December 4, 1995


Wyndham Emerald Plaza 400 West Broadway Crystal Ballroom

San Diego, California


9:30 a.m.



Advisory Panel Members:

JOYCE C. LASHOF, M.D., Committee Chair

School of Public Health

University of California, Berkeley

Berkeley, California


Professor of Chemistry California Institute of Technology Pasadena, California


Bell Industries

Meriden, Connecticut

ADMIRAL DONALD CUSTIS, M.D. (Ret.) Senior Medical Advisor

Health Policy Department

Paralyzed Veterans of America Washington, D.C.

CAPTAIN MARGUERITE KNOX, R.N.C., M.N., C.C.R.N. Clinical Assistant Professor

College of Nursing

University of South Carolina Columbia, South Carolina



San Antonio, Texas

ANDREA KIDD-TAYLOR, Dr.P.H. Health and Safety Department United Auto Workers

Detroit, Michigan

Staff Members:

Holly Gwin

Mark Brown

Lois Joellen Beck, Ph.D.

Joe Cassells

Joan Porter

Thomas McDaniels, Jr.




Captain Don Sprague, M.D., USN 7

Coronado, California

Staff Sergeant Robert Rorick 14

Persian Gulf War Veteran

Battalion Operations Chief

Camp Pendleton, California

Karen Rorick 27

San Diego, California

Pat Broudy 33

National Association of Atomic Veterans

Monarch Beach, California

Jay Brady 37

Retired Physicist

Nevada Test Site

Ruth McGill, M.D. 41

Consultant to Persian Gulf War Veterans

San Angelo, Texas

Sandy Schoppert, R.N. 51

Persian Gulf War Veteran

San Diego, California

Karen McCarthey 63

Wife of Persian Gulf War Veteran

San Clemente, California

Andrew Urbanc, M.D., USN (Ret.) 71

Fallbrook, California

Susan F. Franks, Ph.D. 75

University of North Texas

Health Science Center

Fort Worth, Texas.

Charles Thomas, Ph.D. 83

Pantox Laboratories

San Diego, California


I N D E X (Cont'd.)


Brian Ross, M.D. 87

Huntington Medical Research Institute

Pasadena, California

Kenneth Kizer, M.D. 91

Under Secretary of Health

Department of Veteran Affairs

Washington, D.C.

Chairperson Joyce Lashof, M.D. 114

Report on Subcommittee Meeting

San Francisco, California

Mark Brown 129

Federally Funded Research on

Persian Gulf War Veterans

Lois Joellen Beck, Ph.D. 144

Findings and Recommendations on

Epidemiologic Studies

Mike Kowalok 151

Depleted Uranium Uses


1 P R O C E E D I N G S

2 (9:33 a.m.)

3 MS. WOTECKI: Good morning. I'm Catherine

4 Wotecki. I'm the acting associate director for science at

5 the White House Office of Science and Technology Policy.

6 I'm also the designated federal official for this committee

7 and, in that capacity, I am required to open and to close

8 all of the committee's meetings so this meeting of the

9 Presidential Advisory Meeting on Gulf War Veterans'

10 Illnesses is now in session.

11 CHAIRPERSON LASHOF: Thank you very much, Cathy.

12 I'm Doctor Joyce Lashof, chair of the committee,

13 and I want to assure you that Cathy Wotecki does more than

14 just open and close meetings. She's a very valuable and

15 important person in the work of our committee.

16 It's a pleasure for us to be able to be here in

17 San Diego and welcome all of you to this meeting.

18 It's a special pleasure for me this morning to

19 introduce a new member of the committee. As many of you

20 know, and certainly the committee knows, that General Franks

21 had to resign for personal reasons but I'm extremely pleased

22 to welcome Mr. Thomas Cross who the President has just

23 appointed to this committee. And thanks to a lot of quick

24 staff work we were able to get Mr. Cross here for this

25 meeting.


1 Mr. Cross is a major in the Marine Corps Reserve

2 and during Operation Desert Shield/Desert Storm he

3 participated in the initial attack across the Kuwaiti border

4 in February of 1991 and obviously is well aware of the

5 problems that our veterans faced in the Gulf War, and it's a

6 special pleasure to have him with us.

7 Mr. Cross.

8 MAJOR CROSS: Thank you. Thank you, Doctor

9 Lashof.

10 It's a pleasure being here and I think, although I

11 don't come with many credentials from academia, I think the

12 unique thing I bring is I was there actually on the ground

13 during the war, and hopefully I can add some insight to the

14 committee's work here. Thank you.

15 CAPTAIN KNOX: Thomas, I would like to say I

16 really appreciate you being on the committee. It gives

17 another insight of someone who was there.

18 MAJOR CROSS: Thank you.

19 CAPTAIN KNOX: So you're very appreciated.

20 CHAIRPERSON LASHOF: I think without further ado,

21 then, we'll proceed with the public comment. As you know,

22 all of our meetings we devote the morning session to

23 comments from the public. The first person who will speak

24 is Captain Sprague.

25 //



2 DOCTOR SPRAGUE: Good morning. I'm captain Don

3 Sprague. I'm a senior medical officer on an aircraft

4 carrier and I'm here because of my personal interest and

5 experience. I was given a call last week inviting me to

6 speak and I'm not in any way acting as a representative of

7 the Navy and I'm going to have to get back to the ship as

8 soon as we finish here, so that's why the suit.

9 I spent years in family practice, occupational,

10 and environmental medicine prior to coming back on active

11 duty, and currently, as I mentioned, I'm the senior medical

12 officer and I'm specializing in preventive and aerospace

13 medicine.

14 There have been a number of high-quality studies

15 involving Gulf War illness. There's currently a study

16 involving 18,000 subjects, to be released shortly, where

17 there was no definite link found between the Gulf War

18 Theater and the symptoms relating to the Gulf War illness.

19 The CCEP identified a number of diseases in these

20 patients that were statistically the same as the general

21 population. In other words, no epidemiological explanation

22 has been found for the Gulf War illness to this point.

23 There were extremely sophisticated tests done,

24 giving the best we had to offer, including CAT scans and

25 MRIs at our best medical centers. Now, my suggestion is at


1 this point it's time to narrow the search. Specifically to

2 investigate the immune system and the detoxification enzyme

3 systems, such as was outlined in the National Research

4 Council's report, "Biological Markers in Immunotoxicology."

5 This was published by the National Academy Press in 1992,

6 and the whole question of an immune dysfunction secondary to

7 environmental insult is addressed in this book.

8 There are specific tests that can be run, such as

9 B cells, T helper, and suppressor cells, human natural

10 killer cells, immunoglobulins, and, as far as the enzyme

11 detoxification systems, you can now measure cytochrome P450

12 which is one of our major defense mechanisms.

13 Now, the known sources of environmental insult to

14 the Gulf War veterans were petrochemical, pollution from the

15 oil fires; pesticides used in the field and in the tents to

16 control insects; and fuel contaminated drinking and shower

17 water. There are techniques now that are available using

18 gas chromatography and mass spectrographic analysis to

19 identify and quantify the chemical pollutants in the blood,

20 particular from petrochemical exposure. These are called

21 volatile organic chemicals, benzines is one that's well

22 known. And we can also identify organophosphate pesticide

23 residues in the urine in concentrations as low as a tenth of

24 a part per billion. This has been equivalent to an ounce of

25 dye put in the Mississippi River and later collected down in


1 New Orleans, and you can identify that concentration using

2 these techniques.

3 Doctor John Lassiter, of Acuchem Laboratories, in

4 Richardson, Texas, developed this technique while working

5 with NASA to investigate the pollution levels of off-gassing

6 in equipment in the early space shuttle. So, this has been

7 around a while and has been adapted at least 10 or 15 years

8 ago to identify chemical pollutants in the blood and in the

9 urine.

10 In 1993, I presented a thesis at San Diego State

11 University of 350 patients who had been referred to this lab

12 for suspected organophosphate exposure. Five-percent of

13 these patients -- five-percent of the 350 -- had the

14 presence of organophosphates verified in the urine weeks to

15 years after initial single exposures.

16 Now, organophosphates are usually metabolized in

17 24 hours and if you examined these tissues weeks to years

18 later you would normally find nothing. All but two of these

19 patients has severe health problems, and there's 13 out of

20 the 15 with a range from depression and dementia to

21 myasthenia gravis and parkinsonism. Similar work can also

22 be done with petrochemical exposure and the volatile

23 chemicals as I outlined, particularly benzine can be

24 quantified.

25 Over the course of my medical career, I have


1 worked with farmers and their families with

2 pesticide/herbicide exposure. I worked with Vietnam vets.

3 I worked with people with industrial chemical exposures and

4 found that often the presenting symptoms are similar,

5 particularly mental confusion, short term memory loss, mood

6 swings, decreased ability to concentrate, and also fine and

7 gross motor skills and coordination, hand/eye

8 coordination -- picking up small things -- has been

9 affected. And there are now tests available to

10 differentiate between psychiatric illness and symptoms

11 caused by environmental insult. There will be a

12 presentation later by Doctor Franks of a test that is short,

13 simple, and inexpensive that can do this. If you recall,

14 Doctor Joel Butler published his first paper on pesticides

15 and brain dysfunction 15 years ago. This is not new stuff.

16 I suggest that a subgroup of patients that have

17 demonstrated no organic disease entities be examined with

18 emphasis on neuropsychological testing. Second, using GC

19 mass spec with laboratories such as Acuchem, and there are

20 at least four other labs in the United States that can do

21 this work, to identify patients who as yet are unable to

22 break down these chemicals.

23 Third, immune system and detoxification enzyme

24 studies.

25 Finally, please keep in mind that the end results


1 of immune dysfunction may not manifest themselves for 15 to

2 20 years after the initial insult.

3 Lastly, while there are symptoms that have been

4 attributed to stress it's important to remember that

5 emotional stress is only one part of the stress pie which

6 includes significant stress caused by environmental insult.

7 That's all I have. Thank you.

8 CHAIRPERSON LASHOF: Thank you. Are there

9 questions from the committee?

10 CAPTAIN KNOX: I'd like to ask a question. Could

11 you tell, me are you looking at the T cells and the B cells

12 and seeing if they remember that they were exposed to

13 organicphosphates?

14 DOCTOR SPRAGUE: No, ma'am. Particularly we're

15 looking for T suppressor cell depletion. We found that the

16 T suppressor cells are particularly sensitive to

17 environmental insult. It was shown, probably 10, 12 years

18 ago, that with a 15-minute exposure to an environmental

19 concentration of formaldehyde you can knock out 50-percent

20 of those cells. So I think they're a good early marker for

21 people who are unable to recuperate and recover in a normal

22 fashion, also immune complexes are generated with these as

23 the body's response to the insults. And it's particularly

24 important if you find out that there are sections of the

25 immune system that have been depleted so that a person can


1 no longer fend off environmental insults.

2 CAPTAIN KNOX: So it could be the B cells that are

3 affected as well?

4 DOCTOR SPRAGUE: Precisely.

5 CAPTAIN KNOX: And they would be susceptible to

6 other bacteria in the environment?

7 DOCTOR SPRAGUE: That's the whole problem. Once

8 you knock out your first line of defense, it opens the door

9 to autoimmune disease, it opens the door to infection and a

10 host of other diseases.


12 DOCTOR KIDD-TAYLOR: This is a study of 18,000

13 U.S. Navy personnel?

14 DOCTOR SPRAGUE: No, ma'am.

15 DOCTOR KIDD-TAYLOR: Who is this study of?

16 DOCTOR SPRAGUE: This study is going to be

17 published shortly. I was given this information through a

18 conversation with the Navy Human Research Center here in San

19 Diego. I don't have the specifics but they weren't

20 specifically Navy people that were involved in this study,

21 is my understanding.

22 DOCTOR KIDD-TAYLOR: And the second question. You

23 mentioned there were 350 patients who had the presence of

24 organophosphates?



1 DOCTOR KIDD-TAYLOR: Were all those patients who

2 had served in the Gulf War?

3 DOCTOR SPRAGUE: No, ma'am, none of these patients

4 were in the Gulf War. This is a cross section of the United

5 States. People referred from all over the United States.

6 My point was that five-percent of these people were unable

7 to metabolize the pesticides and the health results were

8 severe as a result of their inability to break these things

9 down as most people can.


11 CHAIRPERSON LASHOF: Do you know whether in the

12 comprehensive assessment, the CCP protocol, in which the

13 Department of Defense has examined veterans, whether any of

14 the tests you've referred to are part of that protocol?

15 DOCTOR SPRAGUE: My understanding with the

16 conversations I've had, with people involved both in

17 Washington and here in San Diego, is that the immune system

18 was not looked at specifically.

19 CHAIRPERSON LASHOF: And those who were found --

20 there's a subgroup in that, if I understand the study, who

21 are referred to one of the specialty centers for those with

22 severe symptoms.

23 DOCTOR SPRAGUE: Yes, ma'am.

24 CHAIRPERSON LASHOF: Do you know whether the

25 specialty centers have looked at this issue?


1 DOCTOR SPRAGUE: My understanding is that they

2 have not. They look more at conventional disease than they

3 do immune system dysfunction. And my understanding is that

4 there is no data at this point involving T cells, B cells,

5 or the cytochrome P450 system.

6 CHAIRPERSON LASHOF: Okay. Any other questions?

7 (No response.)

8 CHAIRPERSON LASHOF: If not, thank you very much.

9 We appreciate your testimony and I'm sure it's something

10 we'll follow up on.

11 The next person I would like to call is Staff

12 Sergeant Robert Rorick.


14 STAFF SERGEANT RORICK: Good morning, ladies and

15 gentlemen. My name is Robert Rorick. I've been in the

16 Marine Corps for almost 17 years. I'm currently an

17 operations chief in an infantry battalion.

18 My most recent trip to the Gulf was from May to

19 December of '92. I'm not really going to discuss too much

20 about my symptoms, my wife knows a lot more about that then

21 me because she does all the research and studying and

22 reading and asks the doctors. I'm going to talk about or

23 bring to your attention the lack of urgency or the lack of

24 care or importance that is given by the hospital, the

25 military hospital that I go to. But, because of that, I


1 need to share a few symptoms with you.

2 Can you all see this rash on my face? I'm sure

3 you can up here in front. I've had this rash ever since

4 I've been back from the Gulf. No one can tell me what it

5 is. Some of my other symptoms are my joints, different

6 joints, throughout my body are always sore and stiff. Like

7 right now my jaw joints are so sore that I couldn't even

8 chew on a piece of gum right now if I needed to.

9 We are both registered with the VA Gulf War

10 Syndrome Registry. This past fall we done that. When we

11 first started to seek out care, very eagerly, the local VA

12 office in Vista, California, told us that -- the gentleman's

13 name was Pete -- he said that when you go to Camp Pendleton,

14 and he mentioned a few doctors by name, and I'm not here to

15 insult any doctors so I'm not going to get into names, he

16 said you're going to be brushed off. You're going to be

17 gaffed off. And I said, yeah, okay. Sure, whatever. And

18 just sort of took it in one ear and out the other. But, as

19 we came to find out, he was very true.

20 We've been trying, or I've been trying since early

21 October, two months now, to get myself evaluated and get

22 myself an appointment. I can't get it done. "Oh, he's in

23 Tucson," or "He's here," or "He's there," or "We're full."

24 And I understand that -- you know, I don't expect the Marine

25 Corps or the Navy or anyone to drop -- the whole Marine Corp


1 to drop and stop existing just for me, but I think two

2 months is unsatisfactory to try to be seen.

3 To this day I still have no appointment. I have

4 nothing, just a lot of pain and discomfort and this rash

5 that I wear every day, I guess for the rest of my life. I'm

6 not sure. No one can tell me.

7 I think the key thing is, I can get an appointment

8 with a doctor but it's just a GP. I need to be seen, as the

9 captain stated, I need to be seen by an internal medicine

10 specialist or an occupational health specialist, and those

11 are the doctors that always either too busy or somewhere

12 else or there's not enough of them. I'm not sure. I get a

13 different excuse every time. Again, I don't want this to

14 sound like a personal attack because it's not.

15 In the same time frame, my wife has also been

16 seeking care for her symptoms which she shortly started

17 getting after I returned. She has been seen one time and

18 this doctor had no experience in the Gulf War Syndrome.

19 This doctor was a general practitioner. She was originally

20 scheduled to see an occupational health specialist and the

21 doctor was gone, so instead of -- and I understand that

22 military doctors do go TAD -- temporary assigned duty other

23 places -- but instead of rescheduling her at a later time,

24 they sent her, "Oh, we'll just send you to see a GP." So

25 that tells me it's not important to the military, or at


1 least the military doctors, or at least this hospital right

2 up the coast here. They just sent her to see a GP.

3 Some of the thins the doctor asked my wife, the

4 doctor asked my wife, "State some of your symptoms." So my

5 wife started to rattle off some of the symptoms and the

6 doctor goes, "No, no, not those symptoms, the symptoms that

7 apply to the Gulf War."

8 My wife goes,"Well, these are. These are the

9 symptoms I've been having since my husband's return from the

10 war."

11 "Well, those aren't important. Don't worry about

12 those." But yet this is someone we -- when I say "we," the

13 military -- appointed in a place of authority to check these

14 kind of things out.

15 My wife was given blood tests for things that

16 don't even show up in blood tests, and my wife will discuss

17 those; leishmanitis and a few other things. She was told by

18 the pathologist the test she needed they don't even do at

19 that hospital for Camp Pendleton. That was straight from

20 the pathologist, Commander -- I forget her name right now

21 but she's the head pathologist at Camp Pendleton.

22 The did the exam without my wife's medical record

23 present, so they could tell no history. Again, I'm just

24 trying to share these little things with you to show that

25 this one particular hospital they just don't care. Now, if


1 one of called to say, "Hey, is this important to you guys?"

2 they're going to tell you yeah. They're going to give you

3 lip service, but if one of you were to throw on a military

4 uniform and just walk around there you'd be amazed.

5 My wife asked some questions. Like I said, my

6 wife has done a lot of reading and a lot of research and my

7 wife asked very specific questions. They either weren't

8 answered or she was told not to worry about it. To me, if

9 every -- I would expect, if I was a civilian paying a

10 doctor, all my questions better be answered. I mean, that's

11 what I'm paying that doctor good money for is to answer a

12 question, not to gaff me off.

13 I know this is going to sound funny but this is

14 true. This rash that I have, my wife has it. Not near as

15 severe as me. The doctor said, "Oh, that rash, Mr. and Mrs.

16 Rorick, that's from when you blow your nose, the tissue rubs

17 against your face," and I've never, never, in my almost 17

18 years in the Marine Corps, not even in boot camp, have been

19 so belittled. I felt just like asking the lady, you're not

20 talking to a five-year-old kid here. You're talking to

21 someone who served his country for nearly 17 years, and to

22 get some kind of answer like that, that is ridiculous. And,

23 again, if I was a civilian paying big money for some

24 ridiculous answer like that, I think I'd be seeking another

25 doctor. But yet we pay this doctor on the 15th and the 1st


1 of every month, big money I'm sure. A lot more than a staff

2 sergeant makes.

3 In closing. I still don't have an appointment.

4 I'm still trying to get one. My wife's been trying. I've

5 been trying to reschedule my wife to see an actual

6 occupational health doctor or an internal medicine doctor,

7 still to no avail. I filled out all the proper complaint

8 forms. Went and actually saw the complaint department

9 people and I told them, "Hey, look, my bottom line here is

10 to get care. If the guy's gone, that's fine, but let's get

11 me care." Well, this and that and I go, "Well, what about

12 the doctor who told my wife I got this rash from a tissue,

13 what's up with that?" They don't want to talk about that,

14 and that doctor still works there to this day.

15 I think the VA -- You know, I told you in the

16 beginning that the VA was -- told me, "Hey, you're going to

17 be gaffed off. You're going to be treated like dirt," and I

18 took that in one ear and out the other, but every day I deal

19 with the hospital it's true, the VA -- Pete was absolutely

20 correct, they don't care. Again, now, if one of you went up

21 there in an official capacity, they're going to tell you

22 they care. They're going to show you all these charts and

23 graphs and everything, how many people they see, but when it

24 comes to where the rubber meets the road, or where the

25 patient needs the care, it's not there. It's just not


1 there.

2 I want to reference two things. Executive Order

3 1296 signed May 26, '95, and Public Law 103-446 signed

4 November 2, 1974, establishes a committee of experts that

5 report to the President. I wish these experts, and if

6 that's you, I mean, great, but I wish these experts could

7 follow me to the hospital and see what me and my wife have

8 to go through just to get care in this one particular area.

9 I'm not saying all their care is bad, because it's not. A

10 lot of their care is good, but when it comes to the Gulf War

11 they don't want to hear it.

12 One last note that I put down here real quick

13 before I walked in this morning. They say, "Well, it's

14 psychological. You have psychological problems, staff

15 sergeant." But yet this lady, this doctor, she was not a

16 psychologist but yet me and my wife's problem is

17 psychological. So, you know, I don't know how she can make

18 that assumption. I'm an infantryman, I'm not a tank

19 mechanic. That would be like me telling a tanker,"Oh, you

20 need a new engine in this tank." I have no expertise in

21 that area, I wouldn't know.

22 And, if it was a psychological problem, why didn't

23 they refer me to the psychological department at the

24 hospital?

25 Have a nice day. See you later.


1 CHAIRPERSON LASHOF: Thank you very much. I hope

2 you'll be willing to answer some questions.

3 STAFF SERGEANT RORICK: Yes, ma'am, I'd love to.


5 DOCTOR KIDD-TAYLOR: Are you still on active duty?

6 STAFF SERGEANT RORICK: Yes, ma'am, I am.



9 DOCTOR KIDD-TAYLOR: And both you and your wife

10 served in the Gulf?

11 STAFF SERGEANT RORICK: No, ma'am. My wife

12 didn't. I came home, about three months after I came home

13 my wife started experiencing some of the same symptoms that

14 I have.

15 MAJOR CROSS: Staff Sergeant, can you give us that

16 time frame again when you were over there?

17 STAFF SERGEANT RORICK: My last tour, sir, was

18 from -- My most recent tour was May to November of '92. It

19 was the first time that we really went back after the war.

20 All the media was over there covering it.

21 MAJOR CROSS: Had you been there during the war,

22 though?


24 MAJOR CROSS: I'm sorry?




2 RR: Do you have any personal knowledge as to what

3 you think you were exposed to while you were there?

4 STAFF SERGEANT RORICK: Sir, I can tell you a lot

5 of things I saw. I saw a lot of dead animals that we lived

6 in -- lived near, around. The captain was talking about

7 showers, I wasn't given a shower when I was there.

8 Sometimes we'd just sort of shake out our clothes but as far

9 as a shower, we never received one.

10 We saw -- We would go through pools of oil. You

11 know, from the fires and stuff we'd go through pools of oil.

12 I don't know -- I'm not an expert enough to say if there's

13 any microorganisms in that stuff or not. I don't know. We

14 ate some of the local food. I know a lot of people got

15 sick. I don't know if it was just food poisoning or not

16 used to that food or what.

17 CHAIRPERSON LASHOF: When did your symptoms first

18 develop?

19 STAFF SERGEANT RORICK: I returned to the United

20 States, ma'am, in November of '92, on my most current trip.

21 I would say around January of '93.

22 CHAIRPERSON LASHOF: And where did you seek care

23 first? Has it always been here at Camp --

24 STAFF SERGEANT RORICK: My first, at my battalion

25 aid station, through the corpsman, and then they referred me


1 to the Camp Pendleton Naval Hospital, and that's as far as

2 I've gotten.

3 CHAIRPERSON LASHOF: You've been at Camp Pendleton

4 since '92 and this is three years of your trying --

5 STAFF SERGEANT RORICK: I've been stationed at

6 Camp Pendleton since '91, ma'am, and they have a fairly big

7 hospital there but I've never been referred anywhere else

8 but there and this where I've been the last year, where

9 we've been receiving all our care on this one area.

10 CHAIRPERSON LASHOF: Okay. So it's been for the

11 past year that you've been trying to see a specialist, not

12 for the past three years. I'm trying to --

13 STAFF SERGEANT RORICK: Exactly. Exactly right,

14 ma'am, the last year we've been trying to see the right kind

15 of people. You have to go through a lot of -- in the

16 military, or at least in the Navy medical, before you can

17 see a specialist you have to see a lot of other people and

18 it takes a long time to get to see a specialist.

19 DOCTOR KIDD-TAYLOR: But you have seen general

20 practitioners in that time frame, though. You've been to

21 other physicians but you weren't able to get a referral?


23 CHAIRPERSON LASHOF: Has the general practitioner

24 indicated that he feels you should have the referral and is

25 trying to get you the referral, or are you trying to -- do


1 you have to try to go around them to get the referral?

2 STAFF SERGEANT RORICK: They -- I've been told by

3 several people, ma'am, that I should be see by a specialist.

4 I've been trying to make an appointment. In fact, on the

5 7th of this month I have an appointment to make an

6 appointment.

7 CHAIRPERSON LASHOF: Okay. I think I --

8 STAFF SERGEANT RORICK: It's sort of like inside

9 the "beltway," works sort of the same way.

10 DC: You did mention, Sergeant, VA. Have you had

11 experience with the VA hospital in this --

12 STAFF SERGEANT RORICK: No, sir, I've never seen

13 the VA Hospital. We called the VA office out in Vista,

14 California, sir, which is just south of Oceanside, and they

15 were the ones that told us to beware of the lack of priority

16 given this illness at Camp Pendleton. But I've never been

17 to a VA Hospital, sir.

18 DOCTOR CUSTIS: Somebody in the VA told you to

19 beware of Camp Pendleton Naval Hospital, is that correct?

20 STAFF SERGEANT RORICK: Yes, sir, that is correct.

21 DOCTOR CUSTIS: Can you be more specific who told

22 you that?

23 STAFF SERGEANT RORICK: His first name is Pete.

24 What's his last name?

25 MRS. RORICK: Ehlich.


1 STAFF SERGEANT RORICK: Pete Ehlich. I believe he

2 runs the VA office out in Vista.

3 DOCTOR CUSTIS: Can you spell his last name?

4 STAFF SERGEANT RORICK: I believe my wife can.


6 MAJOR CROSS: Staff Sergeant, have you considered

7 seeking outside professional help? Unfortunately, the down

8 side of it, that would be out of your pocket expense.

9 STAFF SERGEANT RORICK: Exactly, sir. I'm just a

10 staff sergeant. I make about $19,000 a year. I would

11 expect to see a specialist on the outside -- you know, my

12 income wouldn't even come close. If my commander and chief

13 would like to pay for it, I'd love to though.

14 DOCTOR CUSTIS: You know you do have the

15 prerogative of your own initiative of going to the VA

16 Hospital in San Diego. Have you thought of that?

17 STAFF SERGEANT RORICK: Yes, I've tried that.

18 They asked where is my referral from the Camp Pendleton

19 Hospital. And I can't even get a referral to a specialist,

20 let alone to another hospital.

21 CHAIRPERSON LASHOF: Have you asked specifically

22 of the doctor you're seeing at Pendleton for a referral to

23 San Diego hospital?

24 STAFF SERGEANT RORICK: Yes, ma'am, and they say,

25 "Before we send you down there, why don't we see you here


1 first?" and my response to that is, "When am I going to be

2 seen here?"

3 "Well, you have an appointment to make an

4 appointment."

5 CHAIRPERSON LASHOF: Okay. Are there other

6 questions?

7 MAJOR CROSS: Staff Sergeant, obviously being

8 affiliated with the Marine Corps, there's a process of

9 request mass for chain of command. Have you done that with

10 your --

11 STAFF SERGEANT RORICK: Sir, I haven't officially

12 requested mass. I have sat down with my sergeant major. I

13 had a sit-down with the colonel, and talked to them and

14 shared my concerns. You know, which is really no difference

15 than a request mass except one is official and one is not

16 official. But they say whatever we can do to help you out.

17 I tell them my concerns. I tell them who I see and it's --

18 They want to help but -- and this is just my impression and

19 I'm not saying this is the way it is -- when it comes time

20 to ruffle feathers, they're a little gun shy. And I think

21 that's the way it is in the whole medical area, at least in

22 my experiences, concerning this whole Gulf War Syndrome is,

23 "Well, help you out as long as we don't have to ruffle no

24 feathers or make things happen," you know, or hurt someone's

25 feelings. But I'm to the point that I'm not concerned about


1 feelings anymore because my wife and I just -- we suffer too

2 much.

3 CHAIRPERSON LASHOF: Thank you very much. I think

4 we will proceed to hear from your wife now.

5 STAFF SERGEANT RORICK: Yes, ma'am. Thank you.

6 CHAIRPERSON LASHOF: Karen Rorick will come

7 forward.


9 MS. RORICK: My name is Karen Rorick. My husband

10 and I have been married for nearly 12 years. Prior to him

11 going to the Gulf our health was good to excellent. Since

12 his return, it has been disastrous and difficult and

13 chronic, needless to say.

14 From the day that he returned home I knew

15 something wasn't right. Of course I'm not a doctor so all I

16 could do is go by what I watched happening to him. He began

17 vomiting from the day he came home. This is my

18 recollection, my personal experience in taking care of him.

19 Diarrhea was a regular thing with a lot of stomach cramping.

20 Headaches. There's no description of the headaches. I

21 mean, that is nonstop. He gets chills and body aches

22 anytime. That occurs, in my recollection, at least once a

23 week to twice a month.

24 We at first thought he was going through flu

25 symptoms; being home, back in another environment, but when


1 it continues you start to think that maybe there's more to

2 it.

3 The lack of energy I saw happening with him, he's

4 a very sportsminded person -- unable to play football with

5 the boys because of the aching. It was, "Should I play

6 football or not? I know afterwards I'm going to regret it.

7 It's going to ache."

8 The gastrointestinal problems became of such a

9 nature that we had to take him to the emergency room at Camp

10 Pendleton just to make sure that it wasn't something of a

11 severe nature. It was treated with antacids, that kind of

12 thing, and it would subside for a week or two and I thought,

13 "Great, we're going good again."

14 In 1993 he required a trip in an ambulance to help

15 him breath. He began having difficulties with his

16 breathing. I thought, oh, it's just allergies or something

17 like that. But his breathing, he's had problems ever since

18 being back. That's just off and on. He required oxygen

19 treatment at that time.

20 In regard to reproductive problems. When he

21 returned from Kuwait, I observed on our linens orangish

22 stains from the semen and the urine and the saliva, and

23 intercourse became painful for me because the body fluids

24 now burned the skin on my legs.

25 I began to have menstrual irregularities, within


1 that time, progressing, night sweats, nausea, dizziness, and

2 unbearable ovarian pain -- I doubled over -- and I'm in pain

3 currently.

4 In regard to the rash. I noticed that right away

5 and of course again thinking, oh, it's just another change

6 in the environment. The rash reacts to heat and sunlight

7 which makes me -- even though I am not a doctor, I have used

8 every encyclopedia I can find -- makes me suspicious of

9 either parasites or organisms I cannot understand. These

10 rashes will takes weeks, often months to "heal," but the

11 rash is always under the skin visible but it appears deep

12 and ready to erupt, depending on factors of heat, of

13 sunlight, possibly stress. It causes itching, flaking,

14 oozing, crusting, and loss of many layers of skin, very

15 often bleeding. I have scars on my face from that kind of

16 rash. The location of the rash is basically in the T zone

17 of the face but it also goes into my scalp and is often very

18 unbearable. It is bright red to pink with white powderish

19 flaking patches. I noticed this, like I said, upon his

20 return.

21 When I began developing the same rash, I became

22 concerned and I did visit Naval Hospital Camp Pendleton.

23 Was given various creams; cortisone cream, different things

24 of that nature, and told there wasn't much they could do

25 because it's just allergies, that kind of thing.


1 It wasn't until I began a quest, as I put it,

2 because I began seeing a connection and I feel the

3 connection because it's affected my health and my ability to

4 raise our family.

5 In dealing with the internal medicine doctor at

6 Naval Hospital Camp Pendleton, on the seventh floor, I asked

7 her what was the possibility of me having a form or my

8 husband having a form of a parasite that might be undetected

9 by the basic diagnostic tools, and the diagnostic tools of

10 course, the serology, skin tests can miss various forms,

11 which are stated in the National Institute's of Health

12 report.

13 As my husband stated, I went to the pathologist at

14 Camp Pendleton, the head pathologist. I gave her my list of

15 tests that need to be done to check for leishmaniasis

16 tropica versus leishmaniasis common. She then looked at

17 this. Took it in for ten minutes and two of her workers and

18 herself came out and said, "We are not familiar with some of

19 the words in these tests. We don't even do these here."

20 But when I asked the internal medicine doctor on the seventh

21 floor what was the possibility she said it is provable

22 beyond a shadow of a doubt through the basic standard

23 diagnostic tests and you have nothing to worry about, your

24 blood work is fine.

25 No one has taken bone marrow and tested it from my


1 husband or myself which leaves me concerned. I am not a

2 doctor but in my reading I have read of various parasites

3 and organisms which can cause symptoms that we have

4 experienced. And, of course I'm not a doctor, when I asked,

5 "What can I know about this?" they said, "You do not need to

6 worry about it." So I am concerned about the types of tests

7 that are not available to us and the process going as slow

8 as it is.

9 Thank you.


11 Questions for -- I hope you'll answer questions,

12 too.

13 MS. RORICK: Yes, I will.

14 CHAIRPERSON LASHOF: Could you tell me, the

15 symptoms began in '92, a few months after your husband came

16 back, is that correct?

17 MS. RORICK: Could you repeat that question?

18 CHAIRPERSON LASHOF: I'm sorry. The symptoms for

19 both you and your husband began just a couple of months

20 after he came back?

21 MS. RORICK: Oh, yes. Yes.

22 CHAIRPERSON LASHOF: So that was in '92, 1992?

23 MS. RORICK: Yes.

24 CHAIRPERSON LASHOF: Have they gotten better,

25 worse, are there periods when you're free of symptoms or


1 what has been the course over these three years?

2 MS. RORICK: They have become worse when they

3 occur, but we do have periods where we think, "Oh, good.

4 We're feeling good," and then it starts again, but then it's

5 progressed worse. You can -- It's just something I can just

6 kind of like write down and know within a certain amount of

7 time it's going to happen again, and it's very scary. We

8 worry about the children; kissing the children; close

9 contact. It's affected our relationship in terms of

10 closeness physically because of the current concern of what

11 we don't know about the effect of the body fluids and what

12 is going on. But we do have periods where we feel pretty

13 good, but I personally am constantly in pain.

14 CHAIRPERSON LASHOF: How old are your children?

15 MS. RORICK: My children, our children, are 10 --

16 almost 11, and four years of age.

17 CHAIRPERSON LASHOF: They're fine? They have no

18 symptoms I hope.

19 MS. RORICK: They have scaling on their scalps.

20 So.

21 CHAIRPERSON LASHOF: Other questions?

22 CAPTAIN KNOX: I have one.


24 CAPTAIN KNOX: Did your husband have

25 pyridostigmine bromide or the botulinum vaccine?


1 MS. RORICK: I do not know that. I do not have

2 access to his records. I would like to know that also.

3 STAFF SERGEANT RORICK: No, ma'am, I did not.

4 CAPTAIN KNOX: You did not.

5 CHAIRPERSON LASHOF: Thank you very much.

6 Pat Broudy from Monarch Beach.



9 MS. BROUDY: My name is Pat Broudy. I represent

10 the National Association of Atomic Veterans, and the

11 depleted uranium Network of Military Toxics Project.

12 My thanks to the advisory committee for giving me

13 the opportunity to speak about uses of depleted uranium, DU,

14 before and during the Gulf War and the exposures of military

15 and civilian personnel.

16 Separation of the slow-neutron-fissionable uranium

17 235 isotope, U-235, from the major isotope, uranium 238,

18 which is U-238, was necessary to build the uranium bomb

19 detonated over Hiroshima, Japan, and other gun-type uranium

20 weapons. Natural uranium is almost 99.3-percent U-238 and

21 only about .7-percent U-235. To obtain a few kilograms of

22 U-235 leaves more than a ton of U-238 and remaining U-235

23 waste.

24 What to do with about a billion pounds of DU waste

25 was discussed in meetings as early as 1957. One of the


1 earliest uses of DU was as a substitute for U-235 in the

2 test firings of the Hiroshima gun-type weapons at Los

3 Alamos, New Mexico, in 1945.

4 A more important early use was as tamping material

5 between the high explosives and plutonium core of implosion

6 bombs, such as the first Fat Man bomb design used at

7 Alamagordo, New Mexico; Nagasaki, Japan; and twice at

8 Operation Crossroads. A large mass of U-238 acted both to

9 hold the core together until it could fission more

10 efficiently and to reflect neutrons back into the core for

11 more fissions. The plutonium core of Fat Man was only the

12 size of a grapefruit, but the U-238 tamper and explosive

13 lens surrounding it increased the bomb diameter to five

14 feet.

15 In addition, about 20-percent of the Fat Man TNT-

16 equivalent explosive yield of 21,000 tons was from fast-

17 neutron fission of U-238, because large quantities of fast

18 neutrons are produced in a fission explosion.

19 This capability of U-238 to fast fission led to

20 its use in thermonuclear bombs to create more explosive

21 yield. The reaction became fission of a small trigger

22 fission bomb to create the heat and pressure for fusion of

23 hydrogen-containing components, then fission of U-238 by

24 fast neutrons produced in copious amounts by both the

25 fission trigger and fusion reaction.


1 A negative aspect was production of large amounts

2 of fission products in the fission-fusion-fission reaction

3 from the large amount of DU employed to enhance total

4 explosive yield significantly compared to the large fusion

5 yield. This greatly increased fission product inventory was

6 essentially the opposite of the "clean bomb" development

7 intent.

8 Resultant heavy fallout from tests such as Shot

9 Bravo, during 1954 in the Pacific, caused beta burns and

10 overexposure of Japanese fishermen on the "Lucky Dragon"

11 fishing boat, Americans on Navy ships caught in the fallout,

12 Marshall Islanders caught in the fallout on Rongelap Island,

13 and American military personnel caught on Rongerik Island.

14 Besides nuclear munitions, other military uses

15 were found. Armor-piercing shells made of DU or with DU

16 claddings were developed as well as hardening of armor with

17 DU cladding. Burn tests of DU munitions alone, as well as

18 DU munitions in shipping containers, in lightly armored

19 Bradley fighting vehicles, and turrets and hulls of Abrams

20 tanks, were conducted at the Nevada test site to determine

21 hazards. These uses were prevalent in the Gulf War, the

22 cause of "friendly fire" deaths and injuries.

23 Thus, DU was produced in great quantities during

24 U-235 enrichment operations at Oak Ride, Tennessee, and

25 large numbers of both civilian and military personnel were


1 exposed during World War II during these operations and

2 subsequent fabrication and testing operations at Los Alamos,

3 including manufacturing of fission bomb tampers and

4 components for hydrogen bombs, there and at other locations.

5 Thousands of these personnel have been exposed to DU and its

6 adverse health effects.

7 Military personnel exposed to DU during the Gulf

8 War have developed a variety of illnesses that may have been

9 caused by this synergistic effect of additional exposure to

10 airborne petroleum products, adverse reaction to vaccines,

11 and possible exposure to chemical or biological warfare

12 agents released by Iraq. Our thoughts go back to atomic

13 veterans exposed to ionizing radiation, DU, and probably

14 other toxins throughout atmospheric and underground nuclear

15 testing.

16 Atomic veterans of the Cold War exhibited many of

17 the same illnesses borne by Gulf War veterans and their

18 families upon their return from Desert Storm, as well as

19 sterility, stillbirths, and mutagenic effects suffered by

20 their children.

21 "Friendly fire" deaths of Gulf War vets resulting

22 from depleted uranium munitions are echoed by the deaths of

23 atomic veterans caused by "friendly maneuvers" during

24 atmospheric nuclear testing on orders from the Department of

25 Defense and commanding officers.


1 Both groups of veterans and their families are

2 victims of the same voodoo technology, some as recently as

3 the last underground nuclear test four years ago, where

4 military personnel worked underground in toxic atmospheres.

5 The health of these veterans and their families has been

6 compromised forever in the name of national security.

7 Thank you.

8 I have brought with me today a retired health

9 physicist who was working at the Nevada test site and is an

10 expert on any of the technical questions that you may have,

11 if you have any.

12 CHAIRPERSON LASHOF: Are there any questions from

13 the panel?

14 (No response.)

15 CHAIRPERSON LASHOF: Are you familiar, or whoever

16 you've brought with you, familiar with any of the

17 occupational environmental health studies that have been

18 done on the uranium miners whose exposure to this particular

19 form of uranium is probably one of the greatest and most

20 widely studies, to my knowledge?

21 MS. BROUDY: Yes, and I think that Jay could

22 probably answer that better than I.

23 Jay, you want to come up here for a minute? His

24 name is Jay Brady.

25 MR. BRADY: Jay Brady, retired principal health


1 physicist for the DOE contractor that operated the Nevada

2 test site since 1952. I've been there for 81 atmospheric

3 denotations.

4 The first studies of uranium miners in depth was

5 done by Doctor Robley D. Evans, Professor Emeritus, Nuclear

6 Physics, MIT, and he looked at radon in particular. Based

7 upon his studies of radon in uranium miners, that is one of

8 t he bases for our air concentration standards today. His

9 radium work of courses is the basis for our internal dose

10 standards.

11 As far as epidemiology studies, much has been done

12 on radon exposure of course. As far as uranium exposure

13 itself, we consider uranium primarily a chemical toxic, or

14 toxin; however, hot particles deposited in the lungs could

15 cause local tissue damage and perhaps the synergistic effect

16 again of the hot particle damage with the damage to the

17 kidneys and the liver could produce a more drastic result,

18 and then adding in the exposure to petroleum products is

19 really a tough one. The American Association of Industrial

20 Hygienists said that we should avoid any exposure to

21 petroleum products as a result of the carcinogenic effects

22 of many of those products. For example, benzine causing

23 leukemia, and I did a paper on that. That's about all I can

24 add to that question. Are there others?

25 DOCTOR KIDD-TAYLOR: There are many uses for


1 petroleum products and there are a lot of them still being

2 used in industry today. I guess the question I have is

3 getting back to uranium, a study of uranium miners. What

4 did they find are some of the health effects associated with

5 exposure to uranium?

6 MR. BRADY: The health effects of radon, which is

7 in the uranium chain, include not just malignant disease but

8 nonmalignant diseases as well; fibrosis, for example,

9 pulmonary fibrosis. So in Public Law 101-426, which speaks

10 to the down-winders and the uranium miners, October 15th,

11 1990, as amended by 101-510, November 5th, 1990, to include

12 on-site workers, the uranium miners there are compensated

13 for nonmalignant respiratory diseases.

14 DOCTOR KIDD-TAYLOR: Can you be more specific?

15 Nonmalignant respiratory diseases, what are we talking

16 about?

17 MR. BRADY: Pulmonary fibrosis, for example. A

18 disease of the heart that's related to the diseases of the

19 lung. I think there are three or four of them listed. I

20 can get that information, if you need it. It's listed in

21 101-426.

22 CHAIRPERSON LASHOF: Just one more question.

23 We're running a little late and I don't think we can pursue

24 this very far. We'll be pursuing the whole problem of

25 depleted uranium as part of our charge as we move forward.


1 But most of what you've just said, if I understand you, has

2 been due to the radon found --

3 MR. BRADY: Yes.

4 CHAIRPERSON LASHOF: -- with uranium. Would you

5 expect that radon in the form that depleted uranium was used

6 in the armored tanks and so on?

7 MR. BRADY: No, I wouldn't expect to see radon in

8 purified uranium, because the daughter products are

9 essentially removed and you don't have a concentration in an

10 enclosed area. However, we've used uranium slabs, depleted

11 uranium which was widely available, as you know, for beta

12 sources. You get 220 M RAD per hour beta in contact with

13 depleted uranium and 7 MR per hour gamma, so you have a beta

14 component and the daughters that grow in after it's refined.

15 I thing one of Mrs. Brody's points was well taken

16 that since World War II depleted uranium has been used in

17 large quantities in machines, formed into parts,

18 particularly the tampers in implosion bombs at Oak Ridge,

19 Los Alamos, and other locations, so there are thousands of

20 people out there who have been exposed to DU for a long,

21 long time, and that makes more material for study for

22 scientific purposes.

23 CHAIRPERSON LASHOF: Well, thank you very much.

24 It is on the committee's agenda to look further into the

25 whole problem of depleted uranium and we'll be doing so.


1 MR. BRADY: Thank you.


3 Doctor Ruth McGill.



6 DOCTOR McGILL: I'm Ruth McGill and I'm a

7 volunteer consultant for the past three years. My specialty

8 baloney analysis.

9 Roman one: "Who Dies?"

10 Persian Gulf Syndrome is a

11 neurotoxic/neurometabolic/neuroinflammatory disease with its

12 own mortality rate. Every effort by the federal government

13 so far has aimed to deny and suppress this fact.

14 The only body count available to the public at

15 this date is symbolized in Figure 1. B sets includes

16 veterans for whom the VA pays death benefits. B set has its

17 own administrative definition. B set is artificially too

18 small because the rate of disability compensation for Gulf

19 veterans is also artificially small. The death must result

20 from the disability in order to count.

21 B set excludes suicides and excludes most

22 accidents. B set is artifactually too large because it

23 includes both "theater" and "era" vets pooled together.

24 K set is the Kang study subject group. By

25 definition K set does not include "era" veterans. The high


1 number of accidents reported in K set probably do not

2 overlap with B set very much due to the definition.

3 A further deficiency of the definition of set K is

4 the pooling of all Gulf veterans, those who have complained

5 of illness with those who have not. Failing to separate the

6 sick from the healthy "theater" vets conceals the high rate

7 of death among the sick. There are 700,000 pooled "theater"

8 vets. There are 70,000 sick "theater" vets. Rough numbers.

9 Should we multiply the death rate by a factor of 10 if we

10 find that most of the deaths are taking place in the smaller

11 sick population? Set K does not even pretend to be an

12 absolute number.

13 Set EAS is the 4,400 deaths estimated by the VA's

14 environmental agent service in April of '95. I do not know

15 if the sick are pooled with the well and I have no idea how

16 much all of these sets overlap.

17 Off the screen is set A, sick veterans dying while

18 active in the Department of Defense not VA. DOD has not

19 released this body count, an egregious betrayal of public

20 trust.

21 Also off the screen is set FC, sick dead veterans

22 who fell through the cracks. Failure to count these dead is

23 inexcusable in American society.

24 The archetypal set FC member is the suicide. Of

25 the patients I follow, all have had suicidal ideation and at


1 least two are actively suicidal.

2 The NIH conference in the spring of 1994, the

3 DeFraites cohort of 79 Indianans was presented without

4 mention that on follow-up one had committed suicide and one

5 had a heart transplant. One who should have been included

6 in the DeFraites cohort, but wasn't, was an Indianan with

7 rash and memory problems who committed suicide just before

8 the DeFraites team arrived. A fourth Indianan died in 1995

9 of mysterious metabolic failure. Therefore, of the 79 or 80

10 Indianans, four mortally afflicted patients fell through the

11 cracks. The total absolute number is unknown.

12 Mr. President, in the name of national security,

13 we the public demand the body count.

14 Roman two. "Neurotoxic Disease."

15 Clinicians and researchers who take PGS seriously

16 are all saying the same thing. Figure 2 shows how the

17 different terminology all support a unified formulation.

18 Neurotoxicity is the sine qua non and all else follows.

19 PGS is not a new disease. PGS is one multisystem,

20 multiorgan disease with an astounding array of secondary

21 complication. There is no ICD code number for PGS. This

22 state of affairs has allowed Washington to leap to the

23 conclusion that non-federal experts are confused and

24 confusable. Nothing could be more preposterous. The schema

25 in Figure 2 offers a niche for every thoughtful diagnostic


1 proposal so far.

2 Roman three. Table 1 shows my collection of

3 classical and advanced tests for molecular disease following

4 neurotoxic injury. This is a private research effort with

5 spectacular abnormal findings. To look for molecular neuro

6 disease in the sick Gulf veterans is to find it. Notice all

7 the "plus" signs showing abnormalities found, "minus" signs

8 for no abnormalities found by the government with the MRI

9 exam. These negatives show that the MRI is the wrong test

10 for the wrong disease, and a waste of the tax money, but the

11 results are used to discredit these veterans.

12 All of these patients were at one time given the

13 diagnosis of "somatoform disorder," and patients two and

14 sixteen are battling the diagnosis of Munchausen's Syndrome.

15 I will not discuss today the technicalities on

16 this chart. Instead, I support a planned scientific forum

17 by this body as suggested by Mr. Rios.

18 Abnormal biochemistry of 20 Gulf vets, numbers 12,

19 16, 18, and 20 have lab positive cardiomyopathy, number 10

20 and 12 are suicidal, and number 20 has wrecked her car

21 twice. It is not true that there is no pattern to Persian

22 Gulf Syndrome, and it is impossible to have this much

23 illness without an increased death rate.

24 The patient with the worst and most consistent

25 test results is number 16, Colonel Herb Smith, who submitted


1 his results and his story to you in August of this year.

2 Colonel Smith is in a wheelchair because his balance is

3 destroyed. He has total body pain, and he has lab evidence

4 for exercise intolerance. Get this: Smith's Walter Reed

5 chart now carries the diagnosis somatoform disorder and

6 dandruff.

7 You have received from Doctor Pamela Asa, Smith's

8 immunologist, the Walter Reed report which ignores serious

9 laboratory abnormalities for systemic lupus erythematosus,

10 and further singles out my work in Ox Phos disorder and the

11 work of Doctor Redjko Medenica in plasmapheresis in order to

12 exclusively dismiss our contribution.

13 Doctor Asa further describes to you her upsetting

14 phone discussing with Major Roy, in which he opens himself

15 to litigation. Major Roy accused Colonel Smith of making

16 himself sick by bloodletting and accused Doctor Asa close to

17 killing him by giving him risky treatment for a disease,

18 SLE, that he did not have. This is a violation of medical

19 standards that would result in a fast lawsuit and a license

20 hearing under medicine in private practice.

21 Doctor Phil Caplan, this one is for you. I regret

22 to inform you that last week Doctor Asa experienced a

23 similar dismissal from one of your own staff.

24 Roman four: "Criminal Harassment of Patients,

25 Health Care Personnel, and Activists."


1 In my small community of patients and their

2 supporters, these horror stories are frequent:

3 Cut brake lines. No wonder Doctor Kang finds an

4 increased rate of accidents among Gulf Veterans.

5 Mail open. Mail lost. FEDEX tampered. Arson.

6 Burglary. You read the rest.

7 Because of my bitter experience over the past

8 three years I have moved most reluctantly to the conclusion

9 that Washington actually wants these veterans to die.

10 Because I know of a couple of cases of overt threats to

11 medical colleagues in federal medicine, and because a couple

12 of senior counselors have advised me that the history of

13 unconstitutional secrecy and persecution of whistle blowers

14 in DOD has grown steadily worse since the Manhattan Project,

15 I am moved to make the following:

16 Roman five. "Radical Recommendations."

17 Number one. Demand an absolute body count, and an

18 independent expert analysis of deaths of Gulf War veterans

19 since the war.

20 Two. Demand an independent prosecutor and

21 independent professional investigators of criminal

22 obstruction. Independents should have subpoena power.

23 Three. Commander in Chief should abolish the

24 military wings. All military medical facilities should be

25 privatized and all medical services contracted out.


1 Four. Ditto for the VA.

2 Five. The committee must decide whether to demand

3 an enlarged, deeper mandate with subpoena power and other

4 "teeth."

5 Six. The committee should seize a role to play in

6 the 1996 elections. If playing hard-ball politics violates

7 your own personal life standards and your identity you

8 should,

9 Seven. Resign. Do not underestimate the magnitude of

10 this scandal, and the harm to you personally should you be

11 called to account for it. You owe it to yourselves.

12 In closing I'd like to request thirty moments of

13 silence for the dead.

14 Thank you. My speech has been very harsh. I

15 assure you that there is experience behind it.

16 CHAIRPERSON LASHOF: Does the committee have

17 questions they would like to address to Doctor McGill?

18 DOCTOR KIDD-TAYLOR: Doctor McGill, I'd just like

19 to ask one. Are you treating patients currently that have

20 reported to you with Gulf War veterans' illnesses?

21 DOCTOR McGILL: I refer all patients to the

22 closest competent physician who will manage their case. I

23 myself am disabled with Ox Phos disorder. It's a disease

24 that's so close to what the Gulf Veterans have that the

25 tests and the treatment that my doctors provide for me is


1 appropriate for them, so I work strictly by telephone

2 referral and telephone consultation and I don't charge any

3 money.

4 DOCTOR KIDD-TAYLOR: HOW many have you referred,

5 do you have a number or figure?

6 DOCTOR McGILL: The first -- The list, you have a

7 handout showing the biochemical abnormalities. All of those

8 patients have been referred. There are about 20 on that

9 list and there are about a dozen who are extremely sick that

10 I follow as best I can. I talk to them by phone and I

11 pester them to get the right treatment. I've even put my

12 own money into this. It's cost me about $50,000 in plane

13 tickets, laboratory costs, cost to the physician. The money

14 has been matched by other private consultants, other private

15 laboratories so it's extensive but it's a unique effort. I

16 don't believe anyone else is doing this.

17 DOCTOR KIDD-TAYLOR: So you say you've referred

18 about approximately 20 to 50 or -- because the numbers here

19 I see, if you're looking at identification codes, there are

20 eight, nine codes possibly?

21 DOCTOR McGILL: Right. About half the patients on

22 that list I've never met personally, and then there's

23 another whole list of people that I've met personally who

24 are not on the list. So, I've passed out about 40 kits for

25 metabolic analysis. These are take-home kits and those 20


1 are those that have been returned to the laboratory.

2 CHAIRPERSON LASHOF: You state you've referred all

3 the patients to the physicians who are treating you and you

4 feel the treatment should be the same. Could you tell us

5 something about that treatment? You don't have to

6 demonstrate it. Just tell me what the procedure is that the

7 doctors are using and whether you think they've been

8 successful and helpful to the veterans.

9 DOCTOR McGILL: The best treatment that I know is

10 avoidance of further exposures and high among the list is

11 intense, intense nutritional therapy. There is a protocol

12 for this that's being conducted by Doctor Myra Shavitz at

13 the Massachusetts Veterans Affairs, and she's got it

14 formalized and she will be able to produce a report that

15 will show whether it actually works on them as it has for

16 me.

17 I am a patient of Captain Sprague's former private

18 practice so anything that Captain Sprague would recommend, I

19 have been treated with it. It's -- I'd like to talk a lot

20 more about treatment in a scientific forum.


22 DOCTOR CUSTIS: Doctor, would you spell the name

23 of the disorder from which you suffer?

24 DOCTOR McGILL: It has several names as these

25 esoteric --


1 DOCTOR CUSTIS: You used a name I didn't

2 understand.

3 DOCTOR McGILL: Okay. The shorthand name is Ox

4 Phos. Capital O-x, capital P-h-o-s, and that is --

5 DOCTOR CUSTIS: That is mitochondrial

6 encephalopathy?

7 DOCTOR McGILL: That is one kind of mitochondrial

8 encephalopathy?

9 DOCTOR CUSTIS: What is mitochondrial

10 encephalopathy?

11 DOCTOR McGILL: Every cell in the body has a

12 collection of little tiny organelles inside the cell that

13 are responsible for producing energy. The organelles are

14 called mitochondrial, and a mitochondrial encephalopathy

15 means that the mitochondria don't work properly. They do

16 not produce enough energy. The brain, the nervous system,

17 the skeletal muscles and the heart demand more energy than

18 any other system of the body, and the liver is a close

19 third. So we see the effects of the disease of the

20 mitochondria turning up first in the nervous system then in

21 the skeletal muscle, heart, and liver. Am I clear?

22 CHAIRPERSON LASHOF: Other questions?

23 (No response.)

24 CHAIRPERSON LASHOF: All right. Thank you very

25 much, Doctor McGill, appreciate it.


1 Sandy Schoppert.


3 MS. SCHOPPERT: Good morning to all of you. My

4 name is Sandra Schoppert. I am here on behalf of myself,

5 although I am on inactive status from the United States Air

6 Force Reserve. I spent approximately three months over in

7 Saudi Arabia. I was there for the duration. I got there

8 the day before and stayed for the whole thing.

9 During my time there, I was stationed in Saudi

10 about halfway between Riyadh and the Kuwaiti border, so I

11 was within SCUD missile range. As a result, I did have to

12 take the pyridostigmine bromide and I also did have to take

13 the vaccine for the anthrax. My original thoughts and

14 theories about the problems that I have been experiencing

15 was as a result of these medications that had been given.

16 Approximately a few months after I returned from

17 the Gulf War, I started experiencing a lot of physical

18 symptoms. I kind of brushed them off. I am a nurse and as

19 nurses and medical people generally do, they brush off a lot

20 of things and ignore them thinking they will go away. But,

21 about November, of '91, I started feeling so bad that I

22 decided that I needed a medical evaluation. I went to my

23 own internal medicine physician and had an evaluation done

24 by him. I was experiencing extreme fatigue, that was the

25 biggest part of what I had been feeling, but I also had


1 migratoid joint pain and was experiencing some palpations

2 and tachycardia which I just had no idea what it was being

3 caused by.

4 I'm not -- You know, I'm not underestimating that

5 stress can be a factor in a lot of medical illnesses and I

6 sort of related that possibly some of these symptoms were

7 from stress, not just from that that we had in the Gulf War

8 experience but also personal things that had happened since

9 I had been back from the Gulf War. So I kind of was

10 brushing it off on that.

11 I had a wide battery of tests done: blood work,

12 serologies. I had an echocardiogram. They were trying to

13 rule out a mitral valve, and just nothing really was coming

14 up positive. They could really find no answers to what I

15 had been experiencing. I went back a few months later,

16 because I had not been improving. They put me on Elevil and

17 was kind of saying, "Well, I guess you're depressed." The

18 Elevil did not help. It actually made me feel a little bit

19 worse, just from the side effects of that medication itself.

20 So I discontinued taking that and found that the fatigue was

21 just continuing to get worse and worse. The migratoid joint

22 pain was still there. It would be in my ankle one day. It

23 would be in my elbows and shoulders at another time. I had

24 times when my hip joints would be hurting.

25 I was just learning to ski and so I would not


1 restrict myself -- I am still going to go and do the things

2 that I had done prior to all this. As a result, though,

3 after one day of skiing and I'd probably sleep for two days,

4 and that's just so extremely unusual for me because it just

5 never happened before. I thought maybe I'm just getting

6 old, but then I said I'm not really quite that old yet to be

7 having this much of a problem.

8 I reached a point where it was very difficult even

9 to get out of bed in the morning. I then, again, was having

10 some other problems. Was brushing it off as just stress and

11 that, too. I did go to another physician that had been

12 referred to me that had an interest in chronic fatigue

13 syndrome, so I did go to see her and found that this was the

14 one person that understood a little bit more about what I

15 was experiencing and talking about, and was also aware of

16 what had been going on in the Gulf War and some of the

17 research that had been going on, and did not make me think

18 that I was crazy and imagining, that this possible could be

19 a result of some of the things that had happened over there.

20 This was in Pennsylvania. I've just recently

21 moved out to California, just about a year ago. So she

22 helped me. We experimented with a few medications and I was

23 put on Zoloft. I don't know if any of you are familiar with

24 that, but that did help with the chronic fatigue, and I do

25 get tired but I am better now than what I had been before.


1 I still experience fatigue. I do have some migratoid joint

2 pain. I also find that when I'm off the medication, and

3 this is how I've kind of experimented with it myself, when

4 I'm off the medication I also have this feeling of -- it's

5 not dizziness but it's a light-headedness where you just

6 kind of like, "Okay, where am I?" You know, kind of in a

7 daze.

8 I also find that I have lost some of my fine motor

9 skills where I drop a lot of things, and I have some short-

10 term memory loss. And just being here and listening to some

11 of the things that the people have said today, and reading

12 some of the reports that I've seen -- sparsely -- in

13 newspapers, I find a lot of their symptoms are similar to

14 those that I have. A new one for me is the difference in

15 bowel function, which I hadn't experienced that until about

16 a week ago. I didn't even realize that this possibly even

17 could be part of this whole syndrome thing.

18 I don't believe that I have been exposed to any

19 biological or chemical warfare. I've talked with some

20 people who have more or less convinced me that there was no

21 chemical warfare while we were over there. Whether it's

22 true or not, I don't know, but I don't believe that's what

23 the cause of the problem is. I've thought a lot about what

24 my experiences were, what my exposures were, just the

25 placement. I don't know if that has -- like where we were


1 assigned, our tours, whether that has anything to do with

2 what people are experiencing.

3 I did fly one airvac mission up into the forward

4 area where we picked up Kuwaiti POWs and brought them back.

5 I have no idea if that's a possibility of any exposure to

6 the people or to that area, if that's something. One of the

7 other areas that I looked at was the food. We did eat food

8 prepared by the Saudi people where we were stationed. I did

9 not eat a lot of the meat just because of taste. It just

10 didn't taste right to me so I didn't eat a lot of it. I did

11 eat some. We drank mostly bottled water so I'm not sure if

12 anything came from the water supply.

13 The one thing that I hadn't really looked at and

14 thought about much was what Captain Sprague was talking

15 about with the organophosphates. I hadn't really considered

16 that that much.

17 After I returned from the Gulf, ironically I

18 learned a lot more about organophosphates and the chemical

19 warfare. I took the course down at Edgewood Proving Ground

20 that they had down there, because my civilian job that I

21 went into entailed working with part of the -- My job as an

22 occupational health nurse, I went to work at Mine Safety

23 Appliances who makes the masks, the chem warfare masks and

24 everything, so we did a lot of research there and so we did

25 have a small amount of the agents there so I had to learn a


1 lot about them. And, sadly, I learned so much more from my

2 civilian job about this than I did in the 13 years that I

3 was in the reserves.

4 Had I known half of what I knew before I went over

5 to the Gulf I wouldn't have been half as petrified and as

6 frightened. I would have understood a lot more, but I do

7 know, though, that from the pyridostigmine, I learned a

8 little about that, is that it bound to about a third of your

9 cells, your nerve cells, and that's what protected you if

10 you were to get exposed to the nerve agent. Okay, if it

11 protected you by bonding to one-third of your cells, what

12 happened to that one-third once you stopped taking it? How

13 did it release? Is this a problem like why we don't have

14 our energy because one-third of these cells that we have,

15 the functioning cells, are now gone? This is just one of my

16 questions.

17 I would like to know a lot more about it. I would

18 like to have answers. I know I went to my own GP but he

19 didn't know anything, you know, as far as what to look for.

20 This whole immune system testing, the neurotoxicity, I feel

21 that we should be tested a lot more in that general area.

22 There were other things that I had just tried to

23 think about. The chem warfare suits, which were the

24 charcoal suits, that because some people were so totally

25 petrified they lived in those suits. You know, is that


1 something that could have manifested itself into some of

2 these symptoms just because people would not take them off.

3 Is there anything that they breathed that could have caused

4 them to have their respiratory problems, or anything else.

5 As far as the inhalation, I wasn't up in the area

6 where the fires were to have breathes any of those fumes.

7 However, where I was stationed we did have -- it was cloudy

8 and it wasn't that heavy but we did have some of that smoke

9 down there but not at a great level. But the dust and the

10 sand that blew around, is that something also that could

11 have posed a problem because that fine sand was just

12 absolutely everywhere and there's no way that you could not

13 breath it.

14 I know of some people that did have respiratory

15 problems, people that were not stationed up in the areas

16 that were within SCUD range, they were way down in the areas

17 that were considered to be safe. Even they had problems

18 with breathing conditions.

19 That's pretty much what I've tried to think about

20 and tried to figure out exactly what it is that's going on.

21 I would appreciate knowing a little bit more about what is

22 going on. I came upon this public hearing strictly by

23 accident. One of my other questions is: How are you going

24 about finding all of the people that really are symptomatic

25 and that may not even be relating it, like I did, to


1 anything that possibly could have happened over in the Gulf

2 War, in that area?

3 I know my own base, I went to visit them before I

4 left. I stayed active for about a year after I returned,

5 then I went on inactive status, but I stopped and I asked

6 some questions like, "What's going on? Is there anything

7 happening? Is there anybody else ill?" Everybody's real

8 closed mouth. They don't want to say anything. You know, I

9 found out nothing about hotlines or anything about what to

10 do if you're having problems.

11 I would like to go to have a more thorough

12 examination to find out exactly what the problem is, but I

13 don't want somebody who doesn't know what they are doing to

14 do this. I want them to know what to look for. I

15 understand now, from the information that was faxed to me,

16 there is a place in L.A. I would like to go there and have

17 an evaluation. I am currently without -- Well, I have Cobra

18 medical insurance, which I am paying for myself, but in

19 about two months that's going to run out, too. And if there

20 is -- I'm not looking for compensation or anything as far as

21 disability. I am functional, I just can't do what I used to

22 be able to do because of the fatigue. But is there a way

23 that the medications that do help me, that I can at least

24 have that provided for me? So these are just some of the

25 questions that I have for the committee.


1 CHAIRPERSON LASHOF: Well, thank you very much.

2 Let me ask you a couple of questions about the fact that you

3 haven't had any information.

4 Have you received any notice about coming in for

5 part of the comprehensive evaluation that the Department of

6 Defense offers or the VA offer?

7 MS. SCHOPPERT: I've received absolutely nothing.

8 No questionnaires. No informational thing. Absolutely

9 nothing since I returned.

10 CHAIRPERSON LASHOF: Well, if nothing else, we

11 certainly can make sure that you get that information which
12 supposedly is going out to all veterans. I'm not sure why

13 you haven't been in the loop.

14 MS. SCHOPPERT: Right. That's why I could not

15 figure out if there are all these research projects going

16 on, which I wasn't aware of until just a few days ago when I

17 received this information, why haven't myself and other

18 people that I know been surveyed? You know, been asked.

19 Because there very possibly are people out there that just

20 you don't know about, and these figures and statistics that

21 you have are very inaccurate, I think. And not your fault

22 but just because the communication just is not there.

23 CHAIRPERSON LASHOF: Any other questions?

24 DOCTOR KIDD-TAYLOR: I just had two regarding what

25 you were thinking about some of the exposures that might


1 have occurred.

2 You mentioned the pyridostigmine bromide tablets.

3 Were you taking them very often or how often?

4 MS. SCHOPPERT: We were taking them every eight

5 hours, as we were told that we needed to take them in order

6 for them to be effective.

7 DOCTOR KIDD-TAYLOR: This is every eight hours on

8 a daily basis while you were there?

9 MS. SCHOPPERT: On a daily basis for approximately

10 a week and a half, then mysteriously they said stop taking

11 them. I hear, and I don't have this confirmed or anything,

12 but I hear the reason that we were told to discontinue

13 taking the medication was because people were starting to

14 have symptoms, that they were symptomatic, and so they told

15 us to discontinue taking the medications. They told us it

16 was because the supply was getting low, but the reason that

17 they told us we needed to take them at that time was because

18 if there was going to be any chemical warfare it would be

19 during that time because the chemical weapons were losing

20 their shelf life and they were going to be ineffective so it

21 would have been used at that time. But then all of a

22 sudden, boom, we were to discontinue taking the medication.

23 DOCTOR KIDD-TAYLOR: I have two other questions.

24 One is regarding you mentioned organophosphates. Do you

25 remember any exposures to pesticides while you were there?


1 MS. SCHOPPERT: I don't recall that. The first

2 time that I even thought about that was listening to the

3 presentation this morning, but that's a very good

4 possibility. It's just something else that now I'm

5 considering as a possibility to some of these symptoms.

6 CHAIRPERSON LASHOF: My last question is: Are you

7 aware of any other persons who served in your unit who have

8 similar symptoms like you have?

9 MS. SCHOPPERT: I am aware of one person, or two

10 people that possible could have, who are experiencing some

11 similar symptoms. However, when I left, and many of the

12 other people that had served became inactive, we lost

13 contact and when I went back, before I left Pittsburgh, and

14 tried to find out, it was really difficult to find out if

15 there was knowledge of people that were having -- didn't

16 want to kind of spread this around and kind of like cause

17 any undue -- I'm at a loss for a word now. They just didn't

18 want to --

19 DOCTOR KIDD-TAYLOR: Focus on themselves?

20 MS. SCHOPPERT: Yeah. The one other thing about

21 the anthrax injection. We had to take it and I know that

22 there is local reactions but some people got very ill from

23 that with localized cellulitis, but also some, you know,

24 flu-like symptoms, and we did take two injections of that.

25 I didn't want it but we absolutely had to. I was the very


1 last one in our group to get it. I put it off as long as I

2 could but it was a very -- it was a terrible vaccine to have

3 to take.

4 CHAIRPERSON LASHOF: One more. We are running

5 late.


7 medication, and I thought I heard Zoloft?


9 DOCTOR BALDESCHWIELER: Which you claim was

10 partially effective?


12 DOCTOR BALDESCHWIELER: What is Zoloft and what is

13 it normally used for?

14 MS. SCHOPPERT: It's a medication that my personal

15 physician had prescribed for me that has helped with the

16 chronic fatigue, if that's what it is that I'm experiencing.

17 It's a medication similar to Elevil. It's known mostly as

18 an antidepressant; however, a lot of these antidepressants

19 are now being used for other medical purposes, and it has

20 helped me in alleviating a lot of the fatigue, although I

21 have some it is taking care of most of it.

22 MAJOR CROSS: Sandy, let me encourage you to

23 contact the VA. I contacted them about a year and a half

24 ago and went through their work-up and it was a positive

25 experience for me, so I encourage you to do that.


1 MS. SCHOPPERT: Okay. I'll get the number from

2 someone for the one here in L.A. then.

3 CHAIRPERSON LASHOF: We'll have someone on staff

4 meet with you before the day's over.

5 CAPTAIN KNOX: Joyce, I think, too, isn't December

6 of '95 the last month to go to a VA for an exit physical?

7 Isn't there an ending date on that? We need to find that

8 out.

9 CHAIRPERSON LASHOF: We need to find out and get

10 that to you.

11 CAPTAIN KNOX: If you'll take your DD-214 and go

12 to your nearest VA facility, they'll put you in the system.

13 MS. SCHOPPERT: Okay. All right. Thank you for

14 the opportunity to talk with you.


16 I think we'll take a break now but I'd like to

17 limit it to ten minutes. We're about 15 or 20 minutes

18 behind our schedule.

19 (A short recess was taken.)

20 CHAIRPERSON LASHOF: Let me call on Karen

21 McCarthey.


23 MS. McCARTHEY: I'd first like to thank the

24 President and Hillery Clinton for establishing this

25 committee and to thank all the committee members for their


1 effortless work and research.

2 Many people believe that the Gulf War was fought

3 in one of the most environmentally toxic places on earth.

4 Did you know that 18 chemical facilities, 12 biological

5 facilities, and four nuclear facilities within Iraq were

6 bombed during the Persian Gulf War, and that the prevailing

7 winds during the war were from northwest to southeast? The

8 chemical and biological warfare agent production plants

9 bombed by the coalition forces during this period are locate

10 in Iraq to the northwest of coalition troop deployments

11 along the Saudi and Iraqi -- Saudi/Iraqi and Saudi/Kuwaiti

12 borders.

13 As a result of this toxic place, the men and women

14 of the Persian Gulf War are facing very unique and different

15 problems. The possibility of the use of mixed agents would

16 explain this. I will provide you later with copies of

17 former Senator Riegel of Michigan's in depth study of

18 chemical and biological agents used by and sold to Iraq.

19 I am the wife of Staff Sergeant Michael Bryan

20 McCarthey. I would like to give you my testimony or our

21 testimony of our experience with medical treatment as my

22 husband is an active member of the United States Marine

23 Corps.

24 First I would like to give you background on his

25 service in the Gulf. He landed in Az Zabah about a week


1 after the Czechoslovakian chemical monitors had went off.

2 He landed there from an LST in the Persian Gulf. They had

3 been monitoring what they call the "gator box" in the Gulf.

4 They moved up an through the Wafrao Forrest, where my

5 husband indicated to me that there were many dead animals as

6 they went through this forrest. He said at one point they

7 were about 40 miles behind enemy lines. They were in

8 country about one month and then returned to ship. I asked

9 my husband if he remembered anything strange; rashes,

10 vomiting, et cetera, on any of the men or himself. He said

11 after they had been taking the anti-nerve agent pill three

12 times a day for three weeks that some of the guys couldn't

13 walk or move their arms. It was like when your foot falls

14 asleep. That's the way they explained it to the men, that

15 they had been sitting for too long, et cetera.

16 My husband said his elbow hurt, and still aches

17 occasionally to this day. He said also that after they

18 returned to the ship he noticed his gunny sergeant picking

19 some boils on his arm. He found this "disgusting," in his

20 words, that's why he remembers it. But then realized he had

21 it on his forearms; small, little raised bubbles, but only

22 where his skin had been exposed. You will find a current

23 diagnosis and a list of symptoms in the attachment that I

24 have provided, on pages one to three, and, as previous

25 testimony, he has many of the similar symptoms.


1 My husband is suffering from an illness with which

2 doctors have no experience and they may not be able to

3 identify it, cure it, or even treat it. No one, not the

4 military, the VA, nor the medical, nor the scientific

5 community can tell me for sure what caused my husband's

6 illness. My husband is concerned that he may pass this on

7 to me or possibly our two daughters.

8 We are having difficulty in getting doctors at the

9 Naval hospital on Camp Pendleton to admit that they don't

10 know what he has. He as been diagnosed with the following:

11 Initially we pursued three private doctors, two

12 GPs, and a gastroenterologist on our own. He was up for re-

13 enlistment and promotion and we did not want that to hold up

14 his promotion and re-enlistment so I told my husband that we

15 needed to get this documented in case something did come of

16 it down the road. Within the next three months his illness

17 progressed quite a bit and it forced us to go to the Naval

18 hospital because we couldn't, you know, provide for the cost

19 of private doctors. Initially they said he had sprue, which

20 is an hereditary disease.

21 Next he had Irritable Bowel Syndrome, which I

22 don't know if too many people are familiar with that, but it

23 does not cause 30-plus pounds weight loss, and that is what

24 they have said probably for the last three years that he

25 has, and it's supposed to be brought on by stress.


1 He's also been diagnosed with severe depression,

2 and the latest diagnosis is he has a mood disorder due to

3 general medical condition, and the second access is

4 Idiopathic Chronic Fatigue Syndrome, and the third access is

5 I believe Irritable Bowel Syndrome. The symptoms are

6 attached in the handout.

7 I just wanted to comment on Doctor Matthew's -- I

8 guess he's the director of the CCEP -- his testimony at the

9 September 18th meeting. He said that of the first 36,000

10 health examinations that have been done of Persian Gulf

11 veterans, 76-percent have been give a diagnosis and 24-

12 percent have symptoms but no diagnosis. I laughed at this.

13 With the treatment that we received at the Naval hospital

14 Camp Pendleton, I would say these numbers are bogus. These

15 doctors have done and said everything but admit my husband

16 may have the Persian Gulf Syndrome. He's been seeing these

17 doctors for almost two and a half years now. They haven't

18 been able to cure him so how can they say he definitely has

19 Irritable Bowel Syndrome or Chronic Fatigue Syndrome? These

20 doctors are afraid to say, "We don't know what is wrong with

21 him."

22 I feel that these doctors are under a lot of

23 pressure to negate the Persian Gulf Syndrome. Our first

24 visit in early 1993 with the doctor in charge of

25 occupational health at Camp Pendleton that initially -- the


1 first two testimonies I believe were Robert and Karen, they

2 referred to this doctor as well. This visit was very

3 disconcerting to me and it was the beginning of our fight to

4 get my husband better. I asked my husband to ask the doctor

5 if I could come in with him for the consultation. He asked

6 the doctor and the doctor said -- because my husband and him

7 were off probably about 10 feet, so I waited. When my

8 husband emerged from the office his face was red and he

9 looked up-tight. When we got out to the car he said he felt

10 like he was on trial. The doctor insinuated we were only

11 there to jump on the bandwagon with all the rest of the

12 people who wanted disability. I told my husband you don't

13 spend 13 years in the Marine Corps as a grunt and then throw

14 it all away so you can get disability. All we want is to

15 get my husband better.

16 In seven years he could be retired. Now I have to

17 go back to work full time, pay a baby sitter because my

18 husband can't keep his eyes open for more than three hours

19 at a time. And, finally, daily I watch my husband slip away

20 from the man that he used to be. I would not call this

21 "jumping on the bandwagon."

22 He has currently completed Phase I of the CCEP,

23 which is the Comprehensive Clinical Evaluation Program.

24 Despite all of the CCEP's shortfalls, I think God for the

25 CCEP. It has put pressure on doctors to take a better look


1 at veterans, but still pressures to have a diagnosis.

2 What's wrong with not having a diagnosis and saying, "We

3 don't know?"

4 They asked my husband at the end of Phase I of the

5 CCEP to sign on the dotted line, never explaining what it

6 meant. My husband and I had spoke previous that he would

7 not sign anything and he took it home and we reviewed it.

8 What it said was that we were happy with the diagnosis that

9 the doctor had given us and they were releasing us from the

10 program. We did not sign this. We pressured the doctors

11 and we said we are not happy with the diagnosis. So,

12 therefore, with our efforts we were referred to Phase II.

13 And I'd like to thank Doctor McDougle because he is the

14 first doctor at Camp Pendleton Naval Hospital that has taken

15 an interest and concern in these Persian Gulf vets.

16 My husband will begin tests for Phase II of the

17 CCEP at the Balboa Hospital in San Diego, and that's a Naval

18 hospital. He has been to the Naval hospital in San Diego as

19 a part of his depression and we were not very happy with the

20 care that he was given there as well. I truly believe that

21 my husband's illness is a result of the mixed agents he was

22 exposed to in the Gulf. All of the symptoms closely mirror

23 Chronic Fatigue Syndrome. We have currently contacted a

24 chronic fatigue specialist, in Anaheim, to pursue treatment

25 for my husband. I have started work and I have insurance.


1 We still have a deductible to meet and a co-payment but we

2 can't put a price on his health at this point because he --

3 there's no way he can hold down a job.

4 My husband and I have been following the Persian

5 Gulf Syndrome. We read anything we can get our hands on and

6 CFS is the first thing that very closely resembles his

7 symptoms. I believe the chemical agents wore down his

8 immune system and Saddam Hussein combined these chemicals

9 with a biological agent. The U. S. government needs to

10 recognize this. Non-lethal exposure to chemical warfare

11 agents, mixed chemical biotoxin agents, and the

12 administration of nerve agent pretreatment drugs could

13 explain many of the symptoms of the Gulf War illness, as

14 well as the inability to diagnose the disorders.

15 When the committee gives their interim report to

16 the President in February, and at the end of 1996, please

17 don't miss the forrest for the trees. I see the VA and the

18 Department of Defense trying to explain away each symptom.

19 These symptoms exist as a group. Though they may differ,

20 they are still very will to those of us who live with this

21 illness and live day in and day out with these men and women

22 who have served their country.

23 Our society today has taught us to use people and

24 value things instead of using things and valuing people. If

25 you want to make a different, you have to be different.


1 I just in closing wanted to make a comment on

2 Captain Sprague's statement that they have tested for a

3 number of certain things in the blood of these veterans and

4 they haven't found certain diseases, et cetera. I just

5 wanted to comment that you can test for the presence of

6 certain things and say none of these things are present;

7 therefore, nothing can be linked to the Persian Gulf

8 Syndrome. But if you don't know what you are looking for

9 then how can you test for it? We need to find out what

10 these men and women were exposed to. That's it.

11 CHAIRPERSON LASHOF: Thank you very much.

12 Are there questions?

13 (No response.)

14 CHAIRPERSON LASHOF: If not, thank you again.

15 We'll move along, and Doctor Andrew Urbanc.


17 DOCTOR URBANC: Good morning, ladies and

18 gentlemen. In case nobody has done so before, welcome to

19 San Diego, America's finest city. My name is Andrew Urbanc.

20 I'm a retired Navy physician and maintain a deep dedication

21 to and a profound concern for the health and welfare, combat

22 readiness and the morale of our military personnel and their

23 families, which perhaps best explains my interest in Gulf

24 War illnesses.

25 My first war was World War II, shortly before I


1 became a Navy physician. My last war was the Persian Gulf

2 conflict which occurred shortly after I gave up being a Navy

3 physician. I did serve during the Desert Storm however,

4 between January and May of 1991. I was a Red Cross

5 volunteer physician at Naval Hospital Camp Pendleton.

6 I studied the Regal reports, the Rockefeller

7 reports, the senate hearing on Gulf War Illness reports.

8 Spoken with physicians who have examined Gulf War veterans

9 and their families who presented with medical problems

10 possibly Gulf War related. I communicate by telephone, fax,

11 E-mail, snail mail, the Internet with a number of Gulf War

12 veterans, veterans groups, researchers, physicians,

13 interested parties, elected officials across the United

14 States and throughout cyberspace. All this had led me to

15 conclude that the study of the interaction of the insect

16 repellant data and the nerve gas protectant, pyridostigmine,

17 began by Doctor James Moss, confirmed by the Department of

18 Defense and a group at Duke University, which currently is

19 on hold, needs to be completed and is likely to lead us to a

20 better understanding of at least some portion of the Gulf

21 War illness' mystery.

22 Of the 700,000 persons who deployed to the Gulf,

23 400,000 plus received pyridostigmine and probably an equal

24 number, or maybe a greater number, used the DEET to ward off

25 the pesky Persian Gulf insects. Therefore, this morning I


1 stand before the committee primarily as an advocate for

2 Doctor James Moss who was the original DEET pyridostigmine

3 researcher and he testified before the Senate committee

4 hearings in 1994, but the completion of his research is

5 pretty much dead in the water for lack of funding. I'm

6 aware that it's not the mission of this committee to

7 initiate new programs. You're here to evaluate what's

8 already been done and make recommendations. I would urge

9 the committee, however, to read carefully the note dated 8

10 November that Doctor Moss sent to Miles Ewing and addressed

11 to Robyn Nishimi, and if you find anything in there that

12 interest you might lend your support to getting this back on

13 track.

14 I understand that between $5,000 and $10,000 is

15 all that is needed to completed this research that was

16 started sometime in the back. The time for completion is

17 short. The cost is minimal while the likelihood for a

18 significant breakthrough affording the additional insight

19 into the understanding of Gulf War illnesses is, in my

20 judgment, is quite likely.

21 Of those 700,000 deployed, 400,000 used

22 pyridostigmine. Thousands of these Gulf War veterans suffer

23 from the Gulf War Syndrome, a mix of signs and symptoms

24 among them: Chronic Fatigue Syndrome, the "yuppie flu" if

25 you're among the affluent, chronic diarrhea, progressive


1 arthrologies and myologies. If we could get this little bit

2 of research back on track we may be able to find some relief

3 for the current batch of veterans and it may open a doorway

4 to what we need to do for those that will deploy in the

5 future by way of protecting them.


7 Are there questions? Go ahead.

8 CAPTAIN KNOX: Did he apply for funding in the

9 recent money that was available August 23rd?

10 DOCTOR URBANC: It's my understanding -- It's too

11 long to explain. I can answer your question privately on

12 that. The answer is it's a combination of yes and not.

13 There was a time factor, but I'd be delighted to talk with

14 you about that privately afterwards.

15 CHAIRPERSON LASHOF: Okay. That will be fine,

16 because there was a recent announcement and we should look

17 into that, but we can do that afterwards.

18 DOCTOR URBANC: As I understood -- I've been gone

19 the past two weeks. I found that on my E-mail when I got

20 back so I was delighted to see that.

21 CHAIRPERSON LASHOF: Okay. Is there another

22 question?

23 MAJOR CROSS: Sir, based on your background, the

24 stories you've heard of lack of concern, and maybe a lack of

25 understanding from the doctors at the hospital at Camp


1 Pendleton, can you discuss that a little bit? Are you

2 surprised at that or do you think that's just the nature of

3 Navy medicine, that there's just not a whole lot of experts

4 stationed at that facility at this point?

5 DOCTOR URBANC: Well, first off all, this is an

6 extremely complicated situation that we're dealing with and

7 I have to -- I will say that what experience I've had

8 recently that there is some defense attitude on the parts of

9 certain health care providers, and I don't know more than

10 that. I don't know whether it's coming from above or

11 whether they don't want to admit that they are confronted

12 with something they don't quite understand. But, when you

13 talk with people about this, there is a certain defensive

14 milieu that you perceive.

15 CHAIRPERSON LASHOF: Thank you very much.

16 Our next speaker is Doctor Susan Franks.



19 DOCTOR FRANKS: It's going to be kind of hard to

20 refer to the transparencies. I'm Doctor Susan Franks and

21 I'm from the University of North Texas Health Science

22 Center, in Fort Worth, where I'm an assistant professor in

23 the Department of Psychiatry, and incidentally, as a native

24 Texan, I'm going to have difficulty in saying anything in 10

25 minutes but I'll certainly give it a stab.


1 I have a Ph.D. in health psychology and behavioral

2 medicine with a specialization is neuropsychology which is

3 the study of brain function, and my particular area of

4 research interest is involving the effects of toxic exposure

5 and immune system dysfunction on brain processes, so there

6 are a couple of things I'd like to talk to you about today.

7 The first being -- Well, actually, secondly I'm going to

8 talk to you about a test that a colleague and I have

9 developed, that Captain Sprague referred to earlier, that we

10 have developed in an attempt to try to differentiate the

11 problem in classifying patients who have had toxic exposures

12 and adverse reactivity as a result of that. There's a real

13 big problem in differentiating those patients from patients
14 who has psychiatric disturbances with resultant physical

15 symptomatology, so we've tried to work on a test to help

16 tease that out.

17 But before I talk about that, I'd like to address

18 a rather alarming trend in the field of psychology that

19 involves the use, or misuse of psychological testing

20 techniques that has resulted in grossly overlooking

21 important etiological considerations. And I think the

22 effect that we're seeing that have is in misclassifying

23 patients or misinterpreting their symptoms as resulting from

24 a diagnostic category that doesn't -- that's actually

25 secondary rather than primary, and I'll talk more about


1 that.

2 Psychological testing -- you have the transparency

3 with the major points that I'm going to cover throughout the

4 talk so rather than refer to those individually, it will be

5 a little bit awkward, but psychological tests are designed

6 to detect and classify emotional problems, and for the most

7 part they do a pretty job at what they are purported to do.

8 One of the most often used of these tests is the Minnesota

9 Multiphasic Personalty Inventory or the MMPI, and that is

10 part of the CCEP protocol that's being given to the Gulf War

11 veterans. And because it's a very commonly used test in the

12 field of psychology, and because it's also being used with

13 this population in diagnostic considerations, I'm going to

14 talk about that test for a minute to try to make some of the

15 points that I'd like to make about precautionary

16 considerations.

17 The MMPI is a very valid, very reliable test.

18 It's a good test when it's used for what it's designed to be

19 used, and I'd like to emphasize that. The MMPI was

20 developed to measure the extent and classify emotional

21 problems based on self-reported symptoms, and it does a good

22 job at that, but what it was not designed to do is to

23 determine causative factors or etiology of the presenting

24 emotional disturbance. So basically what the MMPI does is

25 you take a patient's results and it's compared against known


1 diagnostic groups: So, how does this patient compare to

2 groups of depressed patients? How does this patient's

3 profile compare to patients with anxiety disorders? How

4 does it compare to patients with psychotic disorder, and

5 other psychiatric classifications?

6 One of the problems that we have is when we look

7 at patients with chronic medical illnesses or even, for

8 instance, pregnant women, these patients will elevate scales

9 on the MMPI that reflect a concern with physical symptoms.

10 Depressed mood as a result perhaps of the changes in

11 functioning they've experienced and anxiety at not knowing

12 how they're going to feel on a day-to-day basis. So while

13 the MMPI is actually accurately explaining or accurately

14 reflecting this current state of the emotional functioning

15 of the patient, it's not taking into consideration the

16 causative factors. In other words, that the emotional

17 disturbance exhibited by the patient in this case is a

18 result of their physical problems and not the source of

19 their physical problems, and the psychological tests cannot

20 effectively do that.

21 When results of psychological tests are

22 misinterpreted as indicating causality then a course of

23 treatment is going to follow that presumes to address that

24 cause, and obviously that's going to be limited in its scope

25 and it's going to fail to further investigated other


1 possible etiologic considerations so that the presenting

2 complaints, the surface complaints, of depression and

3 anxiety are going to be attended to without identifying what

4 is producing those symptoms.

5 One of the points I'd like you to keep in mind is

6 that diagnosis determines treatment, so a misdiagnosis is

7 going to result in mistreatment and misclassification.

8 The problems are particularly evident when

9 patients have experienced medical and psychological symptoms

10 as a result of exposure and adverse reactivity to toxic

11 substances. The initial symptoms of toxic exposure mimic

12 depression much like the initial symptoms of auto immune

13 dysfunction, immune system disturbances, mimic depression.

14 But these are actually a function of the illness itself. It

15 involves the effects of the toxins. In the case of a toxic

16 exposure patient, direct effects on brain processes that

17 underlie emotional functioning. So depending upon the type

18 of exposure, the severity of the exposure, the stage of the

19 illness, depending on a number of factors, you can see a

20 broad array of psychiatric symptoms that are primarily

21 caused by the illness. These are organic symptoms.

22 One of the problems in evaluating these patients

23 is that these symptoms are quickly complicated by secondary

24 symptoms and those are symptoms that occur, as I stated

25 earlier, when a patient experiences reduced functioning,


1 anxiety over their condition -- as you've heard today --

2 anger and distress over not being recognized, not knowing

3 what they have. Once you start getting these secondary

4 psychological symptoms then you've got a more complicated

5 picture and it's a little more difficult to tease out what's

6 primary and what's secondary.

7 In response to these kind of problems with

8 overlapping symptomatology, a colleague and I have developed

9 a test called the Clinical Environmental Differentials

10 Analysis, or the CEDA. And as we were gathering protocols

11 from various clinics in the United States, England, Germany,

12 and Nova Scotia, we've gotten protocols from psychiatric

13 patients with no medical illnesses, protocols from patients

14 who have documented toxic exposure, and protocols from

15 patients with immune system disturbance such a lupus, and

16 multiple sclerosis that involves multisystems symptomatology

17 and has a fluctuating course, and also protocols from

18 persons who have no major problem areas.

19 As we received these protocols, we discovered that

20 some of the protocols came in from Desert Storm veterans so

21 what I've done is I've done a brief analysis and am going to

22 show you some of the profiles, and you also have that in

23 your packet, of a comparison of the Desert Storm veterans to

24 patients with known toxic exposure which I'm going to call

25 environmental patients, as well as compared to patients with


1 auto immune disturbances and psychiatric patients.

2 One of the important things to look at is the

3 comparative strength of classification. What you're seeing,

4 this is the Desert Storm group. This is the known toxic

5 exposure group. This is the patients with lupus and

6 multiple sclerosis, and these are the psychiatric patients

7 who have no medical illnesses. First of all, you'll notice

8 that the profiles appear very similar between these three

9 groups, with this a lot lower in terms of the medical

10 problems. What's important to look at when you're comparing

11 these are the comparative strength classification and that

12 is comparing the extent of symptoms associated with toxic

13 exposure to the extent of psychiatric disturbance. And

14 you'll notice that the three groups in question -- the

15 Desert Storm patients, the environmental patients, and the

16 auto immune patients -- all have very close ratios.

17 The psychiatric patients, the ratio of symptoms

18 that are known to be associated with toxic exposure as

19 compared to symptoms that are known to be associated with

20 psychiatric disturbance is much lower in the psychiatric

21 patient, and that's statistically significant. So that's

22 one of the things that we've looked at.

23 Another thing that we have available, although I

24 wasn't able to get the analysis done prior to this meeting,

25 is some critical indices that looks at a breakdown of each


1 of those classifications.

2 CHAIRPERSON LASHOF: I'm afraid our time is up but

3 I know that you probably have a great deal more. Let me

4 ask, have you published this in any of the scientific

5 journals or --

6 DOCTOR FRANKS: Not as of yet.

7 CHAIRPERSON LASHOF: -- prepared a manuscript yet

8 for publication?

9 DOCTOR FRANKS: Not yet, no. And actually the

10 number of Desert Storm veterans in this small study is very

11 low and what we would like to do, obviously, is to look at a

12 larger group.

13 DOCTOR KIDD-TAYLOR: What was the number actually

14 that you --

15 DOCTOR FRANKS: It was about ten patients out

16 of -- The total subject group was over 200, so it was very,

17 very small.

18 CHAIRPERSON LASHOF: Well, I think we would be

19 very interested in following this work, and as you are able

20 to enlarge it, we'd appreciate your keeping us informed.

21 DOCTOR FRANKS: All right. Thank you very much.


23 I'd like to move along. Doctor Charles Thomas.

24 //

25 //




3 DOCTOR THOMAS: My name is Charles A. Thomas, I'm

4 the president and director of research of the Pantox

5 Laboratories here in town which measures more than 20

6 different substances in human blood serum that are related

7 to the antioxidant defense system. I'm here to explain what

8 this is all about and how it might be useful to those people

9 who have been effected in the Gulf War.

10 A genuine revolution is now underway in regard to

11 our understanding of the origin of disease in general. It

12 has to do with the metabolism of oxygen in all cells that

13 live in air. The mitochondria metabolize oxygen, and I'll

14 show you that in the first slide I think. Here is a slide

15 which has lots of good visible mitochondria, for example,

16 there, there, there, and there. There are thousands of them

17 in cells that live in air, including all of our cells.

18 The mitochondria convert oxygen to water and

19 adenosine triphosphate which is the energency currency of

20 the cell and necessary for life itself.

21 However, like in all chemical reactions, there are

22 by-products and these by-products are very nasty, and here

23 is the first primary road map to oxygen radicals. Oxygen

24 picks up an extra electron from the mitochondria and this

25 produces superoxides which then gives rise to descendent


1 radicals which destroy all of the substances in the cell.

2 Now of course this would be inconsistent with life itself if

3 there were not an antioxygen radical defense system, and

4 nature over evolutionary time has done just that.

5 I'd like to have the next slide. It does so by

6 compartmentalization: special biochemistry, enzymes, small

7 molecules, and elegant repairing systems. The most

8 assessable for investigation today, and modification, are

9 the small molecules. It is these small molecules and the

10 oxidants that we measure. The mitochondria and the whole

11 cell is so tuned as to minimize the production of these

12 unwanted radicals. Any kind of disease agent, such as toxic

13 substances, infectious disease, trauma, et cetera, et

14 cetera, all these things disturb the cell so that more

15 oxygen radicals are produced. So, in other words, these

16 oxygen radicals are the immediate agents of disease,

17 irrespective of the primary cause.

18 There are the substantial antiradical defense

19 systems, as I've said, but with the passing of time --

20 aging -- these systems begin to fail and that's the reason

21 that we all get cancer or heart disease these days as we get

22 older and older. Here we have the cumulative frequency of

23 cancer in rats and in humans. Rats get cancer earlier and

24 die earlier because they have a much higher metabolic rate

25 and produce more oxygen radicals. And here, these


1 degenerative diseased take most Americans today.

2 Okay, what can be done about this? We're not

3 going to get out of this alive but we can mitigate the

4 oxygen radical damage by maintaining the defense systems.

5 One of the most commonly understood antioxidants is Beta-

6 Carotene, it's one of the 20 that are on our list. Here

7 I've shown a cumulative frequency distribution, the percent

8 of people having a certain level of Beta-Carotene in their

9 serum.

10 We determine a whole lot of these things at Pantox

11 and then plot bar graphs like this. For example, here is

12 Beta-Carotene. This particular fellow has 4.0 micromolar in

13 his serum and that puts him at the very top of the class.

14 For his Q10 he has 1.0 and that only puts him in the 25th

15 percentile. So we plot these graphs and the physician or

16 the patient himself can identify his deficiencies in these

17 antioxidant defense system and take special steps to

18 mitigate and improve his chances.

19 The last panel here is the iron balance, which we

20 consider to be extremely important because iron produces

21 oxygen radicals by catalytic action.

22 I believe I'm at the end. The reason that I think

23 this might be useful is because this approach to health and

24 disease is independent of the cause. Anyone who is under

25 unusual oxidative stress destroys these first small


1 molecules antioxidant defenses and then other agents can

2 come in and do their damage.

3 Thank you very much.


5 Are there questions for --

6 CAPTAIN KNOX: Sir, are you proposing that the

7 veterans might benefit from undergoing such testing?

8 DOCTOR THOMAS: Right. I think many of them would

9 be revealed to have very impoverished antioxidant defense

10 systems and that they could be improved by dietary or other

11 means.

12 CAPTAIN KNOX: What's the cost of this testing?

13 DOCTOR THOMAS: The cost of our test here, for the

14 whole panel -- Well, we make deals, okay, but for research

15 purposes, on the basis of volume of a certain amount, we can

16 do this whole panel for $200.

17 Yes, sir?

18 MR. RIOS: Have you tested any Gulf War veterans?

19 DOCTOR THOMAS: No, we have never, not to our

20 knowledge.

21 CHAIRPERSON LASHOF: Thank you very much.

22 I'm afraid we can't take further comments from the

23 floor at this point. We're about a half hour behind

24 schedule. We can talk with you privately afterwards and

25 respond to questions, if you want.


1 Doctor Brian Ross.



4 DOCTOR ROSS: Good morning. Thank you. I'm

5 presenting the results of medical tests which were

6 undertaken on four Gulf veterans at the request of Doctor

7 Ruth McGill. At that time I was not aware they were

8 associated with the Gulf but I was asked to rule out

9 cerebral defects of metabolism as might occur with oxidative

10 phosphorylation defect, which you've already heard from

11 Doctor McGill about.

12 The test we understood is magnetic resonance

13 spectroscopy. It's just another one of the brain machine

14 things but it has the advantage that it specifically

15 measures chemicals in the brain, and this behind me

16 indicates some of the key chemicals which can easily be

17 measured in this non-evasive test which is very like MRI.

18 At the top of the page is ATP, which you heard

19 about, the source of energy metabolism and a number of other

20 metabolites, all of which are part of the energy and other

21 biochemical process of the normal human brain. The test

22 produces lots of squiggles and we interpret the peaks in a

23 variety of disease sittings, and I just want to show you

24 two. In acute viral disease, for example, we would see

25 changes in glutamine and glutamate. In a chronic neurologic


1 disease, such as Alzheimer's disease, we would see changes

2 in the neuronal marker, which is labeled here as NAA, and in

3 a metabolite which is probably related to a neuro

4 transmitter myo-inositol.

5 What were the results in the four Gulf War

6 veterans? By the way, I should say what would we expect to

7 see in oxidative phosphorylation defect? That's very clear

8 cut. There are several patients who have been investigated.

9 They do show changes in muscle and they also changes in

10 brain, and in particular an accumulation of lactate and loss

11 of creatine.

12 None of the four patients that I was asked to see

13 showed these defects and, indeed, two of them seemed to be

14 completely normal. One showed a mild change in choline, and

15 the fourth is one that I think is worthy of note, showed

16 major changes in biochemistry which I cannot relate directly

17 to defects in any neurometabolism but nevertheless for way

18 outside the normal range, and they're reported in your

19 package.

20 The principal findings was an increase in myo-

21 inositol and increase in choline. It turns out that this is

22 actually the patient of whom you saw a photograph earlier in

23 Doctor McGill's presentation, and in my report letter to her

24 I suggested the possible differential diagnosis which

25 included Lou Gehrig Syndrome, frontal lobe dementia,


1 possibly Alzheimer's disease but a little less likely. And

2 my conclusion is that although we were looking for one thing

3 we found another. It's not easy to ignore the biochemical

4 in the brain of this one patient, and the second abnormality

5 is probably significant. I cannot explain them.

6 And my last point is that this is a rather easy

7 one of these brain imaging techniques which is now widely

8 available throughout the country and might be an addition to

9 any screening tests which are done in a more copious

10 epidemiological survey. Thank you.

11 CHAIRPERSON LASHOF: Thank you. Do you know of

12 whether it has been done on any other Gulf War veterans than
13 those that you just reported?
14 DOCTOR ROSS: As I said, I did them in a sense
15 blindly. They were brought with a diagnosis, not intending
16 to deceive me I'm sure. Doctor McGill would know whether
17 she's asked anybody else to do it. I'm not aware and
18 there's certainly no published series, although there are

19 many thousands of patients in other diseases who have had
20 this test.
21 CHAIRPERSON LASHOF: Okay. Thank you.
22 Other questions?

1 spectroscopy, do you actually localize the spectroscopy to
2 particular regions or is this an average over the whole
3 brain?
4 DOCTOR ROSS: No, we do localize in these
5 individuals as in all our standing testing we would take two
6 locations; one in the occipital cortex, in the principally
7 grey matter, and the other in the parietal cortex, in the
8 principally white matter regions. Volumes of about 10 cc's.
9 They're clearly averages for a very large number of brain
10 cells.
11 CHAIRPERSON LASHOF: What diagnoses is this
12 currently widely used for?
13 DOCTOR ROSS: Alzheimer's disease, as I've shown.
14 Newborn illnesses, including hypoxia and metabolic defects
15 like oxidative phosphorylation defect; in born areas of all
16 kinds, hepatic encephalopathy, liver transplantation, and I
17 can go on.
18 CHAIRPERSON LASHOF: Okay. Thank you very much.
19 Do you have any questions?
20 CHAIRPERSON LASHOF: If not, thank you very much.
21 We will adjourn for lunch now. And, since we're a
22 little behind, we will resume at 1:30 instead of 1:15, if
23 that's okay with everyone.
24 (Whereupon, at 12:10 p.m., the above-entitled
25 matter recessed to reconvene at 1:15 p.m. the same day.)

1 A F T E R N O O N S E S S I O N
2 (1:26 p.m.)

3 CHAIRPERSON LASHOF: We're very happy to have with
4 us Doctor Kenneth Kizer, head of medical affairs for the
5 Veterans Administration.
6 It's a pleasure to have you join us again, Ken,
7 and recognize that you're on an even tighter schedule than
8 we are on and that you need to leave promptly at 2:00, as I
9 understand it.
10 DOCTOR KIZER: That is correct.
11 CHAIRPERSON LASHOF: So if you want to go ahead
12 with opening remarks then we'll have some questions.
15 DOCTOR KIZER: Well, greetings and it's nice to
16 see you all again. Actually I am presuming that you have
17 copies of my written statement, which is not very long, and
18 in the interest of time and since you have heard from some
19 of my staff at other forums about the research program I'm
20 actually going to forego an opening statement, per se, and
21 try to use the limited time that we have to address your
22 concerns and answer you questions, and try to make it as
23 productive from your side as possible. If you want me to go
24 through any of the things that are in the written statement,
25 I'll be happy to do that. I just felt that you could read

1 that at your convenience and it might save some time if I
2 forwent that.
3 CHAIRPERSON LASHOF: Maybe we could just go ahead
4 and start with some questions and then if we run out of
5 questions and there's still time and you want to add some
6 things that you feel are important for us to know, that we
7 haven't covered in our questions, you could do that. So,
8 instead of an opening, we'll give you a closing statement.
9 DOCTOR KIZER: As you wish.
10 CHAIRPERSON LASHOF: One of the questions that I

11 have that actually came up out of some of the testimony we
12 heard this morning, in the registry examination, as I
13 understand it, the comprehensive protocol, CCEP under the
14 DOD terminology, and yours is your VA registry, you're doing
15 pretty much the same examination, are you not?
16 DOCTOR KIZER: They're essentially identical.

17 CHAIRPERSON LASHOF: Right. In our analysis of
18 that, your goal there is to give information to the vets on
19 their status but also for you to get a level of
20 understanding of the kinds of symptomatology they're saying.
21 Could you say a little bit about how you're analyzing that
22 registry information?
23 DOCTOR KIZER: Well, the registry is just that.
24 It is a vehicle by which people self-identify themselves who
25 have complaints or who wish to be put on record in the event

1 that in the future they should develop a complaint, and I
2 forget the exact number but it's around 15-percent or so of
3 people of people who have no complaints on the registry.
4 And it's used primarily as a clinical vehicle both to
5 address the concerns of the individual as well as, you said,
6 to characterize the nature of the symptoms that folks are
7 having. And we also use it in some hypothesis generating
8 and things of that type. But I think it's important to
9 recognize that it is just what it is, it's a registry. It's
10 a tabulation of folks who have complaints or who wish to be

11 on record for future purposes, and as such it's not truly a
12 research tool, per se, and that's true of any registry for
13 whatever purpose. This is not unique or different from
14 registries that are used in other -- for other public health
15 purposes.
16 CHAIRPERSON LASHOF: In view of the fact that it
17 is not, and I quite agree that it's not a research tool, do
18 you still, or do you not, summarize what percentage have
19 specific diagnoses, what percentage are considered to be
20 having symptomatology without a diagnosis, or whether you're
21 just not trying to do those tabulations because they may not
22 be meaningful?
23 DOCTOR KIZER: Well, no, we do those tabulations
24 and there's a great deal of interest from a variety of
25 parties for that information.

1 I think we in doing that sort of descriptive
2 analysis of the folks who have self-identified we also couch

3 those results in the appropriate terms, and I think with the
4 appropriate qualifiers that what it is and not try to make
5 it more than that.
6 CHAIRPERSON LASHOF: Well, the issue that came up
7 this morning around that was whether something like Chronic
8 Fatigue Syndrome would show up as among those for whom there
9 was a definitive diagnosis or whether if that was the
10 diagnosis it would fall into the group that there is no
11 specific diagnosis but rather a series of symptoms. Would
12 you know?
13 DOCTOR KIZER: Is there, indeed, a universally
14 agreed upon diagnosis for Chronic Fatigue Syndrome?
15 CHAIRPERSON LASHOF: I think CDC has some criteria
16 of what they will call Chronic Fatigue Syndrome. I don't
17 think, as far as I know, you know, that that's a general
18 diagnosis. But what I'm saying is if a veteran who goes
19 through the exam, if the physician who examined him writes
20 down as the diagnosis Chronic Fatigue Syndrome, do you
21 consider that a diagnosis of a disease or is that one that
22 falls in -- or are they directed not to write that as a
23 diagnosis?
24 DOCTOR KIZER: As far as I know, they are not
25 directed to not write that down if, indeed, they feel that

1 that is the diagnosis of the person or that that person,
2 that's what they have. I think one of the issues with
3 Chronic Fatigue Syndrome is -- I think you recognize that
4 there is a great deal of controversy in the medical
5 literature among the practitioners if it's a syndrome, if it
6 is a syndrome what, indeed, are the criteria that should be
7 used. Yes, CDC has published criteria. There are other
8 entities who say that that is not adequate or appropriate
9 and that other things should be included, and that's been

10 one of the problems in this whole area of Chronic Fatigue
11 Syndrome is getting people to agree what it is that
12 ostensibly is a condition. And I think that's reflected, or
13 would be reflected in practitioners who are called upon to
14 evaluate people who potential have that, but there certainly
15 is no instructions, you know, as a department that you
16 either do or do not include that.
17 CHAIRPERSON LASHOF: Okay. Let me follow through
18 with some other questions that came up and then I'll open it
19 up for the rest of the panel. I don't want to monopolize.
20 One of the issues we've been looking at is the
21 whole coordination and we have of course heard from the
22 Coordinating Board and we've heard from you and Doctor
23 Joseph about the efforts to coordinate activities and the
24 role of the Coordinating Board. I still have concerns in
25 that regard in terms of the mandate for the Coordinating

1 Board. Although it says in certain documents that they are
2 a policy-setting board, on reviewing various epidemiologic
3 studies and listening to the testimony we've heard about
4 some of the studies, there's no question that some of them

5 are excellent and are moving well and should give us some
6 real answers.
7 There have been external reviews and some other
8 studies that have questioned the validity of the studies,
9 the study design and whether conclusions can be drawn from
10 them, and some have been responsive to those and others have
11 not. I don't think they're necessarily VA studies and I
12 don't want to cite the specific studies, it's the principle
13 that I'm really trying to get out. If one has outside
14 reviewers and scientific advisory boards, such as the Armed
15 Forces Epidemiologic Board, the Defense Science Board, or a
16 specific review or scientific advisory committee for
17 specific studies, if they raise issues about whether a study
18 should be continued, whether it's worthwhile or not, is that
19 something that Coordinating Board should look at? does look
20 at? make decision about which studies might be discontinued?
21 which should be pursued? whether additional studies of a
22 certain type ought to be taken? or whether that is left to
23 others?
24 DOCTOR KIZER: In general the -- and I hesitate
25 for a moment because that was a compound question.

2 DOCTOR KIZER: I was trying to think which part to
3 respond to first. In general the board does look at which
4 areas need further investigations. Which ones would be most
5 profitable to pursue at this point in time, et cetera, et
6 cetera, many of the things that you noted and do make
7 recommendations and advice along those lines, and certainly
8 are open and listen to other entities that are making
9 comments or reviewing the studies underway.
10 They are not taking -- we're going to kind of the

11 other end of the extreme -- They are not an audit committee,
12 per se, that goes and audits an investigation as it's
13 underway, and, indeed, I'm not sure what the model for that
14 type in other circles as well. There are some studies, and
15 I think you understand that the genesis of some studies is
16 variable. For example, Congress can and, in the case of
17 Persian Gulf, has on occasion inserted language that
18 specific studies will be done and ordered that they be done,
19 and it's not entirely clear in some cases what the
20 scientific input was that led to that particular
21 congressional order being put in the law. But, nonetheless,
22 if it is in the law and if it is mandated there is a certain
23 responsibility of the enacting agencies to carry through on
24 it.
25 CHAIRPERSON LASHOF: Let me follow that through a

1 little more. The research plan that we've been through and
2 which we're very pleased to get, and I know you worked hard
3 to see that we got an overall research plan. One
4 understands that the way the research was developed after
5 something like the Gulf War is that there were a lot of
6 efforts to get on top of this, a lot of research was started
7 early, and the plan postdates when some of the research was
8 undertaken and for some it predates it. So the plan merely
9 tried to summarize everything that was being done and tried
10 to break out what were the issues that needed to be
11 addressed and identify which studies were addressing them.

12 It was not a plan that was first plan that was
13 first developed by saying, "Well, here's the questions.
14 Here are the studies we must do and we'll fund this study
15 here and that study there, and then spread out and do the
16 studies." It was a mixture of those two kinds of
17 approaches, I believe.
18 DOCTOR KIZER: I think that's a fair
19 characterization.
20 CHAIRPERSON LASHOF: Is that a fair
21 characterization?
22 DOCTOR KIZER: It's not unlike what generally
23 happens.
24 CHAIRPERSON LASHOF: Yeah. No, I think, you know,
25 I couldn't imagine that it could happen any other way.

2 CHAIRPERSON LASHOF: I mean, one doesn't plan a
3 war and then plan what research you'll do after the war and
4 so on. You have to react to a situation and move. So
5 that's not unusual, and I think appropriate. But I think my
6 and the other members of the committee's concern has been
7 that given that being the circumstances, is there a need for
8 a body that at various points stops and takes a look at
9 everything that's going on and says, "Wait a minute. This

10 study really isn't going to pan out and we shouldn't spend
11 any more money on this one because we really got this one
12 over here which is better and we'll do it." If the

13 Coordinating Board isn't such a body, should there be such a
14 body and what would you like to suggest that body look like?
15 DOCTOR KIZER: I think the function that you
16 describe is quite appropriate in the sense of doing real
17 time monitoring and making sure that the things are -- all
18 the investigations are -- indeed remain appropriately
19 targeted for the information that is generally known at a
20 given point in time. I think what you may be getting at,
21 and I don't really know what studies you're referring to,
22 but (1) if there are studies that this committee or others
23 feel are unproductive I would certainly like to know about
24 it to see if we could take whatever measures would be
25 appropriate to see if that, indeed, is a widely held view

1 and, if so, if we could avoid further spending for those.
2 God knows there's enough questions that remain unanswered

3 that we want the funds to go to get the best return on the
4 science dollars as possible.
5 But, in some cases, if -- again in the case where
6 there may be congressionally mandated studies, it may be
7 that those have not been looked at in the same vein because
8 they have been felt to be off limits as far as --
9 CHAIRPERSON LASHOF: Actually the congressionally
10 mandated studies right now are very good studies. We have
11 no problem with those.
12 DOCTOR KIZER: That's what I say, I --
13 CHAIRPERSON LASHOF: As we go through it, we'll be
14 discussing some of the individual ones, but at this point
15 with you I was more interested in this general principle of
16 how -- what kind of a structure ought to be set up for that
17 kind of an ongoing monitoring. Practically all the studies
18 have had reviews by a number of bodies.
20 CHAIRPERSON LASHOF: And there's some critical
21 things on the record criticizing studies and some of which
22 have been responded to, others haven't been, and we're
23 looking for what's the mechanism for doing that.
24 DOCTOR KIZER: As conceptualized, the Research
25 Working Group and the Coordinating Board should be able to

1 accomplish that function. Having said that, I recognize
2 that there are and always will be disputes among
3 investigators as to the relative value of studies. That's
4 why whenever we publish they have three or four peer
5 reviewers look at that article because there isn't always
6 consensus on what should be the top priority or where
7 something fits in the scheme.
8 But, as you noted, in the case of the working plan
9 and typically what has happened is that the studies have
10 been reviewed by multiple entities and they are very
11 carefully looked at. And, frankly, it's not surprising that
12 there isn't in all cases universal agreement on their
13 priority, but hopefully the differences will be relatively
14 small. But that is a function that the Research Working
15 Group and the Coordinating Board should be able to
16 accomplish.
17 CHAIRPERSON LASHOF: Does the Research Working

18 Group, if it upon review, just hypothetical at this point,
19 if upon review of the studies found that there were a couple
20 of studies that probably weren't going to be worth their
21 money, that weren't going to reveal enough and that other
22 studies were more thorough, and although maybe at the time
23 they were initially started seemed reasonable, but now with
24 more funding of other studies probably aren't worth doing,
25 do they have the authority to tell a group that they should

1 stop, or do they have the responsibility to inform you or
2 Steve or Doctor Joseph of that?
3 DOCTOR KIZER: It would be my understanding that
4 they would bring that forward. They would not have the

5 authority to stop the work in its tracks but they would
6 bring it forward and then, depending on the genesis of the
7 funding and the nature of the study, would make appropriate
8 recommendations.
9 Just in the way of general, and I don't know how
10 relevant this is, but I think as you know I'm not on the
11 Coordinating Board but that I have a wide-open door to the
12 folks on the Research Working Group and I think I can say
13 without exception they've never had any problem getting
14 access to me or, if they felt something needed to be done,
15 getting action taken on it promptly.
16 Shortly after I joined the department, about a
17 year ago, just a little over a year ago, I did elevate the

18 office of Public Health and Environmental Hazards so that it
19 reported directly to me as opposed to being further down in
20 the bureaucracy where it was before. So, if they have those
21 sorts of concerns, it would be my expectation they would
22 bring them to me. We'd discuss them and then decide what
23 was the most appropriate course of action at that point,
24 whether taking it to the board or something else. And my
25 experience to date is that folks aren't shy in coming to see

1 me.
2 CHAIRPERSON LASHOF: Others on the committee,
3 please?
4 DOCTOR CUSTIS: Not about research but we're
5 hearing an awful lot from veterans that they encounter ill-
6 informed staff people, physicians from both military and VA
7 hospitals and seemingly have no satisfaction as to their
8 satisfaction. Can you picture how that could be more
9 effectively identified immediately and those complaints
10 address before they ever get out of the system?
11 DOCTOR KIZER: I'm not sure that I have a specific
12 mechanism or vehicle by which we can do that. Certainly
13 under many of the changes that we're putting in place in the
14 VA, in things like customer service standards and other
15 things, that those would be immediately brought to the
16 attention of management and they would be dealt with.
17 There is in this case, not unlike what I've seen
18 in a number of other situations particularly related to
19 environmental concerns and conditions for which there is not
20 a clear cut answer, there is a certain amount of
21 dissatisfaction that will exist no matter how well trained,
22 how good the service is because the needs of the individual
23 as far as either their condition receiving definitive
24 treatment or definitive diagnosis is not possible. It's not
25 clear what they have or what can be done about it. And, in

1 those cases, the customer, the patient, if you will, is
2 going to be unhappy until they have their condition taken
3 care of, until they have their questions answers. And

4 that's part of the background that we have to I think
5 recognize will occur in this situation as well as other
6 situations where we are dealing with unknowns and the
7 inability to tell people what exactly they have and what we
8 can do about it.
9 I would just add that in those cases it's equally
10 frustrating for the physicians who are there to serve and to
11 provide treatment and to answer people's questions and to
12 hopefully make them well, return them to functionality, and
13 if they're not able to do that then there's a certain degree
14 of frustration on their part as well.
15 Having said that, I would just mention that we
16 have undertaken a number of actions, certainly in the year
17 or so that I've been there, to try to improve the overall
18 degree of information and clinical competence, if you will,
19 of our practitioners. We've held a number of conference

20 calls among the investigators. We've had video conferences.
21 We've had -- A couple of months ago brought everybody in for
22 three days in Washington to go through the findings. We've
23 published protocols and brought this to the attention.
24 We're now actually implementing, or I've sent out the
25 directive on doing an audit, quality assurance audit, of

1 these examinations, which is probably unparalleled in that
2 we're asking for a 10-percent sample of all of them which

3 will be reviewed for completeness of the evaluation for --
4 essentially in all areas to make sure that they are
5 addressing what should be done in evaluating these folks.
6 That information I should have available early next year on
7 the first trounce of those samples to see how we are doing.
8 At that point we can provide you with more specific
9 information on what that audit shows. But I don't know any
10 other clinical program, except under investigatory
11 protocols, where that sort of ongoing quality assurance
12 mechanism is in place.
13 CHAIRPERSON LASHOF: Any other questions?
14 MAJOR CROSS: What's the cut off date for the
15 registry through the VA?
16 DOCTOR KIZER: I'm not sure I understand your
17 question.
18 MAJOR CROSS: There was a question that came up
19 this morning that I guess the end of December of this
20 year --
21 CAPTAIN KNOX: Yeah, and I was in error when I
22 said that. It's not really a cut off for the registry but
23 there was a statement in one of the Gulf War pamphlets that
24 they send. I think it was a cut off maybe for priority care
25 was December '95. Has that been extended?

1 DOCTOR KIZER: It is my expectation that that will
2 be extended. There's still a lot going back and forth
3 between Congress and things these days, and actually I, at
4 the moment, don't know whether that has actually gone
5 through all the hurdles and been signed or not. But it's my
6 expectation that -- my hope is that that will be extended.
7 CAPTAIN KNOX: Will there ever be a cut off,
8 though, for veterans to go and have a CEEP exam?
9 DOCTOR KIZER: I'm not sure I can answer a
10 question that there ever will be or not, but I think our
11 plan and expectation at this point is to continue to do all
12 we can to find out what the answers are.
13 MAJOR CROSS: I would suggest, Ken, that Congress
14 has done in the case of Agent Orange, in similar situations,
15 I mean, there is periodically an extension of authority for
16 the VA to carry for Agent Orange disabilities.
17 DOCTOR KIZER: And that is, indeed, what I would
18 expect in this case as well.
19 CHAIRPERSON LASHOF: Fall back to me. I have a
20 couple more.
21 DOCTOR KIZER: Sure. I've never known you to be
22 short.
23 CHAIRPERSON LASHOF: Watch out. One of the things
24 that's come to us and it's, you know, sort of about fifth
25 hand, that certain VA employees might want to testify but

1 they're concerned about the impact, whether actions would be
2 taken against them. They're discouraged, there's various
3 messages that get out there that they shouldn't come forward
4 to testify before this committee about problems they're
5 aware of. I don't know what scuttlebutt you've gotten on
6 that but I'd love to know what you think you could do about
7 it.
8 DOCTOR KIZER: I, frankly, have not heard that at
9 all. All I can say is that if somebody has something that
10 they think needs to be rectified, we need to improve
11 something, I would hope first they would go to management,
12 whether it be their supervisor or the director of the
13 hospital or whatever, and that we fix the problem. As far
14 as testifying, I don't have any problem with folks
15 testifying. I would, though, hope that we've had the
16 opportunity to fix the problem, though, before one testifies

17 about it. If that's not the case, then I actually think the
18 employee is probably negligent in not bringing it to the
19 attention so it could be fixed.
20 And, you know, I think perhaps, as Doctor Custis
21 and others who have watched this whole year or so that I've
22 been there, we have taken an unprecedented openness and
23 solicited widespread comment on everything that we're doing
24 and have approached things in a very open way.
25 Matter of fact, I will share one small anecdote

1 with you. We are undergoing a RIF procedure with our work
2 force there in Washington, reduction in force, where we're
3 laying off about 25-percent of our work force in Washington,

4 and it's a budget-driven exercise so that every day it goes
5 beyond means somebody else may lose their job or have to
6 take a furlough, and it turns out that we're going to
7 probably have to issue notices the week before the holidays,
8 and that's not a good time but if we delay it means some
9 additional people will probably either get furloughed or
10 lose their job. I said, "Well --" and there are some other
11 circumstances but basically it's a lose-lose. I said let's
12 ask the employees how they felt, so ballots are going out
13 today to all the employees to get their input. When I did
14 that it was kind of like, "Whoa, that's not how we do
15 things." But that's the approach generally that we've taken
16 that involve them in the process and just -- I would just
17 use that same analogy, if there's something that we can do
18 to make our process better at individual medical centers or
19 in the system, I would expect our employees to bring those
20 ideas forward. We want to make it better.
22 DOCTOR BALDESCHWIELER: We're in the -- we, as a
23 nation, are in the process of yet another large overseas
24 deployment. What lessons have you learned that you can
25 incorporate into procedures that will help things work more

1 smoothly after this action?
2 DOCTOR KIZER: I'm not sure that I can respond to

3 that in a definitive way this afternoon. I think one lesson
4 that we certainly have learned over and over again is that
5 war is very messy and dirty and something that should be
6 avoided at all costs whenever possible.
7 DOCTOR BALDESCHWIELER: But are there some
8 specifics with regard to, for example, physicals -- pre-
9 deployment physicals? What actions -- The VA of course is
10 what --
11 DOCTOR KIZER: Let me try to respond to you. We
12 have had this discussion and the point that we've made to
13 DOD, and will continue to make to them, is that one of our
14 greatest difficulties in picking up the causalities after
15 they've happened is having the baseline information.
16 Anything that could be done to improve the collection of
17 information before deployment, before going into a combat

18 theater, would be helpful in dealing with individuals later.
19 And this is especially true as far as mental
20 health issues and reactions to stress and other things which
21 often are hard to get information on. But certainly, if you
22 look through history, in every war the psychological trauma
23 is profound and it manifests itself differently in
24 different -- You know, if you go back to the Civil War and
25 even before, the psychological sequela of combat has been

1 present among thousands, tens of thousands of people after
2 each of those. How it's exactly manifested has been
3 different, but certainly that's an area where we would hope
4 to have better baseline information on before troops are
5 deployed. Being able to educate folks and having more
6 information dissemination is not unlike what's been found
7 with disaster situations, whether Oklahoma City, the
8 hurricane in the Virgin Islands recently. I mean, this has
9 been found over and over again the more quickly that you

10 deal with folks early on, the more information that can be
11 provided to them as far as what they can expect, and then in
12 dealing with it afterwards, the better people are prepared
13 to actually deal with that. So there are some things that I
14 think can be done.
15 We've had some discussions with DOD. I would
16 characterize them more as informal at this point, but there
17 is some experience I think you can look to through the
18 myriad of conflicts that this country has been involved in
19 over the last 200 years and there are some lessons that
20 would be applicable to the future.
21 DOCTOR BALDESCHWIELER: After each of these
22 actions of course I think one can anticipate certain kinds
23 of problems and I wonder if you've taken really specific
24 actions. For example, what special circumstances might you
25 expect to be problematic in the Balkans and have you taken

1 specific steps to anticipate those?
2 DOCTOR KIZER: At this point I don't know. I'm

3 unaware of any specific steps that have been taken in that
4 regard with the recent deployment.
6 DOCTOR KIDD-TAYLOR: I just have one question as a
7 follow-up to what was just asked regarding the possibility
8 of making sure that before deployment persons are made aware
9 of the possibility of environmental exposures, or, if

10 they're going to use pesticides, how they're used; if
11 they're provided with adequate protective equipment;

12 whether they've been told -- Similar to what happens in an
13 industrial setting where employees are informed about the
14 hazards of what they're using, what they're working with, or
15 what they may come in contact with while performing their
16 jobs. Has that been thought about or --
17 DOCTOR KIZER: Oh, it certainly has been thought
18 about. I'm not the most appropriate person to ask about
19 that. Doctor Joseph I think could respond, because this
20 really is his bailiwick. One of the problems in war,
21 certainly in a situation like the Persian Gulf, is that you
22 really don't know and great efforts are taken to prevent
23 your opponent from knowing what some of the things are that
24 they may indeed be exposed to. So while it's a good concept
25 and certainly a valid thought, the rules of engagement in

1 war are somewhat different than in the industrial setting.
2 DOCTOR KIDD-TAYLOR: Industrial setting, right.

3 DOCTOR CUSTIS: You know, it's interesting, Ken,
4 the questions you've -- the last few questions you've been
5 getting remind me whereas in the past historically the VA
6 has, indeed, been at the end of the line standing by to be
7 of help as a contingency backup for the receipt of
8 casualties. You're now in a position with your extensive

9 sharing in joint ventures to share some of your resources in
10 front of the line, don't you think?
11 DOCTOR KIZER: Well, I think we certainly have
12 gained experience and knowledge over decades of dealing with
13 the sequela of war that could be useful in perhaps at least
14 preventing or ameliorating some of the anticipated, or
15 things that you could reasonably anticipate to come out of a
16 conflict regardless of the specific nature of that conflict.
17 It is the sort of thing that I would hope we would have

18 receptivity by the other relevant agencies to embrace the
19 information that we do have such that it may be beneficial
20 to the folks that we end up taking care of down the line.
21 CHAIRPERSON LASHOF: Ken, thank you very much.
22 Let us hope that this, the newer effort in Bosnia is,
23 indeed, peace keeping and not war and so let's not equate it
24 with war. Let us join the President in hoping that this is
25 a peace keeping that will turn out well.

1 Any final remarks. We have two minutes left, I
2 guess.
3 DOCTOR KIZER: I would agree with you that I hope
4 it is peace keeping and that we will inherit few new
5 patients as a result of this conflict potential.
6 CHAIRPERSON LASHOF: Thank you very much.
7 DOCTOR KIZER: Thank you.
8 CHAIRPERSON LASHOF: Okay. I think we're ready to
9 move into our next working session. Does the panel want to
10 take a break. We dashed back from lunch and the panel may

11 have a need to take a brief break because we really didn't
12 get one from lunch before we came back in order to get
13 Doctor Kizer, so maybe we'll take 15 minutes and come back
14 at 2:15 and then launch into the afternoon.
15 (A short recess was taken.)
16 CHAIRPERSON LASHOF: We're back on the record.
17 Okay. We get back in this afternoon into our

18 working session and let me just briefly go over the agenda
19 for this afternoon, for the sake of the committee and the
20 audience and staff, and for staff to tell me if I've got it
21 wrong.
22 First, we'll start off with giving you a brief
23 report of the meeting in San Francisco which dealt with the
24 epidemiologic studies and reports on them that John
25 Baldeschwieler, Andrea Kidd-Taylor, and I were at as a

1 subcommittee of this group. So we'll bring the rest of you
2 up to speed briefly without going into conclusions, because

3 we'll get into that when we get into the test of the interim
4 report and the findings and recommendations that are going
5 to go into that interim report. I'll brief you on that and
6 then staff is going to discuss some of the other aspects of
7 the search and their findings and where they stand to date
8 in their work on research as part of our deciding what goes
9 in on the interim report, and we're going to devote the
10 afternoon to that aspect of it.
11 I think before -- Well, let me go ahead with the
12 San Francisco and then when I finish the San Francisco
13 meeting report we'll take a look at the time line that we're
14 going to have to work under to have our interim report to
15 the President by February 15th. And once you see that time
16 line you'll understand the pressure we're going to work
17 under the rest of today, tomorrow, and the next month -- two
18 months, two and a half months.
20 CHAIRPERSON LASHOF: Now, the purpose of our
21 subcommittee panel meeting, which was held in San Francisco
22 on November 7th and 8th, was to hear from the scientists
23 carrying out some of these epidemiologic studies, to hear
24 from some of the scientists who had done reviews of those
25 studies, and to get a sense of what stage the various

1 studies were at to help inform us around the major issue
2 that is our responsibility over this next year and half,
3 some of which we can address in the interim report and some
4 of which will clearly await the full report, which is to
5 determine whether or not all of the appropriate studies are
6 being done in order to determine what is Gulf War Veterans'
7 Illnesses; if possible, the etiology of those and, in the
8 long run, the treatment and what can be done.
9 It must be very clear to everyone that this

10 advisory panel cannot answer the question, nor is it our
11 responsibility, because it's not possible. I mean, it would
12 be our responsibility if it were possible but it is not
13 possible in our time frame to come up with a definitive
14 answer to all these questions. What we can do and must do
15 is determine whether or not everything is being done that
16 should be done to come up with those definitive answers.
17 We will not undertake any new research. We will
18 look at which research is going on. We will critical, in a
19 positive sense, and make recommendations about that.
20 So, saying that much, let me just very briefly
21 tell you about the studies that we heard about at our San
22 Francisco meeting.
23 Two CDC studies: One is of the Pennsylvania
24 National Guard. The Air National Guard, is that right? And
25 one CDC study with the Iowa Department of Health on the

1 health assessment of Persian Gulf War veterans from Iowa.
2 The Pennsylvania study was undertaken with CDC
3 with the State Department of Health of Pennsylvania in
4 response to a request from the Health Department of
5 Pennsylvania. The Iowa study was one that was mandated by
6 legislation of Congress.
7 We also heard about an environmental epidemiology
8 survey, a national health survey of Persian Gulf veterans
9 and their family members that is being done by the VA, which
10 I believe is also a mandated study, and a mortality follow-

11 up study of Persian Gulf War veterans. And then there was a
12 series of some seven studies that are being carried out by
13 the Naval Health Research Center of DOD.
14 The Pennsylvania study did come to certain
15 conclusions and in their initial phase they try to come up
16 with a case definition that they felt they could use as a
17 working case definition and that they felt there was some
18 symptomatology among the deployed that was greater than
19 those that were non-deployed. The symptoms that they found
20 were not unique. They are symptoms that occur in the
21 general population and symptoms that occurred in the non-
22 deployed as well as deployed but the frequency was greater
23 in the deployed than the non-deployed, and they looked at
24 the constellation of symptoms and tried to come up with what
25 they considered as a working case definition that could be

1 used in further studies and will be used in further studies
2 as they go into other phases of that study.
3 Our general feeling was that this was a well done
4 study. Not positive in -- have to be careful of my wording.

5 Not positive in just the findings but that it was well done,
6 well analyzed, and being carried out in a critical manner.
7 The Iowa study was just getting underway. In
8 fact, the proposal had just been approved and -- that is
9 their survey methodology had just been approved, but this
10 was a very well thought out study involving the CDC, the
11 Iowa Department of Health and the University of Iowa, and it
12 was being carried out as a cooperative agreement with the
13 University of Iowa. And that study we felt should be an
14 extremely -- would be a good study that, you know, would be
15 a while but it has the potential of being extremely
16 valuable.
17 Then, we heard about studies being done by the VA.
18 One being the National Health Survey which was being carried
19 out by Doctor Kang. This study actually had been suggested
20 by the NIH technology assessment workshop panel and was
21 later required by law. Now, this study will survey 15,000
22 Gulf War veterans and 15,000 era veterans, through a mailed
23 questionnaire about health symptoms.
24 The use of the mail survey was raised as a problem
25 for the study because of the response rate. Low response

1 rate is a problem in mailed survey questionnaires, and they
2 are going to try to deal with this by looking at medical
3 records review and physical examination of a portion of the

4 study that could provide additional information. This study
5 is probably, despite its limitations, one of the best
6 opportunities for estimating the occurrence of symptoms and
7 health conditions in the Gulf War veteran population at
8 large.
9 The mortality study -- let me find the mortality
10 study. Where is the mortality study?
11 MS. NISHIMI: Page seven.
12 CHAIRPERSON LASHOF: I've got these in the wrong
13 order.
14 Okay. The mortality study was done by the VA and
15 that was a study of the veterans of the Gulf War comparing a
16 group that were deployed with non-deployed, and their
17 preliminary results through 1993 indicated lower death rates
18 in the Gulf War veterans compared to the non-deployed,
19 except for deaths from external causes such as motor vehicle
20 accidents. The rate ratio of deaths from infectious disease
21 were low, the rate of ratio of deaths from external causes
22 in Gulf War veterans compared to other veterans was somewhat
23 higher, and this will be further broken down with more
24 specific comparisons of diagnoses. But, at this point, that
25 study would support the view that there was not a higher

1 death rate upon returning from non -- you know, not counting
2 war injuries, among that group that were deployed compared
3 to the group that weren't deployed. And we thought that
4 that study was well done but they need to have more details

5 on the specific causes of death for comparison purposes, and
6 that's going to be done.
7 If you want to add anything at any point during
8 this, Lois, feel free to.
9 Then there was a series of studies being carried
10 out by the Seebee group at the San Diego Research Unit here
11 on a Seebee study population. It was with these studies
12 that we had some more of our problems. Preliminary data
13 from the survey that they carried out which dealt with

14 active duty Seebee battalions included those employed to the
15 Gulf and those deployed elsewhere. Their information on
16 symptoms were collected through self-administered
17 questionnaire and, of those who completed the survey, those
18 deployed to the Gulf reported a higher prevalence of most of
19 the symptoms for which questions were asked, and they also
20 had more hospitalizations than those who had been deployed
21 elsewhere. But there were no clear differences between the
22 Gulf deployed and the comparisons in physical examinations
23 and lung function studies.
24 We had a number of problems with this study
25 because it was a pure volunteer. It wasn't a random sample.

1 The response rate to the mailed questionnaire was quite low,
2 and it wasn't clear to us that you could draw any valid
3 conclusions from any of the findings that were presented.

4 And, frankly, this was one of the studies that precipitated
5 some of the questions you heard me ask Doctor Kizer about
6 who's looking at this afterwards. We'd heard from the
7 reviewers who had reviewed these studies and they had been
8 very critical of this study as to what its value would be.
9 I would say in all fairness to the researchers, they noted
10 the limitations and said that there were limitations. But
11 we're not convinced that those limitations were so great
12 that they should have abandoned the study, and we tend to
13 disagree on that point, I would think, at this point.
14 The next study that is planned -- because of the
15 limitations of that they had planned a new Seebee study
16 using a mail survey to be sent to 17,000 Seebees who had
17 served at least one month on active duty. That mailed
18 questionnaire will collect data on exposures and so forth.
19 Now, it avoids some of this problems of the first
20 study in that it isn't dependent upon volunteers and it
21 would have the potential to provide information on a large
22 group of deployed. But, again, it's completely dependent
23 upon mail survey and the reviewers, the outside reviewers,
24 were very -- questioned the wisdom of spending the money,
25 the time and the effort to do that in view of other studies

1 that appear to be much more solid; the other National Health
2 Survey, the Iowa study, and the other national survey which

3 had a better ability to draw on a broader cross section and
4 would have better follow-up.
5 Some of the consulting scientific advisory panel
6 actually recommended against carrying out that study and I
7 think that still needs to be looked at.
8 They also reported on a comparative study of
9 hospitalizations between deployed and non-deployed but it
10 was very hard to generalize from this study because it was
11 collected from -- it dealt only with those who remained on
12 active duty and it failed to capture hospitalizations from

13 those who were separated. And we questioned whether drawing
14 any conclusions from the group that was healthy enough to
15 remain on active duty and didn't include those that had left
16 active duty was going to be worthwhile.
17 We also heard from another study that was designed
18 to look at the hospitalization rates to correct the problems
19 with that study. This one would be to look at a broader
20 group of hospitalizations. That might be generalizable but
21 it would be a study just in California and it might be
22 worthwhile.
23 The other area that is being looked at is the
24 study on reproductive outcomes, and here we heard of two
25 studies. One had been completed and it relied on perinatal

1 hospital records of active duty military personnel and their
2 spouses, compared the rates of birth defects in the Gulf War
3 deployed versus non-deployed. The preliminary results
4 showed no significant difference in risk from birth defects
5 from the active duty and the era veterans who weren't.
6 Again they looked solely at records from the veterans who
7 were still on active duty and that's not likely to be
8 representative of the entire Gulf War veteran population.
9 Furthermore, the computerized hospital records are
10 not seen as a particular good source of birth defect

11 information and ascertainment was likely to vary from
12 hospital to hospital. So, although the study might well --
13 If it had shown up a positive difference it might have been
14 significant, but the lack of a positive thing doesn't tell
15 us a great deal. The are, however, planning another study
16 which was a very well designed study looking at states that
17 had birth registries in which they'd be looking at all the
18 birth defect registries and looking at whether -- the
19 frequency of defects in Gulf War veterans versus non Gulf
20 War veterans. They were pilot testing that in Hawaii and if
21 the pilot test proves successful then that will be carried
22 out, and that will be an extremely worthwhile study.
23 They also are planning a mailed questionnaire
24 followed by telephone interviews of some 5,000 couples.
25 This study we thought was questionable and needed to be

1 further reviewed.
2 In essence, I think I could summarize the San

3 Francisco meeting by saying that we heard of a number of
4 studies that we thought were excellent; we heard of a number
5 of studies that we had questions about. We had response
6 from scientific review groups. We heard from the armed
7 forces epidemiologic board that had been critical of a
8 number of studies. We heard from the scientific reviewers
9 on many of the Seebee studies and their criticisms.
10 We engaged in I think a very healthy give and
11 take with the investigators and I've summarized this much of
12 it for you now and we'll get into some of that when we get
13 into the text and the recommendations, because out of that
14 discussion came some of the recommendations we're going to
15 make about the coordination. And, from the questions I put
16 before Doctor Kizer, you can gather that one of my concerns
17 is that there be an ongoing way to look at these studies and
18 determine which ones should go forward or not. But we can
19 get into that kind of discussion as we go through our
20 interim report and come up with -- open up the discussion on
21 that.
22 That was a longer monologue than I planned but let
23 me ask if there are questions that you have about what I
24 presented, although we'll be going back over a lot of it as
25 we dig into the report itself.

1 Andrea or John, do you want to add anything? You
2 sat through the day and a half with me.
3 DOCTOR KIDD-TAYLOR: I think you did a good job.

4 CHAIRPERSON LASHOF: And I congratulate and thank
5 Lois for summarizing that day and a half for us. She did an
6 excellent job.
7 MS. NISHIMI: Just a question. Did all the
8 committee members receive a copy of the summary?
9 CHAIRPERSON LASHOF: They have not received a copy
10 of this summary. We will get it to them, although much of
11 it's going to be captured in the findings. But so far they
12 haven't seen this yet.
13 Lois, would you like to add anything to this, or
14 Mark? Fine. Okay.
15 Any other questions from any panel members about
16 where we stand on that part?
17 (No response.)
18 CHAIRPERSON LASHOF: Okay. If not, I want you to
19 look at the very back of your book. The last page is a
20 tentative
21 schedule of what we're going to face in the next two and a
22 half months. Today, we're going to go through what's in the
23 briefing book, around the various areas that we're going to
24 cover in the interim report, and we're going to have to come
25 up with a format and come to an agreement on a table of

1 contents and the general structure. Staff will digest all
2 the brilliant thoughts we have.
3 MS. NISHIMI: All of them.
4 CHAIRPERSON LASHOF: All of them. Every last one,

5 between now and January 1st, and between January 1st -- and
6 I'm sure on January 1st, just as a New Year gift -- anyway,
7 by the 5th they hope to mail out the first draft of the
8 interim report to the committee. The committee will have
9 exactly seven days to look at that interim report, review
10 it. They promise we're not going to go beyond 60 pages,
11 we're going to try to be succinct and --
12 MS. NISHIMI: That's the target promise.
13 CHAIRPERSON LASHOF: That's the target promise.
14 You can go less than 60.
15 MS. NISHIMI: Well, yes.
16 CHAIRPERSON LASHOF: But no more than that. How's
17 that?
18 MS. NISHIMI: We'll see.
19 CHAIRPERSON LASHOF: I can see them changing the
20 font size and it getting smaller and smaller to make it into
21 60 pages. A trick many of us use in abstracts. Anyhow,
22 we've got seven days from January 12th to the 15th to get
23 back to staff with our comments. They will turn that around
24 in two days -- I don't know how.
25 MS. NISHIMI: We will do it.

1 CHAIRPERSON LASHOF: And get back out to us by the
2 17th the next draft, and we're to get back to them by the
3 24th a penultimate draft.
4 MS. NISHIMI: The 16th and 17th also incorporates
5 an external review.
6 CHAIRPERSON LASHOF: Okay. And that will go out
7 to an external review, and we'll discuss who that external
8 review ought to be, I think.
9 Yes? We can discuss it now or later.
10 MS. NISHIMI: Why don't we go through the --
11 CHAIRPERSON LASHOF: Let's go through the whole
12 thing and then we can come back to points like that.
13 January 26th they're going to mail out the final
14 draft, and our meeting in scheduled in Washington probably
15 around January 1st to okay that final one and really go
16 through it and critique it for the last time and give staff

17 our final comments. And then they will take that from that
18 meeting, by February 7th, to do the final. And, as I say, a
19 printing miracle will occur between February 8th and
20 February 13th. And I can picture at midnight on the 15th
21 somebody delivering it to the White House so we won't have
22 missed our deadline. No?
23 MS. NISHIMI: I think we'll just see what happens
24 after the miracle.
25 CHAIRPERSON LASHOF: As you can see, this is

1 really very, very tight. I think the only reason I believe
2 that it's possible is the quality of the staff work that's

3 been done so far. The material we have in our book I think
4 is really excellent, so I think we'll have a better sense
5 after this afternoon and tomorrow, having walked through it,
6 how much work the staff is going to keep to this schedule.
7 Anybody have any --
8 DOCTOR KIDD-TAYLOR: I was going to say, Joyce,
9 for those of us who are out of place that first week, I will
10 try and get a good address. 11 CHAIRPERSON LASHOF: I'm going to be out of the 12 country that whole month of January. We're going to be 13 using -- 14 MS. NISHIMI: There are miracles of electronic 15 transmissions. 16 CHAIRPERSON LASHOF: Electronic transmission in 17 the DHL overseas. Packets that are going to follow me all 18 around South Africa. In fact, I land back in this country 19 on January 28th and I leave the country on January 7th, so 20 we're going to have fun. 21 Any of you else going to be out of the country, 22 out of state, wandering anywhere? 23 DOCTOR KIDD-TAYLOR: I'll be out of state but I'll 24 make sure they know where I am. 25 CHAIRPERSON LASHOF: Know where you can be

128 1 reached, everybody. We'll see how much -- Do you know at 2 this point how much of this we're going to be able to do by

3 electronic mail, whether we're going to be able to do this 4 by computer? 5 MS. NISHIMI: I just can't tell you right now, 6 now. 7 CHAIRPERSON LASHOF: Okay. Do you want to discuss 8 who -- the review, or shall we hold that for tomorrow, the 9 external review? 10 MS. NISHIMI: Why don't we hold that until 11 tomorrow. 12 CHAIRPERSON LASHOF: Yeah. Well, we'll get into 13 the question of who's the external reviewers tomorrow. 14 After we've gone through some of this, I think we'll have a 15 better sense. 16 MS. NISHIMI: I do want to say that the staff 17 recognizes that the schedule is very tight, and the staff 18 appreciates that the Advisory Committee is going to have to 19 turn these manuscripts around quickly, too. We're sensitive 20 to the notion that for every word we write and type and 21 means more words that first I would have to edit and then 22 you will have to read, and so we do plan on being succinct 23 and to the point with our draft. 24 I have full confidence in the staff's ability to 25 do it. I think they've done an heroic effort, as Joyce as

129 1 mentioned, to get this far. I'd just like to remind the 2 committee that it's only been six and a half weeks since we

3 met and in between there we had a holiday and a furlough, a 4 shutdown, and they still came through like champs. And I do 5 believe that we will be on target and we'll be able to meet 6 this schedule and deliver an interim report to the President 7 that the committee can be proud of. 8 CHAIRPERSON LASHOF: Okay. Any other questions 9 about this aspect of it? 10 I think we're prepared to turn to tab B in the 11 briefing book and the staff are going to walk us through the 12 discussion of the research, federally-funded research, and 13 our goal is, as we go through this, is to look 14 specifically -- it's only the general wording and the flow 15 of things but certainly to come down and -- around the 16 findings and the recommendations, and we've got to be 17 satisfied that everybody is happy and satisfied with 18 findings, recommendations, which ones we keep, which ones we 19 get rid of, what new ones we add, et cetera. 20 With that said, I'll turn it over to Mark and 21 Lois. Who's kicking off, Mark? 22 MARK BROWN, REPORT ON FEDERALLY FUNDED RESEARCH ON 23 GULF WAR VETERANS' ILLNESSES 24 MR. BROWN: I'm going to start. Thank you. Thank 25 you, Joyce. Thank you, committee.

130 1 I appreciate the confidence that you express in us 2 and our abilities to see this through. I'm going to talk 3 today a little bit about the work we've done looking at

4 federally funded research on Gulf War veterans' health 5 issues and, as you mentioned, this is tab B. The full memo 6 describing this is tab B in your notebooks. 7 With me today is Mr. Michael Kowalok who's been 8 working with me on this end, also Doctor Lois Joellen Beck. 9 MS. NISHIMI: And to your right? 10 MR. BROWN: And Holly. This is the person that 11 makes sure that the staff does the work. 12 As you may have noticed, in the first briefing 13 books that we've looked at, there's an enormous amount of 14 research already underway, federally-funded research already 15 underway directed at looking at Gulf War veterans' health 16 issues, some of which we've heard discussed already: The 17 epidemiological research, but there's other research as well 18 that I'm going to discuss. And our goal was to take a look 19 at this research first just to understand it and then 20 ultimately to make some sort of assessment about where this 21 research is going to lead us in five to ten years, what are 22 going to know about Gulf War veterans' health issues, where 23 the gaps were, are there perhaps holes where research has 24 been -- where there may be issues that have been overlooked. 25 The strategy that we've used is to look at

131 1 protocols, look at research protocols, talk to principal 2 investigators. You heard about the San Francisco meeting

3 where we concentrated specifically on the epidemiological 4 studies. We have pursued in particular the review processes 5 by which these particular pieces of research were put 6 together to the extent that we could get a hold of reviews 7 and so forth to try -- and look at external reviews of the 8 research as it was developed. And we tried to make an 9 assessment of how reviews, how external review was 10 incorporated into research as it progressed, as the idea was 11 developed. And of course one of the issues that came up 12 earlier that we're also very interested in is what -- where 13 the oversight occurs in this whole process, who is 14 responsible for overseeing the entire Gulf War veteran 15 research coordination. 16 Now, I just want to make a point here that the 17 research, our research effort, looking at research that's 18 going on relative to Gulf War veterans, we're doing this in 19 the recognition that there's another component to this issue 20 and that is taking care of sick veterans today. Veterans 21 who are ill today we don't need to wait for the results of 22 these research efforts that are going on to start dealing 23 with these issues now, and that's the subject of our 24 clinical review and so forth that we'll hear about later. 25 But, nevertheless, in the long run, there's certain

132 1 questions that we want to answer about what's going on with 2 Gulf War veterans. 3 As you can all imagine, as we've all heard, the 4 Gulf War was not an ideal situation for gathering data. It 5 was a war. It wasn't some big laboratory experiment. 6 Obviously it wasn't the best conditions to gather exposure 7 data or any health effects that may have occurred during the 8 Gulf. And of course the -- This of course leads to certain 9 consequences in our ability to do any research, the fact

10 that data is not -- is in some cases incomplete or in some 11 cases actually outright missing. And a particular one I

12 want to emphasize is, as I talk, is -- as I move along with 13 this is that exposure data is very hard to come by. We 14 have very poor exposure data for most of the risk factors 15 that people are concerned about relative to the Gulf. 16 Now, the way we -- For the purposes of our work in 17 trying to investigate federally funded research we broke it 18 down into two major categories of research. The first which 19 we've talked about a little bit is the epi studies -- 20 epidemiologic studies -- which is -- I'll talk about in a 21 moment. You've already heard some remarks from Joyce about 22 the San Francisco meeting. But a second category of 23 research is the toxicologic studies and these are studies 24 that are not epidemiologic in orientation. They are using 25 animal models, for instance, to test the effects of certain

133 1 chemicals, for instance, for other risk factors that are 2 associated with the Gulf. 3 The first time I talk about the epidemiologic 4 studies is at the risk of being a little redundant here. 5 You've heard of some of this stuff. Epidemiologic studies, 6 we think it's pretty clear are the -- really the best way we 7 have to get at some of the issues about Gulf War veteran 8 illnesses. 9 Epidemiology studies are designed to measure the

10 occurrence of diseases in human populations and to try and 11 figure out which factors, environmental or otherwise, that 12 may be influencing the occurrence of those diseases. Epi 13 studies we think are the best way to find out what's going 14 on in a case where you don't know -- we don't understand 15 exactly what's going on with our Gulf War veterans. 16 Epidemiologic studies may be the best answer we have to try 17 and study this. 18 I was trying to think of an example that would 19 illustrate this, this point. And one that occurred to me

20 was the example of Legionnaire's Disease which broke out -- 21 which first came in the mid-1970s. And we had a situation 22 of an outbreak of a disease or apparently some disease, it 23 wasn't clear what was going on, through -- people were sick 24 and there seemed to be something going on. And through 25 epidemiologic approaches, through an epidemiologic approach,

134 1 we were able to eventually, to make a long story short, 2 determine that the occurrence of this was a bacteria that

3 was causing it and we were able to use these epidemiologic 4 principles to look at the patterns of outbreak in that 5 particular instance, and the patterns of disease 6 transmission and determine that it was a specific bacterium. 7 So the epidemiologic studies directed at Gulf War 8 veterans will help us ultimately, we believe, to understand, 9 first of all, our veterans' suffering more or less diseases 10 and symptoms than they should be. And, secondly, if they 11 are, if we determine that there are health problems that

12 this population is suffering from, can those problems be 13 linked to any particular environmental exposure or any 14 particular risk factor that they may have experienced in the 15 Gulf. 16 Now, the second category that I'm going to talk 17 about is non-epidemiologic studies and these are the 18 toxicologic studies that I mentioned which are also 19 underway. These use animal models, other models, and they 20 are, in a sense, an indirect means to assess possible health 21 effects from the risk factors that we're concerned about. 22 One of the observations that we came to pretty 23 quickly is that because exposure data is so poor in the case 24 of the Gulf War situation both -- we're probably going to 25 need -- these studies are, in a sense, complimentary. We're

135 1 going to ultimately need both epidemiologic studies and 2 toxicologic studies together to understand the possible 3 impact of possible risk factors on Gulf War veterans' 4 health. 5 A third approach that I'm going to talk about that 6 we think will be very effective in our work is to look at 7 some of the risk factors from an occupation safety and 8 health approach. That is to say as came up this morning in 9 the case of depleted uranium, and we're going to talk a

10 little bit more about this. Some of the risk factors that 11 are of concern in the Gulf War lend themselves to an 12 occupational safety and health approach because there is a, 13 in some cases, a wealth of data about these materials in an 14 occupational setting. 15 Now, of course we recognize that the Gulf War had 16 some unique features which are not comparable to the typical 17 factory, say for instance, but, nevertheless, there is data, 18 there's a wealth of information that we have that could be 19 applicable to understand Gulf War veterans -- the impact of 20 some risk factors on Gulf War veterans. 21 Now, I mentioned that there's a problem with 22 the -- the exposure data in general is very poor. I'm just 23 going to briefly read the suspected risk factors, risk 24 factors and exposures that have been suggested might be 25 associated with any health effects that we're seeing with

136 1 Gulf War veterans. People have -- This is nothing new. 2 People have listed vaccines against things like botulinum

3 toxoid, anthrax and so forth. The pyridostigmine bromide 4 issue of course we're interested in. Various occupational 5 exposures in the sense of the petroleum products and so 6 forth -- smokes. 7 The psychological and physical stress. And 8 psychological and physical stress may be an issue. I mean, 9 everyone -- it's pretty clear that that exposure was pretty 10 universal. Without being able to quantitate it, it's 11 probably fair to say that at least with psychological and 12 physical stress we know that that probably occurred across 13 the board. 14 Insecticides and repellents. We've mentioned 15 depleted uranium. The possibility of chemical and 16 biological warfare agents being -- either by accident or on 17 purpose could have occurred in the Gulf War. And endemic 18 infectious diseases. And there are probably others that we 19 could touch on. 20 But the problem is that there is very poor data 21 about who in the Gulf War, who -- which participants in the 22 Gulf War were exposed to any of these specific risk factors 23 and, if they were exposed, how large that exposure was and 24 when it occurred. The problem is that we just don't, in

25 many cases, have that data available to us which complicates

137 1 the overall picture somewhat. 2 We heard a little bit this morning about the

3 possibility of using some sort of secondary markers for 4 exposure measuring -- taking somebody's blood and looking 5 for, instance, pesticide residues. Well, I think that in 6 general this is not going to be a very effective approach, 7 although I'd be interested in hearing any argument to the

8 contrary. But it seems to me that in general, for instance, 9 the half life of most pesticides in humans is a matter of 10 days or, at the most, weeks and, at this point, it would be 11 very difficult to detect residues of pesticides, for 12 example, in a human subject. 13 Now, as I say, there's very little data about risk 14 factors and exposures that everyone acknowledges occurred, 15 and I used the example of pesticides. We know that 16 pesticides were used in the Gulf, there's no controversy 17 that they were used, but, nevertheless, it's very difficult 18 to get any absolute exposure. I'll talk a little bit more 19 about this in a moment. But the point I want to make is 20 that it's even more difficult to come up with exposure 21 information about some of the more controversial receptors, 22 such as chemicals and biological weapons where there's some 23 controversy about whether or not it actually occurred. 24 And this brings me to finding one, and I just want 25 to reiterate what Joyce said. We're hoping -- We came up

138 1 with some preliminary findings and recommendations and we 2 hope to -- basically we're trying to bounce them off of you, 3 as the committee, and see if you like them or hate them or 4 whatever, have any reaction. 5 Our first finding relative to exposure, and I'll 6 just read it, is this finding one in that memo. "There is 7 little exposure data available for Gulf War veterans to key 8 risk factors. The consequence of poor exposure data is it 9 will be difficult or impossible to link any adverse health

10 outcomes detected by epidemiologic studies to any specific 11 exposure or risk factor." And the point is that if we find 12 out that veterans or sick or showing some type of symptom or 13 illness to a degree that's greater than expected, it will be 14 difficult to link this to any -- lacking exposure data, it 15 will be difficult to link that problem to a specific risk 16 factor. Maybe not impossible but it's just going to be 17 difficult. 18 Finally, you've heard I think a little bit about 19 the Persian Gulf Registry of unit locations data that the 20 Department of Defense is putting together. And just 21 briefly, we expand a little bit more on this issue in the 22 memo but we think this data, although it will be useful, it 23 will be valuable to find, for instance, the possibility of 24 clusters of illnesses, it will not be really a substitute 25 for missing exposure data.

139 1 Just as a historical perspective, in the 1994 2 National Academy of Sciences IOM report on Veterans and

3 Agent Orange, they pointed out that there were numerous 4 health studies on Vietnam era veterans to look at possible 5 health effects that they may -- possible health problems 6 that Vietnam era veterans may have been suffering but that 7 these studies in general were severely -- more or less 8 severely hampered by relatively poor measurements of dioxin, 9 or herbicide exposure. They had only two exposures they 10 were really worried about -- dioxin and the Agent Orange 11 herbicide combination -- and, in our case, we're concerned 12 with possibly a dozen different risk factors, not just one 13 or two but maybe as many as a dozen different exposures. 14 The second finding --

15 CHAIRPERSON LASHOF: Let's stop at this finding. 16 Don't you think the best way to proceed is to stop at each 17 finding and discuss it? 18 MS. NISHIMI: Well, our plan was to brief the 19 committee on the entire picture and then, if we could, go

20 back. Otherwise, my fear is that we won't get through the 21 briefing. 22 CHAIRPERSON LASHOF: Okay. 23 MR. BROWN: Okay. 24 CHAIRPERSON LASHOF: Keep going then. 25 MR. BROWN: Moving right along.

140 1 CHAIRPERSON LASHOF: The committee should feel 2 free to ask questions as we go along. 3 MS. NISHIMI: Sure. 4 CHAIRPERSON LASHOF: So don't hesitate to 5 interrupt Mark and ask a question. But if it's going okay 6 and you're in general agreement why we'll -- okay. 7 MR. BROWN: Hopefully we'll find something that 8 we'll get a reaction to. 9 Our second finding is, I'll just read it. Finding 10 two is, "Because exposure data for Gulf War risk factors is

11 generally unavailable toxicologic studies using laboratory 12 animals and other models become crucial for understanding 13 possible health effects of veterans to these risk factors." 14 And we've studied -- I mentioned that the toxicologic 15 studies are a second category of study which we haven't -- 16 we're just beginning to look at now. We have not had the 17 opportunity yet to look at it to the same extent that we've 18 looked at the epidemiologic studies. But it's our believe 19 that it will be -- they are, in a sense, equally important. 20 You have to look, you need both sets of data to try and get 21 what -- 22 You were about to say something? 23 DOCTOR KIDD-TAYLOR: I just have a question. I 24 agree that there's a need for toxicological studies to be 25 conducted. Do we have information now on who's actually

141 1 doing those and -- 2 MR. BROWN: We have a list. Basically we cribbed 3 it from the Coordinating Board, August '95 Research Plan,

4 and in the appendix of that they just pretty much list all 5 the federally funded research, and we're using that as our 6 start as a means to -- and, again, if you look at it, a part 7 of it is the epi studies and part of it is the toxicologic 8 studies. 9 DOCTOR KIDD-TAYLOR: And I guess the second 10 question is how far along are they compared to the 11 epidemiologic studies that are currently being conducted? 12 MS. NISHIMI: How far is our analysis or how far 13 are the studies? 14 DOCTOR KIDD-TAYLOR: How far are the studies at 15 this point? 16 MR. BROWN: Well, I think it's a mixture. 17 DOCTOR KIDD-TAYLOR: Okay. 18 MR. BROWN: Just as with the epi studies, it was 19 kind of a hodgepodge. They started up at different -- you 20 know, different institutions, different -- some are DOD, 21 some are VA. 22 DOCTOR KIDD-TAYLOR: Are they covering all of the 23 risk factors that we've talked about? 24 MR. BROWN: No. 25 DOCTOR KIDD-TAYLOR: Okay.

142 1 MR. BROWN: They are not. There's some holes. 2 Well, whether or not there are some holes, there's some risk 3 factors which have essentially no research and some -- If 4 you go back and look at the briefing book.

5 DOCTOR KIDD-TAYLOR: Which one? 6 MR. BROWN: The meeting we had in -- 7 DOCTOR KIDD-TAYLOR: October? 8 MR. BROWN: Was it October? Holly prepared a memo 9 that kind of broke down the research by category, by topic. 10 And it's not quite, looking in terms of dollars spent so 11 much, but you can see that there are just a number of 12 research projects per area. And there's some there just 13 simply missing. 14 DOCTOR KIDD-TAYLOR: There's some gaps, though. 15 CHAIRPERSON LASHOF: Mark, I propose that -- We've 16 done a lot more in terms of hearings and discussions about 17 the epidemiologic than the toxicologic. How much do we want 18 to say in this interim report, do you believe, around the 19 toxicologic, or is that something that we will defer to 20 later when we've done a great deal more on that subject? 21 MR. BROWN: Well, we've picked two areas. What 22 we've done to try and answer the fact -- It's a hole in our 23 investigation so far that we going to try now address. 24 We've focused on two major -- two issues that come into this 25 category and that is -- Mike is going to talk about the

143 1 depleted uranium issue. It's a nice issue because it 2 illustrates the power of and the potential of an 3 occupational safety and health approach. 4 On the second, I'm going to talk about again 5 briefly, is the issue of pesticide. We have a little bit of 6 investigation. Again, it's kind of not so much about the 7 research that's going on but about the occupational safety 8 and health background about pesticides. I mean, pesticides 9 are -- So it's a start, but we have a long way to go.

10 CHAIRPERSON LASHOF: My only suggestion around 11 finding two is that -- Well, do you want to come back to -- 12 MS. NISHIMI: Yes. Can we -- 13 CHAIRPERSON LASHOF: I'm sorry. Let him go 14 straight through and then we'll come back. 15 MS. NISHIMI: Thank you. 16 CHAIRPERSON LASHOF: I apologize. 17 MS. NISHIMI: That's okay. 18 MR. BROWN: Next, Lois is going to talk about some 19 of the findings and recommendations we have relative to the 20 epidemiologic studies and then we're going to hear about an 21 occupational safety and health approach that I mentioned. 22 MS. NISHIMI: And then, Mark, you plan to mention 23 just briefly what you plan -- work that you recognize can't 24 be carried in time for the interim report but do plan 25 beyond, is that not correct?

144 1 MR. BROWN: Yeah, I'll talk about that. 2 MS. NISHIMI: Return to that. Thank you. 3 DOCTOR JOELLEN BECK, FINDINGS AND RECOMMENDATIONS 4 EPIDEMIOLOGICAL STUDIES 5 DOCTOR BECK: In our review of the epidemiologic 6 research underway we asked four key questions of the ongoing 7 epi studies and these are: 8 First, is their design adequate to determine if 9 health problems occur more frequently in Gulf War veterans

10 compared to appropriate comparison populations and what risk 11 factors may be associated with such health problems? 12 Secondly, has external scientific review been 13 incorporated to maximize the interpretability and validity 14 of study findings? And Doctor Lashof made some reference to 15 that from our San Francisco meeting. 16 Third. Are the current epi studies directed at 17 the right questions or are there other questions that should 18 be studies as well? 19 And, lastly, how are these epi studies being 20 coordinated to assure that research gaps are addressed and 21 redundancy is limited? 22 We initially focused on the larger epidemiologic 23 studies which were the subject of the San Francisco meeting, 24 and Doctor Lashof has describe that this meeting focused on 25 11 different studies that are being carried out by DOD,

145 1 Department of Veterans' Affairs, and Department of Health 2 and Human Services. 3 I should note at the start that epidemiologic 4 studies are difficult to do. You're studying human beings 5 and not rats, and there are just a lot of challenges and 6 tradeoffs usually involved in doing the study so that 7 epidemiologic studies to examine the health status of Gulf 8 veterans face several different methodologic challenges, and 9 some of these are typical of any epi studies, some are also 10 specific to the circumstances of the Gulf War. 11 For example, the lack of a case definition. 12 Typically epi studies measure the occurrence of a specific 13 disease in populations and researchers have a good sense of 14 how that disease manifests itself, so they can use standard 15 measurements -- excuse me -- established methods to measure 16 it in a group of people, but with the Gulf War population

17 this is more difficult. No single, specific disease has 18 been defined as the source of the reported health problems, 19 and the many Gulf veterans reporting health problems have 20 been diagnosed and treated for specific medical conditions, 21 others have experienced symptoms which have not been 22 connected with the disease diagnosis. Commonly reported 23 symptoms are the ones we've heard about this morning again; 24 fatigue, and memory loss, difficulty in concentrating, joint 25 and muscle pain, and others.

146 1 However, even without a single case definition, 2 you can see if more or different health problems are seen in

3 a given ground and thus our finding, which is finding three, 4 that despite the unique features of the Gulf War situation 5 it should be possible using epidemiologic approaches to 6 determine if Gulf War veterans have more or less mortality 7 or symptoms and diseases, such as adverse reproductive 8 outcomes, chronic fatigue, muscular skeletal diseases, or 9 psychiatric disorders when compared to a control group. And 10 these studies have not yet been completed. 11 In addition to the lack of a single case 12 definition, other methodological problems challenge the 13 problems underway and planned. Some identified by external 14 peer reviews for some of the major Gulf War veteran studies 15 include difficulty in generalizing from a specific set of 16 veterans under investigation to all veterans, problems in 17 low response rate for veterans' groups which can result in 18 possible biases, problems with reliance on hospital records 19 for health data, and possible biases due to reliance on 20 self-reporting by veterans for both the health problems and 21 the exposures and risk factors. And, although some 22 identified design problems have been addressed by those 23 responsible for conducting the studies, other problems are 24 more basic and may not be correctable making the study 25 results less useful for resolving key health issues. Which

147 1 leads to finding four. 2 Because of their methodological difficulties, the

3 current epi studies underway from DOD, VA, and CDC may not 4 be sufficient to determine whether Gulf War veterans are 5 suffering from more adverse health outcomes than expected. 6 In a similar vein, finding six -- jumping here -- 7 is current epidemiological studies are designed to detect 8 substantial differences in levels or patterns of health 9 effects from those expected in Gulf War veterans, and 10 effects that may be occurring in small subpopulations may 11 not be detected. 12 Many challenges and tradeoffs must be considered 13 in the design and execution of epi studies in the Gulf War 14 veteran population. An external scientific review is an 15 invaluable resource in addressing these decisions. The 16 scientific review of the studies has ranged from the non 17 existent to one time review of protocols to standing 18 committees that have met periodically in the course of the 19 study, and it has proved beneficial to some of the studies. 20 However, in some cases, the input of outside reviewers has 21 to some extent been disregarded. 22 A single body with a big picture perspective is 23 needed to monitor whether outstanding research questions are 24 being adequately addressed, how individual studies will 25 contribute to the overall effort, and the extent to which

148 1 the studies are responsive to reviewer input. Since no 2 single study will answer all the questions, this body must

3 help allocate necessarily limited resources to get the best 4 research effort possible. Leads to finding five. 5 An oversight coordination body, such as the 6 Persian Gulf Veterans' Coordinating Board, should have 7 primary responsibility for following the findings and 8 recommendations of scientific review committees and 9 responding appropriately if these draw question to the 10 usefulness of the study as a whole to the research strategy. 11 Another aspect of needed coordination, which 12 emerged in our San Francisco meeting, is in consideration of 13 study questionnaires. Though individual studies have 14 specific goals, some effort should be made to make at least 15 some questions consistent across studies where the research 16 goals are shared, which doesn't mean that the different 17 questionnaires should be made identical. 18 Understanding of the illnesses experienced by Gulf 19 War veterans is still not clear and several different 20 research avenues must be pursued to understand it better. 21 No single study will answer all the questions itself. 22 Nonetheless, it is reasonable that a subset of the questions 23 be carefully developed so that they can be shared and their 24 results rendered comparable of cross studies. 25 This brings us to the recommendations, possible

149 1 recommendations for the committee to consider, the first 2 being that study coordination should take place between 3 principal investigators and survey design experts to arrive 4 at a small shared subset of questions. These might cover 5 basic questions about symptoms, health conditions and 6 exposure. Since understanding of the illnesses are still in 7 early stages, it would be premature to completely 8 standardize the study instruments but a reasonable goal 9 would be to make common questions worded the same way so 10 that the results from different studies could be 11 meaningfully compared. And the Persian Gulf Veterans' 12 Coordinating Board could facilitate bringing the appropriate 13 principal investigators and experts together to develop a 14 scientifically sound survey subset, rather than leaving this 15 task to the Office of Management and Budget. 16 The second recommendation. All epi studies aimed 17 at Gulf War veterans' health issues benefit from outside

18 input and ongoing interaction with appropriate experts 19 throughout the study process. External scientific review 20 should be planned into study designs and analysis 21 procedures. 22 The third recommendation. Here, at this stage, no 23 case definition derived in a single population could be 24 applied widely in all studies. Case definitions developed 25 as working case definitions can be useful as investigators

150 1 develop and test hypotheses about the illnesses and can be 2 considered steps in the evolution of a case definition more 3 widely representative of the illnesses experienced in the 4 larger Gulf veteran population. 5 MR. BROWN: Thank you, Lois. 6 Next I'm going to turn to what I briefly began to 7 describe before Lois' remarks about the epi studies and that 8 is our approach at looking at occupation safety and health 9 data relative to some of the risk factors that Gulf War 10 veterans experienced. We think this approach has basically

11 two parts. First of all, for many of the risk factors that 12 we're concerned about with Gulf War veterans, there's a 13 wealth of occupational safety and health data that will help 14 us -- by reviewing that data might help us evaluate the 15 potential impact of that risk factor on veterans' health. 16 The example that I included here are depleted uranium 17 exposure. There's a lot of information that Joyce 18 mentioned, for instance, with miners and the occupational 19 use of uranium in the U. S., in various U. S. industries, 20 mostly weapons related of course. 21 Pesticides is, you know, you have to generate some 22 data about that exposure and health effects -- possible 23 exposure and health effects in civilian population to get a 24 pesticide registered for use in the United States, through 25 EPA.

151 1 Pyridostigmine bromide of course has a record 2 behind it. It's used as a drug for other diseases. 3 Petroleum products and so forth. 4 Now, obviously we acknowledge -- we recognize the 5 fact that many features of the Gulf War experience were 6 unique from the traditional occupational exposures scenario 7 that most occupational safety and health people think about. 8 The second aspect of our occupational safety and 9 health approach is to examine the process by which the 10 Department of Defense and others use the occupational safety

11 and health approach that the Department of Defense has used 12 in their own evaluation of particular risk factors. That is 13 to say what process did the Department of Defense use to 14 evaluate the safety of pyridostigmine bromide. For 15 instance, the pesticides and repellents that they used, 16 depleted uranium and so forth. And we can look at that 17 process and evaluate it for some accuracy, fairness, and 18 efficiency. 19 Now, we've used this approach to look at two 20 specific risk factors that I mentioned: Depleted uranium 21 and pesticides. And I'm going to talk about the pesticide 22 issue but before that Mike is going to tell us about the 23 work we've been doing on depleted uranium. 24 MICHAEL KOWALOK, REPORT ON DEPLETED URANIUM 25 MR. KOWALOK: Unlike the remarks given by Lois and

152 1 Mark, you will not hear any preliminary findings or 2 recommendations in these remarks but you'll hear the case -- 3 remarks about building a case for an occupational health 4 approach to looking at risk factors in military service in a

5 generic sense, and then specifically about the Persian Gulf 6 experience and depleted uranium. 7 As seen in the Gulf War, advanced technology can 8 enable U. S. forces to achieve quicker than expected 9 victories with fewer than expected causalities. However,

10 many of the current health concerns of the Gulf War veterans 11 are directly linked to question about possible occupational 12 and environmental health hazards associated with advanced 13 weapons' systems and other war-related technologies. 14 For example, the Army defeated enemy armor more 15 readily by using munitions made with depleted uranium; 16 however, exposure to depleted uranium is often cited by 17 veterans as being a major contributor to reported illnesses. 18 Such questions will not be unique to the Gulf War. Long

19 term health concerns will be increasingly prominent as 20 advanced technologies guarantee fewer battlefield 21 causalities. For this reason, it is important to examine 22 the process by which the military considers occupational 23 health and safety issues prior to approving a weapon's use 24 in combat. 25 The case of depleted uranium is one way to learn

153 1 about this process. Although the DOD approved the use of 2 depleted uranium, and I'll refer to that as DU, although the

3 DOD approved the use of DU munitions prior to the Gulf War, 4 such approval failed to prevent or dispel veterans' health 5 concerns after they learned of its use. Hence, in addition 6 to reviewing current research about DU as a specific risk 7 factor in veterans' illnesses, committee staff will study 8 the process by which DOD approved the use of DU and why its 9 safety continues to be an issue today. Staff will then 10 broaden its focus to study DOD's general process for 11 addressing health concerns as it acquires and fields all 12 types of military equipment. 13 To date, the staff has learned that some Army 14 tanks and Air Force aircraft fired depleted uranium 15 munitions to defeat enemy armor. DU is both a radio active

16 and a chemically toxic heavy metal. DU munitions produce an 17 aerosolized dust upon impact with armor or upon ignition in 18 accidental munitions' fires. Only a few dozen soldiers are 19 known to be exposed to DU dust in "friendly fire" incidents 20 or from retrieving and cleaning damaged vehicles hit by 21 depleted uranium munitions. 22 However, some veterans' groups make a plausible 23 case of much broader exposures. The suggestion is that 24 aerosolized DU dust could conceivably have traveled some 25 distance, perhaps exposing the U.S. troops in the area.

154 1 Also, there are at least anecdotal accounts of U.S. solders 2 searching defeated enemy vehicles, perhaps in a hunt for 3 souvenirs. A fraction of these vehicles may have been 4 contaminated with DU dust. Thus 14-percent of the 5 participants in the DOD clinical care evaluation program 6 report exposure to depleted uranium. 7 Committee staff will investigate the nature of the 8 expected health effects of exposures to DU and will study 9 whether the large amounts of occupational health data 10 associated with the domestic uranium industry may be used

11 for estimating the health risks associated with handling DU 12 munitions or working with DU contaminated equipment. 13 The staff has also learned that the Army has been 14 the lead agency in developing military uses for DU. In the 15 early phases of research and development, the Army did 16 commission three studies on potential health and 17 environmental effects. Further, it is also Army policy that 18 prior to fielding, the office of the Army Surgeon General 19 must review all Army weapon systems to assure that all know 20 health issues are satisfactorily addressed. 21 However, a 1993 report by the General Accounting 22 Office was critical of the Army's performance in handling DU 23 contaminated equipment in Operation Desert Storm. The 24 report found that the Army did not have a formal plan or 25 adequate facilities for decontaminating U.S. equipment hit

155 1 by "friendly fire," and that it had not effectively educated 2 Army personnel who could come in contact with such 3 equipment. The DOD concurred with all of the GAO findings 4 and recommendations. 5 Finally, in response to a Senate appropriations 6 committee report, the Army has recently completed another 7 study on the health and environmental effects of using 8 depleted uranium in weapons' systems. Committee staff will 9 receive briefings on the methods, findings, and conclusions

10 of these reviews and then formulate appropriate findings and 11 conclusions for committee consideration. Staff will then 12 broaden this review to examine the process by which the DOD 13 addresses occupational health concerns when it fields 14 weapons' systems as well as other items necessary for 15 conducting a military campaign. 16 MR. BROWN: Thanks, Mike. 17 I'm going to carry this theme of occupational 18 safety and health as a means of investigating Gulf War risk 19 factors into the category of pesticides, which we have some 20 preliminary investigation with. 21 Exposure to pesticides as a potential risk factor, 22 and include with pesticides the insect repellents such as 23 DEET -- exposure to pesticides as a risk factor from the 24 Gulf War is something everyone agrees occurred. There's no 25 controversy that pesticides and DEET were used in the Gulf

156 1 War. Nevertheless, it's interesting to review what we know 2 and what we don't know about that risk factor. 3 We know from discussions with DOD we have 4 information about exactly which pesticides were shipped to 5 the Gulf and the form that they were in, that is as to their 6 physical form, are they powders or liquids and so forth, and 7 the quantities that were shipped to the Gulf. 8 We know from EPA, from discussions with EPA, 9 showing them this list of pesticides that were used in the

10 Gulf that these pesticides were all approved for general use 11 within the United States. And we also understand that the 12 Department of Defense has -- there's no mechanism that would 13 allow them to use an unregistered pesticide, that they are 14 bound by the same types of rules that, say, a domestic 15 applicant or pesticide applicator might use. They can't use 16 something that's, you know, banned within the U.S. There's 17 no exemption that the Department of Defense has. 18 So this leads us to finding eight which is 19 basically just what I just said, that the pesticides sent to 20 the Gulf War theater by the Department of Defense were all 21 registered for such use by the Environmental Protection 22 Agency and are, in fact, pesticides that are commonly 23 available in the U.S. We could go out today to some local 24 store and go buy these and use them as, you know, we saw 25 fit.

157 1 The problem is what we don't know about 2 pesticides. We don't know -- There were virtually no 3 records kept about what happened once those pesticides got

4 to the Gulf. The Department of Defense has described to us 5 a policy for their use which sounds very good. It's 6 mirrored on the domestic policy for pesticide use. They 7 have a training and certification program for the 8 application of pesticides, how they're used in, say, an 9 eating area or an area where people sleep or do other

10 activities. And it sounds very reasonable on paper. 11 Unfortunately, there's essentially no data about how those 12 pesticides were actually used or how much were used, when 13 they were used by different units and so forth, whether they 14 were used early in the deployment phase or during the 15 period, the entire build-up and final breakdown of camps and 16 so forth. There's no information about how pesticides were 17 actually used once they got to the Gulf. 18 So this makes trying to -- The only information we 19 have is anecdotal. We have descriptions from veterans about 20 the different types of applications, and I'm sure you've 21 heard some of the accounts of people spraying their tents 22 and so forth. But we can't -- We have no way to validate 23 any of this data. This means, as I mentioned earlier, it's 24 going to be impossible to link pesticide exposure to any 25 epidemiologic findings that we may come up with.

158 1 We've heard anecdotes of other non-U.S. 2 pesticides, that people maybe bought some pesticides that 3 were over there that maybe were not registered in the U.S.

4 We can't evaluate that either because the information just 5 doesn't exist. 6 Now, of course this means that doing toxicology 7 experiments are all the more important and the example I 8 want to point out that one of the types of experiments 9 that's relevant here is the combined exposures. You look at 10 combined exposures of something like pyridostigmine bromide 11 and some of the pesticides that we used in the Gulf.

12 I'm sure you've heard the concern that maybe 13 somehow each one of these may have been harmless in its own 14 right but together somehow you had this unique exposure, 15 which would be sort of out of the realm of our normal 16 occupational exposure. I mean, that type of exposure 17 wouldn't occur domestically because people aren't usually 18 taking pyridostigmine bromide and then getting close to

19 pesticides. This is not an evaluated hypothesis so far in 20 general. The Department of Defense has some research that 21 we want to look at and I think this is the right way to do 22 it, whether -- testing it using animal studies to test what, 23 you know, what happens if you feed an animal pyridostigmine 24 bromide and pesticides. 25 So I'm going to talk just briefly about future

1 research and answer the point that Robyn brought up about --
2 DOCTOR KIDD-TAYLOR: Could I just break for one
3 second?
4 MR. BROWN: Sure.
5 DOCTOR KIDD-TAYLOR: You know another thing that
6 we look at when you're talking about environmental
7 occupational health exposures is whether DOD provided any
8 type of protective equipment or -- for use. Is that part of
9 what you're doing? Do you have any information on what --
10 MR. BROWN: Absolutely. When we look at the
11 component of the occupational safety and health review, how
12 DOD did it, how they actually carried it out and what
13 policies they put into place, would include the education
14 they provided and training they provided troops, and things
15 like protective equipment. Mike mentioned the issue of the
16 training. They apparently had some pretty good regulations
17 in place, as I understand it, for how to treat -- how to
18 clean up a tank that may have been contaminated with
19 depleted uranium but these weren't adhered to. I would --
20 DOCTOR KIDD-TAYLOR: Not adhered to or maybe that
21 all of the persons who, say, would get on a tank afterwards
22 where the depleted uranium had been used?
23 MR. BROWN: Yeah.
24 DOCTOR KIDD-TAYLOR: They may not have known the
25 hazards associated and that's very important.

1 MR. BROWN: Yeah. In my judgment, I would call
2 that a failure of an occupational safety and health plan.
3 DOCTOR KIDD-TAYLOR: Right. Okay. Then the
4 second part of that is regarding approval of EPA pesticides

5 that were approved by EPA. I mean, that could have changed
6 within the course of when they were there and afterwards.
7 MR. BROWN: You are so smart. That is exactly
8 what has happened.
10 MR. BROWN: And we are going to look into that.
11 DOCTOR KIDD-TAYLOR: Okay, you are going to look
12 into that?
13 MR. BROWN: Yeah.
15 MR. BROWN: Just briefly. We're going to --
16 CHAIRPERSON LASHOF: She was planning to say that
17 about you, Mark.
18 MS. NISHIMI: I was going to reprimand the staff
19 after the --
20 MR. BROWN: I want to say this is the best
21 committee. No --

22 Briefly, what we've talked about so far is what we
23 see as the major contributions we can bring to the interim
24 report. There are other areas of research, particularly in
25 the toxicology, that we will not be able to complete beyond

1 the examples of the pesticides and the depleted uranium, and
2 we think that they are good example of kind of that overall
3 approach, plus they have their own findings.
4 We continued our review of epidemiologic and
5 toxicologic research along the lines we've described. We
6 also want to look at new research. We recognize that there
7 is a body of non-federally funded research that is important
8 and we intend to look at that. We're going to continue this
9 use of an occupation safety and health model to look at
10 various Gulf War risk factors.
11 And that completes my remarks about -- our remarks

12 about the work we expect to do on research, and we hope to
13 hear any of your reactions to our findings and
14 recommendations.
15 CHAIRPERSON LASHOF: Okay. I think first are
16 there any overall concerns that you have for what's been
17 presented, and open up for that first, any just general

18 questions, and then we'll go back and start walking through
19 each finding and general statements in here and see how many
20 we agree with, disagree with; how many we think are
21 appropriate at this point in time; how many we think should
22 be held for later, and how much we do want to really cover
23 in the interim report. I have some concerns as to how much
24 of this latter part actually should go into the interim
25 report, whether we've gone far enough for it to be in the

1 interim report and, if so, in what form. But I think we can
2 take that up as we walk through the findings. So let's go

3 back to page one, two, and three. The first finding is on
4 three but if there are any comments that anybody has made

5 notes as they went along about any of the statements as they
6 go through this.
7 MR. RIOS: Can I ask you a question, a general
8 question. The information that you got from official DOD or
9 VA, did all the information come from the official sources?
10 Did you get any information other than from official sources
11 in reference to, for example, what information they had on
12 exposure for Gulf War veterans to some of these -- you know,
13 or agents, things to that nature, number one.
14 Number two.
15 MR. BROWN: Which agents?
16 MR. RIOS: Any kind of chemical or agents.
17 MR. BROWN: You mean as in terms of chemical and
18 biological weapons?
19 MR. RIOS: Right.
20 MR. BROWN: Well, we have a briefing about that
21 which we'll hear. We also considered the chemical and
22 biological weapons really as a separate issue, but it's
23 another exposure issue and Holly is going to talk about that
24 in a moment.
25 MR. RIOS: But my concern is was the information

1 provided to you through the official sources -- were you
2 happy with the way the information was provided to you? Did
3 anybody try to get you information that wasn't through the
4 official sources?
5 MS. GWIN: We have had had good cooperation from
6 the Department of or the CIA -- Is this better? Okay.
7 Official information about exposure to chemical and
8 biological weapons. We have also talked to veterans and
9 others interested in the area, that I would not call

10 official sources, primarily providing anecdotal data
11 concerning exposure. But we've been very happy with the
12 cooperation.
13 MR. RIOS: You didn't perceive any need for
14 saying, look, we're welcome to hear information from people
15 within the CIA or DOD that had information but are afraid to
16 provide it to us at this point for some reason?
17 MS. GWIN: We actually had good cooperation from
18 CIA in hearing from their employees who do not take an
19 official line, who take a dissenting view --
20 CHAIRPERSON LASHOF: Could I just interrupt a
21 minute? We're going to get into that in depth after we
22 go -- but there's nothing in this first part dealing with
23 biological or chemical. There's a section in here on
24 briefing and Holly's going to give us a complete run-down on
25 how they're going about that, who they're hearing from and

1 so on. So, if you don't mind, I'd just as soon --
2 MR. RIOS: No, that's fine.
3 CHAIRPERSON LASHOF: -- go through these findings

4 and we'll come back to it. Save your questions, they're all
5 valid, and we'll deal with them, I promise.
6 Are there -- I guess by the fact that Rolando
7 brought that up here, since we're talking about exposure
8 data, it might be that even this early in the report you
9 might want to say something about exposure data on this

10 subject will be referenced somewhere else. I mean, we can
11 talk about that format later as to what we're going to
12 include here and when we've left something out that's

13 obviously a glaring thing that we're going to deal with but
14 maybe not deal with it right here, we reference where we are
15 going to deal with it.
16 MR. BROWN: I think that's something we have to be
17 sensitive about, what we decide to defer to later, to the
18 Board to make it clear that we're not ignoring it.
19 CHAIRPERSON LASHOF: That's right, yeah. So that
20 brings us to finding one. Was there any other issues on the
21 first pages?
22 (No response.)
23 CHAIRPERSON LASHOF: I think finding one is
24 correct, certainly, and I have no problems with its wording.
25 I had some concern that we not be too negative about the

1 lack of value of unit locations. My concern is that we put
2 in balance that although you can't get specific exposure
3 data that is going to give you specific answers to just how

4 much they were exposed to -- but we have been making a big
5 point of getting the geographic location information and I
6 still think that information is important and will give us
7 some insights, and I'm worried about the balance between
8 looking at those two.
9 MR. BROWN: Well, if I can just address that. I
10 agree completely with your point, and in the description
11 starting at the bottom of page three where we get into that,
12 maybe the format could be changed here to give that a little
13 more emphasis. We talk about how the geographic locator
14 could be used, and I mentioned the issue of looking at
15 clusters, if there are clusters, of illnesses that turn up
16 in certain locations, certain geographic locations or
17 certain time periods during the Gulf conflict, that would be
18 of course of enormous interest. But, on the other hand,
19 it's important to make it clear that the geographic locator
20 is not some panacea for missing exposure data. It's not
21 going to tell us, for instance, how pesticides were used,
22 probably. It's not going to tell us probably very much
23 about how the depleted uranium was used. Maybe it will
24 but --
25 CHAIRPERSON LASHOF: Maybe it will.

1 MR. BROWN: To some degree it will but it's not
2 a -- it's not really a --
3 CHAIRPERSON LASHOF: It's not a substitute but I
4 think you need a finding in here, maybe even before this
5 finding about exposure data, about what locator information
6 does help you do.
7 MR. BROWN: Okay.
8 CHAIRPERSON LASHOF: And then what it doesn't --
9 in the discussion what it doesn't. Because I think the
10 geographic locator information at least, if it turns out --

11 I mean, it's going to be looked at in relation to the epi
12 studies. It can't be looked at separately and it's not
13 going to give you clear cut exposure data. But if your epi
14 studies show some differences in illness patterns in
15 different units, then looking at it by unit location may be
16 helpful. I mean, if the broad epi studies show that the
17 deployed have more of this than that but it's not very
18 great. But if you break it down and take a look at the
19 location of some units and find the difference between that
20 group and the deployed and the deployed elsewhere is very
21 dramatic, then it could at least lead you to look at, well,
22 what exposures were most likely in this area, and some
23 hints. It has to be used with the epi data, granted, but I
24 think it has value. And the way this read now, to me, it
25 was too negative about the value of it so it draws one to,

1 well, why are we beating them over the head about getting
2 this location data.
3 MR. BROWN: Okay. Well, we'll fix that, because I
4 agree that the locator data is definitely worth pursuing.
5 CHAIRPERSON LASHOF: Any other points on this
6 respect?
7 (No response.)
8 CHAIRPERSON LASHOF: If not, I guess we're ready
9 to move to finding two, which may be finding three by the

10 time you massage what I want. I have one concern with that
11 one and it's -- I agree entirely that toxicologic studies
12 are important. I think they'd be important whether or not
13 we had exposure data, and I'm not sure saying because
14 exposure data is generally unavailable toxicologic studies
15 using laboratory animals and other models become crucial.
16 MR. BROWN: Maybe we should say "more crucial."
17 CHAIRPERSON LASHOF: Either it's because they're
18 more crucial or you say toxicological studies are extremely

19 important and because of that they become even more crucial.
20 But I think even if we thought the epi studies would give us
21 some answers and locators would still -- you know, we're not
22 going to be able by any of that to tell much about the
23 interactions of pyridostigmine bromine, and DEET, nor should
24 we have to wait, for some of the epi studies are going to
25 take us several years and meanwhile we could be doing some

1 work on toxicological studies. So it's not only because we
2 don't have exposure data, it's the length of time it's going
3 to take us to get information. We may be able to get
4 insights by some animal experimentation and some
5 toxicological studies before then.
6 DOCTOR KIDD-TAYLOR: That's very useful. I think
7 that would be good because then you would --
8 MR. BROWN: Yeah. I guess I was trying to put --
9 You're saying it's not positive enough. I was concerned

10 that it might be too positive because one of the things of
11 course, problems that you run into, is undergeneralized from
12 the tox studies. You know, if we get some data showing a
13 certain effect to then generalize to health effects you
14 might expect in people, especially when you're lacking the
15 exposure data. So I was trying to -- That was my attempt to
16 make it as positive as possible, but I take your point.
17 CHAIRPERSON LASHOF: Well, it might be that we can
18 walk the line between the two of those a little more and
19 talk about toxicological studies being one method to enable
20 us to focus some of the epidemiologic studies. I mean, I
21 agree, in your general discussion these two have to go hand
22 in hand. Either one alone may not give us answers; together
23 they tend to give us more information.
24 MR. BROWN: Yes, I think that's my strongest
25 point.

1 CHAIRPERSON LASHOF: Okay. Anyone else?
2 (No response.)
3 CHAIRPERSON LASHOF: Moving along. Then we come

4 to the key questions for the current epidemiologic studies,
5 and here we get a little more controversial, I suspect. I
6 think your four questions in the body of the text are
7 excellent.
8 General discussion. Any comments on the general
9 discussion before we get to finding three?
10 CAPTAIN KNOX: I want to go back to the case
11 definition just a little bit. I know right now there is no
12 case definition, or lack of a case definition, and I'm
13 trying to remember back in what we were talking about with
14 Chronic Fatigue Syndrome, how investigators are classifying
15 that. That's one of many that they're using for defining
16 Gulf War veterans' illnesses or --
17 DOCTOR BECK: Well, at San Francisco, in the
18 Pennsylvania study, they developed -- from what they found
19 from their survey, they developed a working case definition
20 which in their population looked a lot like Chronic Fatigue
21 Syndrome as CDC had come to describe it.
22 CAPTAIN KNOX: And so your recommendation is based
23 on that there needs -- a case definition would be better.
24 If there was a case definition it would be better for
25 researchers? I'm trying to get a feeling of why there's a

1 need for a case definition.
2 DOCTOR BECK: Well, if you had a case definition
3 then it would be easier to go ahead and measure the
4 occurrence of those cases in the population. Since this is

5 kind of an amorphous problem, a set of illnesses, it's a lot
6 harder to know what we're looking at. What the studies are
7 doing are able to look at the rates of various symptoms as
8 symptoms separately and maybe different patterns of those
9 symptoms, but it's hard to really grasp it as a -- is it a
10 problem that is something that's different going on in this
11 population.
12 DOCTOR CUSTIS: May I ask a question?
13 CHAIRPERSON LASHOF: Any question.
14 DOCTOR CUSTIS: What exactly is evolving case
15 definition?
16 DOCTOR BECK: I guess I thought in writing that
17 that --
18 DOCTOR CUSTIS: Does that sound stupid?
19 DOCTOR BECK: No, it's not. But as these studies
20 go on and researchers are able to look at arrays of symptoms
21 that they see as different in the Gulf veteran population,
22 each one may then come up with a case definition that fits
23 the study that they have done. Well, if several of these
24 case definitions come to look very, very similar then maybe
25 that -- maybe they converge.

1 DOCTOR CUSTIS: That's something for the future.
3 DOCTOR CUSTIS: It's not used today.
4 DOCTOR BECK: It can't -- It has to take place
5 over time.
6 MR. BROWN: I think the point is the case
7 definition will improve as we get more information, and we
8 have to be open to changing maybe what useful case
9 definition might be as we get information. The case

10 definition that we get today may be just a working case
11 definition that we have, for lack of a better definition,
12 that we can use now for doing some type of epi study. A
13 year or two years from now, with the benefit of some more
14 data, we may be able to refine that.
15 CHAIRPERSON LASHOF: Are you worried about how
16 they've worded the statements about the evolving --
17 DOCTOR CUSTIS: Yes. I get the impression that
18 there are some researchers that are making use today of an

19 evolving case definition, which confuses me. It seems to me
20 they --
21 CHAIRPERSON LASHOF: No, I think we have to be
22 careful. You're not using an evolving one. They're using a
23 definition which they think is here, which may evolve later
24 on into something else. I guess that's one of the questions
25 about the lack of case definition discussion. At the San

1 Francisco meeting, we did hear that CDC basically, in the
2 Pennsylvania study, came up with what they now consider a
3 case definition which they want to use in trying to look at
4 them and which they think is close to Chronic Fatigue
5 Syndrome. And we raise the question with researchers and I
6 think I got slightly misunderstood and I clarified it with
7 them afterwards, I was pushing them to say if they would use
8 that case definition in evaluating their material, or their
9 studies, and my point being that if CDC has come up with

10 something they think is a case definition, as you carry out
11 other studies, you ought to be sure that you are able to
12 gather the data that would allow you to at least apply that
13 not as "the" case definition but as one that you could
14 consider and see whether you could validate it, or find out
15 that it wasn't very good and then try to develop your own,
16 or change, or come up with an evolving case definition. I
17 don't know whether we want to get into that in this
18 discussion of a case definition but I think we may have to
19 recognize the fact that they think they have a case
20 definition. Others are not willing to accept that yet, by a
21 long shot.
22 DOCTOR BECK: I don't think, though, that they
23 believe it's a case definition that applies to the whole
24 Gulf veteran population.

1 DOCTOR BECK: I think they're careful to say that
2 it was developed from this specific population.
3 CHAIRPERSON LASHOF: But my point is, if they've

4 developed from this specific population and they think it's
5 valid, we ought to again look at it against other
6 populations and test it as a hypothesis and see whether it
7 seems to make sense in other populations or whether other
8 definitions make much more sense. Not apply it rigidly, by
9 a long shot.
10 Okay. Finding three is a key finding and we
11 really ought to spend some time discussing finding three.
12 Despite the unique features it should be possible using the
13 epi approach -- of more or less mortality or symptoms and
14 adverse reproduction, et cetera.
15 It's really coupled -- I think finding three is
16 correct, that despite it's features we ought to be and that
17 we haven't yet completed any studies to do it. So it's
18 couple it with finding four, which is even the more critical
19 one: Current epi studies underway may not be sufficient to
20 determine whether veterans are suffering from more adverse
21 health outcomes than expected.
22 DOCTOR BALDESCHWIELER: I must admit I don't
23 understand what that means. Can somebody expand on that?
24 CHAIRPERSON LASHOF: Yeah, expand on four.
25 DOCTOR BECK: That stems out of the discussion

1 that preceded on those pages about the methodological
2 challenges and that it may be -- for example, the National

3 Health Survey is sending out a mailing to 15,000 Gulf War
4 veterans and 15,000 era controls. Mail surveys have --
5 DOCTOR BALDESCHWIELER: Just tell me what it --
6 what the words mean.
7 DOCTOR BECK: Oh, okay. Well, it may be at the
8 end of the day, from this set of studies that are going on,
9 we won't know for sure that Gulf War veterans are suffering
10 from more adverse health outcomes.
11 DOCTOR BALDESCHWIELER: Than expected by whom?
12 DOCTOR BECK: Than expected compared to the
13 control population.
14 MR. BROWN: "Expected" means -- We use it in the
15 sense of compared to some suitable control. You know, are
16 they showing -- the expected would be what the control, what
17 the background rate in a suitable control would be.
18 DOCTOR CUSTIS: But the previous finding says just
19 the reverse, doesn't it?
20 CHAIRPERSON LASHOF: Yeah. That's why I want
21 those two looked at together.
22 MR. BROWN: What we're trying to say there, and
23 maybe we could say it better, we're saying on the one hand
24 it may be possible given this situation, there's no
25 fundamental reason why you couldn't do epidemiological

1 studies on this population that would ultimately tell you
2 whether or not they're suffering these health effects and to
3 what degree. That's the first point.
5 MR. BROWN: Compared to a suitable control, and
6 that's of course an important point.
7 DOCTOR BALDESCHWIELER: I think I believe that.
8 How about four?
9 MR. BROWN: And then the second point is, though,

10 even though in principle there's no reason why you can't do
11 that, it's not clear that the current crop of studies are
12 going to get you there, that you may need additional
13 studies.
15 CHAIRPERSON LASHOF: Okay. The problem with that
16 is --
17 DOCTOR BALDESCHWIELER: So the key word is
18 "current."
19 CHAIRPERSON LASHOF: Yeah, the key word here is
20 "current," but that implies that if we make a finding like
21 that, unless we modify it in some way, or play around with
22 "the may not be," it's almost saying we're not convinced
23 that the studies you're doing now are able to do this and,
24 therefore, we think you ought to be doing A, B, C, or X, Y,
25 Z. Are we ready to do that?

1 MR. BROWN: That's the questions: Are there
2 additional studies? I should add here, when you talk to

3 some of the epidemiologists that are involved with this,
4 that we spoke to, talk about something they kind of put in
5 terms of an iterative approach, that you don't necessarily
6 expect to do a single study which then answers all your
7 questions.
9 MR. BROWN: You may do one study, particularly in
10 a difficult case like this, where it's unclear what's going
11 on at first. You may do a series of studies and that gets
12 you a little bit of information that really just helps you

13 design the next generation of studies. So that's one aspect
14 of it, that it may not be reasonable to expect a single
15 batch of studies to do it all.
16 CHAIRPERSON LASHOF: A batch? A single study we
17 know will never answer. I think the question is: Do we
18 feel at this point or are we prepared to say one way or the
19 other whether the current group of epidemiologic studies
20 that are underway are sufficient to give us the information
21 we need? Or do we feel that the current group of epi studies
22 is not sufficient? Or, third alternative, do we feel that
23 the current studies will probably give us an answer and we
24 think they are sufficient for the time but cannot rule out
25 the possibility that when they are completed they could not

1 give us a full answer and at that time we'll know enough
2 more to recommend further studies, but at this point in time

3 we think the studies are adequate? There's three different
4 alternatives. I've thrown them all out and I think maybe we
5 should take them one at a time and discuss them and see if
6 we reach a consensus.
7 DOCTOR KIDD-TAYLOR: Most of the current studies
8 are based on self-reports, right?
9 MR. BROWN: That's one concern.
10 DOCTOR KIDD-TAYLOR: And that's one concern I'm
11 sure. And I remember, and I have to go back because that's
12 been a couple of weeks ago and several trips in between, but
13 I'm trying to figure out if there are any studies proposed
14 where they will actually conduct medical evaluations of
15 control groups and other --
16 DOCTOR BECK: In the National Health Survey
17 they're planning to do that for a subset. The mailed survey
18 will go to 15,000 but in 2,000 they will -- 2,000 of each
19 group they will --
20 CHAIRPERSON LASHOF: Four thousand.
21 DOCTOR BECK: -- have physical examinations.
22 They'll go through and review medical records. So that's a
23 very important part of that study.
24 MR. BROWN: I should just add there, the exposure
25 data will be purely self-reported.

1 DOCTOR BALDESCHWIELER: Are all the current
2 studies flawed?
3 CHAIRPERSON LASHOF: Every epidemiologist will say
4 every epi study is flawed, just by the nature of
5 epidemiology, in the sense that positive results are
6 meaningful but negatives can't rule it out in an epi study.
7 And there are always difficulties in one as complex as this
8 situation between surveys and individual reviews. I think
9 some of them are excellent and they are as good as you can
10 expect, but whether they are big enough to catch small
11 differences -- they'll catch clear cut big differences but

12 whether they are big enough to catch small differences. And
13 especially I think the real problem with them, and I think
14 that's why the locator information is important, if there
15 was something unique in certain units that were in certain
16 areas they could be missed en mass in an across the board
17 study while you might find something if you had some smaller
18 units you were looking at and concentrating on because you
19 had a specific hypothesis, but we don't have that at this
20 point.
21 DOCTOR KIDD-TAYLOR: So, then, maybe the wording
22 for finding four may or may not be sufficient or that there
23 could be something to indicate that there may be additional
24 studies needed from the results that are received?
25 MS. NISHIMI: What if we don't comment on their

1 sufficiency and just say, "may not determine?"
3 CHAIRPERSON LASHOF: You missed my throwing out
4 some alternatives.
5 MS. NISHIMI: I know. I got the other one but --
6 CHAIRPERSON LASHOF: Yeah. I think the question
7 we have right now to try to decide is whether or not we're
8 satisfied that the studies that are ongoing right now are
9 all that they should be doing right now and we're not -- Are

10 we prepared to say they should be doing some other things or
11 don't we think they should be doing some other things?
12 MR. BROWN: I didn't mention that we're also
13 looking at this broad agency announcement which is starting
14 up a new series of research efforts directed at Gulf War
15 veterans. That was just closed. The Request For Proposals
16 was closed last August and it should be announced I think in
17 January, and some of those studies will be epidemiologic as
18 well. So, in a sense, there is a new generation of studies
19 coming along.
20 MS. NISHIMI: Right. So then the question is for
21 the purposes of the interim report, and we will not be able
22 to fully integrate that, is whether or not the committee is
23 comfortable with the way this finding is worded or whether
24 Joyce's point that perhaps what is -- whether or not what
25 exists now is sufficient for what reasonable expectations

1 might be, how's that?
2 CAPTAIN KNOX: Well, do we have to say anything at
3 this time or can we delay that?
4 MS. NISHIMI: That's something the committee can
5 determine also.
6 CHAIRPERSON LASHOF: We can decide.
7 CAPTAIN KNOX: I mean, I would rather be right
8 when I said it and then, you know, go ahead and delay it now
9 if we weren't sure about what the result would be.
10 CHAIRPERSON LASHOF: Well, I think if we -- Let's

11 put it this way: If we were convinced at this point that
12 the studies that are ongoing now would not do it and we had
13 identified some specific studies that needed to be done,
14 then we want to get them in the interim report. We don't
15 want to wait. If, at this point, we have not come to that
16 conclusion then I think we can say something about that the
17 current epidemiologic studies may or appear to -- I'm not

18 sure I know how I want it worded. I'm looking for help from
19 staff.
20 MS. NISHIMI: Well, I mean, if you're going to put
21 something to the effect that they may or may not, then I
22 would argue that such a finding isn't even necessary.
23 MR. BROWN: Well, there's an issue, too, of
24 expectation; what's reasonable to expect from these studies,
25 you know.

2 MR. BROWN: Should people be prepared to have the
3 answer when these studies are completed? and I think the
4 answer is probably no.
5 CHAIRPERSON LASHOF: On the other hand, we're now
6 prepared to say they're so inadequate you ought to be doing
7 something else now.
8 MR. BROWN: Yeah.
9 CHAIRPERSON LASHOF: So what we might want to say
10 is something to the effect that the current epidemiologic

11 studies seem appropriate at this point in time. They will
12 need to be followed to determine whether additional ones --
13 we will need results from these to determine whether
14 additional ones also be necessary. And you can put in
15 something, "We recognize that calls for further studies has
16 gone out and we will be looking and evaluating those."
17 Something to that effect.
18 MS. NISHIMI: Is that statement then essentially
19 saying that the committee is prepared to rule that all
20 current epidemiologic studies underway, because that's what
21 that captured in my --
22 CHAIRPERSON LASHOF: No. I think that's -- It
23 captured that all were good and should all be continued?
24 MS. NISHIMI: From what you just said, that's what
25 I my sense of it said.

1 CHAIRPERSON LASHOF: I don't want it to say that,
2 because we'll get to that in the next finding.
3 MS. NISHIMI: That's why I wanted to clarify that,
4 yeah.
6 DOCTOR BALDESCHWIELER: We're not really adding
7 much value here, are we?
8 CHAIRPERSON LASHOF: At this point are we adding
9 much?
11 CHAIRPERSON LASHOF: Well, I can attest that
12 they're -- A number of the studies are really excellent and,
13 you know, should go forward. And it's not clear, at least
14 in my mind, and, you know, correct me if staff feel
15 otherwise, that I could at this point say, "Here's this
16 study they haven't done and they better gosh darn do it." I
17 don't feel that way myself right now. But, I mean, there

18 are some studies they're doing that I think they shouldn't
19 be doing and I think that money could be better spent to
20 expand on certain studies they've got or save it for further
21 follow-up studies. We'll get to that point.
22 DOCTOR BALDESCHWIELER: Suppose we go back to
23 finding three. Is what you mean there, despite the unique
24 features of the Gulf War situation it should be possible in
25 principle --

2 DOCTOR BALDESCHWIELER: -- using epidemiological
3 approaches. Is that the meaning of that finding.
5 DOCTOR BALDESCHWIELER: Well, I think that's an
6 important --
7 CHAIRPERSON LASHOF: That's a good --
8 DOCTOR BALDESCHWIELER: And then in finding four
9 do we want to say that some but not all of the current
10 studies will have the power implied in finding three?
11 MS. NISHIMI: I think that's what you're trying to
12 say.
13 DOCTOR BALDESCHWIELER: Do we believe that, that
14 some of the studies are good enough to --
15 MR. BROWN: Maybe you can just say it's as good a
16 start as one can do under these difficult circumstances.

17 DOCTOR BALDESCHWIELER: Certainly the mortality
18 study from the VA, I thought, was simple but it had all the
19 power required, didn't it?
20 DOCTOR BECK: I think a lot of this judgment, in
21 my mind, hinges on the National Health Survey. That's the
22 one that really is the biggest to look at the general
23 population and see if there's a difference, and it's not
24 perfect. Of course nothing is perfect. Could it be
25 improved? Perhaps with more telephone instead of mail, for

1 example, to try to get around that problem of low response
2 rate which might be the fly in the ointment that makes it
3 hard to generalize from. But that horse might have left the
4 barn in that these surveys are being mailed out.
5 MS. NISHIMI: Have been.
6 DOCTOR BECK: Have been mailed out. So that's the
7 difficulties here. I think that that survey will provide
8 some information, some good information. Will we be able to
9 say absolutely? It remains to be seen what the response

10 rate is and what differences there are in the people who
11 respond and the people who don't respond.
12 MS. NISHIMI: I think the question really is --
13 for the committee is whether the committee feels that the
14 body of current epidemiologic studies minus, you know, one,
15 two, or three, whichever ones you may want to define, is
16 what one can reasonably expect will meet, as John said, the
17 power of finding three. I think it's as important to make a
18 positive finding that the government's efforts are moving
19 forward in a good faith and in a reasonable and more than
20 reasonable fashion as it is to criticize any efforts that
21 are also ongoing, and that's why I urge the committee to
22 make that kind of positive finding, if the committee is
23 possible.
24 MR. RIOS: Let me see if I understand. What
25 you're saying is that you're impressed with what's going on

1 right now but you're unprepared to say that that is
2 sufficient to make the finding in paragraph three?
3 CHAIRPERSON LASHOF: Yes. I think just because of
4 the nature of epidemiologic studies that you launch them
5 with the idea that certainly if the difference between the
6 control and the experimental group, or the group that you're
7 concerned about, is big enough you're going to get some
8 reasonable information. If it isn't -- In other words, a
9 positive study could come out of what they're going on now,
10 and that could be extremely helpful and may well give us
11 some of the answers we're looking for.
12 A negative study won't necessarily rule out that
13 there could still be some units, some groups, that had a
14 higher level because of some specific situations that have
15 not yet been looked into. But the initial body of studies
16 ought to give us some direction of future looking. And
17 whether we can say something to the effect that we believe
18 that the -- that a number of the current epidemiologic

19 studies underway should give us important information to
20 enable us to, if not to answer the question now, to point
21 the directions for future work. Something like that.
22 MR. BROWN: We've identified methodological
23 problems but we can't say that therefore they're not going
24 to tell us the answers.
25 CHAIRPERSON LASHOF: Yeah. I think saying,

1 "Despite some of the methodological difficulties that have
2 been identified that there are a number of studies that hold
3 promise -- hold a promise -- of giving us important
4 information later in our understanding." I mean, maybe
5 that's wishy-washy but that's pretty much where we're at.
6 MR. BROWN: That's pretty much it.
7 CHAIRPERSON LASHOF: Do other's feel better or
8 stronger?
9 MR. RIOS: The only concern that I have is while
10 we want to be positive in the sense that we feel that

11 they're doing -- that we're impressed with what they're
12 doing, I'm also concerned with being too optimistic in the
13 sense that prematurely they're going to -- their reaction's,
14 "Well, they say we're doing everything we can."
16 MR. BROWN: We found some criticisms in some of
17 their findings.
18 CHAIRPERSON LASHOF: Put those in. We can't get
19 it all in one finding and that's why I wanted this finding
20 worded enough so that we could be critical about some others
21 and talk about other things that need to be done.
22 MAJOR CROSS: Let me try this sentence on you just
23 to see if we have the right understanding here.
25 MAJOR CROSS: I would cross out "because of their

1 methodological difficulties," and begin, "Some of the
2 current epidemiological studies underway from DOD, VA, and
3 CDC should be sufficient to determine whether Gulf War
4 veterans are suffering for," let's not say "ever," "from

5 different outcomes than expected from appropriate control
6 groups." You can go either way. "However, some of the
7 current studies suffer from methodological problems."
8 MR. BROWN: I like it my way better. I say they
9 all have methodological problems.
10 MAJOR CROSS: Yeah. 1 1 MR. BROWN: But maybe in spite of those 1 2 methodological problems they'll be able to -- 1 3 MS. NISHIMI: There will be some results. 1 4 MR. BROWN: Anyway. 1 5 DOCTOR BALDESCHWIELER: But two things. It seems 1 6 to me one should not at this point not bias the outcome and 1 7 rather than say more adverse call it different health 1 8 outcomes. 1 9 MR. BROWN: Sure. 2 0 CHAIRPERSON LASHOF: You know, I'm not sure what 2 1 you mean by "different health outcomes." 2 2 DOCTOR BALDESCHWIELER: Different health outcomes 2 3 than expected from appropriate control groups. 2 4 CHAIRPERSON LASHOF: Come on, they're not going to 2 5 be healthier. I mean, what we're looking for is whether

188 1 they are sicker and they've had -- are suffering from some 2 illness and that their health -- maybe "outcome" is a bad 3 word. 4 MS. NISHIMI: Health status. 5 MR. BROWN: Healthy -- 6 DOCTOR BALDESCHWIELER: But, in fact, isn't that 7 the way the VA study came out, that -- at least in some 8 categories -- 9 MR. BROWN: They were actually healthier. 1 0 DOCTOR BALDESCHWIELER: -- veterans' groups that 1 1 had served in the Gulf were healthier. 1 2 CHAIRPERSON LASHOF: In terms of mortality, I 1 3 guess. But which one was it? You're right, which study was 1 4 that? Refresh my mind quickly. 1 5 MS. GWIN: It was the mortality study on -- 1 6 CHAIRPERSON LASHOF: It was a mortality study.

1 7 There was lower mortality, but that was a question not that 1 8 they had healthier outcomes, but a question of whether it 1 9 was a healthier population that went and -- 2 0 DOCTOR BALDESCHWIELER: But the control group was 2 1 reasonably selected I think in that case. Remember there 2 2 are more auto accidents but less, you know, other kinds of 2 3 infectious diseases and other things. 2 4 MS. NISHIMI: Perhaps, not to cut this discussion 2 5 short, I think that the staff probably can capture a sense

189 1 of where the committee is at. We can review the transcript 2 and we'll, you know, make another stab at it. Maybe we'll

3 make, you know, Version A, B, or C, and get it back to the 4 committee and then -- 5 DOCTOR KIDD-TAYLOR: Make a selection. 6 DOCTOR BALDESCHWIELER: Are we confident enough to 7 really critique some of the studies? 8 MS. NISHIMI: Well, I think that the staff has a 9 sense from the discussion. 1 0 CHAIRPERSON LASHOF: Oh, yeah. To critique some 1 1 of the studies, yeah, I think -- 1 2 DOCTOR BALDESCHWIELER: Are we that good to 1 3 provide a list of those that we think are good and those 1 4 that we think are -- 1 5 CHAIRPERSON LASHOF: That's the other question, 1 6 whether we want to do that, and let's discuss that in 1 7 relation to finding four -- five, which I think is a 1 8 recommendation not a finding. 1 9 If you look down at five, I think we need some 2 0 discussion of the fact that the Board is concerned about the 2 1 methodological issues -- some of the problems in the 2 2 methodological in a number of studies raised enough concern 2 3 that we felt they needed to be further reviewed and 2 4 assessed. See, it's a question -- I mean, I may personally 2 5 think from everything I heard and from some of the reviewers

190 1 that were there and what they told me, and some they told in 2 public and some they told me in private, that a few studies 3 ought to be just dropped because they really mislead. 4 They're going to be misleading and we should not be wasting 5 the money and we could use that money elsewhere. It's 6 whether we think it's the role of this committee to be that 7 specific about individual studies or to raise that as an 8 issue that we have concern that certain studies should be, 9 and then put into the recommendation that the -- I think 1 0 from my discussions, questions I put to Ken Kizer this 1 1 morning, or this afternoon, that the Research Working Group 1 2 ought to be reviewing all of those, reviewing those 1 3 critiques and bringing those to the attention, if not making 1 4 a decision themselves, then to the appropriate secretaries 1 5 of the three agencies, or something. I don't know how we 1 6 want to do that but that I think is the big issue we need to 1 7 discuss and come up with. 1 8 MR. BROWN: Well, Joyce, if I could just make a

1 9 quick comment. The thoughts behind finding fault wasn't so 2 0 much that we, staff or committee, would recommend cutting 2 1 any single project so much as that the process, the people 2 2 who have responsibility -- the organization, the body that 2 3 has responsibility for evaluating, say, external reviews and 2 4 making decisions about what research might be redirected, 2 5 where funds might be redirected, needs to be identified.

191 1 Not that we would necessarily take the -- 2 CHAIRPERSON LASHOF: Yeah. So I think the finding

3 might well be, because five is really a recommendation, and 4 the finding might be something to the effect that external 5 reviews of a number of studies have raised serious question 6 as to the validity, value, and have, indeed, suggested they 7 be dropped. You know, they can go back and look at which 8 studies themselves. That should be a finding. It doesn't 9 have to be us. It's, you know, everyone we heard from 1 0 DOCTOR CUSTIS: When you go that far aren't you 1 1 more or less obligated to specify which studies you're 1 2 talking about? 1 3 CHAIRPERSON LASHOF: We can. You know, what's 1 4 your philosophy? Do you want to specify in this report, 1 5 which becomes a public report, which studies, or do we want 1 6 to just say that certain studies, and then make a 1 7 recommendation that the oversight coordinating body should 1 8 have the primary responsibility for following the findings 1 9 or recommendations -- I like the way this is worded except 2 0 you lost me in the language at the end of it, but I think 2 1 you left out a phrase. 2 2 DOCTOR KIDD-TAYLOR: I prefer that we not make 2 3 comment on specific studies, but however that we refer to

2 4 the Coordinating Board and the scientific review committees. 2 5 That's my preference. That's why I like this statement,

192 1 too. 2 DOCTOR CUSTIS: I guess what I am saying is if you 3 don't want to specify the studies you think should be 4 dropped then perhaps you don't want to say there are studies 5 that should be dropped. 6 CHAIRPERSON LASHOF: I think what I was suggesting 7 we say is that there are external reviewers and scientific 8 reviewers have recommended that certain studies be dropped, 9 so that we're not recommending them and we're suggesting 1 0 that this board ought to review all the recommendations 1 1 they've gotten from external reviewers -- 1 2 MAJOR CROSS: With a view as to whether -- 1 3 CHAIRPERSON LASHOF: -- who have reviewed -- 1 4 MR. BROWN: Who exactly is the Gulf Veterans' 1 5 Coordinating Board? 1 6 CHAIRPERSON LASHOF: That's a group that --

1 7 MS. GWIN: It's the secretaries -- The board 1 8 itself is the Secretary of Defense, HHS, and VA, and they 1 9 have staff perform various working groups that report to 2 0 them. 2 1 DOCTOR BALDESCHWIELER: Ah-ah. So what you're 2 2 suggesting is that they be a group which acts as an 2 3 executive, in the sense of taking external recommendations 2 4 and then acting to -- 2 5 CHAIRPERSON LASHOF: Well, they have a Research

193 1 Working Group under it. We may want to suggest that the 2 research -- that a recommendation would be that the Research

3 Working Group of the Board review all external and bring to 4 the attention the -- to the attention of the controlling 5 board, which would be the secretaries, those recommendations 6 or analyses, or something. I mean, you know, what I kept 7 pushing Ken on this morning, and yet they're not VA studies 8 that I'm critical of, it's the DOD studies. But I think -- 9 I don't know, there may be some VA ones, too. 1 0 DOCTOR BALDESCHWIELER: Actual reviews being 1 1 carried out by whom? Are these peer reviews? 1 2 CHAIRPERSON LASHOF: Well, the Research Working 1 3 Group, I think, should be reviewing the reviews that they've 1 4 already had. They've had umpteen reviews but no one seems 1 5 to do anything with the information from those reviews. 1 6 They have reviews from the Army and that's what we need in 1 7 here, I think is a clear statement that the Army 1 8 Epidemiologic Board has reviewed studies. They've had 1 9 scientific review committees review some individual studies. 2 0 The defense -- whatever that board -- 2 1 MS. NISHIMI: There's VA, there's DOD. 2 2 CHAIRPERSON LASHOF: There are enough of them. I 2 3 can't remember them all. 2 4 DOCTOR BALDESCHWIELER: But it must be a very 2 5 mixed bag in terms of quality and independence and all of

194 1 the things one looks for in the review process. 2 CHAIRPERSON LASHOF: Yeah. 3 DOCTOR CUSTIS: I bet there's another factor, too. 4 A little bit of territoriality is getting in the way. 5 CHAIRPERSON LASHOF: Yes, that's been their big 6 problem is that the Research Working Group hasn't felt that 7 it's their business to go into this and that it's the 8 individual researchers to look at the reviews that are done. 9 And this is a critical issue, it seems to me, for us to 1 0 decide upon. 1 1 The individual researchers and the individual

1 2 departments have sort of said, "Well, we call on these 1 3 advisory groups. We have these scientific reviews. We'll 1 4 look at them. We'll respond, and we'll do whatever we think 1 5 is best and no one else should be telling us." Like none of 1 6 us would like to be told. On the other hand -- And that's 1 7 the way it's been going. 1 8 On the other hand, you have this coordinating

1 9 board that's supposedly overseeing the whole governmental 2 0 effort in research, and, although -- Maybe it doesn't do any 2 1 harm to have some studies go forward that there's a 2 2 consensus on that they're not going to be very helpful. I 2 3 mean, maybe that doesn't do any harm. Maybe you just let it 2 4 go because we respect the rights of individual researchers. 2 5 On the other hand, in something as complex as this where

195 1 money could be better spent elsewhere and where you do have 2 coordinating boards, it's supposed to be developing an 3 overall research plan and taking some responsibility for 4 being sure that we get the answers. 5 Isn't this different than if you got an NIH grant 6 and some other group came out and said, "God, why did they 7 ever give John that grant. I think it should be pulled," 8 you wouldn't want anybody pulling it. And, you know, that's 9 a worry. 1 0 DOCTOR BALDESCHWIELER: In the finding category,

1 1 isn't the finding then that there have been a variety of 1 2 reviews of ongoing studies of variable quality and as far as 1 3 we can tell there's been no action taken on the bulk of 1 4 these research -- 1 5 CHAIRPERSON LASHOF: Well, essentially there's no 1 6 action taken. Many of the researchers made efforts to

1 7 correct some of the things. The problem has been that 1 8 some -- on some of the studies, as far as I could tell, it 1 9 was consensus of the outside reviewers that the steps that 2 0 they took were probably as much as they could do but 2 1 wouldn't correct the problems enough to make the study 2 2 worthwhile. 2 3 DOCTOR BALDESCHWIELER: It sounds to me like 2 4 that's the language for a finding. 2 5 MR. BROWN: The way I put it is, if you're going

196 1 to submit an article to a journal and it was reviewed and 2 your reviewer didn't like it and you had -- and it was up to

3 you to answer what that reviewer said that didn't like your 4 article, if there was an editor there that didn't take any 5 role in that then you would probably just tell that 6 reviewer, you know, you disagree with him and that would be

7 the end of it. There's no editor here. There's nobody with 8 the authority to make a decision about, you know, whether 9 the response to the reviews have been adequate or not, for 1 0 instance. 1 1 DOCTOR BECK: Maybe the language of the finding is 1 2 on page seven, under finding four, the second sentence to 1 3 the end: "External scientific review has ranged from none 1 4 to plenty. It's beneficial to several studies, in some 1 5 cases it has not been followed." Just that observation. 1 6 DOCTOR BALDESCHWIELER: That sounds to me like a 1 7 good statement of the finding, and then the recommendation 1 8 that follows from that is that there should be -- 1 9 CHAIRPERSON LASHOF: Yeah. Yeah, I think that 2 0 could be the finding. That's an excellent statement. And 2 1 your next paragraph I also thought -- I had marked on my 2 2 thing was excellent. 2 3 DOCTOR BECK: Well, in that -- 2 4 CHAIRPERSON LASHOF: I mean, that's the 2 5 justification.

197 1 DOCTOR BECK: Exactly. 2 CHAIRPERSON LASHOF: That next paragraph you keep

3 in as the big text following on to that finding which then 4 leads to five becoming a recommendation. 5 DOCTOR BALDESCHWIELER: Is five the existing 6 research subcommittee of the Persian Gulf Coordinating Board 7 should act as an executive agent in responding to their -- 8 CHAIRPERSON LASHOF: Yeah. I think -- 9 DOCTOR BALDESCHWIELER: -- reviews. 1 0 CHAIRPERSON LASHOF: Yeah. I think the Research 1 1 Working Group either ought to be empowered to act or to 1 2 review and recommend to the Board that they act after 1 3 they've done this review. Does that seem logical? I just 1 4 lost Andrea. 1 5 MR. BROWN: She's been agreeable so far. 1 6 CHAIRPERSON LASHOF: The only problem I had down 1 7 the sentence, "If these draw into question the usefulness of 1 8 the study..." You can write better wording. I couldn't 1 9 read the words "If these draw questions to the 2 0 usefulness..." 2 1 MR. BROWN: Probably a slip on the word processor. 2 2 MS. NISHIMI: No doubt. We'll clean that up. 2 3 CHAIRPERSON LASHOF: I'm sure. I'm sure I don't 2 4 have to worry. 2 5 MS. NISHIMI: Is the committee comfortable with

198 1 then that being the recommendation, to play devil's 2 advocate, mindful of the fact that the position of the 3 Research Working Group and the coordinating board is that

4 their current procedure is to receive the critical comment 5 arguing that scientists criticize each other through peer 6 review all the time, and that the burden and responsibility 7 to respond to the criticism lays with the individual 8 investigator not with a government oversight body or a group 9 of government individuals, under the notion that this could 1 0 be viewed as, you know, government of "big brother" 1 1 interfering with what might otherwise be viewed as an 1 2 independent peer review process. 1 3 DOCTOR BALDESCHWIELER: I think Mark is on target 1 4 when he says this doesn't work without somebody adjudicating 1 5 it. 1 6 MS. NISHIMI: I just want to play the devil's 1 7 advocate and point out to the committee that this might be 1 8 the flip side of this recommendation and so that the 1 9 committee considers that in the context of the finding and 2 0 the recommendation that's now on the table. 2 1 CHAIRPERSON LASHOF: Well, you know, obviously I 2 2 think this is one of the most critical decisions we have to 2 3 make, frankly. And listening to -- and I'll push Steve 2 4 Joseph tomorrow and we may want to come back to this again 2 5 after we hear Doctor Joseph tomorrow. But when I was

199 1 pushing Doctor Kizer all he was saying was the Research 2 Working Group, you know, ought to be looking at this, at 3 least. And he said, "I would think that if they found that

4 they would let me know. And if you found studies that are 5 that back, you ought to let me know." Well, I think what 6 we're saying here then would be that the Research Working 7 Group ought to pay attention to this. They ought to review 8 it and they ought to inform the Board. They don't have the 9 power to pull the money, or pull the plug, but the 1 0 secretaries -- the defense do, just as I think if at your 1 1 university, like at the UC Irvine when a clinic gets out of 1 2 line and does things it shouldn't be doing their money gets 1 3 pulled. 1 4 MS. NISHIMI: No, actually I'm not -- I just 1 5 wanted to raise the issue just so that we've fully aired it

1 6 because I also concur that this is one of the most important 1 7 recommendations and findings related to the research in the 1 8 interim report. 1 9 DOCTOR BALDESCHWIELER: But it seems to me all the 2 0 usual channels prevail. If an editor or a program officer 2 1 decides the reviews are sufficiently weak that the program 2 2 shouldn't be funded he has the authority to stop the 2 3 program. On the other hand, the researcher has various 2 4 routes of appeal. 2 5 CHAIRPERSON LASHOF: That's right. And even if

200 1 their study's been started -- I mean, will a cancer study, 2 if they found something that wasn't right in it, or your on- 3 site reviewers come out and find things aren't going well, 4 they have they power to act. 5 MS. NISHIMI: I am not saying I disagree. I want 6 you to sharpen your thinking to make sure you're absolutely 7 comfortable with the words that you're putting forth. 8 DOCTOR BALDESCHWIELER: It seems to me that the 9 secretaries or deputy secretaries of Defense, and VA, and so 1 0 forth are not going to review individual grants. 1 1 MS. NISHIMI: Which is why it has to be reworked

1 2 to include the language about the working group, the general 1 3 notion about the working group. 1 4 DOCTOR BALDESCHWIELER: It's got to stop at a 1 5 place where -- 1 6 MS. NISHIMI: We're trying to make sure the 1 7 committee's comfortable with it, sure. Okay? 1 8 CHAIRPERSON LASHOF: Okay. 1 9 MS. NISHIMI: I think our staff has a good sense 2 0 of where we need to go with this one. 2 1 CHAIRPERSON LASHOF: Okay. All right. How are we 2 2 doing on time then? When do you want to quit, 4:30? 2 3 MS. NISHIMI: We have about five minutes. Maybe 2 4 we can do the one last finding, if you think, on six. 2 5 CHAIRPERSON LASHOF: Finding six and the three

201 1 recommendations. Maybe we can take a quick look at those 2 and not go into the further discussion on CDW this 3 afternoon. We'll do that tomorrow. 4 MS. NISHIMI: Right. If we could at least wrap up 5 the findings, certainly. 6 DOCTOR BALDESCHWIELER: On six, is it that the 7 studies are designed to detect large differences or is that 8 just a question of the numbers that -- 9 DOCTOR BECK: Yes. This isn't a methodological

1 0 flaw, it's just the way that the start out question is to 1 1 look at the big picture and see, you know, is there any

1 2 difference large enough to see with epidemiologic studies in 1 3 the overall picture of health of Gulf War veterans compared 1 4 to the controls. 1 5 DOCTOR BALDESCHWIELER: But is a question of 1 6 design or simply the number of subjects that are involved? 1 7 MR. BROWN: It's not a question of design. I 1 8 think it's a question of expectation, that these studies are 1 9 designed to find by their -- you know, it's just very much 2 0 more difficult to detect a very tiny difference in a 2 1 population than it is a big difference. These studies are 2 2 looking for larger effects, large health effects, and the 2 3 first order of business is to see are there any large health 2 4 effects in this population. 2 5 DOCTOR BALDESCHWIELER: That's usually the result

202 1 of the number of subjects in the study, isn't it? 2 CHAIRPERSON LASHOF: Right. 3 MR. BROWN: Yes. Yeah, the power of the study is 4 related to the size of the population being investigated,

5 but it has to do with the expectation, too, that there may 6 be -- if they turn out to be -- we're not going to pick 7 up -- there may be the expectation among some people looking 8 at these studies that this is going to tell us even if 9 there's a very small effect, a small population there

1 0 showing some health effects, and they won't. They're 1 1 looking at only large effects, potential large effects.

1 2 DOCTOR BECK: Well, this has to do right now with 1 3 the hypotheses that it's possible to test. Right now we 1 4 have this series of risk factors but no really good 1 5 hypotheses to test about particular subpopulations of the 1 6 people who were in the Gulf. So that right now the question 1 7 is, looking at everybody who was there, does there seem to 1 8 be an increase or a difference in the health effects that 1 9 they are experiencing. Perhaps once we have the locator 2 0 data, and again not to pin too many hopes on it, but 2 1 something like that might help generate hypotheses to look 2 2 at smaller populations, for example. Then you could go and 2 3 say, "Well, are seeing differences at the levels of the 2 4 units?" Does that make sense to you? Or, for example, if 2 5 research into differences in enzymes suggest that certain

203 1 types of people who have a certain type of enzyme are more 2 susceptible that would suggest a hypotheses that you could

3 test to try to look and see, well, how many folks have that 4 difference in enzymes and, therefore, can we look at those 5 people and see if they are experiencing different levels of 6 health effects. But, for right now, the question has to be

7 generalized over the entire population, "Are we seeing gross 8 differences in the rates or patterns of health effects?" 9 MR. BROWN: In other words, if 10,000 vets are 1 0 sick these studies might well pick it up. If it's 1,000 or 1 1 100 they certainly won't. 1 2 CHAIRPERSON LASHOF: The question I guess is 1 3 whether this -- certainly it shouldn't be the last finding. 1 4 It's badly placed in terms of what we've just discussed, I 1 5 think. I think -- and I'm wondering whether that is really 1 6 a finding or whether that's something that goes into the 1 7 discussion preceding findings three and four which talk 1 8 about how many studies we've got, and where we stand, and 1 9 that they are not going to answer all the questions, but 2 0 that this is a good first start and we'll go from there. I 2 1 think I'd rather see that buried in the text as one of the 2 2 issues that -- 2 3 MS. NISHIMI: As one of the issues that are not 2 4 addressed. That seems a reasonable approach. 2 5 DOCTOR BALDESCHWIELER: I would like to understand

204 1 what it is that we're trying to say. In effect, is it that 2 one is testing only a limited number of hypotheses? 3 DOCTOR BECK: Well, let's say that there are 100

4 people who were exposed to some agent and those people are 5 now sick as a result. These epidemiologic tests that are 6 going out and randomly sampled, in what should be a 7 representative population, may not even hit one of those 100 8 people. 9 DOCTOR BALDESCHWIELER: But you also won't find 1 0 something you're not looking for, in general, in such a 1 1 test. You have to ask the questions. 1 2 DOCTOR BECK: Right. 1 3 MR. BROWN: But the basic question is: Is this 1 4 population sicker than the control? 1 5 CHAIRPERSON LASHOF: I mean, the only question 1 6 we're really asking now is: Of all those people who went to 1 7 the Gulf, are they basically -- have they come back sicker 1 8 than all those who didn't go to the Gulf? 1 9 MR. BROWN: On average. 2 0 CHAIRPERSON LASHOF: On average. Overall. And 2 1 that's about all one can do as a first cut until you've had 2 2 some very specific hypotheses, which is why I think 2 3 toxicological data and the geographic locator data is 2 4 important information that may lead you to some specific 2 5 hypotheses that may -- you may decide, "Gee, we ought to

205 1 look at that 1,000 people that were at such and such a spot 2 where we know they took pyridostigmine for three months and 3 were exposed to DEET for the whole time, and maybe that 4 group is a unique group." I mean, I'm making up a 5 hypothesis just as an example, but it's premature. We don't 6 have that kind of data yet so I think, again, this is what 7 sort of goes into the general discussion that this first cut 8 of studies are designed to tell us across the board, among 9 all those sent over, are they less healthy than those who

1 0 stayed home. And, are the current studies going to tell us 1 1 that? We think the current studies will tell us that. We 1 2 think at the same time, as we're going to say under the 1 3 toxicological and the geographic locator, that further 1 4 information may lead us to some specific hypotheses that 1 5 you'll want to do some different studies to address those 1 6 specific hypotheses. Right now we don't have much in the 1 7 way of an hypothesis except you're sicker than when you went

1 8 for some reason, because you were exposed to umpteen things. 1 9 Is that clear? 2 0 MS. NISHIMI: I understand that. 2 1 CHAIRPERSON LASHOF: John, you follow me? You're 2 2 having trouble? 2 3 DOCTOR BALDESCHWIELER: I'm not quite clear. Is 2 4 this the difference between focused and unfocused -- 2 5 CHAIRPERSON LASHOF: That's right.

206 1 DOCTOR BALDESCHWIELER: -- studies? 2 CHAIRPERSON LASHOF: If we knew -- For instance, 3 if we had, and I'll take this, you know, should probably use 4 an outlandish example instead but I can't think of an

5 outlandish one. If we knew that a particular exposure 6 caused disease in a certain population and we wanted to find 7 out whether that exposure -- that's not a good example. How 8 do I explain this more clearly? 9 If you had a specific hypothesis of a specific 1 0 exposure and you wanted to find out does this exposure cause 1 1 disease, and you know -- and you wanted to find it at some 1 2 level, and you understand obviously the statistical power, 1 3 you could figure out who was the population who was exposed 1 4 to it and who wasn't exposed to it and you'd do a very 1 5 targeted study around those who were definitely exposed to 1 6 that particular item that you're looking at and compare it 1 7 to a group that you know weren't exposed to that particular 1 8 item. 1 9 DOCTOR KIDD-TAYLOR: Another example, I just want 2 0 to use an industrial setting like the steelworkers. 2 1 Initially we were looking at coke oven emissions and 2 2 exposure to benzene, the entire population, they said the 2 3 steelworkers were getting ill from, but no one knew the 2 4 exact exposure. And, then they looked specifically at 2 5 different departments in areas where steelworkers worked and

207 1 where there could be a possibility of exposure, and then 2 they looked at coke oven emissions and found that employees 3 who worked near coke ovens, and it also depended on where

4 they worked on the coke over, had a great risk of cancer 5 than others. So then you get more specific. 6 DOCTOR BALDESCHWIELER: But is the finding here 7 then that leads -- leads -- would lead us to more specific 8 focused studies are not yet available? 9 CHAIRPERSON LASHOF: That was the whole -- 1 0 DOCTOR BALDESCHWIELER: Is that what we believe? 1 1 CHAIRPERSON LASHOF: That would be the idea, that 1 2 you're doing the broad studies now. At the same time, we're 1 3 going to be doing toxicological studies, we're going to be 1 4 getting geographic information. Some of those may lead us 1 5 to some specific hypotheses that would enable us to do some 1 6 more focused studies. 1 7 DOCTOR KIDD-TAYLOR: Right now you're just looking 1 8 at the total picture. You're looking at everyone who went. 1 9 CHAIRPERSON LASHOF: Why don't we talk about it 2 0 over dinner? 2 1 DOCTOR BALDESCHWIELER: Do we really believe that, 2 2 is the question. 2 3 MS. NISHIMI: I don't think we're making a lot of 2 4 progress right now. Do you want to consider -- I mean, I 2 5 hate to break this up.

208 1 DOCTOR KIDD-TAYLOR: I think Joyce's suggestion 2 that this finding not be included as a finding but put into 3 the text of the epidemiological studies, that would be -- 4 MS. NISHIMI: Would that make you -- 5 DOCTOR BALDESCHWIELER: I would be comfortable 6 with that. 7 MS. NISHIMI: The staff -- yeah. 8 CHAIRPERSON LASHOF: I think everybody sort of 9 accepts that so I think that gets us there. 1 0 Do you want to try to finish the recommendations 1 1 or start with the recommendations first thing in the 1 2 morning? What do you want to do people? 1 3 Why don't we -- Yeah, I think we're getting pretty 1 4 exhausted. I think we've come to grips with one of the 1 5 toughest things we have to. We've come to grips with one of 1 6 the toughest recommendations. I think we could tomorrow 1 7 morning take a look at the last of these three 1 8 recommendations you've got that. 1 9 MS. NISHIMI: Last two findings. 2 0 CHAIRPERSON LASHOF: We've got the findings. 2 1 MS. NISHIMI: You have seven and eight on the last 2 2 page. 2 3 CHAIRPERSON LASHOF: Oh. Oh, that's right, we 2 4 have two more findings on seven and eight we need to 2 5 discuss. Okay.

209 1 MS. NISHIMI: And -- 2 CHAIRPERSON LASHOF: Yeah, and that will lead to 3 more discussion. I think we'd better call it quits for 4 tonight. 5 MS. NISHIMI: That's good. We can recess. Just a 6 housekeeping matter for the committee. You can leave your 7 books here and the staff will gather them up, make sure your 8 name's on it, and put it in place tomorrow. If you want to 9 take it obviously tonight to mull further over the words 1 0 just, please, feel free. 1 1 CHAIRPERSON LASHOF: Now, let's talk a little bit 1 2 about the agenda for tomorrow. We're going to start -- 1 3 MS. NISHIMI: 9:00 a.m. 1 4 CHAIRPERSON LASHOF: That's the first thing, we're 1 5 going to start at what hour. But then I want to clarify 1 6 where we are, just for my peace of mind, and see what I take 1 7 home with me to read yet tonight because there are a few 1 8 things I haven't gotten to yet. 1 9 Okay. Tomorrow morning we ought to start with 2 0 this discussion. Finish up these findings. Then we're 2 1 going to hear from you, Holly, on a briefing on where we 2 2 stand on looking at biological and chemical warfare, 2 3 correct? 2 4 MS. GWIN: Correct. Except Doctor Joseph will be 2 5 here at 10:15 so it depends on how far we get.

210 1 CHAIRPERSON LASHOF: If we finish up this 2 discussion in a half hour. 3 MS. NISHIMI: The committee can consider starting

4 at 8:30, since the committee is here. It might not be a bad 5 idea. 6 CHAIRPERSON LASHOF: Yeah, considering everything 7 we have to do. Although I think these have been tougher, 8 but you all have a sense about the rest of these. We've got 9 a lot to go through before we adjourn tomorrow. 1 0 MS. GWIN: We have a similar exercise on each of 1 1 the tabs. 1 2 CHAIRPERSON LASHOF: Pardon? 1 3 MS. GWIN: We have a similar exercise on -- 1 4 CHAIRPERSON LASHOF: Exercise on each tab, and if 1 5 we get into this long a discussion on each one -- what do 1 6 you think about starting at 8:30, people? 1 7 Okay. We'll start at 8:30, see how far we can get 1 8 before Steve comes, then we'll hear from him. 1 9 MS. NISHIMI: We're under similar time constraints 2 0 with Doctor Joseph. We have a window with which to discuss 2 1 with him and then we'll return to business, okay? 2 2 CHAIRPERSON LASHOF: And let me ask this, what 2 3 time do people have planes? Does anybody have to leave 2 4 before 4:30 tomorrow? 2 5 DOCTOR KIDD-TAYLOR: I do.

211 1 DOCTOR CUSTIS: My flight is at 4:30 2 CHAIRPERSON LASHOF: Shall we start at 8:00? 3 MS. NISHIMI: We can start at 8:00, yes. 4 CHAIRPERSON LASHOF: Anybody willing to start at 5 8:00? 6 Okay, let's start at 8:00. We've got a lot of 7 work to do people. 8 (Whereupon, the above-entitled matter was recessed 9 to reconvene at 8:00 a.m. the following day, Tuesday, 1 0 December 4th, 1995.) 1 1