1
UNITED STATES OF AMERICA
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PRESIDENTIAL ADVISORY COMMITTEE ON
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GULF WAR VETERANS' ILLNESSES
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PUBLIC MEETING
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TUESDAY
AUGUST 15, 1995
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WASHINGTON, D.C.
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The Avisory Committee met in the
Congressional Room of the Capital Hilton, 16th and K
Streets, N.W., Washington, D.C., at 9:00 a.m., Dr.
Joyce Lashof, Committee Chair, presiding.
COMMITTEE MEMBERS:
JOYCE LASHOF, Chairperson
JOHN BALDESCHWIELER
ARTHUR L. CAPLAN
DONALD CUSTIS
FREDERICK M. FRANKS, JR.
DAVID A. HAMBURG
JAMES A. JOHNSON
MARGUERITE KNOX
PHILIP J. LANDRIGAN
ELAINE L. LARSON
ROLANDO RIOS
ANDREA KIDD TAYLOR
2
DESIGNATED FEDERAL OFFICIAL:
CATHERINE WOTEKI
STAFF PRESENT:
ROBYN NISHIMI
THOMAS McDANIELS
ALSO PRESENT:
KARL T. KELSEY
DIANE J. MUNDT
GERARD BURROW
KELLEY BRIX
3
A G E N D A
PAGE
I. OPENING REMARKS 4
II. BRIEFING: INSTITUTE OF MEDICINE,
NATIONAL ACADEMY OF SCIENCES
A. COMMITTEE TO REVIEW THE HEALTH 4
CONSEQUENCES OF SERVICE DURING
THE PERSIAN GULF WAR
B. COMMITTEE ON THE DOD PERSIAN GULF 12
SYNDROME COMPREHENSIVE CLINICAL
EVALUATION PROGRAM
III. DISCUSSION OF ADVISORY COMMITTEE 57
GOALS/OBJECTIVES/STRATEGIES
IV. FUTURE MEETINGS 161
V. PUBLIC COMMENT 173
4
1 P-R-O-C-E-E-D-I-N-G-S
2 9:04 a.m.
3 CHAIRPERSON LASHOF: I believe we are
4 ready to begin this morning. I think we had a very
5 full day yesterday. We heard a great deal, both from
6 the Departments and from the Gulf War Veterans.
7 This morning, we are going to have a
8 briefing from the Institute of Medicine, the National
9 Academy of Sciences. They have had two studies
10 ongoing. One, the Committee to Review the Health
11 Consequences of Service During the Persian Gulf War.
12 And then, the Committee on the DOD Persian Gulf
13 Syndrome Comprehensive Clinical Evaluation Program.
14 And I would like to ask the people who are
15 going to present to come forward at this point. Take
16 their places at the table.
17 Dr. Kelsey, will you be starting off?
18 DR. KELSEY: Yes.
19 CHAIRPERSON LASHOF: Okay. Please
20 proceed.
21 DR. KELSEY: Thanks, Dr. Lashof.
22 I first want to thank the Committee for
23 inviting me and send greetings from John Bailar, who
24 is the chairman of the committee, who couldn't be here
25 today.
5
1 What I am going to do is very briefly give
2 you an overview of the Institute of Medicine process,
3 which is familiar to many of you. And then, describe
4 the workings of our committee, touching primarily on
5 the points from our first report.
6 As many of you know, the Institute of
7 Medicine is a part of the National Research Council.
8 And the members who serve on these committees serve as
9 volunteers. It was established congressionally and
10 operates as an independent body.
11 Our committee was established by public
12 law, a law passed in November of 1992, which was about
13 the time the oil fires were a very large part of the
14 Congressional mind. The law requires the VA and the
15 Department of Defense to enter into a joint agreement
16 with medical follow-up agency, the Institute of
17 Medicine, to fund a study to end in 1996.
18 The funding level is $500,000.00 a year,
19 as you can see, equally split between the two
20 agencies. The study really began with money arriving
21 in October of 1993. And the first meeting was held
22 then, in January of 1994.
23 We issued our first report on January 4th
24 of 1995, with the final report due approximately some
25 time around the summer of 1996.
6
1 We have an 18-member committee. And we
2 have -- I've got the members of the committee listed
3 here, with John Bailar, as I mentioned, the chair.
4 The committee has met nine times. And we are
5 scheduled again to meet in September.
6 We have members with various expertise,
7 including epidemiology, toxicology, biostatistics,
8 infectious disease and vaccination, reproductive
9 health, psychiatry, respiratory illness, immunology --
10 the areas, broadly speaking, needed to touch on the
11 health consequences of service during the Persian Gulf
12 -- in a very broad sense.
13 We have obtained information through a
14 wide variety of means, including presentations from
15 members of the government. Some of the members of the
16 panel have presented information to us.
17 We have also had an excellent staff that
18 have made inquiries broadly, and looking also through
19 the open literature, much of which has been found to
20 be actually quite lacking.
21 The public law that established the
22 committee then, really had three direct points. The
23 first one was to assess the effectiveness of actions
24 taken by the Secretaries of the Veterans
25 Administration and the Department of Defense to
7
1 collect and maintain information useful in assessing
2 these health consequences.
3 That was specifically the first point.
4 The second one was to make recommendations on the
5 means of improving collection and/or maintenance of
6 this information, again aimed at the data base issue.
7 And then finally, to make recommendations
8 as to whether there was a sound scientific basis for
9 an epidemiological study or studies for the follow-up
10 of the veterans' health. And we were also mandated to
11 discuss or recommend the nature of such study or
12 studies.
13 So that, explicitly, is our mandate. As
14 I have mentioned, we released a report on January 4th,
15 an interim report, so to speak, which was motivated by
16 the committee's sense that there were some
17 recommendations that we wanted to make prior to the
18 end of the three years, primarily because we felt that
19 there was some immediate recommendations that could be
20 utilized by the VA and the Department of Defense in
21 moving forward with some of these important and
22 pressing issues.
23 We really stress three areas, data and
24 data bases, coordination, and study design needs.
25 Specifically then, in addressing what we recommended,
8
1 we talked a little bit about the registry, which you
2 have heard quite a bit about.
3 We stressed that this was a self-selected
4 population. That the population itself was not
5 designed for research. And so, while it should be
6 reviewed and updated regularly to monitor sentinel
7 events, which really was its chief purpose. That is,
8 to monitor for sentinel events.
9 We also stressed that it would be useful,
10 certainly, for following up the Persian Gulf Veterans,
11 and definitely for future conflicts, to take a very
12 strong look at the data systems and try very hard to
13 link them.
14 This currently is very difficult, as I am
15 sure you are aware. And it's instances like this that
16 led us to believe that considerable effort might be
17 made to make the data available in linkage systems.
18 Again, we also recommended that the
19 Department of Defense Unit Location Registry be
20 completed with a high priority since, in fact, that
21 could give us both denominator information as well as
22 potential to look at exposure information.
23 We also touched on coordination and
24 recommended that funding be based on scientific merit
25 for any studies that were deemed useful while the
9
1 committee was ongoing.
2 We strongly urged that all activities
3 undergo external peer review and that they be based on
4 scientific merit. This was something that we felt was
5 very important. And there were examples of how this
6 had been lacking in the past.
7 We also recommended that active
8 coordination of the activities of various agencies be
9 undertaken to reduce redundancy. There was a
10 considerable amount of duplication in efforts early
11 on. And we felt the need to stress that coordination
12 was important in this endeavor.
13 The third point then involved study design
14 needs. What we recommended was that we define really
15 what is needed for research. We recommended a
16 population-based epidemiologic study using what we
17 have deemed really data which will be, if it is not
18 currently, available with the completion of some of
19 the work of the Department of the Defense and the VA.
20 We also stressed that information derived
21 from cluster or outbreak investigation was minimally
22 useful. And while it was important in a sentinel
23 sense, this was not the goal of future studies.
24 The mortality study that the VA was
25 conducting -- we also agree it should be extended to
10
1 observe any excess from chronic disease.
2 We use the example of lead to illustrate
3 that many of the possible events that have been tied
4 to chronic disease have not been fully investigated.
5 And certainly, lead deserves a closer look in future
6 studies.
7 We also recommended that the various
8 agencies continue their work looking for appropriate
9 models to evaluate potential interactions in terms of
10 compounds to which the troops were exposed. That is,
11 Deet, permethrin, insecticides, and vaccines,
12 pyridostigmine as well.
13 And then, we further recommended that
14 leishmania tropica be a subject of intensive research
15 as this had been a hypothesis for a considerable
16 amount of disease and represented a very serious
17 research challenge. We felt that it was very
18 appropriate to intensively study this particular
19 problem.
20 We also then addressed some of the
21 putative outcomes associated with servicing the
22 Persian Gulf War. I list here for you some of the
23 things that we have heard about from veterans and
24 which we have considered as part of our list of
25 putative outcomes associated with service.
11
1 And I won't read the list for you. I only
2 show it in an effort to let you know that the list is
3 considerable and is something that we have wrestled
4 with. We also likewise have thought about a number of
5 putative exposures. And the committee has expertise
6 in all these areas.
7 And we looked very closely then at any
8 associations between these putative exposures and the
9 outcomes. And again, I show you the list to
10 illustrate the areas that we are looking at.
11 Finally then, my last overhead really
12 involves our future plans. We continue to look at the
13 evaluation of data collection and the ongoing
14 research. We are continuing, as I have indicated, to
15 look closely at the health problems in general, not
16 just the unexplained illness associated with the
17 Persian Gulf service.
18 Our committee is charged with a broad
19 range of health consequences. And we continue to look
20 at them closely. And finally, we are also continuing
21 to look at potential exposures and outcomes for our
22 research recommendations, as part of our mandate.
23 Thank you. I will be happy to address any
24 questions that you have as well at any point.
25 CHAIRPERSON LASHOF: Thank you very much,
12
1 Dr. Kelsey.
2 I think we will proceed to hear the second
3 annual report. We'll hear from Dr. Burrow, and then
4 open it up for questions from the panel for both
5 reports.
6 DR. BURROW: Thank you. I'm Gerard
7 Burrow, the dean of the Yale University School of
8 Medicine and chairman of the Institute of Medicine
9 Committee on the DOD Persian Gulf Comprehensive
10 Clinical Evaluation Program.
11 The committee was formed in October of
12 1994 at the request of Dr. Stephen Joseph, the
13 Assistant Secretary of Defense for Health Affairs.
14 In the brief time allotted, I'd like to
15 address three topics: a description of the charge to
16 our committee since we have two IOM committees, a
17 summary of the major findings included in our first
18 report on CCEP which was released on December 2nd,
19 1994, and a summary of the major findings included in
20 our second report which we released to your Committee
21 and to the general public yesterday.
22 The charge to our committee was to
23 evaluate the protocol for the Comprehensive Clinical
24 Evaluation Program or CCEP for short, to comment on
25 the interpretation and the results that have been
13
1 obtained so for, to make recommendations relevant to
2 the conduct of the program in the future, and to make
3 recommendations on the broader program of the DOD
4 Persian Gulf health studies, if appropriate.
5 The IOM committee was comprised of 12
6 individuals with a distribution not unlike the other
7 committee, with Dr. Kelley Brix as the study director.
8 We will have held four meetings and produced three
9 reports by the end of the project on September 30th,
10 1995.
11 You have heard about the structure, as Dr.
12 Kelsey has addressed, of the selection and procedures
13 of that IOM committee. Let me simply state that the
14 goal is to make these IOM scientific reports
15 independent, authoritative, and objective.
16 The first report of this committee was
17 released on December 2nd, 1994 based on the
18 information on the CCEP that was available from the
19 DOD in October of 1994. And remember again that it
20 started in June of 1994, so this was very early.
21 The committee at that time concluded that
22 the CCEP design represented a serious attempt by the
23 DOD to evaluate and treat the health problems of
24 military personnel who were on active duty in the
25 Persian Gulf.
14
1 The committee suggested at that time that
2 attention be paid to three issues: the division of
3 labor and other resources between the local medical
4 treatment facilities and regional medical centers and
5 between Phase I, the beginning phase, and Phase II,
6 the referral phase, in the CCEP in light of the
7 enormous large numbers of CCEP patients, and in the
8 light of the apparent use of CCEP by patients to
9 obtain timely, high-quality medical care which would
10 otherwise not be as readily available.
11 We thought there should be attention to
12 the relationship between the clinical care aspects of
13 CCEP for which it was designed and research functions
14 and commented on the prominence of stress and
15 psychiatric disorders as diagnosis and/or as
16 contributing factors in the CCEP findings.
17 The purpose of the second report is to
18 comment upon an unpublished confidential draft DOD
19 report entitled "Comprehensive Clinical Evaluation
20 Program For Gulf War Veterans Report on 10,020
21 Participants."
22 That report was dated June 7th, 1995. I
23 believe you have the report that was issued on August
24 1st which was a revised report. Although the DOD had
25 not seen the IOM's second report, the final DOD report
15
1 which was released on August 1st contained several
2 revisions compared to the June 7th draft.
3 These revisions in the final DOD report
4 address some of the concerns expressed in our second
5 report, even though the IOM committee had no
6 opportunity to review the August 1st report before it
7 was published. So that -- you will see some
8 dissynchrony.
9 The IOM committee reviewed several
10 documents relating to illnesses among Persian Gulf
11 Veterans. These were authored by the Department of
12 Defense and others.
13 I would emphasize that the committee has
14 not performed its own independent research, nor
15 examined individual patients.
16 Second, the committee's second report was
17 based on the following: review of two published and
18 one unpublished report by the Department of Defense
19 which described the results of the program, three IOM
20 committee meetings that included presentations by DOD
21 CCEP physicians, review of several reports which are
22 listed in the appendix of our second report, and
23 attendance by the Institute of Medicine staff at a
24 number of meetings organized by the DOD and Department
25 of Veterans Affairs.
16
1 The CCEP has developed -- has been
2 developed as a thorough, systematic approach to the
3 diagnosis of a wide spectrum of diseases. DOD has
4 made a conscientious effort to build consistency and
5 quality assurance into the CCEP at the many military
6 medical facilities across the country.
7 The protocol has resulted in specific
8 medical diagnosis or diagnoses for most patients. The
9 signs and symptoms of many patients could be explained
10 by well-recognized diseases that are readily
11 diagnosable and treatable.
12 The committee concludes that this is a
13 more likely interpretation -- that a high prevalence -
14 - than the interpretation that a high prevalence of
15 CCE patients are suffering from a unique previously
16 unknown mystery disease that has a very large number
17 of supposedly pathognomonic symptoms.
18 A major DOD conclusion in their report of
19 June 7th, quote:
20 "To date, the CCEP has identified
21 no clinical evidence for a unique or new
22 illness or syndrome among Persian Gulf
23 Veterans."
24 The committee -- our committee urged
25 caution or more justification for this statement. As
17
1 members of the committee are aware, it is always
2 harder in epidemiology to prove that a new disease
3 does not exist than to prove that it does exist.
4 If a new or unique illness were either
5 mild or only affected a small proportion of veterans
6 at risk, the illness might go undetected even in a
7 large case series.
8 On the other hand, if indeed there were a
9 new, unique Persian Gulf-related illness that could
10 cause serious disability in a high proportion of
11 veterans at risk, it would probably be detectable in
12 a population of 10,020 patients. This pattern has not
13 been detected.
14 Dr. Stephen Josephs and other DOD
15 physicians have discussed the likelihood that at least
16 a few CCE patients had developed illnesses that are
17 directly related to the Persian Gulf service.
18 It is also likely that some CCE patients
19 had developed illnesses that are coincidental and
20 therefore unrelated to their Persian Gulf illness.
21 And in some cases, they had predated their Persian
22 Gulf service. These possibilities should have been
23 mentioned in the DOD report.
24 In summary, our overall conclusions were
25 that the program was designed primarily as a clinical
18
1 program to evaluate and treat the health problems of
2 individuals who have served their country during the
3 Persian Gulf conflict.
4 As a secondary goal, the DOD has published
5 a series of reports which describe and interpret the
6 symptoms and diagnoses of the entire group of CCE
7 patients.
8 Overall, our committee is impressed with
9 the quality of the design and the efficiency of the
10 implementation of the clinical protocol. The
11 committee has been particularly impressed with the
12 dedication and commitment of the DOD physicians who
13 actually care for the Persian Gulf Veterans.
14 The committee is also impressed by the
15 considerable devotion of resources to this program and
16 the remarkable amount of work that has been
17 accomplished in just now, a little over a year.
18 Thank you again for the opportunity to
19 address the committee. And I would also be delighted
20 to try and answer any questions that you might have.
21 CHAIRPERSON LASHOF: Thank you very much,
22 Dr. Burrow.
23 The panel is now open for questions. And
24 we can move around our group and --
25 Andrea, any questions?
19
1 (No response.)
2 CHAIRPERSON LASHOF: Rolando, any
3 questions?
4 (No response.)
5 CHAIRPERSON LASHOF: Elaine?
6 DR. LARSON: Several quick questions.
7 First of all for Dr. Kelsey, we heard
8 testimony yesterday about a couple of things I'd like
9 to ask you about. First of all, we heard testimony
10 that there were long months of waiting for
11 examinations. And I am wondering if the committee is
12 going to address anything about timeliness of data
13 collection because that has not only clinical
14 implications, but certainly research implications.
15 And one related question about what we
16 heard yesterday. That is, concern about if there is
17 a Persian Gulf-related syndrome or illness that is
18 characterized by a multiplicity of signs and symptoms.
19 And I understand from yesterday that the data
20 collection is cut off after six symptoms. Is that
21 correct?
22 DR. KELSEY: You know, Dr. Burrows may be
23 a more appropriate person for the question. Certainly
24 the issue of timeliness is critical in a lot of ways.
25 The committee certainly considered that
20
1 issue in trying to determine how to use the registry
2 information because it bears on interpretation of that
3 data. And I think that's part of our recommendation
4 that the data be treated in a certain fashion. With
5 respect to --
6 DR. BURROW: The question of timeliness
7 was why we made that comment after the first meeting.
8 I mean, they were -- the process was simply being
9 overwhelmed by individuals coming in and attempting to
10 see them. And everyone was getting a very complete
11 protocol. And that was altered in that they have
12 processed a very large number of patients.
13 The number of both symptoms and diagnoses
14 are cut off after seven, I think. If one looks at
15 these, there are a multitude of diagnoses, but they
16 vary so that there is a wide variety and --
17 DR. LARSON: Two other questions. What
18 has been the response of the DOD to your
19 recommendations from the report in December of 1994?
20 It's been seven and a half months.
21 DR. BURROW: They have been responsive,
22 have changed the direction in the way that the
23 patients are being used. In a more recent -- in the
24 first draft that we saw of the Defense Department
25 report in June, that they had gone on at some length
21
1 about environmental threat.
2 We question whether that was -- should be
3 in there. And that has been modified in the new
4 report. So that -- in fact, I think that they have
5 been responsive to the committee.
6 DR. LARSON: And last question, what's the
7 interface between your two committees? How do you
8 interact and communicate?
9 DR. BURROW: The two people on either side
10 of me are the probably major interactors.
11 CHAIRPERSON LASHOF: Phil?
12 DR. LANDRIGAN: Yes. Good morning. I'd
13 like to -- one of the recommendations that was made in
14 the report "Health Consequences of Service" -- is that
15 -- is that yours, Karl?
16 -- was a report that the Vice President
17 should chair a committee. I guess this committee is
18 an approximation of that. And that one of our tasks
19 should be to devise a plan to link data systems on
20 health outcomes with standardized forms and an
21 organized system of records.
22 One of the things that we heard repeatedly
23 yesterday were tales of lost records, records that
24 didn't get from the DOD system to the VA, records that
25 were lost in transfer from one hospital to another.
22
1 Basically a system that seems to be still operating
2 largely on paper and not in electronic form.
3 And I wondered if you -- this
4 recommendation is good, but it's also rather brief --
5 if you had any plans to further elaborate upon that
6 recommendation and spell out in more detail your
7 thoughts.
8 DR. KELSEY: Certainly. I think you've
9 hit upon a -- what we view as a very important
10 recommendation. It's something that's crucial to the
11 endeavor we're all about.
12 The word "denominator" has come up I know
13 in your meeting and obviously, if you are interested
14 in following up any of the health consequences of
15 anything like this, the absence of a denominator is a
16 big problem.
17 Our view is that in fact the linking of
18 the data systems between the Department of Defense and
19 the VA is critical in follow up of any soldiers
20 anywhere. And in our view that is very much lacking.
21 It obviously also is going to take major effort to
22 link these systems.
23 But the committee I think in its first
24 report was very much trying to say -- given the amount
25 of effort and the amount of money that has been spent
23
1 to date on this problem, it might be best to think
2 about prevention.
3 And the best way we know of to prevent
4 this type of thing is to get systems in place where
5 denominators are a little more forthcoming.
6 And obviously we feel data systems and
7 data bases exist to computerize this and to make the -
8 - not only the record, but potentially, then,
9 caregiving improved by swift and easy flow of
10 information.
11 So the Vice President's name was there, I
12 think, because of the importance we felt due to this
13 problem. And I think we'll revisit that. I have no
14 doubt that it is still an important problem.
15 DR. LANDRIGAN: Right. It would seem to
16 me that it has implications for the future too. The -
17 - I mean, the world is unfortunately -- remains an
18 unsettled place.
19 And there are likely to be further
20 deployments of American troops overseas to
21 environments that are less than friendly. And these
22 problems in one form or another are going to recur I
23 am afraid in the years ahead. And it would be nice to
24 have the system in place beforehand the next time.
25 DR. KELSEY: I mean, I think your point is
24
1 a very good one. And I'm glad you've raised it. And
2 I think you've hit upon something the committee feels
3 very strongly about.
4 DR. LANDRIGAN: One more question. I --
5 this may go beyond the purview of your committee. And
6 if it is, you'll tell me. But we heard yesterday an
7 interesting point that I had not been previously been
8 aware of.
9 And that is that the Veterans
10 Administration doesn't compensate veterans for
11 service-related disease if the disease first becomes
12 manifest more than two years -- I don't know if it's
13 more than two years after discharge from the service,
14 or more than two years after the exposure has taken
15 place.
16 But in either event, it's an approach that
17 basically cuts off from consideration within the
18 workers comp. -- the VA compensation system -- any
19 disease with long latency.
20 This is an approach, of course, that some
21 state workers compensation systems used to have. And
22 most of them dropped it in the 1950's, recognizing
23 that diseases like the diseases caused by asbestos can
24 develop as long as decades after the exposure takes
25 place.
25
1 And I wondered if you folks had given any
2 consideration -- if either of the two committees had
3 given any consideration to that point.
4 DR. BURROW: Dr. Brix just informed me
5 that we believe it's two years after leaving the Gulf
6 for individuals with unexplained illness. I mean --
7 but our committee didn't really deal with that at all.
8 DR. KELSEY: And we are really not dealing
9 with compensation issues, although it's an interesting
10 point.
11 CHAIRPERSON LASHOF: Marguerite?
12 DR. KNOX: Was there any data related to
13 that about identifiable diseases that are diagnosed
14 after the two-year periods? Do you know anything
15 about that, patients who have diagnosable diseases
16 after the two years?
17 DR. BURROW: I have no information on it.
18 DR. KNOX: I wondered if there was --
19 after your recommendation to DOD --
20 DR. BURROW: I'm sorry. Dr. Brix just
21 said that we do not think there is any limit on that.
22 It was just for the unidentified diseases. I mean
23 that is our understanding. In other words, if you
24 have a specific label, then that time limit doesn't
25 hold.
26
1 DR. KNOX: Still, I think veterans are
2 having to prove that the disease was related. And
3 without any patterning and aggregating of certain
4 health diseases, that's very difficult to prove.
5 So I hope there will be some long-term
6 studies looking at patients who have been diagnosed
7 with neoplasias, either benign or malignant, that have
8 occurred in Gulf War Veterans. And I don't think that
9 we've really looked at that very well.
10 DR. BURROW: I feel like a puppet.
11 DR. KNOX: Sorry.
12 DR. BURROW: Both the DOD and the Veterans
13 Administration have information on that.
14 CHAIRPERSON LASHOF: I have no problem
15 with Kelley Brix and Diane Mundt also contributing and
16 speaking and not having to puppet through. We are
17 informal. And we certainly -- it's within our
18 protocol to -- please, I welcome Kelley and Diane to
19 freely speak for themselves.
20 Yes?
21 DR. BRIX: Dr. Knox, you said you were
22 interested in neoplastic activities in particular? I
23 believe that both the Department of Defense and the
24 Department of Veterans Affairs have data on both --
25 particularly this have malignant cancers.
27
1 And they have tables in their -- in the
2 materials that they passed out in the August 1st
3 report, as well as the DVA's most recent report has a
4 list of all the known patients diagnosed with cancer.
5 And all the different types.
6 DR. KNOX: Could you tell me if the exam -
7 - veterans who did not receive the recommended
8 Comprehensive Clinical Evaluation -- I guess, could
9 those veterans go back and have that comprehensive
10 evaluation? Those that did not receive it early on?
11 DR. BURROW: There are two kinds of
12 veterans: one, people who served in the Persian Gulf
13 and are still on active service, and others who have
14 been discharged. If they have been discharged, it
15 would be done through the Veterans Administration.
16 DR. KNOX: So it would be available, is
17 your understanding?
18 (No response.)
19 DR. KNOX: Could you tell me about the
20 environmental toxin, the serum assays that maybe were
21 recommended for that evaluation?
22 (No response.)
23 DR. KNOX: Were there any?
24 (No response.)
25 DR. KNOX: For instance, lead poisoning or
28
1 depleted uranium for those patients that complained of
2 that?
3 DR. KELSEY: Yes. We -- the issue of lead
4 and depleted uranium were both addressed in our first
5 report. And we're -- we recommended that, I think, a
6 little bit more work be done around those issues.
7 The lead levels that were initially drawn
8 clearly indicated that there needed to be some follow-
9 up, certainly of some individuals. And that was one
10 of our recommendations.
11 In addition, the depleted uranium issue
12 also left a small cohort, but albeit a defined cohort
13 that could be followed. And we recommended that as
14 well.
15 There is a serum bank -- that you referred
16 to serum. There is a serum bank. And obviously, this
17 can provide a resource for a lot of research. Areas
18 that we touched on where that might be useful include
19 leishmaniasis and other infectious disease. Exactly
20 what's ongoing at the moment, I think, is unclear to
21 me as I sit here. But I'm certain that that's a
22 resource that many people are thinking about.
23 DR. BURROW: Perhaps it's worth explaining
24 -- the initial in the program -- the initial -- if
25 somebody identifies himself and wants to be cared for,
29
1 that there is a physical -- this Phase I, the primary
2 care treatment, which is probably equivalent to a very
3 thorough executive physical.
4 If then things are identified in problems
5 or areas -- it is -- they are referred on to regional
6 centers where it's really case finding so that it is
7 not necessarily screening for every environmental
8 toxin.
9 But if there were evidence that the
10 individual might have lead poisoning or have a uranium
11 slug, it would be looked for. So it was really case
12 finding rather than screening.
13 CHAIRPERSON LASHOF: Dr. Hamburg?
14 DR. HAMBURG: I wonder whether there are
15 plans for a continuing role for the Institute of
16 Medicine in relation to the Gulf War health problems?
17 And if so, what the nature of that role is likely to
18 be?
19 DR. BURROW: As far as our committee is
20 concerned we are in negotiation with the Department of
21 Defense to continue our committee and we should know
22 then -- obviously by the end of -- that when it ends.
23 DR. HAMBURG: Thank you.
24 And the other committee?
25 DR. KELSEY: We're to issue our final
30
1 report in 1996. And at that point this committee will
2 be disbanded. With respect to other activities of the
3 Institute of Medicine -- Diane?
4 DR. MUNDT: None.
5 DR. KELSEY: As far as I know, there's
6 none planned.
7 DR. HAMBURG: I wonder if there has been
8 any consideration of the areas not covered in the
9 mandates given to the two committees? There've been
10 occasions when there has been concern that the IOM was
11 not really in a position to look into an important
12 problem because it didn't fall within the mandate of
13 either committee, implying that perhaps there should
14 be some new initiative or conceivably even a broad
15 gauge board to address these problems over the longer
16 term.
17 DR. BURROW: Well, I think in answer, I
18 mean, our study is really in response to a contract
19 with the Department of Defense so that we are limited
20 in those areas.
21 CHAIRPERSON LASHOF: Dr. Mundt?
22 DR. MUNDT: To my knowledge, there is no
23 information or no plans for such a board, although it
24 is an excellent idea.
25 DR. HAMBURG: Well, I raise the question
31
1 because it seems to me that this Committee is going to
2 have to think about the question of whether some kind
3 of independent scrutiny of the highest level of
4 objectivity and penetration can be created to go
5 beyond the life of this Committee.
6 These problems are not likely all to go
7 away any time soon. We heard about long latency
8 diseases and so on. I think we will have to address
9 that. And obviously the IOM is an institution that
10 comes to mind as suitable for that role.
11 I suspect -- at least while speaking for
12 myself, I think there will be a continuing need for
13 independent non-governmental scrutiny of the highest
14 caliber over an extended period of time. And that's
15 why I raise the question of an IOM board as one
16 possibility.
17 CHAIRPERSON LASHOF: Well, I would like to
18 ask Dr. Burrow -- the Comprehensive Clinical Protocol
19 Exam -- these are done at DOD facilities on active --
20 people who are still actively in service? Or, those
21 who have been discharged, the veterans who have been
22 discharged, are they included in this common protocol
23 or not?
24 DR. BURROW: No. They are not. I mean,
25 this is specifically a DOD protocol. And I meant to
32
1 correct something because I may have left that
2 impression -- is that if it's a veteran who has been
3 discharged, they could go to the VA hospital, but it
4 would not be part of the CCEP protocol.
5 DR. KNOX: So let me just say that of the
6 700,000 veterans who served in the Persian Gulf,
7 according to the data that they have given us in our
8 notebook, 587,000 have separated from the military.
9 So you are looking at a huge population that has
10 medical services unavailable to them.
11 CHAIRPERSON LASHOF: And it also raises
12 the question of the selection of this population being
13 those that are still on active duty when it is
14 somewhat logical that many of those that would be ill
15 have already left service. Can you tell me how
16 representative you feel this eventual 20,000 will be
17 of the total group that served in the Vietnam War?
18 DR. BURROW: Of the Persian Gulf --
19 CHAIRPERSON LASHOF: Of the -- sorry. The
20 Persian Gulf. Apologies.
21 DR. BURROW: I think that you raise the --
22 one of the issues that the committee raised when they
23 start making comparisons. I mean, this is a self-
24 selected group of individuals who have felt that they
25 -- who were on active duty and felt that they had
33
1 problems and called to do this.
2 So it is a self-selected sample. And it
3 makes it difficult in terms of what the control would
4 be. The issue of others -- I don't -- yes -- I'm
5 saying that the VA has a similar program, but that's
6 not the question.
7 CHAIRPERSON LASHOF: Well, that -- I'll
8 ask that question to accommodate Diane. In the VA
9 program, are they following the same protocol? And do
10 you have any information of where they are in theirs?
11 How many they have done and whether the data looks
12 similar or dissimilar?
13 DR. BRIX: Yes. There's a similar
14 protocol. And in fact, it is my understanding --
15 someone from the VA or the DOD should speak up if this
16 isn't correct -- is that they worked together to
17 develop the protocol that we have been examining for
18 the CCEP. And the VA has a similar protocol. They
19 even call their protocol Phase I and Phase II.
20 I think you heard yesterday something
21 about the Persian Gulf Registry Exam. That's also --
22 that's called Phase I. So they have a similar Phase
23 I. And there are many thousands of people who have
24 been through that program -- is my understanding.
25 They also have a Phase II. Only a small
34
1 handful have been through their Phase II as far as I
2 understand. But again, I'm not as familiar with the
3 VA program as the DOD program. But they are eligible
4 for care.
5 CHAIRPERSON LASHOF: Those that have gone
6 through the Phase I -- if this is beyond you we can
7 just ask staff to get us further information,
8 obviously, direct from VA -- does it appear similar
9 that the pattern of illness and symptom diagnoses --
10 similar among those that have gone through the VA
11 protocol to the DOD protocol?
12 DR. BURROW: I don't think we really know
13 enough to comment.
14 CHAIRPERSON LASHOF: Okay. Fine.
15 Dr. Custis?
16 DR. CUSTIS: I would like the Committee
17 not to be -- not to have the impression that the VA
18 healthcare system is a paper system. It's highly
19 automated. The patient treatment file is only one of
20 many computerized systems. The DHCP, the
21 Decentralized Hospital Computer Program got started
22 something like 30 years ago and today compares
23 favorably with the private medical sector as far as
24 computerized data is concerned.
25 CHAIRPERSON LASHOF: Do you have any
35
1 questions to --
2 DR. CUSTIS: I have no questions for the
3 panel.
4 CHAIRPERSON LASHOF: Dr. Caplan? Art?
5 DR. CAPLAN: I guess I would like to -- I
6 would like to get clearer about making sure that the
7 information that needs to be collected about this
8 problem is getting collected.
9 In some ways our charge is to make sure
10 that things are going well and that all that can be
11 done is being done to identify the nature of Gulf War
12 illness and problems, and set up infrastructure to do
13 things about it, both in the future and to compensate
14 those who may have been injured or become ill now.
15 And one of the things I find troubling is
16 this confusion that's broken out just over the past
17 couple of days about well, is there, is there not Gulf
18 War Syndrome?
19 And I'm looking at the response to the
20 report that you issued yesterday, the August 7th
21 report, in which you commented on the fact that there
22 was not enough evidence for the statement that there
23 was not unique illness or syndrome among Gulf War
24 Veterans.
25 My first question to you is: This report
36
1 appears to have come out after you saw an earlier
2 draft. Could you have seen a second draft? Is there
3 some reason you didn't see that before this one came
4 out? What led you to have to comment after the fact
5 on this second version of the DOD report?
6 DR. BURROW: Our comments were directed to
7 the first version. And the DOD -- I can be corrected
8 by the people next to me -- wanted their report -- I
9 mean, it was a contract -- early so that they would
10 have this -- so that we did not see the second report.
11 And the IOM has a review process it goes
12 through so that, in fact, the IOM by the time we had
13 issued our report, they had already issued the second
14 report without either of us seeing the issue. Is that
15 --
16 CHAIRPERSON LASHOF: John?
17 DR. CAPLAN: I --
18 CHAIRPERSON LASHOF: Oh, I'm sorry. If
19 you have another question, please, Art?
20 DR. CAPLAN: Is there a need then to make
21 sure that that sort of situation is rectified? In
22 other words, if we'd had an advisory board out there
23 trying to watch the protocol, and we're getting
24 announcements that X doesn't exist, and then we have
25 to have retractions that say well, maybe X exists.
37
1 And there are various methodological
2 reasons to think that X might exist, that doesn't seem
3 to be an optimal situation.
4 DR. BURROW: I think for an ethicist
5 that's a fair statement.
6 (Laughter.)
7 DR. BURROW: Let me go on and add. I
8 mean, you are reading the first sentence that was
9 lifted out of the paper. I mean, we do go on in that
10 report to say that if there were, as I mentioned
11 earlier -- as I said, a disability with a high
12 proportion of veterans at risk, it would probably be
13 detectable.
14 I mean, it was the need to couch the
15 statement that the DOD -- in some terms that would
16 leave it open. And it would certainly have been
17 better to be able to work that out because I think a
18 lot of it was simply a matter of wording.
19 DR. CAPLAN: Let me just ask one more
20 question about the protocol because this is important.
21 Again we want to make sure that people are clear. I
22 think we owe it to the veterans and to all Americans
23 that we not give impressions that are false about what
24 does or doesn't exist with respect to the illness and
25 the disease.
38
1 And it plays to my philosophy interest a
2 bit. We've got claims we made about who is ill,
3 what's a syndrome, what's a disease, what's a cluster
4 of diseases. And all of these things swirl around
5 this thing called Gulf War Syndrome which is a lot of
6 things -- a lot of balls up in the air.
7 My question is: When you looked at this
8 protocol, in particular the Defense Department one,
9 we've heard one comment that it may be a sampling
10 problem to talk about Gulf War Syndrome in general.
11 We want to be careful that we always
12 qualify that and say on active military. There
13 doesn't appear to be a description adequate to say we
14 have a single disease going on.
15 But what I am asking is: Are you
16 confident, even within that protocol for the active
17 military personnel, that the reporting by soldiers --
18 they're going to feel comfortable identifying
19 themselves to go in for the physicals?
20 Are you satisfied that the comparison
21 group that was used was adequate? In other words, can
22 you tell us a little bit more -- I don't mean for you
23 to rehash the whole report -- might be improved upon
24 in terms of methods for this DOD study?
25 DR. BURROW: Well, it would have been at
39
1 the beginning to really have a comparable control
2 study. And I tried to -- we emphasized in the report
3 and the committee felt that -- we felt that in terms
4 of case finding, I mean, a responsibility to take care
5 of individuals who had reported themselves not well,
6 if you will, who had been on active duty -- that the
7 Department of Defense had merely set up a system of
8 good quality controls and delivering the best possible
9 care in an attempt to make a diagnosis of specific
10 diseases.
11 Where one gets into less firm ground --
12 and I think the questions that our co-committee talks
13 about when you talk about the comparison groups
14 because then you have to decide who are these
15 comparison groups.
16 And I think one has to look at this as a
17 protocol primarily to deliver care to that group of
18 individuals. Hopefully that answers some of the
19 things you've mentioned.
20 CHAIRPERSON LASHOF: John?
21 DR. BALDESCHWIELER: I think it's
22 important to bear in mind that -- the potential for
23 causative factors that perhaps have not yet been
24 identified. And typically in assays that one performs
25 you only find those things that you look for.
40
1 That is, with the extremely sensitive
2 types of immune assays, for example, you only find
3 those things that you choose to look for. So it's
4 crucial, it seems to me -- the process of postulating
5 potential things to look for is a crucial part of the
6 process.
7 Do you have some thoughts as to how one
8 composes the list of things to look for? Or how well
9 that has been done in fact in this search?
10 DR. KELSEY: Well, I think that's well
11 put. And one of the goals of our work is to look
12 exactly at how questions are asked. Because as you
13 say, you only find what you look for.
14 If you look well, you are likely to find
15 the things that can be repeated and the things that we
16 want to be concerned about. If you do a poor job of
17 looking, you are likely to find things that may not be
18 so important to go after.
19 So I think one of our real concerns, and
20 in particular, one of the motivations for issuing a
21 first report was to stress that people think very hard
22 about how they are going to look.
23 We were impressed with the poor job, if
24 you will, that had been done with coordination and
25 with initial research. And this is why we felt the
41
1 pressing need to issue some recommendations for
2 ongoing work.
3 And I think your questions are good ones.
4 And they are ones that we are very concerned with.
5 And our committee has tried to cast the net broadly.
6 But the mandate is really about the health
7 consequences of the war. And I don't know if you can
8 get any broader than that.
9 So we're -- we're trying to cast the net
10 broadly and begin by really hoping that as research
11 goes forward the quality can be maintained so that, in
12 fact, we can really uncover that which we need to
13 follow up.
14 DR. BURROW: I would just simply say that
15 -- to go back to my earlier statement -- that it's
16 easier to find a disease that is there than a disease
17 that isn't there. And part of the issue that Dr.
18 Caplan is raising is exactly this question.
19 I mean, can we say that there isn't
20 something there that we haven't found. No. And so --
21 that we haven't been able to find it with as complete
22 a study as, I think, that they could do. That needs
23 to remain an open question. And it's part of the
24 research.
25 DR. BALDESCHWIELER: But quite
42
1 specifically, does there exist an operational list of
2 things that are being tested for? And what's on that
3 list? I mean, a list of pathogens? Of potential
4 environmental factors?
5 DR. BURROW: No. Let me repeat that this
6 was self-reported individuals who said they were
7 unwell, who had an initial screening, a very thorough
8 screening. And if one could not make a diagnosis,
9 they were referred on in that at that time it was case
10 finding.
11 In other words, if they complained of
12 musculoskeletal disease, that they were thoroughly
13 evaluated for anything that was wrong in the
14 musculoskeletal system. There was not a screening of
15 any -- of the whole panel of pathogens or viruses or
16 environmental toxins.
17 DR. CAPLAN: But what -- would that be a
18 useful component of a future program?
19 DR. BURROW: I think it would be a better
20 -- part of a research program, I mean, set up to
21 specifically screen, looking for this unit
22 identification. There a number of ways of getting at
23 this.
24 DR. BRIX: I could add one thing about the
25 way the CCEP is designed. In the referral phase, if
43
1 the person has not been able to reach a diagnosis by
2 the time they have gone through the initial
3 examination, they go to a regional medical center.
4 And there is a set of tests that is
5 mandated for a variety of symptoms. And those
6 symptoms were chosen because they are the types of
7 symptoms that people are frequently complaining of.
8 So, for example, for fatigue there is a
9 list of mandated tests that anybody who goes through
10 the regional medical center, who has fatigue gets
11 those tests and those specialty -- subspecialty
12 consultations.
13 Likewise, if a person has headaches, they
14 get a mandated neurological consultation and a CAT
15 scan of the head and so on. So there is a protocol
16 that's laid out very specifically for those symptoms
17 that are very common in this group.
18 CHAIRPERSON LASHOF: Further follow-up
19 questions?
20 DR. LARSON: Yes. A follow-up question.
21 Really, I don't know if there is anybody on the panel
22 who can answer this, maybe Dr. Stoto or somebody from
23 the Institute of Medicine in the audience.
24 From Dr. Hamburg's question, the Institute
25 of Medicine for years has been the repository of the
44
1 data base called the Medical Follow-up Study, which
2 includes data from several wars. I think from World
3 War II, the Korean Conflict, Vietnam.
4 And I think there are some limitations, as
5 I understand it. In the past it has been a data base
6 of primarily, if not completely, white males.
7 And given that that's fixed, and that the
8 data base is expanded to be more representative of who
9 is in the wars, is that a potential source of -- or a
10 repository for data on the Persian Gulf Conflict that
11 could be used for long-term follow-up?
12 I'm not even sure what's in that data
13 base. Maybe you could give us some information.
14 DR. MUNDT: We -- I am, in fact, staff in
15 the medical follow-up agency. We do studies in
16 veteran populations on cohorts of data that have been
17 assembled over the years for various purposes.
18 And you are correct. They are primarily
19 in white male veterans. There are projects being
20 conducted in atomic veterans and in veterans exposed
21 to microwaves, etc.
22 The cohorts are formed primarily to do a
23 specific study.
24 There are several hundred cohorts. We
25 have no cohort data related to Persian Gulf Veterans
45
1 and Persian Gulf service at this point in time.
2 DR. LARSON: But you could?
3 DR. MUNDT: Potentially, yes.
4 CHAIRPERSON LASHOF: David?
5 DR. HAMBURG: I want to ask about the
6 possibilities for a beneficial interplay between IOM
7 committees and the government agencies, particularly
8 the DOD. In part, my question articulates with what
9 Arthur Caplan raised a few minutes ago.
10 The question is on the one hand
11 stimulation by IOM committees -- for the committees
12 from the agencies that have problems and bring the
13 problems to the IOM and say please help us figure this
14 out.
15 But on the other hand particularly
16 focusing on the feedback from the IOM committees to,
17 let's say, the Department of Defense, not only with
18 respect to procedure as we heard -- is this curious
19 disjunction in procedure in the past couple of months
20 about the latest version of the DOD report, which I
21 find puzzling and troubling frankly, but putting that
22 to one side -- substantive issues, for example, in
23 your report, Dr. Burrow, your very interesting report,
24 on page 13 and 14, committee comments having to do
25 with the likely -- say that it's likely that at least
46
1 a few CCEP patients have developed illnesses that are
2 directly related to their Persian Gulf Service.
3 And it gives some categories. And your
4 third category is psychological stress during or
5 immediately after the war.
6 And you go on to say the basis for
7 research in many fields, of course -- it's important
8 to understand that such stressors produce adverse
9 psychological and physical effects that are as real
10 and as potentially devastating as chemical or
11 biological stressors.
12 And you comment that the psychological
13 stressors of the Persian Gulf war have been
14 insufficiently examined by the DOD. That seems to me
15 a very important issue, a very constructive suggestion
16 that you make.
17 There is by now a vast body of research on
18 the biology and psychology and severe stress that it
19 appears not to have been adequately taken into account
20 recently. Although I may say the DOD has a
21 distinguished tradition of research in this field.
22 For example, the Walter Reed Army
23 Institute of Research going back to the 1950's. But
24 it seems to me that's an example. There are other
25 examples in here of a possible connection between the
47
1 IOM's work and the DOD.
2 Is it possible in real time to give them
3 feedback perhaps in more depth beyond the printed page
4 that would help the DOD to address the stress problem
5 or other currently neglected problems that are really
6 salient and should be addressed?
7 DR. BURROW: I think a great deal of that
8 interchange went on at our committee meetings, which
9 really involved interacting with the physicians that
10 were carrying out the program and a number of
11 individuals from Walter Reed and -- specifically in
12 regard to psychological stressors.
13 So I think that this is going on. I mean,
14 the committee disjunction, if you will, or committee
15 report disjunctions, needs to be resolved.
16 But I think that my -- a personal comment
17 -- that they were trying very hard to look for
18 physical causes and to attempt not to focus as
19 strongly on the psychological stressors though they
20 were aware that those were there.
21 CHAIRPERSON LASHOF: I'd like to ask Dr.
22 Kelsey whether -- we heard yesterday that there a
23 number of different epidemiologic studies going on.
24 And we did quiz the panel as to the comparability of
25 those different studies and the ability to pool the
48
1 data from all of them.
2 Certainly you've been looking at that
3 issue and at the whole -- how scientific and solid the
4 epidemiology is. I wonder if you would comment upon
5 that, and how you feel about the fact that there are
6 multiple epidemiologic studies, and how comparable
7 they are, and how well that agencies are really
8 working together to make them more comparable.
9 DR. KELSEY: Well my -- chiefly what I
10 would say is we've been provided protocols for many of
11 the ongoing studies. And we're looking at the
12 questions that they specifically want to ask.
13 It's obviously part of our mandate. And
14 I think we've urged that these things be done in a
15 coordinated fashion, subject to peer review. And I
16 think that issue is important.
17 And it's something we look at. And
18 obviously something very important for you to look at.
19 Beyond that I don't think I can comment on specifics.
20 CHAIRPERSON LASHOF: I guess part of my
21 question is: You made a series of recommendations.
22 And we clearly are going to have to look at whether
23 your recommendations are being followed. And if you
24 have any insights or ideas at this point about how
25 well -- or any suggestions for us as we look at that,
49
1 it would be helpful.
2 DR. KELSEY: Sure. And I think we'd be
3 happy to be in contact with the committee at any point
4 as well. For us, obviously, it's an ongoing process.
5 And it's -- those questions are very important. And
6 we are actively searching for and asking for protocols
7 and any information that you can provide.
8 And I think the presence of this Committee
9 has made a lot of information available to us more
10 rapidly than it might otherwise have. So it's been
11 useful for us as well. But I think that Dr. Mundt
12 would be happy to provide anything that we have that
13 you can use.
14 CHAIRPERSON LASHOF: Thank you.
15 Elaine?
16 DR. LARSON: It's pretty safe to say, I
17 think, that the resulting -- could be acute
18 musculoskeletal disease, stress, and infectious
19 disease from the indigenous area.
20 That's pretty safe. And that is part of
21 any war. What's missing here is any specific comment
22 about the testimony that we heard yesterday related to
23 autoimmune symptoms and immune dysfunctions of various
24 sorts. And I assume that's what some people refer to
25 as the Gulf War Syndrome.
50
1 You haven't commented that in your report.
2 Did you hear testimony on that? Did you see evidence
3 that that's being examined or looked for?
4 DR. BURROW: Well, I can only go back and
5 repeat that the people who had complaints -- and they
6 are listed -- were examined and if not satisfied by
7 the physician, were again looked at.
8 And what came out were specific diagnoses
9 and not large numbers of any particular autoimmune
10 disease or anything else. So the -- that in that
11 structure, nothing of this sort surfaced in any number
12 that was different than one would expect.
13 And by saying that, let me say there were
14 people who had lupus arimethrotosis, but may have had
15 it before. I mean, if you examine that many people,
16 you are going to get people with illnesses. But there
17 wasn't anything that was particularly out of the
18 ordinary.
19 CHAIRPERSON LASHOF: Dr. Custis?
20 DR. CUSTIS: In connection with Dr.
21 Lashof's question, I wonder, Dr. Mundt, would you
22 repeat your definition of the term "coordinated
23 effort?"
24 DR. MUNDT: I think that the term
25 "coordination" is something that our committee
51
1 discussed at length. And I believe that the committee
2 has looked at coordination in terms of coordinate the
3 activities and the interactions and the participation
4 of the various agencies on particular projects.
5 The word "coordination" -- it's become our
6 understanding -- relates more to the knowledge of or
7 the awareness of various activities. So I think that
8 the word "coordination" may need to be defined
9 explicitly, both in terms of how our committee
10 understands its use as well as how the various groups
11 that we are dealing with are defining the word
12 "coordination."
13 CHAIRPERSON LASHOF: Would it be correct
14 to say that we are talking about coordination and not
15 integration, and maybe we need some more integration
16 of the efforts? Or not?
17 DR. MUNDT: That's really not my place to
18 answer.
19 CHAIRPERSON LASHOF: That's our job, I
20 guess.
21 Any further questions for the --
22 Yes? Phil?
23 DR. LANDRIGAN: Karl -- for Dr. Kelsey --
24 Karl, on page 12 of your report you make the very
25 sensible recommendation that the VA and the DOD should
52
1 determine the specific research questions that need to
2 be answered and should develop methodologies etc. to
3 pursue those questions.
4 It sort of follows up on Dr.
5 Baldeschwieler's question. Have you given any thought
6 to what additional items ought to be on the list?
7 We've obviously heard about some: depleted uranium,
8 leishmaniasis, lead. Any others that you would like
9 to offer specifically?
10 DR. KELSEY: Well, I can comment that I
11 think our mandate is broad. And so that this second
12 report will be much broader than the first. This
13 really was an attempt to direct hypothesis-driven work
14 in the interim. And to the extent that we've done
15 that, we've accomplished our goal with that report.
16 I can -- I can't give you specifics other
17 than to tell you that clearly our second report will
18 be much more broad and address other health
19 consequences.
20 DR. LANDRIGAN: Yes. We learned yesterday
21 that there were -- there either has started or will
22 shortly be starting in the state of Iowa an
23 examination of 3,000 veterans, half of whom were
24 deployed in combat areas, and half of whom were in the
25 service at the same time, but not in combat areas.
53
1 And it seems like a nice start in that
2 direction. It would also be good, though, if that
3 effort were energized by specific hypotheses before it
4 began in fact.
5 CHAIRPERSON LASHOF: Other --
6 DR. KNOX: I just have one more question
7 as to whether you made a recommendation, maybe, about
8 the predeployment physical, now that you've looked at
9 exit physicals from being deployed?
10 DR. BURROW: Well, I think actually it's
11 an -- if I understand the question -- it's an
12 interesting -- because clearly, I mean, there was a
13 war going on. And it's a bad way to set up an
14 experiment.
15 But if, in fact, one really thought about
16 this kind of thing before going in, there were ways in
17 terms of unit identification -- who got vaccinated,
18 when, medications that would be enormously helpful
19 later. So I think that's an area of interest. We
20 have not dealt with that. But it certainly is an
21 area.
22 DR. KNOX: One of the problems that I
23 recognize -- when you look at this study and you look
24 at the number of illnesses that the reserve components
25 complained about, their physicals on active duty
54
1 reserve are only every four to five years unless they
2 are over the age of 40. So that may be some of the
3 reason for the increased number of illnesses in that
4 group.
5 DR. BURROW: Very good.
6 CHAIRPERSON LASHOF: Art?
7 DR. CAPLAN: This is for Dr. Kelsey. In
8 your sort of overall examination of the issues -- one
9 of the things that came up yesterday in the testimony
10 we heard is that people face tremendous problems if
11 they are discharged in terms of insurance coverage and
12 follow-up.
13 I just had two questions for you. One,
14 are you looking at all at the ability of the
15 investigators to protect subject privacy and
16 confidentiality in the various inquiries that are
17 being made?
18 And, two, are they doing a good job
19 warning people about what may happen to them if they
20 get identified as having a problem or syndrome or
21 chronic condition that -- at discharge.
22 In other words, are they -- can you make
23 some recommendations not only about what's there, but
24 about the protection of the subjects of the
25 populations that are involved in some of these studies
55
1 since there clearly are consequences that aren't
2 always beneficial if you are identified as being ill?
3 DR. KELSEY: An excellent point. The
4 overarching fragmentation of healthcare really does
5 not lend itself to endeavors like the epidemiologic
6 examination of this cohort of 700,000. And I think
7 insurance is but one of the many enormous problems.
8 We have discussed at length -- and there
9 is -- it's obviously important both for the individual
10 patient and for caregiving, as well as for data
11 gathering and integration of the resources so the
12 economics of healthcare play a very big role here.
13 In addition -- and that's from our
14 standpoint. It will come out in the report because
15 that's a very important part of this. The other issue
16 of informed consent, if you will, for participating in
17 studies is a concern. And it's one that we have to
18 take into account when we advocate linking records.
19 It's, as you know, a complex problem. At
20 this point, I think we are advocating linking medical
21 records and then dealing with these problems in the
22 way that epidemiologists deal with medical records.
23 That's, I think, the model. And that's what, at this
24 point, we are really thinking about.
25 Going beyond that would require,
56
1 certainly, a rethinking of how one deals with this
2 data because it is a massive data base. And to the
3 extent that a massive data base is being put together
4 with identifiers, that's a critical question.
5 And it's further a critical question when
6 you deal also with the armed services because their
7 confidentiality has an entirely different meaning. So
8 I think your point is a good one. It's one that we
9 have thought a lot about. It certainly will be in our
10 report.
11 CHAIRPERSON LASHOF: Are there any other
12 questions?
13 (No response.)
14 CHAIRPERSON LASHOF: If not, I want to
15 thank you all very much. This has been helpful. And
16 there is no question that we will be in touch. And
17 our staff will be working closely with Kelley and
18 Diane. And any further suggestions you have for our
19 work are certainly welcome. Thank you very much.
20 The committee would like to take a stretch
21 just right here just for a couple minutes.
22 (Whereupon, the proceedings went off the
23 record at 10:14 a.m. and went back on the
24 record at 10:22 a.m.)
25 CHAIRPERSON LASHOF: Can I ask the
57
1 Committee to take their places again?
2 Well, I think we've had a very thorough
3 briefing now for a day and a half. Now we have to
4 face that task of deciding just what our job is and
5 how we are going to do it. And develop some type of
6 time line for accomplishing our goal.
7 What I'd like to do is start first with a
8 discussion of the elements of the charter. Each of us
9 has reviewed the charter ourselves. And each of us
10 discussed it at the time we agreed to serve on this
11 Committee.
12 But we haven't had a chance to discuss it
13 as a Committee, as a whole, and make sure that we all
14 interpret the charter in the same way. Or, if we have
15 differences in views about the charter and our
16 responsibilities, we need to air those and hopefully
17 reach a consensus as to what we need do.
18 If you'll turn in your briefing book to
19 tab B -- the charter is in tab B. And we might all
20 just take a look at it at this point. I think item C
21 is clearly where we are at, at which the duties of the
22 Committee are solely advisory. That, I think we all
23 understand.
24 We have no implementing authority. But I
25 think the weight of our advice -- it will carry a
58
1 great deal of weight. Let me put it that way. I
2 think there is no question that the President, the
3 First Lady, the heads of the departments, are looking
4 to us for advice. And I think they will be
5 responsive.
6 The areas at which we are supposed to look
7 are the research, which we have heard a fair amount
8 about this morning; the coordination efforts we also
9 discussed briefly and again this morning.
10 We are to look at medical treatment. In
11 that regard we have heard primarily from the veterans
12 and their families. We are to look at the outreach
13 issues, which we have had some brief questions about
14 and have been touched on.
15 And we are to look at the external reviews
16 and the -- which really refer to the IOM and others
17 and whether those have been implemented. Look at the
18 NIH reviews and the Health Technology Assessment
19 reviews.
20 We are to look at what possible risk
21 factors. We are again to look at the question of
22 chemical and biological weapons. My view of how we
23 look at those -- well, how we look at them will be the
24 subject of our major discussion.
25 I think that really covers a broad range
59
1 and leaves out only one thing. And I think it's
2 important to note what it does leave out. And it
3 leaves out the issue of compensation. It is not the
4 responsibility of this Committee to look at issues of
5 compensation.
6 And it's also my understanding of the
7 charge that as we look at each of these issues, we
8 will not be undertaking any new research. But rather,
9 we will be reviewing everything that is ongoing and
10 make recommendations about new research.
11 But within a year and a half, which is the
12 life of our Committee, it's clear that we could not
13 launch new research activities in the traditional
14 sense of research.
15 Digging into and researching what has been
16 done in that sense of research is obviously
17 appropriate. Listening and hearing and asking
18 questions and searching, rather than researching, may
19 be the way to put it. Well, that's enough said from
20 me.
21 Let me ask any of the members of this
22 group to raise any questions, feelings, their
23 interpretations of the charter itself.
24 Elaine?
25 DR. LARSON: Two comments. First of all,
60
1 it -- one of the other things that is missing is any
2 consideration about the sort of, if you will, ethical
3 or social implications of all this and whether there
4 are processes in terms of the way people were handled
5 or treated that need to be considered. And we might
6 want to talk a little bit about whether we are
7 interested in making any comments about that.
8 Secondly, obviously, we were reminded
9 several times yesterday that we are the fifth group --
10 and there is a clear mood of discouragement if not
11 questioning about whether any of these are going to be
12 that useful.
13 The first thing we've got to do is make
14 some kind of a chart and figure out who has done what
15 in each of these areas, collect the information,
16 collect the committee reports. That's a staff
17 function.
18 We have some of them. I don't think we
19 have all of the information. And then see where it is
20 that we really can have an oversight function and make
21 some statements that will be of benefit.
22 CHAIRPERSON LASHOF: That's correct.
23 Others?
24 Art?
25 DR. CAPLAN: One of the things that has
61
1 come up a bit in our somewhat sparse comments -- but
2 it's probably the time to bring it up now -- is I
3 think it's not clear to me, although I know which way
4 I lean about this, that it's part of our mandate to
5 make suggestions about what Phil was talking about
6 earlier, the future deployments, repeating the same
7 problems in that we may want to say things about
8 either research or structure or infrastructure that
9 needs to be said.
10 And I lean toward thinking that that would
11 be important and should be part of what we are up to.
12 But it's not clear to me as I look at this that
13 anybody asked, so to speak.
14 CHAIRPERSON LASHOF: I think I can respond
15 to that in the positive. In my discussions with the
16 National Security Council and the representatives of
17 the Agency in assuming this role, that was one of the
18 things that was stressed, that they do look to us to
19 make recommendations as to how future issues of this
20 kind can be addressed so that we don't find ourselves
21 in this situation this long after a deployment of
22 troops.
23 Are there any other questions that come to
24 mind on the Committee on just reading the charter
25 itself and understanding what our responsibilities
62
1 are?
2 (No response.)
3 CHAIRPERSON LASHOF: I suspect there is
4 just one other thing that needs to be said to that.
5 And it's only fair to the veterans that they
6 understand that. We heard so much yesterday of their
7 need to have answers.
8 We are not in a position, probably, to
9 give a definitive answer for all people's individual
10 problems at the end of this time. What we hope we
11 will be able to do is to say whether or not the
12 studies that are ongoing will provide those definitive
13 answers.
14 If studies that are ongoing during the
15 course of our time give us answers, we certainly will
16 act on that and state that. But epidemiologic studies
17 take time. And what we must be sure of, I think, is
18 that everything that should be done is being done.
19 Everything that can be done is being done.
20 And if not, to identify those and
21 recommend that they be done. That is, I think, our
22 final goal. And we need to be clear to ourselves and
23 to the community at large that that's our goal.
24 Phil?
25 DR. LANDRIGAN: Yes. I think in that
63
1 vein, we heard testimony yesterday from many veterans,
2 their families, members of veterans' groups, laying
3 out a long series of diseases and syndromes and
4 symptoms that are bothering them.
5 And we saw a similar list up on the slide
6 a while ago during the IOM presentation. It behooves
7 us to look very carefully at that list and look at the
8 minutes that will be provided us to make sure that
9 we've got all the details of the testimony that was
10 presented.
11 And make sure, as you say, that each of
12 these points is being addressed, at least to the
13 extent it can be, by either the various committees
14 that are already going on, the various studies that
15 are underway.
16 And if they are not, it -- I think it's
17 our job to make suggestions as to how any gaps can be
18 filled so that, indeed, no stone is unturned.
19 CHAIRPERSON LASHOF: All right.
20 Art?
21 DR. CAPLAN: Just following up on the
22 issue of coming up with the answers.
23 I think you put it very well, Madam Chair,
24 about our inability to answer some of these questions,
25 that it's going to have to fall to those actually
64
1 doing the studies to answer some questions.
2 But we did hear yesterday as part of the
3 testimony claims about difficulties in getting
4 physicals, chilling effect if one reported complaints,
5 problems about fears of retribution, and what happened
6 in terms of loss of benefits or coverage for people
7 who are discharged and so forth.
8 And I think it might be appropriate for us
9 not again to try and solve every problem and
10 difficulty that has come up, but at least to look at,
11 again, structural means as part of the research to see
12 that those sorts of things -- what's going on and what
13 could be done to attend to some of that as well. Not
14 just, in other words, the biology, but some of these
15 administrative problems that we hear about.
16 CHAIRPERSON LASHOF: Andrea?
17 DR. TAYLOR: I guess I wanted to follow up
18 with that as far as active duty versus those who have
19 been discharged who are no longer in service --
20 whether they are receiving the help that they need.
21 And I guess that was we heard over and over again. We
22 definitely have to address that.
23 CHAIRPERSON LASHOF: I think the last
24 couple of remarks lead us right into the next things
25 I wanted to take up as we run through, which is a
65
1 discussion of our first day and what issues came out
2 that we feel are burning that we need to look at.
3 But before I move on to that, let me ask
4 whether there are any other questions or
5 interpretations of the charter that anyone wants to
6 make any further comments on before we move into --
7 what I planned to do was -- the structure of our
8 discussion this morning will be around, after the
9 charter, to discuss the first day and what things came
10 out and then to go systematically through what the
11 thrust of our report will eventually look like.
12 How we are going to go about -- staff,
13 what kind of staff we are going to need, and then how
14 the Committee and staff are going to function. What
15 will be staff functions, what kinds of things the
16 Committee is going to have to address as a Committee,
17 a whole, and some of the operational issues.
18 And we -- I think that will follow
19 naturally from this discussion.
20 Anybody have any other suggestions about
21 how we go about this task at this point?
22 (No response.)
23 CHAIRPERSON LASHOF: Okay. If not, then
24 let's launch into further discussion of issues that
25 people feel came up yesterday that they want to
66
1 explore further, either by getting staff to get
2 further information, or by further testimony at future
3 times. Whatever.
4 Andrea?
5 DR. TAYLOR: I wrote down a few things.
6 I've heard a lot of information regarding chemical
7 environmental exposure, or some. I am interested --
8 one of the persons who testified yesterday talked
9 about the kerosene exposure, kerosene use.
10 So I am really interested in following up
11 on that as far as the contents of kerosene, what was
12 being actually used at the point -- in the tents for
13 heating -- whether that had any effect, along with
14 some of the other issues around, the chemical warning
15 signals that constantly went off.
16 And although we've been told that there
17 was no chemical warfare, then why would the chemical
18 warning signals go off and react? And people would be
19 asked to don their equipment as well as take the
20 tablets, the nerve tablets?
21 And that's something that I think we have
22 to investigate further, to make sure that the correct
23 studies are being done.
24 The other thing that came up -- and I am
25 sure we've talked about it before -- is the mycoplasma
67
1 incognitas. I think that's the name that we heard.
2 I've never heard of that before.
3 And I think we need some more background
4 information on that illness or disease. Actually what
5 it is. Who is getting it. How many people are
6 affected. And I think that's what I have. And also
7 the inoculations, whether that had any impact. And we
8 have had a lot of researching done on that.
9 CHAIRPERSON LASHOF: Rolando?
10 DR. RIOS: That's one of the issues that
11 came up to me yesterday -- that loomed in my mind
12 yesterday -- is to try to establish the facts, what
13 actually happened, what kind of elements were the
14 troops actually exposed to.
15 And I think that a significant part of our
16 report should be where we address every claim and what
17 the government's response to it is. We have some
18 pretty important group made up of citizens that
19 believe that the Department is hiding something or --
20 there is this kind of suspicion that is -- I think
21 there is a broad perception that it's difficult to
22 imagine that all this happened over there and that
23 there was no exposure to chemical war agents.
24 And I think that's why people are worrying
25 that there must be something going on here, but the
68
1 government doesn't want to tell us.
2 I do think that an important part of our
3 report must address each claim and what the response
4 of the government is, and what we have been able to
5 determine -- whether or not we agree or whether or not
6 we disagree, or whether or not we, you know, we can't
7 conclude one way or the other.
8 So we've got to address the issue of what
9 are the facts, what were they exposed to. Were
10 chemical war agents there? The government has agreed
11 that they inoculated everybody. So we know that they
12 were exposed to that.
13 We all know that there was a lot of
14 kerosene, a lot of the fires from the wells. That's
15 there. Those are facts that they admit to. So I
16 think that we do need to focus on what we can conclude
17 insofar as what our troops were exposed to.
18 And I think that's going to be an
19 important part because it underlines a lot of the
20 suspicions that people have about what the government
21 is saying these days.
22 CHAIRPERSON LASHOF: Andrea?
23 DR. TAYLOR: I just thought of one other
24 thing regarding the chemical warning signals. We need
25 to know what kind of equipment was used, what was the
69
1 actual equipment, why it -- that was the one thing
2 that I wanted to ask.
3 CHAIRPERSON LASHOF: Elaine?
4 DR. LARSON: Well, first I have to make a
5 comment about the signals going off. That -- it
6 doesn't bother me as much as I think it does other
7 people.
8 And that's probably because in the past,
9 as a nurse I worked in critical care units where
10 monitors are always going off because you have them
11 set so that they go off for muscle movement and
12 everything else just so that you will check.
13 And it's very common in healthcare that
14 you have monitors for everything, EKG's and I.V.
15 lines. And they're buzzing and sort of burping all
16 the time. But anyway, it is something.
17 I think the main thing, again, is that
18 we've got to get the facts straight. Yesterday we
19 heard conflicting information. I don't know what's
20 true. There are some things that we can determine are
21 true, and not true.
22 And I think we may need some more hearings
23 specifically about the infectious diseases, the
24 microsporidium, the mycoplasma. And leishmaniasis,
25 and Q fever to a lesser extent because those are
70
1 expected. And those are endemic in the area. But
2 particularly the new things.
3 We may need some expert help in addition
4 to what's on the panel with the chemical exposures and
5 what the implications of that are. What people were
6 actually exposed to and what the implications are. I
7 think we need some expert help with the vaccine and
8 the potential for the kinds of side effects or that as
9 an exposure.
10 And then we need someone to give us more
11 information about teratogenicity and some of the
12 congenital issues that came up yesterday. That
13 factual information we need.
14 Lastly, I think we need to know what's
15 actually lost and what -- by virtue of whatever you
16 want to call it, inefficiency or whatever -- versus
17 what is available in terms of data on who got what.
18 And we may, again, want to make some
19 recommendations on what data need to be kept in the
20 future for long-term follow-up.
21 CHAIRPERSON LASHOF: Phil?
22 DR. LANDRIGAN: No.
23 CHAIRPERSON LASHOF: Any further comments
24 from yesterday?
25 Marguerite?
71
1 DR. KNOX: I just have a couple of things.
2 I think it's very important, again, that we look at
3 the predeployment physical that veterans have,
4 especially for the Reserve and Guard components.
5 Active duty army has a physical every
6 year. But that's not so. And I think some of the
7 that patients we saw with GI bleeds and myocardial
8 infarcts during the war were because people were not
9 screened well. They really were not physically fit.
10 The other thing is I want to comment on
11 the VA system. I think for the largest healthcare
12 system available, that it is a very good one. VA
13 employees do their very best to meet the needs of
14 veterans. But because of federal funding, it is
15 difficult.
16 I will admit that the VA has problems with
17 records because of the transfer from one facility to
18 the other. And that might be something that we could
19 address to the VA for an administrative purpose.
20 CHAIRPERSON LASHOF: Thank you.
21 David?
22 DR. HAMBURG: Well, our colleagues have
23 already raised a whole series of major questions that
24 came up yesterday that we should clarify. I certainly
25 agree that getting the facts straight is the most
72
1 important task we have.
2 I have to say, having been through many
3 similar exercises on other subjects, that it's easy to
4 say and very hard to do. It's very complex. We heard
5 yesterday vivid and poignant and moving accounts of
6 the suffering and the concerns and hope for our
7 veterans and their families.
8 And we have to take those very seriously
9 into account, do everything in our power to see to it
10 that those are matched up with the best available
11 scientific and professional resources of the country.
12 And that will be our ongoing and fundamental task.
13 But it is hard to do. I think we mustn't
14 be presumptuous. That is, the extent to which we can
15 mobilize the capacity throughout the country will be
16 very important. How much we an do ourselves, a
17 relatively small group -- and these issues are very
18 complicated.
19 We will need to think not only about our
20 own staff, about our own members, but I think -- how
21 do we get, for example, people who are doing the best
22 ongoing research on these thorny questions, either