UNITED STATES OF AMERICA
PRESIDENTIAL ADVISORY COMMITTEE
ON GULF WAR VETERANS' ILLNESSES
January 31, 1996
5 PRESIDENTIAL ADVISORY COMMITTEE
6 ON THE GULF WAR VETERANS' ILLNESSES
2 JOYCE C. LASHOF, M.D.
3 School of Public Health
University of California, Berkeley 4
5 JOHN BALDESCHWIELER, Ph.D.
Professor of Chemistry
6 California Institute of Technology
ARTHUR L. CAPLAN, Ph.D.
8 Director Center for Bioethics and
Trustee Professor of Bioethics 9
University of Pennsylvania
ADMIRAL DONALD CUSTIS, M.D.(Ret.) 11
Senior Medical Advisor
Health Policy Department
12 Paralyzed Veterans of America
DAVID M. HAMBURG, M.D.
14 President, Carnegie Corporation of.
15 New York, New York
16 JAMES A. JOHNSON
Chairman and Chief Executive Officer 17
Federal National Mortgage Association
CAPTAIN MARGUERITE KNOX, R.N.C., M.N. 19
Clinical Assistant Professor
20 College of Nursing
University of South Carolina
21 Columbia, South Carolina
1 PHILIP J. LANDRIGAN, M.D.
Ethel H. Wise Professor.
2 Chairman, Department of Community
3 Mount Sinai School of Medicine
New York, New York
ELAINE L. LARSON, R.N., Ph.D.
5 Dean, Georgetown University School of
6 Washington, D.C.
7 ROLANDO RIOS
8 San Antonio, Texas
9 ANDREA KIDD TAYLOR, Ph.D.
Health and Safety Department
10 United Auto Workers Detroit, Michigan
11 * * * * *
1 P R O C E E D I N G S
2 (8:45 a.m.)
3 MS. WOTEKI: Good morning, everyone, my
4 name is Catherine Woteki. Among the
5 responsibilities that I have is to be the
6 designated federal official for this Presidential
7 Advisory Committee on Gulf War Veterans'
8 Illnesses. And as part of those duties, I convene
9 these meetings and adjourn the meetings.
10 And ladies and gentlemen, you are now in
12 DR. LASHOF: Thank you very much,
14 This morning, our agenda is really quite
15 clear cut. We have two people who requested to
16 make public comment. We will begin with those
17 two, then we will move to a discussion of the
18 draft of the interim report, which is due to the
19 President on February 15th.
20 Let me first ask Mr. Albert Donnay, who
21 is going to present for Dr. Ziem, who is ill.
22 MR. DONNAY: Thank you, ladies and
1 gentlemen. Dr. Ziem, who I work for as a research
2 associate had meant to be here to present this to
3 you. I'm sorry that she could not be.
4 You were sent before the meeting a copy
5 of our memorandum, dated 26th of January. Another
6 copy was given to you this morning, along with two
7 other sheets with handwriting over them.
8 What we would like to review with you
9 this morning is the Institute of Medicine's
10 Evaluation of the CCEP Program. We've previously
11 critiqued the CCEP Program for, we feel,
12 presenting misleading summaries of its data. And
13 we're disappointed to report that we think the
14 Institute of Medicine has done the same in its
15 evaluation of CCEP Program.
16 I'd like to draw your attention
17 primarily to the two tables. First, the one
18 that's circled in red. This is the press release
19 of the Institute of Medicine, and is widely
20 reported by the media. It reported that 37
21 percent of the first 10,200 participants in the
22 program, had psychiatric conditions. And it urged
1 greater emphases on those conditions in the
2 future. And that is indeed how the story was
4 However, inside the Institute of
5 Medicine report, as it was buried inside the DOD
6 report, our information on two other categories of
7 illness that ranked higher than the 37 percent was
8 psychiatric. And those are 45 percent with
9 musculoskeletal problems and 41 percent with
10 unexplained illness.
11 In addition, there's a startling
12 revolution in the IOM evaluation on page 21 that,
13 despite the primary ranking of musculoskeletal
14 conditions in this group, neither the VA or the
15 DOD have done, are doing, or are currently
16 planning any research into these musculoskeletal
18 One, two, three -- maybe four paragraphs
19 are devoted to these topics in their report, while
20 six pages are devoted to the psychiatric
22 The other table shows how the DOD
1 handled the same data. In the top is a table that
2 Dr. Joseph has presented to Congress and to your
3 committee. It has just one column listing primary
4 diagnoses. And, the DOD focused, at first, on the
5 19 percent with psychiatric conditions.
6 But overall, you see, in the lower
7 table, which was buried in the report, that there
8 is another column showing overall diagnoses of 37
9 percent psychiatric, 41 percent unexplained, and
10 45 percent with musculoskeletal.
11 There's also an unexplained discrepancy
12 in the next row showing healthy patients. 11
13 percent received a primary diagnosis of healthy.
14 19 percent received primary or secondary diagnosis
15 of healthy.
16 Well, if there's 19, or 11 -- 11 to 19
17 percent healthy in this population, that should
18 have been subtracted out of all these other
19 percentages because it merely dilutes the total of
20 what we're looking for, which is illness among
21 those who are sick. This was a self-select
22 population, as many healthy as wanted could walk
1 in the door. Yet, all the statistics are diluted
2 by the inclusion of these healthy individuals.
3 The last concern we have is the way in
4 which they reviewed the CCEP's efforts to
5 investigate chronic fatigue syndrome,
6 fibromyalgia, and multiple chemical. None of the
7 reports issued by the CCEP to date have included
8 any data on these conditions.
9 There was an expert on the IOM
10 Committee, Dr. Harold Kipen, who has published
11 quite a bit in this field. In speaking with him,
12 after the fact, we learned that he was not aware
13 of any CCEP data on multiple chemical sensitivity.
14 And when Dr. Ziem asked him, "Well,
15 didn't they show you the questionnaire?" he said,
16 "No. What questionnaire?" He was not aware that
17 they had even made efforts to collect this data,
18 and we're still waiting to see it.
19 The report dismisses multiple chemical
20 sensitivity as something that it felt DOD did not
21 need to track because it's not a recognized
22 disease. We've taken issue with that as well,
1 because both the DOD and VA have diagnosed MCS in
2 Gulf patients. And we have the documentation of
4 In addition, chronic fatigue, multiple
5 chemical sensitivity, and fibromyalgia overlap to
6 a significant degree in the archives of Internal
8 Last year, there was this paper that
9 found a percent overlap among all three groups
10 with the primary symptoms. And Dr. Ziem and I
11 wrote a letter to that journal commenting on that,
12 pointing out that they're probably the same
13 condition, when all those three cardinal symptoms
14 are present.
15 And of course, what is critical from
16 this discussion is the treatment that flows from
17 these diagnoses. Because if one has chronic
18 fatigue, fibromyalgia, and/or multiple chemical
19 sensitivity, one should be treated very
20 differently than the current pharmacological
21 symptom-by-symptom approach that's being used to
22 treat veterans now.
1 And that brings me to the final point.
2 The DOD continues in its reports and the IOM has
3 supported their efforts to characterize their
4 treatment efforts as positive and successful, yet
5 there is no data in the CCEP on treatment. We are
6 aware that neither the DOD nor the VA has launched
7 a single follow-up questionnaire for any of their
8 treatment protocols. And it's really a grossly
9 vacuous claim to assert that these treatments are
10 succeeding, when there's simply no data.
11 We hope that now that this CCEP
12 Committee has finished its work, you will return
13 to the original IOM oversight committee the
14 responsibility for following the CCEP program.
15 That committee should have been involved from the
17 As it was, this CCEP Committee at the
18 IOM, which was chartered in June of 1994 -- there
19 was a typo in my original report -- it was
20 chartered in June 1994. The first two members met
21 in October, and the full committee did not meet
22 until March of 1995. I suggest to you that they
1 were not in a hurry to review this.
2 And I have tried checking with the
3 Institute of Medicine. I find no precedence for a
4 committee that was instituted or chartered to
5 review a protocol taking nine months to get
6 started, especially when they only had a one year
7 mandate to begin with.
8 Thank you very much.
9 DR. LASHOF: Does the committee have any
10 questions they would like to address to Mr.
12 If not, thank you very much.
13 MR. DONNAY: Thank you.
14 DR. LASHOF: We will take your testimony
15 into consideration.
16 The next person who is requested is Mr.
17 Dan Hayes of the American Federation of Veterans,
18 vice president of the Legislative Issues.
19 MR. HAYES: Good morning, ladies and
21 I am a retired and disabled vet and a
22 local veterans' advocate. And just a few minutes
1 ago, I received a fax, here at the hotel, from the
2 Desert Storm Justice Foundation. Their
3 representative could not make it into town this
4 morning, so they have asked me, very quickly, to
5 present some questions they have to you.
6 As it is a fax and just received,
7 obviously, I did not have enough have enough time
8 to make a lot of copies. So, what I will do is
9 just briefly run over a couple of things, and then
10 just present that to you for your study.
11 The Desert Storm Justice Foundation
12 apparently has some strong concerns in regards to
13 some of the procedures from the committee and
14 information that's available to the public.
15 One of their concerns is of the need for
16 further outreach to Gulf veterans around the
17 country. And they also feel there needs to be
18 more information made available not only to
19 veterans, but to the general public, especially to
20 family and friends.
21 I'd like to read over just some of the
22 topics real quickly for you. One of their areas
1 of concern is some of the existing programs for
2 medical treatment being presented by local medical
3 personnel across the country -- which apparently
4 been given on occasion as far as testimony -- but
5 nothing further has come out, as far as
6 information regarding this, as far as studying, as
7 far as treatment.
8 And they feel that perhaps the
9 questionnaire, again, is not reaching the
10 individual vets and that a lot of the veterans
11 calling the VA are still being given inaccurate
12 information. And they ask that you look into
13 these matters and determine whether the veteran is
14 being served.
15 And with that, I'll close. Thank you.
16 Are there any questions?
17 Yes, ma'am.
18 DR. LARSON: Just for points of
19 clarification so that we get this clear -- the
20 concerns are the need for further outreach by this
21 committee, or about this committee?
22 MR. HAYES: By the committee.
1 DR. LARSON: And were there suggestions
2 about what that might be. And in a related
3 question, more information made available in what
4 form and how would it be distributed?
5 Any suggestions?
6 MR. HAYES: I am a little unclear on
7 that --
8 DR. LARSON: Yes, so am I.
9 MR. HAYES: -- since I just received
10 this a few minutes ago; however --
11 DR. LARSON: It would be helpful if you
12 could get clarification on that --
13 MR. HAYES: I will.
14 DR. LARSON: -- because we are very
15 concerned to get the outreach and to, you know,
16 get the communication in the right way. So, if
17 you could -- and then a couple of other questions.
18 The questionnaire not reaching the vets,
19 which questionnaire is that?
20 MR. HAYES: The one that Dr. Ziem's
21 representative just spoke of a few minutes ago,
22 unless I misheard something.
1 DR. LARSON: I'm not clear what that is.
2 Do you mean the CCEP?
3 MR. HAYES: Right.
4 MR. DONNAY: It was originally intended
5 to be part of page 3. It seems to have
6 disappeared when they shifted from a three-page
7 program into a two-page program. It was
8 originally designed by Carol Lang (phonetic) and I
9 was involved in the reading, the end of page 3.
10 For those who still have it, I just want
11 to be able to make that point.
12 MR. HAYES: That's right.
13 DR. LARSON: So -- okay.
14 DR. LASHOF: The staff can follow up on
16 DR. LARSON: All right. And then one
17 last question for clarification.
18 There was an expressed concern about the
19 testimony given in the hearings around the country
20 by local people. And the issue was that there
21 should be some follow-up on the accuracy, the
22 validity of the that testimony.
1 Is that the issue?
2 MR. HAYES: I think the issue, perhaps,
3 is in the minutes that they've received from the
4 committee. Sometimes, the people that presented
5 testimony, that information was not included in
6 the minutes. So the question is, was it really
7 accepted or did just somebody stand up there and
8 give a presentation and nothing happened.
9 I think -- and this is my personal
10 opinion -- is that perhaps because they did not
11 see their representatives, or other friends,
12 listed in some of the documentation that the
13 committee put out, that they're wondering if that
14 testimony was accepted and considered.
15 DR. LARSON: Well, it would be real
16 helpful for us to understand what the issues are
17 that are of concern, and I'm not yet clear on what
18 the issues are.
19 MR. HAYES: Right.
20 DR. LARSON: And what I hear you
21 saying --
22 MR. HAYES: It's fairly detailed --
1 DR. LARSON: Okay.
2 MR. HAYES: -- in this fax --
3 DR. LARSON: Okay. Fine.
4 MR. HAYES: -- and what I would like to
5 do, because they did provide me a second copy go
6 over it in detail and contact them by phone
7 tomorrow. And then I'll be glad to get back,
8 specifically, with the committee, since I'm local.
9 DR. LARSON: Or maybe what you have in
10 writing would be helpful.
11 DR. LASHOF: I think you could follow up
12 with the staff and supply the staff with further
13 clarification on the issues and then we'll be glad
14 to take them up.
15 MR. HAYES: Thank you, ma'am, for your
17 DR. LARSON: Thank you.
18 Okay, that concludes our public comment.
19 And I think our plan of action for the day is
20 really to go through the current draft report that
21 each member of the committee has in front of them,
22 and determine whether any changes, further
1 changes, or issues need to be addressed.
2 I'd like to just make a few comments
3 about the development of the report. First, I'd
4 like to congratulate the staff. I think they've
5 done a magnificent job in pulling together the
6 information, the findings, and conclusions that
7 we've come to with our series of meetings that we
8 have held since August.
9 As you remember, in our San Diego
10 meeting, we went over various reports that the
11 staff had developed dealing each of the major
12 headings or chapters, here, that are covered by
13 our charge. I think it was a very successful
14 meeting, where we came to fairly good consensus on
15 the findings and recommendations.
16 The staff took this information and
17 prepared the first draft, which all of you
18 received early in January. And I thank the
19 committee for being very prompt in revealing that
20 and getting comments back to the staff. A
21 revision was made.
22 And I really congratulate the staff who
1 managed to come into work during the snowstorm,
2 when no one else was working, in order to revise
3 the draft and get it out, and under really
4 difficult circumstances.
5 That second draft did go out to the
6 departments, to veterans' groups, to the Institute
7 of Medicine, and to other parties that have been
8 working on this problem. And we received comments
9 from the majority of those people to whom it was
11 The staff incorporated many of those
12 comments and feel that they wish to thank the
13 external reviewers. They believe it did improve
14 the draft. Many of the comments, however, did
15 refer to future work and recommendations, the
16 things that they would like the committee to look
17 into. We will be taking those under consideration
18 as we continue our work, since we have another 10
19 months before our final report is due. And we
20 will be responsive, I believe, to those concerns.
21 I met with the staff, again, yesterday
22 and walked through the major comments that had
1 come in. I'm satisfied that the staff have been
2 very responsive to the reviews and to the
3 suggestions and recommendations. And that the
4 document you have, in front of you, is in quite
5 good form. And I think ready for our final
7 My suggestion as to how to operate,
8 unless there is any objection, is to start not
9 with the executive summaries, since that really is
10 just summarizing our findings but rather to begin
11 with chapter 1 and to proceed in the following
13 That we take a look, generally, at the
14 background information that precedes the findings;
15 that we then -- and I request any comments that
16 any of you have on that background information,
17 short of editorial or grammatical or spelling
18 errors -- any of those -- or stylistic things that
19 you want.
20 I'd appreciate it if you just mark those
21 in the margin of your copy, tab the page on which
22 you've written comments, and give that to the
2 And that we devote our time to reviewing
3 in more substance any concerns that anyone has
4 concerning any of the findings or conclusions;
5 and that we walk through this chapter- by-chapter.
6 Is that acceptable to the committee?
7 Are there any suggestions?
8 Okay. Beginning, then, with chapter 1,
9 which provides an introduction, I would draw your
10 attention to page 11, lines 10, 11, and 12. There
11 has been a suggestion that those sentences be
12 modified in the following manner, and that the
13 sentence should read: "The committee is concerned
14 that some veterans suffer from real debilitating
15 illnesses linked to service in the Gulf War."
16 Those are just some minor changes in the
17 wording that exists on the pages you know have.
18 If there are no problems with that wording, we'll
19 proceed that way.
20 Are there any other comments on the
21 introductory chapter, which just sort of sets the
22 tone of the report? If not, I think we can move
1 to chapter 2, Outreach, starting on page 16.
2 Again, we start with the general
3 introduction, give some background, describe
4 essentially the outreach efforts. I think these
5 are well-described.
6 We come to the findings, begin on page
7 -- findings begin, actually, on page 27. So, if
8 there are any comments up to page 16 to 27, let me
9 pause and give you a chance to scan those and see
10 whether any of you have any substantive issues you
11 want to raise in the descriptive material.
12 If not, on page 27 -- if the committee
13 has no objection, I would suggest that I will
14 first give some comments and changes that I have
15 agreed to with the staff, working yesterday, since
16 we spent a lot of time on it. And, then, take
17 additional comments from all of you.
18 On page 27, line 11, we would insert
19 between "contradictory" and "reports" the word
20 "intelligence" so that that would read, "since --
21 link contains contradictory intelligence reports."
22 Then the rest would be the "net effect
1 of posting these declassified documents." Remove
2 "intelligence" before "documents" and put "these"
3 before "declassified" -- felt this clarified which
4 of the reports were actually contradictory.
5 Any questions?
6 If not, does anyone else have anything
7 in findings?
8 Let us move, then, to recommendations.
9 Anything in the recommendations? Are
10 all of the recommendations -- John?
11 DR. BALDESCHWIELER: I like
12 particularly, on page 29, line 15, the
13 recommendation that "for future conflicts one
14 should anticipate the nature of outreach services
15 and implement them expeditiously."
16 I'd like to ask what the authors of this
17 line had in mind. Was this a standby service?
18 For example, with regard to service in
19 Bosnia, would you say that such an outreach
20 service should be in place now, or --
21 MS. NISHIMI: Or at least plan on
22 perhaps creating a registry immediately, rather
1 than waiting two years for a mandate to come, and
2 then start planning it and implementing it, yes.
3 DR. LARSON: I would suggest we add --
4 well, I'll read the whole thing.
5 "Future conflicts are likely to generate
6 controversial and unexplained health concerns, and
7 DOD and VA should anticipate the need for, and
8 plan for, outreach services."
9 That's clearly more of a recommendation
10 than anticipate -- i.e., think about.
11 DR. LARSON: Does that clarify it for
12 you, gentlemen?
13 MR. HAMBURG: Yes, that would help.
14 DR. LASHOF: Anybody else have any
15 concerns, or is that satisfactory? Okay.
16 On chapter 3, we move to the medical and
17 clinical issues. Again, are there any questions
18 concerning the background material?
19 You're going to get off easy, staff,
20 just sit there and smile. You've worked hard.
21 You deserve it.
22 The findings begin on page 40. Anybody
1 have anything preceding that? Is there general
2 agreement on the findings, or are there
3 suggestions, corrections, additions, deletions?
4 We'll get through this thing very
6 The recommendations begin on page 42.
7 On line 9, prior to "timely," I would insert
8 "include" and I'd cancel out "as essential."
9 That's almost a stylistic issue. It's
10 not a substantive one. You better clarify things
11 for me.
12 This section I draw to your attention to
13 does deal with the issues of informed consent --
14 the issues of the use of experimental drugs and
15 vaccines and making some recommendations about
17 Now, this was an issue that was taken up
18 in a panel meeting and that has not been fully
19 reported to the committee. So I think it's worth
20 stopping for a few minutes and seeing whether the
21 committee feels comfortable with everything there,
22 wishes any further report on that panel meeting.
1 You've not seen a staff report on that
2 panel meeting. But these recommendations and
3 findings that deal with the interim rule, the use
4 of experimental drugs and vaccines did come out of
5 that meeting.
6 MS. NISHIMI: The staff report is
7 essentially the text as you see it in the
8 document. If there are any questions, we can
9 discuss them. It might be better to wait until
10 Art Caplan, who chaired the panel, perhaps comes.
11 I think he must be late in coming.
12 DR. LASHOF: He is expected, and he
13 chaired the panel meeting. So if there are any
14 questions, why don't you think about them, tab it,
15 and we'll come back to it, if you wish, when Dr.
16 Caplan arrives.
17 DR. BALDESCHWIELER: Question on page --
18 DR. LARSON: Yes.
19 DR. BALDESCHWIELER: -- on page 42.
20 DR. LARSON: Page 42, yes.
21 DR. BALDESCHWIELER: Line 7.
22 DR. LARSON: Line 7.
1 DR. BALDESCHWIELER: The recommendation
2 that "prior to any deployment, DOD should
3 undertake a thorough health assessment of a large
4 sample of troops to enable better post-deployment
5 medical epidemiology."
6 Again, what is the vision of this? Take
7 a small sample from each of a large number of
8 units or pick several units? It's difficult to
9 know our priority or where the --
10 DR. LASHOF: I would think --
11 DR. BALDESCHWIELER: -- units will be
12 deployed, for example.
13 DR. LARSON: Well, I would have thought
14 that the DOD would know which units it's sending
15 where, what things they might be concerned about
16 in advance.
17 And that it might help any future
18 epidemiologic development to be sure that they
19 have some baseline thorough assessment of the
20 sample, of any groups that are going to
21 particularly areas that are hazardous, and not --
22 DR. BALDESCHWIELER: But is that --
1 DR. LARSON: We can't judge what those
2 are. The advise is that they should think about
3 it. If they think they're going to have people
4 exposed to possible things, then they ought to
5 take a sample, get a thorough assessment, and be
6 prepared to follow them up afterwards, and not
7 have to do as we've done here.
8 DR. BALDESCHWIELER: In an active
9 engagement, of course, active engagement is likely
10 to be quite fluid.
11 DR. LARSON: Yes.
12 DR. BALDESCHWIELER: And the units will
13 be deployed, redeployed. So your sample might not
14 turn out to be --
15 DR. LARSON: I think all they can do is
16 the best they can do. And I don't know that we
17 could specify. Do you think it's a problem
18 recommending this at all?
19 DR. BALDESCHWIELER: Well, I'm trying to
20 envision how they would carry it out.
21 MS. NISHIMI: I think it might depend on
22 the conflict, and so, hence, the generic "prior to
2 DR. LASHOF: Does anyone from the staff
3 who worked on this have any discussion with DOD
4 concerning it?
5 Dr. Cassells, do you have some comments?
6 DR. CASSELLS: There's a medical annex
7 to any operational plan, so that there is an
8 assessment in advance of the deployment, of what
9 is likely to present itself as a hazard, both from
10 infectious disease standpoints, environmental
11 hazards, and things of this sort. That is known
12 in the advance in the deployment.
13 It is true that, during the course of a
14 deployment itself, events can become quite fluid.
15 But it is possible to at least make an attempt to
16 put together an sample of those individuals, those
17 troops, that are going to be deployed, so that
18 they can be followed up vigorously upon the
19 post-deployment period.
20 DR. BALDESCHWIELER: And if you sampled
21 1 out of 10, for example, regardless of where the
22 units came from and where they are, would that be
1 a useful sample for epidemiological purposes?
2 DR. CASSELLS: I think it would be, yes.
3 MS. NISHIMI: I would just hesitate to
4 put 1 out of 10, in --
5 DR. BALDESCHWIELER: Well, I -- no, no,
6 no. I understand.
7 MS. NISHIMI: Okay. I wanted to clarify
9 DR. LASHOF: Yes, I think the sample
10 size, you know, is dependent on how big the total
11 population is.
12 DR. BALDESCHWIELER: Sure. Sure.
13 DR. LASHOF: And I think we'd be
14 guessing what would be an appropriate sample size.
15 DR. BALDESCHWIELER: But, it's --
16 DR. LASHOF: But, if what you're looking
17 for, the total population, etcetera, you know.
18 DR. BALDESCHWIELER: But if sampled
19 randomly at some fraction of the total number of
20 deployed troops, would that be a useful base for
22 DR. LASHOF: Yes. Yes, that's certainly
1 would be.
2 Any other questions?
3 Okay. Moving right along.
4 The chapter on research. The background
5 discusses the various types. We've included a
6 table at the end of the chapter, the epidemiologic
7 studies that we actually reviewed.
8 The findings begin on page 58.
9 MS. GWINN: Can I interject a comment?
10 DR. LASHOF: Please.
11 MS. GWINN: Page 57, beginning on line
12 3. We discuss the anticipated conclusion date of
13 the unit locator data base --
14 DR. LASHOF: Yes.
15 MS. GWINN: -- and have their December
16 1st, 1995 -- in fact, they're still working on
18 And it has not been completed. So,
19 we're going to have to change --
20 DR. LASHOF: Okay.
21 MS. GWINN: -- in that paragraph to
22 reflect that fact.
1 DR. LASHOF: Do we have a new
2 anticipated date from the department?
3 MS. GWINN: From the person who
4 testified for us in October, we think -- April,
6 MR. NALLNER: That's correct. April is
8 DR. LASHOF: April. Do we have any
9 information about how far along this is and what
10 level -- 50 percent, 70 percent, 80 percent
12 Could you provide the staff with that,
13 or can you provide it now?
14 MR. NALLNER: I can give a general
15 response now. I think it's slightly more than 50
16 percent, I believe. What happened was that the
17 Army filed a whole other set of several hundred
18 boxes -- of operational records -- in late
20 That was what been delaying its
21 completion in April. And I think, we're slightly
22 more than 50 percent, maybe up towards 60 percent.
1 I can get the staff more definitive information
2 later today.
3 DR. LASHOF: I think that would be
4 helpful. And based on that, we leave it to the
5 staff to modify this accordingly so that it
6 reflects the accurate status.
7 Any other questions there? Findings
8 begin on page 50.
9 MS. NISHIMI: In the meeting yesterday,
10 there was discussion about inserting a new
11 finding. And perhaps Holly could review that.
12 MS. GWINN: Okay. We would insert a new
13 finding which would appear now on line 13. So it
14 would be the second finding, and it would read:
15 "Most of the studies examined by the committee
16 appear to be well-designed and appropriate to
17 answer these questions," with "these questions"
18 referring back to the finding above, which
19 identifies them as whether Gulf War veterans have
20 more or less mortality, symptoms, or diseases than
21 a appropriately chosen comparison population.
22 DR. LASHOF: Could you read it again,
1 very slowly?
2 I would like everyone to take note of
3 this because it's a very significant addition,
4 which I discussed in some detail with the staff
5 yesterday, and felt it was a important one to add.
6 But I'd like to be sure that everyone
7 does concur with it. So read it once more, Holly,
9 MS. GWINN: "Most of the studies
10 examined by the committee appear to be
11 well-designed and appropriate to answer these
13 DR. LASHOF: It was my sense that that
14 represents the conclusion that our panel came to
15 in San Francisco, when we reviewed the various
16 epidemiologic studies. You'll note that the next
17 sentence talks about some of the studies that we
18 felt were not up to snuff, if you will.
19 But I thought it was important, if we
20 were going to comment upon those that we felt were
21 not as well-planned, we first make the statements
22 about those that are well-planned.
1 Is there general agreement from the
2 committee on that?
3 Okay, then, we'll accept that addition.
4 The recommendations begin on page 59.
5 Are there any suggestions, additions to the
7 I guess not.
8 MS. GWINN: We did --
9 DR. LASHOF: Holly, we have something?
10 MS. GWINN: We did discuss yesterday on
11 page 60, line 5.
12 DR. LASHOF: Yes.
13 MS. GWINN: Which was to change the
14 recommendation -- the word "encourage". It would
15 read "DOD, DHHS, and VA should recommend their
16 principal investigators use public advisory
18 DR. LASHOF: Recommend that and take out
19 the two, or just recommend -- well, editorial,
20 stylistic -- not to worry about that.
21 The essence being that, rather than
22 encourage, we recommend that principal
1 investigators use public advisory committees in
2 deciding and executing.
4 DR. CASSELLS: The recommendation on
5 line 15 of page 60, "DOD should make reasonable
6 and practical efforts to collect and record better
7 treatments, exposure data during future conflicts"
8 and so forth.
9 Again, what do you envision there? That
10 there be a unit created and assign that
11 responsibility in the DOD organization. This
12 might happen unless somebody is really tasked to
13 do it.
14 MS. GWINN: There is a draft directive
15 underway at the DOD that envisions a more vigorous
16 program in the future, not only doing medical
17 surveillance, but collecting exposure data as
18 well. And I don't know at this point whether they
19 envision creating a new unit to perform this
20 function, or whether it's something they feel they
21 can work into their existing structure.
22 DR. BALDESCHWIELER: But is there, in
1 fact, an existing part of the organization that
2 could do this part of the medical organization, or
3 somewhere else, in DOD?
4 MS. GWINN: Do the skills exist? Yes.
5 Whether any existing unit feels that it
6 can take on the additional duty without, you know,
7 adding resources, I don't know.
8 DR. LASHOF: But this is actually
9 something that is being considered and is underway
10 at DOD at this time?
11 MS. GWINN: It's a draft.
12 DR. LASHOF: Oh, a draft.
13 MR. BROWN: It's something that --
14 DR. LASHOF: Directive is -- pardon?
15 MR. BROWN: We're going to be looking
16 into this. It's on our schedule to examine this
18 DR. LASHOF: Okay.
19 MS. GWINN: I don't think it's necessary
20 to say anymore now on that. This is the intern
22 DR. BALDESCHWIELER: But it's
1 interesting, I think, before the final report to
2 understand exactly where that responsibility is
4 DR. LASHOF: All right. We'll take note
5 of that and be sure that we do address it.
6 Dr. Hamburg.
7 DR. HAMBURG: This may be as good a
8 place as any to comment on the future orientation.
9 Of course, this is the second time we've been
10 discussing the suggestion about future conflicts.
11 I noticed there are a number of places,
12 in the report that we've got to set down. I think
13 that's a very important point, even more so as we
14 come to the final report.
15 Of course, our primary mission is to
16 clarify what happened in the Gulf and to make
17 sense out of that. But it seems to me that we
18 really have an opportunity to help diminish the
19 likelihood of similar problems in the future if we
20 pay a lot of attention to the lessons from this,
21 for future conflicts, and be as explicit as we can
22 all the way through.
1 DR. LASHOF: Yes. Thank you very much.
2 The staff and I have discussed that, and I think
3 there is a strong commitment to do that.
4 Dr. Caplan has arrived, so let me ask if
5 anyone wishes to go back to chapter 4 and address
6 any questions to him concerning the panel meeting
7 they had on the ethics and use of experimental
8 drugs and experimental vaccines, and specifically
9 on any of the findings or recommendations that we
10 put forward.
11 I guess your panel did such a good job,
12 and the staff does a good job of writing it up
13 that everybody is satisfied that they understand
14 what went on, and concur with both findings and
16 Okay, if not -- going, going, going.
17 All right. Then I think we are ready to
18 move to chapter 5, which deals with chemical and
19 biological weapons.
20 Again, the staff has given us --
21 reviewed the background material that they've been
22 able to cover, up until this time. This is a
1 major issue for future work. And what we discuss
2 here is really quite limited because we've only
3 done limited work on this, at this point. And it
4 will be the subject of further panel meetings and
5 full committee meetings in the months ahead.
6 But at this point, we have some findings
7 that are listed on page 68 and 69, and
8 recommendations on page 69.
9 DR. BALDESCHWIELER: If --
10 DR. LASHOF: Yes.
11 DR. BALDESCHWIELER: If I could comment
12 on --
13 DR. LASHOF: Please.
14 DR. BALDESCHWIELER: -- on the first
15 recommendation on page 69, that "the CIA should
16 broaden its analysis to include the complete
17 record of the Gulf War, including operational
18 records, and eyewitness incidents and reports, and
19 make a full and prompt disclosure of all
21 Essentially, the DOD is committed to do
22 this, isn't that right? And so, this would be an
1 overlap of effort.
2 MS. GWINN: Yes, the Persian Gulf
3 investigation team has that responsibility as
4 well, which is a DOD entity.
5 DR. BALDESCHWIELER: And so, isn't that
6 duplication of effort here? Is that what you
7 intended, that the CIA duplicate what the DOD is
9 DR. LASHOF: To a degree. Holly, do you
10 want to -- or Mark, or whoever on the staff would
11 like to come and further comment.
12 We had some discussion of this
13 yesterday. There is some concern by CIA, and I
14 think it's an issue worthy of further discussion
15 by the committee before we agree on the
17 MS. GWINN: The CIA is conducting an
18 investigation now that includes a thorough review
19 of intelligence records, and significant -- not
20 coordination, maybe -- but discussion with PGIT to
21 see the Persian Gulf Investigation Team, the DOD
22 unit, to make sure they share information as
2 We discussed this at some length in San
3 Diego, where we started out with a suggestion for
4 a recommendation that PGIT and CIA coordinate
5 their activities to make sure as thorough and
6 comprehensive an analysis was conducted, as
8 It seemed to me from that discussion
9 that at least part of the committee viewed an
10 independent, but comprehensive, effort by the CIA
11 as having significant to the effort. However,
12 this does have resource implications for the CIA
13 because it would require them to expand beyond
14 what they consider their real expertise, which is
15 the focus on the intelligence records.
16 DR. BALDESCHWIELER: As written, this is
17 enormous. I think an enormous operational
18 commitment to the CIA. And I wonder if the
19 overlap with the DOD wouldn't be so significant as
20 to make the recommendation that --
21 DR. LASHOF: We apparently discussed
22 this the San Diego meeting. And this
1 recommendation came out of the committee at the
2 San Diego, but it may be necessary to revisit it.
3 DR. BALDESCHWIELER: If there were some
4 words here like "coordination" --
5 MS. NISHIMI: The original suggestion
6 for the recommendation was coordination between
7 DOD and CIA. And we had a somewhat lengthy, I
8 thought, discussion on the value of coordinating
9 versus independent.
10 And it was the staff's sense that an
11 independent, recognizably somewhat duplicative
12 effort had value. And so that's why this
13 recommendation was altered.
14 If the committee feels that we should go
15 back to the coordination recommendation, that's
16 fine. And we can go back to that one.
17 DR. BALDESCHWIELER: That certainly
18 would amount to be my feeling.
19 DR. LASHOF: Any others who remember
20 that discussion more thoroughly? I don't know
21 that we have the minutes with us.
22 DR. HAMBURG: I think what's clear is
1 that the CIA contribution ought to be -- that is,
2 at the end, there ought to be no question that the
3 CIA has withheld important information.
4 How that's done -- independently or in
5 coordination with DOD -- I don't have a clear
6 position. But I think we've got to be reassured
7 that the information the CIA has toward our
8 inquiry is, in fact, made available.
9 DR. LASHOF: What if we get -- I mean,
10 the real concern -- and we discussed at some
11 length yesterday with the staff, too -- is how you
12 can be sure that there can be a kind of -- both
13 DOD and CIA looking at this in such a way not to
14 overly duplicate, but to assure that everything
15 that needs to be looked at is looked at.
16 And when you leave it just to one group,
17 there is a feeling that if just DOD does it
18 without CIA looking at some of those, there could
19 be some view that it was not as thorough, and vice
21 And not to cast dispersions on DOD or
22 CIA, but if either one does it alone, since this
1 has been such a controversial issue, was there
2 something to be gained by both agencies taking a
3 look at it and being sure that they both concurred
4 with whatever conclusion is reached concerning
6 Now, how that can be done without it
7 appearing that they're both doing the exact same
8 thing and duplicating effort, versus one just
9 accepting the other without being critical or
10 having any independent review is what we were
11 struggling with here. It really is that sense and
12 that balance that we think that we need to come to
13 some agreement on.
14 Apparently, in San Diego, we came to the
15 position that we needed to be duplicative. But I,
16 myself, was revisiting it yesterday and I'm not
17 sure. And I think I'd like to hear further
18 comment --
19 DR. BALDESCHWIELER: I mean, as written,
20 this is a huge assignment. And it seems to be
21 that the DOD and the CIA may have somewhat
22 different sources of information. And when that's
1 the case, coordination, it seems to me, is the
2 right sense.
3 MR. CROSS: John, I second that in that
4 in terms of coordination. To me, coordination
5 assumes the duplicity will be taken out by the two
6 organizations working together. I agree with your
8 MS. GWINN: The recommendation as
9 written doesn't foreclose a decision by CIA and
10 DOD to achieve this by coordinating their
11 activities. It just makes it clear that we want
12 the CIA to do an independent review of all the
14 DR. LASHOF: Would it work to -- I mean,
15 it's where we put in coordination, and whether we
16 do have them broaden their analysis to include the
17 complete record, and then put in something about
18 including coordinating a review of operational
19 records and eyewitness reports with DOD.
20 DR. LARSON: Do we know what that would
21 entail? I mean, do we know how big an assignment
22 that is?
1 I have no idea. It's discussed on page
2 66. Mine is 8 through 10, where it says that the
3 CIA has limited its review to intelligence records
4 and excluded assessment of operational records and
5 eyewitness accounts.
6 How many operational records would that
7 mean? How many eyewitness accounts? I don't
8 know -- you know, it's hard to make a
9 recommendation when we don't know the scope of
10 what we're recommending, and what's available.
11 MS. GWINN: I don't know what
12 conclusions CIA would come to about many people it
13 would require. I think the PGIT, which would be a
14 comparable unit, has a team of about 22 people in
16 MR. KOENIGSBERG: That's not true.
17 MS. GWINN: No? I'm sorry.
18 MR. KOENIGSBERG: We have a team of 12
19 people working on this. We're looking at records
20 that will probably be close to half a million
21 records that have to be looked at. CIA has their
22 independent organization looking, and they're
1 primarily looking at intelligence, but they are
2 also looking at operational data.
3 We do coordinate with each other, in
4 that when we find things that look interesting, we
5 will pass it onto the CIA, and vice versa, if they
6 give us information back.
7 We don't work together. We don't look
8 at items together. Each one is doing their
9 independent work. But this would task CIA to come
10 up -- right now, they do not have anywhere near 12
11 people working on this program -- and it would be
12 a tremendous task getting the CIA, which they're
13 having some trouble accepting, in this. I would
14 agree with what Dr. Baldeschwieler is saying.
15 But we do have two different groups
16 working right now. It's just that they're not
17 going into all the operational records that the
18 Department of Defense has. They do have a bunch
19 of them. But they don't go into all of the same
20 things that we do, so it's not completely
22 MR. CROSS: And you're saying the reason
1 being is because they only have a small group of
2 people working on it.
3 MR. KOENIGSBERG: Partly because they
4 have a small group, they've got -- we're spending
5 several million dollars in Department of Defense
6 just to run the Persian Gulf investigation team
7 that we have going. So, what you're asking them
8 to do would make them go out and spend probably an
9 equal amount of money to set up a program that is
10 going to do the same thing that we're trying to do
11 on our side of the house.
12 They already are looking at the all the
13 intelligence stuff, which is where their expertise
14 is. And they're already looking a lot of the
15 operational data or intelligence pieces of
16 information, and looking specifically at those
18 DR. LARSON: So, this would mean looking
19 at the same operational records by two independent
20 folks, if you will. And maybe we're inaccurate
21 here in saying that this has excluded assessment
22 of operational records -- on line 9, page 66 -- if
1 in fact what he said is true, that they are
2 looking at it.
3 There's a discrepancy between what we
4 just heard and what we're saying here.
5 MS. GWINN: I think it's matter of
6 detail. There's a significant portion of the
7 operational record that CIA has excluded from its
8 review, so it's not as clear as it could be.
9 DR. LASHOF: Wouldn't we be more correct
10 to say the CIA is concentrating its review on
11 intelligence records?
12 DR. LARSON: Yes.
13 DR. LASHOF: I'm not sure how we could
14 change "excluded." And as I --
15 DR. LARSON: "Limited."
16 DR. LASHOF: "Limited."
17 I'm just looking at limited -- doing a
18 limited assessment of operational records and
19 eyewitness accounts.
20 DR. LARSON: Is that accurate?
21 DR. LASHOF: Is that accurate?
22 MS. GWINN: Yes.
1 DR. LARSON: Okay.
2 DR. LASHOF: Okay. If we make that
3 change in the finding, let us now go back for this
4 recommendation, and see whether we want to strike
5 "broaden its analysis to include the complete
6 record," and say something about "CIA should
7 coordinate its review of operational records and
8 eyewitness reports with those of DOD," or how we
9 worded it previously.
10 DR. BALDESCHWIELER: That would have the
11 right sense from my viewpoint.
12 DR. LARSON: Sounds more reasonable.
13 DR. LASHOF: Okay.
14 MS. NISHIMI: I think the staff will
15 know what to do.
16 DR. LASHOF: Okay. The staff can go
17 back to our previous recommendation.
18 DR. LARSON: Just a format issue. Since
19 we've got so many acronyms throughout this entire
20 report, can we do away with "CW" and "BW" in the
21 recommendations because that's what will appear in
22 the executive summary.
1 It's just our internal --
2 MS. NISHIMI: I'm sorry, I --
3 DR. LARSON: -- spell out "chemical
4 warfare" and "biological warfare," to get rid of
5 one -- all throughout the report?
6 DR. BALDESCHWIELER: Well, I think just
7 in the recommendation.
8 DR. LARSON: In the recommendations
9 because those appear -- they should be readable in
10 the executive summary.
11 MS. GWINN: Actually, the way we handled
12 that for this draft, was to spell them out in the
13 executive summary, and then also include the
14 acronym so that it is a slight modification of the
15 actual finding, or recommendation, as it appears
17 MS. NISHIMI: Thanks.
18 DR. LASHOF: Okay. Noted.
19 DR. BALDESCHWIELER: Could I go back to
20 page 64?
21 DR. LASHOF: Yes.
22 DR. BALDESCHWIELER: And ask just one
1 point of information.
2 DR. LASHOF: Sure.
3 DR. BALDESCHWIELER: On line 13, the
4 bullet "aflatoxin" appears. I wonder where that
5 came from.
6 It's clear that aflatoxin is a
7 carcinogen, but that doesn't make any sense at all
8 as a chemical or biological weapon. And then
9 there has been added "acute toxicity."
10 Where did aflatoxin come from, at all,
11 on these lists? Is that in fact an accepted,
12 potential weapon?
13 MR. BROWN: I think that the data was
14 that aflatoxin was under development by Iraq came
15 from the OMSCOM (phonetic) findings. I'm not
16 positive about that. But it is on the list of
17 materials that Iraq was developing, apparently for
18 warfare purposes.
19 We've asked some people at DOD who study
20 such things. I asked them exactly the same
21 question -- "Why would use a material that caused
22 cancer in maybe decades as a military weapon?"
1 And they had no theories about that that they
2 would share with us either.
3 The facts are that it was in
4 development, whether it made sense or not.
5 DR. BALDESCHWIELER: But on that bullet
6 has been added "acute toxicity," and is that
7 really right?
8 MR. BROWN: Aflatoxin in high doses can
9 cause severe liver damage.
10 DR. BALDESCHWIELER: Well, that's very
11 high doses. I mean, I --
12 MS. NISHIMI: Well, if you weaponize it,
13 you're close. I mean, I think it was Iraq's --
14 what we're reporting is what Iraq did, not whether
15 it's logical.
16 MR. BROWN: You're not commenting on the
17 wisdom of Iraq.
18 MS. NISHIMI: Right, thank you.
19 DR. BALDESCHWIELER: I was just
20 wondering whether it's right.
21 MR. BROWN: Apparently, it's correct.
22 DR. BALDESCHWIELER: It makes no sense.
1 MR. BROWN: Your question was it seems
2 so far that it seems inaccurate. But it is, in
3 spite of sounding far out, it is accurate.
4 DR. HAMBURG: It's not the only item of
5 the Iraqi behavior that makes no sense.
6 DR. LASHOF: Are there any other
8 DR. BALDESCHWIELER: It might be worth
9 going back to the fundamental source there to see
10 if there has been some error.
11 MS. GWINN: I don't think we have access
12 to the fundamental source. But after we talked,
13 during one of the reviews, I did go back to the
14 OMSCOM Office in D.C. and check with that on them.
15 And they came back and said this is a correct part
16 of the executive secretary's findings.
17 But, at this point, we have not gone
18 back and said, you know, "Are you sure this is
20 DR. BALDESCHWIELER: Well, could there
21 be an error in translation, for example?
22 MS. GWINN: We haven't checked.
1 DR. LASHOF: We apparently have some
2 views in their experts from the department.
3 MR. KOENIGSBERG: Correct. That's
5 DR. LASHOF: I think the staff should be
6 flattered. We, at this point, have reached the
7 end of all of our findings and recommendations.
8 The next part does deal with our next 10 months,
9 and where we want to go from there.
10 Before I go to that, should we go back
11 to the executive summary? The executive summary
12 really just -- let's take a quick look back at the
13 executive summary, and then we can go right into a
14 discussion of our next period.
15 The executive summary does take pretty
16 much verbatim the findings and recommendations --
17 or rather the recommendations, really. We don't
18 repeat all of the findings, but we do give the
20 Did anyone note anything that gave them
21 any concern or any views about whether we need to
22 put anything more in the executive summary or
1 whether this is adequate?
2 DR. LARSON: This figure on page 15 is
3 very helpful. And when we get to discussing
4 what's going to be in the final report, I hope
5 that we'll have perhaps even another chapter on
6 the coordination. In other words, not just
7 research, outreach, et cetera, but some final
8 statements about whether, in fact, all of these
9 things are coordinated and working together.
10 DR. LASHOF: It's an interesting point.
11 That's a good point.
13 DR. CAPLAN: Maybe I can take advantage
14 of this, looking at the executive summary, to just
15 comment on one issue about research and
16 investigational things that weren't captured
17 exactly in the recommendation we made. This is
18 back on 42, 43, I think.
19 I'm not sure how to phrase it -- and
20 that was the issue that came out of the Kansas
21 City Hearing -- about that, if you waive informed
22 consent, you have a strong obligation to follow up
1 in health problems or what took place with people
2 who were given vaccines or drugs.
3 And looking at the executive summary
4 reminds me about this sort of -- the justification
5 of the waiver imposes an obligation. It probably
6 goes into that final rule of recommendation about
7 not just IOB review, but the importance of
8 follow-up of people involved with experimental or
9 innovative vaccines or drugs, as part of
11 So, I'd be looking to amend it in that
12 way, although I don't have the precise language in
13 my mind. But I remember we talked a lot about
14 that, so --
15 MS. NISHIMI: The long-term follow-up is
16 not adequately captured in your mind at 42, line
17 17, or --
18 DR. LARSON: On page 42?
19 MS. NISHIMI: Yes, on page 42.
20 DR. CAPLAN: Just maybe adding that to
21 say there's a strong obligation, because when
22 informed consent is waived or when this happens,
1 really take this seriously. So it's linking it
2 to, if you get a special waiver or exemption,
3 that's where you're really bound to follow
5 I mean, you're bound to closely follow
6 any experimental subject, anyway. But here,
7 you've got a set of people that is particularly
8 important to follow closely because they haven't
9 consented to whatever they're doing.
10 MS. NISHIMI: So, the finding would be
11 that when consent is waived there is a strong
12 obligation, and then we make the recommendation
14 DR. CAPLAN: Right.
15 MS. NISHIMI: Okay.
16 DR. LASHOF: Is the recommendation, as
17 laid out in the lines 15 through 18 --
18 MS. NISHIMI: Right.
19 DR. LASHOF: -- is fine.
20 DR. CAPLAN: It's probably in support
21 for the recommendation.
22 DR. LASHOF: So, the recommendation is
2 DR. CAPLAN: Yes.
3 DR. LASHOF: We just needed to amplify
4 in the finding.
5 Right, got it. Anything else in the
6 executive summary?
7 The staff will capture, under research,
8 the additional statement we put in the finding, so
9 that the opening sentences in the research part
10 reflect both findings concerning the current
11 epidemiologic studies underway. We've agreed on
12 some wording, then.
13 Do you have that, Holly, so that the
14 first sentence under -- it will be page 6.
15 MS. GWINN: Yes, starting line 2.
16 DR. LASHOF: Yes.
17 MS. GWINN: The sentence would now read,
18 "The committee found the large studies sponsored
19 by DOD, VA, and the Department of Health and Human
20 Services, are well-designed and appropriate to
21 determine," and then no other changes.
22 So, you would strike "in examining
1 several" in line 2 and strike "the committee found
2 it should be possible to use epidemiologic
3 approaches" in line 3 and 4.
4 DR. LASHOF: Would the committee like
5 Holly to re-read that once more for you? Please
7 MS. GWINN: Okay. As newly constructed,
8 "The committee found the large studies sponsored
9 by DOD, VA, and the DHHS are well-designed and
10 appropriate to determine," and then no other
12 DR. LASHOF: Okay. All right. And I
13 think we are ready to discuss the final chapter in
14 this interim report which talks about what we're
15 going to do for the next 10 months.
16 What we've tried to do here, in very
17 brief form, is just highlight major issues that we
18 know need to be addressed. And this is a
19 relatively brief kind of overview. And we will be
20 developing more detailed approaches as we develop
21 the agenda for each of our meetings and long-term
1 And it might be worthwhile, at this
2 point, for me to ask Robin to discuss the process
3 that we hope to use over the next 10 months, and
4 come to some consensus and feeling about how we're
6 MS. NISHIMI: The staff's intent would
7 be to proceed over the next 10 months as we have
8 the past six months. That would be, to hold full
9 committee meetings every other month and then to
10 supplement the work between those meetings,
11 obviously, with staff research, as well as the
12 focused panel meetings that were held prior to
13 this meeting.
14 If you recall, we had one focused on
15 clinical issues. We had a panel meeting focused
16 on the epidemiologic research, the large studies,
17 and, most recently, the ones surrounding the
18 waiver of informed consent.
19 And that the panel meetings would be
20 reviewed by the full committee at the following
21 committee meetings, as well as whatever staff work
22 occurred on a given topic, as well as invited
1 testimony by department officials and independent
2 scientist and observers.
3 DR. LARSON: Joyce.
4 DR. LASHOF: Yes.
5 DR. LARSON: I didn't send any critique
6 about this, or any overall critique, because it's
7 there. But I find it hard to sort out what we've
8 already done, what we're going to do, and whether
9 we're going to do qualitatively or quantatively
11 Let me give you an example. On page 71,
12 "the committee will review carefully the content
13 of the department's outreach message, and whether
14 its level of complexity makes it accessible for
15 their audiences."
16 Well, we've already done that to some
17 extent. And I'm not exactly clear, as we've
18 already made recommendations about that. Are we
19 going to do more review or different review?
20 And I had the same kind of questions
21 throughout. That sometimes I couldn't sort out
22 whether it was a quantitatively increased or a
1 different thing that we're going to do for the
2 next 10 months.
3 MS. NISHIMI: It would be both. Well,
4 in this particular case, we haven't really looked
5 at the accessibility issue, in terms of the
6 reading comprehension level.
7 DR. LARSON: Makes it accessible for the
9 Well, if there's a way to more clearly
10 delineate after today's meeting, when we discuss a
11 little bit more specifically what our plan is
12 between what has been done and what we're going to
13 do that's different, I think it would be helpful.
14 It's all right. I was reading it. I
15 thought we've already some of that. What more are
16 we going to do, and what haven't we done that
17 clearly needs to be done?
18 Somehow, I was looking for, like,
19 bullets -- "in the next 10 months, this is what is
20 going to be done." And I think we have to discuss
21 it today. That's what we have to do.
22 But this part of the report I felt the
1 least comfortable with, in terms of clarity. And
2 here's the next step.
3 MR. CROSS: I think we're almost --
4 DR. LASHOF: Are there any other
6 MR. CROSS: We're almost at a point
7 where we need to develop the agenda for the, you
8 know, the rest of the meetings here. Maybe the
9 agenda, then, gives us the road map of where we're
10 going to go and how we're going to cover some of
11 these issues here.
12 DR. LARSON: Yes, that might help.
13 DR. LASHOF: Maybe this would be a good
14 time to take a brief break. We've gone through
15 the meat of this.
16 Take a brief break, and then come back
17 and get into the more thorough discussion of what
18 are the issues that we really need to address over
19 the next 10 months, and highlight some of the
20 things that we really want to be sure are in that
21 final report. And then we can come back and say
22 how much more we need to capture that in this last
2 All right. Why don't we take 20 minutes
3 or so, and come back at 10:15 a.m.
5 DR. LASHOF: I know we've moved very
6 quickly, so everyone took an even longer coffee
8 I think the way I'd like to proceed now
9 is, before trying to give the staff marching
10 orders on works plans and so forth, that possibly
11 the easiest thing to do would be for me to go
12 around and ask each of our committee members what
13 they see are some of the issues that they feel are
14 extremely important and that we address in the
15 next 10 months.
16 And we'll just take them in order and
17 list them and then adjust them afterwards, to come
18 back to try to summarize into a work plan. And
19 then we can have a final discussion about how much
20 of that we put in this final chapter, how vague or
21 how specific we want to be in an interim report
22 about what we're going to do over the next 10
2 So, Marguerite, I'll let you start off.
3 What are the burning issues to you that
4 we haven't addressed at this point, and that you
5 feel it is essential that we address in the next
6 10 months?
7 MS. KNOX: I don't have any really
8 burning issues that I can think of right this
9 minute. But I do think there are several issues
10 that we need to follow up on. I think Elaine's
11 statement about the interim report concerning
12 outreach -- it's very difficult, at this point, to
13 really give a final conclusion on the outreach.
14 I'm glad we didn't close that chapter
15 because I think there are some other things to
16 assess. And I think that was very clear at the
17 last meeting.
18 In Kansas City, there were veterans that
19 had some very big concerns and were very angry
20 about not knowing when the committees were going
21 to be held, when the meetings were going to be
22 held, and not having information about the
1 meetings being held and the location far in
2 advance. And I don't know if we can do anything
3 about that, but that was one of the issues that
4 the veterans brought up.
5 DR. LASHOF: Don.
6 DR. CUSTIS: I think I have a particular
7 interest and hope that we can find more definitive
8 answers under the heading of "chemical and
9 biological warfare."
10 DR. LASHOF: Biological warfare, right.
11 There's no question we'll be going further into
12 that. All right.
13 DR. CAPLAN: Since I'm the third one, I
14 can now get three things on my list to trap
16 I would say the three issues that
17 interest me are (1) a revisiting of the issue of
18 the policy with respect to the use of
19 investigational and other types of new and
20 innovative procedures in war, or in deployment
21 situations -- making sure, in other words, that we
22 get a thorough look at the FDA Interim Final
1 Rule -- that great oxymoron.
2 And in the spirit of what David Hamburg
3 said, that we make some recommendations into the
4 future so that we have some clear-cut idea of what
5 should happen with respect to untested, unproven,
6 or still new anti-biological, anti-chemical
7 warfare, or other intervention agents. So that's
8 one area.
9 Second, I still remain troubled -- and
10 would like to know more about quality of the care
11 for those who say their illnesses are related to
12 their being there. I'm not satisfied I understand
13 why the gap is there between what we're told, and
14 what some of the veterans report.
15 And the other one is just to really push
16 hard on this recommendation about doing
17 epidemiology, to understand really what can now be
18 done retrospectively and then what should be done
19 prospectively so that we have better ability to
20 monitor health effects from modern war.
21 DR. LASHOF: Elaine.
22 DR. LARSON: Just to reiterate two
1 things. One, I do think, again, that we need to
2 look at sustainability and the future of the
3 recommendations -- that there is coordination.
4 And we need to look at coordination across groups.
5 Second thing is, I agree. I'm still not
6 real clear about some of the validity of the local
7 testimony and the wide variation we've heard in
8 the quality of the care delivery system,
9 specifically, how -- and I know there's wide
10 variation, you know, in regions across the country
11 -- but we still do have quite a discrepancy
12 between what some people have said and others have
13 said in testimony about waiting lists, information
14 that they're given, how they are responded to when
15 they come into the system, and maybe
16 misunderstandings or inaccuracies.
17 So, with the care delivery, I think we
18 need to really look at.
19 DR. LASHOF: Tom.
20 MR. CROSS: I'm also concerned about the
21 delivery of care to sick veterans, whether through
22 active duty, hospital, or the VA. This is
1 something that has been brought to the forefront
2 most recently. I think we need to delve a little
3 bit more into, the monitor -- subject of birth
4 defects among Desert Storm vets.
5 I'm concerned about the information flow
6 to veterans and veterans' organizations about Gulf
7 War illnesses.
8 And I'm also quite concerned that we
9 monitor the award of research dollars in the
10 ongoing research on Gulf War illnesses.
11 DR. LASHOF: Okay. John.
12 DR. BALDESCHWIELER: Two small things.
13 One is that I'm must I'm interested in
14 the issue of efficacy for the prophylactic
15 messages for chemical and biologic warfare. I'm
16 not sure how you do that and how one can be
17 confident that, for example, the pyridostigmine
18 bromide really conveyed any protection, and so,
19 should one take the risk if it's not really
20 delivering any benefit?
21 So, some method of developing endpoints
22 to understand the efficacy of those things seems,
1 to me, to be useful.
2 On the research agenda, I was most
3 impressed with the MRI findings that we saw at our
4 last meeting. And it seems to me that there will
5 be a number of things like this that won't
6 automatically come into that research via
7 proposals. So I think we need some perspective
8 way of encouraging certain kinds of research
9 topics to come into that program.
10 And then, finally, if I can Dave
11 Hamburg's lead, I think that we should have a "to
12 do" list that is very clear and that would help us
13 minimize these kinds of problems in the next
14 commitment of U.S. troops abroad.
15 We also should do -- or have in place at
16 the time of commitment, so that we understand what
17 the exposures were. And then -- so we can deal
18 with it much more effectively.
19 DR. LASHOF: David, what I'm doing at
20 this point is asking everybody what are their
21 priorities for the next 10 months' issues that we
22 need to address in the final report.
1 DR. HAMBURG: I'd particularly like to
2 echo John's point about stimulating the research
3 community to look at some of these questions. My
4 hunch is that they would tend to be
5 under-investigated or inadvertently neglected if
6 left to the usual mechanisms. We should seek some
7 way to stimulate the research community to look at
8 these questions in depth.
9 DR. LASHOF: Others?
10 From many one of the important issues --
11 and I'm sure it is for you, too, David -- is the
12 whole problem of psychological stress and the
13 impact on the immune system and the relationship
14 between psychological stress and physical illness,
15 and what kinds of predictors there might be that
16 would help us screen people in advance, where
17 we're going with treatment and working with
19 Every war has stressors. Every war
20 results in people who are going to suffer from
21 illness that is related to psychological stress.
22 I think we need a better understanding of where
1 that is, whether we need more research on it, what
2 kind of treatment protocols, and what we do to
3 explain that to veterans. I think one of the
4 concerns that I have is that if you mention
5 psychological stress, a veteran often feels like
6 we're just saying that everything is in his mind;
7 they're imagining their illness.
8 And we need to learn how to communicate
9 what the impact of this is on the physical
10 condition and get it recognized.
11 DR. HAMBURG: I agree very strongly. We
12 have to recognize, frankly, the fact that this has
13 historically been a stigmatized field. And
14 today's veterans still react in a somewhat -- in a
15 way that reflects that concern. And if you say it
16 is -- is this just reaction somehow; it's not
17 real. But, of course, it is real.
18 There's actually an immense and growing
19 body of research on the biology and psychology of
20 stress responses. That research was drawn
21 together in a definitive way about 15 years ago by
22 the Institute of Medicine.
1 As far as I know, there has not been a
2 similar definitive synthesis that's really
3 credible and intelligible by an authoritative body
4 like the Institute of Medicine.
5 On the other hand, there has been a
6 burgeoning of literature since then. It has
7 vastly more nuances since then, and this is a
8 subject that involves many different fields. And
9 I think that in some way we need to, at a minimum,
10 draw attention to the best available research
11 sources and to make some summary of knowledge
12 about that.
13 There's nothing occult about it.
14 There's nothing or remote or fanciful about it.
15 It is a very tough-minded set of interacting
16 scientific disciplines that illuminate a very
17 fundamental quality of human biology, namely a set
18 of stress responses that involve not only the
19 brain and nervous system, but the immune system,
20 cardiovascular system, and gastrointestinal
21 system, among others.
22 So, I think we really need to address
1 that, stigma or no stigma. To the extent we can
2 de-stigmatize it and make it reality, not fantasy,
3 we should do so.
4 DR. LASHOF: I think the other issue
5 that I don't know how we're going to address, but
6 I think we need to explore, is we've heard so many
7 anecdotal stories and various treatments being
9 And I think that was one of the issues
10 that was raised in the public comment this morning
11 is that you get anecdotal stories, you get various
12 treatments being used throughout the country by
13 different groups.
14 I don't know whether there is some way
15 we can look at some of this and make some general
16 recommendations of how one gets information out,
17 and how one stimulates appropriate research around
18 some of these difficult problems.
19 Any other additions? Robin, do you want
20 to now, further, sort of give a broad-brush view
21 of how the kinds of panels we expect to be looking
22 at? I know that we don't want to pin ourselves
1 down with a rigid work plan at this stage of the
2 game. We know we have all these issues, and the
3 staff will be meeting, and I'll be meeting further
4 with the staff to work on that.
5 I don't think we want to pin ourselves
6 down in this interim report as to a specific work
7 plan, because new information can come out, new
8 data can arrive that would lead us in different
10 But I think all of the issues that have
11 been raised by all of you, we will address. And
12 we will do it by a combination of staff
13 investigation, sub-panel meetings, and full panel
15 Do you want to say anymore on that?
16 MS. NISHIMI: No. I think we heard
17 about eight or nine sort of areas of interest here
18 that can be captured in the fashion that Joyce has
19 outlined -- that is, a full committee meeting with
20 invited testimony from independent scientists
21 and/or government scientists, for example, and
22 supplemented by committee work -- staff work that
1 would have been done in advance through literature
2 view, interviews, and perhaps a site visit.
3 Then bring before the committee a
4 combination of staff work and new testimony for
5 the committee to scrutinize. Then, to do as we
6 did in San Diego: Prepare briefing materials,
7 summarizing that, with possible staff
8 recommendations in any one of these particular
9 areas, outreach, clinical access, et cetera.
10 Have the committee again review possible
11 recommendations to consider and findings and then
12 proceed, obviously, to a final draft.
13 DR. LARSON: Joyce.
14 DR. LASHOF: Elaine. Yes, please.
15 DR. LARSON: I wonder if we shouldn't --
16 and maybe, Robin, you're already doing this, but
17 our charge, which is on Appendix A -- why don't we
18 think about drafting the final report exactly as
19 the functions are laid out in section 2, with
20 those sections?
21 MS. NISHIMI: It is our intention to --
22 DR. LARSON: Okay.
1 MS. NISHIMI: -- address each element of
2 the charge, specifically, the final report, I
3 guess. It might not be in that order, but, yes,
4 that is what we've been tasked to do by the
6 DR. LASHOF: I guess the only chapter
7 that we don't have as a specific chapter, at this
8 point, that appears on the charter, is the one on
9 coordination -- coordinating efforts. Although,
10 we discuss context in each of the areas,
11 specifically, we didn't research --
12 MS. NISHIMI: Similarly with the
14 DR. LASHOF: -- implementation.
15 MS. NISHIMI: I think we could make a
16 judgment, as we move through this process, whether
17 in fact the final report breaks those out, or
18 whether we adopt a structure, you know, that's
19 literally seven items. I don't think I could say,
20 right now, what the best possible way to present
21 that prose would be.
22 DR. LASHOF: I think there probably is
1 no question that -- well, there's always a
2 question; we can always change our mind -- but
3 that there be addressed, in the final report, an
4 overview of the complexity which we got ourselves
5 into in this situation. And much of what we
6 talked about -- making recommendations and the
7 future of what the government should do -- should
8 be designed to avoid our having the complexity of
9 the charts we see here. And the number of
10 different groups looking at the issue from
11 different perspectives.
12 DR. CAPLAN: Exactly. I was just going
13 to follow-up.
14 Elaine's comment reminded me that the
15 one thing that we don't say much about is an
16 analysis of exactly that set of studies, groups,
17 reviews, that has taken place. And I think it is
18 very important in the final report that we just
19 tease that out more and say why we're there.
20 Seven or eight groups that took a look
21 at this, and then required somebody to step in and
22 see whether that was enough or wasn't enough, in
1 this area, what ought to be done in future with
2 respect to that analysis of different types of
3 health issues, or care issues that might come up,
4 post a conflict, or a deployment.
5 So it's reviewed in here, that certainly
6 the documents and studies are mentioned. But we
7 don't really peer-review them, we just kind of
8 list them. And we haven't bit that bullet yet.
9 DR. LASHOF: Well, that does raise a
10 question, your last statement -- we don't
11 peer-review previous studies, other studies. I
12 don't know how much we want to peer-review the
13 studies. I think we want to discuss the fact that
14 there had to be these vulnerable studies, and
15 where they --
16 DR. CAPLAN: I would even make that,
17 Madam Chairman, to comment upon.
18 DR. LASHOF: Okay.
19 MS. NISHIMI: Okay. I was just a little
20 troubled, too. So I'm not troubled anymore.
21 DR. LASHOF: Are there others?
1 DR. HAMBURG: I understand that they're
2 just starting an inquiry similar to ours in the
3 U.K. And they expect to go two or three years, so
4 obviously we can't wait for their conclusions.
5 On the other hand, my impression is
6 they've put together an excellent panel of
7 scientists. And it seems to me it would be wise
8 for the staff to be in touch with them -- maybe
9 that has already happened -- primarily to get a
10 sense of their electoral framework they're using
11 and the major purchase -- the problem that they're
13 And also, the technical resource they're
14 drawing upon, some of which may have been
15 classified in Britain until recently. But, in any
16 case, to find out what they're doing and see if
17 there's any way in which we can benefit from it.
18 MS. NISHIMI: Yes. We're aware that the
19 U.K. study was just announced. And we've actually
20 some preliminary contact already with individuals
21 involved in the issue in Britain, just because of
22 committee interests ancillary to the fact that
1 they're now doing their own study.
2 DR. LASHOF: That's very interesting.
3 Okay. Well, then, shall we go back to
4 chapter 10 -- chapter 6, the next 10 months, and
5 see whether there are any further comments?
6 I think we understand that we probably
7 need to clarify at various places with phrases
8 like, "the committee will extend its review" or
9 "will add to the previous work" and, you know,
10 those kinds of phrases, periodically, so that it
11 doesn't look like we've ignored the fact that
12 we've already done some work on this.
13 But that there are some other issues
14 that need to be explored. And if we can highlight
15 some of those, we put them in.
16 But I will say that we were deliberately
17 vague in writing the last chapter, so as to
18 highlight the major things we want to look at, but
19 not walk ourselves into a rigid plan that we may
20 want to change as new developments come along.
21 If others feel that we've gone too far
22 in being too vague, and need to be more explicit,
1 I'm open to further discussion on that point.
2 MS. NISHIMI: Well, if there was
3 anything that was said today that changes the
4 nature of the report, it would be helpful to add
5 it. Otherwise, understanding what that's supposed
6 to do in that chapter, I think it's all right.
7 DR. LASHOF: Okay. Is there any other
8 business to come before us this morning?
9 I mean, this is record time. John and
10 I, we've brought you from California, and me from
11 Africa on the way back to California. But I've
12 put in a few days.
13 I really am pleased. I'm very pleased
14 both with the staff work and with the committee
15 work, as well as the amount of work that has gone
16 on over the last several months that leads us to
17 be able, within a couple of hours, to essentially
18 put our stamp of approval on what I consider a
19 very -- really excellent interim report.
20 In a sense, it's almost the beginning.
21 It's still got a lot to do. And I think we'll
22 have a fascinating 10 months ahead of us with a
1 lot of work.
2 If there are no other issues to come
3 before us, I'll turn it over to Cathy to close the
4 meeting. And I just want to say thanks once more.
5 MS. WOTEKI: Before I do that, Robin,
6 would you like to announce the site of the next
7 committee meeting?
8 MS. NISHIMI: Sure. There will be a
9 panel meeting in San Antonio, on February 27th,
10 looking at clinical syndromes. And then there
11 will be a full committee meeting that's
12 tentatively been scheduled for March 26th, in
13 Boston, Massachusetts.
14 MS. WOTEKI: And, I guess, in my
15 capacity as designated federal official, this
16 committee meeting is now adjourned.
17 (Whereupon, at 10:40 a.m., the
18 hearing was adjourned.)
19 * * * * *