January 31, 1996






















Committee Chair
3 School of Public Health
University of California, Berkeley 4
Berkeley, California

Professor of Chemistry
6 California Institute of Technology
Pasadena, California
8 Director Center for Bioethics and
Trustee Professor of Bioethics 9
University of Pennsylvania
Philadelphia, Pennsylvania
Senior Medical Advisor
Health Policy Department
12 Paralyzed Veterans of America
Washington, D.C.
14 President, Carnegie Corporation of.
New York
15 New York, New York

Chairman and Chief Executive Officer 17
Federal National Mortgage Association
Washington, D.C.
Clinical Assistant Professor
20 College of Nursing
University of South Carolina
21 Columbia, South Carolina

Ethel H. Wise Professor.
2 Chairman, Department of Community
3 Mount Sinai School of Medicine
New York, New York
5 Dean, Georgetown University School of
6 Washington, D.C.

8 San Antonio, Texas

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

11 session.

12 DR. LASHOF: Thank you very much,

13 Catherine.

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

3 carried.

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

17 conditions.

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

21 conditions.

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

3 that.

4 In addition, chronic fatigue, multiple

5 chemical sensitivity, and fibromyalgia overlap to

6 a significant degree in the archives of Internal

7 Medicine.

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

16 start.

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.

11 Donnay?

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

20 gentlemen.

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

15 that.

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

16 time.

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

10 sent.

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

6 perusal.

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

12 manner:

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

1 staff.

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?


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

5 quickly.

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

16 that.

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.


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

1 deployment."

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

8 that.

9 DR. LASHOF: Yes, I think the sample

10 size, you know, is dependent on how big the total

11 population is.


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

21 epidemiology?

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

17 that.

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,

5 maybe.

6 MR. NALLNER: That's correct. April is

7 correct.

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

11 complete?

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

19 December.

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,

8 please.

9 MS. GWINN: "Most of the studies

10 examined by the committee appear to be

11 well-designed and appropriate to answer these

12 questions."

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

6 recommendations?

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

17 committees."

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.

3 John.

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

17 program.

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

21 report.



1 interesting, I think, before the final report to

2 understand exactly where that responsibility is

3 placed.

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

15 recommendations.

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.


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

20 findings."

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

8 doing?

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

16 recommendation.

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


1 appropriate.

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

7 possible.

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

20 versa.

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

5 this.

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

7 assessment.

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

13 records.

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

15 all.

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

21 duplicative.

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

17 items.

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

16 here.

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.


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

7 questions?

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

19 right?"

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

4 correct.

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

19 recommendation.

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.

12 Art?

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

10 procedures.

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

4 closely.

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

13 here.

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

1 okay.

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

6 do.

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

11 changes.

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

22 goals.


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

5 doing.

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

10 more.

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

8 audiences.

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


1 chapter.

2 All right. Why don't we take 20 minutes

3 or so, and come back at 10:15 a.m.

4 (Recess)

5 DR. LASHOF: I know we've moved very

6 quickly, so everyone took an even longer coffee

7 break.

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


1 months.

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

15 Marguerite.

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

18 veterans.

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

8 tried.

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

9 directions.

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

14 meetings.

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

5 President.

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

13 implementation.

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?

22 David.

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

12 taking.

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 * * * * *