11 particularly interested, for example, in something related
12 to that area and who will be able to use that database to
13 create a research program that focuses in it in a way that
14 we can't at this level.
15 I think some of the most important findings both
16 from the VA and DOD, certainly the DOD data -- clinical
17 database, won't come out for 10 or 15 years as people mine
18 this information that will be there, and there's really no
19 other way to do it but that.
20 CHAIRPERSON LASHOF: Andrea?
21 DOCTOR KIDD-TAYLOR: I'm sure this may have been
22 answered before but I have a question regarding reservists
23 and other veterans who are no longer on active duty.
24 DOCTOR JOSEPH: Yes.
25 DOCTOR KIDD-TAYLOR: How do they receive access to
328
1 medical care, how is that considered other than a post-
2 deployment physical? What follow-up is done after that?
3 DOCTOR JOSEPH: First of all, reservists when they
4 leave active duty are not eligible beneficiaries in our
5 system. Those who are -- who served in the Gulf and who
6 have health complaints related to that are eligible either
7 for the VA Registry or in certain cases eligible for our
8 registry, but their on-going medical care for whatever, they
9 are not in that population. And that's an issue. I mean,
10 that's also an issue in terms of predeployment care for
11 people in the reserves.
12 CHAIRPERSON LASHOF: Okay. John?
13 DOCTOR BALDESCHWIELER: Can I ask about the
14 research program? I understand from your testimony that $12
15 million in FY95 has been apportioned and an additional $12
16 million for FY96?
17 DOCTOR JOSEPH: We're planning $12 million for
18 '96.
19 DOCTOR BALDESCHWIELER: Can you characterize the
20 FY95 program in terms of the nature of the research
21 proposals that have come in, generally what is being
22 supported?
23 DOCTOR JOSEPH: Well, I gave you in the testimony
24 the research that is underway that is federally funded in-
25 house research. Of the external research proposals in
329
1 response to that broad agency announcement, those have not
2 been funded yet. Those are in the --
3 DOCTOR BALDESCHWIELER: Sure. So what's in --
4 DOCTOR JOSEPH: I cannot, for very appropriate
5 reasons, tell you, not because I don't want to but because I
6 don't know, what that array of proposals or the specifics of
7 them looks like. What I gave you was the three broad areas
8 in which proposals have been solicited. And, as I say, the
9 funding for that should begin early in '96.
10 CHAIRPERSON LASHOF: I have a couple of questions,
11 Steve. On the CCEP, being very careful in recognizing self-
12 selected group there is no comparison group, it's not a
13 research tool, it's a medical. But as one breaks down and
14 lists categories of illnesses that are seen, what percent --
15 one of the figures I don't see here, and maybe stopped
16 presenting it that way, but we previously seen as a figure
17 that's been bandied about, about what percentage are sort of
18 undiagnosed and we have --
19 DOCTOR JOSEPH: Other than unspecified.
20 CHAIRPERSON LASHOF: Unspecified. And the
21 question came up in some of the testimony that I thought of
22 interest was whether a diagnosis like Chronic Fatigue
23 Syndrome is considered, has a specific diagnosis rather than
24 the unspecified diagnosis, like mood disorder was considered
25 as a diagnosis, so we really knew what they were rather than
330
1 unspecified, and others like that. You know, there are no
2 physical findings, there are symptomatology, where do you
3 categorize them? What kind of instructions are given to the
4 people who code the diagnosis for CCEP as to where they --
5 what they do with that?
6 DOCTOR JOSEPH: Let me begin my answer with two
7 important pieces of background. First of all, I know you
8 know, when I make that strong disclaimer that should in no
9 way be taken as saying that the findings that come out of
10 the CCEP are not important or terribly, terribly useful.
11 They are enormously useful in understanding the clinical
12 array. They are enormously useful in generating hypotheses,
13 and they -- I hope that the program has had real importance
14 in making clear our commitment to taking care of our people.
15 When we began the program and tried to set up the
16 diagnostic categories that we used for the clinical thing,
17 we were immediately faced with the following problem:
18 On the one hand we could use the ICD-9
19 classification of diseases strictly. That has some problems
20 associated because it is always several years out of date
21 and it is in no way a perfect system, and many entities that
22 a physician would write down as a diagnosis, Chronic Fatigue
23 Syndrome being among them, do not appear in the ICD-9
24 classification but rather appear in that group of other and
25 unspecified. So we knew that many of the symptom complexes
331
1 that we were seeing would not fit neatly into the ICD-9
2 bins.
3 On the other hand, had we begun by saying we are
4 going to devise our own classification, or manipulate -- and
5 I use that word advisedly -- the ICD-9 system so that we'll
6 group diagnoses some other way, immediately there would have
7 been a reaction to that that you're fudging the data or
8 creating something, whatever. So we decided, and you can
9 look in hindsight, I think it was the right decision, to
10 strictly follow the ICD-9 classification.
11 The answer to your question: There is both. If
12 one of the physicians at a military center writes on that
13 bottom line "Chronic Fatigue Syndrome," we'll get into in a
14 moment what that means, or "Multiple Chemical Sensitivity."
15 What that means is is that a diagnosis, is that a disease
16 entity? If that person should write that diagnosis then
17 that's the diagnosis. But in the CCEP that would be
18 classified in the bin that is other and unspecified. That's
19 again the kind of example I mean in how valuable it's going
20 to be to have people who have specific probes in mind, in
21 the scientific community, be able to take that data, sort it
22 different ways and sift through it. We had to choose a
23 classification system. I think there were sound reasons for
24 doing it as we did.
25 CHAIRPERSON LASHOF: Well, I think that's very
332
1 helpful to understand what bin it's put in when you sort of
2 say, you know, this number had clear-cut diagnosis and this
3 number didn't. It's what bin, something like even irritable
4 bowel syndrome and some others.
5 DOCTOR JOSEPH: In another room we could have --
6 We could be part of a very volatile debate if once you've
7 said someone had Multiple Chemical Sensitivity, whether
8 that's a diagnosis or not. I mean, there are those kinds of
9 problems with --
10 CHAIRPERSON LASHOF: Yeah. Right.
11 DOCTOR JOSEPH: One of the things this has taught
12 me is a lot more about the limits of our knowledge here.
13 CHAIRPERSON LASHOF: Another question I have does
14 deal with the Coordinating Board and it's responsibility and
15 role. You state that one of its responsibility is assessing
16 the state and direction of the research. Assessing the
17 state of the research is something I'd like to explore a
18 little bit further with you.
19 As you know, we have had hearings around most of
20 the important epidemiologic studies. We have not completed
21 our review of the research program. We obviously have been
22 over the big research plan and we have looked at some of the
23 epidemiologic studies. There are other studies that we have
24 yet to look at as we continue our work. But, in the process
25 of looking at some of those research studies, we also looked
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1 at what the Armed Forces Epidemiologic Board had to say
2 about certain research studies. We looked at the Science
3 Defense Board, and we looked at what individual
4 researchers --
5 DOCTOR JOSEPH: Peer-review groups.
6 CHAIRPERSON LASHOF: -- peer reviewers and
7 advisory groups have had to say about them, and we went into
8 that in some detail on some of the studies at our San
9 Francisco meeting that was devoted just to the Research
10 Working Group. From that, we gained the impression that
11 there were certain studies that the limitations of the data
12 were such that the peer reviewers questioned the validity
13 and the value and whether it was worthwhile pursuing some of
14 those studies. Some of them were peer reviewed before they
15 were started and suggestions made and many of those
16 suggestions incorporated. Others were looked at after they
17 had already started and there weren't corrections that could
18 be made. There were a couple of studies that hadn't been
19 started yet that at least some of the advisory group that
20 looked at them thought they should not be undertaken.
21 But the decision as to what gets done with that
22 kind of review appears to be left in the hands of the
23 individual researcher and does not apparently -- is not
24 apparently reviewed by the Coordinating Board or its
25 Research Working Group. And I wondered whether you felt
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1 that this was a responsibility of the Research Working Group
2 and the Coordinating Board to look at all of those and to
3 make some determinations as to which studies should be
4 pursued or which might now be abandoned for others? And
5 it's very understandable, considering how the research plan
6 developed, which was logical after the war we begin hearing
7 about things and different groups began doing different
8 research, and your plan was not completely -- it wasn't like
9 you could sit down at the end of the war and say, "Well,
10 we've got so many people with this illness, let's decide how
11 we carry out a research to do it and develop an orderly
12 plan." They developed and you had to look at those.
13 But, once you had a whole body of research
14 proposals developed and started there was the opportunity,
15 and I think there still is the opportunity, to look at that
16 whole array and say, "Now, given that we've got this study
17 going on, does this study really add anything or are the
18 limitations in this study such that it would be misleading
19 and maybe we should stop this one or we should expand that
20 one?" That kind of overview of the whole effort I would
21 have thought was the responsibility of the Research Working
22 Group, and I would have read your testimony as assessing the
23 state and direction of the research that being the
24 responsibility. But the testimony we had from the
25 Coordinating Board was they did not feel that was their
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1 charge. How do you view it?
2 DOCTOR JOSEPH: Let's talk first about quality and
3 validity at the end of the research study. I'm going back
4 then up into your area. I think there are three issues:
5 The final determination of quality and impact
6 really needs to be in our established process of peer-
7 reviewed scientific publication;
8 The relationships between -- The way I view the
9 relationship between the Coordinating Board and its
10 constituent agencies or membership agencies is that you can
11 think of them as two places neither of which is completely
12 subservient to the other but both of which are dependent on
13 the other. The Coordinating Board is not set up as an
14 independent research funding body and so actual decisions
15 about how much money to allocate, which studies to fund, who
16 signs those documents, whether we continue a particular
17 study there I think have to rest in the hands of the
18 individual agency. But those decisions should not, and I
19 don't believe are not, be made by the individual agency
20 without that important filter and sounding board of the
21 Coordinating Board.
22 Now, I believe -- If you can cite instances to
23 the contrary I, you know, certainly put them on the table,
24 but I believe that the seriousness with which both the
25 individual investigators and with which the responsible
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1 agency who is funding those investigators takes the peer-
2 review comments and recommendations I think has
3 been certainly as good in this sequence as you see in any
4 other.
5 I would agree with you that there is a role for
6 the Coordinating Board in looking at peer-review comments
7 and other external recommendations. For example, some that
8 might come from this body and having their say as a
9 Coordinating Board on how those comments should effect the
10 conduct or the progress or the continuation or even the
11 initiation of further work in a research area. And if that
12 is not now the case, and your comment about the board not
13 seeing it as their view, I think that would be a useful
14 recommendation for the committee to make and I would welcome
15 such a recommendation. I mean, that board was set up not to
16 be a way to keep stuff away but a way to bring in the three
17 agency positions so that we could avoid duplication and fund
18 in the most important areas and, where we could, make sure
19 that the research designs were congruent. That's not as
20 easy as it sometimes sounds, "make sure that the research
21 designs were congruent," and part of that process I think
22 involves looking at external peer-reviewed and other
23 recommendation comments and seeing where it lies.
24 That's my view of how de facto that board has
25 operated. Now, if the people on the board are telling you
337
1 differently, then maybe I'm in error. But I think it's the
2 way it should operate and I think a recommendation towards
3 that effect would be welcome.
4 CHAIRPERSON LASHOF: You'll get it. I mean, that
5 will be one of our recommendations. We will deal with this.
6 Let me ask you, though, so that we're not out of
7 line and are sure that we've got all the appropriate
8 information so that as we write up our findings and our
9 recommendations to you that we do understand. Do I
10 understand what you've said that the Research Working Group
11 should be looking -- obviously you just said should be
12 looking at the peer-review comments that have been made
13 about the various studies.
14 DOCTOR JOSEPH: Yes.
15 CHAIRPERSON LASHOF: If peer review has suggested
16 that a study be abandoned, would it be the role of the
17 Research Working Group to present that to the Board, to the
18 overall board and to the agency heads, saying this is one of
19 the recommendations; we concur, or don't concur?
20 DOCTOR JOSEPH: Let's be sure we're -- I don't
21 think it's the role of the Coordinating Board to decide that
22 question. I think it's the role of the Coordinating Board,
23 quite appropriately, to recommend on that question and to
24 have a role in the negotiation of what does get decided. I
25 mean, I don't think it's appropriate, for example, nor
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1 feasible for the Coordinating Board to say to the CDD --
2 let's take the CDC to push it a step, you know, away from
3 the personal -- to say to the CDC, "We think that this
4 specific study should be stopped and therefore it will be
5 stopped." But I think it's perfectly -- That's what we have
6 a Coordinating Board for I think, in my view, for the
7 Coordinating Board to say the three agencies in this
8 together trying to make it fit best and work most
9 effectively think this is a blind alley and you need to take
10 that seriously into account when you make your future
11 funding decisions, your future program decisions.
12 CHAIRPERSON LASHOF: So they would report to the
13 agency head so, you know, if the Coordinating Board, using
14 CDC, felt that a particular study that CDC was doing was
15 either duplicative or something, or so small considering the
16 size of some other study that is now going, even if it's a
17 valid study, if it's a small study that's not going to
18 contribute a great deal, and thinks this could be abandoned,
19 the Coordinating Board could review that. It would come, I
20 assume, from the Research Working Group to the Coordinating
21 Board, the Coordinating Board would say, "Umm. Yeah, we'll
22 notify Doctor Satcher that this is the way we feel and then
23 it's up to Doctor Satcher to decide what to do."
24 DOCTOR JOSEPH: Right. I see no difference in
25 that and the board saying, "We think this is an important
339
1 area to go forward in."
2 CHAIRPERSON LASHOF: That's right.
3 DOCTOR JOSEPH: I mean, it's the same question.
4 CHAIRPERSON LASHOF: Yeah. And that's --
5 (Doctor KIDD-TAYLOR left the hearing room.)
6 DOCTOR BALDESCHWIELER: Let me see if I can
7 sharpen this a little bit for my understanding.
8 CHAIRPERSON LASHOF: Sure, please do.
9 DOCTOR BALDESCHWIELER: I'd like to know who plays
10 the role of the normal program officer? That is someone has
11 to solicit the reviews, has to --
12 DOCTOR JOSEPH: That's done at the agency level.
13 DOCTOR BALDESCHWIELER: -- agree to the funding.
14 Has to monitor the quality. Is responsible for the
15 expenditure of the funds. Who does that?
16 DOCTOR JOSEPH: That's done at the agency level.
17 That would be the agency program officers.
18 DOCTOR BALDESCHWIELER: So there would be an
19 identifiable program officer or program director?
20 DOCTOR JOSEPH: Sure.
21 DOCTOR BALDESCHWIELER: And then how do they
22 receive the more general guidance from the coordinating
23 committee?
24 DOCTOR JOSEPH: Well, that whole portfolio and all
25 those actions are what the Coordinating Board and the -- I
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1 mean, if you read the Research Plan, that's the process that
2 the Coordinating Board goes through.
3 DOCTOR BALDESCHWIELER: So they would receive a
4 package of all the decisions that had been made, post-facto?
5 DOCTOR JOSEPH: I believe they do. I'm not sure
6 on that. I can check it to you but I would assume they do.
7 I mean, when you say "all of the decisions," I don't think
8 the Coordinating Board gets all the responses to requests
9 for proposals that comes in and looks at the scores that
10 were on them, but the Coordinating Board I'm quite sure,
11 I'll get back to you if I'm wrong, has a very clear sense of
12 what's been funded and why, what the -- and what the
13 expectations on that research line are.
14 DOCTOR BALDESCHWIELER: So the individual program
15 directors are operating essentially independently the way
16 they normally would within their agency?
17 DOCTOR JOSEPH: Yes.
18 DOCTOR BALDESCHWIELER: And their decisions are
19 funneled up to the Coordinating Board, is that --
20 DOCTOR JOSEPH: I think the decisions that are
21 made by the individual -- I think what Joyce and I are
22 saying that the decisions that are made by the individual
23 agencies and their program officers are very heavily
24 influenced by what the Coordinating Board has been doing.
25 Again I refer you back to the Research Plan, and the
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1 reciprocal part of that loop is the findings and the status
2 and directions and implications of the research that's being
3 carried out in the normal way thorough that program officer
4 in that agency is back-looped into the Coordinating Board so
5 that they know where the overall effort is going.
6 DOCTOR BALDESCHWIELER: So they then would comment
7 on the balance of the program if they think there's too
8 much --
9 DOCTOR JOSEPH: The Coordinating Board, sure.
10 DOCTOR BALDESCHWIELER: -- awarded in one area and
11 not enough in another area they would be able to provide
12 guidance to the program officer to change the mix?
13 DOCTOR JOSEPH: I wonder if it might not be
14 useful -- I know you've had people come and testify but it
15 might be useful for staff or member of the community to
16 actually sit in on a working meeting of the Coordinating
17 Board. It might give you a better sense of the way that
18 flows, and we certainly could arrange it.
19 CHAIRPERSON LASHOF: I'm not sure whether staff
20 have done that yet or not. I know they have sit in on the
21 Armed Forces Epidemiologic Board meeting and some of the
22 Science Defense Board meetings, some various meetings. I'm
23 not sure about the Coordinating Board meeting, per se.
24 MS. NISHIMI: There's been some discussion of
25 that. There have also been I think some concerns on some of
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1 the Working Group members, an earlier stage in time, that
2 there was some preference to them discussing certain aspects
3 of the Research Plan and their business in the absence of
4 committee staff.
5 DOCTOR JOSEPH: Well, I'm sure there are --
6 MS. NISHIMI: So --
7 DOCTOR JOSEPH: -- things they would want to
8 reserve but I think you could not get a better sense of how
9 the mechanism operates and how you might want to recommend
10 that it alters, than some sense of how they actually do
11 their business.
12 CHAIRPERSON LASHOF: Well, as I say, obviously, as
13 you know, we did have testimony. This question was sort of
14 asked and they did not feel -- it's my understanding of
15 their answer that they were to assess the quality and to act
16 as another peer reviewer, and we don't think they should and
17 we're not suggesting that but we are suggesting that when --
18 that they should be reviewing the peer reviews and
19 recommendations that have been made on the research plans
20 and make some recommendations to agency heads about
21 continuation, modification and so forth of research if
22 they're not being followed at the level of the research.
23 DOCTOR JOSEPH: Let me suggest that -- I don't
24 want to put tasks on Ken Kizer, but I don't think he'd have
25 any trouble with this. Let me suggest that we develop and
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1 get back to you the clearest statement we can of the
2 relationship between the Coordinating Board and the
3 individual agency research oversight process on this topic
4 of peer review and how that loops through the system. Try
5 to get you one page that lays it out as clearly as we can.
6 Get that back to you and then we can go back and forth on
7 it.
8 CHAIRPERSON LASHOF: That will be fine.
9 Are there other questions that people have?
10 There was one other that came up and I'm not sure
11 how best you can handle it. We've gotten some feedback from
12 people on active duty who feel that they would like to
13 testify before the committee but are afraid to do so. They
14 feel, through spoken or unspoken or other advice, that they
15 shouldn't come forward. What can you do to assure and help
16 assure people, because I know your own feelings would be we
17 should hear anything that anyone has to say and people
18 shouldn't have to worry about retribution. What can you do
19 to assure people on the line that they should feel free to
20 come forward, submit material through the committee or
21 testify before the committee, if they wish, without concerns
22 that they'll be -- have any adverse affect on their career
23 in the military?
24 DOCTOR JOSEPH: I heard this come up yesterday in
25 the VA context so I checked back this morning to find out
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1 exactly what is the policy. And what I learned is that
2 there probably is no policy that relates specifically to
3 Presidential Advisory Committees or other expert committees,
4 but there is a policy that relates to testimony before the
5 Congress. And the Department policy is that people are and
6 should be at liberty to come and express their personal
7 opinions as long as two criteria are met:
8 One. They make very clear when they're expressing
9 a personal opinion and when they're speaking for their
10 organization; and,
11 Two, that if they're bound by any other duties
12 such as, for example, attorney/client privilege or medical
13 confidentiality or classified information, that privilege
14 doesn't get revoked.
15 CHAIRPERSON LASHOF: Obviously.
16 DOCTOR JOSEPH: The requirement doesn't get
17 revoked just because one is expressing a personal opinion.
18 But, with those two caveats, that is the policy of the
19 Department, remains the policy of the Department.
20 I'm not sure that's a helpful answer to your
21 question because the real issue is at the unit level or at
22 the squad level or on the base is there some way, in some
23 circumstances, that direct or indirect, you know, pressure
24 is to -- You know, I guess beginning with the President and
25 going down, there have been so many statements: no stone
345
1 unturned; we're really trying to get to the bottom of this;
2 we want to be available to care for our people and to learn.
3 I think if anyone -- and this perhaps is a fruitful area for
4 your recommendations -- if anyone can suggest any further
5 ways that we can get that message clearer to people we'd be
6 happy to entertain them. I mean, I think the record is for
7 both the agencies that we have really tried to reach out and
8 make this a very open process. Make the information that we
9 get back open, both in the declassification area and in the
10 data area. I'm sure there are limits to the effectiveness
11 of that process.
12 Whether those are real strictures placed on
13 individuals or concerns that they have that may not reflect
14 the reality. I mean, I'd be amazed if that wasn't so. I do
15 not think it's a major phenomenon. I mean, I think
16 especially you go back and you look at some of the early
17 congressional hearings when this was really a hot topic, in
18 '93 and '94, and the kinds of statements that were made by
19 individuals who came forward both in the congressional
20 hearing rooms and in the media on television, in uniforms,
21 et cetera, this has not been a process where there's been a
22 lot of hesitation, but I'm sure there's some.
23 One of the things that gives me a chuckle, we work
24 pretty closely on this issue with our colleagues in the
25 British Ministry of Defense there. Most recently in
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1 parliament there was some discussion about how well the
2 Americans have done this and how much they're trying and why
3 aren't we, the Brits, you know, why are we covering it up
4 and why do we have the arrogant attitude in the Ministry of
5 Defense that we don't want to, you know, open this up, and
6 the rest of it. So I guess, in part, it depends on where
7 you see it.
8 But any specific suggestions you can give us on
9 either better outreach for the programs themselves and any
10 further way to reduce any inhibitions that might be there --
11 I mean, I don't when the last time that the Secretary of
12 Defense and the Chairman of Joint Chiefs of Staff sent a
13 letter down through the system, as they did in the spring of
14 1994, and said, "Come forward. If you have a problem, come
15 forward. We want to help you with it." That's a rather
16 unprecedented event and you would assume that it would have
17 some impact as it goes down through the chain of command. I
18 guess I can't give you a better answer to that, Joyce.
19 CHAIRPERSON LASHOF: Further questions any member?
20 Marguerite?
21 CAPTAIN KNOX: I just wanted to same something.
22 Before your arrival, Doctor Joseph, we talked about access
23 to care and one of the things that we note is under review
24 is the military departments were conducting a joint
25 preventive medicine support of military operations to
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1 include comprehensive medical surveillance. I just want
2 commend those efforts and ask that those efforts continue.
3 DOCTOR JOSEPH: Well, I thank you for that and I
4 would hope in the near future to be able to talk with you or
5 send through the staff more detail on some of those things.
6 It's just inappropriate at the exact moment.
7 MAJOR CROSS: I do want to say that we had two
8 representatives here yesterday, one on active duty in the
9 Marine Corps and, number one, he did voice a hesitation
10 about working through the system and highlighting of his
11 problem for fear of his career. But also I just wanted to
12 let you know there's still a problem with availability of
13 proper medical attention out there and these people voiced
14 their frustration in getting --
15 DOCTOR JOSEPH: What do you mean by that?
16 MAJOR CROSS: Well, in other words, reporting into
17 the hospital and saying, "I have a problem. I think it's
18 related to service in the Gulf," and then being kind of
19 shoved around the system without any proper care or even
20 advice or guidance as to how to solve their problem.
21 DOCTOR JOSEPH: You see, I'm pretty hard over on
22 that one. I think that is not at all representative to
23 either the way this particular issue has been handled by the
24 military health services system nor the way that health care
25 is delivered in the military health services system. I'm
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1 sure you can find some people who have had that experience
2 both genuinely and in their own perception, you know, some
3 of each kind or some of both. But I think it in no way
4 reflects a trend, and we would be happy I guess to do two
5 things:
6 On an individual instance, to know about what that
7 specific -- I mean, that Marine that was here yesterday,
8 what his specific issue was and track it down and follow it
9 down and see where the reality lies. And if it lies on his
10 side of the argument, well, then, there's a way to deal with
11 that.
12 And I think we'd also be happy, and some of the
13 members of the committee have a great deal of experience
14 with the military health care system, to give you any better
15 sense we can about whether there is a "problem" with that in
16 the system or whether that represents any kind of trend, I
17 think very clearly it does not and especially does not on
18 this issue.
19 CAPTAIN KNOX: I think one of the things that the
20 soldier hit upon was that he had to -- he was given an
21 appointment day to call to make an appointment, and I think
22 that's very common in military medicine if you are assigned
23 to a specialist or you've been referred you are given a date
24 to call to try and make an appointment with that specialist,
25 and I think in everyday medical practice in the private
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1 sector that's not so common.
2 DOCTOR JOSEPH: I don't know when the last time --
3 I know the last time my wife called our private -- civilian
4 sector HMO and tried to get an appointment with a designated
5 specialist, I think increasingly and particularly with our
6 managed care, our regionalized program with Tri-Care we're
7 doing a lot better than most of the civilian sector. It
8 ain't perfect and I'm sure there are a lot -- You know, one
9 can find any day lots of stories. Doctor Custis is smiling
10 at me but you can find lots of individual stories. But I
11 think we do much better than that which is why I reacted so
12 strongly.
13 CAPTAIN KNOX: Well, his time period for waiting
14 was two months so --
15 DOCTOR JOSEPH: Well, it's not appropriate, nor do
16 I think in any way it is representative that someone who
17 tries to register for the CCEP would have a two month wait
18 before they could get initial exam. That's not appropriate
19 and if that's what happened that's wrong and we ought to fix
20 that both for that individual Marine and, if there's any
21 pattern to that, in the particular facility. But that is
22 not at all characteristic of this program.
23 CAPTAIN KNOX: He actually had had his initial
24 evaluation. He had just been referred to a specialist and
25 he had waited two months. He still has not seen that
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1 specialist.
2 DOCTOR JOSEPH: Well, then what he should do of
3 course, I mean, this is easier to say when you're sitting
4 here, he ought to kick that up through the system and then
5 you get back to Doctor Lashof's question, but --
6 CHAIRPERSON LASHOF: That's why I was going to
7 follow that one up actually in another way and say, you
8 know, obviously there are times when the system doesn't work
9 the way it should and there's an unhappy soldier or naval
10 man, or whatever, that can't get the care or can't see the
11 doctors or isn't getting much results and is pretty unhappy.
12 Is there a systematic way for them, an ombudsman, a
13 mechanism for them to voice their complaints somewhere?
14 Someone to go to and say, "Hey, you know, the doc I saw
15 today is putting me off. He's not paying attention. I
16 asked to see a specialist and they're telling me two months
17 from now I can call up and then I can try to make an
18 appointment to see a specialist, and it's really been a year
19 that I've been playing around," so on and so on. Obviously
20 those who come before us are those that are unhappy and had
21 such experiences and, you know, we've had quite a few. And
22 the question is not, "Well, what do we do for this one
23 person?" You know, obviously we could follow up and notify
24 the commander that they better pay attention to sergeant so
25 and so. But more important, is there an automatic system
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1 that can be put in place where people feel that there's
2 rights in the waiting room and if you're not happy here so
3 you talk to -- some mechanism to deal with these things?
4 DOCTOR JOSEPH: Well, I think you have a point.
5 To the best of my knowledge, we do not have such -- and for
6 the purpose of this discussion let's call it ombudsman
7 system -- at the system level for the CCEP beyond anything
8 that's in the individual facility. That's not a bad idea,
9 and I think that might also be a useful recommendation.
10 We did have when we set up the registry -- We set
11 up the registry such that -- going back to your question of
12 a few moments ago -- such that a, for example, an active
13 duty service member who did not want to be seen in our
14 clinical system, for whatever reasons, could be seen in the
15 VA. There was very little use of that, by the way. I don't
16 have the numbers in my head but it was a very small number
17 of people, but there were some. But perhaps we ought to set
18 up, and I realize it's late in the day, but perhaps we ought
19 to have within the overall CCEP system a way for somebody
20 who feels that they're not getting taken care either
21 adequately or in a timely fashion to raise that issue in the
22 system rather than in the individual facility. Not a bad
23 idea.
24 CAPTAIN KNOX: That would be good.
25 CHAIRPERSON LASHOF: Okay.
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1 DOCTOR JOSEPH: We'll report back to you on it.
2 It's not a bad idea.
3 DOCTOR CUSTIS: I think we ought to assure Doctor
4 Joseph that we're not going to recommend there be a hotline
5 to your office to receive these calls.
6 CHAIRPERSON LASHOF: Oh, I think that's what we
7 should do.
8 DOCTOR JOSEPH: There is a hotline.
9 CHAIRPERSON LASHOF: Not for this --
10 DOCTOR JOSEPH: It runs in both directions.
11 CHAIRPERSON LASHOF: Are there any other
12 questions?
13 (No response.)
14 CHAIRPERSON LASHOF: If not, thank you very much
15 for coming, Doctor Joseph. It's a pleasure as always.
16 DOCTOR JOSEPH: It's a pleasure to be with you.
17 CHAIRPERSON LASHOF: Okay. Let us see. Okay.
18 Can we ask staff to return to the table and we'll proceed
19 with further discussions.
20 MR. CASSELLS: Joan Porter will describe for you
21 the efforts we're going to undertake to address the ethical
22 issues surrounding the use of the botulinum toxoid and the
23 pyridostigmine bromide by waiver of informed consent.
24 JOAN PORTER, REPORT ON ETHICAL ISSUES
25 MS. PORTER: An area committee members asked us to
353
1 examine last time we met is use of agents in investigational
2 status with a waiver of informed consent. In that regard,
3 we have been reviewing the decision-making processes
4 concerning waiver of informed consent for use of
5 pyridostigmine bromide, PB, and botulinum toxoid vaccine
6 which were and still are in investigational status for
7 military use.
8 Another vaccine for anthrax, an approved and
9 licensed vaccine, is also of interest because its use in
10 theater encompasses some of the same considerations about
11 deployment of agents to protect against chemical and
12 biological warfare. Other investigational agents were
13 considered for use with waiver of informed consent but these
14 ultimately were not deployed.
15 Staff have been collecting data through interviews
16 and review of literature and documents concerning
17 circumstances under which the Food and Drug Administration
18 regulations were modified to permit waiver of informed
19 consent in theater. We are looking at Department of Defense
20 and Food and Drug Administration interaction in that
21 process. We also want to examine, to the extent possible,
22 what occurred in the theater of operations in use of these
23 agents.
24 To help us clarify the events that occurred in the
25 past and the ethical and sociological dimensions of some of
354
1 these events, and to consider recommendations for the future
2 about military waiver of informed consent, staff will have a
3 consultation next week with representatives of the
4 Department of Defense, the Department of Health and Human
5 Services, the Department of Veterans Affairs, and several
6 ethicists and other scholars.
7 The consultation will provide background for an
8 Advisory Committee panel meeting in Kansas City, Missouri,
9 on January 12th that will be chaired by Doctor Caplan in
10 which we will review the decision-making issues.
11 In your briefing books, in the second part of tab
12 C, are tentative agenda and roster for the December 12th
13 consultation, along with a draft paper providing a partial
14 chronology of decisions with regard to waiver of informed
15 consent and a series of questions we plan to address. We
16 would appreciate any advice you have on this approach, or
17 other facets of this issue area the committee would like to
18 review.
19 CHAIRPERSON LASHOF: This information, as you
20 say -- and people, if you're having trouble finding it, page
21 seven has the questions to be addressed at the consultation
22 of a document listed as "Background Draft." It's right
23 before Attachment B, and then there's a lot of background
24 information in here to help us.
25 Just for the process purposes, first let me
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1 clarify that it is not our intention to try to pursue this
2 in enough depth to say anything in the interim report and to
3 have any series of recommendations, or is it? I mean, do
4 you expect to come out of the January 12th meeting with
5 stuff you want to share with us and you want to get stuff
6 into this interim report, or will this be more a statement
7 in the interim report that this is what we're exploring
8 here, is where we're at and we'll let you know more when we
9 get our final?
10 MS. GWIN: Our goal is to actually have findings
11 and recommendations on this issue in the interim report. So
12 this is, in fact, an area where you will be expected to be
13 doing extensive review right up to the last minute, in terms
14 of our report length.
15 CHAIRPERSON LASHOF: Is that wise. Is there some
16 overriding reason we feel we need to -- I mean, I think we
17 need some -- I'm worried about you all as well as about us,
18 that we not push ourselves to the point that we act
19 prematurely on anything, but I'm open to hear why we need to
20 put this as part of, you know --
21 MS. GWIN: I think if you look at the background
22 memo in the briefing book you will see that Joan has done a
23 fair amount of research on this already as far as pulling
24 the background together. And many of the ethicists and all
25 of the government officials whom we've invited to our
356
1 consultation on December 12th have dealt with this issue
2 extensively.
3 CHAIRPERSON LASHOF: This is December 12th or
4 January 12th?
5 MS. GWIN: Well, we're having a consultation, an
6 in-house consultation on December the 12th which will enable
7 us to prepare even better text for you to look at in the
8 first draft of the interim report, and then we're going to
9 have a panel meeting that Art Caplan will chair on January
10 12th that will enable us, the members of the committee, who
11 have taken the most, you know, detailed look at this to come
12 to some fairly strong conclusions I think about what they
13 feel comfortable saying in the interim report, which should
14 aid the rest of the committee members in coming to any final
15 judgment about whether they're ready. So we have a lot of
16 work planned but we're ready for it so we really hope to
17 make these statements in the interim.
18 CHAIRPERSON LASHOF: Okay. My hesitation of
19 having anything in the interim report that the whole
20 committee has not had a chance to discuss and digest is
21 there, but if we have a good subcommittee panel meeting in
22 January, we all get it, then we can make the final decision
23 at the February or the end of January meeting whether we're
24 all satisfied well enough to include it or drop it at that
25 point.
357 1 MS. PORTER: Correct. I think we need to see how 2 this evolves, if the recommendations are agreed to then we
3 can include that. If there is additional dialogue that has 4 to occur about the recommendations then we may need to not 5 include those. 6 DOCTOR CUSTIS: This may be one of those issues
7 where some of my friends say I should and some of my friends 8 say I shouldn't, and I never disagree with my friends. 9 DOCTOR BALDESCHWIELER: Joan, could you give us 10 just kind of a brief synopsis of what actually happened? 11 That is the DOD did interact with the FDA on this issue? 12 MS. PORTER: Yes. They had a series of extensive 13 interactions between August 1990 and thereafter concerning 14 review of investigational agents for prophylactic needs in 15 Gulf War. 16 DOCTOR BALDESCHWIELER: And in the background of 17 regulations the FDA has an exclusion for military operations 18 as they can exclude informed consent? I mean, this is 19 viewed as an IND process? 20 MS. PORTER: Yes. The agents in use in Gulf War 21 preventative means were basically PB and botulinum toxoid 22 vaccine. Those are and were in investigational status. 23 They were used not for research purposes, however. They 24 were used for prophylactic need, not in accordance with the 25 research protocol.
358 1 DOCTOR BALDESCHWIELER: But PB is approved for 2 other indications? 3 MS. PORTER: Yes, it is but it was not approved 4 for the indication for use in military. 5 DOCTOR BALDESCHWIELER: So this would then be 6 called an IND in the FDA? 7 MS. PORTER: Yes. 8 DOCTOR BALDESCHWIELER: A series of things, and 9 they have an allowance for carrying out an IND without 10 informed consent if a military operation is involved? 11 MS. PORTER: Yes. At Title 21, Part 50.23, is the 12 FDA regulation that deals with waiver of informed consent 13 and the circumstances under which that is permissible. The 14 circumstances that were in the regulation before December 15 21, of 1990, had some circumstances under which waiver of 16 informed consent could take place but they did not really 17 address the situation of military exigency, and these 18 were -- FDA issued an interim final rule on December 21st,
19 1990, I believe, that modified the Section 23 to add another 20 part, another section, to deal with military exigency and 21 the circumstances under which the Commissioner of Food and 22 Drugs could decide that that informed consent was not 23 feasible. And these are listed in the background paper, on 24 page seven I believe. I'm sorry, page two, at the bottom of 25 the page, the criteria that the Commissioner must consider
359 1 in making his or her determination about waiver of informed 2 consent in a military situation. 3 DOCTOR BALDESCHWIELER: So was this a change in
4 regulation that was made for the specific purpose of the 5 Gulf War? 6 MS. PORTER: Yes, I would say that that's a 7 correct statement that the consideration to modify the 8 regulation and interim final rule was precipitated by the -- 9 DOCTOR BALDESCHWIELER: The Commissioner has that 10 rule making authority? 11 MS. PORTER: Yes. This is an interim final rule 12 so it's not a notice of proposed rule making. There were, 13 in fact, 23 public comments which came in in response to the 14 interim final rule but it went into effect on the day that 15 it was signed. 16 CHAIRPERSON LASHOF: What is an interim final 17 rule? How long is it allowed to be enforced before it stops 18 being interim and it's just final? I mean, the definition 19 of "interim final," what does that mean? 20 MS. PORTER: My understanding is that it's interim 21 final forever; however, I will -- 22 CHAIRPERSON LASHOF: But what does the use of the 23 word "interim" mean in this context? 24 MS. PORTER: Well, I think the implication there 25 is that public comment can be received and entertained and
360 1 that the departments and agencies can consider modification 2 of that rule. 3 I think an important thing to remember is that the 4 Commissioner's waiver of informed consent, or finding that
5 informed consent is not feasible in this situation. It has 6 to be reviewed annually or the Department of Defense has to 7 indicate before that time that the waiver is no longer 8 needed, which was in fact done. In March, DOD indicated to 9 the Commissioner that waiver of informed consent for PB and 10 botulinum toxoid vaccine was no longer required. 11 CHAIRPERSON LASHOF: Holly, can you tell us when 12 an interim gets removed or not, or does it hold interim 13 forever? 14 MS. GWIN: I don't want to appear to be an expert 15 in legal doublespeak but -- 16 CHAIRPERSON LASHOF: But you are. 17 MS. GWIN: In the same way that some of you have 18 interim secret clearances, it just means that they are still 19 looking at it but it's -- you have -- it's the rule until we 20 say it's not the rule. 21 CHAIRPERSON LASHOF: But there's no point in time 22 in which you withdraw the interim and call it just a final 23 rule? I mean, it can be called an interim for 10 years or 24 20 years? 25 MS. GWIN: Yes.
361 1 CHAIRPERSON LASHOF: Okay. 2 MS. GWIN: It's the wonders of the English 3 language. 4 DOCTOR BALDESCHWIELER: So pyridostigmine went in 5 as an IND with a waiver on informed consent, and the 6 botulinum toxoid also went in as in IND? 7 MS. PORTER: Yes. 8 DOCTOR BALDESCHWIELER: And does it have another 9 use? Does it have existing approval for another indication? 10 There is no other indication, is there? 11 MS. PORTER: PB is an approved agent for 12 myasthenia gravis. 13 DOCTOR BALDESCHWIELER: I understand. But the 14 botulinum toxoid -- 15 MS. PORTER: The botulinum toxoid has been used in 16 an investigational status for workers in the Centers for 17 Disease Control and Prevention, in the Food and Drug 18 Administration actually some of their staff take that for
19 purposes of inspections, and also the Department of Defense 20 employees, laboratory workers, take the vaccine as well. 21 CHAIRPERSON LASHOF: Why is it still considered 22 investigational and what is the timetable for a decision as 23 to whether botulinum toxoid would be approved for use in 24 limited conditions or under certain circumstances but would 25 no longer be considered investigational, can you tell us
362 1 that? 2 MS. PORTER: My understanding is that the 3 Department of Defense holds INDs for both PB and botulinum
4 toxoid vaccine and are working toward the approval of those 5 agents. One has to realize that it's very difficult to test 6 the efficacy of those agents without exposing the persons 7 who are vaccinated to the actual chemical or nerve gas 8 involved, so there might be a possibility at looking at 9 surrogate markers or other measures of efficacy without 10 direct exposure. And that I think is part of the problem in 11 ever having these moved to full approval. 12 CHAIRPERSON LASHOF: In other words, the feeling 13 probably at FDA and DOD, and others, at this point is those 14 two, the pyridostigmine for this use and botulinum toxoid, 15 will probably always be on investigational status, that it's 16 unlikely that one would ever go through the whole process 17 that would be necessary for FDA to approve them for other 18 than investigational, mainly because that process is 19 probably not possible to do? 20 MS. PORTER: I think that's one of the things we 21 want to look at is to find out the circumstances under which 22 approval could be obtained without some of the more 23 traditional investigations and data collection activities. 24 If there are animal models or surrogate markers or other 25 type of data that would lead to approval or limited types of
363 1 approval then we would want to find out about that, and on 2 December 12th I think we will be exploring with our 3 consultants what discussions have go on in that vein.
4 CHAIRPERSON LASHOF: May I direct all of our 5 attention to page seven where a lot of the questions we're 6 now asking are listed, and I don't mean to cut off anything, 7 John, go ahead. But I thought it might help structure it as 8 if we looked down at those questions and see if those are 9 addressing the kind of questions we're asking, whether there 10 are other questions that we want the staff to address at 11 their consultation. Go ahead, John, please. 12 DOCTOR BALDESCHWIELER: Just to finish the 13 summary, the situation with the anthrax, this is an 14 approved -- 15 MS. PORTER: Yes, it's an approved and licensed 16 vaccine since 1972, I believe. It's produced by the 17 Michigan State Department of Health. 18 DOCTOR BALDESCHWIELER: So that gets a completely 19 clean slate as far as the use or is there a problem there as 20 well? 21 MS. PORTER: I think it depends on how one is 22 looking at it. In terms of the issue of informed consent, 23 there was not the necessity for a waiver of informed consent 24 because this agent was not in investigational status, such 25 that we had to go to the Food and Drug Administration
364 1 regulations to see if those criteria could be satisfied for 2 the waiver of informed consent. However, it was an agent 3 that was used as a prophylactic measure in Gulf War and 4 which some of the service personnel did receive during Gulf
5 War. So some of the same kinds of decision-making processes 6 about when it was deployed, if it would be used, who got it, 7 what kind of follow-up was done for persons who received it, 8 those come into play as well. So there are not all of the 9 same issues with anthrax vaccine that there are with PB and 10 botulinum toxoid vaccine, but there are some of the -- there 11 are some overlapping considerations. 12 DOCTOR BALDESCHWIELER: There's not an FDA issue, 13 is there? I mean, this is approved and -- 14 MS. PORTER: I think an issue might be again 15 record keeping; who received the drug and what kind of 16 information we have about adverse reactions -- not the drug, 17 the vaccine -- who received the vaccine and what kind of 18 adverse reactions might have come from anthrax vaccine, what 19 was the use of anthrax and PB and botulinum toxoid vaccine 20 all together. Some of those issues have been raised. 21 CHAIRPERSON LASHOF: But is there an issue with 22 anthrax vaccine that would be any different than influenza 23 vaccine? 24 CAPTAIN KNOX: Can I speak to that? 25 MS. PORTER: Yes.
365 1 CAPTAIN KNOX: I just think what the issue was 2 that because it was a security problem people were not 3 informed that it was, indeed, anthrax. They were informed
4 that it was injection A1, and that's where the problem came 5 in was that they didn't know what they were receiving. 6 MS. PORTER: Yes, I think that's a good point. It 7 was used as a prophylactic measure against biological 8 warfare and, therefore, there were some security 9 considerations. 10 An additional consideration is that there was a 11 limited amount of vaccine that could be deployed rapidly, as 12 there was with botulinum toxoid vaccine. 13 CHAIRPERSON LASHOF: Okay. So the ethical issue, 14 if you will, here is under warfare conditions if you are 15 going to use a vaccine as a prophylactic against something 16 that is not in the common -- I mean, it's not flu, it's not 17 tetanus, it's something unusual, what are the circumstances 18 that must -- and what is the decision-making process that 19 ought to be followed before you could give it without 20 telling the people what it is you're giving? So the ethical 21 issue comes around giving a vaccine to someone without 22 telling them what vaccine they're getting, even if they 23 don't have a choice. I assume, in the military if they 24 decide everybody's got to get tetanus and flu shots they're 25 told they're flu shots and they're tetanus and you don't
366 1 have a choice, you're going to get them, and you get them 2 and you get meningococcal, et cetera, and then here we come 3 with one that we say you're going to get A1. 4 MS. PORTER: Uh-huh. 5 CHAIRPERSON LASHOF: "Thanks. What the hell's 6 that?" 7 "Well, can't tell you." That's where the issue 8 come up and that would be something you would explore with 9 the ethicists at your panel in January, when and how that 10 gets done, or what? 11 MS. PORTER: I think that's in part an ethical
12 issue, but it's in part a public administration issue as 13 well as how people are told about what they're receiving and 14 how their records are documented so that they will know what 15 they've been given. And, if they have subsequent problems, 16 they can have that information available to them to help 17 identify the source of the problems. 18 DOCTOR BALDESCHWIELER: Is informed consent an 19 issue with anthrax? That is do they have to agree? 20 MS. PORTER: No. Since it's an approved and 21 licensed vaccine there are not the same kinds of issues of 22 informed consent for investigational agents. 23 DOCTOR CUSTIS: The policy underlying this however 24 did not deny authority to give the information as to what 25 these inoculations were?
367 1 MS. PORTER: I think we'll want to -- 2 DOCTOR CUSTIS: Individuals could have been told 3 what they were getting, right? 4 CHAIRPERSON LASHOF: No. 5 MS. PORTER: Well, in a case where one is being 6 given an agent for biological or chemical warfare, I'm not 7 sure the extent to which individuals were always informed of 8 that. That's something we'll want to explore. 9 DOCTOR CUSTIS: I'm not saying that -- From your 10 paper which, incidentally, I think is beautifully done. 11 It's a fascinating job you did.
12 MS. PORTER: Thank you. 13 DOCTOR CUSTIS: I'm not saying that individuals 14 were supposed to be told or were supposed not to be told, 15 I'm just asking the question there was no reason why they 16 could not be told if the commanded wanted them informed, 17 isn't that true? 18 MS. PORTER: I believe that's correct, but we will 19 pursue that specific question. 20 DOCTOR BALDESCHWIELER: I think the rationale on 21 the other side was that, in fact, this was viewed as a 22 security issue. It was not clear whether the Iraqis would 23 use anthrax or not and, by the way, which strains since 24 there are at least six or seven different strains and the 25 toxoid is effective only against some of those. So I think
368 1 the argument on the other side of that was that you don't 2 want the Iraqis to know what you're protected against. 3 DOCTOR CUSTIS: You're saying so there was an 4 order not to inform those -- 5 DOCTOR BALDESCHWIELER: At least I can imagine the 6 rationale for that, and I think that was it. 7 MS. NISHIMI: Let's add that question to the list 8 of areas we want to have more specific information about. 9 CHAIRPERSON LASHOF: I think that's, you know,
10 clearly the question: Was it uniform policy not to inform 11 and, if there is such a uniform policy, either here or in
12 the future, not to inform what should be the decision-making 13 process by which it's agreed there will be a uniform policy 14 not to inform a soldier that he's going to get this, that or 15 the other? Would that not be the appropriate question? 16 CAPTAIN KNOX: Right. 17 MS. PORTER: By the way, I don't believe that we 18 have any reason to believe that there was a policy of that 19 nature, but we will find that out. 20 CHAIRPERSON LASHOF: If there wasn't a policy then 21 the question becomes: Should there be a policy to inform? 22 Because what we're hearing is that many of them received it 23 without being informed. Now, if there was no policy that 24 they were not to be informed, why weren't they informed and 25 shouldn't there be a uniform policy one way or the other?
369 1 So maybe those are the kinds of questions we'd like you to 2 explore. I mean, I don't know the answer. I'm throwing 3 them out as questions. 4 MS. PORTER: In fact there was an information 5 sheet prepared for PB and an information sheet prepared for 6 botulinum toxoid vaccine which was to be given to 7 individuals who received these agents. So, with that in 8 hand, we're lead to believe that it was not only the policy 9 but the -- that they be informed but there was specific 10 language prepared so that people would have adequate 11 information about the investigational drugs and biologics 12 that they received. 13 In fact, in theater we have information that 14 indicates that an order was given for the botulinum toxoid 15 vaccine individuals would be actually given a choice as to 16 whether or not they wanted to receive it, in the end. 17 CHAIRPERSON LASHOF: So it turns out that for the
18 investigational drugs they were given more information than 19 apparently they were given for the non-investigational 20 drugs, which seems a little bizarre. 21 DOCTOR CUSTIS: When you say "in the end," are you 22 speaking anatomically? 23 MS. PORTER: No, I'm speaking chronologically. 24 DOCTOR BALDESCHWIELER: It was my understanding 25 with the botulinum that they, in fact, had only a small
370 1 number of doses, of the order of 8,000 doses, and at the 2 time it was kind of a critical command decision as to who
3 should get it, and it was allocated to those parts of the 4 forces that were likely to be, at least thought to be most 5 likely to be exposed. 6 MS. PORTER: At greatest risk, right. 7 DOCTOR BALDESCHWIELER: At greatest risk. 8 MS. PORTER: The estimates that we have are not 9 doses but actual individuals, so there may have been more 10 than 8,000 doses but 8,000 persons who received it.
11 DOCTOR BALDESCHWIELER: Whereas the situation with 12 anthrax was quite different. I think the numbers there are 13 135,000. The Brits, for example, were able to vaccinate all 14 of their force, but, again, I think at the time it was 15 viewed as a priority to get the vaccine. 16 CHAIRPERSON LASHOF: Okay. Well, look down the 17 questions, people. Any other questions you can think of at 18 the moment? If not, you certainly can read them on the 19 plane back and over the next few days and get back to staff 20 as to any other questions that you think should be addressed 21 and recognize that they hope they'll get far enough that we 22 can put this in the interim report. And it will come up for 23 full discussion, back and forth with drafts, but probably 24 most thorough at their February 1st or 2nd meeting, whatever 25 date that falls one.
371 1 DOCTOR BALDESCHWIELER: It seems to me an 2 important part of the mission here is to be sure that the 3 trail that was followed was, you know, fully conformed up to 4 legal requirements. 5 CHAIRPERSON LASHOF: Well, that's one, but also 6 whether the legal requirements are what we think they should 7 be or whether there should be other legal requirements or 8 whether the interim rule should have some changes in it 9 since it's only an interim. 10 Okay. Well, you've given us lots of information.
11 We certainly do appreciate it and recognize you have a lot 12 of work to do and wish you well with it. Thank you very 13 much, Joan. 14 Other questions for Joan before we move on? 15 MR. RIOS: Let me ask one question, Joan. Do you 16 look into the issue of -- When you say "informed consent," 17 when I was in the military we got inoculations all the time, 18 for whatever reason, what does it really mean, because a lot 19 of these troops will not, even if you tell them we're giving 20 you whatever it is that we're giving you, they're not going 21 to understand what the implications are of that. You know 22 what I'm saying, technically they do not understand what 23 does it mean that I'm getting this and what are the risks 24 and so on and so forth. So are you looking into that 25 overall question of what is informed consent, and when do
372 1 you reach the threshold of actually calling it informed 2 consent if they really don't understand what you're giving 3 them? 4 MS. PORTER: You know, I think that's a much 5 broader issue because even in a non-military context there's 6 issues of how meaningful the process of informed consent is 7 for individuals. But I think we probably will be exploring 8 the type of information and the packaging of information in 9 such a way that it has the most possibility of being
10 understood, and under the circumstances in which this 11 information is being conveyed how we can do the best job 12 possible to make sure that people do understand. But it's a 13 much broader kind of an issue. 14 CHAIRPERSON LASHOF: I guess one of the issues 15 that comes up in this -- You know, here we're talking about 16 a waiver of informed consent and what Rolando is saying, 17 assuming you didn't get a waiver and you were required to 18 give informed consent, what does informed consent mean in 19 the service, should one -- should a serviceman have the 20 opportunity to say, "I don't want to take that," and, if so, 21 what happens? Is this grounds for discharge, courts 22 martial, or just, "Well, you won't go overseas," in which 23 case maybe a lot of people would refuse to take things to 24 avoid going overseas. I mean, it gets very complex kind of 25 issue to try to handle in the military. I don't know how
373 1 far you want to go into that aspect. 2 MS. PORTER: Well, I think that we will have to 3 look at that. Look at the ramifications of not waiving
4 informed consent or waiving informed consent, what comes 5 from that? But I think the point is well taken that if 6 informed consent cannot be obtained, if it's not feasible, 7 if we are at least providing information to individuals 8 about that which they are receiving and the risks and 9 benefits and the fact that they might be contacted again in 10 the future to find out the reactions and so on, can we do 11 this in such a way that it's the best that can be done.
12 CHAIRPERSON LASHOF: I guess the possibility comes 13 up is can one consider something like a waiver of 14 responsibility, so if a soldier says, "Well, I just refuse 15 to take that vaccine but I'll sign a statement that if I get 16 sick from this I won't blame you. It's my fault." 17 MS. PORTER: Well -- 18 CHAIRPERSON LASHOF: Is that a wild approach? I 19 don't know. You're asking me what are the questions I can 20 think of to throw out and I'll think of some wild ones if 21 you give me free reign. 22 MS. PORTER: That's one scenario. I guess lay it 23 on the table. 24 CHAIRPERSON LASHOF: I mean, you know, that's not 25 as outlandish as it sounds. I mean, you know, in a hospital
374 1 if you're under medical care and you refuse to follow the 2 therapy advised or if you want to sign out of the hospital
3 when your doctor says you need to be in the hospital, you 4 have to sign a form saying, "I'm signing out against advice 5 and without consent," and indicate that you're not going to 6 sue the hospital because you got sick after you left the 7 hospital when you were told not to. That sort of thing. 8 It's in that realm that I was thinking that this -- 9 DOCTOR CUSTIS: Joyce, the trouble is under close 10 quarters in the military an opportunity given puts others at 11 risk also. 12 CHAIRPERSON LASHOF: Yeah. I mean, it may be that 13 this is completely inapplicable and, if so, maybe we need to 14 say that. I don't know how many of these various scenarios 15 have to be thrown into the pot, looked at and discarded for 16 one reason or another, or whether we should limit ourselves. 17 MS. NISHIMI: I think these are the things that we 18 will cover at the consultation. I can say that the issue of 19 waiving informed consent and the notion of informed consent 20 in the military medical context, particularly with respect 21 to this issue, is a source of endless fascination with many 22 individuals and we have some of them at the consultation. 23 CHAIRPERSON LASHOF: That's why I guess I'm 24 hesitant as to whether we're going to come to a conclusion 25 for the January interim report -- or for the February
375 1 interim report. But give it a good try. Give it a try. 2 MS. NISHIMI: That's right. 3 CHAIRPERSON LASHOF: Okay. Thanks very much. I 4 think we ought to break at this point, though. We 5 originally said we'd break at 12:30 but I think this is a 6 good breaking point and I think we're a little worn down. 7 We have two major areas to cover yet: The 8 Outreach area and the Implementation area. And I hope that 9 most of you can hang in with us and we can get through that 10 this afternoon. If not, why we'll give you a lot of 11 homework and writing back and forth. 12 Let's try to be back by 1:15 -- 1:30, okay. 13 MS. NISHIMI: Give people some time since we 14 rushed through yesterday. 15 CHAIRPERSON LASHOF: Yeah. 16 (Whereupon, at 12:12 p.m., the above-entitled 17 matter recessed to reconvene at 1:30 p.m. the same day.) 18
376 1 A F T E R N O O N S E S S I O N 2 (1:40 p.m.) 3 (Major Cross and Doctor Kidd-Taylor not present 4 for afternoon session.) 5 CHAIRPERSON LASHOF: Okay. Last lap. Holly, Tom? 6 Tom, it's all yours. 7 MR. McDANIELS: Okay. 8 CHAIRPERSON LASHOF: Okay. We're going to 9 "Outreach Issues," tab D in your book, and Tom. 10 THOMAS McDANIELS, REPORT ON OUTREACH ISSUES 11 MR. McDANIELS: Good afternoon. Communication
12 through good outreach programs plays an essential role in 13 health promotion but it may be a challenging task to convey 14 health information which is inconclusive, controversial, and 15 subject to change with new findings. 16 Certainly the unexplained illnesses effecting some 17 Gulf War veterans fall into these categories of health 18 issues. We believe outreach to Gulf War veterans should 19 educate them and the public about these illnesses and the 20 health care and disability benefits available to veterans. 21 There are four questions that are key to assessing 22 whether the outreach programs of DOD and VA effectively 23 communicate to Gulf War veterans the special programs and 24 health issues related to illnesses possibly resultant from 25 service in the Gulf:
377 1 Do the outreach programs use sensible methods to 2 educate the interested public and members of the unique 3 population of Gulf War veterans? 4 Is there efficient coordination within each 5 department in the implementation of the outreach components, 6 and is there outreach program coordination between DOD and 7 VA? 8 Do the departments use any performance measure and 9 self-assessment techniques to determine the effectiveness of
10 outreach components in communicating their intended message? 11 And, finally, are lessons learned in the 12 development and implementation of Gulf War veterans' 13 outreach programs applicable to future situations? 14 The memo on "Outreach" in your briefing book 15 describe the research plan which focuses on evaluating the 16 Outreach Programs of DOD and VA, using these questions. For 17 the interim report we are prepared to assess many of the 18 outreach components and offer initial findings to the 19 committee. There are also some initial suggestions for 20 possible committee recommendations. 21 The outreach components that will be evaluated for 22 the interim report include: 23 DOD's Medical Registry hotline and incident 24 reporting line; 25 VA's Persian Gulf veterans' help line;
378 1 DOD's Leave and Earnings Statement Outreach; 2 Newsletters and memos from both departments;
3 DOD's Gulflink worldwide Web Internet site; 4 VA's online computer bulletin board; and 5 VA's worldwide Web Internet site Home Page. 6 Even though we have received some recent briefings 7 and information on the remaining components there will not 8 be enough time to conduct a complete evaluation of them for 9 the interim report. These components include: 10 DOD's American Forces Information Services, and 11 armed forces radio and television service; 12 The outreach aspect of the CCEP and VA Persian 13 Gulf Health Registry; 14 VA's Persian Gulf Health Days; 15 VA's Transition Assistance Program, active 16 duty/pre-separation briefings on Gulf War veterans' illness 17 issue; 18 VA's special programs for women veterans and 19 outreach to Spanish speaking people. 20 Coordination, performance measure, and self- 21 assessment techniques, and lessons learned will be ongoing 22 assessments. 23 At the last meeting there were attachments to the 24 Outreach memo showing examples of Outreach, and I played 25 some public service announcements from VA.
379 1 DOD has responded with some broadcast spots 2 produced by the American Forces Information Service that 3 were broadcast to service members through the Armed Forces 4 Radio and Television Service. 5 I'll pause here to show this video and then go 6 over initial findings and recommendations. 7 (Whereupon the video was played off the record.) 8 MR. McDANIELS: I've organized the findings into 9 categories of methods, coordination, and trends. The
10 following findings fall under the category of methods. 11 Finding number one. The DOD Medical Registry 12 hotline data transfer infrastructure efficiently refers
13 callers to sites of medical evaluation and education. DNBC 14 operates both lines and collects persuasive usage data 15 indicating that these components are well used. 16 Table Two shows the latest data on members of the 17 DOD Medical Registry and numbers of those referred for CCEP 18 evaluation. That's also in your book. 19 The next table, Table Three, breaks down the DOD 20 Medical Registry membership into service categories. 21 We know the hotline has been publicized through 22 press conferences, media releases, the American Forces 23 Information Service which provides clippings to DOD 24 newspapers around the world, and through the Armed Forces 25 Radio and Television Service which broadcasts radio and
380 1 television spots to troops overseas. 2 The operators do not answer questions clinical in 3 nature but inform callers that their questions will be 4 answered during the CCEP evaluation process. The hotline
5 offers a satisfactory eduction service but this hinges on 6 proper referral to the medical treatment facility. 7 The data on re-referral is the only data available 8 to committee staff so far indicating the efficiency of the 9 referral process. Overall 17-percent of CCEP participants 10 had to be referred a second time, but in the past few months 11 the rate has decreased to single digits. This may indicate 12 that medical treatment facilities are becoming more familiar 13 with the hotline referral process, and Figure 1 shows 14 referral data over time and also re-referral data. And the 15 re-referrals are people who have not been contacted in the 16 two week period and have called the hotline for re-referral. 17 Finding number two. VA's help line provides a 18 satisfactory information resource to callers. It would be 19 an excellent source if operators answered all the calls 20 instead of the voice mail system. The system is adequate at 21 referring callers to points of contact at medical treatment 22 facilities but has an impersonal feel that is not user 23 friendly. The voice mail auto attendant can anger some 24 callers and if they need medical evaluation they must call 25 another number and face another large agency red tape
381 1 situation at the medical treatment facility. 2 VA feels that the voice mail give standard 3 information whereas an operator giving the same scripted 4 information every workday of the year may sound disingenuous
5 of her time. They also point out that operators do mailings 6 as well as answer phones and that having them solely answer 7 phones would be an inefficient use of resources. 8 With the downward trend in call volume, VA has 9 reduced the help lines operator staff. They are able to do 10 this because the voice mail system will fill the gap. 11 From my site visit to the help line center in St. 12 Louis, I found that operators do, in fact, perform other 13 tasks along with answer calls but most were waiting for 14 calls. And I argue that the operators are trained enough to 15 give standard, accurate information and that they would be 16 glad to offer this information every workday. 17 Finding number three. VA on-line service offers 18 computer users Gulf War veterans' illness outreach 19 information in a convenient format. The VA on-line service 20 which offers a computer bulletin board for personal computer 21 users provides the same information offered by the voice 22 mail of the help line, which is a Persian Gulf review 23 newsletter, a question and answer pamphlet on Gulf War 24 veterans' illnesses, ongoing research pamphlets, available 25 medical care program pamphlet, disability compensation form
382 1 and Persian Gulf illness fact sheets. Users can download 2 information from the bulletin board. The service appears to 3 be utilized heavily with 127,801 accesses and 65,801 4 downloads of information. 5 Finding number four. VA's worldwide Web site 6 provides an inadequate outreach service to Gulf War 7 veterans. VA's worldwide Home Page usage has steadily 8 increased during the last year to nearly 30,000 accesses per 9 week. The outreach about Gulf War veterans' illness on the 10 Home Page is non-existent. The help line number and 11 information on the Medical Registry and priority care are 12 listed nowhere on the Home Page. There are hypertext 13 options to DOD's Gulflink and VA on-line so a person could 14 eventually get some information, but I ask why not place the 15 items conspicuously on the Home Page. They are buried 16 within the different pages. 17 Finding number five. Gulflink, DOD's worldwide
18 Web site, offers a user friendly assessable information 19 resource that deposits DOD' Gulf War related declassified 20 documents into a central location. 21 Finding number six. It is difficult to assess the 22 reliability of many declassified documents posted on 23 Gulflink, particularly intelligence information reports, 24 IIRs, containing raw, human intelligence information from 25 the field since no framework is provided for assessing them.
383 1 The Gulflink Home Page merely notes that, "IIRs 2 are not finally evaluated intelligence. Reports are from 3 all sorts of sources which have not been assessed for 4 reliability or veracity." 5 In briefings for Advisory Committee staff, DIA has 6 explicitly disavowed the accuracy of many of its own field 7 intelligence reports posted on Gulflink, particularly more 8 than a dozen IIRs reporting the deployment of Iraqi chemical 9 munitions to the Kuwait theater of operations. 10 Unfortunately, Gulflink provides no criteria for assessing 11 the veracity of the information contained in the 12 declassified documents, such as an explanation of the 13 difference between raw and finished intelligence. As a 14 result, the net effect of the declassified documents has 15 been to confuse rather than enlighten the interested public. 16 DOD critics contend that this lack of clarity is intentional
17 in that it has the effect of casting doubt on the veracity 18 of all declassified intelligence reports of chemical and
19 biological weapons' exposures, even those that may be true. 20 The following findings fall under the category of 21 coordination. 22 Finding number seven. VA intradepartment 23 coordination between the Veterans Health Administration, the 24 VHA, and Veterans Benefits Administration, VBA, played an 25 integral part in effectively establishing the Persian Gulf
384 1 Help Line. The Veterans Assistant Services Department, of 2 VBA, which as expertise in operating phone systems and 3 hotlines worked with VHA clinicians to create the voice mail 4 script for the help line and trained the contracted 5 operators. The help line also operates on a joint VBA, VHA 6 budget. Ongoing consultation between the administrations 7 occurs to ensure script accuracy. 8 Finding number eight. Interdepartment 9 coordination exists between the VA's central Public Affairs
10 Office and DOD's American Forces Information Service, AFIS. 11 For example, AFIS has broadcast spots about the VA on-line 12 service as well as an interview with Secretary Brown. There 13 also appears to be an informal information loop between the 14 DOD and VA Public Affairs Offices where the two exchange 15 news clips and information on report releases, et cetera. 16 Finding number nine. DOD intradepartment 17 coordination between Health Affairs, Public Affairs, and 18 AFIS plays an important role in the promotion of outreach 19 components. For example, the Medical Registry hotline was 20 conceived by Health Affairs, publicized through the press 21 and media through DOD Public Affairs, and communicated to 22 the service member through AFIS broadcasts. 23 And the final two findings fall under the category 24 of trends. 25 DOD's Outreach Program started very late,
385 1 effectively with the CCEP hotline effort of June 1994. 2 Public and congressional concern for the health of Gulf War 3 veterans has been prevalent since the world witnessed the 4 1991 oil well fires on television. DOD did not proactively
5 approach setting up hotlines or sites at medical treatment 6 facilities to provide information and medical referral 7 service to Gulf War veterans. 8 Finding number eleven. In terms of number and 9 variety of outreach components, the Outreach Programs of 10 both DOD and VA have improved over time. Future funding for 11 various components is unclear. 12 CHAIRPERSON LASHOF: Any questions about the 13 findings before Tom goes ahead with the recommendations? 14 MR. RIOS: Tom, was there any effort to any of the 15 outreach work in Spanish? 16 MR. McDANIELS: I don't think DOD has any. VA has 17 some and I haven't gotten a briefing on that but that is 18 something that's going to be happening. I don't know 19 exactly what the method is or what the component is but I've 20 been told that it exists, so that will happen shortly. 21 CHAIRPERSON LASHOF: Okay. Want to go ahead with 22 your recommendations? 23 MR. McDANIELS: Suggestions for possible committee 24 recommendations. The four of these were presented at the 25 October meeting. These are organized into the categories of
386 1 methods, coordination, and self-assessment techniques. 2 Under methods, suggestion for possible committee 3 recommendation number one: 4 In its outreach campaign VA should state clearly
5 what priority care privileges mean to veterans. Outreach 6 literature implies that Gulf War veterans have priority over 7 others when receiving medical care. In fact, the term 8 "priority" signifies that the medical examinations are 9 considered as treatment of a service-connected condition and 10 not means tested. 11 Suggestion for possible committee recommendation 12 number two: 13 VA's Persian Gulf help line operating procedures 14 should be changed so that callers initially contact a real 15 person, not the auto attendant. There are several 16 contracted operators assigned to receive calls during peak 17 usage hours. All of the operators receive a comprehensive 18 one week training session on the Department of Veterans 19 Affairs, Gulf War veterans issues, and veterans benefits and 20 compensation policies. The operators also have access to an 21 experienced Veterans Services officer located in the same 22 building, in addition to a tabbed index reference manual 23 designed specifically for them. This suggests that a caller 24 would have quicker and smarter service by first encountering 25 an operator. Use of the auto attendant should be limited to
387 1 after hours or when all other operators are otherwise 2 engaged. 3 Just to put a point in here. VA argues that the 4 caller would receive quicker service with the auto 5 attendant. That may be something the committee wants to 6 discuss, but that's their position. 7 Suggestion for possible committee recommendation 8 number three: 9 VA should implement DOD's hotline medical referral 10 system. Callers contacting DOD's Persian Gulf Medical
11 Registry hotline are contacted within two weeks by the 12 medical treatment facility nearest them for examination 13 scheduling. VA should emulate DOD's hotline database and 14 transfer infrastructure so that callers receive prompt 15 personal attention. Currently VA's help line serves only as 16 a point of information dissemination. Callers are left to 17 contact facilities on their own which, as mentioned in the 18 clinical issue discussion, is another hurdle. 19 Suggestion for possible committee recommendation 20 number four: 21 VA should make it's future public service 22 announcements more explicit. The public service 23 announcements publicize the help line number but they never 24 mention illness or any specific reason to call the number, 25 and those are the ones that were played at the last meeting.
388 1 Suggestion for possible committee recommendation 2 number five: 3 In order to assist the general public in 4 interpreting the declassified intelligence documents on 5 Gulflink, the intelligence community should prepare a users 6 guide. This guide would explain in general terms the 7 various sources of intelligence information, how they may 8 differ in quality and reliability and how intelligence 9 analysts compile and evaluate reports from a variety of 10 sources in the field to obtain corroboration before 11 preparing a final assessment. This guide should be featured 12 prominently on the Gulflink Home Page. 13 Suggestion for possible committee recommendation 14 number six: 15 VA should include Gulf War veterans' illness 16 outreach information on its Home Page worldwide Web site.
17 At the very least, there should be a display of the help 18 line number and information about the Medical Registry and 19 priority care services. A description of the full range of 20 VA's efforts to address this issue would be helpful to 21 veterans and would improve the usefulness of the Home Page. 22 Suggestion for possible committee recommendation 23 number seven. These are falling under the category of 24 coordination: 25 VA help line needs to be place firmly in the
389 1 information loop. VA needs to keep the help line staff 2 informed of the latest developments concerning Gulf War 3 veterans' issues. For example, committee staff contacted
4 all hotlines to determine if callers inquiring about the 5 Presidential Advisory Committee on Gulf War Veterans' 6 Illnesses would be properly referred. VA help line 7 operators were not aware of the formation of the Advisory 8 Committee, although DOD's hotlines provided accurate 9 information that allowed a caller to reach us. 10 One note. I've been recently informed that the 11 help line and VA's central Public Affairs Office have 12 established a strong information and transfer link. I'll be 13 able to check this out when I get back to Washington. I was 14 just told this last week. So the committee may want to 15 consider not of course including this recommendation. 16 The following recommendation falls under the topic 17 of performance measures and self-assessment. Suggestion for 18 a possible committee recommendation number eight: 19 In creating the next CCEP and EOV evaluation 20 questionnaire, DOD should include a question about referral 21 satisfaction via the Medical Registry hotline in addition to 22 the, "Were you satisfied with the care you received in the 23 program?" question. This would go in concert with what 24 Secretary Joseph said this morning about forming a survey. 25 This is some way of getting some feedback.
390 1 Suggestion for possible committee recommendation 2 number nine: 3 Operators at the DOD Medical Registry hotline, DOD 4 incident reporting line, and VA help line, should be 5 instructed to ask, "How did you find out about this number?" 6 as a method of qualitatively measuring the success of the 7 outreach components publicizing the numbers. 8 CHAIRPERSON LASHOF: Okay. Why don't we stop 9 there an go through the recommendations and we can 10 discussion further plans. So going back to page seven, I 11 think on the very first one, Tom, on the priority care
12 privileges mean to veterans. It's a question of who 13 everyone is that's going to be reading our report as well, 14 that somewhere in there we might say more clearly what it 15 does mean. 16 MR. McDANIELS: What priority care does mean? 17 CHAIRPERSON LASHOF: Yeah. 18 MR. McDANIELS: Okay. 19 CHAIRPERSON LASHOF: I mean, you say, in fact, 20 that priority care signifies that the medical examination 21 are considered as treatment of a service-connected condition 22 and not means tested. To call medical examinations as 23 treatment is awkward and somewhat incorrect. An examination 24 isn't treatment, and what we're really saying is that 25 priority care means that they just won't be means tested if
391 1 they have an illness that they want to be seen for, isn't 2 it? I mean, that's where we're at. 3 Don, do you have suggestions along that regard? 4 DOCTOR CUSTIS: I would also have trouble with the 5 term "service-connected condition." That's to be 6 established. I don't think that they -- I wouldn't think 7 that -- 8 MR. McDANIELS: Maybe it should be, "like a 9 service," as opposed to -- 10 DOCTOR CUSTIS: I have trouble with, as Joyce 11 does, with the term "treatment," and also "service-connected 12 condition." 13 CHAIRPERSON LASHOF: I guess isn't the reality 14 that basically anyone who served in the Gulf War can go to 15 the VA for care without means testing? 16 MS. GWIN: No. 17 CHAIRPERSON LASHOF: No. Okay. 18 MS. GWIN: They can go for a Gulf War protocol
19 examination and should that examination reveal a need for 20 further care continue in the course of care. But they can't 21 just go because they have a broken leg now, for instance, 22 and get care. 23 CHAIRPERSON LASHOF: Okay. If they go because 24 they're feeling lousy, to get care they would first be given 25 an appointment for the CCEP?
392 1 MS. PORTER: Well, that's DOD. 2 CHAIRPERSON LASHOF: That's DOD's, okay. They 3 would have their registry if they showed up? 4 MS. GWIN: Yes. 5 CHAIRPERSON LASHOF: I mean, a veteran comes back 6 and six months, a year later he's not feeling good and he 7 goes and shows up with the VA. They would say, "Well, let's 8 examine you and if we think you have something that falls 9 into a category of Gulf War then we'll take care of you?" 10 MS. GWIN: I don't think that make that 11 distinction then about whether they think it falls into the 12 Gulf War category, at that point. I think once you -- 13 unless they can clearly exclude it at -- 14 CHAIRPERSON LASHOF: In other words, if they come 15 in with a broken leg it clearly isn't. If they come in with 16 an acute -- say they showed up with pneumonia what would 17 happen? Are they eligible or not? 18 MS. GWIN: I think that would be means tested 19 because now it's too far away from the Gulf to have gotten 20 it there. 21 CHAIRPERSON LASHOF: Okay. So they wouldn't be 22 eligible for treatment for some acute condition unless they 23 fell under the property or the means testing protocol. 24 MS. GWIN: And could I -- 25 CHAIRPERSON LASHOF: I mean, it's taking us this
393 1 long, after the third meeting, to really understand this. 2 I'm wondering how clear we can make it or how clear they can 3 make it to all the vets so they know when they're eligible 4 for what. 5 MS. GWIN: I actually think that this language 6 that Tom has put as explanation for the finding falls back 7 on words used by Fran Murphy at one of our meetings. And 8 Fran, as you recall, is a -- 9 CHAIRPERSON LASHOF: Yeah. Yeah, I remember that. 10 But that's the point, that's the language she used. We're
11 still struggling to understand this language. What language 12 can be used so that the veteran can understand it? 13 DOCTOR CUSTIS: I would submit that what Fran is 14 trying to say then is that they are being treated as though 15 they were service-connected. 16 MS. NISHIMI: That is correct. 17 MR. McDANIELS: Right. 18 DOCTOR CUSTIS: But they have not yet been -- It 19 has not yet been determined at this point that they have a 20 service-connected condition? 21 MS. NISHIMI: My understanding is there are 22 different hurdles, and service connected receives -- what is 23 it? first in line with this priority care privilege, and 24 then there's, you know, means testing. You don't have to 25 reach the means test hurdle to get in the queue, that's what
394 1 priority care means. There's somewhat of an initial 2 assumption that it's at the same level of entry as service- 3 connected. It might not be service connected but your 4 ability to, let's say, make an appointment for a one month
5 waiting period versus a five month waiting period -- not to 6 use real numbers but just to exaggerate the situation. 7 Let's say it's one month for service connected, five months 8 if you're just coming in. Priority means you can get in the 9 one month queue. 10 DOCTOR CUSTIS: I'm sure that the VA is leaning 11 over backwards not to be accused of displacing a known
12 service-connected patient in order to evaluate a Persian 13 Gulf veteran. I wonder if these are quotations from Doctor 14 Murphy if she really means what she says. On the occasion 15 she testified before the committee I believe she said 16 something along the line that Robyn first referenced, 17 namely, it only means the elimination of the means test. 18 MS. NISHIMI: Why doesn't the staff -- We can go
19 back to Fran and the VA and take another run at this and run 20 it by the committee. If the staff, however, could get the 21 sense on whether the recommendation, the first part of it, 22 that VA should state clearly what "priority care privileges" 23 mean to veterans, whether or not the committee in fact 24 supports that recommendation. 25 CHAIRPERSON LASHOF: I don't think there's any
395 1 question we think the need to do that. I guess the question 2 is whether in our report we have to go through and define
3 that in the recommendation section. We probably need to 4 have something in the discussion section about the confusion 5 about that, the different interpretations, and then our 6 recommendation really is -- and it's clearly stated in a way 7 that is meaningful and understandable to the veterans, and 8 let it go at that and let us not try to figure out what that 9 is. 10 MS. NISHIMI: Right. Okay. That's what we will 11 do then. 12 CHAIRPERSON LASHOF: Okay. Pushing along. Is 13 that okay with everyone on that one? 14 (No response.) 15 CHAIRPERSON LASHOF: Second. Now we're on the 16 help line operating procedure should be changed so that 17 callers initially contact a real person not the auto 18 attendant. Now, we know that they don't agree with that 19 already. 20 MR. McDANIELS: You might want to look on also 21 page 16 in your tab D which will give you the latest help 22 line call data, which for total calls will be 116,638, and 23 you'll see that only 20,926 were referred to an operator. 24 That's they push the right button to speak to a real 25 operator, that's what that means, that table.
396 1 CHAIRPERSON LASHOF: Okay. 2 MR. McDANIELS: Just to give you an indication of 3 who the callers are talking to, if they're talking to the 4 voice mail system or if they're talking to -- 5 CHAIRPERSON LASHOF: Now, at what point in the 6 discourse in that auto answer do they get the chance to push 7 a button and talk to a live body? 8 MR. McDANIELS: At various points. The earliest 9 point would be about 30 seconds into it, then throughout it 10 says if you want to speak to an operator push zero, or
11 something like that, and that's throughout the script. 12 CHAIRPERSON LASHOF: Do you interpret the fact 13 that only 20,000 asked to talk to an operator as meaning 14 that they're really perfectly happy with the auto system and 15 are perfectly happy to talk to the computer spieling on 16 and -- 17 MR. McDANIELS: Well, I think -- 18 CHAIRPERSON LASHOF: Or do they get tired and hang 19 up? 20 MR. McDANIELS: I think the operators are prepared 21 to tell the caller all the information that the voice mail 22 script does, and I don't think the operators could tell them 23 more. And if they had questions the operators could go to 24 the Veterans Service officer that's located in the hotline 25 center, so I think we're really dealing with just a question
397 1 of convenience and ease as far as -- 2 CHAIRPERSON LASHOF: Yeah. But, I mean, your 3 observation was that the operators were sitting around and 4 could do it? 5 MR. McDANIELS: Yes. 6 CHAIRPERSON LASHOF: The VA -- 7 MR. McDANIELS: Since that time the VA has let 8 some of them go so the staff has been reduced, and so now I 9 don't know how many are there. 10 CHAIRPERSON LASHOF: Well, considering the need
11 for manpower or personpower or personnel -- sorry, I'm the 12 older generation -- having the -- I was going to say having 13 the manpower -- having the personnel receive 116,000 calls 14 instead of 20,000 is a big jump in the kind of personnel 15 that one would need, and are we prepared to really say that 16 a human being is that much better than the script is? 17 MS. NISHIMI: What's the current volume? 18 MR. McDANIELS: The current volume has fallen. I 19 would guess it's around 200 or 300 a week. 20 CHAIRPERSON LASHOF: Oh, really. 21 MR. McDANIELS: Yeah. It's really fallen quite a 22 bit from its inception. It may be even less than that. 23 CHAIRPERSON LASHOF: Well, in one sense it sort of 24 becomes, if it's fallen that low, it sort of is, in my mind, 25 not very important whether it is a human being or a script.
398 1 If there are only a couple of hundred calls a week a human 2 can do it, but also if that's how little it is it's not
3 causing much of a problem to use an automated script. I 4 don't know. How do other people feel? I'll shut up at this 5 point. What do you think, do we want to go in with this? 6 CAPTAIN KNOX: I don't really have a problem with 7 the automated as long as at sometime you can speak to 8 someone live. But, I mean, that's the way of the world, 9 everything is automated. I admit that it's easier if you 10 can speak directly to an individual but as long as you do 11 have that option I think that's a pretty good system. 12 MR. McDANIELS: I think you also have to take into 13 consideration the population. I guess with Gulf War 14 veterans you're dealing with a younger population that would 15 be used to operating one of these voice mail scripts whereas 16 if you were dealing with Korea era or World War II vets then 17 that would be a major difficulty. 18 CHAIRPERSON LASHOF: Ah, come on. Okay, young 19 fellow. 20 DOCTOR CUSTIS: Don't underestimate us, Tom. 21 MR. McDANIELS: But you know what I mean. 22 CHAIRPERSON LASHOF: I've plugged into the VA on- 23 line. 24 MS. NISHIMI: Thomas was speaking as a Gulf War 25 vet. He misspoke and --
399 1 CHAIRPERSON LASHOF: I know. 2 MS. NISHIMI: Well, then, it seems to me that the
3 sense of the committee is that the recommendation for a real 4 person is not a priority and we can abandon this one, is 5 that what I'm hearing? 6 CHAIRPERSON LASHOF: I think so. Anybody else 7 have other feelings about it? 8 (No response.) 9 CHAIRPERSON LASHOF: Okay. The medical referral 10 system, that's more intriguing. How do you feel about that 11 one? 12 MR. McDANIELS: If you need some background on 13 DOD's system, that was from the last memo, I'd be happy to 14 give that to you. 15 CHAIRPERSON LASHOF: Yeah. 16 MR. McDANIELS: That's the system where the caller 17 calls the DOD hotline. It's housed in the same building as 18 the Defense Manpower and Data Center. They send the medical 19 treatment facility information that verifies the caller's 20 service in the Gulf as well as information about the caller 21 and then that medical treatment facility is supposed to 22 contact the caller within two weeks to set up an 23 appointment. 24 MS. NISHIMI: That's DOD's. 25 MR. McDANIELS: That's the DOD system. That's the
400 1 one I think should be emulated. The VA system, as it 2 stands, they are -- their help line is strictly to offer
3 this information that's on the script and also to offer 4 points of contact at the VA medical treatment facilities, so 5 that once you call the help line you get a number to call 6 the nearest VA place to you to set up your own appointment. 7 CHAIRPERSON LASHOF: Do we have any data to 8 indicate really that one works better than the other? I 9 mean, I could see an argument that being given a number 10 where you can call at your convenience to make the 11 appointment might work better than having them call you; you 12 may not be home; they may call a few times; they leave a 13 message or maybe you don't have a message answering machine. 14 I'm not sure. 15 MR. McDANIELS: I don't have any data for VA. The 16 only data I have for DOD was that re-referral data which
17 suggests a certain amount of inefficiency because those 18 people had to call back a second time because the medical 19 treatment facility never called them to set up the 20 appointment. That's what that chart was on re-referrals, 21 that's basically what that's indicating. 22 CHAIRPERSON LASHOF: So, if that's the case, then 23 the VA system might be better. If you're given a number to 24 call it may be more efficient than having the others call 25 you back. I think unless we have strong data to show that
401 1 one works better than the other, I'm not sure that we should 2 get into this. 3 MR. McDANIELS: Okay. 4 CAPTAIN KNOX: But once you call that VA facility, 5 is there someone they put you in touch with? 6 MR. McDANIELS: At each VA facility there's 7 supposed to be a Persian Gulf coordinator. 8 CAPTAIN KNOX: Okay. 9 CHAIRPERSON LASHOF: What do you think? Anybody? 10 Don, have a feeling? 11 DOCTOR CUSTIS: I'd keep the VA. 12 CHAIRPERSON LASHOF: Okay. Let them each keep 13 their own system. 14 MR. McDANIELS: Okay. 15 CHAIRPERSON LASHOF: We don't need to micromanage. 16 Now, the public service announcement should be 17 more explicit. I think I would agree with that. I mean, we
18 looked at those things and we had no idea why you would want 19 to call this help line. I mean, if you needed help with 20 anything. Anyone else have any feelings on that one? 21 (No response.) 22 CHAIRPERSON LASHOF: Go with it as it stands. 23 The next one's a tougher baby. We discussed that 24 somewhat at the last meeting of the committee when we were 25 quizzing about this whole declassification and everything
402 1 that's up on the link and what it means and whether it does 2 anybody any good to have all that declassified material. 3 DOCTOR BALDESCHWIELER: I don't think this could 4 hurt. 5 CHAIRPERSON LASHOF: I think it's good. I'm just 6 trying to think through how they would do it and what it 7 would look like on the Gulflink. 8 DOCTOR CUSTIS: 6,500 pages. 9 CHAIRPERSON LASHOF: I think the way you've worded 10 it is fine because basically they really need to -- 11 MS. NISHIMI: It's a recommendation that they 12 should do this, and as -- 13 CHAIRPERSON LASHOF: Well, I want to make sure a 14 recommendation is feasible so I was thinking in my own mind 15 what would this look like and I could visualize their 16 classifying the material as confirmed, verified, or the
17 general source. They could develop a code and every item 18 could have next to it a category, whether it's in category 19 A, B, C, or D, and the initial part could give you what the 20 categories are. 21 MS. NISHIMI: And even if they were not to prepare 22 it, you know, item by item a general guide on how this 23 information was obtained and caveats to keep in mind as you 24 evaluate would be useful. I think that's also captured in 25 this recommendation. Obviously they're just recommendations
403 1 of the committee and the Department could just ignore the 2 entire committee or -- 3 CHAIRPERSON LASHOF: Oh, heavens no, not after all 4 this work. 5 MS. NISHIMI: And so I think that the way it's 6 worded shows the types of information the committee would 7 like to see to assist those that use the Web page and we'll 8 see what happens. 9 DOCTOR BALDESCHWIELER: I would view this as sort
10 of a short tutorial and, you know, in intelligence analysis 11 and it could be, you know, a three, four, or five page 12 document with lots of caveats and disclaimers in it. 13 MS. NISHIMI: Okay. I think the staff 14 understands. 15 CHAIRPERSON LASHOF: Next is, should include 16 veterans outreach information on its Home Page. Yeah. 17 MS. NISHIMI: Yeah? 18 CHAIRPERSON LASHOF: Yes, definitely. The 19 hypertext thing on priority care would be a good 20 description. 21 MS. NISHIMI: Okay. 22 CHAIRPERSON LASHOF: I haven't looked at the Home 23 Page that VA has at the moment. You've given us some 24 description of it but that looks all right to me. 25 MR. McDANIELS: I've been told that it's fairly
404 1 new in being implemented so that's why they haven't gotten 2 around to putting that on it yet. 3 CHAIRPERSON LASHOF: Okay. What's the code for 4 going into the VA Home Page, do you know? 5 MS. NISHIMI: It's one of the memos. We can get 6 that to you. 7 CHAIRPERSON LASHOF: All right. I'll get it, 8 don't worry about it. I can do my search anyway and find 9 it. 10 Now we're up to coordination. This is the next
11 one that you've said they've taken care of that you think 12 and you'll check on it, and if they have you'll drop it? 13 MR. McDANIELS: That's right. 14 CHAIRPERSON LASHOF: And if they haven't we 15 obviously want them to know we're alive and well. 16 MR. McDANIELS: But I was told by the people at 17 the central office of Public Affairs of VA that they 18 actually have established the link with the help line where 19 they're sending them new developments as they come out, so 20 as soon as I can check on that I will -- 21 CHAIRPERSON LASHOF: Okay. We'll leave it for the 22 time being and assume if it disappears it's because you've 23 confirmed that we don't need that recommendation anymore. 24 Okay. Well, the first one, number eight. Anybody 25 have any problems with eight?
405 1 (No response.) 2 CHAIRPERSON LASHOF: Nine. Well, if we're going 3 to suggest they ask that, they obviously need to have a
4 method of tabulating and keeping track, and whether they 5 need to do that on every one or on every fifth call or 6 something, or random sample to keep data I think we could 7 almost leave it up to them on that. But -- 8 MS. NISHIMI: But it's the general sense that 9 asking, "How did you find out about this number?" is 10 something the committee would like to recommend? 11 CHAIRPERSON LASHOF: Yeah. In order to help them 12 assess the effectiveness of their outreach and which 13 outreach has something. This is a good method to use and it 14 can be done on every call or on a sample. 15 CAPTAIN KNOX: Did the VA have an end of 16 evaluation questionnaire as well, they didn't, did they? 17 MR. McDANIELS: The registry, I don't know at this 18 time. 19 MS. NISHIMI: We can look into that. Of course 20 we're not suggesting that the VA help line be answered by a 21 live person, that would have to be dropped from this. 22 MR. McDANIELS: Unless the people -- 23 CHAIRPERSON LASHOF: No, it can be asked. 24 MR. McDANIELS: -- go to the operator. 25 MS. NISHIMI: You go to the operator, sure, those
406 1 individuals could be asked. You would get data on the one- 2 sixth who opt out to go to an operator which -- 3 CHAIRPERSON LASHOF: You could at the end of the
4 automated thing say -- well, I guess you'd have to know the 5 possible sources and say if you learned of this number 6 through blank push one; if you learned about it through 7 blank push two. I'm so used to pushing one, two, three four 8 whenever I -- I mean, it can be done in an automated system. 9 You can get answers to lots of questions on automated
10 systems if you want it. It depends on how important you 11 think it is. 12 MS. NISHIMI: But is it the committee's general 13 sense, and it sounds like it is, that this type of question 14 query through the hotline in some fashion is a good 15 recommendation to make? Okay. 16 CHAIRPERSON LASHOF: Okay. Let me go back a 17 little bit on -- and we will discuss this later -- back over 18 under you findings -- Oh, never mind. I see there was a 19 finding in which in the finding you suggested that they 20 ought to have a person, but since we're taking it out of the 21 other you'll take it out of there. It was that you sort of 22 had a recommendation buried in a finding earlier. 23 I think we'll save the discussion of the whole 24 format. Obviously you've done a very fine job, and 25 everybody's done a very fine job, but each person has done
407 1 it in a slightly different format because each of you were 2 doing your thing to get ready for today. Eventually, before 3 we finish up today, we'll have a general discussion of the
4 format that we want to see all this in, but this is fine, 5 Tom. Thank you very much. 6 Any other questions for Tom before we move on? 7 (No response.) 8 CHAIRPERSON LASHOF: Do we have anything we want 9 to say about any of the things we saw or not? 10 MR. McDANIELS: I just got all that information 11 just before we came out so I have stuff from AFIS, or the
12 Armed Forces Information Service, it appears that could be a 13 very effective way or it was a very effective -- and is a 14 very effective way of outreaching to active duty service 15 members, but it's like a lot of information I have to go 16 through before I can make that finding. But it appears that 17 that could be very effective. 18 CHAIRPERSON LASHOF: You want to discuss a little 19 bit the plans for the future work that we might yet deal 20 with because we almost felt we had completed outreach before 21 this but we need to have ongoing look at outreach anyway, 22 because as reports come out, as studies get done, how that 23 information gets out is going to be a very important thing. 24 And we really haven't talked at all about that, nor do I 25 think we have to for the interim but, you know, we had
408 1 presentations from DOD and the VA, the public health 2 associations, some of the newspapers carried some articles 3 about it. The veterans might read those articles in some of 4 the newspapers and since some of them I thought were not
5 very good articles and garbled -- I mean, how do they get 6 the ongoing information as results of various studies come 7 out? What's being done to get that information out to vets 8 and put it in a way that they can understand it? 9 MR. McDANIELS: You're talking from DOD and VA, 10 how do they disseminate that information or how does the 11 press carry it? 12 CHAIRPERSON LASHOF: No, how VA and DOD -- 13 MR. McDANIELS: How DOD -- 14 CHAIRPERSON LASHOF: The press I've given up 15 trying to influence. 16 MR. McDANIELS: When I was just speaking of AFIS 17 and the Armed Forces Radio and Television Service, that is 18 exactly what they do and they are responsible for 19 disseminating this type of information to DOD newspapers 20 where they actually have editorial control throughout the 21 world, and those are like local based newspapers, and also 22 disseminating that information to the two "Stars and 23 Stripes" newspapers; there's the Pacific and also the 24 European, and DOD does not exercise editorial control but 25 they do send them press packages and things like that. And
409 1 then there's also the broadcasts that you just saw that go 2 to overseas service members and also to service members to 3 ships deployed at sea. 4 So those are some of the ways, but that is the
5 next level. And then there's also each service has their 6 own outreach responsibilities and that's something I haven't 7 discovered or gotten into deeply yet. That's something 8 that's remaining to see what the overlap is and to see how 9 much each service has done besides what DOD as a whole 10 umbrella has done. So those are the things that I have to 11 continue to evaluate, and the same with VA, but that type of 12 thing, and also monitoring the trends and coordination 13 efforts and the performance and self-assessment techniques 14 that come up. Like if they actually do implement this 15 survey that Secretary Joseph was talking about, that's 16 exactly the type of tool that we could use to determine the 17 effectiveness of these outreach components because it's hard 18 to tell, to know exactly how many veterans are being reached 19 by these methods. It's hard to measure without actually 20 surveying. I mean, you can look at data on how many people 21 have called but it doesn't tell you how many people would 22 have called if they had gotten better information. 23 CHAIRPERSON LASHOF: Yeah. I guess one of the 24 things when you look at various service announcements, news 25 clips and so on, whether they ever do any focus groups
410 1 around how helpful and whether people really understand what 2 they've just said. Get a group of people to watch one of
3 these and then have a focus group around what they do get 4 out of this sort of thing, whether they do that sort of 5 thing would be worthwhile I think. 6 MS. NISHIMI: I think that one of the things is, I 7 know that you and I in our initial discussions had thought 8 that, you know, big chunks of the outreach evaluation could 9 be dispatched within the interim report and I think Tom has 10 dispatched large chunks. It's just turned out to be a 11 bigger issue. I think it's also potentially important in 12 terms of future recommendations for future conflicts and so 13 that being quite thorough throughout with the interim report 14 and throughout the process is particularly important and is 15 a topic area that should be stressed. Because of all the 16 issues that we're covering for generalized ability this may 17 well be one of the more important areas and so Tom will 18 continue to focus his energies on evaluating everything. I 19 think it's quite important. 20 CHAIRPERSON LASHOF: Anything else on this? 21 (No response.) 22 CHAIRPERSON LASHOF: Thanks very much, Tom. 23 MR. McDANIELS: Sure. 24 CHAIRPERSON LASHOF: The next two things we've got 25 to do is go over implementation of recommendations of the
411 1 external reviews, and actually we'll find that a good bit of 2 it has been addressed in various ways and we'll discuss 3 that, and then we're going to go into format. 4 But we'll take a ten minute break. Be back in ten 5 minutes. 6 (A short recess was taken.) 7 (Rolando Rios not present after break.) 8 CHAIRPERSON LASHOF: Okay. We're now to tab E. 9 We're getting to the back of the book, people.
10 CAPTAIN KNOX: We're slowly shrinking. 11 CHAIRPERSON LASHOF: We're shrinking in who's 12 here, too. In fact, this is the last tab in the book 13 because we've covered G before.
14 If you remember a long time ago -- it seems a long 15 time ago, probably the previous meeting, or maybe it was the 16 meeting before that, we said that the major focus of our 17 interim report would be around the implementation issues. I 18 guess when we did our first work plan we said we would start 19 by looking at what were all the previous recommendations and 20 then try to see what it is that -- how well they've been 21 followed. It's obviously gone a lot further than that and 22 we covered all these other activities, but now we're going 23 to take a look at these implementation of recommendations. 24 Holly, are you going to walk us through this or 25 how do you want to do this?
412 1 MS. NISHIMI: I should just mention that Kathy 2 Hanna who prepared the memo for the Advisory Committee took 3 ill just before she boarded the plane and so she didn't
4 board and so Holly Gwin is pinch-hitting on very short 5 notice for her. 6 CHAIRPERSON LASHOF: And how is Kathy? 7 MS. NISHIMI: I haven't talked to her today. 8 CHAIRPERSON LASHOF: Just overworked, huh? 9 MR. McDANIELS: Battle fatigue? 10 CHAIRPERSON LASHOF: Battle fatigue syndrome. 11 HOLLY GWIN, REPORT ON IMPLEMENTATIONS OF RECOMMENDATIONS 12 OF EXTERNAL REVIEWS 13 MS. GWIN: You'll notice in the memo that the 14 deliberative bodies that have looked at the Gulf War issues 15 in the past have made findings and recommendations in many 16 of the areas that we have touched on at least briefly in the 17 last two days, and these are the validity of the terms: Gulf 18 War Syndrome; Coordination Across Departments; The Adequacy 19 of Existing or Planned Databases; Pre and Post-deployment 20 Clinical Issues; Evaluation of Risk Factors; and Outreach to 21 Veterans. 22 First I'll talk a little bit about Gulf War 23 illnesses and case definition. 24 Although the popular term for the array of 25 symptoms reported by veterans is Gulf War Syndrome, most
413 1 advisory bodies that have reviewed the available data have 2 concluded that a syndrome, per se, cannot be adequately 3 defined. In our review of epidemiology yesterday afternoon 4 we discussed the usefulness of a case definition in 5 conducting the epi studies and suggested that current 6 researchers might test the case definition developed by CDC 7 in their study of Pennsylvania veterans in ongoing and 8 future studies. 9 When the NIH panel was first constituted they 10 believed that they could develop a case definition but
11 quickly concluded that the data were too limited to draw 12 conclusions regarding the incidents of unexpected illnesses 13 in this population. As a result, they made a broad 14 recommendation that DOD and VA establish a more accurate 15 estimate of symptom prevalence. 16 As we heard and discussed yesterday, VA has 17 responded to this recommendation by launching the national 18 survey of Persian Gulf veterans and their family members 19 which will be sent to 30,000 veterans. It is staff's 20 opinion that this survey should help determine the 21 prevalence of symptomatology experienced by veterans and
22 thereby assist both scientific and clinical efforts and is a 23 good response to the NIH recommendation. 24 Moving on to "Coordination Across Departments," 25 which is another issue that we discussed yesterday and
414 1 today. Some of the very first criticisms of departmental 2 activities regarding the health of Gulf War veterans were
3 about the lack of coordination in clinical affairs as well 4 as research. The NIH workshop panel concluded that 5 evaluation of undiagnosed illnesses was not uniform, leading 6 to, among other things, inconsistent treatments. Since 7 then, efforts have been made to better describe and quantify 8 symptoms and to do so in a more uniform manner. 9 There has been considerable standardization of 10 data collection and analyses across departments, and a 11 comparable assessment and diagnostic process are now used by 12 both DOD and VA. 13 The IOM committee recommended that the Persian 14 Gulf Veterans' Coordinating Board actively coordinate all 15 studies developed from new initiatives that receive federal 16 funding. We worked on the committee's iteration of that 17 recommendation yesterday afternoon so I guess it's fair to 18 say it hasn't been fully implemented yet. We believe that 19 the Research Working Group has been successful in
20 communicating research plans across agencies but they ought 21 to play a greater role in quality control. 22 Moving on to databases. 23 CHAIRPERSON LASHOF: Do you want to stop as you 24 go? Let's put it this way: If you have any questions or 25 any reservations about anything let's pick them up as we go
415 1 rather than trying to go through the whole thing and go 2 back, because this is covering so many different areas. Is 3 everybody comfortable at this point? 4 (No response.) 5 CHAIRPERSON LASHOF: Okay. Move on. 6 MS. GWIN: Okay. Databases. Several review 7 bodies have assessed the adequacy of data collected and the 8 responsiveness of DOD and VA in improving and maintaining 9 databases, including the health care registries of DOD and 10 VA and the DOD's unit locator database. First I'll talk 11 about the VA registry. 12 The original VA registry was limited to veterans 13 exposed to oil fire smoke. In 1992 Congress mandated that 14 VA expand its registry to include all Gulf War veterans. It 15 directed the Office of Technology Assessment to evaluate 16 whether DOD's assessment of health risks from the Kuwaiti 17 oil fires met the provisions under the law. OTA made 18 several recommendations to improve the quality in overall
19 utility of the VA registry. We believe that VA has been 20 very responsive to the OTA recommendations incorporating 21 nearly all of them, all the revisions, in their final 22 version. 23 The VA registry came under review again in 1995 24 when the IOM concluded that the registry is not a population 25 database and is not administered uniformly; therefore, it
416 1 cannot serve the purposes of research into the etiology or 2 treatment of possible health problems. 3 As we heard from Doctor Kizer yesterday, VA now
4 appears fully aware that the data in the registry are part 5 of a clinical program, the results of which cannot be 6 generalized. Staff have concluded that there is no evidence 7 that the data in the registry are being used or interpreted 8 inappropriately. 9 Moving on to the CCEP. The IOM committee 10 reviewing the CCEP concluded its design represented a 11 serious attempt on the part of DOD. However, they cautioned 12 the research aims of CCEP are not stated explicitly nor does 13 there appear to be a concrete epidemiologic study plan. The 14 IOM committee recommended, among other things, that DOD 15 consider the need for balance and clear delineation of the 16 clinical care and research functions of the CCEP, especially 17 in light of the apparent use of the CCEP by patients to 18 obtain timely, high quality medical care. Doctor Joseph 19 addressed this issue in his remarks this morning. 20 It appears to staff that DOD is considering the 21 balance between the clinical and research functions of the 22 CCEP and is considering the need for comparison groups in 23 future studies. The CCEP has been evaluated extensively and 24 it is the staff's perception that DOD has been responsive to 25 its critics in redesign of the CCEP.
417 1 However, serious misperceptions have been created 2 by DOD's representation of the CCEP as a research tool for 3 generating hypotheses, and the advisory committee might want
4 to consider DOD to harmonize its position on the use of that 5 database with that of VA. 6 CHAIRPERSON LASHOF: Let's stop on this one. This 7 is obviously the hottest one of those we've come to at this 8 point. In view of what I would consider this morning in the 9 text of the statements given by Steve Joseph, he's gotten 10 obviously a lot more careful than he was when he gave the 11 results in August, I guess it was, when he did comparison 12 groups and all the rest, and he's backed off doing that and 13 has improved. And I thought his summary this morning was 14 okay, in terms of how he presented the CCEP. What about the 15 rest of you, how do you feel? 16 DOCTOR BALDESCHWIELER: I concur. I thought he 17 was rather careful. 18 CHAIRPERSON LASHOF: So the question is then, what 19 do we need to say? Do we want to leave the statement about 20 serious misperceptions rather than perceptions have been 21 created as a research tool for generating an hypotheses on 22 the -- yeah, this whole phrase about harmonizing it with the 23 VA and misperceptions. Holly, you want to talk to it? 24 MS. GWIN: I think there still is in the broader 25 community some misunderstanding about what the CCEP is and
418 1 how the results should be interpreted. Is DOD saying that 2 there is no Gulf War -- that people aren't sick or are they 3 simply drawing a distinction that's somewhat esoteric to 4 some of the interested community. So it may be more of an 5 outreach issue than it is -- 6 CHAIRPERSON LASHOF: I was going to say that gets 7 into more of an outreach maybe than the other. But this was 8 an IOM recommendation so I guess it's a question do we think 9 they've been responsive to that recommendations. Is that 10 what we're dealing with here? 11 MS. GWIN: Yes. 12 CHAIRPERSON LASHOF: Whether they've implemented 13 it. I think we could say that -- well, let's be honest, 14 that initially presentations of it led to it being perceived 15 as research tool, in recent presentations this approach has 16 been avoided -- I don't know. 17 MS. GWIN: As a committee you're relatively 18 satisfied with what, the way they've responded to the --
19 CHAIRPERSON LASHOF: Well, let's see. We're 20 relatively satisfied with the way it was presented this 21 morning. I don't know about next week or last week. 22 MS. BRIX: Can I say something? 23 CHAIRPERSON LASHOF: Sure, please. 24 MS. BRIX: Just as an update. I'm curious what 25 will happen in the next month or so because the IOM will be
419 1 releasing another report within the next few weeks about the 2 CCEP. In addition to that, the DOD plans to release a 3 report itself, probably in January, on 18,000 patients in 4 the CCEP. So I agree with you that they've been more 5 careful more recently but I don't know what will happen when 6 there's another release and a lot of publicity, I expect in 7 January. So I think that, you know, that needs to be 8 revisited. 9 CHAIRPERSON LASHOF: Okay. Why don't we hold this 10 one and say this is -- we'll have to -- 11 MS. GWIN: We're watching. 12 CHAIRPERSON LASHOF: We'll watch it, and this is 13 one that we'll have to sign off on at the very last minute 14 depending on how things go in January and we'll keep an eye 15 on it. 16 DOCTOR BALDESCHWIELER: He sounded very sensitized 17 to me, I would say, in the presentation he made this 18 morning. That really met the criticism of the previous INH 19 report. 20 MR. BROWN: We just want to make sure he doesn't 21 backslide. 22 CHAIRPERSON LASHOF: Yeah, that's basically -- If 23 he continues to be as cautious as this we can say he has 24 taken this to heart, or it now appears that they are now 25 presenting a clearer picture of CCEP. But, if not, we'll
420 1 just have to wait until January. 2 Okay. 3 MS. GWIN: Geographical Information System, the
4 unit locator database. This is believed by many to be the 5 best approach to understanding the characteristics of the 6 population at risk and their associated symptoms and 7 illnesses. Both the IOM committee and this Advisory 8 Committee in the past have commented that the DOD registry 9 needs to be completed as quickly and as accurately as 10 possible. Last week we heard again from the Coordinating 11 Board that by December 31st, 1995, the system will be 95- 12 percent functional and that, in fact, the Boston VA Medical 13 Center already has access to some of the data relevant to 14 its research. 15 CHAIRPERSON LASHOF: Okay.
16 MS. GWIN: I'm going to do clinical issues and pre 17 and post-deployment now. 18 Previous review panels have issued recommendations 19 regarding the need to provide care for veterans absent a 20 definitive diagnosis or case definition. The staff concurs 21 and will continue monitoring implementation of the VA and 22 CCEP protocols next year through site visits and focus 23 groups. 24 In 1994, the Defense Science Board Task Force 25 concluded that DOD needed substantial improvements in pre
421 1 and post-deployment medical assessments and data handling. 2 We discussed that issue at this morning's session on 3 clinical issues. Again I think it's fair to say that DSB's
4 recommendation has not been fully implemented, although DOD 5 is working on it and this committee will be adding it's own 6 recommendations to that work. 7 The next area is risk factors, a number of risk 8 factors. These have been the focus of several findings and 9 recommendations from other review panels. Findings 10 addressed the role of: anecdotal evidence, the possible 11 effects of exposure to small amounts of chemical or
12 biological agents, lack of sufficient data to confirm 13 exposures and possible etiologies, the effects of stress, 14 the need to compare epidemiologic cohorts, the similarity of 15 some symptoms to Chronic Fatigue Syndrome, and the lack of 16 data on attack rates. There's overwhelming consensus that 17 these risk factors cannot be considered fully until the unit 18 locator database is complete. 19 Now I'll talk about several of the specific risk 20 factors identified in previous reports, the first being 21 leishmaniasis. 22 NIH and IOM both recommended studies of 23 leishmaniasis. We found that VA and DOD have already 24 notified physicians throughout their health care systems 25 about leishmaniasis symptoms and VA has distributed specific
422 1 guidelines to all VA medical facilities. 2 Currently the Army has an extensive leishmaniasis
3 research program and is investigating a serologic assay and 4 skin test in a field diagnosis system. It's our impression 5 that the government has adequately and responsibly responded 6 to the recommendations of external reviews concerning 7 leishmaniasis research. 8 CHAIRPERSON LASHOF: Anybody? As we go through 9 each paragraph, unless somebody objects we're just going to 10 move on. But if you have an comments, please, interrupt. 11 MS. GWIN: Okay. Vapors, solvents, and combustion 12 products. You'll recall that the oil well fires in the Gulf 13 first focused attention on the potential health effects of 14 the War and petroleum products have been the focus of 15 several previous research recommendations. When completed, 16 we believe that DOD's Geographical Information System and 17 its associated Risk Assessment System will meet the 18 congressional mandate for individualized estimates of 19 exposure from Persian Gulf oil fires. 20 The NIH panel recommended that the military should 21 also conduct a retrospective cohort study to investigate 22 pulmonary function related to oil fire fume exposures. DOD 23 has informed the committee staff that these data would be 24 very difficult to obtain with any reliability. 25 In addition, preliminary findings from the CCEP
423 1 and the VA registry revealed very few chronic pulmonary 2 problems among veterans. In addition, troop based surveys 3 conducted in the theater revealed no acute pulmonary 4 complications that could not be attributed to sand 5 inhalation, asthma, or allergies. Although the 6 environmental hazards research centers continue to consider 7 relevant exposures in their research designs, pulmonary 8 disease does not appear to be a significant factor in 9 veterans' illnesses. 10 The IOM committee recommended that DOD conduct a 11 study that simulates exposure in tents heated by diesel
12 fuel. DOD reports that it is currently investigating low 13 level chemical exposures of military forces while serving in 14 the theater. A tent exposure simulation using rodents is 15 being conducted at Wright-Patterson Air Force Base. 16 In addition, the Army is developing a rodent model 17 to define and characterize the pathology resulting from 18 smoke inhalation under controlled conditions. 19 And, finally, the National Cancer Institute is 20 supporting studies using immunoassays on blood samples from 21 individuals exposed to coke ovens, aluminum plant fumes, and 22 oil well fires to determine levels of polycyclic aeromatic 23 hydrocarbons bound to nucleated blood cell DNA. 24 It appears that the government has adequately and 25 responsibly responded to the recommendations of external
424 1 reviews concerning pulmonary and environmental exposure in 2 the Gulf War theater of operations. 3 CHAIRPERSON LASHOF: Let's stop on this one for a
4 minute because we really, except for reading it here, have 5 not had a discussion of these other studies that have been 6 going on in this regard and it's an area that, you know, 7 staff have said they're going to be taking up and looking 8 at. 9 I remember one brief abstract or article coming
10 out of the Robert Wood Johnson Medical Center in New Jersey, 11 medical school, that had done some pulmonary function 12 studies and claimed there was a difference, increased 13 impaired pulmonary function in Gulf War vets. Anybody 14 remember that study? 15 CAPTAIN KNOX: Wasn't there some discussion also 16 in Charlotte about sleep apnea, some pulmonary conditions. 17 That was the number one condition that they had found, sleep 18 apnea in some of the DOD evaluations? 19 MR. CASSELLS: It didn't appear as number one or 20 two, as I recall, but sleep apnea has appeared in the list 21 of symptoms certainly, but not at the top. 22 CHAIRPERSON LASHOF: I'm just not sure whether 23 we've looked adequately enough at all of these studies to 24 have an opinion as to -- Well, I mean, if the IOM's and DOD 25 said they ought to look at this area and we can say they're
425 1 looking at it, then maybe that's okay. But I think to in 2 here -- That to say we don't think there are any pulmonary 3 problems yet may be premature for us. 4 MS. BRIX: Joyce, you asked me a question. I know 5 that at least one of the three VA research centers -- 6 there's one in New Jersey, one in Boston, and one in 7 Portland -- at least one of them, if not all three of them, 8 have some kind of component where they are going to be 9 looking at pulmonary function tests. But I don't know if
10 they are far enough along to have released any results. I 11 haven't seen any results. I do know that what it states 12 here about preliminary findings from the CCEP and the VA 13 registry reveal very few chronic pulmonary problems among
14 veterans, that is true. The rates of chronic bronchitis and 15 asthma are very small so far. 16 MR. BROWN: Yeah, just to follow that up. I think 17 it's the Environmental Hazards Center in East Orange, New 18 Jersey, that is doing some work on pulmonary function and 19 monitoring pulmonary function, and so forth, but I don't 20 think that they've released any data or anything but 21 preliminary data. So I don't think anyone really is in a 22 position to say anything that would sound like the last 23 word. 24 MS. NISHIMI: Well, then it seems like the general 25 sense might be that instead of saying the Advisory Committee
426 1 concludes that the government has adequately and responsibly 2 responded the sense is that the Advisory Committee notes 3 that the government is responding and then leave any mention 4 as to the -- 5 CHAIRPERSON LASHOF: Well, it depends what they 6 recommended. If what they recommended was they look into it 7 then we're satisfied that they've responded by looking into 8 it. What we need to take out of the body part, the fact 9 that we think there's no pulmonary problem. Somewhere it 10 said -- 11 DOCTOR CUSTIS: Do we know whether or not the 12 contract personnel to put out the fires have been included 13 in any of these surveys? 14 MS. BRIX: The only survey that I'm aware of that 15 I know they took part in was the CDC survey looking at 16 volatile organic compounds in their blood while they were
17 actively taking part in the fire-fighting activities. I 18 don't know if they've been involved in any kind of long term 19 follow-up. 20 DOCTOR BALDESCHWIELER: It seems to me that the 21 real risk here is the long-term carcinogenesis, and of 22 course obviously you don't see that for another 20 years or 23 so and it will be difficult at that time to separate 24 exposure in the Gulf to exposure, all kinds of other 25 exposures over, you know, a lengthy period. But it may be
427 1 worth a comment here somewhere. This is an exposure which 2 is rich in carcinogens. 3 MR. BROWN: And it effects, preliminary effects
4 that include things like lung cancer might not show up for 5 10 to 20 years. 6 DOCTOR BALDESCHWIELER: No, if it's -- 7 CHAIRPERSON LASHOF: That's not -- 8 MS. GWIN: Maybe we could note that they have 9 responded to the specific IOM recommendation which is they 10 do this tent simulation and then make a note that we will be 11 evaluating in our next report the quality of the research 12 protocols and whether any additional research is warranted. 13 CHAIRPERSON LASHOF: Just say a lot less right 14 here. 15 MS. NISHIMI: Right. 16 DOCTOR BALDESCHWIELER: They've clearly been 17 responsive from the standpoint of short term -- 18 MS. NISHIMI: They're starting to do it. 19 CHAIRPERSON LASHOF: They're doing the studies 20 which is all they were asked to do is take a look at it. 21 MS. NISHIMI: The government is responding. The 22 Advisory Committee is looking into it, yes. Okay. I think 23 we have that. 24 CHAIRPERSON LASHOF: Okay. Radiation exposure. 25 MS. GWIN: Okay. NIH panel concluded that
428 1 quantitation of radiation exposure should be attempted and 2 the information made available; however, it also concluded
3 that commonly reported symptoms do not appear to be related 4 to uranium. DOD and VA are conducting clinical follow-up of 5 a small number of veterans who had embedded fragments of 6 depleted uranium. No other research on radiation is 7 underway or planned. 8 Our staff's review of depleted uranium research is 9 ongoing. We have no recommendation at this time for 10 additional research, but we're looking at it. 11 CHAIRPERSON LASHOF: Okay. Well, we can go ahead 12 and say the Advisory Committee believes the government 13 response is sufficient at this time. What exactly was -- 14 Was there a specific recommendation from NIH on this or was 15 it merely that NIH -- 16 MS. GWIN: This is where you get into the funny 17 sort of -- NIH made findings and recommendations. Some of 18 their findings were at least as -- or appear to have been at 19 least as influential in the further development of the 20 government's research plan as the recommendation. But we 21 can't point to a specific NIH recommendation that a 22 particular research plan be undertaken. 23 CHAIRPERSON LASHOF: Well, this is an area that we 24 haven't really thoroughly evaluated yet. And if there was 25 no specific recommendation that we have to comment on and
429 1 say whether this recommendation was implemented or not, I 2 wonder whether we should -- 3 MS. GWIN: Be silent? 4 CHAIRPERSON LASHOF: Just be silent. 5 MS. NISHIMI: On of the difficulties with that 6 approach, however, is that, though, in fact on a finding, 7 let's say, the government opted not to pursue a line of 8 research, so the finding in itself did have the power of a 9 recommendation. 10 CHAIRPERSON LASHOF: Yeah, but I don't know that
11 we've tried to go through all the previous studies and look 12 for every finding that might have resulted in some action or 13 inaction. 14 MS. NISHIMI: Kathy did review the reports with 15 that in mind, noting in particular that there were findings 16 that, in essence, had the force of a recommendation, and 17 those are accounted for, yes. 18 CHAIRPERSON LASHOF: Okay. Well, how do you feel, 19 people? 20 MS. NISHIMI: One approach with this particular 21 issue would be to take -- adopt the same approach the 22 committee just concluded was appropriate for the vapors, 23 solvents, and combustion products and take note that the 24 government is doing some areas and that the advisory 25 committee itself is evaluating radiation exposure.
430 1 CHAIRPERSON LASHOF: Okay. 2 DOCTOR BALDESCHWIELER: I don't think it's bad as 3 is. It seem to me this more or less dismisses it, and I
4 guess I would feel comfortable leaving it the way it is. 5 MS. NISHIMI: You would feel comfortable with 6 dismissing it and not even having the Advisory Committee's 7 evaluation? 8 DOCTOR BALDESCHWIELER: Well, has somebody looked 9 to see if they are really doing what this says? 10 MR. BROWN: Well, one issue is that as we look at 11 uranium exposure issues, which we have just begun to do now 12 so we don't have that information, but it may turn out that 13 we may make a decision that the information that is 14 available to make some kind of hazard assessment isn't 15 sufficient. 16 DOCTOR BALDESCHWIELER: But it's been my 17 assumption that somebody's really monitoring the people who 18 have had direct exposure. 19 MR. BROWN: In the case of direct exposure that's 20 true, but there may be other exposures. We don't know yet. 21 CHAIRPERSON LASHOF: We haven't dug enough into 22 the whole question of other exposures besides the 22 that 23 have, you know, fragments. 24 MR. BROWN: So it's an open question that we're 25 beginning to investigate.
431 1 CHAIRPERSON LASHOF: Yeah. It's in our work plan. 2 DOCTOR BALDESCHWIELER: The work on the 22 is 3 really happening, isn't it? 4 CHAIRPERSON LASHOF: Yeah, the work on the 22 is 5 happening. 6 MR. BROWN: That's happening. 7 DOCTOR BALDESCHWIELER: Do we really know that? 8 Has somebody -- 9 CHAIRPERSON LASHOF: Yeah. 10 MR. BROWN: We have an address of some principal
11 investigators so it must be happening. They have a budget. 12 MS. BRIX: I've actually heard the presentation of 13 the results on that study. It's ongoing and they've given 14 the results at public forums. 15 CHAIRPERSON LASHOF: Okay. Okay. Pesticides. 16 MS. GWIN: Okay. NIH looked at pesticides and 17 concluded that any chronic effects of exposure were 18 unlikely. The IOM committee concluded that there's little 19 information on how pyridostigmine bromide, DEET, and 20 permethrine might interact. It recommended studies to 21 resolve uncertainties about whether these have any additive 22 or synergetic effects. 23 DOD's Army Research and Material Command, and the 24 U.S. Army Environmental Hygiene agency are conducting animal 25 studies of PB in combination with DEET and permethrin. In
432 1 addition, VA's Environmental Hazards Research Center in 2 Portland is conducting toxicology studies to assess the 3 impact on human and animal neural and skin tissues of 4 selected chemical agents encountered in Gulf War theater of 5 operations. 6 If research is to proceed in this area all 7 agencies seem to be in agreement that low dose modeling is 8 what is needed. High dose acute exposure data are already 9 being generated. 10 Chemical and biological weapons -- 11 CHAIRPERSON LASHOF: Wait a minute. You end up 12 with us in the italicized, we believe there must be 13 continuing, carefully designed, et cetera, monitored 14 studies. That basically is our agreeing with the IOM, is 15 that what we're saying here? Page 12. You're reading from 16 a different sheet than I'm reading from. The italics on 12. 17 MS. GWIN: We are agreeing and we should also 18 recognize that the research is underway. 19 CHAIRPERSON LASHOF: Yeah. I think that's the 20 important thing, and that we're going to be continuing to 21 look at this. Again, it's like almost the radiation. 22 MS. NISHIMI: But that would go a little bit 23 further, so does the Advisory Committee even want to concur 24 or is the preference to just note that the research is 25 ongoing, that the Advisory Committee itself is evaluating,
433 1 et cetera, et cetera? 2 CHAIRPERSON LASHOF: Yeah, I think that's the 3 approach, right? 4 MS. NISHIMI: Okay. So don't go as far as 5 concurring that there must be continuing? 6 CHAIRPERSON LASHOF: Oh -- 7 MS. NISHIMI: Just take note that it is ongoing 8 and the Advisory Committee -- 9 CHAIRPERSON LASHOF: Well, I don't know. I mean, 10 I don't have strong feelings whether -- 11 MS. NISHIMI: The argument would be -- 12 CHAIRPERSON LASHOF: That we haven't looked at 13 this enough ourselves to -- 14 MR. BROWN: We know it's ongoing. 15 MS. NISHIMI: We know it might be that. 16 CHAIRPERSON LASHOF: Yeah. 17 MS. NISHIMI: Just as with radiation and whatever.
18 MR. BROWN: It seems like in all these cases what 19 we're saying is we know it's ongoing. We're aware that 20 these studies are going on, have been started up, and we 21 intend to evaluate them but we haven't yet. 22 CHAIRPERSON LASHOF: Yes, I guess that's the 23 policy on all of these where they have recommended the 24 studies be done. Okay. 25 MS. GWIN: Chemical and biological weapons.
434 1 Previous groups that have considered CBW found no evidence 2 of CBW use or exposure. So what you get into is more of a 3 difference in attitude toward what that means, still NIH
4 felt it would -- it should be treated as an open question 5 until the absence of exposure was unequivocally established. 6 In contrast, the Defense Science Board Task Force was more 7 dismissive of the link between health effects and CBW 8 exposure. At the same time, however, the DSB Task Force 9 predicted that high tech, low casualty military campaigns in 10 exotic places will engender a preoccupation with residual 11 health effects. If chemical or biological weapons are ever 12 actually employed there will be a gross multiplication of 13 those residuals and further research is needed on long-term 14 consequences of exposure. 15 Committee staff have been informed that in 16 addition to studies of the effects of BP currently underway 17 in the Army Medical Research and Material Command, studies 18 of the health effects of chemical and biological agents are 19 underway as part of DOD's core research program. If the 20 Advisory Committee would like more information on that 21 research staff can request a briefing. Still, it's staff's 22 impression that DOD is not taking seriously the DSB 23 recommendation that research be conducted on the potential 24 long-term effects of exposures in Gulf War veterans, 25 particularly repeated exposures. And it's possible that a
435 1 retrospective analysis might not be possible but that should 2 not exclude the possibility of prospective study. 3 CHAIRPERSON LASHOF: Gee, we used "possible" three 4 times in that sentence. That's a record. 5 DOCTOR BALDESCHWIELER: The italics seem 6 inconsistent with the previous paragraph which says, 7 "Committee staff have been informed that in addition to 8 studies of the effects of pyridostigmine bromide currently 9 underway..." 10 MS. NISHIMI: The italicized -- 11 DOCTOR BALDESCHWIELER: "Studies of the health
12 effects of chemical and biological agents are underway in 13 DOD's core research program." 14 MS. NISHIMI: That's why Holly -- 15 MS. GWIN: The core is the problem or where the 16 distinction lies. The working plan for research on Gulf War 17 veterans' illnesses includes no research on chemical or
18 biological weapons, the effects of the exposure. We have 19 recently been informed that there is research in the core 20 program which we cannot yet describe, so what we're drawing 21 here is a distinction between the core program and the Gulf 22 War veterans. 23 MS. NISHIMI: The italicized text, John, should 24 have a clarifying factor that was in Holly's oral 25 presentation, and that is that the potential long-term
436 1 effects of exposures in Gulf War veterans. I think that's 2 where you place the emphasis there. 3 DOCTOR BALDESCHWIELER: Oh. 4 MS. NISHIMI: The DSB recommendation pertaining to 5 the Gulf War, the Persian Gulf -- the coordinated -- 6 coordinated research plan does not contain any research of 7 the specificity, therefore this finding -- 8 DOCTOR BALDESCHWIELER: I guess it's hard for me 9 to envision what that would be. That is when -- It seems to 10 me that there's interest in long-term effect of low level 11 repeated exposure but I don't know what you do that would be 12 different for Gulf War veterans. I mean, isn't that an 13 intrinsic technical issue? What is it that would be 14 specific for Gulf War -- 15 CHAIRPERSON LASHOF: I'm with John. I don't quite 16 understand the distinction of saying they're doing some work
17 on this in the core, they're not doing it under the research 18 plan for the Gulf War. Maybe they didn't do it under the 19 research plan of the Gulf War because they knew what's going 20 on in the core. And it's somewhat splitting hairs to say 21 it's got to only be related to the Gulf War people if it's 22 doing the research -- but I guess my other position on this 23 one is sort of like the previous ones. This is an area 24 we've not dug into. We've not been briefed on all research. 25 This is one where a recommendation was made and it's one
437 1 we're going to continue to look into, and let's punt on it 2 for this point in time. 3 MS. NISHIMI: Okay. 4 DOCTOR BALDESCHWIELER: There is an issue in 5 carrying out such research. I mean, it cannot be done by a 6 normal investigator in a university laboratory setting. 7 These are very hazardous agents that have to be handled, you 8 know, in special facilities. 9 MR. BROWN: We won't do it a Cal Tech then. 10 DOCTOR BALDESCHWIELER: So we won't do it at Cal 11 Tech for sure. 12 So I don't think you can solicit your investigator 13 proposals to do this. 14 MS. NISHIMI: Okay. Then it seems we can handle 15 this in the same fashion as we handled the other -- 16 MS. GWIN: Okay. 17 CHAIRPERSON LASHOF: Okay. Okay, John? 18 Okay. Vaccines. 19 MS. GWIN: Vaccines. The NIH panel has a finding 20 that the anthrax and botulinum vaccines have been available 21 for many years and no long-term adverse effects have been 22 documented. They say that this appears -- Well, we have 23 found that this appears to be the definitive statement for 24 government research to date as few studies have been 25 proposed to evaluate potential adverse effects.
438 1 One of the few currently funded is the CDC's 2 investigation of veterans in Pennsylvania which is 3 attempting to measure antibody response in veterans. In 4 1995 the IOM committee recommended the DOD maintain its list 5 of those receiving anthrax and botulism vaccines for the 6 purpose of conducting follow-up studies on those cohorts. 7 DOD responded that all vaccinations are required to be 8 annotated in a service members medical records. Testimony 9 at our October meeting, however, revealed that this is not 10 necessarily so and DOD admitted that recordkeeping in the 11 theater was insufficient. 12 CHAIRPERSON LASHOF: All right. So, in terms of 13 saying here's a recommendation, has it been met or is it 14 being met or not, I'm not sure what we've said on this one. 15 MS. GWIN: I think we've said they can't meet this 16 recommendation because they don't have the records. 17 MS. BRIX: Those records haven't married up yet. 18 MS. NISHIMI: This would be a finding that, in 19 fact, they cannot meet the recommendation. 20 CHAIRPERSON LASHOF: The recommendation, okay. 21 Let's make it clear. 22 MS. NISHIMI: But is the committee comfortable 23 with that? 24 DOCTOR BALDESCHWIELER: Yes. 25 CHAIRPERSON LASHOF: Appears to be.
439 1 MS. GWIN: Okay. Reproductive effects. In 1994 2 GAO concluded that the minimal efforts taken to monitor 3 servicemen and women for reproductive effects after 4 deployment have major shortcomings. GAO recommended VA use a
5 revised questionnaire to query the veterans who had already 6 completed the VA registry examination but were not asked 7 questions about infertility and miscarriages. VA has 8 redesigned its survey for this group to match that of the 9 national survey. Questions pertaining to exposures and
10 reproductive health will be comparable to those in the new 11 survey. After a prolonged OMB review the survey will be 12 mailed to all 50,000 veterans who had not been asked these
13 questions in February, and we believe this represents a good 14 faith effort on the part of VA to respond to the GAO 15 recommendation. 16 MS. NISHIMI: I think this differs from the 17 previous risk factors, or whatever, if you will, because we 18 have the -- the staff has and the committee has evaluated 19 this particular study and so staff's recommendations is that 20 the committee be prepared to issue the finding that it has 21 been a good faith effort. 22 CHAIRPERSON LASHOF: Yes. Okay. Are you 23 comfortable? 24 MS. NISHIMI: Not to preempt Holly but it seems 25 the next two are areas that we haven't evaluated and perhaps
440 1 would be dispatched in the same way as the previous ones. 2 Would that -- Would you concur with that, as we have with 3 the oil -- the CBW, vapors, radiation, and pesticides? 4 MS. GWIN: We'll be looking at reproductive toxins 5 as we go through evaluation of the tox protocols. 6 MS. NISHIMI: And so those do fall in the category 7 of the previous. I just wanted to make a point, though, on 8 that one VA, in fact, the committee's finding. 9 CHAIRPERSON LASHOF: In other words, that the 10 italicized thing on page 14 would be redone to fall into the 11 other one? 12 MS. NISHIMI: Right. 13 CHAIRPERSON LASHOF: That this is an area that -- 14 MS. NISHIMI: Right. 15 CHAIRPERSON LASHOF: -- we are still looking at 16 and we're not prepared to say one way or the other -- 17 MS. NISHIMI: Right. 18 CHAIRPERSON LASHOF: -- is that right? 19 MS. NISHIMI: And I would argue that the same 20 might be true for 15, the text at 15. 21 MR. CASSELLS: We're just beginning to initiate 22 how to look at that. 23 MS. NISHIMI: So there are a body of these 24 findings, if you will, and evaluations that will be changed 25 to indicate that the government has responded ongoing and
441 1 the committee is taking its own look, with the exception of 2 those areas that we've noted in our discussion here now.
3 CHAIRPERSON LASHOF: Are you following, Holly? 4 MS. NISHIMI: That's okay. Holly's deaf. 5 CHAIRPERSON LASHOF: Holly's not following. If 6 Holly's not following I'm not sure the committee is 7 following either. We're all wearing thin. I think I know 8 what you're getting at. It really raises -- Let me try it 9 another way, Robyn. It raises a question in my mind about 10 how this whole section should be handled, and there are one 11 or two ways of doing it. One is to go back through this 12 section and limit it to a statement of specific 13 recommendations with very little text and a review and a 14 statement, you know, of this is a recommendation on this 15 area, it has been followed, it is being done, or we're still 16 looking and this and are not prepared to state whether it's 17 adequately been implemented. Very concise. Very brief kind 18 of summary at one point. That's one approach. 19 The other approach, since all of these deal with 20 each of the areas in which we are doing extensive work, is 21 fit them into the appropriate chapters. That is, we're 22 going to write a chapter on research and in that chapter on 23 research we come to our own things and in there, either at 24 the very beginning or the very end of our own section, 25 they're meshed in, depending on how best it flows. We
442 1 include in there the recommendations of previous committees. 2 That is, we've looked at this research. We've come to this. 3 Here are our findings. Here are our recommendations. 4 Previous groups had looked at this, had come to the 5 following, and here they are. 6 I'm not sure which approach will work better, and 7 staff may want to play around with it and wee which they 8 feel more comfortable and which works better. I don't think 9 we want this long of discourse about all the material 10 relating to these previous recommendations after, or even 11 before, the kind of detailed discussion we're going to have. 12 It begins to get redundant. 13 MS. NISHIMI: Sure. 14 CHAIRPERSON LASHOF: So either we tighten this up 15 to a very concise list of recommendations; our opinion 16 they've been followed or not, or we work them into and mesh 17 them in. 18 How do the rest of you feel about this? 19 DOCTOR BALDESCHWIELER: This gets very repetitive 20 the way it's done here. 21 CHAIRPERSON LASHOF: Yeah. 22 MS. NISHIMI: As you recall, in the previous 23 iteration we had done what you had suggested without the 24 yes, no, yes, no, yes, no, because we had just compiled it, 25 and then the suggestion was made to reorganize it in this
443 1 fashion. So are you suggesting that we might go back to the 2 other? 3 MS. GWIN: Version number two which is taking
4 the -- doing an introductory portion of each area of our 5 charter that we're looking at and telling people what other 6 committees have had to say about it and making some 7 observations about that and then launching into our own 8 findings and recommendations. 9 MR. BROWN: So it uses introductory material for 10 each section on our research work. 11 CHAIRPERSON LASHOF: I think it's worth trying it 12 that way and see if it works. 13 MS. NISHIMI: So reverting back to book two? 14 MS. GWIN: But two is more like -- 15 CHAIRPERSON LASHOF: Well, no, I -- 16 MS. NISHIMI: Two is sort of in between, yes. 17 CHAIRPERSON LASHOF: The problem and why we 18 changed and so on is we didn't at that time have our own 19 stuff done. Now we've got our own and we've written up our 20 own in great detail, and once we've done that having this 21 approach then is, you know, of less value. We're at a 22 different stage, and as we get to different stages we have 23 to relook at the format, in my opinion. 24 Anybody else have some thoughts on that? 25 No.
444 1 MS. NISHIMI: Okay. Then I think the -- 2 CHAIRPERSON LASHOF: The staff has done such a
3 good job we'll defer to their trying it out and seeing if 4 we're happy with it. 5 MS. NISHIMI: We'll go for it. 6 CHAIRPERSON LASHOF: Okay. That then brings us to 7 the very back, right before the timetable is the table of 8 contents, the proposed contents and structure. 9 MS. NISHIMI: Those are just discussed, right, the 10 "Implementation of Past Reports." We believe now we have a 11 suggestion, proposed structure from the Advisory Committee 12 and we will reflect that. 13 CHAIRPERSON LASHOF: Otherwise, so the one change 14 will be in the section on findings and recommendations, the 15 chapter marked "Implementation of Past Reports" we're going 16 to try to get those in as introductions to each section. 17 The rest seems pretty straightforward, to me. Are there 18 other things that people don't see in the table of contents 19 or things they see in the table of contents that they would 20 like not in the table of contents? 21 DOCTOR BALDESCHWIELER: Is the order under -- 22 "Findings and Recommendations," is the order -- 23 MS. NISHIMI: I typed that in and I knew that 24 question was going to come up and I have to tell you I think 25 I just kind of didn't have an order.
445 1 DOCTOR BALDESCHWIELER: Because it seems to me 2 medical and clinical issues might be first. 3 MS. NISHIMI: I think I just kind of winged it so,
4 no, there is not -- not meant to be an order, so perhaps the 5 committee could direct an order. 6 CHAIRPERSON LASHOF: How's the charter read? 7 What's the order in the charter? 8 MS. GWIN: The charter goes: Research, 9 Coordinating Efforts, Medical Treatment, Outreach, External 10 Reviews, Risk Factors, Chemical and Biological Weapons. 11 In our approach to going about things, we've 12 already lumped Risk Factors and Research, so we're not 13 exactly following the charter in terms of -- 14 MS. NISHIMI: Actually we believed it would 15 created to much redundancy and so we did some lumping. 16 CHAIRPERSON LASHOF: Right. 17 MS. NISHIMI: And I do believe that the proposed 18 structure that the staff and committee has been working 19 around these broad areas works quite well while also meeting 20 the elements of the charter. So the question really would 21 be for some guidance to staff on how the presentation of 22 these topics might be ordered, as John indicated. 23 DOCTOR BALDESCHWIELER: I would think it would be 24 more logical to have your clinical and medical issues first. 25 MS. NISHIMI: Okay.
446 1 DOCTOR BALDESCHWIELER: Then health risks and 2 health effects, and chemical and biological second and
3 third. Research fourth, and outreach last, because the 4 outreach sort of sums up what you do about all the things 5 you've learned in the previous pieces. 6 CHAIRPERSON LASHOF: I think I like research up 7 higher than where you would have put it, especially since 8 chemical and biological we're not saying as much about. And 9 I'm tempted to look at those things we've devoted the most 10 time and effort to and put them in that sort of order and go 11 by what have we really concentrated on, and we've 12 concentrated on, really, outreach and research, even 13 clinical and medical issues we've done some on but most of 14 that's still yet to be done and we're going to be talking 15 about a work plan. 16 And I think when you read a report like this you'd 17 like to get at the meat of what you've done and not read 18 chapter and chapter about what we're going to do and how we 19 haven't done and then find yourself later on with what we 20 have. So I would prefer to see either outreach or research 21 first and then clinical, medical, and then chemical and 22 biological, and health risks and health effects have sort of 23 been put into both research and clinical and medical, 24 haven't they? 25 MR. BROWN: And that can be adjusted with the
447 1 final report into some other order. 2 CHAIRPERSON LASHOF: Yes. I think once -- You 3 know, it's not essential that today we decide this order.
4 That may fall out as you get it and rework it and you may 5 see how it flows better. My guess is either outreach or 6 research will go first and the other second, and the others 7 will fall after that. But why don't we defer that. 8 MS. NISHIMI: I think that's useful, though, as a 9 guiding principle the staff can be guided by the fact that 10 where we have the most information those should be highest 11 in the report. That's useful for us to know. 12 MR. BROWN: Put the thinnest parts last. 13 CHAIRPERSON LASHOF: Yeah. I mean, put your best 14 foot forward and where we've done work and have substantial 15 recommendations. Especially in terms of those things that 16 we have significant recommendation. 17 MS. NISHIMI: Right. 18 CHAIRPERSON LASHOF: Those should be in the
19 forefront, which would argue towards research first. 20 MS. NISHIMI: Okay. 21 CHAIRPERSON LASHOF: Okay. Are there other things 22 that need to come before us before we wrap it up? 23 I want to congratulate staff for a job they've 24 done to get us to this point today. After two days I'm 25 feeling more optimistic about this timetable because I think
448 1 they've done quite a job and if they keep turning out stuff 2 as good as this, at this speed, why they'll make it. 3 MS. NISHIMI: We'll make it. 4 MR. BROWN: It's the inspiration of our committee. 5 CHAIRPERSON LASHOF: Thank you, Mark. 6 CAPTAIN KNOX: Well done, Mark. 7 CHAIRPERSON LASHOF: That makes up for the crack 8 that -- 9 MS. NISHIMI: Except Andrea was not here to hear 10 it. 11 CHAIRPERSON LASHOF: Anything else to come before 12 us? 13 Robyn? Cathy? Anybody? 14 Cathy, I give you permission to close the meeting. 15 MS. WOTECKI: You are now adjourned. 16 (Whereupon, at 3:43 p.m., the above-entitled 17 matter was concluded.) 18